目的：按照中国药典2015年版进行中成药的微生物限度检查法适用性试验，以达到减少中成药微生物日常检测方法建立工作量和提高检测效率的目的。方法：按照中国药典2015年版通则1105、1106和1107，采用平皿法和薄膜过滤法分别对包括口服溶液剂、颗粒剂、丸剂、胶囊剂和片剂的5类50种（每类10种）常见中成药进行需氧菌、霉菌和酵母菌检查法的适用性试验。结果：需氧菌总数计数：口服溶液剂1种可以采用原液平皿法，剩下9种采用1∶10平皿法检查；颗粒剂9种可以采用1∶10平皿法，剩下1种采用1∶20平皿法检查；10种胶囊剂和10种丸剂全部均需稀释后再采用平皿法进行检查；片剂3种可采用1∶10平皿法，5种需稀释后采用平皿法，剩下2种则需要采用薄膜过滤法检查。霉菌和酵母菌总数计数：口服溶液剂全部可以采用原液平皿法，颗粒剂、丸剂、胶囊剂和片剂全部可以采用1∶10平皿法检查。结论：中成药口服液和颗粒剂的抑菌性一般较弱，宜在较低稀释级下采用平皿法进行微生物检测；丸剂和胶囊剂大的抑菌作用一般比较明显，宜采用高稀释级平皿法检测；片剂有些抑菌作用很弱，有些抑菌作用则很强，需根据实际情况采用不同稀释级平皿法或薄膜过滤法检测。
Objective: To establish and validate the microbial limit test methods for determination of Chinese patent drugs(CPTs),via "Chinese Pharmacopoeia 2015",to achieve the purposes of reducing daily workload for method development and improving test efficiency.Methods: According to the general guidelines of 1105,1106,and 1107 in Chinese Pharmacopoeia 2015,the experiments were performed by using plate method and membrane filtration method to validate the aerobic bacteria,mycete,and saccharomycetes test methods for determination of 50 CPTs including oral liquids,granules,pills,capsules,and tablets(10 drugs for each form).Results: For the test of count of the aerobic bacteria,one oral liquids sample can be carried out by original solution plate method,and the remaining 9 using 1:10 plate method.1:10 plate method can be used for 9 granules drugs,and 1:20 plate method was used for the rest one.All the pills and capsules investigated were performed with dilution and then plate method.Three tablets can be tested with 1:10 plate method,5 should be diluted and then tested by plate method,and the remaining 2 must be tested by membrane filtration method.For the test of enumeration of mycete and saccharomycetes,all of the investigated oral liquids could be carried out by original solution plate method,and all of the investigated granules,pills,capsules,and tablets were tested by 1:10 plate method.Conclusion: The antibacterial activities of CPTs with forms of oral liquid and granule were weak generally,and they could be tested by plate method at low level of dilution.The antibacterial activities of many CPTs with forms of pill and capsule were obvious,and thus they should be tested by plate method with high dilution level.The antibacterial activities of CPTs with form of tablet vary greatly,and plate method with different dilution and membrane filtration method should be used for their microbial limit test depending on the actual situation.
