Optimization of particle forming process and quality evaluation of Yindan huoxue tongyu granules
- VernacularTitle:银丹活血通瘀颗粒成型工艺优化与质量评价
- Author:
Dandan WANG
1
;
Xueping CHEN
1
;
Shuxian BAI
1
;
Zuomin WU
1
;
Jingyuan DONG
1
;
Xiaotao YU
1
Author Information
1. Dept. of Pharmacy，Luohe Central Hospital，Henan Luohe 462300，China
- Publication Type:Journal Article
- Keywords:
Yindan huoxue tongyu granules;
molding process;
Plackett-Burman design;
analytic hierarchical analysis;
entropy
- From:
China Pharmacy
2025;36(11):1329-1334
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To optimize the forming process of Yindan huoxue tongyu granules， and evaluate the quality of the granules. METHODS Taking forming rate， angle of repose， moisture， moisture absorption rate and dissolution rate as indexes， single factor experiment combined with Plackett-Burman design was adopted to screen key process parameters； analytic hierarchy process combined with entropy weight method and Box-Behnken response surface method were used to optimize the molding process of Yindan huoxue tongyu granules， and the forming process was verified. The relative homogeneity index， bulk density， vibration density， Hausner ratio， angle of repose， moisture and hygroscopicity were used as secondary physical indexes to establish the physical fingerprints of 10 batches of Yindan huoxue tongyu granules to evaluate particle quality consistency. RESULTS The optimal molding process of Yindan huoxue tongyu granules was as follows： mannitol as the fixed excipient， the drug-assisted ratio was 1∶1（m/m） and the drying time was 1 h； 90% ethanol was used as wetting agent and the amount of it was 32%， the drying temperature was 70 ℃. The results of validation tests showed that the average comprehensive score was 97.45， which was close to the predicted value of 97.18. The similarities between the physical fingerprints of 10 batches of Yindan huoxue tongyu granules prepared by the optimal molding process and the reference physical fingerprint were all higher than 0.99. CONCLUSIONS The molding process is stable and feasible， and the quality of Yindan huoxue tongyu granules produced is stable and controllable.
