乙胺吡嗪利福异烟片的制备及其质量和稳定性研究  

Preparation, quality control and stability investigation of ethambutol hydrochloride, pyrazinamide, rifampicin and isoniazid tablets

作　　者：周雪芹[1] 张修宇[1] 殷莉莉[1] 孙进[1] 

机构地区：[1]沈阳药科大学药学院

出　　处：《中国药剂学杂志（网络版）》2011年第3期45-50,共6页Chinese Journal of Pharmaceutics：Online Edition

基　　金：辽宁“百千万人才工程”人选资助项目(2008921027);国家科技部重大新药创制项目(2009ZX09301-012)

摘　　要：目的制备乙胺吡嗪利福异烟片,并对乙胺吡嗪利福异烟片进行质量和稳定性研究。方法用干法制粒压片制得乙胺吡嗪利福异烟片;采用HPLC法对主药成分利福平、异烟肼、吡嗪酰胺、盐酸乙胺丁醇的含量和稳定性进行考察;采用比色法对利福平的溶出度进行考察。结果乙胺吡嗪利福异烟片不同批次间4种主药的含量符合《中华人民共和国药典》规定,稳定性试验表明,样品质量均未见明显改变,暂定本品有效期为2年。溶出度试验表明,利福平45min的溶出度大于标示质量的70%(w),且同一批次和不同批次间的溶出度均一性良好。结论制备的乙胺吡嗪利福异烟片的含量均匀,产品稳定性好且溶出度符合要求。Objective To prepare ethambutol hydrochloride, pyrazinamide, rifampicin and isoniazid tablets, establish quality control method and investigate stability of the tablets. Methods The tablets were prepared by dry granulation method. Quality of the tablets, including drug contents and stability, was determined by HPLC. A colorimetric method was used to investigate the dissolution of rifampicin from the tablets. Results Contents of the four main drugs met the requirements described in Chinese pharmacopoeia. Based on the stability experiment data, shelf life of the tablets could be as long as 2 years. The cumulative dissolution percentage of rifampicin was beyond 70% in 45 min, with good reproducibility with samples of different batches. Conclusions The contents uniformity and stability of the ethambutol hydrochloride, pyrazinamide, rifampicin and isoniazid tablets are good and the dissolution percentage is up to the standard.

关 键 词：药剂学 乙胺吡嗪利福异烟片 干法制粒 溶出度 含量测定 稳定性 

分 类 号：R94[医药卫生—药剂学]