CAJ | 학술논문

目的：优选具有缓释特征的盐酸苄丝肼固体分散体的制备工艺。方法以与左旋多巴微囊溶出行为的相似度为指标，采用均匀试验优选出满足缓释要求的盐酸苄丝肼固体分散体制备工艺，并对其制剂特征进行考察。结果优选出的盐酸苄丝肼固体分散体处方为：主药与辅料的质量比为1∶1，聚乙烯吡咯烷酮（PVP）与乙基纤维素（EC）的质量比为1∶3。结合 X-衍射试验结果及释放度行为，采用优选工艺处方制得了盐酸苄丝肼固体分散体。初步稳定性试验表明盐酸苄丝肼固体分散体的理想贮存条件是室温、遮光密封干燥保存。结论优选出的盐酸苄丝肼固体分散体处方合理，制备工艺稳定、科学、可行。制得的固体分散体满足缓释的要求，同时盐酸苄丝肼的释放行为与左旋多巴的释放行为相似。
목적：우선구유완석특정적염산변사정고체분산체적제비공예。방법이여좌선다파미낭용출행위적상사도위지표，채용균균시험우선출만족완석요구적염산변사정고체분산체제비공예，병대기제제특정진행고찰。결과우선출적염산변사정고체분산체처방위：주약여보료적질량비위1∶1，취을희필각완동（PVP）여을기섬유소（EC）적질량비위1∶3。결합 X-연사시험결과급석방도행위，채용우선공예처방제득료염산변사정고체분산체。초보은정성시험표명염산변사정고체분산체적이상저존조건시실온、차광밀봉간조보존。결론우선출적염산변사정고체분산체처방합리，제비공예은정、과학、가행。제득적고체분산체만족완석적요구，동시염산변사정적석방행위여좌선다파적석방행위상사。
Objective To optimize the preparation program of solid dispersion of benserazide hydrochloride. Methods According to the in vitro release behavior of levodopa microcapsules,the data which were ana-lyzed by the statistical method-similar factor method were selected as indexes,the uniform design was used to optimize the process of benserazide solid dispersion.And the character of dosage form was elevated. Results The selected preparation formula is as following:the mass ratio between benserazide and excipi-ents is 1∶1,the mass ratio between polyvinyl pyrrolidone and ethyl cellulose is 1∶3.According to the re-sults of X-ray and dissolution,benserazide solid dispersion is prepared successfully.Benserazide solid dis-persion should be stored in shading and seal conditions.Conclusion The selected preparation formula is reasonable.The condition of preparation is stable,reasonable and feasible.The solid dispersion has slow release behavior and the release behavior is the same as levodopa microcapsules.