20种中成药微生物限度检查方法验证

目的：建立20种中成药微生物限度检查方法。方法：按《中国药典》（2010版）的规定，进行各品种微生物限度检查方法的验证。结果：13个品种（感冒清热颗粒、解郁安神颗粒、千柏鼻炎片、男宝胶囊、心脑康胶囊、利肺片、养血安神片、护肝片、清脑降压片、治咳枇杷露、小儿化痰止咳糖浆、复方胆通片、血栓心脉宁胶囊）无抑菌作用，回收率均大于70%，可采用常规法进行细菌数测定；5个品种（抗骨增生片、炎立消片、痹欣片、炎可宁片、痔速宁片）对金黄色葡萄球菌和枯草芽孢杆菌有不同程度的抑菌作用，可采用培养基稀释法（前3个0.5 mL/皿、后2个0.2 mL/皿）进行细菌数测定；2个品种（四季三黄片、板兰根咀嚼片）对金黄色葡萄球菌和枯草芽孢杆菌有较强的抑制作用，可采用薄膜过滤法进行细菌数测定，所有品种的霉菌、酵母菌和控制菌数均采用常规法进行测定。结论：以上验证方法作为各品种微生物限度检查方法是可行的。

Method Validation on Microbial Limit Test of 20 Kinds of Traditional Chinese Medicines

Objective： To establish a method for microbial limit test of 20 kinds of traditional Chinese medicines. Methods：According to the requirements set furth in the Chinese Pharmacopoeia of 2010 edition,method validation was conducted on microbial limit test of different varieties of traditional Chinese medicines. Results：About 13 varieties （such as cold heat particles,jieyu anshen granules,qianbai biyan tablets,male capsules,xinnaokang capsules,the lung,nourishing and sedative tablets,hugan tablets,qingnaojiangya tablets,cough loquat,pediatric phlegm cough syrup,compound dantong tablets and xueshuanxinmaining capsules） had no bacteriostatic effect,the recovery rate was more than 70% and the conventional method can be used to determine the number of bacteria. Five varieties （such as kangguzengsheng tablets, yanlixiao tablets,bixin tablets,yankening tablets and zhisuning tablets） had bacteriostatic effect to some extent on Staphylococcus aureus and Bacillus subtili. The culture medium dilution method （0.5mL and 0.2mL per dish for the first 3 and later 2 respectively） can be used for bacterial counting. Two medicines （four seasons in sanhuang tablets and chewable tablets of banlangen） had strong bacteriostatic effect on Staphylococcus aureus and Bacillus subtilis,and the bacterial numbers can be determined by membrane filtration method. Mould and yeast counts and control bacteria of all varieties can be determined by conventional test methods. Conclusion：The method verification showed that the microbial limit test is feasible for different varieties of traditional Chinese medicines.