消除药物微生物检测的错误结果

I. A. Buylova, N. Sakhno, G. M. Bulgakova, O. Gunar
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引用次数: 2

摘要

药品微生物质量检测的有效性取决于所采用的检测程序的充分性。本研究的目的是分析在非无菌药品微生物质量检测中导致错误结果的因素,并找到消除错误结果的方法。材料与方法:以微生物质量检测的非无菌药品为研究对象:n-甲基葡萄糖胺、l -苹果酸、Xeroform、盐酸芬戈莫德、琥珀酸、链霉素、阿立哌唑、Doxazosin、氯吡格雷、Moxonidine、Tilorone、霉酚酸、叶酸、加巴喷丁、杜他雄胺、伊马替尼、替莫唑胺。该研究涉及使用以下试验菌株:枯草芽孢杆菌、蜡样芽孢杆菌、白色念珠菌、大肠杆菌、巴西曲霉,以及试剂和生长培养基。所采用的方法是微生物质量检测条件下抗菌活性的测定,以及根据俄罗斯联邦国家药典第13版的要求对药品微生物质量的深度检测进行修改。结果:通过文献来源分析,揭示了导致微生物检测结果错误的主要因素,并确定了消除方法。本文阐述了固体制剂两种样品制备方法的实验比较结果:俄罗斯联邦国家药典第13版中描述的标准方法和使用实验室摇床的方法。本文提供了消除枯草芽孢杆菌和蜡样芽孢杆菌抗菌活性的具体方面的实验数据以及在特定药品中使用特定灭活剂的实验数据。结论:一套旨在防止假阳性和假阴性检测结果的措施应包括:使用的生长介质和试剂的无菌控制,设施的监测;生长介质促生长特性和选择性的控制;选择适当的孵育条件和接种程序,并适当考虑剂型;样品、稀释剂和稀释因子用量的证明;考虑药品的抗菌活性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
ELIMINATION OF FALSE RESULTS OF MEDICINES MICROBIOLOGICAL TESTING
The validity of medicines microbial quality testing relies on the adequacy of the test procedure employed. The aim of the study was to analyse factors triggering false results during microbial quality testing of non-sterile  medicinal products, as well as to find ways of their elimination.  Materials and methods: the study was focused on non-sterile  medicinal products tested for microbial quality: N-methylglucamine, L-Malic  acid, Xeroform, Fingolimod hydrochloride, Succinic  acid, Streptocide,  Aripiprazole, Doxazosin, Clopidogrel,  Moxonidine, Tilorone,  Mycophenolic acid, Folic acid, Gabapentin, Dutasteride, Imatinib,  Temozolomide. The study involved the use of the following test strains: Bacillus subtilis, Bacillus cereus, Candida albicans, Escherichia coli, Aspergillus brasiliensis, as well as of reagents and growth media. The methods  used were determination of antimicrobial  activity under conditions of microbial quality testing, and modified in-depth  testing of microbial quality of medicinal products according to the requirements of the State Pharmacopoeia of the Russian Federation, 13th edition. Results: the analysis of literature sources helped reveal the main factors causing false results of microbiological  testing and determine  ways of their elimination.  The article sets forth the results of experimental comparison of two ways of sample preparation  for solid formulations: the standard one described in the State Pharmacopoeia of the Russian Federation, 13th edition, and the one involving the use of a laboratory shaker. The article provides experimental data on specific aspects of elimination of antimicrobial activity against B. subtilis and B. cereus and the use of specific inactivators for particular medicinal products. Conclusions: a set of measures aimed at prevention of false-positive and false-negative testing results should include: sterility control of the growth media and reagents used, monitoring  of facilities; control of growth promotion  properties and selectivity of the growth media; selection of adequate incubation  conditions  and inoculation procedure with due regard to the dosage form; justification of the amount of sample, diluents and dilution factor used; consideration  of the antimicrobial activity of a medicinal product.
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