Preparation and Quality Evaluation of Gastric Floating Tablets of Schisandra chinensis Total Lignans
- VernacularTitle:五味子总木脂素胃漂浮片的制备及质量评价
- Author:
Xiang ZOU
1
;
Tian GONG
1
;
Shiru ZHU
1
;
Lin ZHOU
1
;
Shuang WU
1
;
Yijing YIN
1
;
Zhongyuan QU
1
;
Wenlan LI
1
Author Information
1. College of Pharmacy/Engineering Research Center of Natural Anticancer Drugs，Ministry of Education，Harbin University of Commerce，Harbin 150076，China
- Publication Type:Journal Article
- Keywords:
Schisandra chinensis total lignans;
Gastric floating tablets;
Schizandrol A;
Formulation optimization;
Quality
- From:
China Pharmacy
2020;31(11):1336-1341
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To study the prepar ation technology of gastric floating tablets of Schisandra chinensis total lignans （SCTL），and evaluate the quality of prepared tablets. METHODS ：Based on single factor test ，the orthogonal experiment was conducted to optimize the formulation of SCTL gastric floating tablets with the contents of hydroxypropylmethylcellulose （HPMC） K15M，NaHCO3 and microcrystalline cellulose as the factors ，using starting time ，holding time and cumulative release rate of gastric floating tablets as evaluation indexes. The properties ，weight difference ，floatability and accumulative release rate of the prepared SCTL gastric floating tablets were determined. The gastric floating tablets were qualitatively identified by TLC ，and the contents of schisandrin A and total lignans were determined by HPLC and UV spectrophotometry. RESULTS ：The optimal formulation of SCTL gastric floating tablets was made up of 23％ SCTL extract ，20％ HPMC K 15M，40％ microcrystalline cellulose，15％ sodium bicarbonate ，1％ octadecyl alcohol and 1％ polyvinylpyrrolidone. The results of detection of this preparation were in line with the related provisions of “0101 tablet”stated in 2015 edition of Chinese Pharmacopoeia （part Ⅳ）. TLC indicated that the chromatogram of the test sample showed the main spots of same color as the corresponding positions of the chromatogram of schizandrol A control ，Schisandra chinensis reference substance and raw material ，while the negative control has no interference. Content determination results shows that the average content of schizandrol A and total lignans in SCTL gastric floating tablets is 3.187，19.617 mg. It was preliminarily formulated that the content limitation of schizandrol A in one tablet should not be less than 2.50 mg，and the content of total lignans （calculated by schizandrol A ）should not be less than 15.50 mg. CONCLUSIONS：The preparation technology of SCTL gastric floating tablets is stable ，feasible and controllable in quality.
