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目的:应用星点设计-效应面法优化夏天无总生物碱微孔渗透泵片处方。方法:以NaCl用量、致孔剂含量、包衣增质量为自变量,药物累积释药量及累积释放量曲线的线性相关系数(r)为因变量,应用Design Expert对处方进行优化,并对优化处方进行验证。结果:最优处方为NaCl用量34 mg,致孔剂质量分数99%,包衣增质量4%;优化处方呈零级释放特性。结论:通过星点设计-效应面法成功建立了处方优化模型,实现了夏天无总生物碱微孔渗透泵片的处方筛选。
OBJECTIVE: To optimize the formulation of summer total alkaloid microporous osmotic pump tablets by the combination of apices design and response surface methodology. Methods: Design Expert was used to optimize the prescription based on the linear correlation coefficient (r) of NaCl concentration, porogen content, coating mass gain as independent variable, drug cumulative release amount and cumulative release curve as the dependent variable Optimize prescriptions for validation. Results: The optimal prescription was NaCl dosage 34 mg, porogen 100%, coating quality 4%, and the optimal formulation was zero-order release. Conclusion: The prescription optimization model was successfully established by the apical design-response surface method, and the prescription of the total alkaloid microporous osmotic pump tablets was achieved in summer.