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.
作者
田香
拉喜那木吉拉
哈日呼
美丽
张尧
饶小勇
罗晓健
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)
出处
《中国药业》
CAS
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]。
关键词
蒙药
地格达-4颗粒
中心复合设计
制备工艺
Mongolian medicine
Digda-4 Granules
central composite design
preparation process
作者简介
第一作者:田香,女,蒙古族,博士,讲师,研究方向为蒙药固体制剂与剂型改革,(电子信箱)tx9622@126.com;通信作者:罗晓健,男,博士,教授,研究方向为中药制剂及其工艺,(电话)0791-87119619(电子信箱)luoxj98@126.com。
