Improvement of the quality standard for Kunxian capsules
10.12206/j.issn.1006-0111.202106102
- VernacularTitle:昆仙胶囊的质量标准提升研究
- Author:
Chunfang XU
1
;
Zhexuan LI
1
;
Luoying ZHOU
1
;
Ni ZHANG
2
,
3
;
Hong YANG
1
;
Xia TAO
1
Author Information
1. Department of Pharmacy, the Second Affiliated Hospital of Naval Medical University, Shanghai 200003, China.
2. Department of Pharmacy, the Second Affiliated Hospital of Naval Medical University, Shanghai 200003, China
3. School of Pharmacy, Xuzhou Medical University, Xuzhou 221000, China.
- Keywords:
Kunxian capsules;
TLC;
triptolide;
HPLC;
quality standards
- From:
Journal of Pharmaceutical Practice
2022;40(2):152-156
- CountryChina
- Language:Chinese
-
Abstract:
Objective To improve the quality standards of Kunxian capsules (KC) and effectively control the product quality. Methods Triptolide, icariin and hypericin were used as the indicator components, to increase or improve the thin layer chromatography (TLC) identification methods of Kunming begonia, epimedium and dodder. Agilent ZORBA SB-C18 (4.6 mm×250 mm, 5 μm) as a chromatographic column, the HPLC method for the determination of triptolide was improved with acetonitrile-0.1% formic acid solution as the mobile phase and 220 nm as the detection wavelength. Results The spots in the TLC method of Kunming begonia, epimedium and dodder has strong specificity, good and clear separation of characteristic spots, negative and no interference. The quantitative analysis of the content of triptolide in KC showed that there is a good linear relationship (r=0.9995) between the mass concentration of triptolide and the peak area in the range of 40.16-502.00 μg/ml, the average recovery was 98.12%, RSD was 8.25%, and the accuracy was good. Conclusion The TLC identification method and HPLC method established in this experiment have strong specificity and good reproducibility, and can effectively control the quality of KC.
