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目的:考察不同溶出介质对利培酮口溶膜剂溶出度的影响,为其制剂质量判断提供依据。方法:分别考察自制利培酮口溶膜剂和参比制剂在水、0.1 mol·L~(-1)盐酸溶液、pH 4.5醋酸-醋酸钠缓冲液、pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,以HPLC法进行测定,并采用溶出相似(f_2)因子法评价自制制剂和参比制剂溶出曲线的相似性。结果:在4种介质中,自制制剂与参比制剂的f_2因子均大于50。结论:自制制剂与参比制剂在4种介质中的溶出行为相似,表明该制剂的处方工艺稳定可行。
OBJECTIVE: To investigate the effect of different dissolution media on the dissolution rate of Risperidone oral mucosa, and provide the basis for judging the quality of its preparation. Methods: The effects of self-made risperidone oral solution and reference formulation in water, 0.1 mol·L -1 hydrochloric acid solution, pH 4.5 acetate-sodium acetate buffer solution, pH 6.8 phosphate buffer solution In vitro dissolution behavior by HPLC method, and dissolution similar (f_2) factor method was used to evaluate the similarity of dissolution profiles of homemade and reference preparations. Results: The f 2 factors of homemade and reference preparations were all greater than 50 in the four media. Conclusion: The dissolution behavior of homemade preparations and reference preparations in four kinds of media is similar, indicating that the formulation process is stable and feasible.