格列齐特片的制备工艺和溶出一致性评价

Preparation of gliclazide tablets and consistency study of their dissolubility

目的制备格列齐特片,进行体外溶出一致性评价。方法通过单因素实验考察黏合剂的浓度、外加崩解剂的量、外加润滑剂和助流剂的量、颗粒的大小和片剂的硬度几个因素对溶出的影响,进行处方工艺的筛选。放大制备3批格列齐特片,考察在4种不同溶出介质中自制片和参比制剂的溶出一致性。结果 3批自制片在磷酸盐缓冲液(pH7.4)中15 min内溶出大于85%,在水、pH1.2盐酸溶液、pH6.0磷酸盐溶液中的f_2均大于50。结论在4种不同的溶出介质中,自制片与参比制剂体外溶出一致。

Objective To prepare gliclazide tablets and to evaluate its consistency of dissolution tests. Methods The single factor experiments were applied to investigating several factors on the dissolution, such as the amount of the adhesive, the amount of lubricant, the particle size and tablet hardness.708-DS Dissolution Tester was used to conduct the dissolution tests which were carried on four different dissolution media. Then the similar factor（f2） was adopted to evaluate the similarity of dissolution between the original drug and generic drug. Results Three batches of homemade-tablets were eluted more than 85% within 15 min in phosphate buffered saline（pH7.4）, and the f2 values were greater than 50 in water, pH 1.2 hydrochloric acid solution and pH 6.0 phosphate solution. Conclusion In four different dissolution media, self-made tablets and reference formulations in vitro dissolution consistent.