Quality study of Prunellae spica dispensing granules based on standard decoction
10.3760/cma.j.cn115398-20210103-00012
- VernacularTitle:基于标准汤剂的夏枯草配方颗粒质量标准研究
- Author:
Zhenyu LI
1
;
Qing DING
;
Wanfa CHEN
;
Liwei WANG
;
Yueyi LIANG
;
Xiaojun PAN
;
Xiangyuan ZHOU
;
Liye PAN
;
Wenjie HUO
Author Information
1. 广东一方制药有限公司，佛山 528244
- Keywords:
Prunellae spica;
Standard decoction;
Dispensing granules;
Rosmarinic acid;
Quality control
- From:
International Journal of Traditional Chinese Medicine
2022;44(2):188-194
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the quality evaluation method of Prunellae spica dispensing granules based on three quality indexes of standard decoction. Methods:Fourteen batches of Prunellae spica were collected from different habitats. According to technical requirements, fourteen batches of Prunellae spica standard decoction and three batches of formula granules were prepared and the paste-forming rates were calculated. The fingerprints of Prunellae spica standard decoction and formula granules were established by Ultra High Performance Liquid Chromatography (UPLC). The similarity values of fingerprints between dispensing granules and standard decoction were calculated. The content and transferring rate of Rosmarinic acid were determined and calculated. Results:The average paste-forming rate of Prunellae spica was (12.59±2.32)%. The paste-forming rates of the three batches were 11.14%, 10.78% and 10.39% respectively. The average content of Rosmarinic acid in standard decoction was (18.99±9.74)mg/g. The average transferring rate was (60.58±7.87)%. The contents of three batches were 7.40 mg/g, 7.49 mg/g and 7.09 mg/g. The transferring rates were 52.06%, 50.10% and 50.40% respectively. Nine common fingerprint peaks were identified in the fingerprints of standard decoction and formula granules, two of which were identified as Rosmarinic acid and Caffeic acid by comparison of reference substance. The fingerprints similarity of Prunellae spica dispensing granules and standard decoction were 0.954, 0.973 and 0.952, respectively. Conclusions:The quality indexes of three batches of formulation granules are consistent with standard decoction. This method could provide reference for the establishment of quality standard of Prunellae spica dispensing granules.
