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海布胶囊原料药稳定性实验研究
引用本文:王喜斌,左红香,王曼力,黄耀林,刘庆波,孙亚楠.海布胶囊原料药稳定性实验研究[J].北华大学学报(自然科学版),2015(1):54-57.
作者姓名:王喜斌  左红香  王曼力  黄耀林  刘庆波  孙亚楠
作者单位:北华大学药学院,吉林 吉林,132013;吉林省吉林中西医结合医院,吉林 吉林,132011
基金项目:吉林省中医药管理局科技资助项目
摘    要:目的考察海布胶囊原料药的稳定性.方法按药物稳定性实验指导原则进行影响因素实验、加速实验和长期实验.结果海布胶囊原料药在实验前后的外观、鉴别、吸湿性、微生物限度检查等均符合规定,实验前后比较差异无统计学意义(P0.05).结论海布胶囊于室温条件下保存质量稳定,有效期可达2 a.

关 键 词:海布胶囊  原料药  稳定性  加速实验

Stability Investigation of Bulk Drug in Haibu Capsule
Wang Xibin,Zuo Hongxiang,Wang Manli,Huang Yaolin,Liu Qingbo,Sun Yanan.Stability Investigation of Bulk Drug in Haibu Capsule[J].Journal of Beihua University(Natural Science),2015(1):54-57.
Authors:Wang Xibin  Zuo Hongxiang  Wang Manli  Huang Yaolin  Liu Qingbo  Sun Yanan
Institution:Wang Xibin;Zuo Hongxiang;Wang Manli;Huang Yaolin;Liu Qingbo;Sun Yanan;College of Pharmacy,University of Beihua;Jilin Province Hospital of Integrated Traditional and Western Medicine;
Abstract:Objective The stability of bulk drug in Haibu capsule was investigated. Method Stress test, accelerated test and long-term test were carried out according to the principles referring to the drug stability. Results The quality of the principal agent in Haibu capsule, including appearance, identification, moisture absorption and microorganism limitation, accorded with regulation after the stability tests, and no statistical difference was detected ( P<0 . 05 ) . Conclusion The bulk drug can maintain its stability and feasibility for 2 years at room temperature.
Keywords:Haibu capsule  bulk drug  stability  accelerated test
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