两种内服医院中药制剂微生物限度检查方法验证

目的：建立儿康合剂和清咽宁颗粒的微生物限度检查方法。方法：通过2种制剂对5个试验菌种的回收率来确定检查方法,同时验证控制菌大肠埃希菌的检查方法。结果：儿康宁合剂对5个规定菌株的正常生长无影响;清咽宁对大肠埃希菌、枯草芽孢杆、白色念珠菌和黑曲霉的没有生物毒性,但抑制金黄色葡萄球菌的生长。结论：可采用常规法检查儿康宁合剂的霉菌、酵母菌数和细菌总数以及控制菌;采用培养基稀释法检查清咽宁颗粒细菌总数,常规法检查霉菌、酵母菌数和控制菌。

Validation of Microbial Limit Test Method for Two Kinds of Oral Chinese Drugs Pharmaceutics

Objective： To establish the method of microbial limit test for ErKang mixture and QingYanNing granule. Methods： The inspection method was determined according to recovery of the 5 test strain rate of the two kinds of Pharmaceutics, and method to control the bacteria Escherichia coli was checked. Results： ErKang mixture showed no affecting the normal growth of the 5 provisions to mixture strains; QingyanNing granule showed no biological toxicity on Escherichia coli, Bacillus rod, Candida albicans and Aspergillus niger, but inhibited the growth of Staphylococcus aureus. Conclusion： The conventional methods can be used to check the mold, yeast mixture and the number of total bacteria as well as the control bacteria of ErKang mixture; The medium dilution method can be used to check the total number of bacteria of QingYanNing granule, and conventional methods for mold, yeast mixture and the control bacteria.