小规格口服固体制剂混合工艺综述  

Mixing Process Strategy of Small Size Oral Solid Preparation

作　　者：肖峰 樊丽娟 李媛媛 溥榕 张伟 XIAO Feng;FAN Lijuan;LI Yuanyuan;PU Rong;ZHANG Wei(Yunnan Longjin Kangyou Biomedical Company,Kunming 650503,China;Kunming Longjin Pharmaceutical Company,Kunming 650503,China;School of Pharmacy and Yunnan Key Laboratory of Pharmacology for Natural Medicines,Kunming Medical University,Kunming 650500,China)

机构地区：[1]云南龙津康佑生物医药有限公司,云南昆明650503 [2]昆明龙津药业股份有限公司,云南昆明650503 [3]昆明医科大学药学院暨云南省天然药物药理重点实验室,云南昆明650500

出　　处：《山东化工》2024年第24期87-88,91,共3页Shandong Chemical Industry

摘　　要：混合均匀性是口服固体制剂生产的关键控制指标,对产品的最终质量有至关重要的影响,甚至关乎终产品进入人体的有效性和安全性。在混合均匀度的考察中,制剂规格的大小决定了混合均匀性的难易,大规格制剂因为原料药在处方中的占比大而易于混匀,而那些规格较小,特别是单位剂量小于1 mg的口服固体制剂产品,混合均匀性一直是工艺开发过程中的重大难点和挑战。本文从目前指南要求、常规混均方式、原理等方面,对极小规格口服制剂的混匀工艺策略及优缺点进行综述,以此为该类药物的生产工艺研究提供参考。Mixing uniformity is a key control index for the production of oral solid preparations,which has a crucial impact on the final quality of the product,and even the effectiveness and safety of the final product into the human body.In the investigation of mixing uniformity,the size of the preparation determines the difficulty of mixing uniformity.Large-size preparations are easy to mix because of the large proportion of raw materials in the prescription,while those with smaller specifications,especially for oral solid preparation products with a unit dose of less than 1 mg,mixing uniformity has been a major difficulty and challenge in the process development.In this paper,from the current guideline requirements,conventional mixing methods,principles and other aspects,the advantages and disadvantages of mixing technology of minimal oral preparations were reviewed,so as to provide a reference for the production process research of this kind of drugs.

关 键 词：小规格口服固体制剂 混合 工艺 

分 类 号：TQ460[化学工程—制药化工]