益气通便颗粒微生物限度检查法研究

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。

Study on the Method of Microbial Limit Test of Yiqitongbian Grain

Objective： To establish the method of microbial limit test of Yiqitongbian grain. Methods：According to the China Pharmacopoeia 2010 Edition appendix of microbial limit test method test guideline, use the culture medium dilution method and the routine method to determine the microbial limits of Yiqitongbian grain. Results：The recovery of the strain rate was more than 70 %, the experimental group were verified by test bacteria in the control bacterium of conventional method;by method validation indicated that bacteria, rail dew and yeast inspection, medium dilution can be used to control bacteria, mildew and yeas（s inspection of bacteria test, the routine method can he used to check Controling bacteria. Conclusion. The established Yiqitongbian grain of microbial limit test method is accurate,reliable,feasible,and can carry out the measurement of microbial limit for its effective.