清热消肿止痛膏的制备及其皮肤安全性评价研究

Study on preparation and skin safety evaluation of Qingre Xiaozhong Zhitong Ointment

关键词:  清热消肿止痛膏  皮肤安全性  正交实验  制备工艺  安全性评价  大耳白兔  豚鼠

Key words:  Qingre Xiaozhong Zhitong Ointment  skin safety  orthogonal test  preparation process  safety evaluation  big ear white rabbit  guinea pig

摘要:

[目的] 制备清热消肿止痛膏并考察其皮肤安全性。[方法] 采用正交实验，以盐酸小檗碱和盐酸黄柏碱含量之和及收膏率作为评价指标，优选清热消肿止痛膏醇提工艺；考察稠膏的密度、基质的制备、稠膏的用量，筛选制剂成型工艺参数；以大耳白兔、豚鼠为模型，对制剂进行皮肤刺激性和过敏性实验。[结果] 提取工艺：分别以6、5倍量的50%乙醇提取处方量药材两次，每次提取时长为1.5 h。制剂成型工艺：稠膏相对密度为1.22~1.27（80℃）；基质用压敏胶与乙酸乙酯10：1（g/g）制备，采用稠膏与基质1：2体积制成膏体。皮肤安全性实验：清热消肿止痛膏对皮肤无刺激性及过敏性现象发生。[结论] 清热消肿止痛膏的制备工艺科学合理，稳定可行，成品制剂外用安全性良好。

Abstract:

[Objective] To prepare Qingre Xiaozhong Zhitong Ointment and investigate its skin safety.[Methods] The orthogonal experiment was used to optimize the alcohol extraction process of Qingre Xiaozhong Zhitong Ointment with the sum of berberine hydrochloride and the extract rate as the evaluation index. The density of thick ointment, the preparation of matrix, the dosage of thickened ointment and the processing parameters of the preparation were investigated, and the skin irritation and hypersensitivity of the preparationwere tested with the model of big ear white rabbit and guinea pig.[Results] The optimum extraction conditions were as follows:60% ethanol was used as the extraction solvent, adding 6 times and 5 times of the amount of medicinal materials to extract twice, each time for 1.5 h. Forming process:the relative density of thick paste was 1.22×1.27 (80℃), the matrix was prepared by pressure sensitive adhesive and ethyl acetate 10:1 (g/g), and the paste was prepared by the weight of thickened paste and matrix 1:2. The skin safety test shows that Qingre Xiaozhong Zhitong Ointment had no irritating and allergic phenomenon to the skin.[Conclusion] The preparation technology of Qingre Xiaozhong Zhitong Ointment is scientific, reasonable, stable and feasible, and the preparation is safe for external use.