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العنوان
Microbiological Study on The Microbial Contamination of Certain Non Sterile Pharmaceutical Preparation Commonly Used in The Egyptian Market /
المؤلف
Aly, Reham Aly Ibrahem.
هيئة الاعداد
باحث / Reham Aly Ibrahem Aly
مشرف / Mohamed Seif El-Din Ashour
مشرف / Gamal Fadl Mahmoud Gad
الموضوع
Drugs - Microbiology. Microbiology. Microbial contamination - Prevention. Pharmaceutical industry - Quality control.
تاريخ النشر
2009.
عدد الصفحات
168 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
العلوم الصيدلية
تاريخ الإجازة
1/1/2009
مكان الإجازة
جامعة المنيا - كلية الصيدلة - علم الاحياء المجهري
الفهرس
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Abstract

The present study was undeliaken to determine the microbial contamination of 300 samples of certain non sterilized pharmaceutical preparations that are commonly used in the Egyptian market. These samples included 120 items representing 60 brands of syrups, 60 items representing 30 brands of oral DROPs, 20 items representing 10 brands of suspensions, 20 items representing 10 items of nasal DROPs and 80 items representing 40 brands of tablets.
To fulfill this aim, the microbiological examination included the following:
Determination as well as identification of total aerobic bacterial count and anaerobic bacterial detection especially the presence of Clostridia spp. In addition, Detection and identification of fungi.
For syrup samples, results of aerobic bacterial count showed that out of 120 samples 42 samples (35%) showed bacterial count less than 102 CFU/ml while, 14 samples (11.7%) showed bacterial count ranged from 102-103 CFU/ml and 7 samples (5.9%) with bacterial count more than 103 CFU/ml.
The following bacterial isolates were recovered and identified:
Staphylococcus epidermidis was the most prevalent (27.5%) followed by S. aureus (25.8%) and B. subtilis (8.3%).
For fungi: Aspergillus niger was the most prevalent (40%) followed by A. fumigatus (16.7%), A. flavus (13.3%), Penicillium spp. (9.2%), Rhizopus(5.830/0), Clado!1porium (2.5%) and Alternaria (50/0).
On the other hand, 74.2% of syrup samples showed microbial contamination.
Suspensions showed the highest bioburden rate and the aerobic bacterial count results were: out of 20 samples 3 samples (15%) showed bacterial count less than 102 CFU/ml while, 5 samples (25%) showed bacterial count ranged from 102-103 CFU/ml and 2 samples (10%) with bacterial count more than 103 CFU/ml.
The following bacterial species were recovered and identified: S. epidermidis was the most prevalent (35%). S. aureus (5%) and B. subtilis (10 0/0) were the less prevalent.
The recovered fungi were: A. niger was the most prevalent (35%) followed by A. fumigatus (15%), A. flavus (15 %) and Alternaria (5%).
The study showed that (850/0) of suspension samples showed microbial contamination.
The studied oral DROPs had intermediate microbial load and results of aerobic bacterial count were: out of 60 samples 20 samples (33.3%) showed bacterial count less than 102 CFU/ml while, 5 samples (8.3%) showed bacterial count ranged from 102_103 CFU/ml.