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目的:建立对2种含硫黄制剂(硫软膏和喘舒片)进行微生物限度检查的方法。方法:硫软膏供试液分别采用常规法、培养基稀释法、中和(加入中和剂亚硫酸钠)-常规法等进行验证试验,喘舒片供试液分别采用常规法、培养基稀释法和离心沉淀-薄膜过滤法、中和-培养基稀释法进行验证试验,并对筛选出的可行方法进行控制菌验证试验。结果:硫软膏检查中只有中和法对各菌的菌回收率均高于70%;喘舒片检查中细菌计数中只有中和法的菌回收率高于70%;控制菌验证试验中试验组结果均为阳性。结论:加入亚硫酸钠后可中和制剂中所含的硫黄而消除供试品抑菌活性。硫软膏细菌计数采用中和-常规法,喘舒片细菌计数采用中和-培养基稀释法,霉菌和酵母菌计数、控制菌检查采用常规法,试验结果符合要求。建立的方法简便、有效、可行,可作为这2种含硫黄制剂的微生物限度检查方法。
Objective: To establish a method for the determination of two kinds of sulfur-containing yellow preparations (sulfur ointment and asthma tablets) microbial limit test. Methods: The sulfur ointment test solution was respectively tested by conventional method, medium dilution method, neutralization (adding neutralizer sodium sulfite) - conventional method, etc. The test solution of astragalus membranaceus was respectively tested by routine method, medium dilution method and Centrifugal sedimentation - membrane filtration, neutralization - medium dilution method validation test, and the screening of feasible methods for control bacteria validation test. Results: Only the neutralization method in the sulfur ointment test for the recovery rate of each bacteria were higher than 70%; bacterial count in the asthmatic tablets only neutralization method of bacteria recovery was higher than 70%; control bacteria validation test Group results were positive. Conclusion: Adding sodium sulfite can neutralize the sulfur contained in the preparation to eliminate the antibacterial activity of the tested product. Sulfur ointment bacterial count using neutralization - conventional method, asthma Shu tablets bacterial count using neutralization - medium dilution method, count of molds and yeasts, control bacteria check by conventional methods, the test results to meet the requirements. The established method is simple, effective and feasible, and can be used as the limit of microorganisms for the two sulfur-containing yellow preparations.