Identification of taste critical quality attribute and formulation optimization of Xiaoer Qingrening Granules based on electronic tongue and human senses
10.16438/j.0513-4870.2022-1329
- VernacularTitle:基于电子舌与人感官的小儿清热宁颗粒滋味关键质量属性辨识及配方优化
- Author:
Xiao-yan HU
1
;
Ying LU
2
;
Xiao-meng WANG
2
;
Li-juan MA
2
;
Yu-nan WEI
2
;
Ping DAI
1
;
Chao-fu MA
2
;
Han ZHANG
2
;
Jing WANG
2
;
Nan LI
2
;
Xing-xing DAI
2
;
Lu YAO
3
;
Bei-lei XU
4
;
Wei XU
1
;
Zhi-sheng WU
5
Author Information
1. School of Pharmacy, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China
2. School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China; Engineering Research Center of Chinese Medicine Production and New Drug Development, Beijing 102488, China
3. Beijing Tongrentang Technology Development Co., Ltd., Beijing 100079, China
4. School of Pharmacy, Harbin University of Commerce, Harbin 150076, China
5. School of Pharmacy, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China; School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China; Engineering Research Center of Chinese Medicine Production and New Drug Development, Beijing 102488, China
- Publication Type:Research Article
- Keywords:
oral preparation;
electronic tongue;
human sense;
bitterness;
critical quality attribute
- From:
Acta Pharmaceutica Sinica
2023;58(10):2875-2881
- CountryChina
- Language:Chinese
-
Abstract:
This study primarily concentrated on scientific problems of poor taste caused by unclear critical quality attributes of oral preparations manufactured by Chinese materia medica, successfully established an identification method for taste critical quality attribute and a taste improvement method combining electronic tongue with human senses, and determined the optimal taste formula, to improve patients' oral medication compliance. The study received ethical approval from the Review Committee of the Beijing University of Chinese Medicine. The results showed that the proportion of bitterness of Xiaoer Qingrening Granule was 61.8%, and its bitterness grade was 3.70, it was determined that bitterness is the critical quality attribute that caused the poor taste of Xiaoer Qingrening Granule. Additionally, the optimal taste formula per milliliter of Xiaoer Qingrening sugar-free intermediate was determined with allowable daily intake, solubility, and sweetness as the limiting conditions, which was 40 mg hydroxypropyl β-cyclodextrin, 180 mg trehalose, and 1.5 mg acesulfame potassium. Compared with the Xiaoer Qingrening Granule, the sensory evaluation score of the optimal taste formula was increased by 37.5 points. In conclusion, this study achieved the taste improvement of Xiaoer Qingrening Granule and formed a set of taste improvement strategies including the identification of taste critical quality attribute, the selection of the type and dosage of corrigent, and the optimization of taste formula, which provided a thought reference for the taste improvement of other oral preparations and a new perspective for quality control of intelligent manufacturing of traditional Chinese medicines.
