Analysis of the Problems in the Naming of Commercially Available Chinese Patent Medicine in China and Improvement Suggestions Based on the Naming Technical Guidelines for Generic Name of Chinese Patent Medicines
- VernacularTitle:基于《中成药通用名称命名技术指导原则》分析我国已上市中成药命名存在的问题与改进建议
- Author:
Qi CHEN
1
;
Lei ZHANG
2
;
Jing WU
3
;
Xin LI
4
;
Junting FANG
4
;
Yuqing HE
4
;
Liping LIU
4
Author Information
1. Dept. of Finance，Sanjiang University，Nanjing 210012，China
2. Kangda College of Nanjing Medical University，Jiangsu Lianyungang 222000，China
3. School of Biomedical Engineering and Informatics，Nanjing Medical University，Nanjing 211166，China
4. School of Pharmacy，Nanjing Medical University，Nanjing 211166，China
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
Generic name;
Guidelines;
Situation;
Suggestion
- From:
China Pharmacy
2019;30(10):1302-1306
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To investigate the situation and existing problems of the naming of commercially available Chinese patent medicine （CPM） in China， and to put forward the improvement suggestions. METHODS： Announced in Dec. 31， 2017 by CFDA， there were totally 169 601 kinds of national coded drugs. Total of 35 513 kinds of CPM with drug approval number “Z” and 68 kinds of imported CPM with importing registration certificates “Z” was screened by using Excel 2013 software. Based on Naming Technical Guidelines for Generic Name of Chinese Patent Medicines （hereinafter referred to as the Guidelines）， the unqualified situation of domestic CPM were summarized， and unqualified domestic Chinese patent medicine were analyzed statistically in respects of dosage form， special population medication and area. RESULTS： There were 5 091 kinds of drugs named nonconformity with the “Guidelines”， accounting for 14.34％ of domestic CPM. The problems of naming mainly focused on exaggerated naming （1 723 kinds， 33.84％）， dosage form un-located after naming （1 118 kinds， 21.96％）， naming by endangered protected animals and plants （851 kinds， 16.72％）， naming by pharmacology and other related terms （848 kinds， 16.66％）. Names emboding “traditional cultural features” （1 324 kinds， 4.35％） took the lower proportion. Top 5 dosage forms of domestic CPM with unqualified naming were tablets （1 203 kinds， 23.63％）， capsules （821 kinds， 16.13％）， mixture （802 kinds， 15.75％）， pills （706 kinds， 13.87％）， granules （448 kinds， 8.80％）. The problems of special population medication for domestic CPM with unqualified naming concentrated on children’s medication （608 kinds， 11.94％）. The main manufacturers of domestic CPM with unqualified naming came from Guangdong （613 kinds， 12.04％）， Guangxi Zhuang Autonomous Region （371 kinds， 7.29％）， Jilin （265 kinds， 5.21％）， Shaanxi （245 kinds， 4.81％） and Beijing （233 kinds， 4.58％）. CONCLUSIONS： There are many problems in naming of commercially available domestic CPM in China， mainly reflecting as naming type， dosage form， pediatric drugs， etc. There are fewer names emboding “traditional cultural features”. It is suggested that we should further standardize the naming of CPM by strengthening and perfecting the management and examination system of CPM， highlighting the naming principles of Chinese traditional culture and protecting traditional classical brands.
