International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Development and Validation of Stability Indicating HPTLC Method for Estimation of Salmeterol Xinafoate
Damle M, Choudhari S
A simple, rapid validated stability indicating HPTLC method for estimation of Salmeterol xinafoate was successfully developed. This method is based on HPTLC separation followed by UV detection at 252 nm. The separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 using Chloroform: Methanol: Ammonia (7:3:0.5 v/v/v) as a mobile phase and scanning was done by using TLC Scanner III. Salmeterol xinafoate gave well defined and sharp peak at Rf 0.52 ± 0.05 at 252 nm. Calibration curve was linear in range 1000-3000 ng/band for Salmeterol xinafoate. Stress degradation study includes hydrolysis under different pH, oxidation, thermal and photolytic conditions. The suitability of this HPTLC method for quantitative estimation of Salmeterol xinafoate was proved by validation in accordance with requirements of ICH guidelines Q2A (R1).

2. Validated Spectrophotometric Determination of Rizatriptan Benzoate in Pharmaceutical Formulations using Alizarin Derivatives
El Sheikh R, Hassan W S, Gouda A A, Al Owairdhi A, Al Hassani K K H
Two simple, sensitive, accurate, precise and economical spectrophotometric methods have been developed and validated for the determination of rizatriptan benzoate (RZT) in pure form and pharmaceutical formulations. These methods were based on the formation of charge transfer complex between RZT as n-electron donor and alizarin red S (ARS) or quinalizarin (Quinz) as π-acceptor in methanol to form highly colored chromogens which showed an absorption maximum at 532 and 574 nm using ARS and Quinz, respectively. The optimization of the reaction conditions such as the type of solvent, reagent concentration and reaction time were investigated. Under the optimum conditions, Beer’s law is obeyed in the concentration ranges 1.0-16 and 2.0-20 mg mL-1 using ARS and Quinz, respectively with good correlation coefficient (r2 ≥ 0.9996) and with a relative standard deviation (RSD% ≤ 1.16). The molar absorptivity, Sandell sensitivity, detection and quantification limits were also calculated. The methods were successfully applied to the determination of RZT in its pharmaceutical formulations and the validity assesses by applying the standard addition technique. Results obtained by the proposed methods for the pure RZT and commercial tablets agreed well with those obtained by the reported method.

3. Report on Antidiabetic, Diuretic and Analgesic Activities of Methanolic Extract of Leaves of Strychnos colubrina Endangered Medicinal Plant
Indira Priyadarsini A, S K M Basha, Chakrapani I S, Nagalakshmi Devamma M
Strychnos colubrina L. belongs to family Loganiaceae was known as snake wood tree.The methanolic extracts from Strychnos colubrina L. leave collected from different provinces in Penchalakona of Nellore district were prepared by decoction and maceration with methanol and evaluated for their antidiabetic, diuretic and analgesic activities. Methanolic extracts from Strychnos colubrina L. leaves (SCM) were evaluated for anti diabetic effect in Streptozocin (STZ) induced diabetes in rats. The blood sugar levels were analysed as indices of diabetes. 200 mg/kg b.w. of the extract showed a greater reduction in blood glucose level which was comparable to glibenclamide. To find out diuretic efficacy, SCM of leaves were administered to experimental rats orally at doses of 100 and 200 mg/kg and compared with Furosemide (20 mg/kg,o.p) as the standard. The rats treated with SCM of leaves in a dose of 200 mg/kg shown near similar urine output and electrolytes excretion when compared to the respective control. The analgesic activity of SCM of leaves is estimated using tail flick in mice. Results demonstrated that SCM of leaves exhibited a potent dose-dependent analgesic activity in all tested models for analgesia. This report could be used for medicinal and pharmaceutical exploration in the future.

4. Development of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Amlodipine and Olmesartan in Pure and Pharmaceutical Dosage Form
Dhiraj Kumar, Sushant Kumar Panda, Sudhir Kumar Sahoo
A simple reverse phase HPLC method was developed for the simultaneous estimation of Amlodipine and Olmesartan in bulk and tablet form. Chromatography was performed by isocratic reverse phase separation on a stainless steel column 4.6 x 150mm, symmetry column packed with octa decyl silane bonded to porous silica (C18) with particle size 5 micron with mobile phase containing TEA Buffer of pH 3.0 and Acetonitrile in proportion of 25:75 respectively. The flow rate was 1.0 ml/ min and effluent was monitored at 258 nm. The retention times were 2.39 min and 3.33 min respectively. The standard curve was linear over a working range of 05–35 µg/ml for both Amlodipine and Olmesartan and gave an average correlation coefficient of 0.999, and 0.999 for Amlodipine and Olmesartan respectively. The limit of quantitation (LOQ) of this method was 2µg/ml for Amlodipine and Olmesartan. The absolute recovery was 100% for Amlodipine and 100.3 for Olmesartan. Degradation products produced as a result of stress studies did not interfere with the detection of Amlodipine and Olmesartan and the assay can thus be considered stability-indicating.

5. Pharmacokinetic and Pharmacodynamic Modelling in Paediatric Bone Marrow Transplantation
Elham Alshammari
Building pharmacokinetics and pharmacodynamics models that describe the relationship between drug concentration and its clinical response in different disease conditions and age groups should be emphasized. This review aims to explore modelling in case of bone marrow transplantation staring from bone marrow and immune system, transplantation process, immune reconstitution and graft versus host disease, the difference in case of children, to handling of data that arise from patients.

6. Synthesis, Spectral and Antimicrobial Investigation of 2-(Naphthalene-l-ylamino)-2- Phenylacetonitrile and 1, 10-Phenanthroline with Five Divalent Transition Metal Ions
Mohammed Al-Amery, Ashraf Saad Rasheed, Dina A Najeeb
Five new mixed ligand metal complexes have been synthesized by the reaction of divalent transition metal ions (Hg, Ni, Zn, Cu and Cd) with 2-(naphthalen-l-ylamino)-2-phenylacetonitrile (L1) and 1,10-phenanthroline (L2). The coordination likelihood of the two ligands toward metal ions has been suggested in the light of elemental analysis, UV-Vis spectra, FTIR, 1H-NMR, flam atomic absorption, molar conductance and magnetic studies. Results data suggest that the octahedral geometry for all the prepared complexes. Antibacterial examination of synthesized complexes in vitro was performed against four bacterias. Firstly, Gram-negative bacteria namely, Pseudomonas aerugin and Escherichia. Secondly, Gram-positive bacteria namely, Bacillus subtilis, Staphylococcuaurouss. Results data exhibit that the synthesized complexes exhibited more biological activity than tetracycline pharmaceutical.

7. Isolation and Molecular Diagnosis of Leishmania major and Study Activity of Aqueous Extract of Plant Nigella sativa Against the Parasite In Vitro
Enas Abdul Kareem Jabbar, Bassad A. AL-Aboody, Basim Abdulhussein Jarullah, Nada Noori
The current study included isolating and diagnosing the cutaneous leishmaniasis parasite from patients with Baghdad boil and the reviewers of Al Hussein Teaching  Hospital in Thi-Qar province for the period from November to December 2016 and then studying the effect of aqueous extract of the plant  Nigella sativa  in the vitality of isolated parasite in vitro. Through the results, the isolated parasite was diagnosed depend on lesions appearance and characterization then confirm the diagnosis by KDNA- PCR which revealed that leishmania spp. was Leishmania major  . In this study three different concentrations from aqueous extract of the Nigella sativa plant were used (50, 100 and 150  mg / ml), the parasite growing in  NNN medium (3 replicates used)It was observed that the percentage of parasite destruction increased with prolong  exposure time of the extract and increased concentration of the extract, results also exhibited that the percentage of the destruction was 100% after four hours of exposure to the concentration of 150 mg / ml which was the highly killed percentage compared to control, which was 5. 98%.

8. The Safety and Efficacy of Mupirocin Topical Spray for Burn Wound Healing in A Rat Model
Sritharadol Rutthapol, Chunhachaichana Charisopon, Kumlungmak Sukanjana, Buatong Wilaiporn, Dechraksa Janwit, Suwandecha Tan, Sriwiriyajan Somchai, Nopparat Jongdee, Srichana Teerapol
This study evaluated the effect of mupirocin topical spray on burn wound healing in a rat model. Fifteen male Sprague Dawley rats were used to create full-thickness burns on the rat dorsum using a cylindrical stainless steel rod. The rats were topically treated with normal saline solution (NSS), mupirocin spray, ointment, and solution. The wound size and morphological evaluation were investigated by photographs and clinical criterions for wound healing. The histology was observed by hematoxylin and eosin (H&E) staining assay. The immunohistochemical study was evaluated by detection of transforming growth factor-beta 1 (TGF-β1), and the ratio of matrix metalloproteinase-9 to the tissue inhibitor of matrix metalloproteinase-1 (MMP-9/TIMP-1) was quantified using the enzyme-linked immunosorbent assay (ELISA) assay. A complete healing was observed at 28 days in all treatments. Mupirocin formulations accelerated the wound healing faster than NSS in size. However, the clinical criteria indicated a desirable skin appearance in the mupirocin spray and ointment treated groups. The histological evaluations showed no differences between the treatments while the immunohistochemical study revealed that all treatments reduced the level of TGF-β1 over time, particularly on day 28 in the mupirocin spray and ointment treated groups. The MMP-9/TIMP-1 ratio was significantly lower in the mupirocin spray and ointment treated groups than in the NSS and mupirocin solution groups. This study shows the safety and efficacy in the use of mupirocin topical spray. The topical mupirocin spray is an alternative suitable for development as a human topical anti-infective and wound protection spray.

9. Phenolic and Flavonoids Analysis of Pomegranate Peel Extracts and their Antiniflammatory and Antioxidant Activities
Qabaha K, Al-Rimawi F, Nusseibeh S, Abbadi J, Abu-Lafi S
An in-vitro evaluation of the anti-inflammatory and antioxidant activities of pomegranate peel extract from Palestine were investigated. In parallel, the total phenolic content (TPC) and the total flavonoids content (TFC) were measured. The antioxidant activities were determined spectrophotometrically by DPPH, FRAP, CUPRAC and the ABTS methods. The phenolic and flavonoid contents were separated and partially identified using HPLC and LC-MS. In-vitro inhibitory effect of the extract on production of Interlukin-6 (Il-6) and Tumor Necrosis Factor-α (TNF-α) by Lipopolysacaride (LPS)-induced polymorphonuclear Cells (PMNCs) was evaluated. Pomegranate peel extract was found to have strong antiinflamatory activity as revealed by the reduction in the levels of IL-6 and TNF-alfa. It was also found that it is rich in phenoloic and flavonoids that enhanced its reducing activity and free radical scavenging ability.

10. Age of Menarche in Females of Al-Ramadi City/Iraq
Rafal Mustafa Murshid
Aim of the study: Estimate the age of menarche in females of Al-Ramadi city/Iraq. Methodology: This is a retrospective descriptive cross sectional study carried out in Al Ramadi city from the 1stof March to the 1st of May 2017. Data were collected from 404 secondary school girls selected randomly from different secondary schools according to the population density of Ramadi city areas. Age of menarche divided in to early menarche (8-<11 years age), normal menarche (11-14 years), and late menarche (14-16 years). Questionnaire was filled by the family and included female’s age, age of onset of her menarche, father and mother’s job, education, residency, economic, psychological status and the level of stress the family during onset of menarche. Results: The age range of the studied females was 12 to 18 years. Their mean age of menarche was 13.25 years. About 89% of the respondents were found to be within normal age of menarche, 10.3% of late menarche, and 0.5% had early menarche. The most frequent age of starting menarche was at 13 years (39.1%) followed by 14 years. Normal age menarche was found to be more prevalent among urban dwellers, females of house wife mothers, employed fathers, educated parents, living in their owned houses, and of less life stress. Conclusion: The mean age of menarche in Ramadi city was 13.25 and was higher than age recorded in Baghdad and consistent with ages recoded in many other neighboring and far countries.

11. Incidence of Multiple Myeloma in Iraqi People
Farhan A Risan
Multiple myeloma patients were carried out the period (October/2017-February/2018), for measurement the concentrations of IgM, IgM & IgG antibodies, types of light chains (kappa & Lambda) alpha-1,2 and gamma as well as albumin & protein levels in the sera of 47 (25 males & 22 females) patients compared with 29 healthy humans as control group. The diagnosis of patients were done by immunofixation technique.The positive titer of immunoglobulins showed 2(2.6%) IgM ,6(7.6%) IgA &33(43.4%) IgG, while 6(7.8%) was negative titer. The light chains Kappa 22(28.9%), Lambda 20(26.3%), while 5(6.6%) negative, it was noticeable changes among patients and healthy group. The alpha-1 in patients 19(25%), alpha-2 14(18.5%), beta 9 (11.8%), gamma 37(48.7%) were abnormal in patients of multiple myeloma (observed changes). Abnormal concentration of albumin and protein in the multiple myeloma patients showed 28(36.8%),18(23.6%) respectively also highly observed changes within patients and healthy group.

12. Sidrophore Production and Phosphate Solubilization by Bacillus cereus and Pseudomonas fluorescens Isolated from Iraqi Soils and Soil Characterization
Zaid Raad Abbas, Aqeel Mohammed Majeed Al-Ezee, Sawsan H Authman
This study was conducted to explore the ability of Pseudomonas fluorescens & Bacillus cereus to solubilizing a phosphate in soil for enhancing the planting growth &, its relation with soill characterization. The isolates were identified as P.fluorescens and B. cereus using convential analysis and, its phosphate solubilization ability and sidrophore was shown by the clear zone formation on National Botanical Research Institute’s Phosphate medium. Moreover, Pseudomonas fluorescens isolates (n = 9) and three of B. cereus isolated from agricultural area in Baghdad university, Mustansiriyah university and Diyala bridge. Results displayed that bacterial count were varied in soil samples according to their region,,and ranging from 30 to 60 *10 2 CFU/g in Baghdad university soil to 10—20 *10 2 CFU/g in Mustansiriyah university soil ,.,the  Baghdad  soil macronutrient which included: NH4 , NO3 ,P,and K  were .,  8.42 ,  20.53 , 19.09      218.73  respectively, While the physio analysis revealed that the mean of pH was 7.3 and EC was 8.63. on the other hand the micronutrient analysis indicated that the soil samples were included Ca ,Fe ,Mn ,Zn and Cu which gave their mean 5025.9  ,  8.9,  4.9,  0.5   and 1.5 respectevily. Results revealed that all isolated bacteria (9 isolates of P.fluorescens  and three isolates of B. cereus gave ahalo zone which mean their ability to be phosphate solubilizing bacteria at 100%. Results revealed that all isolated bacteria  were detected a ability to produce high levels from chelating agents(( siderophores)) by P.fluorescens  &. B cereus at 100%,when appeared ahalo clear zone. Furthermore, the high levels of phosphate solubilization and siderophore production were grouped in bacterial species isolated from Iraqi soils. might be attributed to many soil factors such as soil nutrient status, soil acidity, water content, organic matter and soil enzyme activities.

13. Study the Level of Certain Biochemical Parameters in Iraqi Patients with Thyroid Disorder
Shatha H Jwaid, Ahmed G Sabbar, Amani M Touma
Aim: This study aimed to evaluate changes in serum levels of some elements (phosphorus   and chloride ions) and relationship with hypothyroidism, hyperthyroidism; and euthyroidism as a control groups. Method: Analysis of serum phosphorus and chloride were done by enzymatic methods using AGAPPE  kit. Result: Patients with hyperthyroidism and hypothyroidism showed highly significant increase in serum phosphorus levels (p<0.001). In case of hypo- and hyperthyroidism significant difference could not be obtained among euthyroidism and patients (p>0.05) in chloride level. While a positive correlation with thyroid stimulating hormone (TSH), serum phosphorous and chloride in case of hypothyroidism.  In hyperthyroid patients, the correlation was negative for phosphorous and positive for chloride, also none of correlations were statistically significant (p>0.05).  Conclusion: Thyroid patients should be regularly checked for serum electrolytes. Early discovery and management can prevent the further complications and will be useful during the controlling of thyroid patients.

14. Isolation of Lytic Acinetobacter baumannii Phage vB_Acib_C_A10 from Iraq pond waters and Comparing Its Antibacterial Effect with Cefotaxime Antibiotic
Zahraa Falah Azeez, Wathiq Abbas Hatite Al-Daraghi
Bacteriophages are viruses that attack bacteria and lead to their lysis in an efficient and highly specific manner. These phages could be an ideal option for microbial control. These natural enemies of bacteria were used as therapeutic agents before the advent of antibiotics. Currently, with the rapid spread of multidrug resistant bacteria, phage therapy can be an effective alternative treatment for antibiotic resistant bacteria. This study evaluated the effectiveness of bacteriophages in removing Cefotaxime-resistant clinical Acinetobacter baumannii strains (CTX_RAB) in vitro. Our A. baumannii strains were isolated and identified by standard and genetic methods. The antibiogram resistant was ascertained using phenotypic and genotypic method for cefotaxime antibiotics. The bacteriophages were isolated from environmental water samples. They were exposed to the host bacteria by the double-layer agar technique (DLA) to observe plaques. Cross reaction of the phages on test A.baumannii strains was performed to determine broader-spectrum phages. We successfully isolated Bacteriophage vB_Acib_C_A10 (ф Acib_A10) active against clinical strains of CTX_RAB by enrichichment from activated pond water samlies using representatives of those strains.  Purified bacteriophage suspensions obtained were tested on a range of clinical isolates that included representatives of multiple strains of each of the international clonal lineages, as well as minor and sporadic strains. An effective bacteriophage was isolated for each strain. Examination by transmission electron microscopy revealed bacteriophage of the Corticoviridae family. The cross-reaction showed phages which affect more than six A.baumannii strains. They can be a good choice for clinical therapeutic use. Conclusions: According to the results, six strains were resistant to all concentration of cefotaxime antibiotics. However, for each of these resistant bacteria one bacteriophage was isolated from environmental samples, which showed the effectiveness of Effective bacteriophages to remove clinically resistant A. baumannii in vitro.

15. Optimized Conditions for Pharmaceuticals and Personal Care Products Removal by Ozonation Using Response Surface Methodology
Hind M Ewadh, Siti Rozaimah Sheikh Abdullah, Hassimi Abu Hasan, Nurina Anwar
This study investigated the optimum conditions for the total pharmaceutical and personal care products (PPCPs) removal from PPCPs-contaminated tap water using ozonation treatment. The optimum conditions for maximum PPCPs removal were determined through a Box-Behnken Design (BBD). Three operational variables, i.e. PPCPs concentration (1-600 µg/L, retention time15-30 min and pH 6-9 units) were investigated by setting PPCPs removal concentration as the maximum. The optimum conditions were selected with the highest desirability of 0.967 using the maximum concentration of PPCPs and highest removal of PPCPs from the water (95-100 %) with the minimum retention time for 15 min and the pH was set at pH 8.9. From a validation test of the optimum conditions, it was found that the maximum PPCPs removal from contaminated tap water was closely to the predicted ones with less than 5% error for all the four compounds which give an evidence that ozonation is a good technique to remove PPCPs from water stream.

16. Validations of Prognostic Scoring Systems in Iraqi Patients with Chronic Myeloid Leukemia. in Single Center
Hussein Saeed AL-mafragy, Hiyame Abdul Ridha AL-Awade
Chronic myeloid leukemia and known as chronic myelogenous leukemia (CML) is one of the indolent myeloproliferative neoplasms. It is characterized by the presence of the Philadelphia chromosome, a translocation between chromosomes 9 and 22 or BCR‑ABL1 gene. Consistency in prognostic scores used to estimate the risk group of CML patients before therapy commencement can increase clinician trust in the treatment decision and play important role in modern medicine for CML changing treatment modalities. Inconsistency in prognostic scores occurs where two different risk categories are applied to the same chronic myeloid leukemia (CML) patient. The aims of this study were to validate the effectiveness of Sokal, Euro, EUTOS and ELTS scoring systems in predicting the outcome in Iraqi CML-chronic phase (CML-CP) patients treated with Tyrosine kinase inhibitors (TKIs) in Karbala city in Iraq and evaluate characteristics of CML patients and their molecular response. Seventy‑one patients with CML were recruited in this retrospective and prospective study from April 2017 to March 2018, the Center of Oncology for Hematology of Al-Hussein Medical City in Karbala, Iraq. They were evaluated from clinical point of view and their laboratory data, and molecular responses to TKIs based on polymerase chain reaction were analyzed. The median age of participants was 43 years; the male: female ratio was 1.03:1. In low risk category were 44, 41, 64, and 46 from 71 patients of them Sokal; Euro; EUTOS; ELTS scores respectively. In intermediate risk were 15, 22, 17 of 71 patient of them Sokal; Euro; ELTS scores respectively, and in high risk were 12, 8, 7, 8 from 71 patients of them Sokal; Euro; EUTOS; ELTS scores respectively. Follow- up of 30 patients who newly diagnosis was completed treated with TKIs in 3 & 6 months, 20 (66.7%) versus 28 (93.3%) achieved complete hematological response (CHR), while 9 (30%) versus 1(3.3%) were non CHR (xCHR), and 1 (3.3%) was (CCyR or MMR). In the current study, CML patients were at a younger age of onset, scoring systems are the most reliable clinical prognostic method evaluating CML patients indicates. That Sokal, Euro, EUTOS and ELTS scoring systems are effective in predicting early treatment response.

17. The Role of Vitamin B6 in Reducing Serum Prolactin in Comparison to Cabergoline
Suha J Witwit
Hyperprolactinemia is a common endocrine disorder of hypothalamic-pituitary axis. It affect about 4-17% of women in reproductive age & about 3-10% of patients with polycystic ovaries. Vitamin B6 is an effective prolactin inhibitor that is extremely cheap and exerts hypothalamic dopaminergic effect which causes a significant reduction in prolactin level. The aim of the study is To evaluate the effectiveness of vitamin B6 in reducing serum prolactin in Hyperprolactinemic  patient. Compare this effect to that of cabergoline.

18. Interictal Electroencephalogram Changes in Patients with Seizure Disorder in Al-Basrah General Hospital
Suroor Mohamed Dahiam, Farah Nabil Abbas, Ahmed Abdaljawad Salim
The epilepsy is a chronic neurological disorder characterized by recurrent spontaneous seizure, accompanied by neurophysiological, cognitive, psychological and behavioral changes. It is one of the most common neurological disorders in the world that impacts about fifty million of the population globally in all age groups comprising .The aim of  this study was to establish the EEG sensitivity in the diagnosis and identify different changes in different seizure disorder in Al-Basrah city. Assistance in define specific epilepsy syndrome which can support our health care services to provide a proper management in our providence. This study was a case-control study dealing with a total of 220 (male and female) subjects, 110 of them as the group presented with unprovoked seizure and the other 110 considered as a control group done during the period from February  2017 to September  2017.  EEG was performed for 20 minutes duration and activation procedures were done. The result of this study shows the normal EEG in 41 of cases while the abnormal finding in 69 patients, interictal epileptiform discharges represented by 34.5% focal changes and 28.2% generalized changes. The results showed a sensitivity of 62.7% and a specificity of 100%. The epileptic patients had a positive family history of epilepsy. Time of last seizure to EEG performed was a significant factor to detect epileptic discharge. Used within first days from seizure time to promote detection of EEG abnormalities. Epileptic discharges noticed mainly in children and adolescent with male predominantly in our province.

19. Simultaneous Antibacterial and Antibiofilm Activities of three Types of Silver Nanoparticles against Human Bacterial Pathogens.
Suhad Hadi Mohammed, Maysaa Saleh Mahdi, Abbas Matrood Bashi, Mohanad Mohsin Ahmed
Emergence of antibiotic resistant bacteria result in an approximately 550,000 deaths from bacterial infections annually. Several studies reported interesting antibacterial and anti-biofilm activities of silver nanoparticles synthesized by different physical, chemical and biological methods as an alternative to antibiotics. However, the resultant nanoparticles were varying in size, shape, and had different antibacterial and antibiofilm activities with different concentrations. Moreover, previous studies had investigated the antibacterial and antibiofilm activities in separate protocols and didn’t investigate the real-time or dual effect of silver nanoparticles on both planktonic and sessile cells within single protocol. This study aimed to synthesize silver nanoparticles through three methods and analyzing the simultaneous antibacterial and antibiofilm activities against planktonic and sessile bacterial cells. Three methods were applied to analyze silver nanoparticles and used to investigate the dual effect against bacterial biomass and biofilm formation. The results showed that synthesized silver nanoparticles cause significant inhibition to bacterial cell biomass and bacterial biofilm formation when compared with controls at low concentration. Significant Higher antibiofilm activity than antibacterial activity was observed at very low concentration (0.0125 µg/ ml). The antibacterial and antibiofilm activity do not differ according to the type of bacteria. Whereas, the antibacterial effect differs significantly according to the methods of silver nanoparticles synthesis.

20. Epidemiological Study of Cryptosporidium Infection in Al-Najaf City
Raad Ajam Sayal
This study was aimed to investigate the infection caused by the parasite Cryptosporidium for patients complained from diarrhea and abdominal discomfort in Najaf city during the period from November 2017 to March 2018. Fifty stool samples were collected from patients their age ranging from 1-60 years obtained from Al-Sader Medical City, Al-Hakeem hospital, Al-Furat Al-Awsat Hospital and Al-Zahraa hospital. Diagnosis of the parasite was done by using Modified Kinyoun Acid-Fast stain (cold method).The total percentage of positive result was 58% .There was no significant difference (P>0.5) between male and female infection 16 (55.2%) and 13(44.8%) respectively, also high infection rate was recorded among ages between 1-10 years 11(22%) with significance difference (P<0.5). The highest rates of infection in this study were 7(24.1%) in March and lower rate of infection was in January 4(13.8%).

21. Use Powder of Earthworm to Increase Growth and Spores Numbers of Two Species of Fungi (Aspergillus niger & Pencillium expansum)
Nebrass Falih, Zaid Naji Hassan, Moayad Salih Hussein
The present study prepars various concentrations  of dried earthworm powder from ( 200 – 250 – 300 – 350 – 400 – 450 – 500) mg / ml used to increase the growth of Aspergillus niger&Pencillium expansum and the spore number , the result show the growth of A.niger and the spore number more than P. expansumin all concentrations along the period of experiment and analysis show differences significant ( p˂ 0.05 ) among the different concentrations of earthworm powder.

22. Cloning and Expression of Recombinant Human Insulin Gene in Pichia pastoris
Rafid A Abdulkareem
The main goal of the current study was cloning and expression of the human insulin gene in Pichia pastoris expression system, using genetic engineering techniques and its treatment application. Total RNA was purified from fresh normal human pancreatic tissue. RNA of good quality was chosen to obtain a first single strand cDNA. Human preproinsulin gene was amplified from cDNA strand, by using two sets of specific primers contain EcoR1 and Notl restriction sites. The amplified preproinsulin gene fragment was double digested with EcoRI and Not 1 restriction enzymes, then inserted into pPIC9K expression vector. The new pPIC9K-hpi constructive expression vector was transformed by the heat-shock method into the E.coli DH5α competent cells.  pPic9k –hpi, which was propagated in the positive transformant E. coli cells, was isolated from cells and then linearised by restriction enzyme SalI, then transformed into Pichia pastoris GS115 using electroporation method. Genomic DNA of His+ transformants cell was extracted and used as a template for PCR analysis. The results showed, that the pPic9k – hpi was successfully integrated into the P. pastoris genome, for selected His+ transformants clones on the anticipated band at 330 bp, which is corresponded to the theoretical molecular size of the human insulin gene. To follow the insulin expression in transformans, Tricine–SDS gel electrophoresis and Western blot analysis were conducted. The results showed a successful expression of recombinant protein was detected by the presence of a single major band with about (5.8 KDa) on the gel. These bands correspond well with the size of human insulin with the theoretical molecular weight (5.8 KDa).

23. Effect of Turmeric & Ginger on Lipid Profile in Male Rats Exposed to Oxidative Stress
Eman A Al-Rekabi, Dheyaa K Alomer, Rana Talib Al-Muswie, Khalid G Al-Fartosi
The present study aimed to investigate the effect of turmeric & ginger on lipid profile of male rats exposed to oxidative stress induced by hydrogen peroxide H2O2 at a concentration of 1% given with consumed drinking water to male rats. Methods: 200 mg/kg from turmeric & ginger were used, and the animals were treatment for 30 days. Results: the results showed a significant increase in cholesterol, triglycerides, low density lipoprotein (LDL), very low density lipoprotein (VLDL), whereas it explained a significant decrease in high density lipoprotein (HDL) of male rats exposed to oxidative stress when compared with control group. the results showed a significant decrease in cholesterol, triglycerides, (LDL), (VLDL), whereas it explained a significant increase in (HDL) of rats treated with turmeric & ginger at dose 200 mg/kg when compared with male rats exposed to oxidative stress.

24. Histological Comparative of Kidney of Neonatal Mice Exposed to Silver Nanoparticles During Fetal Development
Najat F Mohammed Salih, Gazwa D Al-Nakeeb
This study aimed to compare the histological changes in the neonatal kidney after their mothers exposed to different doses of silver nanoparticles colloidal solution (AgNPs) during the three stages of pregnancy. Pregnant Swiss albino mice (n=60) were randomly divided into three treated groups. They were intraperitoneally injected with AgNPs for 7 days during each stage of the gestational period. The newborn mice were sacrificed immediately after the birth, and the kidneys were being collected for histopathological analysis. The results showed that the AgNPs caused histological changes in the neonatal kidneys; vacuolation of some renal vesicles and cortical tubules, cystic tubular dilation, glomerular tuft shrinkage, and focal tubular necrosis in the first week-dose exposed pregnant. Disintegrating of immature glomeruli, distention of Bowman’s space of mature glomeruli, tubular necrosis, loss of renal parenchyma, medullar tubules containing hyaline casts, and subcapsular haemorrhage in the second week-dose exposed pregnant. Massive hypercellularity in the deeper part of the renal cortex, cortical and medullary tubules dilation, atrophy of subcapsular immature tubules, cortical cyst formation, glomerular tuft necrosis, dilation of Bowman’s space with evidence of crescent formation, and medullar portion replaced by scant loose connective tissue containing few numbers of tubules the third  week-dose exposed pregnant. The results showed that the AgNPs has more negative effects on the kidney development at the third week-high dose and comparing the histological changes in the neonatal kidney were appeared in a time-depended manner and in a dose-depended manner. More researches must be carried out to obtain better understanding of AgNPs toxicity on fetal development and its ability as a teratogenic agent to induce external and internal abnormalities in the fetus

25. Clinical Study of the Serotonin, Melatonin, Estradiol, and Adiponectin Hormones in Women with Breast Cancer in Thi – Qar Governorate – Iraq
Hadeel Rashid Faraj, Husam Mohammed Kredy, Maha Shakir Hasan
Objective: Breast cancer is the most widely cancer among women, involving 18% of all female cancers, and worldwide, breast cancer is the fifth most common cause of cancer mortality. The study was designed to determine and compare the levels of Serotonin (ST), Melatonin (MT), Estradiol (E2), and Adiponectin (ADP) Hormones in Breast cancer patients and apparently healthy individuals. Material and Methods: Blood Serotonin (ST), Melatonin (MT), Estradiol(E2), and Adiponectin (ADP) Hormones levels were determined in 85 Breast cancer patients and 55 apparently healthy subjects. Results: The levels of serum Serotonin (ST), Melatonin (MT), and Adiponectin (ADP) Hormones were showing significant decrease in Breast cancer patients as compared to control group. ( P ≤ 0.05 ).While the level of serum Estradiol (E2) was showing significant increase in Breast cancer patients as compared to control group.( P ≤ 0.05 ). Conclusion: In Breast cancer patients, we finding decrease in Serotonin (ST), Melatonin (MT), and Adiponectin (ADP) Hormones. While we finding increase in Estradiol (E2) in Breast cancer patients as compared to control group.

26. Field Efficiency of Certain Biopesticides and Neem Products Against Helicoverpa armigera (Hubner) on Chickpea (Cicer arietinumL.)
Nihad H Mutlag, Ameer S A Al-Haddad
A field study was conducted to evaluate the efficiency of four microbial insecticides viz. Beauveria bassiana; HaNPV (Helicoverpa armigera Nuclear Polyhedrosis virus); (Bacillus thuringiensisvar.kurstaki 2 gm/L); HaNPV+Bt; neem oil; neem cake and D.D.V.P EC 76% @0.05% at Research  Farm SHIATS,Allahabad during rabi season of 2011-2012. The experiment was laid out in randomized block design with seven treatment and replicated thrice. The observation larval populations of H. armigera  were recorded one day before treatment  was recorded at 3,7, and 10 days after treatments. The larva population of H. armigera appeared in the third week of February (8 the Standard week) and reached its peak of 14.65 larvae in first week of April and decline rapidly with maturation of crop. There was only one peak in the larval population observation in the 1st week. Bacillus thuringiensis was the most effective chemical  by D.D.V.P.76%@0.05% . Among the microbial  insecticides. HaNPV ,was the most effective followed by  HaNPV+Bt and neem cake . The combination treatments were less effective  than the individual treatment neem oil  and B. bassiana  were  the least effective treatment in reducing the larval population of Heliverpa armigera.

27. Bioactivity of Phenolic Compounds Extracted from Strawberry against Formation of Pseudomonas aeruginosa Biofilm
Baydaa Hussein, Zainab A Aldhaher, Shahrazad Najem Abdu-Allah, Adel Hamdan
Background: Biofilm is a bacterial way of life prevalent in the world of microbes; in addition to that it is a source of alarm in the field of health concern. Pseudomonas aeruginosa is a pathogenic bacterium responsible for all opportunistic infections such as chronic and severe. Aim of this study: This paper aims to provide an overview of the promotion of isolates to produce a biofilm in vitro under special circumstances, to expose certain antibiotics to produce phenotypic evaluation of biofilm bacteria. Methods and Materials: Three diverse ways were used to inhibited biofilm formation of P.aeruginosa by effect of phenolic compounds extracts from strawberries. Isolates produced biofilm on agar MacConkey under certain circumstances. Results: The results showed that all isolates were resistant to antibiotics except sensitive to azithromycin (AZM, 15μg), and in this study was conducted on three ways to detect the biofilm produced, has been detected by the biofilm like Tissue culture plate (TCP), Tube method (TM), Congo Red Agar (CRA). These methods gave a clear result of these isolates under study. Active compounds were analyzed in both extracts by Gas Chromatography-mass Spectrometry which indicate High molecular weight compound with a long hydrocarbon chain. Conclusion: Phenolic compounds could behave as bioactive material and can be useful to be used in pharmaceutical synthesis. Phenolic contents which found in leaves and fruits extracts of strawberries shows antibacterial activity against all strains tested by the ability to reduce the production of biofilm formation rate.

28. Immunohistochemical Expression of TGF-β3 in Oral Squamous Cell Carcinoma
Asmaa Ali Hussein
Squamous cell carcinoma characterized by poor prognosis due to aggressive tumor growth and dissemination high rate of tumor cell . age ranged of patient case included in the study 40-62 years and mean age 55±99. The sex distribution male/female ratio 1:1. Male case  15 and female 15 of the present study The results of  clinical forums showed in the current study was endophytic 10(33.3%) in the same time  Exophytic were presented in 20 cases (76.7%).   Regarding distribution of the tumors site, the preponderance of them 19 cases 73.3% were located alveolar mucosa, followed by in the tongue 11 cases(36.7%) Tumor stage was analyzed and recorded in Oral squamous cell carcinoma included cases, the preponderance of them were Stage II 11 cases 36.7% followed by stage III 10 cases 33.3% , 9 cases 30.0% were stage I. While Concerning tumor grade, majority of them 15 cases  50% had grade II moderately differentiated SCC, while 11 cases 36.7% had grade III poorly differentiated SCC and 4 cases 13.3% had grade I well differentiated SCC Positive TGF-β3 immunostaining was detected as cell with staining brown color, all tissues sections included show Positive expression based on IHC teqnique. Positive Transforming Growth Factor TGF-β3 Immuno staining was found in all case results  and display that 4 samples with percentage 13.3% expressed strong positive 87.67  ± 1.45 expression ,  11cases  36.7%  showed 51.33  ±0.88  positive  expression moderate at the same time 15 samples 50.0% showed  positive weak expression.

29. Phenotypic and Genotypic Characterizations of Non-Biofilm Producer Porphyromonas gingivalis Associated with Periodontitis in Al-Najaf Al-Ashraf/Iraq
Hiba Redha Hussain, Ahlam Kadhum Al-Yasseen
This study aims to investigate the correlation between some virulence factors and biofilm production among Porphyromonas gingivalis associated with periodontitis. One hundred and two sub gingival swabs have been collected from patients suffering from acute and chronic periodontitis admitted to Specialty Dental center in the Holy city of Najaf and specialized clinics in the Faculty of Dentistry of the University of Kufa from both sexes during the period from September 2017 to January 2018. A total of 34 isolates (28.43%) were identified as P. gingivalis by amplification of 16S rRNA using PCR technique.  luxS, lux pro and lux down genes were investigated and the results of PCR showed that none of the strains were possess luxS, 3 strains of P. gingivalis were possess lux pro and 2 strains of P. gingivalis were possess lux dwn. Only 10 strains of P. gingivalis were selected for detection of some virulence factors. The results showed that all strains were unable to produce biofilm with variant abilities of bacterial strains for autoaggregation have been observed (decrease in O.D of bacterial growth after 1 hr. of incubation), and one strain gave +ve results for hemagglutination.

30.Transaminase and Creatinine Predict Diastolic and systolic dysfunction in patients with  myocardial infarction
Wafa Mansor Merza, Zina Hasan Abdul-Qahar, Zainab Alsharifi
Acute myocardial infarction occurs due to coronary artery blockage usually caused by atherosclerotic clot or spasm of the arteries. Aspartate transaminase (AST or GOT) is found in the liver, heart (cardiac muscle), skeletal muscle, kidneys, brain, and red blood. Alanine aminotransferase cells (ALT or GPT) is mainly distributed in the liver, and increased serum ALT is a marker of liver injury. Creatinine is a breakdown product of creatine phosphate in muscle, and is usually produced at a fairly constant rate by the body (depending on muscle mass). This study aimed to explore the level and relationship of serum alanine aminotransferase [ALT] , aspartate aminotransferase [AST] and creatinine  with different risk factors, systolic dysfunction, Diastolic dysfunction and Mitral Regurgitation  in myocardial infarction. A total of 90 patients were recruited and 20 healthy person as controls group. Initial coronary echocardiography was performed to evaluate the severity of coronary lesions, Serum GOT,GPT,Creatinine, glucose, lipid profile was done (within 24 h from admition) by colorimetric method in all patients group and control group. Estimation of Logistic regression analysis was employed for the evaluation of clinical characteristics and biochemical parameters, aiming to explore the relationship between biochemicals and CHD.

31. Knowledge and Attitudes About the Human Papilloma Virus and Cervical Cancer Among a Sample of Paramedical Students in Baghdad Teaching Hospital
Atta Ah Mousa Al-Sarray
Human papillomavirus (HPV) is commonly associated with sexually transmitted diseases (STD) and is regarded as one of the major causes of global disease burdens. To determine the level of knowledge and attitude about the human papillomavirus and cervical cancer among asample of paramedical students in Baghdad teaching hospital. A cross sectional study was carried out for a period of seven month stating on 1st of August 2017to 30 Decmber 2017. Mean age of study sample 20±9 higher percentage in the age groups 20-29 and lower percentage  in the age groups (<20), most cases were females 52.96% & from urban area74.67%  regarding level of education 34.21% from  college of health &medical technologies ,28.95%  College of  Nursing,22.37% Baghdad medical institute&14.47% from Al-mansour medical institute. Overall knowledge score , higher percentage of study sample (63%) had fair score of knowledge regarding Human Papilloma Virus & age had no influence on knowledge score, Males had better knowledge the females students & nursing &Baghdad institute students displayed better knowledge compared to other students & urban residence students  display better knowledge score  about HPV the association between knowledge score and gender and level of education & residence was found to be statistically significant . Regarding attitude  higher percentage of study sample more than 90% agree with the question (Having only one sex partner decreases the risk of acquiring HPV infection) &more than 80% agree with  preventive measures such as Education on HPV & cervical cancer better started at primary school.& Condom prevents HPV virus equally as it prevents HIV transmission while( 54.93%) of study sample agree with the question Pap smear test is a screening test to detect cervical cancer . (46.38%) of study sample agree with HPV vaccine can prevent the development of genital warts & cervical cancer. While  ( 44.40 % ) of study sample agree with  HPV vaccine is delivered in a series of 3 shots injection over 6 month schedule. Higher percentage (49.01%) of study sample had good attitude score while lower percentage 13.82% had poor score. The findings of this study conclude that the level of knowledge of paramedical student was fairly lacking; Males had better knowledge the females students & nursing &Baghdad institute students displayed better knowledge compared to other students, urban residence students display better knowledge score about HPV overall, their attitude score is good about the severity of cer­vical cancer and the benefit of HPV vaccina­tion.

32. Collation, compilation and comparison of GLP Compliance requirements to support Regulatory Approvals for select category of pharmaceutical products in selected countries.
Balamuralidhara V, Kaushik Devaraju, Karthik S, M. P Venkatesh
The present study activity to shed light on to the role of the GLP inspections which is helps to overcoming non-compliance activity. The objective of the present study is to identify the GLP inspection and understanding the underlying concepts for GLP compliance for licenses pertaining to Pre-Clinical study. The study compared and contrasted the GLP requirements and their inspection procedure of the regulatory authorities in India, EU & Singapore.

33. Molecular identification of Talaromyces islandicus  isolated from clinical sample (first record in Iraq)
Wafaa K. Al-Mansour
The analysis of ITS4 gene sequences has been the technique generally used to study and confirm the identification and taxonomy of fungi However, fungal species cannot always be distinguished from each other using cultural methods. Thus,   clinical samples were collected from  cases with aspergillosis  infections, were applied for microbiological and molecular identification. DNA was extracted from Talaromyces islandicus and the ITS4 gene were amplified by using specific primer, then sequencing of nucleic acid of genes was performed by machine is AB13730XL, Applied Biosystem, Macro gen company, the DNA sequencing results of flank sense of ITS4 gene from Talaromyces islandicus was confirm the identification into species level :  Talaromyces islandicus. analysis of the sequences appeared that there two substitution(Transversion, Transition) in the Talaromyces islandicus strain with  Sequence ID LC540.1 location at Range of nucleotide from 9 to 77, 100% compatibility with NCBI while no substitution appeared in the  Talaromyces islandicus Gene Bank accession number: KY30.1.

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