5种蒙药医院制剂微生物限度检查方法建立及探讨

Establishment and discussion of microbial limit test method for 5 kinds of Mongolian preparations

中文关键词:  蒙药  微生物限度  方法适用性  回收比值

英文关键词:Mongolian preparations  microbial limit  method validation  recovery ratio

中文摘要:

      目的 探讨5种蒙医院制剂的微生物限度检查方法。方法 采用2015年版《中国药典》第四部微生物限度检验方法, 对5种蒙医院制剂进行需氧菌、霉菌及酵母菌总数计数适用性实验以及控制菌的方法适用性进行实验。结果 需氧菌方法适用性中, 5种蒙医院制剂用1:10供试液按平皿法对枯草芽孢杆菌有抑菌作用, 森登二十五味丸、胡日查-6用1:10供试液按平皿法对金黄色葡萄球菌有不同程度的抑菌作用, 回收比值在0.5~2范围内; 5种蒙药制剂霉菌及酵母菌总数计数方法适用性可采用1:10供试液按平皿法进行测定。采用直接接种法进行5种制剂的控制菌检查, 无抑制作用。结论 森登二十五味丸、特木仁-5汤、苏龙嘎-4汤、哈布德仁九味散可用试液平皿法进行需氧菌方法适用性实验, 而胡日查-6可通过薄膜过滤法进行实验; 5种制剂平皿法进行霉菌和酵母菌数的检查, 而控制菌检查均可按直接接种法进行。

英文摘要:

      Objective To explore the microbial limit test method of 5 kinds of Mongolian preparations. Methods According to the provisions of the 2015 edition of the Chinese Pharmacopoeia (Part Ⅵ), 5 kinds of Mongolian hospital preparations were tested for aerobic bacteria, molds and yeasts count and applicability of control bacteria. Results In the applicability of aerobic bacteria, 5 kinds of Mongolian hospital preparations were bacteriostasis against Bacillus subtilis by the plate method at 1:10, Sendeng Ershiwu pills and Huricha-6 were bacteriostasis against Staphylococcus aureus by the plate method at 1:10, and the recovery ratios were within the range of 0.5-2. The applicability of the method for enumeration of fungi and yeast counts, 5 kinds of Mongolian medicine preparations could be determined at 1:10 for the test solution by plate method. The direct inoculation method was used to check the control bacteria of the 5 Mongolia preparations without any inhibitory effect. Conclusion Sendeng Ershiwu pills, Temuren-5 soups, Sulongga-4 soups and Habuderen 9 flavor powder can be used for the applicability test of aerobic bacteria by the method of test plate method, while the of Huricha-6 can be tested by membrane filtration. The 5 kinds of Mongolian preparations can be checked by the plate method for the number of molds and yeasts, and the control bacteria examination can be carried out according to direct inoculation method.