蒙药地格达-4颗粒成型工艺研究  

Forming Process of Mongolian Medicine Digeda-4 Granules

作　　者：田香[1,2] 拉喜那木吉拉 哈日呼 美丽 张尧 饶小勇[4,5] 罗晓健[4,5] Tianxiang;Laxinamujila;Harihu;Meili;ZHANG Yao;RAO Xiaoyong;LUO Xiaojian(College of Mongolian Medicine,Inner Mongolia Minzu University,Tongliao,Inner Mongolia,China 028000;Key Laboratory of Mongolian Medicine Research and Development Engineering,Ministry of Education,Inner Mongolia Minzu University,Tongliao,Inner Mongolia,China 028000;Affiliated Hospital of Inner Mongolia Minzu University,Tongliao,Inner Mongolia,China 028000;National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine,Nanchang,Jiangxi,China 330006;Jiangxi Universiy of Chinese Medicine,Nanchang,Jiangxi,China 330006)

机构地区：[1]内蒙古民族大学蒙医药学院,内蒙古通辽028000 [2]内蒙古民族大学蒙医药研发工程教育部重点实验室,内蒙古通辽028000 [3]内蒙古民族大学附属医院,内蒙古通辽028000 [4]中药固体制剂制造技术国家工程研究中心,江西南昌330006 [5]江西中医药大学,江西南昌330006

出　　处：《中国药业》2022年第15期33-38,共6页China Pharmaceuticals

基　　金：内蒙古自治区自然科学基金[2020BS08001];内蒙古民族大学博士科研启动基金项目[BS596]。

摘　　要：目的优选蒙药地格达-4颗粒的成型工艺。方法以颗粒得率、脆碎度、溶化时间为考察指标,采用单因素试验结合中心复合试验设计优选颗粒处方参数及干法制粒工艺参数,并对制得的颗粒进行质量检查。结果最佳制备工艺参数为蒙药地格达-4喷雾干燥粉-乳糖-微粉硅胶(9∶1∶5‰,m∶m∶m),干法制粒机液压40 bar,滚轮间隙1 mm,滚轮转速3.0 r/min,破碎频率30 Hz,所制得的颗粒得率、溶化时间等项目检查都符合2020年版《中国药典(四部)》要求。结论优选出的蒙药地格达-4颗粒成型工艺可行,可为工业化生产提供参考。Objective To optimize the forming process of Mongolian medicine Digeda-4 Granules.Methods The prescription parameters of granules and process parameters of dry granulation were optimized by the single-factor test combined with the central composite design(CCD)with the yield,friability and dissolution time of the granules as the investigation indexes,and the quality of prepared granules was checked.Results The optimal preparation process parameters were as follows:the mass ratio of Mongolian medicine Digeda-4 spray drying powder to lactose to micron silica gel was 9∶1∶5‰(m∶m∶m),the hydraulic pressure of dry granulator was 40 bar,the roller clearance was 1 mm,the rotation speed of roller was 3.0 r/min,and the crushing frequency was 30 Hz.The obtained yield,dissolution time and other items of the granules all met the requirements of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ).Conclusion The optimal forming process of Mongolian medicine Digeda-4 Granules is feasible,which can provide a reference for the industrial production of this medicine.

关 键 词：蒙药 地格达-4颗粒 中心复合设计 制备工艺 

分 类 号：R932[医药卫生—生药学] R29[医药卫生—药学] TQ460.6[化学工程—制药化工]