单剂量吸入混悬液剂量均一性抽样方案及评价分析  

Analysis of the sampling plan and evaluation on uniformity of dosage units for single-dose inhalation suspension

作　　者：晏菊姣 李苗 耿颖[2] 卢劲涛 陈路 魏宁漪[2] YAN Ju-jiao;LI Miao;GENG Ying;LU Jin-tao;CHEN Lu;WEI Ning-yi(Wuhan Institute for Drug and Medical Device Control,NMPA Key Laboratory for Quality Research and Control of Drug Products,Wuhan 430075,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]武汉药品医疗器械检验所,国家药品监督管理局药物制剂质量研究与控制重点实验室,武汉430075 [2]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2022年第8期1465-1471,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：ICHQ4指导原则(理化分析方法)转化的关键问题研究(第一阶段)(No.2021Y01)。

摘　　要：目的:比较单剂量吸入混悬液剂量均一性不同测定方法得到的结果,提出合理的吸入液体制剂的剂量均一性检测及评价方法。方法:对不同企业生产的吸入混悬液采用完全转移和可提取体积法2种不同方式测定装量,并制备剂量均一性供试品溶液供HPLC测定含量,采用中国及欧美药典的不同评价方法对结果进行比较。结果:混悬液为非均一体系,以装量和完全转移的方法控制剂量均一性不能反映产品的最终质量的实际情况。单剂量吸入混悬液应以可提取体积法测定剂量均一性,并依据2020年版《中华人民共和国药典》四部通则0941“含量均匀度检查法”进行判定。此方法更加准确直观地反映了吸入混悬液剂量均一性的情况。结论:本文提出的方法更适合单剂量吸入混悬液剂量均一性的检测及评价。Objective:To compare the results of uniformity of dosage units for single-dose inhalation suspension obtained by two methods,and to put forward a reasonable method for the uniformity test.Methods:The uniformity of dosage units of the aerosol suspensions for inhalation produced by two manufacturers were prepared by complete transfer method and extractable method for HPLC determination,as well as filling quantity.The results were discussed according to content uniformity testing program requirements of Chinese Pharmacopoeia,USP,and European Pharmacopoeia.Results:Suspension was different from solution in that it was a non-homogeneous system.The uniformity of dosage units by filling quantity and complete transfer method could not reflect the practical clinical application.The uniformity of dosage units of single-dose inhalation suspension should be determined by extrusion method and evaluated according to General Rule 0941 of Chinese Pharmacopoeia 2020 edition.The new method could reflect the quality of the uniformity of dosage units.Conclusion:The new method proposed in this study is more suitable for the uniformity of dosage units t of single-dose inhalation suspension.

关 键 词：单剂量吸入混悬液 剂量均一性 可提取剂量 抽样方案及评价 

分 类 号：R917[医药卫生—药物分析学]