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目的:改良传统祛风止痛膏的基质处方并考察其皮肤安全性,为提高该制剂的患者依从性提供参考。方法:以外观、涂抹性、黏稠度、离心稳定性和p H为评价指标,筛选祛风止痛软膏的基质组成,采用响应面法对该制剂的油相水相比、甘油、聚氧乙烯-2(21)硬脂醇醚(72/721乳化剂)和硬脂酸添加量进行优化,改良后的剂型进行皮肤刺激性、皮肤过敏性及皮肤急性毒性试验。结果:改良祛风止痛膏软膏的基质组成配比为甘油添加量16.5 g,72/721乳化剂添加量25.5 g,硬脂酸添加量26 g,油相-水相(1∶7.8)。经皮肤刺激性试验、过敏性试验、皮肤急性毒性试验证明祛风止痛膏软膏无刺激性、过敏性及皮肤毒性。结论:改良后的祛风止痛膏软膏制备工艺优良,制剂性能稳定,外用安全无毒。
Objective: To improve the traditional prescription of Qufeng Zhitong cream matrix and study its skin safety, in order to improve the compliance of the preparation of patients provide a reference. Methods: The matrix composition of Qufeng Zhitong Ointment was screened by appearance, smear, viscosity, centrifugal stability and p H. The response surface methodology was used to compare the oil phase water content of the preparation with glycerol and polyoxyethylene - 2 (21) stearyl ether (72/721 emulsifier) and the amount of stearic acid were optimized. The improved formulations were tested for skin irritation, skin irritation and acute skin toxicity. Results: The matrix composition ratio of Modified Qufeng Zhitong Ointment was 16.5 g glycerin, 25.5 g 72/721 emulsifier, 26 g stearic acid, and oil-water phase (1: 7.8). Skin irritation test, allergic test, skin acute toxicity test shows that Qufeng Zhitong ointment non-irritating, allergic and skin toxicity. Conclusion: The improved Qufeng Zhitong Ointment preparation process is excellent, the preparation is stable, and the external use is safe and nontoxic.