盐酸普萘洛尔乳膏的研制及质量标准研究

Preparation and quality control of propranolol hydrochloride cream

目的优选盐酸普萘洛尔乳膏的最佳基质配方和工艺条件,并对其进行质量控制。方法以乳化温度、硬脂酸、单硬脂酸甘油酯及吐温-80用量为考察因素,采用正交试验优选最佳基质配方和工艺条件;采用HPLC法测定盐酸普萘洛尔的含量,并对其进行质量控制。结果筛选出了最佳基质配方和工艺条件为硬脂酸10%,单硬脂酸甘油酯7.5%,吐温-803%,乳化温度70℃,制备的盐酸普萘洛尔乳膏外观及稳定性均良好,质量可靠,平均回收率为98.65%,RSD为0.52%(n=9)。结论盐酸普萘洛尔乳膏制备工艺可行,质量稳定,质控方法简便快速。

Objective To optimize matrix formula and process conditions and control the quality of propranolol hydrochloride cream. Methods Emulsifying temperature, dosages of the stearic acid, glyceryl monostearate and Tween-80 were taken as variable factors and the orthogonal experiment was adopted to optimize matrix formula and process conditions. HPLC was chosen to determine the content of propranolol hydrochloride and control its quality. Results The optimized matrix formula of propranolol hydrochloride cream was composed of 10% of stearic acid, 7.5% of glyeeryl monostearate, 3% of Tween-80 and emulsifying temperature was 70 ℃. The appearance and stability were good and the quality was good. The average recovery rate was 98.65% , RSD was 0.52% （ n = 9）. Conclusion The preparation process of propranolol hydrochloride cream was rational and stable in quality. The quality control method was simple and fast.