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目的制备格列喹酮双层渗透泵控释片,并对处方进行优化。方法应用星点设计-效应面优化法,以含药层聚氧乙烯质量(m1,mg,以 X1表示)、含药层氯化钠质量(m2,mg,以 X2表示)和包衣膜质量占片芯质量的百分比(w,%,以 X3表示)为自变量,自制处方溶出曲线与理想溶出曲线相比而得的相似因子(f2)为应变量优化处方。结果根据效应图得到最优处方:含药层 PEO 的质量为 117.5 mg,含药层 NaCl 的质量为 122.5 mg,包衣增质量为 9.3%。以优化处方制备样品,其溶出曲线与目标溶出曲线相似。结论星点设计-效应面优化法可以实现格列喹酮双层渗透泵处方优化,其模型具有很好的预测性与使用性。
Objective To prepare Gliquidone double osmotic pump controlled release tablets and optimize the prescription. Methods The apical design-response surface optimization method was used to determine the mass of polyoxyethylene (m1, mg, expressed as X1), the mass of sodium chloride (m2, mg, The percentage of core mass (w,%, expressed as X3) as independent variable, the similarity factor (f2) of self-made prescription dissolution curve compared with ideal dissolution curve is the optimal formulation of strain. Results According to the effect diagram, the optimal prescription was obtained: the mass of the drug-containing layer PEO was 117.5 mg, the mass of the drug-containing NaCl layer was 122.5 mg, and the mass gain of the coating was 9.3%. To optimize the preparation of the sample preparation, the dissolution curve and the target dissolution curve similar. Conclusion The method of star-point design-response surface optimization can optimize the prescription of Gliquidone double-layer osmotic pump, and its model has good predictability and usability.