Similarity Evaluation of Dissolution Curves for Generic Preparation and Reference Preparation of Bisaco-dyl Enteric-coated Tablets
10.6039/j.issn.1001-0408.2017.09.32
- VernacularTitle:不同厂家比沙可啶肠溶片仿制制剂与参比制剂溶出曲线的相似性评价
- Author:
Ting SUN
;
Jianguo JIANG
;
Yonghui GUO
;
Xuejing HAN
- Keywords:
Bisacodyl enteric-coated tablets;
Generic preparation;
Reference preparation;
HPLC;
Similarity factors method;
Dissolution curves
- From:
China Pharmacy
2017;28(9):1268-1271
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To investigate the similarity of dissolution curves between generic preparations and reference prepara-tions of Bisacodyl enteric-coated tablets in various dissolution mediums,and to provide reference for improving production technolo-gy and internal quality of generic preparations. METHODS:Paddle method was adopted with rotation speed of 75 r/min. The disso-lution test was performed using 1000 mL pH 6.0 phosphate buffer solution,pH 6.8 phosphate buffer solution,water containing 2% sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor(f2)meth-od was used to the similarity of dissolution curves. RESULTS:Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50,namely the similarity. CONCLUSIONS:The quality of generic Bisacodyl enteric-coat-ed tablets produced by different manufacturers is obviously different;the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation,it is necessary to strengthen the real-time monitoring of its dissolution curve,to ensure the drug quality.
