International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Antibacterial Effectiveness of Chloramphenicol Ophthalmic Hydrogel Against Staphylococcus aureus ATCC 25923 and Bacillus subtilis ATCC 6633
Kurniawansyah I S, Sulistiyaningsih, Maulia M G, Budiman A
Background: Hydrogels are the unique three-dimensional polymeric materials that can hold a large fraction of water thus aims to release the drug in a controlled manner. Controlled drug delivery systems that are meant to deliver the drugs at predetermined rate for a pre-programmed period is a good alternative to accomplish and overcome the inadequacy of low bioavailability of conventional dosage form. Aims and Objectives: To determine the effectiveness of antibacterial activity of chloramphenicol in ophthalmic hydrogel preparations against S. aureus and B. subtilis comparing with eye drops dosage form. Materials and Methods: Ophthalmic hydrogel and eye drops of chloramphenicol were used for comparing the effectiveness of antibacterial activity against S. aureus and B. subtillis using agar diffusion methods with perforation technique. The observations were made ​​for 28 days with evaluation of the physical preparation includes organoleptic, pH, viscosity. Result: The chloramphenicol eye drops preparation showed that the largest inhibition diameter at concentrations 20%,10% and 5% were 2.87-2.90; 2.64-2.76 and 2.48-2.55 cm. During comparison with opthalmic hyrdogel preparations there was not a very significant difference observed at opthalmic hydrogel preparation of  20% , 10% and 5% inhibition diameter obtained were 2.85-2.98; 2.58-2.69 and 2.42-2.46 cm. This showed that both preparations were equally effective in inhibition of S. aureus and B. subtilis growth. The minimum inhibitory concentration growth of the hydrogel opthalmic preparations against the bacteria B. subtilis was 10% and S. aureus at concentration 20%. In the evaluation of the physical preparation includes organoleptic, pH, viscosity showed good results, and still within the range of requirements. Conclusion: The effectiveness of antibacterial preparations in chloramphenicol ophthalmic hydrogel were not much of a difference compared to the form of eye drops preparations against S. aureus and B. subtilis.

2. Linagliptin: A Review on Bio-analytical and Analytical Methods
Kirtimaya Mishra, Balamurugan K, Suresh R
This is a collective data for Linagliptin from previously published methods either in alone or in combination with Metformin or Empagliflozine . Many spectroscopic methods like derivative techniques, chromogenic techniques were used for newly developed as well as improved chromatographic methods were reported for biological fluids and pharmaceutical formulations. Apart from these two techniques few LC-MS/MS and HPTLC methods also available. Now in this present analytical research world quality by design or design by expert technique is used to get improved method for method validation. This concise review work can guide an analyst to choose most appropriate method for a best analytical method development and validation of Linagliptin alone or in combination with Metformin or Empagliflozine.

3. Development and Validation of UV-spectrophotometric Procedures for Efavirenz Quantitative Determination
Slabiak Oksana I, Ivanchuk Iryna M, Klimenko Lina Yu, Tokaryk Galyna V, Kolisnyk Iuliia S
Efavirenz is a non-nucleoside reverse transcriptase inhibitor and attributed to the group of antiretroviral medicines used for treatment of HIV infection. For efavirenz determination the method of HPLC is widely used, but efavirenz is applied in high concentration and less sensitive methods of analysis such as spectrophotometry may be useful for its quantification. The aim is to develop UV-spectrophotometric procedures of efavirenz quantification and carry out step-by-step validation of the developed procedures. UV-spectra of efavirenz in 96% ethanol and 0.1 M sodium hydroxide solution have been investigated and the absorption maximums are observed at 247 nm and 267 nm respectively. The procedures of efavirenz quantitative determination by the method of UV-spectrophotometry have been developed using the mentioned solvents and wavelengths respectively. Their validation by such parameters as stability, linearity, accuracy and precision in the variants of the method of calibration curve, method of standard and method of additions has been carried out. All procedures of efavirenz quantitative determination are acceptable for application. The best linearity, accuracy and repeatability have been fixed for the procedure with application of 0.1 M sodium hydroxide solution as a solvent in the variant of the method of additions.

4. Present Status of Supplemental Application Submission in USFDA
Misri P, Verma S, Yashwant, Haque A
Objective: In order to reach to the market, a drug product has to undergo various phases of scrutiny assuring its quality, safety and efficacy. Once the experimental drug promises its safety, efficacy and quality it is permitted to be marketed by the regulator. The drug is still present under surveillance for possibility of any adverse drug reaction or any other alteration or a new indication. If any modification is to be done, then the applicant/sponsor needs to file a supplemental application.  This article provides information about present status of supplemental new drug application submitted and approved to the United States food and drug administration. Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000 to 2016. The data has been segregated and statistically analyzed using ANOVA on the basis of different categories of approved applications. Results: As per the analysis, from the year 2000 to 2016, a total of 69,585 applications was filed to USFDA, amongst which 9499 were original applications and 60,086 were supplemental applications.

5. Pharmacognostic and Pharmacological Studies on Flower Buds of Capparis spinosa L.
Sambasivam Manikandaselvi, Pemaiah Brindha, Vellingiri Vadivel
Capparis spinosa L. (Capparaceae) is growing wild on walls or in rocky coastal areas all over India and normally known as Maratimokku in Tamil. The current study was aimed reveal the botanical and chemical pharmacognostic standards, and pharmacological and toxicity properties of aqueous extract of C. spinosa flower buds. Powder microscopy revealed the characteristics features of the sample, which are useful in fixing the pharmacognostic standards. Preliminary phytochemical screening revealed the presence of alkaloids, reducing sugars, carbohydrates, saponins, phenolic compounds, tannins, anthraquinones and lignins in aqueous extract. LC-MS/MS analysis revealed the presence of quercetin as the major constituent in the aqueous extract. Strong antioxidant activity was observed in aqueous extract centered on the outcomes of DPPH radical scavenging (IC-50 1.74 µg/ml) and inhibition of lipid peroxidation (IC-50 4.01 µg/ml) assays. The aqueous extract exhibited anti-inflammatory activity in terms of inhibition of protein denaturation (IC-50 8.01 µg/ml), inhibition of protease activity (14.24%) and RBC membrane stabilization (IC-50 226.69 µg/ml) and also possess antibacterial activity against Bacillus cereus, Staphylococcus aureus, Campylobacter jejuni and Salmonella enteritidis strains. Acute oral toxicity study revealed that it is safe up to the dose level of 2000 mg/kg bw in the experimental animals.

6. Novel Electro Polymerization Method to Synthesized Anti-corrosion Coated Layer on Stainless Steel Surface from (N-Benzothiazolyl Maleamic Acid) and Study its Biological Activity
Khalil S Khalil, Khulood A Saleh, Muna I Khalaf
Electro polymerization of N-benzothiazolyl maleamic acid (NBM) was carried out on stainless steel plate electrode in a protic medium of monomer aqueous solution using electrochemical oxidation procedure in electrochemical cell. Spectroscopic characterization techniques were investigated to obtain information about the chemical structure of polymer. The anti-corrosion action of polymer was investigated on stainless steel by electrochemical polarization method. In addition, the effect of adding nanomaterial (TiO2, ZnO (bulk-nano)) to monomer solution on the corrosion behavior of stainless steel was investigated. The results obtained showed that the corrosion rate of S-steel increased with temperature increase from 293K to 323K and the values of inhibition efficiency by coating polymer increase with nanomaterial addition. Apparent energies of activation have been calculated for the corrosion process of S-steel in acidic medium before and after polymeric coating. Furthermore were studied the effect of the preparing polymer on some strain of bacteria.

7. Effectiveness of Fish Oil Containing Omega-3 in Improving Symptoms and Lung Function in Asthma Outpatient in Surabaya, Indonesia
Amelia Lorensia, Mariana Wahyudi, Nadia Aisah Mayzika
Indonesia as a potential maritime country in fish production, can be processed into fish oil containing omega-3. Based on previous libraries, omega-3 fish oils can be used to improve asthma control and improve lung function. The effects of a drug are individualized depending on genetic and environmental factors. The aim of the study was to investigate the effect of fish oil containing omega-3 on improving asthma symptoms and improving lung function. The research method used is pre-post test design, using data collection technique with asthma control test questionnaire to see clinical symptoms of asthma and measure lung function with peak flow meter. Intervention given is a fish oil product with once daily doses, then follow up every week for 4 weeks. The subject of research is adult age. Pulmonary function data and asthma symptoms will be tested for normality with shapiro-wilk test and followed by anova one way. The research was conducted in 2016-2017 in Surabaya and the data obtained 28 respondents. At the control level of asthma and total ACT score (P <0.05) it can be concluded that there was significant difference between before and after omega-3 fish oil therapy for 4 weeks. In the improvement of lung function there is a significant improvement of lung function starting from before therapy until the increase every week until the 4th week. Fish oil containing omega 3 for 4 weeks may decrease asthma symptoms in the asthma control level category and total ACT score. In addition, fish oil can also improve lung function significantly in every week.

8. 3D Printing: An Emerging Technology in Pharmaceuticals
Sharma S, Saxena V
Three-dimensional (3D) Printed medicines can be defined as the potential tools/medicines to achieve personalized treatments adapted to the specific requirements of each patient, taking into account their age, weight, comorbidities, pharmacogenetic, and pharmacokinetic characteristics. The aim of this review is to give an overview of 3D printing in pharmaceuticals, highlighting their advantages, disadvantages and applications. 3D printing technologies will emerge as boon to the pharmaceuticals and humanity.

9. Study of Diabetic Mellitus and Knowledge of Lotion Foot Care on the Community
Athiyah U, Hendradi E, Rosita N, Erawati T, Purwanti T, Hariyadi DM
The prevention of Diabetic Mellitus (DM) and its complications is the main aim of this study, in addition to the training of lotion foot care application and the development of small scale industry. The research team delivered knowledge in the form of training on Diabetic Mellitus, healthy food, treatment and prevention of complications, and small-scale production of cosmetic products. The aim of this study was to determine the correlation between training on diabetic and lotion foot care application as preventive measures against diabetic complications on the patient’s blood glucose levels in the community of residents in Banyuurip Jaya, Surabaya. It was expected from this training that the knowledge of the residents increases and people living with diabetic undergo lifestyle changes and therefore blood sugar levels can be controlled. The parameters measured in this research were blood glucose levels, the anti diabetic drug types consumed, and compliance on diabetics. This study used the data taken from 60 patients with DM over a period of one month. Questionnaires and log books was used to retrieve data and changes in blood glucose levels in diabetic patients. The results showed the demographic data of patients with type 2 diabetic of 85% female and 15% male, with the range of patients aged of 61-70 years of 46.67% and had history of diabetic (90%). The history of drugs consumed by respondents was anti diabetic drugs such as metformin (40%), glimepiride (33.37%) and insulin (6.67%). In addition, the increased knowledge of DM patients after being given the training compared to before training was shown in several questions in the questionnaire. A statistical analysis using t-test analyzed a correlation between training provided in order to enhance understanding of the patient, as well as correlation with blood glucose levels. A paired T-test showed that there was a relationship between the knowledge of trainees before and after training (p <0.05). An interesting result was that there was no relationship between blood glucose levels before and after training provided (p> 0.05).

10. Comparative Study of the Biologically Active Substances Composition and Content in Meadowsweet (Filipendula ulmaria (L.) Maxim) Crude Herbal Drugs (Herb, Leafs, Flowers) of Russian Origin
Tatyana Yuryevna Kovaleva, Valentina Alekseevna Ermakova, Daria Aleksandrovna Trashchenkova, Ekaterina Anatolievna Dorovskih, Dmitry Olegovich Bokov, Inessa Vladimirovna Shilova, Irina Aleksandrovna Samylina
Filipendula ulmaria (L.) Maxim. (Meadowsweet) is known in traditional medicine as anti-inflammatory, wound-healing, astringent and antibacterial remedy. However recent studies show that it also has neurotropic activity. In Russia meadowsweet flowers are used as crude herbal drugs (temporary pharmacopoeial monograph 42-1777-87), also leafs and herb are used in the traditional medicine. Objective of the study was to carry out comparative investigation of composition and content of major biologically active compounds (BAC) in Filipendula ulmaria herb, flowers and leafs by thin-layer chromatography, differential spectrophotometry with aluminum chloride reagent (total flavonoids in terms of rutoside), gravimetry (total extractives, extracted by water), permanganatometric titration (total tannins in terms of tannin). Rutoside, tannin, gallic acid and salicylic acid were identified in Filipendula ulmaria herb, flowers and leafs by TLC. Also we analyzed content of substances extracted by water, flavonoids and tannins. Total extractives, extracted by water in F. ulmaria herb is 13.12±0.10%, in leafs – 13.98±0.37%, in flowers – 18.09±0.17%. Total tannins in F. ulmaria herb is 11.87±0.47%, in leafs – 12.06±0.18%, in flowers – 12.26±0.29%. Total flavonoids in F. ulmaria herb 4.34±0.17%, in leafs – 6.98±0.23%, in flowers – 11.75±0.57%. The obtained data will be used for development of a pharmacopoeial monograph project “Filipendula ulmaria (L.) Maxim., herba” for inclusion in the State Pharmacopoeia of the Russian Federation.

11. Validation and Various Qualifications in HVAC System – A Review from Pharmaceutical Quality Assurance Prospect
Varun kumar K R, Amit B Patil, Ajay P Karnalli
The safety of personnel and efficacy of the material including raw ingredients, in-process goods and finished products as well as machineries in the pharmaceutical industry is majorly impacted by the air ventilation quality within the industry. HVAC system stands for Heating, Ventilation and Air Conditioning system, which ensures the optimum quality of air environment as directed by regulatory authorities. The performance of HVAC system is ascertained by conducting validation of this system within specified duration.  Validation of HVAC system is achieved at three levels such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ); Which is subject to provide documented evidence about the accuracy of results produced by it. The validation of HVAC system involves systemized and assembled documents of its functional specifications such as design drawings, plans, and specifications; followed by validation master plan involving testing, adjusting, and balancing (TAB); and finally, the startup reports. The parameters analyzed are air flow velocity, air flow pattern, air changes per hour, filter leak test, particle count, viable monitoring, filter integrity test, pressure difference, recovery test for temperature and humidity, temperature and humidity uniformity, and fresh air determination.

12. Technology Transfer in Pharmaceutical Manufacturing – A Review
Bharath Kumar B, Amit B Patil, Ajay P Karnalli
Technology Transfer (TT) is vital action from drug development in Research & Development (R&D) Department to commercial manufacturing till the product discontinuation. This review is an attempt to give an insight about the transfer of pharmaceutical product from R&D to production including necessary documents required to review the supporting documents and execution procedures in production shop floor. TT is considered effective, if there is a documented evidence that the process and its parameters, repeatedly results in desired product quality which was established upon during TT between the transferee and transferor. For the execution of TT process, expertise from different department such as Engineering, R&D, QA, process analyst and production are teamed.  the transmission comprises of arrangements procured in these flows of improvement to achieve the quality as planned throughout manufacture.

13. Development and Validation of HPLC/UV-Spectrophotometric Procedures for Metronidazole Quantitative Determination
Klimenko Lina Yu, Shkarlat Galyna L, Shovkova Zoia V, Yaremenko Vitaliy D, Shpychak Oleg S
Metronidazole is the most popular representative of antiprotozoal medicines from the group of 5-nitroimidazoles. Metronidazole blocks the enzymes of alcohol dehydrogenase and acetaldehyde dehydrogenase, therefore when its joint taking with alcohol it is observed the strong intoxication syndrome and fatal poisonings too. Therefore metronidazole can be a potential object of chemical toxicological investigations. The purpose of our paper is to develop HPLC/UV-procedure of metronidazole quantification with application of the system of HPLC-analyzer MiLiChrome® A-0230 implemented in practice of forensic medical laboratories in Russia and Ukraine and carry out step-by-step validation of the developed procedure. Chromatographic conditions: Eluent A (0.2 M LiClO4 – 0.005 M HClO4) and Eluent B (acetonitrile) were used as the mobile phase components; HPLC microcolumn Ø2×75 mm and ProntoSIL 120-5-C18 AQ, 5 μm were used as an analytical column; temperature was 40°С; flow rate was 100 μl/min; gradient elution mode was from 5% to 100% Eluent B for 40 min, then 100% Eluent B for 3 min; detection was performed at 277 nm. Retention time for metronidazole is 5.95 min. Since metronidazole is easy soluble and stable enough in the solutions of diluted alkalis 0.001 M sodium hydroxide solution has been proposed for preparation of the solutions in developing HPLC/UV-procedure of metronidazole quantification. Validation of the procedure has been carried out in the variants of the method of calibration curve and method of standard by such parameters as in process stability, linearity/calibration model, accuracy and precision within 3 different analytical runs using different batches of reagents and different glassware; experiments have been performed by three different analysts. New procedure of metronidazole quantitative determination by the method of HPLC/UV has been developed. Its validation has been carried out and acceptability for application has been shown.

14. In vitro Anti-Helminthic Study of Ficus Dalhousiae Leaf Extracts in Pheretima posthuma
Mohammed Idrees Hussain, Syed Safiullah Ghori
The aim of the present investigation was to evaluate the anti-helmintic activity of extracts of methanol, petroleum ether, n-hexane and water of Ficus dalhousiae Miq leaves in Earthworms. The plant material was collected from Tirupati was authenticated by Department of Botany, Osmania University, Hyderabad. Fresh plant leaves were used for the present study.  The leaves were made free from dust and foreign material and dried and powdered.  The powder was weighed (50 gm) and was extracted by successive solvent extraction process. Phytochemical screening was carried out for the detection of phytoconstituents. The parameters like paralysis time and time of death were determined by using the extracts of methanol, petroleum ether, n-hexane and aqueous solvent at the concentrations of 25mg/ml, 50mg/ml and 100mg/ml.The extracts of Ficus dalhousiae leaves exhibited significant antihelmintic activity at concentrations of 25mg/ml, 50mg/ml and 100mg/ml as compared with Albendazole as standard drug. The results from the study suggest that extracts of Ficus dalhousiae Miq leaves has shown significant anti-helminthic effect when compared to the standard drug, Albendazole.

15. Molecular Detection of wzx1 and wzy Genes in Multi Drugs Resistance E. coli   Isolates
Mona Al-Terehi, Saba Saadoon Khazaal, Haidar J Muhammed, Russul Hikmat Behjet
Escherichia coli  have been genetically changes in Iraqi environments, the present study was carried out to detection E coli isolates sero-group using o-antigens gene cluster, tow genes were amplified used multiplex PCR, the results of present study show that present isolates have more than one plasmid in different size  (500-700 bp). PCR results show about 100% of isolates were had a positive results of PCR products of O45 wzx1 gene (451 bp) while 25% of isolates were a positive PCR products of O45 wzy1 gene (255 bp) and about 25% of isolates have tow genes. A new finding in present study that 50% of isolates have other copy of  O45 wzx1 gene, these results concluded that it may be important in Iraqi isolates identification and classification however we need more information about genes sequencing.

16. Relationship Between Chordin Like-1 Protein Level and Patients with Pulmonary Arterial Hypertension Disease
Mohammed Noori Al-Dujaili, Khamaal Hussein Abod Al-Khafaji, Arshad Noori Ghani Al-Dujail
Pulmonary arterial hypertension (PAH) is a serene executioner, which can incite irreversible changes in pneumonic vascular structure and point of confinement, developing pulmonary vascular resistance (PVR), right ventricular disappointment, and death. Background and Objective: This study was done at the Cardiac Centre of Al-Sader Medical City Hospital in Al-Najaf Al-Ashraf province for the period from December 2016 to May 2017 to investigate the level of biomarker of Chordinlike-1for patients with pulmonary arterial hypertension as predictive indicators of the disease for detection, diagnosis and early treatment of patients. Materials and Methods: The study was applied on 88 people aged 30-69 years; 67 patients group with pulmonary arterial hypertension (PAH) and 21 healthy group. The group of patients was divided into subgroups based on gender, age, body mass index (BMI), waist circumference, smokers and non-smokers, type of primary and secondary arterial hypertension, types of secondary arterial hypertension, and disease grade. The healthy group was divided according to gender and age. Results The study emerged a significant decrease (p <0.05) in the level of Chordin like-1  in the group of pulmonary arterial hypertension patients compared to the healthy group, the female group compared to the males, the age group at the age of 30 to 69, Secondary compared with a primary and the disease grade group was found that sever lower than moderate and mild.While the level of Chordin like-1   in the healthy group divided by gender and age have no significant differences.The study produced that in comparing secondary PAH types, there was a significant decrease (p <0.05) in the level of Chordin like-1  for both COPD and Left Heart Disease systolic dysfunction or diastolic dysfunction (LHD sys or dia) compared with Valvular, Congenital, and Pulmonary embolism. While there was no significant difference in the level of Chordin like-1between Valvular, congenital and pulmonary embolism. The study revealed no significant difference in the level of Chordin like-1 for the patients group of pulmonary arterial hypertension divided according to BMI group (normal weight, overweight, obese weight), waist circumference group (70-80 cm, 81-90 cm, 91-100 cm, 101-110 cm, 111-120 cm) and the group of smokers compared to non-smokers. conclusion: The biomarker Chordin like-1consider cautioning sign as a prognostic marker for determination PAH patients.

17. Molecular Detection of Human Papilloma Virus 31&33 in Prostate Carcinoma and Prostate Benign Tissues from a Group of Iraqi Patients
Noor Sami Al- Lebawy
Background: Human papillomavirus (HPV) has been connected to the progress of different types of human cancers. Prostate cancer is the second most common cause of cancer in men that might have such relation with Human papillomavirus (HPV). Objective: To assess the rates of occurrence HPV infection in the samples of prostate tissues with carcinoma and benign. Patients and methods: Seventy blocks of formalin-fixed, paraffin- embedded prostate tissues were used in present study; (30) biopsies from prostate carcinoma, (20) biopsies from prostate benign tissues and (20) from apparently normal prostate tissues as a control group. Detection of HPV-31 &33 was done by ultra-sensitive version of (ISH) whereas immunohistochemistry (IHC) technique was followed to display the cdk2 gene expression. Results: Detection of HPV-31&33-CISH reactions in the prostate carcinoma tissues was observed in 17 out of 30 (46.67%), while in those tissues with prostate benign was 35% (7 out of 20). No positive HPV-31 &33-CISH reactions in apparently normal prostate tissues of control group were revealed. The positive CDK-2-IHC reactions was detected in 46.67% (14 out of 30 cases) of prostate carcinoma and 30% (6 out of 20 cases) of benign prostate.The statistical difference between the rates of CDK-2 in prostate carcinoma and prostate benign tissues was highly significant (P value = < 0.0001).  Conclusions: Our results indicate that the HPV might contribute to the development of a subset of prostate malignant tumors and benign.

18. Analysis of the Glycine max role of Syntaxin (SYP22) in resistance to Rotylenchulus reniformis
Weasam A R Aljaafri, Fadhal A Al-fadhal, Ameera Naji Hussein Al-jouburi
Syntaxin proteins are involved in the process of membrane fusion. G. max syntaxin genes (Gm-SYP22-3, and Gm-SYP22-4) that were similar in amino acid composition have been found to contribute to the ability of Glycine max to defend itselffrom infection by the plant- parasitic nematode Rotylenchulus reniformis. The Gm-SYP22-3and Gm-SYP22-4 genes were expressed in root cells (syncytia) undergoing a resistant reaction while not being expressed in control cells. The Gm-SYP22-3 and Gm-SYP22-4 genes have been isolated from genetically engineered in G. max [Williams 82/PI 518671], a genotype typically susceptible to R. reniformis parasitism. Genetically engineered plants in G. max [Williams 82/PI 518671] that lack the overexpression of Gm-SYP22-3 or Gm-SYP22-4 genes have also been produced to serve as a control. The transgenic Gm-SYP22-3 or Gm-SYP22-4 overexpression lines with their pRAP15 control have then been infected with R. reniformis. Infection was allowed to proceed for 30 days. At the end of the 30-day life span, R. reniformisstages were extracted from the soil and eggs from the roots, enumerated and compared to control plants. Plants overexpressing Gm-SYP22-3 or Gm-SYP22-4 had suppressed R. reniformis. In contrast, the gene expression levels of Gm-SYP22-3 and Gm-SYP22-4 were reduced in transgenic lines engineered for their RNA interference (RNAi) in G. max [Peking/PI 548402], a genotype normally resistant to R. reniformis. In comparison to genetically engineered control G. max [Peking/PI 548402] lines, RNAi of Gm-SYP22-3 or Gm-SYP22-4 resulted in an increase in parasitism in the normally R. reniformis resistant G. max [Peking/PI 548402].

19. Detection of Aspergillus fumigatus by Polymerase Chain Reaction (PCR)
Zainab H Abood AL-Asadi
Aspergillosis refers to fungi infections of the respiratory tract caused by Aspergillus species especially Aspergillus fumigatus.Infection of A. fumigatus were increased  in last few years , due to either resistances to antibiotics or to influence of other factors such as other fungal infections.The aims of the present study were to review the impact of Aspergillus fumigatus in Aspergillosis  cases, and study the role of Singleplex PCR for amplification of ITS1,ITS4 of rRNA gene in the detection of fungal isolate  . In this study One hundred sputum samples were collected from patients admitted to the specialize chest and respiratory diseases center / Baghdad who were suffering from respiratory problems.  During these studied, molds were isolation  and identification based on Conventional method (Direct microscopy by using 10% KOH, and fungal culture was done on Sabouraud Dextrose agar supplemented with chloramphenicol and on Czapek-Dox agar incubated at 37°C and examined for 3-7 days then  macroscopic, microscopic examination of the colony by(lactophenol cotton blue stain )and molecular  methods by using Polymerase chain reaction  (PCR)technique foridentification. The 10% KOH examination was positive for 35 cases while laboratory culturing was positive for 53 cases. Aspergillus sp were isolated from 44(83%) patients; A. fumigatus was isolated in 23 (42.4%) patients while A. flavus, A. niger,  and A. terreus were isolated from 11 (20.08%),  (13.2%) and 3 (5.7%) patients respectively, also isolated Penicillium spp. at percentage 1(1.9%).. In this study.The ages of participants ranged from 10-70years with a mean age of 34years, the males were more susceptible for fungal infection were recorded 35/53 (66.3), compared to females were 18/53 (33.96).The infection of fungi were more prevalent in ages 30-40recorded 26(53.06%) followed by  ages 40-50 ,13(26.5), while the lowest infection recorded in age group 10- 20 years was 2(2.04%). DNA isolated from twenty three A.fumigatus isolates was used as template and the specific of oligonucleotide primer sequences were used in conventional PCR to detect the presence of internal transcribed spacer region ( ITS) region of the rRNA gene for Aspergillus fumigates. The results of the PCR amplification of the rRNA gene showed that, this gene was present in 19 samples out 23 positive samples which isolation with a PCR product size of approximated 385 bp, while 4 samples out 23 positive samples showed negative results for the presence of this gene as indicated by the absence of the PCR products in their relevant lanes.Statistical analysis revealed that the PCR to have a sensitivity of 95.1 % in the detection of Aspergillus fumigatus in Aspergillosis cases.Polymerase chain reaction (PCR) is a rapid, specific and sensitive method to detect Aspergillus fumigatus in aspergillosis cases of human.

20. Effect of Allicin in Reducing the Cytotoxicity of Cyclophosphamide on Reproductive System of Wister Male Rats
Saadeya Ali Lefelef Al-Gnami, Hussein Khudair Aubaies Al–Mayali
The aim of the present study is to investigate the positive role of Allicin in reducing the side effects induced by cyclophosphamide drug in reproductive system of male rats.  In this experiment, fifty adult male Wister rats were used, about four month old, with average weight about (162.5±13gm). They were divided randomly into five equal groups (10 animals for each group) and drenched for 60 consecutive days as follows:  The results of this study revealed significant differences (P ≤  0.05) represented by increasing in concentration  of testosterone, SSH and ICSH hormones in T1 group as compared with other groups, while there was a significant  decrease in T2 group as compared with other groups. Also, there was a significant difference represented by increasing levels of these hormones in T3 and T4 groups as compared with T2 group ,and there was a significant difference in concentration of testosterone, SSH and ICSH  between T3 and T4 groups represented by increasing the concentration of these hormones in T4 group as compared with T3 group. It is concluded that allicin has in dose of 50 mg/kg/B. W. both a preventive and a therapeutic role in ameliorating cyclophosphamide toxicity in adult Wister male rats. The use of allicin as a therapeutic agent showed more amelioration in cyclophosphamide toxicity  than a preventive agent.

21. Electroencephalogram and Visual Evoked Potential Studies in Patients with Stroke
Sura ZaKi Gaffat AL- Nasriwy, Farah Nabil Abbas, Abdul-Kareem Al bermany, Fizel Abbas Al-Himyari
Stroke or cerebrovascular accident occurs when the blood supply to the brain is cut off (an ischemic stroke) or when a blood vessel bursts (a hemorrhagic stroke).  Most strokes are of the ischemic type.  Without oxygen, brain cells begin to die.  death or permanent disability can result. High blood pressure, smoking,D.M, and having had a previous stroke or heart attack increase a person’s chances of having a stroke. The aims of this study: Evaluate the role of electroencephalography and visual evoked potential in patients presented with stroke. Determine the electroencephalographic abnormalities in stroke patients. Evaluate the clinical  manifestations and medical history of patient with stroke. This study is a case-control study dealing with a total of 170(male and female) subjects, 85 of them as group presented with stroke  and the other 85 considered  asa control group. The electrophysiological tests were done at the neurophysiology unit of Mirjan Teaching  center in Babylon City, during the period from 1ᵗʰ/12/ 2015 until 20ᵗʰ / 5/2016.Electroencephalography and Visual evoked potential were performed for the patients and the control in parallel.This study shows the differences between patients with stroke and control by EEG changes there were significant differences between patients and control by EEG changes. There were 35% of stroke patient presented with abnormal EEG changes ,While 26%of stroke patient presented with abnormal VEP. The purpose of the study was to compare sensitivity and specificity of these two analytical procedures (EEG and VEP) in the diagnosis of stroke. The sensitivity and the specificity of EEG in stroke The results showed a sensitivity of35.3% and a specificity of 97.6%.p value < 0.01 is highly significant.The sensitivity and the specificity of  VEP in stroke The results showed a sensitivity of 25.9% and a specificity of  100% p value < 0.01 is highly significant.The  EEG abnormal findings in stroke patients were (35%) of all patient group (68%) of them were generalized while (32% )were partial seizure.The distribution of different EEG abnormalities in stroke patients were (slow wave 48%,spike wave26%,poly spike wave13% and sharp wave13%).The VEP abnormal findings in stroke patients were(26%) of allpatient group, the majority of abnormal VEP findings were prolonged latency of P100, P75 and P145 respectively.There were significant differences between stroke patients and control group  regarding the clinical manifestations and medical history (DM, Headache, Dysarthria , Visual disorder, Facial weakness, dizziness  hypertension  and Hemiphgia.

22. Histological and Physiological Study of the Effect of Silver   Nanoparticles and Omega-3 on Asthma of Male Mice Induced by Ovalbumin
Leena Adeeb Mehdi AL-waealy, Arsha D Noori Ghani Al-Dujaili
In the current study ninety one of male mice weighting (25-30 g) aged (15-17) weeks at the animal house faculty of science / university of Kufa during the period from January  2017 to September  2017. This study included some physiological and histological criteria to evaluate the protective role of omega-3(2 and 3 mg/kg) and silver nanoparticles (5 and 10 mg/kg) against asthma that induced by ovalbumin. The animals experimental are divided into 16 groups (n= 6 mice per each group) for duration of one  and two  months. The results showed significant increase (p<0.05) in the leukocyte count (eosinophil, neutrophil, lymphocyte, monocyte) in asthma group as compared with control group .Also ,the results showed significant decrease (p<0.05) in the leukocyte count  in the treated group of  omega-3 and silver nanoparticles for both concentration as compared with asthma group. The result sowed significant increase(p<0.05) in the serum level of periostin and Galectin -3 and Interleukin -33 in asthma group as compared with control group. The histological study of lung tissue revealed that induced the tissue with ovalbumin caused necrosis, degeneration and increase of mucous in bronchiole as well as acute inflammation around bronchioles while the effect of ovalbumin in trachea tissue were sluphing, necrosis and degeneration around the epithelium of bronchioles.


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