Quality control of substance benchmarks for Danggui Sini Decoction.
10.19540/j.cnki.cjcmm.20220311.301
- Author:
Chen-Na LU
1
;
Xiao YE
1
;
Xiao-Qian LIU
1
;
Wei-Hong FENG
1
;
Yao-Hua LIANG
1
;
Chun LI
1
;
Zhi-Min WANG
1
Author Information
1. National Engineering Laboratory of Quality Control Technology of Chinese Materia Medica, Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences Beijing 100700, China.
- Publication Type:Journal Article
- Keywords:
Danggui Sini Decoction;
aristolochic acid I;
content determination;
fingerprint;
quality control
- MeSH:
Ammonium Compounds;
Benchmarking;
Chromatography, High Pressure Liquid/methods*;
Chromatography, Liquid;
Drugs, Chinese Herbal/chemistry*;
Quality Control;
Tandem Mass Spectrometry/methods*;
Water
- From:
China Journal of Chinese Materia Medica
2022;47(15):4007-4014
- CountryChina
- Language:Chinese
-
Abstract:
A comprehensive quality control method was established to provide references for quality control and evaluation of substance benchmarks of Danggui Sini Decoction(DSD). The HPLC separation was performed on a Kromasil 100 C-8 column(4.6 mm×250 mm, 5 μm) with acetonitrile(A)-0.05% phosphoric acid in water(B) as mobile phase in a gradient elution mode at the flow rate of 1 mL·min~(-1). The column temperature was 25 ℃ and the detection wavelength was set at 275 nm. Under these conditions, the content of seven components, including paeoniflorin, liquiritin, cinnamic acid, cinnamaldehyde, ammonium glycyrrhetate, ligustilide, and asarinin was simultaneously determined. Under the same chromatographic conditions, the HPLC fingerprint method for analysis of 15 batches of DSD was established. The content determination of aristolochic acid I, using the same test solution as the content determination item, was performed on an ACQUITY UPLC BEH C_(18) column(2.1 mm×50 mm, 1.7 μm) with methanol(A)-water(including 0.1% formic acid and 5 mmol·L~(-1) ammonium formate)(B) as the mobile phase in a gradient elution mode at the flow rate of 0.4 mL·min~(-1) and the column temperature of 40 ℃ by LC-MS/MS. The MS conditions included electrospray ionization(ESI) as an ion source, positive ion ionization, selective reaction monitoring(SRM), the parent ion of 359.3, and the daughter ion of 297.8. The results of the methodological investigation all met the requirements of content determination/fingerprint determination. As a result, the content ranges of paeoniflorin, liquiritin, cinnamic acid, cinnamaldehyde, ammonium glycyrrhetate, ligustilide, and asarinin were 5.419 8-11.267 3, 1.023-3.669 8, 0.145 6-0.444 1, 0.099 1-0.321 9, 3.159 1-7.731 9, 0.146 4-0.471 7, and 0.237 3-0.401 0 mg·g~(-1), respectively. Twenty-two common peaks were selected and 10 of them were identified by the comparison with the reference substances. The fingerprint similarity of 15 batches of DSD was in the range of 0.91-0.996 and the content of aristolochic acid I in DSD was 300.03-638.13 ng·g~(-1). The method established in this study is reliable and easy to operate and has great practical value, which can be used for overall quality control of substance benchmarks for DSD.
