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目的:考察并比较自制盐酸鲁拉西酮片与原研片的溶出度。方法:溶出度测定采用桨法,以pH 3.8 McIlvaine缓冲溶液900 ml为溶出介质,转速为50 r/min,温度为(37±0.5)℃;采用反相高效液相色谱法测定盐酸鲁拉西酮的含量,色谱柱为C8,流动相为0.05 mol/L磷酸盐缓冲液(pH 3.0)-乙腈(60∶40),检测波长为230 nm,流速为1.2 ml/min,柱温为40℃。对5批自制片与1批原研片的溶出行为采用相似因子法和威布尔法进行评价。结果:盐酸鲁拉西酮检测质量浓度线性范围为10~100μg/ml(r=0.999 9),平均回收率为99.88%(RSD=0.55%,n=3)。5批自制片与原研片的相似因子均大于85,威布尔法中各溶出参数比较差异无统计学意义(P>0.05)。结论:建立的溶出度测定方法简便、快速、准确、可靠;自制片与原研片体外溶出度一致。
OBJECTIVE: To investigate and compare the dissolution of home-made lurasidone hydrochloride tablets and original tablets. Methods: The dissolution method was determined by paddle method, 900 ml of pH 3.8 McIlvaine buffer was used as dissolution medium, the rotation speed was 50 r / min and the temperature was 37 ± 0.5 ℃. The concentration of ketone was C8, the mobile phase was 0.05 mol / L phosphate buffer (pH 3.0) - acetonitrile (60:40), the detection wavelength was 230 nm, the flow rate was 1.2 ml / min and the column temperature was 40 ℃ . The dissolution behavior of five batches of homemade tablets and one batch of original tablets was evaluated by similar factor method and Weibull method. Results: The calibration curve of lusalone hydrochloride was linear within the range of 10-100 μg / ml (r = 0.999 9). The average recovery was 99.88% (RSD = 0.55%, n = 3). The similarities between the five batches of self-made tablets and the original tablets were all greater than 85. There was no significant difference in the dissolution parameters among the five batches of homemade tablets (P> 0.05). Conclusion: The established dissolution method is simple, rapid, accurate and reliable. The in vitro dissolution of self-made tablets and original tablets are the same.