中药乳香、没药配方颗粒微生物限度检查方法适用性验证  

The Suitability of Methods of the Microbial Limit Test for Boswellia Carterii and Myrrh Chinese Herbal Granules

作　　者：周志 庄意琼 罗俊 应国红 ZHOU Zhi;ZHUANG Yiqiong;LUO Jun;YING Guohong(Shenzhen Institute for Drug Control,Shenzhen,Guangdong 518000,China)

机构地区：[1]深圳市药品检验研究院,广东深圳518000

出　　处：《今日药学》2018年第7期442-444,共3页Pharmacy Today

摘　　要：目的建立活血祛瘀类中药乳香、没药配方颗粒的微生物限度检查方法。方法按2015年版中国药典4部通则1105和1106,进行微生物限度检查方法适用性试验。结果需氧菌总数:乳香采用1∶500供试液薄膜过滤法(500 m L/膜),没药采用1∶50供试液平皿倾注法;霉菌和酵母菌总数均采用1∶10供试液平皿倾注法,控制菌均采用常规法检查。结论中药配方颗粒乳香、没药均对枯草芽孢杆菌有抑制作用,但乳香抑菌作用更加强烈,需通过增大稀释比例的薄膜过滤法消除抑菌作用。OBJECTIVE To establish methods for microbial limit test on Boswellia Carterii and Myrrh Chinese herbal granules which can promote blood circulation and remove stasis. METHODS The suitability of methods of the microbial limit test were performed based on the regulations of 1105 and 1106 of Chinese Pharmacopoeia（ 2015 Edition） Vol Ⅳ. RESULTS TAMC in Boswellia Carterii Chinese herbal granules could be tested by the membrane filtration method（ test solution 1 ∶ 500,500 m L/film）.TAMC in Myrrh Chinese herbal granules can be tested by Pour-plate method（ test solution 1 ∶50）. TYMC in both granules can be tested by Pour-plate method（ test solution 1 ∶10）. Specified micro-organisms can be tested by routine method. CONCLUSION Both granules have bacteriostasic effect on Bacillus Subtilis. The bacteriostasis of Boswellia Carterii is more intense which need to use the membrane filtration method with high dilution ratio to eliminate.

关 键 词：中药配方颗粒 乳香 没药 微生物限度 方法适用性试验 

分 类 号：Q93-332[生物学—微生物学]