医院开展个体化浓缩丸工艺研究及质量回顾性评估  

Process Study of Individualized Concentrated Pills in a Hospital and Retrospective Evaluation of Its Quality

作　　者：陈洁[1] 丘振文[1] 蔡庆群[1] 李冠鑫 李得堂[1] CHEN Jie;QIU Zhenwen;CAI Qingqun;LI Guanxin;LI Detang(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,Guangdong,China 510405)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405

出　　处：《中国药业》2022年第11期33-35,共3页China Pharmaceuticals

基　　金：广东省科学技术厅科技发展专项资金项目[2017A030313626];广州中医药大学第一附属医院创新强院工程项目[2017ZWB10]。

摘　　要：目的探讨医院开展个体化浓缩丸工艺研究的可行性,促进院内个体化浓缩丸的规范生产。方法选取临床治疗慢性疾病的不同方药处方20张,参照医院制剂浓缩丸生产工艺制备临床复方中药个体化浓缩丸(编号为S1-S20),以丸剂水分、重量差异、溶散时限、微生物限度检查为指标,回顾性评估医院开展的个体化浓缩丸生产工艺研究及质量。结果编号为S1-S20的个体化浓缩丸质量稳定,水分为2%~6%,均能在40 min内完成溶散,重量差异和微生物限度检查均符合2020年版《中国药典(四部)》丸剂项下相关要求。结论医院开展个体化浓缩丸的工艺参数可控、质量稳定,具有可推广复制的可行性。同时,微生物限度检查需作为个体化浓缩丸主要的质量控制指标。Objective To investigate the feasibility of carring out the individualized concentrated pills process in a hospital and to promote the standardized production of individualized concentrated pills in the hospital.Methods Twenty different prescriptions for clinical treatment of chronic diseases were selected.Clinical compound traditional Chinese medicine(TCM)individualized concentrated pills(No.:S1-S20)were prepared according to the preparation process of pills in the hospital.The preparation process and quality of individualized concentrated pills carried out in the hospital was retrospectively evaluated with moisture,weight difference,dissolution time limit and results of microbial limit test of pills as indexes.Results The individualized concentrated pills(No.:S1-S20)had stable quality and could be dissolved within 40 min,with the moisture content of 2%-6%.The weight difference and microbial limit test of the individualized concentrated pills were in line with the requirements of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ).Conclusion The process of individualized concentrated pills in the hospital has controllable process parameters and stable quality,which is feasible to popularize and replicate.Meanwhile,microbial limit test should be used as the main quality control index of individualized concentrated pills.

关 键 词：个体化制剂 制备工艺 质量控制 

分 类 号：R932[医药卫生—生药学] R283[医药卫生—药学]