Formulation process optimization and quality control of Qingyan Zhitong Granules
10.3969/j.issn.1001-1528.2025.10.005
- VernacularTitle:清咽止痛颗粒成型工艺优化及其质量控制
- Author:
Jing LIU
1
;
Zhi-rong GU
;
Rui ZHANG
;
Bin GE
Author Information
1. 甘肃中医药大学药学院,甘肃兰州 730000
- Publication Type:Journal Article
- Keywords:
Qingyan Zhitong Granules;
formulation process;
quality control;
Box-Behnken response surface method;
entropy weighting method;
fingerprints;
TLC;
HPLC
- From:
Chinese Traditional Patent Medicine
2025;47(10):3200-3212
- CountryChina
- Language:Chinese
-
Abstract:
AIM To optimize the formulation process for Qingyan Zhitong Granules,and to conduct quality control.METHODS With drug-excipient ratio,ethanol concentration,ethanol consumption and drying temperature as influencing factors,comprehensive score for molding rate,dissolution rate,moisture absorption rate and repose angle as an evaluation index,the formulation process was optimized by Box-Behnken response surface method combined with entropy weighting method on the basis of Plackett-Burman design.The physical fingerprints and HPLC fingerprints were established,after which TLC was adopted in the qualitative identification of Lonicerae japonicae Flos,Forsythiae Fructus,Arctii Fructus and Prunellae Spica,HPLC was used for the content determination of chlorogenic acid,glycyrrhizin,luteoloside A,rosmarinic acid,arctiin,forsythoside and baicalin.RESULTS The optimal conditions were determined to be 1∶1 for drug-excipient ratio,95％for ethanol concentration,3.75 mL for ethanol consumption,67.5 ℃ for drying temperature,and 10 min for drying time,the comprehensive score was 97.717 8.The clear TLC spots demonstrated good reproducible without negative interference.The contents of chlorogenic acid,arctiin and baicalin were not less than 6,5 and 3 mg in 1 g preparation.The physical fingerprints for 5 batches of samples displayed the similarities of more than 0.99.There were 23 common peaks in the fingerprints for 15 batches of samples with the similarities of more than 0.98,7 of which were identified.CONCLUSION This stable and feasible method can provide basis for the industrial production and quality evaluation of Qingyan Zhitong Granules.
