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目的:建立益气通便颗粒微生物限度检验方法。方法:按《中国药典》2010版附录微生物限度检查法的验证试验指导原则,采用培养基稀释法和常规法对三个批号的益气通便颗粒进行微生物限度测定。结果:各菌种的回收率均大于70%,在控制菌常规法验证中实验组检出试验菌;通过方法学验证表明,细菌、霉菌及酵母菌检查可采用培养基稀释法检验,控制菌可采用常规法进行检验。结论:建立的益气通便颗粒微生物限度检验方法准确可靠、可行性强,能有效地对其进行微生物限度的测定。
Objective: To establish a method for testing the limits of microbiology of Yiqi Changbai granules. Methods: According to the Guiding Principles of Microbiological Limit Test of “Chinese Pharmacopoeia” (2010 edition) appendix, the microbiological limits of three batches of Yiqi Tongxu Granules were determined by medium dilution method and routine method. Results: The recoveries of all strains were more than 70%. The test strains were detected in the experimental group by the routine test of control bacteria. The validation of the method showed that the tests of bacteria, molds and yeasts could be carried out by the medium dilution method, Can be used to test the conventional method. CONCLUSION: The established method for the limit test of the Yiqi Changbai granules is accurate, reliable and feasible, and can be used for the determination of microbial limit effectively.