【摘要】 目的:制备复方维A酸乳膏,并建立其质量控制方法。方法:以三乙醇胺、甘油、尼泊金乙酯、甲硝唑、氯霉素、纯化水为水相,硬脂酸、羊毛脂、维生素E、维A酸、己烯雌酚为油相制成乳膏;采用抗生素微生物检定法和紫外-可见分光光度法分别测定氯霉素和甲硝唑的含量。结果:成品为浅黄色细腻、粘稠度适中的O/W型乳膏;甲硝唑检测浓度在1.82μg/ml~16.38μg/ml范围内与峰面积积分值线性关系良好,氯霉素、甲硝唑平均加样回收率为99.8%(RSD=0·27%)、102·0%(RSD=0·22%);样品在常温下避光贮存12mo内均无明显变化,离心15min后也无乳析分层现象。结论:该制剂制备工艺简单、质量可控。更多还原

【Abstract】 OBJECTIVE:To prepare compound tretinoin cream and to establish a method for its quality control.METHˉODS:The cream was prepared with trolamine,glycerin,ethylparaben,arilin,chloromycetin and purified water as water phase and with stearic acid,agnolin,vitamin E,tretinoin and estrobene as oil phase.Antibiotics bioassay and UV-spectrophotomˉetry were used respectively for the determination of chloromycetin and arilin.RESULTS:The finished product was O/W type buff fine cream with moderate viscosity.The linear correlation of arilin was obtained over the concentrations of1.82μg/ml～16.38μg/ml.The average recovery rates of chloromycetin and arilin were99.8%(RSD=0.27%)and102.0%(RSD=0.22%),respectively.Stored away from light under room temperature for12months,the sample experienced no marked change,and creaming stratification was failed to be seen15min after centrifugalization.CONCLUSION:The preparation is simple in production and controllable in quality.更多还原