天癸苁盈颗粒制剂工艺研究  

Study on the preparation process of Tiangui Congying Granules

作　　者：张哲 王珊珊 张敏 胡开永 刘军 李艳英 黄能听 夏忠庭 ZHANG Zhe;WANG Shanshan;ZHANG Min;HU Kaiyong;LIU Jun;LI Yanying;HUANG Nengting;XIA Zhongting(Increasepharm(Tianjin)Innovative Medicine Research Co.,Ltd.,Tianjin 300382,China;Shanghai Dinghui Pharmaceutical Co.,Ltd,Shanghai 201400,China;Beijing Increasepharm Corporation Limited,Beijing 102200,China)

机构地区：[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

出　　处：《中国医药科学》2024年第1期83-86,141,共5页China Medicine And Pharmacy

基　　金：“科技助力经济2020”重点专项项目(SQ2020YFF0409431)。

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。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 

分 类 号：R283[医药卫生—中药学]