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目的:制备双嘧达莫水包油型微乳制剂,并对其稳定性及质量进行考察。方法:通过双嘧达莫在各溶媒中的溶解度初步确定处方组成,通过绘制伪三元相图对处方进行优化,考察优化处方的黏度、电导率、折光率、Zeta电位、粒径分布等理化性质,并对其稳定性进行测试。结果:在Km=3∶1时,伪三元相图形成的微乳区域最大,微乳平均粒径为59.7 nm,在高速离心、高温、强光下无分层,也无絮凝或药物析出。结论:双嘧达莫微乳制剂增加了药物的溶解度,制剂稳定,含量测定方法可靠,重复性好。
OBJECTIVE: To prepare dipyridamole oil-in-water microemulsion formulation and investigate its stability and quality. Methods: Prescription was preliminarily determined by the solubility of dipyridamole in each medium. The prescription was optimized by plotting the pseudo-ternary phase diagram. The physicochemical properties such as viscosity, conductivity, refractive index, Zeta potential and particle size distribution were optimized. Nature, and test its stability. Results: When Km = 3:1, the pseudo-ternary phase diagram formed the largest microemulsion region with an average particle size of 59.7 nm. Without any delamination or flocculation or drug precipitation under high-speed centrifugation, high temperature and high light, . Conclusion: The dipyridamole microemulsion increases the solubility of the drug, the preparation is stable, the determination of content is reliable, and the repeatability is good.