Comparative study on the suitability of chemical fingerprint and anti-platelet aggregation/anti-inflammatory biopotency in the overall quality evaluation of Xiaojin pills
10.16438/j.0513-4870.2019-0667
- VernacularTitle:化学指纹图谱与活血、抗炎生物效价在小金丸整体质量评价中的适宜性对比研究
- Author:
Bi FENG
1
;
Bo CAO
1
;
Peng TAN
2
;
Jiao SONG
1
;
Hai-zhu ZHANG
3
;
Hong XU
4
;
Xiao-juan DU
4
;
Ming NIU
5
;
Run-chun XU
1
;
Ming YANG
6
;
Li HAN
1
;
Ding-kun ZHANG
1
Author Information
1. State Key Laboratory of Characteristic Chinese Medicine Resources in Southwest China, College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China
2. State Key Laboratory of Quality Evaluation of Traditional Chinese Medicine, Sichuan Academy of Traditional Chinese Medicine, Chengdu 610041, China
3. Department of Pharmacy and Chemistry, Dali University, Dali 671000, China
4. Chengdu Yongkang Pharmaceutical Co., Ltd., Chengdu 611137, China
5. China Military Institute of Chinese Medicine, the Fifth Medical Centre of Chinese People’s Liberation Army General Hospital, Beijing 100039, China
6. Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China
- Publication Type:Research Article
- Keywords:
Xiaojin pill;
quality evaluation;
fingerprint;
antiplatelet aggregation;
COX-2 inhibition rate
- From:
Acta Pharmaceutica Sinica
2019;54(12):2195-2203
- CountryChina
- Language:Chinese
-
Abstract:
Xiaojin pills, the first choice for clinical treatment of breast hyperplasia, were selected to explore the suitability of a bioactivity assay with chemical fingerprinting for the development of an overall quality evaluation assay. The liposoluble and water-soluble fraction fingerprints of Xiaojin pills were established. The ability to inhibit platelet aggregation and the rate of inhibition of cyclooxygenase-2 (COX-2) for 16 batches of Xiaojin pills from several manufacturers was analyzed; the chemical fingerprints of these samples were correlated with the bioactivity and chemical analysis. The animal protocol was approved by the Committee on the Ethics of Animal Experiments of Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Approval, ID: 2018BL-002. Results showed that the antiplatelet aggregation activity of 16 batches was 0.712-1.278 U∙mg-1, with a relative standard deviation (RSD) of 15.4%. COX-2 inhibition was 52.07%-68.95% and the RSD was 8.91%. The results showed that there was little difference in the biological effects of these samples. However, the chemical fingerprint consistency of these 16 batches of Xiaojin pills was poor, and the similarity of nearly half of the samples was less than 0.9. The total peak area of Xiaojin pills was 32.74%-165.37% across samples, showing very poor chemical consistency. In order to explore the reasons for the poor chemical consistency despite good consistency in the biological assays, the fingerprint chromatogram was analyzed by multivariate statistical analysis. The main chromatographic peaks were identified. The results showed that the similarity of Xiaojin pills was mainly determined by the prominent chromatographic peaks 17, 18, 20, 23 and 27 in the liposoluble fingerprints, which were identified from Liquidambaris resina and Angelica sinensis Radix. However, Liquidambaris resina and Angelicae sinensis Radix had almost no anti-platelet aggregation activity or COX-2 inhibitory effect at the normal prescription ratio. As a result, the ability to utilize chemical fingerprints to evaluate the quality consistency of Xiaojin pills is limited. The selection of biological evaluation methods that reflect clinical efficacy could make up for the shortcomings of chemical evaluation methods for quality assessment, and provide new ideas and methods for the overall quality evaluation of complex Chinese patent medicines.
