盐酸小檗碱肠溶缓释片制剂工艺研究 |
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作者姓名: | 林青薇 钟华林 李沛波 吴灏 彭维 苏薇薇 程春雷 王永刚 |
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作者单位: | 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 |
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基金项目: | 广州市科技计划项目(No.202002020030) |
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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。
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关 键 词: | 盐酸小檗碱 肠溶缓释片 体外释放 |
Preparation of Berberine Hydrochloride Enteric Coated Sustained Release Tablets |
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Authors: | LIN Qingwei ZHONG Hualin LI Peibo WU Hao PENG Wei SU Weiwei CHENG Chunlei WANG Yonggang |
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Institution: | 1. 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; 2. Shandong Institute for Food and Drug Control, Jinan, 256603, China |
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Abstract: | Objective To study the preparation of Enteric-coated Sustained-release Tablets of Berberine Hydrochloride.Methods Using the in vitro release evaluation method, the formula and process of berberine hydrochloride enteric-soluble sustained release tablets were screened by single factor design and orthogonal design, and the tablets were coated with Enteric-coating. Berberine hydrochloride enteric-soluble 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 Enteric-coated Sustained-release Tablets of Berberine Hydrochloride is stable; in vitro drug release meet the design requirements . |
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Keywords: | Berberine hydrochloride Enteric-soluble sustained-release tablets In vitro release |
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