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3种软膏剂的微生物限度检查验证
引用本文:陆益萍. 3种软膏剂的微生物限度检查验证[J]. 安徽医药, 2008, 12(4): 318-319
作者姓名:陆益萍
作者单位:浙江省金华市第五医院,浙江,金华,321001
摘    要:目的建立3种医院乳膏剂的微生物限度检查方法。方法采用5种阳性对照菌,通过回收率试验,测定它们是否有抑菌活性。结果复方曲安奈德樟脑乳膏(Ⅱ)、维生素E尿囊素乳膏(Ⅱ)这二种供试品试验菌回收率均高于70%,证明无抑菌作用;15%复方硫乳膏(Ⅲ)有抑菌作用,但通过培养基稀释法可消除抑菌作用。结论复方曲安奈德樟脑乳膏(Ⅱ)、维生素E尿囊素乳膏(Ⅱ)可按常规方法进行微生物限度检查,15%复方硫乳膏(Ⅲ)需按培养基稀释法进行微生物限度检查。

关 键 词:医院制剂  微生物限度  方法验证  抑菌作用
修稿时间:2007-11-27

Determination of microbial limit in three hospital creams
LU Yi-ping. Determination of microbial limit in three hospital creams[J]. Anhui Medical and Pharmaceutical Journal, 2008, 12(4): 318-319
Authors:LU Yi-ping
Affiliation:LU Yi-ping ( The Fifth Hospital ,Jinhua, Zhefiang 321001, China )
Abstract:Aim To establish an examination method for microbial limit determination of three hospital creams. Method Five positive control bacterium was employed, and determined microbial inhibitory activity by means of reclaim rate test. Results Regarding the compound triamcinolone acetonide acetate ( Ⅱ ) and the compound vitamin e cream ( Ⅱ ), the recovery rate of each batch was more than 70%. It proved no bacteriostasis existed. 15% of compound sulphur cream ( Ⅲ )have bacteriostasis, but the bacteriostatic action could be eliminated by medium dilution method. Conclusion The compound triamcinolone acetonide acetate ( Ⅱ ) and the compound vitamin e cream ( Ⅱ ). The conventional examination method of microbial limit determination can be carried out for the compound triamcinolone acetonide acetate,while medium dilution methods are carried out for 15% of compound sulphur cream ( Ⅲ ).
Keywords:hospital preparation  microbial limit  method validation  bacteriostasis
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