Box-Behnken响应面法结合BP神经网络优化黑胡椒脐贴处方研究

Box-Behnken Response Surface Method Combined with Backpropagation Neural Network to Optimize Black Pepper Navel Patch Formulation

目的采用Box-Behnken响应面法结合BP神经网络优化黑胡椒脐贴处方。方法在前期预试验的基础上,以载药量、促渗剂用量、聚乙二醇(polyethylene glycol,PEG)6000与微粉硅胶的比例为影响因素,进行单因素试验。结合体外透皮试验,利用高效液相色谱法测定胡椒碱的含量,对胡椒碱峰面积、指纹图谱的总峰面积和脐贴的成型性、剥离残留度和基质填充情况赋以权重,所得结果为综合评价指标。在单因素试验的基础上利用Box-Behnken响应面法结合BP神经网络优化脐贴处方。结果黑胡椒脐贴的最佳处方为载药量7%、氮酮4.5%、PEG6000与微粉硅胶的质量比为43∶1。结论黑胡椒脐贴的处方合理,可为后续贴剂的药效学研究提供基础。

Objective To optimize the formulation of a black pepper navel patch by using the Box-Behnken response surface method combined with the backpropagation neural network algorithm.Methods On the basis of pre-experimental data,the single factor experiment was carried out with drug loading,penetration enhancer content,and the mass ratio of PEG6000 to silica gel as influencing factors.We determined the content of piperine through high-performance liquid chromatography in combination with the in vitro transdermal test,and assigned weights to the peak area of piperine,the total peak area of the fingerprint,and the formability,peel-off residue,and matrix filling of the umbilical patch,constructing a comprehensive evaluation index.On the basis of the single-factor experiment,the navel patch formulation was optimized using the Box-Behnken response surface method combined with the backpropagation neural network algorithm.Results The optimal black pepper navel patch formulation was:drug loading,7%;azone,4.5%;the mass ratio of PEG6000 to silica gel,43∶1.Conclusion The black pepper navel patch formulation is reasonable,which can provide a basis for the future pharmacodynamic study of patches.