云南白药胶囊微生物限度检查方法学研究

Study on Verification of Microbial Limit Test of Yunnan Baiyao Capsules

目的建立云南白药胶囊的微生物限度检查方法。方法按照《中国药典》2020年版四部通则1105、1106,分别采用常规法、稀释法、中和法进行方法适用性试验,计算各试验菌回收比值。结果中和法可消除药物抑菌性,微生物计数法各试验菌回收比值均在0.5~2范围内;控制菌检查阳性对照组检出相应控制菌,阴性对照组无菌生长。结论中和法适用于云南白药胶囊微生物限度检查。

Objective To establish a method for microbial limit test of Yunnan Baiyao Capsules.Methods According to General Rules 1105,1106 of Chinese Pharmacopoeia(2020 Edition),the applicability test of the method was carried out by the conventional method,dilution method and neutralization method respectively,and the recovery ratios of the test bacteria were calculated.Results The neutralization method could eliminate the bacteriostasis of the drug,and the recovery ratios of all the tested bacteria in the microbial counting method were in the range of 0.5-2.The corresponding control bacteria were detected in the positive control group,and aseptic growth was shown in the negative control group.Conclusion Neutralization method can be suitable for microbial limit test of Yunnan Baiyao Capsules.