Comparation and considerations for general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia
10.19778/j.chp.2024.01.006
- VernacularTitle:《中国药典》与《日本药典》凡例的比较研究与思考
- Author:
ZHU Jia
;
LOU Yongjun
;
PAN Fangfang
;
GENG Xiaoting
;
TANG Dengfeng
;
SHANG Yue
;
ZHENG Jinqi
;
ZHENG Cheng
;
TAO Qiaofeng
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia;
Japanese Pharmacopoeia;
general notice;
coordination;
drug standard;
quality control
- From:
Drug Standards of China
2024;25(1):035-040
- CountryChina
- Language:Chinese
-
Abstract:
Objective: The characteristics and differences of the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia were investigated to provide references and suggestions for the compilation of the Chinese Pharmacopoeia.
Methods: From the perspective of frame structure and main contents, the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia was compared.
Results: Each volume of the Chinese Pharmacopoeia had its general notice, including 34 to 48 items and 10 to 12 chapters based on different varieties collected in each volume. The Japanese Pharmacopoeia had 49 items not arranged by chapters. There are many differences on the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia, such as the definitions and expressions of names, determination of appearance, revision rules, risk assessment and quality control conception. The framework of the general notice in the Chinese Pharmacopoeia was clear, the content was specific and the operation was friendly. The term description of the general notice in the Japanese Pharmacopoeia was concise, and some terms need to be implemented under the guidance of professional knowledge.
Conclusion: In light of comparative study, every volume’s general notice of the Chinese Pharmacopoeia has its own characteristics. By integrating advanced analytical technique, combining the requirements with laws and regulations, and optimizing content and terms, all volume’s general notice could be explored to be coordinated and unified.
- Full text:202408101321362451720240206.pdf
