目的 采用星點(diǎn)設(shè)計(jì)–效應(yīng)面法優(yōu)化五參分散片的處方工藝。方法 以填充劑微晶纖維素（MCC）用量、崩解劑交聯(lián)羧甲基纖維素鈉（cCMC-Na）用量、交聯(lián)聚維酮XL（PVPP XL）用量為自變量，崩解時(shí)間、溶出度為因變量，對(duì)指標(biāo)與因素進(jìn)行數(shù)學(xué)模型擬合，以效應(yīng)面法預(yù)測(cè)優(yōu)化處方并驗(yàn)證。結(jié)果 優(yōu)化的最佳成型工藝為MCC用量為35%，cCMC-Na用量為12%，PVPP XL用量為10%，優(yōu)化處方各設(shè)定的預(yù)測(cè)值和測(cè)定值非常接近。結(jié)論 采用星點(diǎn)設(shè)計(jì)–效應(yīng)面法建立了五參分散片處方的優(yōu)化模型預(yù)測(cè)性良好。

Objective To optimize the formulation of Wushen Dispersible Tablets by central composite design-response surface method (CCD-RSM)．Methods The amounts of MCC, cCMC-Na, and PVPP XL were regarded as independent variables, and disintegration time and dissolution rate were regarded as dependent variables. The optimal formulation was predicted by response surface method and was verified as well. Results The optimal molding technology was as follows: MCC was 35%, cCMC-Na was 12%, and PVPP XL was 10%. The predicted value was very close to the measured value. Conclusion The mathematical model of Wushen Dispersible Tablets formulation could be achieved by CCD-RSM with the prefect prediction.