川芎续骨止痛胶囊、芦黄参花胶囊及黄连止泻胶囊的微生物限度检查方法  

Microbial limit test methods of Chuanxiong Xugu Zhitong capsule,Luhuang Shenhua capsule and Huanglian Zhixie capsule

作　　者：高军 钟天明 何进 任雪 何静 Gao Jun;Zhong Tianming;He Jin;Ren Xue;He Jing(Department of Pharmacy,General Hospital of the Northern Theater Command,Shenyang 110016,China)

机构地区：[1]北部战区总医院药剂科,沈阳110016

出　　处：《中国临床实用医学》2021年第6期12-16,共5页China Clinical Practical Medicine

基　　金：军队医疗机构制剂标准提高科研专项课题(13ZJZ02)。

摘　　要：目的建立川芎续骨止痛胶囊、芦黄参花胶囊及黄连止泻胶囊的微生物限度检查方法。方法按照《中国药典》2015年版四部通则1105、1106、1107的有关规定和"军队医疗机构制剂标准提高计划"的总体要求,采用自然沉降法联合常规平皿法检测川芎续骨止痛胶囊和芦黄参花胶囊的需氧菌总数、霉菌及酵母菌总数。采用培养基稀释法检测黄连止泻胶囊的需氧菌总数、霉菌及酵母菌总数。采用常规法检查川芎续骨止痛胶囊、芦黄参花胶囊及黄连止泻胶囊的控制菌。结果计数方法试验中,各试验菌回收率均在0.5~2.0之间;控制菌检查中,均可检出阳性菌。结论建立的检查方法准确可重复,简便可行,适用于川芎续骨止痛胶囊、芦黄参花胶囊、黄连止泻胶囊的微生物限度检查。Objective To establish a microbial limit test method for Chuanxiong Xugu Zhitong capsule,Luhuang Shenhua capsule and Huanglian Zhixie capsule.Methods According to the relevant provisions of general principles 1105,1106 and 1107 of the fourth part of the"Chinese Pharmacopoeia"2015 edition and the overall requirements of the"preparation standard improvement plan for military medical institutions",the total number of aerobic bacteria,molds and yeasts in Chuanxiong Xugu Zhitong capsule and Luhuang Shenhua capsule were detected by natural sedimentation method combined with conventional plate method.The total number of aerobic bacteria,molds and yeasts in Huanglian Zhixie capsule were detected by medium dilution method.The control bacteria of Chuanxiong Xugu Zhitong capsule,Luhuang Shenhua capsule and Huanglian Zhixie capsule were examined by routine method.Results In the counting method test,the recovery of each test strain was between 0.5 to 2.0;Positive bacteria can be detected in the control bacteria test.Conclusion The established method is accurate,repeatable,simple and feasible.It is suitable for the microbial limit test of Chuanxiong Xugu Zhitong capsule,Luhuang Shenhua capsule and Huanglian Zhixie capsule.

关 键 词：川芎续骨止痛胶囊 芦黄参花胶囊 黄连止泻胶囊 微生物限度检查 计数方法适用性试验 控制菌检查方法适用性试验 

分 类 号：R286.0[医药卫生—中药学]