星点设计-效应面法优化复方酮康唑凝胶的制备工艺  

Design-response Surface Method to Optimize Preparation Technology of Compound of Ketoconazole Gels

作　　者：郑小燕 张慧慧 黄清清 申玉婷 ZHENG Xiaoyan;ZHANG Huihui;HUANG Qingqing;SHEN Yuting(Yangjiang Hospital of Traditional Chinese Medicine,Yangjiang,Guangdong 529550,China)

机构地区：[1]阳江市中医医院

出　　处：《今日药学》2019年第10期663-668,共6页Pharmacy Today

基　　金：湖北省自然科学基金(2018CFB326);武汉市卫生局课题(WX13D01)

摘　　要：目的通过星点设计优选复方酮康唑凝胶最佳成型工艺条件。方法以酮康唑和硝酸咪康唑的渗透量为指标,以卡波姆-940质量分数、甘油质量分数、聚乙二醇400质量分数为考察因素,分别设置不同的含量范围,优选最佳复方酮康唑凝胶成型工艺条件。结果优选最佳处方成型工艺为卡波姆-940质量分数为0.3%、甘油质量分数为35%、聚乙二醇400质量分数为10%,OD值达到最大为0.8837。结论3批验证试验结果,酮康唑平均渗透量为49.05μg·cm^-2和硝酸咪康唑平均渗透量为28.21μg·cm^-2,计算总评归一值为0.8968,预测值0.8837,偏差1.48%,说明优选的工艺条件稳定可行。OBJECTIVE To optimize the molding process of compound of ketoconazole gels through star point design.RESULTS With ketoconazole and miconazole nitrate quantity as an index,Carbomer-940 mass fraction,Glycerin mass fraction,Polyethylene glycol 400 quality scores to examine factors,set up different content range,select the best compound of ketoconazole gels molding process conditions.RESULTS The best prescription molding process optimization of Carbomer-940 mass fraction was 0.3%,Glycerin mass fraction was 35%,Polyethylene glycol 400 mass fraction was 10%,the maximum OD value 0.8837.CONCLUSION 3 batch verification test results,ketoconazole osmotic quantity was average 49.05μg·cm-2,and miconazole nitrate osmotic quantity an average of 28.21μg·cm-2,calculate the overall rating to return a value of 0.8968,predictive value of 0.8837,deviation of 1.48%deviation,optimization of process conditions stable and feasible.

关 键 词：星点设计 渗透量 酮康唑 硝酸咪康唑 

分 类 号：R943[医药卫生—药剂学]