益肺止咳胶囊微生物限度检查方法适用性研究

Study on Microbial Limit Test Method of Yifeizhike Capsule

目的建立益肺止咳胶囊的微生物限度检查方法。方法参考2015年版中国药典,采用平皿法对不同稀释倍数供试液进行微生物计数方法适用性试验;并考察不同体积培养基对控制菌检查方法适用性的影响。结果当供试液稀释倍数在1∶30时,需氧菌总数计数方法回收比值在0.5~2之间;当供试液稀释倍数在1∶10与1∶20时,霉菌和酵母菌总数计数方法回收比值均在0.5~2内;当采用常规法时,控制菌检查方法均能检出阳性对照菌。结论供试液稀释倍数分别为1∶30、1∶20,需氧菌总数计数、霉菌和酵母菌总数计数方法适宜、操作性好、重现性佳,可用于益肺止咳胶囊的微生物限度检查。

OBJECTIVE To establish microbial examination method for Yifeizhike capsule.METHODS According to the 4 th general rules of ChP(2015 Edition),the microbial counting method applicability test for different dilution factor of test solution by plate method was taken.And meanwhile the applicability test for control bacteria examination method was taken by using different volume culture medium.RESULTS With the 1∶30 dilution ratio,the recovery ratio of total aerobic bacteria counting method was between 0.5 and 2.The recovery ratio of the total number of mould and yeast was both in the range of 0.5-2,when the dilution ratio of the test solution was 1∶10 or 1∶20.Positive control bacteria could be detected by routine methods.CONCLUSION The methods of total aerobic bacteria count,total mould and yeast count are suitable,operable and reproducible,while the dilution factor of the test solution are 1∶30 and 1∶20,respectively.And the method which is obtained from this study can be used for the microbial examination.