固态药物痕量晶体定量技术的研究进展  

Progress of research on quantitative techniques for trace amount of crystals in solid state drugs

作　　者：丁甜甜 苏美玲 钱帅[1] 张建军[2] 高缘[1] 魏元锋[1] DING Tiantian;SU Meiling;QIAN Shuai;ZHANG Jianjun;GAO Yuan;WEI Yuanfeng(School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198;School of Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学中药学院,南京211198 [2]中国药科大学药学院,南京211198

出　　处：《中国药科大学学报》2024年第2期181-193,共13页Journal of China Pharmaceutical University

基　　金：国家自然科学基金项目(No.82373824,No.82104401,No.82274217,No.82204636);中央高校基本科研业务费重点项目(No.2632021ZD15)。

摘　　要：晶型是影响药物理化性质的关键因素,进而影响药物的体内药效、安全性及稳定性。固态药物的晶型研究对于药物的生产工艺开发、质量控制、临床疗效评价等至关重要。化学计量学方法与分析检测技术的联合应用,表现出对大量多维数据极强的分析能力,为痕量晶体(<1%)的定量检测提供了可能。同时,利用过程分析技术(process analytical technology,PAT)对制剂制备过程中的晶体含量进行实时监测,可进一步实现对制剂质量的控制,并作为支撑晶型专利保护的核心技术。本文概述了晶体定性定量分析技术和化学计量学方法联合应用于痕量晶体的定量测定,以期为药品的生产和质量控制提供指导。It is well-known that crystal form of a drug is a key factor impacting the physicochemical properties of the drug,which in turn affects its in vivo efficacy,safety and stability.The study on crystal forms of solid-state drugs is crucial for drug quality control,selection of production process and evaluation of clinical efficacy.The combination of chemometric and analytical techniques exhibited its great ability to analyze a large amount of multidimensional data,providing the possibility for quantification of trace amount of crystals(<1%).Meanwhile,using the process analytical technology(PAT)to monitor the crystal content real-time during prescription preparation process can further realize the control on formulation quality and serve as a core technology to support the patent protection of crystalline forms.In this review,the combined application of crystal analytical techniques and chemometric methods for the quantitative analysis of trace crystals were summarized,aiming to provide guidance for the manufacturing of pharmaceutical preparations and their quality control.

关 键 词：痕量晶体 定量分析 光谱法 粉末X射线衍射法 化学计量学 

分 类 号：R944[医药卫生—药剂学]