盐酸咪达普利片的制备及其体外溶出评价

Preparation and in Vitro Dissolution Evaluation of Imidapril Hydrochloride Tablets

关键词:  盐酸咪达普利片  制备工艺  体外溶出  相似因子

Key words:  imidapril hydrochloride tablets  preparation process  dissolution in vitro  similarity factors

摘要:

目的 探索盐酸咪达普利片的制备方法，以期得到与原研制剂Tanatril^®相似的体外溶出曲线。方法 采用参比制剂逆向研究和单因素试验等手段，考察盐酸咪达普利片处方比例。并采用湿法制粒工艺制备盐酸咪达普利片。以原研制剂作为参比制剂，考察自制制剂在4种溶出介质中的溶出情况，以评价其体外溶出相似性。结果 自制制剂与参比制剂对比，4条溶出曲线相似因子(f₂)均>50，说明体外溶出相似。结论 自制制剂处方和工艺研究为盐酸咪达普利片生物等效性试验的可行性提供依据，并对工业化生产具有指导意义。

Abstract:

OBJECTIVE To explore the preparation method of imidapril hydrochloride tablets, in order to obtain Tanatril^® similar in vitro dissolution curves. METHODS The prescription proportion of imidapril hydrochloride tablets was investigated by reverse study of reference preparation and single factor test. Imidapril hydrochloride tablets were prepared by wet granulation process. Using the original formulation as a reference, investigate the dissolution of the self-made formulation in four dissolution media to evaluate its in vitro dissolution similarity. RESULTS Compared with the reference preparation, the similarity factor(f₂) of the four dissolution curves of self-made preparation was more than 50, which indicated that the dissolution was similar in vitro. CONCLUSION The study of self-made preparation prescription and process provides a basis for the feasibility of bioequivalence test of imidapril hydrochloride tablets, and has guiding significance for the industrial production.