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目的应用星点设计-效应面优化去甲斑蝥素壳聚糖肝动脉栓塞微球的制备工艺,以提高微球性质的可预测性,并对微球的部分特性进行表征以及对微球的体外释药行为进行考察。方法以微球收率、载药量、包封率、平均粒径和跨距为指标,计算各指标的归一值,并利用几何均数得出总评归一值(overall desirability,OD),去甲斑蝥素和壳聚糖的重量百分比(X1)、油水比例(X2)、壳聚糖浓度(X3)3个主要因素的各水平进行多元线性回归和二项式拟合,并进行模型预测分析及方法验证。结果 OD值的二项式拟合方程较好(r2>0.92,P<0.05),以最优处方制备的微球平均粒径为123μm,载药量为10.09%。预测值与实测值偏差均较小。结论星点设计-效应面能更好的优化微球的处方工艺,增加模型的实用性。
OBJECTIVE: To optimize the preparation of norcantharidin-chitosan hepatic artery embolization microspheres by means of apical design-response surface, in order to improve the predictability of microsphere properties and to characterize the microspheres’ Drug release behavior inspection. Methods The normalized value of each index was calculated based on the yield of microspheres, drug loading, entrapment efficiency, average particle size and spans, and the overall average desirability (OD) Multivariate linear regression and binomial fitting were carried out for each of the three main factors of the weight percentages (X1), oil-water ratio (X2) and chitosan concentration (X3) of norcantharidin and chitosan, and model prediction Analysis and method validation. Results The binomial fitting equation of OD value was better (r2> 0.92, P <0.05). The average diameter of microspheres prepared by optimal formulation was 123μm and the drug loading was 10.09%. The deviation between the predicted value and the measured value is small. Conclusion The design of apices - effect surface can better optimize the prescription of microspheres and increase the practicability of the model.