Quality Evaluation on Huatan Pingchuan Tablets Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.01.005
- VernacularTitle:基于国家药品抽检的化痰平喘片质量评价
- Author:
Dan LI
1
;
Xianling YANG
;
Hongyu ZHAI
;
Yuhua SHEN
;
Qiaosen REN
;
Jing HAN
;
Zhenbin FENG
;
Jialiang ZHU
Author Information
1. 吉林省药品检验研究院中药与民族药室,长春 130033
- Publication Type:Journal Article
- Keywords:
Huatan Pingchuan tablets;
National drug sampling and testing;
Quality evaluation
- From:
Herald of Medicine
2025;44(1):39-46
- CountryChina
- Language:Chinese
-
Abstract:
Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.
