摘要
目的:对自制羟基喜树碱(HCPT)缓释片进行质量评价以及初步稳定性考察。方法:对以最优处方所制备的缓释片进行片质量差异、含量均匀性以及释放均一性测定和质量控制;缓释片分别于空气、高温、高湿、光照条件下放置,测定其稳定性。结果:自制HCPT缓释片的片质量差异限度符合规定,含量约在20%左右,释放均一性良好;经各种影响因素试验,仅高温对制剂的外观、含量、累积释放百分率等无显著性影响。结论:自制HCPT缓释片制剂应在30℃,25%相对湿度条件下避光保存。
OBJECTIVE To investigate the quality and stability of hydroxycamptothecin（HCPT） sustained-released tablets （SRT）. METHODS Evaluating the SRT quality via determination of weight variation, content uniformity and release homogeneity; after exposure to air, high temperature, high humidity or light, determination of the SRT stability. RESULTS The weight variation of prepared SRT consistent with regulation, content was 20%, release homogeneity was good; the influencing factor test showed the SRT need to preserve under drying and protect from light. CONCLUSION The HCPT SRT is stable in 30 ℃ ,relative humidity 25% and away from light.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2011年第5期384-388,共5页
Chinese Journal of Hospital Pharmacy
关键词
羟基喜树碱
缓释片
质量评价
稳定性
hydroxyeamptotheein
sustained-released tablet
quality determination
stability
