盐酸小檗碱肠溶缓释片制剂工艺研究  

Preparation of Berberine Hydrochloride Enteric-coated Sustained Release Tablets

作　　者：林青薇 钟华林 李沛波[1] 吴灏 彭维[1] 苏薇薇[1] 程春雷 王永刚[1] LIN Qingwei;ZHONG Hualin;LI Peibo;WU Hao;PENG Wei;SU Weiwei;CHENG Chunlei;WANG Yonggang(Guangdong Engineering and Technology Research Center for Quality and Efficacy Re-evaluation of Post-marketed TCM,Guangdong Key Laboratory of Plant Resources,School of Life Sciences,Sun Yat-sen University,Guangzhou 510275,China;Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]中山大学生命科学学院,广东省中药上市后质量与药效再评价工程技术研究中心/广东省热带亚热带植物资源重点实验室,广东广州510275 [2]山东省食品药品检验研究院,山东济南250101

出　　处：《药学研究》2022年第5期307-311,共5页Journal of Pharmaceutical Research

基　　金：广州市科技计划项目(No.202002020030)。

摘　　要：目的研究盐酸小檗碱肠溶缓释片的制剂工艺。方法采用体外释放度评价的方法,以单因素设计及正交设计筛选片芯处方及工艺,并对片芯进行肠溶包衣,制备盐酸小檗碱肠溶缓释片。结果体外释放度实验显示,片芯及肠溶片均符合Higuchi释药模型。结论盐酸小檗碱肠溶缓释片工艺稳定,体外释放符合设计要求。Objective To study the preparation of Berberine Hydrochloride Enteric-coated Sustained Release Tablets.Methods Using the in vitro release evaluation method,the formula and process of Berberine Hydrochloride Enteric-coated Sustained Release Tablets were screened by single factor design and orthogonal design,and the tablets were coated with enteric-coating.Berberine Hydrochloride Enteric-coated Sustained Release Tablets were prepared.Results In vitro release test showed that both core and enteric-coated tablets fit Higuchi′s drug release model.Conclusion The technology of Berberine Hydrochloride Enteric-coated Sustained Release Tablets was stable;In vitro drug release met the design requirements.

关 键 词：盐酸小檗碱 肠溶缓释片 体外释放 

分 类 号：TQ460.6[化学工程—制药化工]