摘要
目的:优选洛伐他汀胶囊处方工艺。方法:设计正交试验优选最佳制备条件并进行体外溶出度试验。结果:根据单因素分析及正交试验结果,得最佳处方:以10%聚乙烯吡咯烷酮为黏合剂、羧甲基淀粉钠内外加法(2∶1)为崩解剂,并以颗粒装囊,二次制粒时以75%乙醇为润湿剂。优选工艺所制胶囊30min体外溶出度在92%以上。结论:该制剂工艺稳定,重现性好,体外溶出速率高。
OBJECTIVE: To optimize the preparation technology for the lovastatin capsules. METHODS: Orthogonal test was used to optimize the conditions for the technology of preparation meanwhile a dissolution test was conducted. RESULTS: According to the results of the single factor analysis and orthogonal test, the optimal condition for the lovastatin capsules were as follows: agglomerant: 10%PVP; disintegrator: CMS-Na was used by combining exterior and interior addition (2 : 1); stuffing capsule by granules; wetting agent of twice granulating: 75% alcohol. The 30 min dissolution rate of the capsules prepared in the optimized technology reached above 92%. CONCLUSION: This preparation is stable in technology, reproducible and with high dissolution rate.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第31期2435-2437,共3页
China Pharmacy
基金
河北省科技攻关项目(42761220)
河北省中医药管理局资助项目(05015)
河北大学人才引进项目(y2004039)
河北大学自然科学基金资助项目(2005Y08)
关键词
正交设计
洛伐他汀
聚乙烯吡咯烷酮
处方工艺
Orthogonal design
Lovastatin
Polyvinylpyrrolidone
Formulation and technology