中文摘要：

目的：优选复方冰甲乳膏的基质配方和制剂工艺参数。方法：分别制备水相和油相基质溶液,将前者加入后者中混匀,通过外观性状和高温、低温、离心试验后油水分层的综合总分为评价指标,优选基质配方。采用高效液相色谱法测定甲硝唑含量、气相色谱法测定冰片含量;以加入主药混合物时基质的温度、基质用量、乳化方式和乳化时间为考察因素,以甲硝唑含量、冰片含量和制剂综合总分（制剂外观及稳定性评价得分之和）的综合评分为考察指标,设计L9（34）正交试验,优选复方冰甲乳膏的制剂工艺参数并进行工艺验证。结果：优选的油相基质配方为十六醇10 g、单硬脂酸甘油酯16 g、硬脂酸20 g、白凡士林8 g,水相基质配方为三乙醇胺2 g、甘油24 g;优选的制剂工艺参数为加入主药混合物时基质温度50℃、基质用量300 g、胶体乳化、乳化时间30 min,此工艺参数下甲硝唑含量为1.83%、冰片含量为2.88%;3次验证试验中,制剂综合总分均为25分,甲硝唑含量分别为2.1%、2.1%、2.2%（RSD为2.71%,n=3）,冰片含量分别为3.2%、3.3%、3.1%（RSD为3.12%,n=3）。结论：优选的制剂基质配方和工艺参数稳定、可行,适合批量生产。

英文摘要：

OBJECTIVE：To optimize the matrix formulation and preparation technological parameters of Compound Bingjia Cream.METHODS：To prepare water phase and oil phase matrix solutions respectively,and then the former was added into the latter and well mixed together.The matrix formulation was optimized with the overall scores of appearance,high temperature,low temperature and oil and water stratification after centrifugal test as the evaluated indexes.High performance liquid chromatography was used to determine the content of metronidazole.Gas chromatography was adopted to determine the content of borneol.With the matrix temperature at the time of adding the main drug mixture,matrix quantity,emulsification method and emulsification time as observed factors,and the overall scores of metronidazole content,borneol content and the overall scores of preparation（the overall scores of appearance and stability tests）as the observed indexes,L9（34）orthogonal test was designed to optimize the preparation technological parameters of Compound Bingjia cream and verification for technology was conducted.RESULTS：The optimal oil phase matrix formulation was as follows as cetanol of 10 g,glyceryl monostearate of 16 g,stearic acid of 20 g,albolene of 8 g,while the optimal water oil matrix formulation as triethanolamine of 2 g,glycerinum of 24 g.The optimal preparation technological parameters were the matrix temperature of 50 ℃ at the time of adding the main drug mixture,matrix of 300 g,emulsification method of colloid emulsification,emulsification time of 30 min,where metronidazole content was 1.83%,borneol content 2.88%.The results of 3 verification tests showed the overall scores were all 25,with metronidazole content of 2.1%,2.1%,2.2%（RSD=2.71%,n=3）,borneol content of 3.2%,3.3%,3.1%（RSD=3.12%,n=3）.CONCLUSIONS：The optimal matrix formulation and technological parameters of the preparation are stable and feasible,and suitable for mass production.