Investigation on improving the quality standard of Mongolian medicine compound preparation Zhuanglun-5 decoction
10.19778/j.chp.2024.02.005
- VernacularTitle:蒙药复方制剂壮伦-5汤质量标准提升研究
- Author:
Wenyuan AN
1
,
2
;
Junsheng HAO
;
Zengyun JI
;
Jianan JING
;
Xue SHENG
;
Yanyan WANG
;
Xinamujila LA
Author Information
1. 通辽市市场检验检测中心,内蒙古通辽 028000
2. 国家药品监督管理局中药(蒙药)质量控制重点实验室,内蒙古通辽 028000
- Keywords:
Mongolian medicine;
Zhuanglun-5 decoction;
swertiamain;
quality evaluation;
HPLC
- From:
Drug Standards of China
2024;25(2):141-146
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the qualitative and quantitative methods of Lomatogonium carinthiacum(Wulf.)Reichb.in the prescription of Mongolian medicine Polypill Zhuanglun-5 decoction,and solve the phe-nomenon of Lomatogonium carinthiacum(Wulf.)Reichb.being replaced.Methods:Microscopic identification method was used to observe the pollen grains in the powder;The reference substance of swertiamarin and Lomato-gonium carinthiacum(Wulf.)Reichb.were used as the control,and the ethyl acetate methanol water formic acid(12∶2∶2∶0.5)was used as the developing agent for TLC identification;HPLC was used under the condin-tion including Agilent Eclipse Plus C18(250 mm × 4.6 mm,5 μm)as chromatographic column and 0.2％phosphoric acid solution(A)-acetonitrile(B)as mobile phase with gradient elution at 238 nm of detection wavelength were used.Contents of Zhuanglun-5 decoction from different manufacturers were determined with swertiamarin as reference substance.Results:Among the 12 batches of Zhuanglun-5 decoction,8 batches were Lomatogonium carinthiacum(Wulf.)Reichb.,2 batches were Viola yedoensis,and 2 batches were other medicinal materials.The content of swertiamarin in 8 batches of Zhuanglun-5 decoction ranged from 0.2 to 11.7 mg·g-1.Conclusion:The established identification method is simple and effective,and the content determination method is stable and has strong specificity.It can provide technical support for the supervision of the preparation,and has a reference effect for the improvement of traditional Chinese and Mongolian pharmaceuti-cal preparation standards.
