六种中药胶囊剂微生物限度检查方法验证

Validation of microbial limit test methods for six kinds of traditional Chinese medicine capsules

目的建立6种中药胶囊剂微生物限度检查方法。方法按照《中国药典》(2015年版)的规定,采用平皿法、薄膜过滤法对各胶囊剂试验菌株进行回收率试验,并对控制菌检查方法进行验证。结果复方乌参胶囊、夜宁胶囊、复方银杏叶胶囊、复方珍珠粉胶囊、黄元胶囊可采用平皿法进行需氧菌总数的测定;郁福来胶囊对金黄色葡萄球菌和枯草芽孢杆菌有较强的抑制作用,需采用薄膜过滤法去除其抑菌作用后方可进行需氧菌总数测定。复方乌参胶囊、复方珍珠粉胶囊及黄元胶囊采用培养基稀释法进行乙型副伤寒沙门菌控制菌检查,其他所有胶囊霉菌酵母菌总数和控制菌检查可采用常规法测定。结论所建验证方法可用作不同类型的中药胶囊剂的微生物限度检查,方法准确可靠,重复性好。

Objective To establish a method for microbial limit test of 6 kinds of traditional Chinese medicine capsules. Methods According to the 2015-edition Chinese Pharmacopoeia,conventional test method and membrane filtration method were used to do the recovery test,and the methods of checking control bacteria were also validated.Results Fufangwushen capsules,yening capsules,fufangyinxingye capsules,fufangzhenzhufen capsules and huangyuan capsules could use the plate method for total aerobic microbial counting. But the yufulai capsules had strong bacteriostatic effect on Staphylococcus aureus and Bacillus subtilis,and the total aerobic microbial count of them should be determined by membrane filtration method to eliminate the antibacterial effect. The Salmonella paratyphi B was detected by medium dilution method in fufangwushen capsules,fufangzhenzhufen capsules and huangyuan capsules,and the mould and yeast counts and the other control bacteria of the other capsules could be determined by conventional test methods. Conclusion The established microbial limit test is accurate,reliable and reproducible for different varieties of traditional Chinese medicine capsules.