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目的:研究复方双嘧达莫缓释片的处方工艺及其对释放的影响。方法:以甲壳胺(CS)和海藻酸钠(AL)为辅料制备复方双嘧达莫缓释片,考察了制备工艺和辅料性质对骨架片释放度的影响,并建立高效液相色谱法测定复方双嘧达莫缓释片的含量测定方法。结果:复方双嘧达莫缓释片直接压片释放过缓;润湿剂对干颗粒的理化性质有影响。CS的用量和CS的脱乙酰度和对释放度影响显著;CS的密度、AL的粘度及AL的粒度对释放度有一定影响。结论:此处方缓释效果好,分析方法简便、灵敏、准确。
Objective: To study the prescription technology and its effect on the release of compound dipyridamole sustained-release tablets. Methods: Chitosan (CS) and sodium alginate (AL) were used as the excipients to prepare the compound dipyridamole sustained-release tablets. The effects of preparation technology and excipients on the release of matrix tablets were investigated. High performance liquid chromatography Determination of compound dipyridamole sustained release tablets. Results: The dipyridamole sustained-release tablets were released slowly. The wetting agents affected the physicochemical properties of the dry particles. The amount of CS and the degree of deacetylation of CS have a significant effect on the release rate; the density of CS, the viscosity of AL and the particle size of AL have an impact on the release degree. Conclusion: The prescription slow release effect is good, the analysis method is simple, sensitive and accurate.