To prepare the Eriodictyol chewable tablet and to evaluate its quality.
METHODS
2
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
2
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
2
Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of
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Related Author
LI Wenshuang
DAI Zeqi
SUN Qingran
WAN Chuchuan
LIAO Xing
XI Xiaoyu
ZHANG Xiaohui
TONG Liguo
Related Institution
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University
Dept. of Pharmacy, Shanxi Hospital of Traditional Chinese Medicine
Dept. of Pharmacy, Changzhi Medical College
Central Laboratory, Shanxi Academy of Traditional Chinese Medicine