本文選題：復方冰甲乳膏 + 甲硝唑��； 參考：《中國藥房》2015年22期

【摘要】：目的:優(yōu)選復方冰甲乳膏的基質配方和制劑工藝參數。方法:分別制備水相和油相基質溶液,將前者加入后者中混勻,通過外觀性狀和高溫、低溫、離心試驗后油水分層的綜合總分為評價指標,優(yōu)選基質配方。采用高效液相色譜法測定甲硝唑含量、氣相色譜法測定冰片含量;以加入主藥混合物時基質的溫度、基質用量、乳化方式和乳化時間為考察因素,以甲硝唑含量、冰片含量和制劑綜合總分(制劑外觀及穩(wěn)定性評價得分之和)的綜合評分為考察指標,設計L9(34)正交試驗,優(yōu)選復方冰甲乳膏的制劑工藝參數并進行工藝驗證。結果:優(yōu)選的油相基質配方為十六醇10 g、單硬脂酸甘油酯16 g、硬脂酸20 g、白凡士林8 g,水相基質配方為三乙醇胺2 g、甘油24 g;優(yōu)選的制劑工藝參數為加入主藥混合物時基質溫度50℃、基質用量300 g、膠體乳化、乳化時間30 min,此工藝參數下甲硝唑含量為1.83%、冰片含量為2.88%;3次驗證試驗中,制劑綜合總分均為25分,甲硝唑含量分別為2.1%、2.1%、2.2%(RSD為2.71%,n=3),冰片含量分別為3.2%、3.3%、3.1%(RSD為3.12%,n=3)。結論:優(yōu)選的制劑基質配方和工藝參數穩(wěn)定、可行,適合批量生產。
[Abstract]:Objective: to optimize the matrix formulation and preparation parameters of compound Bing A cream. Methods: water phase and oil phase matrix solution were prepared, and the former was mixed in the latter. The composite score of oil and water stratification after centrifugation was selected as evaluation index through appearance characteristics and high temperature and low temperature. The content of metronidazole was determined by HPLC, the content of borneol was determined by gas chromatography, and the content of metronidazole was determined by the temperature, dosage, emulsification mode and emulsification time of the matrix when the main drug mixture was added. The synthetic score of the content of borneol and the total score of the preparation (the sum of the evaluation score of the appearance and stability of the preparation) was used as the inspection index. The orthogonal test was designed to optimize the preparation parameters of compound Bing A cream and to verify the process. Results: the optimized oil matrix formula was hexadecanol 10 g, glycerol monostearate 16 g, stearic acid 20 g, white vaseline 8 g, water phase base formulation 2 g triethanolamine and glycerol 24 g. The substrate temperature is 50 鈩，

本文編號：1982014