QbD理念的中药缓控释制剂的设计与研发研究
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica（2019）
Abstract
该文旨在应用质量源于设计(quality by design,QbD)理念,针对当今中药缓控释制剂研发过程中多种因素影响其最终产品质量的现状,提出开展基于质量源于设计理念的中药缓控释制剂的设计与研发研究.综述了近几年来瞩目的西药与中药缓控释制剂的发展,依据中药工艺复杂性等特点,提出基于QbD理念的中药缓控释制剂的设计与研发,应用QbD理念对影响中药缓控释制剂的复杂因素进行梳理,确定影响终产品质量的高风险因素,从过程中着手对高风险因素进行控制,达到质量可控的目的,为中药复杂组分的缓控释制剂提供研究思路,以促进中药缓控释制剂的研发.
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Key words
quality by design,sustained and controlled release preparations,traditional Chinese medicine pharmaceutics
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