title: [Present situation and prospect of quality standardization of Chinese patent medicines].
abstract: This article reviews rectification and protection of Chinese patent medicines, establishment and improvement of the new drug approval, and historical evolution of the pharmacopoeia of the People's Republic of China. The article analyzes the present situation and the challenges of quality standardization of Chinese patent medicines in the new era. The article also points out strategies and guidelines to be taken to promote the globalization of Chinese patent medicines and compliance with the international standards.
authors.affiliation: Department of Chinese Herbal Formulae and Materia Medica, School of Preclinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, China. zylab208@163.com
authors.forename: Xue-Min
authors.initials: XM
authors.lastname: Gao
authors.forename: Jian-Jun
authors.initials: JJ
authors.lastname: Zhang
authors.forename: De-Qin
authors.initials: DQ
authors.lastname: Zhang
authors.forename: Jing-Xia
authors.initials: JX
authors.lastname: Wang
authors.forename: Li-Na
authors.initials: LN
authors.lastname: Ou
authors.forename: Shao-Hong
authors.initials: SH
authors.lastname: Chen
mesh_terms: D002681:China; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004340:Drug Contamination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000592:standards*; D004366:Nonprescription Drugs / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards; D011786:Quality Control
chemical_list: D004365:Drugs, Chinese Herbal; D004366:Nonprescription Drugs