4种医院制剂的微生物限度检查及适用性研究

Microbial limit tests and applicability research of 4 kinds of hospital preparations

目的建立4种医院制剂(儿咳清合剂、亚甲康胶囊、清宁胶囊、古墨愈痔膏)的微生物限度检查方法。方法按照《中华人民共和国药典》(四部)2015年版制剂通则中的方法进行试验,对4种医院制剂进行需氧菌、霉菌及酵母菌检查,并进行适用性试验。结果儿咳清合剂、古墨愈痔膏采用常规法检查,无抑菌作用;清宁胶囊采用常规法检查,对金黄色葡萄球菌有抑制作用,采用培养基稀释法(每皿0.2 mL)检查,可消除其抑菌作用;亚甲康胶囊采用常规法检查,对金黄色葡萄球菌和枯草芽孢杆菌均有抑制作用,采用培养基稀释法(1∶100供试品溶液,每皿0.5 mL)检查,均可消除其抑菌作用。结论通过方法学适用性试验,能有效地消除或减弱制剂中抑菌成分的影响,从而使检测结果与实际更接近,进一步说明了医院制剂微生物限度检查及适用性研究的重要性和必要性。

Objective To establish the microbial limit tests method for 4 kinds of hospital preparations[Erkeqing Heji( 儿咳清合剂),Yajiakang Jiaonang( 亚甲康胶囊),Qingning Jiaonang( 清宁胶囊) and Gumo Yuzhi Gao( 古墨愈痔膏) ]. Methods According to the methods in the 2015 edition of the general provisions for preparations in Pharmacopoeia of the People’s Republic of China( part Ⅳ),aerobe,fungus and saccharomycetes were tested for 4 hospital preparations,together with their applicability test. Results Erkeqing Heji and Gumo Yuzhi Gao were tested by routine examination method without bacteriostasis. Qingning Jiaonang was tested by routine examination method with inhibition on staphylococcus aureus,which could be eliminated by culture medium dilution method( 0.2 m L per dish). Yajiakang Jiaonang was tested by routine examination method with inhibition on staphylococcus aureus and bacillus subtilis,which could be eliminated by culture medium dilution method( 1 ∶ 100 test solution,0.5 m L per dish). Conclusion Through the methodological applicability test,the influence of bacteriostatic ingredients in the preparation can be effectively eliminated or weakened,so that the test results are closer to the reality. It further illustrates the importance and necessity of microbial limit test and applicability research of hospital preparations.