10%水杨酸软膏微生物限度检查方法的适用性试验  

The validation of microbial limit test for 10% salicylic acid ointment

作　　者：沈秋莲 叶财发 倪晓霞[1] 陈锦珊[1] SHEN Qiu-lian;YE Cai-fa;NI Xiao-xia;CHEN Jin-shan(Department of Pharmacy,the 909th Hospital of the Joint Logistics Support Force of PLA/the Affiliated Southeast Hospital of Xiamen University,Zhangzhou 363000,Fujian,China)

机构地区：[1]解放军联勤保障部队第九○九医院(厦门大学附属东南医院)药剂科,漳州363000

出　　处：《东南国防医药》2021年第2期159-163,共5页Military Medical Journal of Southeast China

摘　　要：目的建立医院制剂10%水杨酸软膏的微生物限度检查方法。方法根据《中国药典》2015年版四部通则1105、1106及1107检测规则,对10%水杨酸软膏微生物限度检查的稀释剂种类、稀释级及pH值等进行考察,并对需氧菌总数、霉菌和酵母菌总数计数及控制菌检查方法进行适用性验证。结果以0.9%氯化钠注射液作为供试液稀释剂时,1∶10~1∶100稀释级供试液pH值在2.30~2.81之间,采用常规法、培养基稀释法时5种试验菌种的回收率均低于0.5,且该制剂有抑菌作用,表明选用的稀释剂及方法不适用。以pH 7.0氯化钠-蛋白胨缓冲液为供试液稀释剂时,1∶10~1∶100稀释级供试液pH在5.53~6.88之间,采用常规法时5种试验菌种的回收率均在0.5~2.0范围内,且该制剂无抑菌作用,表明选用的稀释剂及方法适用。结论10%水杨酸软膏微生物限度检查宜选用pH 7.0氯化钠-蛋白胨缓冲液作为供试液的稀释剂,检查方法为常规法。Objective To establish a microbial limit test method for 10%salicylic acid ointment which is hospital preparation.Methods The test was carried out according to the requirements of provision 1105,1106 and 1107 of rules of preparation in volume IV of Chinese Pharmacopoeia of 2015 edition.The dilution type,dilution grade and pH of microbial limit test for 10%salicylic acid ointment were investigated,and the total number of aerobic bacteria,molds and yeasts and the control bacteria inspecting methods were validated for applicability.Results When 0.9%Sodium Chloride Injection was used as the diluent of the test solution,the pH of the test solutions at 1∶10-1∶100 dilution level were between 2.30-2.81.And the recovery ration of five test bacteria was ranged under 0.5 using the routine method and culture medium dilution method.Moreover,the preparation had antimicrobial activities.These results showed that the selected diluent and method were not suitable for this preparation.When pH7.0 sodium chloride-peptone buffer was used as the diluent of the test solution,the pH of the test solutions at 1∶10-1∶100 dilution level were between 5.53-6.88.And the recovery ration of five test bacteria was ranged from 0.5 to 2.0 using the routine method.Moreover,the preparation had no antimicrobial activities.These results showed that the diluent and method were suitable for this preparation.Conclusion The microbial limit test of 10%salicylic acid ointment should choose pH7.0 sodium chloride-peptone buffer as the diluent of the test solution and the inspection method should use routine method.

关 键 词：水杨酸软膏 微生物限度检查 常规法 培养基稀释法 适用性试验 

分 类 号：R927[医药卫生—药学]