Improvement on Quality Standard of Yuanhu Zhitong Oral Liquid
10.13422/j.cnki.syfjx.20240364
- VernacularTitle:元胡止痛口服液的质量标准提升
- Author:
Lu FU
1
;
Chengyu CHEN
2
;
Jin GAO
2
;
Dan WU
1
;
Chun LI
1
;
Zhiming CAO
2
;
Jianli GUAN
3
;
Ping WANG
1
;
Haiyu XU
1
Author Information
1. Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences， Beijing 100700，China
2. Jiaheng（Zhuhai Hengqin） Pharmaceutical Technology Co. Ltd.，Zhuhai 519000，China
3. Henan Fusen Pharmaceutical Co. Ltd.，Nanyang 474450，China
- Publication Type:Journal Article
- Keywords:
Yuanhu Zhitong oral liquid;
quality standard;
thin layer chromatography（TLC）;
high performance liquid chromatography（HPLC）;
fingerprint;
similarity evaluation;
content determination
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(9):125-131
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo improve the quality standard of Yuanhu Zhitong oral liquid in order to strengthen the quality control of this oral liquid. MethodThin layer chromatography（TLC） was used for the qualitative identification of Corydalis Rhizoma and Angelicae Dahuricae Radix in Yuanhu Zhitong oral liquid by taking tetrahydropalmatine， corydaline reference substances and Corydalis Rhizoma reference medicinal materials as reference， and cyclohexane-trichloromethane-methanol（5∶3∶0.5） as developing solvent， Corydalis Rhizoma was identified using GF254 glass thin layer plate under ultraviolet light（365 nm）. And taking petroleum ether（60-90 ℃） -ether-formic acid（10∶10∶1） as developing solvent， Angelicae Dahuricae Radix was identified using a silica gel G TLC plate under ultraviolet light（305 nm）. High performance liquid chromatography（HPLC） was performed on a Waters XSelect HSS T3 column（4.6 mm×250 mm， 5 μm） with acetonitrile（A）-0.1% glacial acetic acid solution（adjusted pH to 6.1 by triethylamine）（B） as the mobile phase for gradient elution（0-10 min， 20%-30%A； 10-25 min， 30%-40%A； 25-40 min， 40%-50%A； 40-60 min， 50%-60%A）， the detection wavelength was set at 280 nm， then the fingerprint of Yuanhu Zhitong oral liquid was established， and the contents of tetrahydropalmatine and corydaline were determined. ResultIn the thin layer chromatograms， the corresponding spots of Yuanhu Zhitong oral liquid， the reference substances and reference medicinal materials were clear， with good separation and strong specificity. A total of 12 common peaks were identified in 10 batches of Yuanhu Zhitong oral liquid samples， and the peaks of berberine hydrochloride， dehydrocorydaline， glaucine， tetrahydropalmatine and corydaline. The similarities between the 10 batches of samples and the control fingerprint were all >0.90. The results of determination showed that the concentrations of corydaline and tetrahydropalmatine had good linearity with paek area in the range of 0.038 6-0.193 0， 0.034 0-0.170 0 g·L-1， respectively. The methodological investigation was qualified， and the contents of corydaline and tetrahydropalmatine in 10 batches of Yuanhu Zhitong oral liquid samples were 0.077 5-0.142 9、0.126 1-0.178 2 g·L-1， respectively. ConclusionThe established TLC， fingerprint and determination are simple， specific and reproducible， which can be used to improve the quality control standard of Yuanhu Zhitong oral liquid.
