响应面法制备枸橼酸铋钾智能喷雾水凝胶工艺研究

Response surface methodology for the preparation of bismuth potassium citrate intelligent spray hydrogel process

目的为制备一种治疗复杂口腔溃疡的新型外用制剂,研究枸橼酸铋钾智能喷雾水凝胶的制备工艺参数。方法以可喷性和黏度为综合评分,通过单因素实验考察去乙酰化结冷胶、甘油、泊洛沙姆188的用量、水浴温度,以及凝胶基质与等渗液的体积比对智能喷雾水凝胶的影响,并建立以去乙酰化结冷胶浓度、泊洛沙姆188用量、凝胶基质与等渗液体积比为因素的星点设计-效应面优化法试验。结果通过Design Expert 8.0.6.1软件分析,得到枸橼酸铋钾智能喷雾水凝胶优化的制备工艺参数为去乙酰化结冷胶质量分数0.23%,泊洛沙姆188用量1.03 g,混合基质为凝胶基质与等渗液体积比13∶1制得。结论该工艺制得的枸橼酸铋钾智能喷雾水凝胶综合评分高、重现性好、可操作性强,适合枸橼酸铋钾智能喷雾水凝胶工业生产。

Objective To prepare a novel topical formulation for the treatment of complicated oral ulcers,the process parameters for the preparation of bismuth potassium citrate intelligent spray hydrogel were investigated.Methods The effects of the dosage of deacetylated gellan gum,glycerol,and poloxamer and the water bath temperature,and the volume ratio of gel matrix to isotonic solution on the intelligent spray hydrogel were investigated by one-way experiments using sprayability and viscosity as the composite scores,and the star-point design-effect surface optimization method test with the concentration of deacetylated gellan gum,and the volume ratios of poloxamer,and the gel matrix to the isotonic solution as the factors was established.Results The optimal process parameters for the preparation of bismuth potassium citrate intelligent spray hydrogel were analyzed by Design Expert 8.0.6.1 software and obtained as the mass fraction of gelling gel of 0.23%,the dosage of Poloxamer 1881.03 g,and the mixed matrix is made from the volume ratio of gel matrix to isotonic soloution 13∶1.Conclusion The process produced a bismuth potassium citrate intelligent spray hydrogel with high comprehensive score,superior reproducibility and excellent operability,which is suitable for the industrial production of bismuth potassium citrate intelligent spray hydrogel.