Research on the standardization of “Indications”in package inserts for Chinese patent medicines
- VernacularTitle:中成药说明书“主治”项规范化表述探析
- Author:
Meiwei ZHANG
1
;
Keqian LI
1
;
Keyu YAO
2
;
Yan ZHU
2
Author Information
1. School of Medical Information，Changchun University of Chinese Medicine，Changchun 130117，China
2. Research Laboratory for Application Methodology of Digital Traditional Chinese Medicine，Institute of Traditional Chinese Medicine Information，Chinese Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicines;
package inserts;
indications;
standardization;
template
- From:
China Pharmacy
2025;36(5):513-518
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia （Volume Ⅰ） and various national and regional standards. Identification criteria were established for syndrome， pathogenesis， disease name， and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements， followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these， the majority （7 991） contained symptom terminology， followed by disease names （5 867） and pathogenesis descriptions （5 167）. Within disease name terminology， Western medical disease names predominated （4 446）， followed by traditional Chinese medicine disease names （2 018）. The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably， the secondary classifications of “disease name”， as well as the tertiary classification of “disease name+symptoms” and “symptoms”， failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome：“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information， adhere to standardized formatting， and employ appropriate conjunctions and punctuation. For non-prescription patent medicines， package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.
