Preparation and quality evaluation of Eriodictyol chewable tablet
- VernacularTitle:圣草酚咀嚼片的制备及质量评价
- Author:
Chunmeng QIN
1
,
2
;
Wenjun LI
2
;
Liaoping LI
3
;
Jie LIU
3
;
Songqing LIU
1
Author Information
1. College of Pharmacy，Chongqing Medical University，Chongqing 400010，China
2. Dept. of Pharmacy，the Third Affiliated Hospital of Chongqing Medical University，Chongqing 401120，China
3. Chongqing Liyang Medical Pharmaceutical Development Co.，Ltd.，Chongqing 400050，China
- Publication Type:Journal Article
- Keywords:
eriodictyol;
chewable tablet;
formulation optimization;
orthogonal test;
quality evaluation
- From:
China Pharmacy
2024;35(4):449-452
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To prepare the Eriodictyol chewable tablet and to evaluate its quality. METHODS The chewable tablet was prepared by the wetting granulation method by using microcrystalline cellulose （MCC） and mannitol as fillers， polyvinylpyrrolidone （PVP） as adhesive， citric acid and sucralose as flavor correction agents， magnesium stearate as lubricant. The comprehensive evaluation was conducted on Eriodictyol chewable tablets with the dosage of each excipient as a factor using the appearance， taste， flavor and texture as indicators. The ratio of excipients was optimized by orthogonal test， and the quality of Eriodictyol chewable tablets prepared by optimized formulation was evaluated in terms of appearance， weight difference， hardness， fragility， eriodictyol content， dissolution and content uniformity. RESULTS The optimal formulation was as follows： 26.4% eriodictyol （50 mg each piece）， 45% mannitol， 25% MCC， 0.3% citric acid， 0.3% sucralose， 1% magnesium stearate， 2% PVP （preparing 5% solution using purified water）. The scores of 3 batches of Eriodictyol chewable tablets in the validation test were 8.76， 8.75 and 8.80 （RSD＝0.30%， n＝3）， respectively. The Eriodictyol chewable tablet had a complete appearance and a smooth surface； the average tablet weight was 192.57 mg， the average hardness was 57.36 N， the fragility was 0.09%， the average content of eriodictyol per tablet was 50.74 mg， the cumulative dissolution within 30 min was exceeding 80%， and the content uniformity was 5.51. CONCLUSIONS Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of Chinese Pharmacopoeia.
