曲克芦丁注射液无菌检查法方法学研究

目的:验证曲克芦丁注射液无菌检查方法,确认曲克芦丁注射液在该检验量、该检验条件下无抑菌活性或其抑菌活性被充分消除到可以忽略不计。以保证检验结果的准确、可靠及检验方法的专属性。方法:按照《中国药典》2010年版二部附录ⅪH无菌检查法进行方法学验证试验。结果:与对照组比较,含供试品的各滤筒中试验菌均生长良好,并与各对照组中相应的菌落生长情况相似,供试品对照组、阴性对照组均无菌生长。由此说明,在此检验条件和检验量下,供试品不存在抑制微生物生长的因素。因此,可照此检查法和检查条件进行曲克芦丁注射液的无菌检查。三批供试品无菌检查符合规定。结论:经方法学验证,采用薄膜过滤法进行曲克芦丁注射液的无菌检查,可有效检测样品无菌情况,为控制产品质量提供检测依据。

Objective: To verify the Troxerutin Injection asepsis inspection method, confirm Troxerutin Injection in the inspection, the inspection conditions without the antibacterial activity of the antibacterial activity was sufficient to eliminate or to negligible. In order to ensure the accuracy of the testing result, reliable and test method specificity. Methods: According to the Pharmacopoeia method 'China' 2010 two edition appendix Xi H sterility test method validation test. Results: Compared with the control group, the tested bacteria containing the cartridge products are growing well, and the colony growth of each control group of similar, the sample control group, negative control group are sterile growth. Therefore, the test conditions and test, samples of microbial growth inhibitory factor does not exist. Therefore, can according to the examination and inspection of Troxerutin injection asepsis check ding. Three batches of sterility test in accordance with the provisions. Conclusion: After verification methodology, asepsis check Troxerutin Injection using membrane filtration method can effectively detect the samples, sterile conditions, on the basis of testing for the product quality control.