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目的研究热熔法制备曲普瑞林长效生物可降解微粒的处方工艺,并对其质量进行考察。方法首先进行单因素实验,对骨架材料PLGA的种类、PLGA与曲普瑞林重量比值、热熔挤出温度和时间、粉碎温度等参数进行筛选。在此基础上,对热熔挤出时间、热熔挤出温度、挤出后粉碎冷却温度3个因素进行正交试验,优化处方工艺,将制得的样品进行湿、热、光照影响因素试验,加速试验和长期试验考察。结果热熔法制备的曲普瑞林微粒外观形态良好,且经加速试验考察,有关物质含量符合要求,微粒释放情况良好。结论热熔法制备出的曲普瑞林质量稳定,该研究为制备出安全有效、质量可控的微粒提供理论与实践依据,适合进一步开发。
Objective To study the preparation process of triptorelin long-acting biodegradable microparticles by hot-melt method and investigate its quality. Methods Firstly, single factor experiments were carried out to screen the parameters of PLGA, PLGA and triptorelin weight ratio, temperature and time of hot melt extrusion, and temperature of pulverization. On this basis, orthogonal test was carried out on the three factors of hot-melt extrusion time, hot-melt extrusion temperature and post-extrusion comminution cooling temperature to optimize the formulation process. The wet, heat and light influencing factors , Accelerated test and long-term test investigation. Results The triptorelin particles prepared by hot melt method showed good appearance and accelerated test. The content of related substances met the requirements and the release of microparticles was good. Conclusion The quality of triptorelin prepared by hot-melt method is stable. This study provides a theoretical and practical basis for the preparation of safe, effective and quality-controllable particles and is suitable for further development.