正鑫一消贴制备工艺优化研究.docVIP

正鑫一消贴制备工艺优化研究 　　[摘要] 目的 初步研究含有番荔枝科植物精油的正鑫一消贴，优选正鑫一消贴水凝胶剂的最佳制备成型工艺条件。 方法 通过正交设计试验法，把制备工艺的炼合时间、搅拌速度以及基质各组分的添加顺序作为关键条件的影响因素，并以水凝胶剂的基质均匀性、涂展性、膜残留性、皮肤粘贴性为综合感官考察指标，以涂布均匀性、初黏性、内聚力、剥离强度为量化指标进行综合考察，开展制备工艺优化的试验研究。同时对正鑫一消贴水凝胶剂的含水量、pH值进行单一因素的考察。 结果 优选出来制备工艺的最佳条件为炼合时间30 min，搅拌速度660 r/min，增稠剂组分应先与交联剂组分进行充分混合，最后再加入黏稠调节剂组分；膏体含水量为每100克水凝胶不少于40 g时粘贴性能稳定，pH值在6.0～7.0时皮肤粘贴性能最佳。 结论 采用该优化工艺制备的正鑫一消贴水凝胶贴剂的初黏性良好，剥离性能优良，内聚力适中，且制备工艺简单，质量可控性好，产品符合相关规定。 　　[关键词] 正鑫一消贴；水凝胶；制备工艺；正交试验 　　[中图分类号] R927.1 [文献标识码] A [文章编号] 1673-7210（2015）08（a）-0008-05 　　Study on optimization for preparation process of Zhengxin Yixiao Patches 　　CHEN Gang1 SONG Qin1 ZHI Dongjian1 YUAN Shengwei2 ZHONG Feng2 　　1.Medical Equipment Testing Center of Guizhou Province， Guiyang 550004， China； 2.Guizhou Zhengxin Industrial Co.， Ltd.， Guizhou Province， Guiyang 550002， China 　　[Abstract] Objective To preliminary study on Zhengxin Yixiao Patches containing Annonaceae plant oils， so as to preferably choose the best process conditions of preparation and molding for the hydrogel of Zhengxin Yixiao Patches. Methods By orthogonal designing， the mixing time， stirring speed and adding order of the matrix were regarded as the effective factors of key conditions， and matrix uniformity， spread ability， film residual and skin adhesion of hydrogel were considered as the integrated sensory study indicators. Also， the uniformity， initial adhesion， cohesion and peel strength of the coating were seen as the quantitative indexes in order to have a comprehensive study for experimental research on optimization of preparation and molding process. And at the same time， the moisture content and pH value of Zhengxin Yixiao Patches was respectively investigated as sole factor. Results The preferable optimal conditions for the preparation process： the mixing time was 30 min， stirring speed was 660 r/min， thickener component should be thoroughly mixed with the cross-linking component， and finally add the viscosity modifier component. The adhesion was