Research advances in secondary development of Chinese patent medicines based on quality by design concept

GONG Xing-chu1 CHEN Teng1 QU Hai-bin1

(1.Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China 310058)

【Abstract】Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy. In this work, recent research advances in QbD concept implementation methods in the secondary development of Chinese patent medicines were reviewed, and five promising fields of the implementation of QbD concept were pointed out, including the research and development of TCM new drugs and Chinese medicine granules for formulation, modeling of pharmaceutical processes, development of control strategy based on industrial big data, strengthening the research of process amplification rules, and the development of new pharmaceutical equipment.

【Keywords】 quality by design; Chinese medicine; pharmaceutical engineering; design space; control strategy;

【DOI】

【Funds】 National Science and Technology Major Project of Major New Drug Creation (2014ZX09201022-009-001)

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(Translated by YI T)

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This Article

ISSN:1001-5302

CN:11-2272/R

Vol 42, No. 06, Pages 1031-1036

March 2017

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Article Outline

Abstract

  • 1 Determination of the critical processes and its evaluation indexes
  • 2 Identification of the critical material attributes and critical process parameters
  • 3 Establishment of the mathematical model of the critical process unit
  • 4 Construction of design space
  • 5 Implementation of production control strategy and continuous improvement
  • 6 Establishment of analysis methods
  • 7 Conclusions and prospect
  • References