Comparative Studies on Dissolution of Gansukang Capsules from Different Manufacturers in Two Dissolu-tion Media
- VernacularTitle:不同厂家肝速康胶囊在两种溶出介质中的溶出曲线比较
- Author:
Wang LEI
- Publication Type:Journal Article
- Keywords:
Gansukang capsules;
Oleanolic acid;
HPLC-ELSD;
Dissolution
- From:
China Pharmacist
2015;(11):1888-1891,1892
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the dissdution behavior of Gansukang capsules from different manufactures in two different dissdution media and to provide theoretical basis for evaluating the quality of medicine. Methods:According to the dissolution test con-ditions in Japan’ s “quality of medical drugs information set” and the physicochemical properties of Gansukang capsules, two dissolu-tion media were chosen. The dissolution behavior of Gansukang capsules from 3 manufacturers in pH 6. 8 phosphate buffer (containing 0. 25% sodium lauryl sulfate) and water (containing 0. 25% sodium lauryl sulfate) was determined by the method I in Appendix XC of Chinese Pharmacopoeia Volume II (2010 edition), and the dissolution rate was determined by HPLC-ELSD. Results:The assay dis-played a good linearity over the concentration range of 2. 0-40. 0 mg·ml-1 for oleanolic acid, the recovery of oleanolic acid in pH 6. 8 phosphate buffer and water was above 98%, and Gansukang capsules had the similar property in the two media. The dissolution behav-ior of Gansukang capsules from 3 manufacturers in water was similar to each other, while in pH 6. 8 phosphate buffer, that was signifi-cantly different. Conclusion:As for the dissolution medium for Gansukang capsule, pH 6. 8 phosphate buffer can reflect more differ-ences in the dissolution of products with different batches and from different manufacturers than water. The method is simple, accurate and reproducible in the dissolution determination of the capsules.
