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目的:考察两面针分散片最佳处方,确定工艺流程。方法:采用单因素考察和正交试验,以分散均匀性和溶出度为综合指标筛选和优化两面针分散片的最佳处方与工艺。结果:按优化后的处方工艺制备的两面针分散片的崩解时间为20s,分散均匀性好;分散片体外释药参数T50和Td明显小于市售普通片的溶出参数(P<0.01)。结论:所制备两面针分散片具有溶散快,分散均匀,有效成分溶出速率快的特性。
OBJECTIVE: To investigate the optimal formulation of two-sided needle dispersible tablets and determine the technological process. Methods: Single factor test and orthogonal experiment were used to screen and optimize the optimal formulation and process of the two-needle needle dispersible tablets with the indexes of dispersion uniformity and dissolution. Results: The disintegration time of two-needle dispersible tablets prepared by optimized prescription was 20s, and the dispersion uniformity was good. The in vitro release parameters T50 and Td of the dispersible tablets were significantly lower than those of the common tablets (P <0.01). Conclusion: The two-sided needle dispersible tablets have the characteristics of quick dissolution, uniform dispersion and rapid dissolution rate of active ingredients.