质量源于设计在缬沙坦胶囊处方开发中的应用  

Application of Quality by Design in the Formulation Development of Valsartan Capsules

作　　者：张晓娟 宋如顺 张双双 古双喜[1] ZHANG Xiaojuan;SONG Rushun;ZHANG Shuangshuang;GU Shuangxi(Pharmaceutical Research Institute,School of Chemical Engineering and Pharmacy,Wuhan Institute of Technology,Wuhan 430205;Hangzhou Neptunus Biotechnology Co.,Ltd.,Hangzhou 311101;Hangzhou Hunter BiotechnologyInc.,Hangzhou 310051)

机构地区：[1]武汉工程大学化工与制药学院,药物研究院,湖北武汉430205 [2]杭州海王生物工程有限公司,浙江杭州311101 [3]杭州环特生物科技股份有限公司,浙江杭州310051

出　　处：《中国医药工业杂志》2024年第11期1519-1522,1523-1525,共7页Chinese Journal of Pharmaceuticals

基　　金：国家自然科学基金项目(22377097、21877087);湖北省自然科学基金项目(2021CFB556、2022CFB156)。

摘　　要：基于质量源于设计理念,通过风险评估确定影响缬沙坦胶囊溶出行为的关键处方风险变量。以原研制剂“代文”作为参比制剂,以溶出行为一致性为评价指标,利用单因素法,考察了崩解剂用量、黏合剂配制方法、助溶剂加入方式、空心胶囊生产厂家以及原料药粒径等变量对溶出行为的影响情况。采用优化处方自制的缬沙坦胶囊与“代文”在4种不同溶出介质中的溶出行为一致。Based on the quality by design concept,the key risk variables in the formulation of valsartan capsules were identified through risk assessment.Using the original drug“Diovan”as a reference and consistency in dissolution behavior as the evaluation index,a single factor method was employed to investigate the impacts of the variables such as the disintegrant amount,the preparation method of the adhesive,the addition method of the solubilizer,the capsule shells from different manufacturers,and the particle size of API on the dissolution rate.The self-made valsartan capsules prepared with the optimized formulation and“Diovan”exhibited consistent dissolution behaviors in four different dissolution media.

关 键 词：缬沙坦 胶囊 质量源于设计 风险评估 溶出行为 一致性 

分 类 号：R944.5[医药卫生—药剂学] R972.4[医药卫生—药学]