药典讨论组的药用辅料标准工作的进展及其对中国药典的启示

Progress on Pharmacopeial Discussion Group Standards for Pharmaceutical Excipients and its Enlightenment to Chinese Pharmacopoeia

目的 借鉴药典讨论组(pharmacopeial discussion group,PDG)对欧洲药典、美国药典和日本药局方药用辅料标准协调的经验,探析中国药典协调工作的思路和方法。方法 查阅PDG协调工作背景、工作程序、工作进展,分析三方药典协调标准的特点,梳理PDG药用辅料标准与中国药典异同点。结果 中国药典2020年版四部相应药用辅料标准有一定的先进性,也有提升空间。结论 建议结合中国国情,加强与PDG联系,明确标准协调的原则,提高中国药用辅料标准水平,稳步推进中国药用辅料标准国际协调工作。

OBJECTIVE To explore the ideas and methods of international harmonization of the Chinese Pharmacopoeia,drawing on the experience of the pharmacopeial discussion group(PDG) on the harmonization standards for pharmaceutical excipients in the European Pharmacopoeia, the United States Pharmacopeia and the Japanese Pharmacopoeia. METHODS By reviewing the PDG working background, procedures, and progress, analyze the characteristics of harmonization standards, and sorted out the similarities and differences between the harmonization standards and the Chinese Pharmacopoeia for pharmaceutical excipients. RESULTS The corresponding standards for pharmaceutical excipients in the Chinese Pharmacopoeia(2020 edition) volume Ⅳ had a certain advancement, and still need to be further improved. CONCLUSION It is recommended that Chinese Pharmacopoeia Commission strengthen the connection with PDG, combine the national conditions of China, clarify the principles of standards harmonization, improve the level of pharmaceutical excipients standards, and steadily promote the progress of the international harmonization standards of pharmaceutical excipients.