中国医药科学2024,Vol.14Issue(1) :83-86,141.DOI:10.20116/j.issn2095-0616.2024.01.19

天癸苁盈颗粒制剂工艺研究

Study on the preparation process of Tiangui Congying Granules

张哲 王珊珊 张敏 胡开永 刘军 李艳英 黄能听 夏忠庭
中国医药科学2024,Vol.14Issue(1) :83-86,141.DOI:10.20116/j.issn2095-0616.2024.01.19

天癸苁盈颗粒制剂工艺研究

Study on the preparation process of Tiangui Congying Granules

张哲 1王珊珊 1张敏 2胡开永 2刘军 3李艳英 3黄能听 3夏忠庭1
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作者信息

  • 1. 盈科瑞(天津)创新医药研究有限公司,天津 300382
  • 2. 上海鼎辉医药有限公司,上海 201400
  • 3. 北京盈科瑞创新医药股份有限公司,北京 102200
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摘要

目的 研究天癸苁盈颗粒的制剂工艺,为产业化生产提供参考.方法 比较两种制粒方式,选择最优制粒方式;以制粒情况及成型率等为评价指标,选择辅料种类及载药量,确定制剂处方和成型工艺,并进行放大验证.结果 选择干法制粒方式,以糊精为填充剂,0.1%阿司帕坦为矫味剂,载药量为 65%,制得颗粒成型性好且硬度适中.结论 研究确定的制剂处方和制备工艺合理,工艺稳定性可控,重现性好,适合产业化生产.

Abstract

Objective To study the preparation process of Tiangui Congying Granules and provide a reference for industrial production.Methods The two granulation methods were compared and the optimal granulation method was selected.With the granulation situation and molding rate as evaluation indicators,the type of excipients and the drug loading were selected,the preparation formula and molding process were determined,and the amplification verification was conducted.Results The dry granulation method was selected,with dextrin as the filling agent and 0.1%Aspartame as the corrigent.The drug loading was 65%,resulting in good particle formability and moderate hardness.Conclusion The preparation formula and preparation process determined by the study are reasonable,with controllable process stability and good reproducibility,suitable for industrial production.

关键词

天癸苁盈颗粒/制剂工艺/湿法制粒/干法制粒

Key words

Tiangui Congying Granules/Preparation process/Wet granulation/Dry granulation

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基金项目

"科技助力经济2020"重点专项项目(SQ2020YFF0409431)

出版年

2024
中国医药科学
海峡两岸医药卫生交流协会 二十一世纪联合创新(北京)医药科学研究院

中国医药科学

影响因子:1.083
ISSN:2095-0616
参考文献量15
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