Preparation and Quality Evaluation of Azelnidipine Enteric Solid Dispersion
- VernacularTitle:阿折地平肠溶固体分散体的制备及质量评价
- Author:
Ting JIANG
1
;
Lingli ZHENG
1
;
Mingyong YUAN
1
;
Xuehua JIANG
2
Author Information
1. Dept. of Pharmacy，the First Affiliated Hospital of Chengdu Medical College，Chengdu 610500，China
2. West China School of Pharmacy，Sichuan University，Chengdu 610041，China
- Publication Type:Journal Article
- Keywords:
Azelnidipine;
Enteric solid dispersion;
Solvent method;
Quality evaluation;
Stability
- From:
China Pharmacy
2021;32(15):1862-1867
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To prepare Azelnidipine enteric solid dispersion and evaluate its quality. METHODS ：Azelnidipine enteric solid dispersion was prepared by solvent method. Taking cumulative dissolution rate as the index ，single factor test was used to optimize carrier material type and its ratio. The quality of the product was evaluated by DSC ，XRD and FTIR ，and its stability was investigated. RESULTS ：After azelnidipine and carrier material of Eudragit L 100-55 acrylic resin were prepared to enteric solid dispersion at a ratio of 1∶5（m/m），its dissolution rate was significantly improved. DSC ，XRD and FTIR method had all verified the crystal form of azelnidipine changed and it existed in amorphous form. The results of stability test showed that Azelnidipine enteric solid dispersion was stable under high temperature （60 ℃），high humidity （75％）and strong light [ （4 500±500）lx] for 10 days. CONCLUSIONS ：Azelnidipine enteric solid dispersion by solvent method with Eudragit L 100-55 acrylic resin as carrier can eliminate the influence of crystal form ，improve dissolution and has good stability.
