Application of QAMS for quality evaluation and control of Chinese patent medicines:taking Bufonis Venenum-contained preparations as examples.
10.19540/j.cnki.cjcmm.20210420.301
- Author:
Li-Yao SHI
1
;
Yun-Ge FANG
2
;
Liang-Mian CHEN
2
;
Zong-Yun LI
3
;
Rui WANG
4
;
Zhi-Min WANG
2
;
Hui-Min GAO
2
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 Shanxi University of Chinese Medicine Jinzhong 030619, China.
2. 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.
3. Harley International Peace Hospital Hengshui 053000, China.
4. Shanxi University of Chinese Medicine Jinzhong 030619, China.
- Publication Type:Journal Article
- Keywords:
Bufonis Venenum;
bufalin(BF);
cinobufagin(CB);
quantitative analysis of multi-components by single-marker(QAMS);
resibufogenin(RB)
- MeSH:
China;
Chromatography, High Pressure Liquid;
Medicine, Chinese Traditional;
Nonprescription Drugs;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(12):2931-2941
- CountryChina
- Language:Chinese
-
Abstract:
As a new strategy capable of uncovering the characteristics of traditional Chinese medicines, the quantitative analysis of multi-components by single-marker(QAMS) has been widely employed for the quality evaluation of Chinese medicinal materials, slices, and extracts. However, its application in the assessment of Chinese patent medicines is yet to be explored. By referring to the determination of three bufogenins in Bufonis Venenum by QAMS described in Chinese Pharmacopoeia(2020 Edition), this paper selected seven representative preparations containing Bufonis Venenum and explored whether the relative correction factors(RCFs) of cinobufagin(CB) to bufalin(BF) and resibufogenin(RB) could be directly used for the quality control of Bufonis Venenum-contained preparations. Based on the qualitative analyses under the same chromatographic conditions as used for toad venom, combing specificity test, five preparations such as Yatong Yili Pills, Houzheng Pills, Xiongdan Jiuxin Pills, Liushen Pills and Niuhuang Xiaoyan Pills, were expected to use validated RCFs for the direct determination of three components. Taking Houzheng Pills as an example, the methodological validation of bufalin, cinobufagin and resibufogenin was carried out, and the recoveries of bufalin, cinobufagin and resibufogenin were 90.64%-106.1%. The obvious difference was not observed between the contents of bufalin and resibufogenin in 24 batches of preparation samples by QAMS and external reference method. In the tested samples, the content of bufalin, cinobufagin and resibufogenin were 1.27-2.61, 2.44-5.66 and 0.988-3.16 mg·g~(-1) in 10 batches of Liushen Pills samples. The contents of bufalin, cinobufagin and resibufogenin were 0.760-1.32, 1.35-2.39 and 0.600-1.55 mg·g~(-1) in 10 batches of Houzheng Pills samples from three manufacturers. The obtained data contribute to improving the quality standard of Bufonis Venenum-contained preparations, and they also provide some ideas for the application of QAMS in the quality evaluation and control of Chinese patent medicines.
