药品微生物限度检查方法适用性试验中加菌方式的实验研究

目的：考察药品微生物限度检查方法适用性试验中不同加菌方式对实验结果的影响。方法：选择具有代表性的95种非无菌制剂，以《中华人民共和国药典》（以下简称中国药典）2010年版规定的5株验证菌70%回收率为指标，分别在样品（A）、供试液（B）和培养基（C）环节加入验证菌株进行计数方法的回收验证实验。结果：95种样品中可在样品阶段加菌通过回收实验的有36种（38%）；可在供试液环节加菌通过回收实验的有52种（55%）；必须在培养基环节加菌才能通过验证实验的有43种（45%）。结论：方法适用性实验中供试品溶液制备和实验过程及样品本身的抑菌活性对验证菌株存在多重影响，微生物限度检查法选择首选在供试液环节加入验证菌株，具有可操作性和合理性。

Objective:To investigate the effects of different microorganism introduction method-in suitability test of microbial limit test.Method:According to ChP 2010,the recovery-rates of 5 bacteria strains all showed over 70%,which was the acceptance criteria.For 95 kinds of selected nonsterile products,we validated the recovery rate of counting method by adding validation-strains in the sample (A),in the sample solution (B)and in the medium (C),respectively.Result:Through the recovery experiment in all 95 samples,introduction of validation strains in the sample (A)worked for 36 (38%)samples;introduction of validation-strains in the sample solution (B)worked for 52 (55%)samples and there were 43 (45%)samples that had to introduce validation strains in the medium (C).Conclusion:There are multiple effects for tested strains during method validation,such as solution preparation,experimental process and antibacterial activities of the sample itself. It is such a method of operability and reasonableness that added the validation strains in the sample solution.

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