银黄口腔崩解片的制备工艺研究及体外评价

Preparation technology and in-vitro evaluation research on Yin-huang orally disintegrating tablets

目的:优选银黄口腔崩解片的处方和制备工艺。方法:采用单因素考察和星点设计-效应面法,以崩解时限为主要评价指标,优选最佳制备工艺和处方;采用体外溶出度实验考察制备的口崩片与普通片剂的溶出度差异。结果:经效应面法筛选出了最佳处方组合,以优选出的处方,制备3批银黄口崩片,片面光洁圆整、均匀无斑点,口感良好,片重差异在±5%以内,硬度在40N左右,体外崩解时间为(29±0.3)s,口腔内崩解时间为(28±0.5)s。体外溶出度实验表明,所制备的口崩片在15 min内累积溶出达到80%以上,30 min累积溶出达90%以上,明显优于普通片剂。结论:制备的银黄口腔崩解片达到设计要求,硬度适中,崩解迅速,口感良好,服用方便,工艺简单易行。

Objective: To optimize the formulation and preparation process of Yin-huang orally disintegrating tablets. Method: Disintegration time was used as the main evaluation index to optimize the formulation and preparation process of Yin-huang orally disintegrating tablet using single factor and central composite design-response surface methodology. In vitro dissolution experiment was applied to examine the dissolution difference between orally disintegrating tablets and common tablets. Result: The formulation was optimized. Three batches of Yin-huang orally disintegrating tablets prepared according to the best prescription were smooth-sided round, uniformity without spots, and had good taste. And tablet weight difference was within ± 5%. The hardness was about 40 N. In vitro disintegration time was(29 ± 0.3) s. The disintegration time in oral cavity was(28 ± 0.5) s. In vitro release of the disintegrating tablets was better than the common tablets. Conclusion: Yin-huang orally disintegrating tablets prepared in the experiment satisfy the design requirements which have moderate hardness, quick disintegration and good taste. The processing technology is easy and feasible.