【摘 要】
:
目的:基于载体控制型的溶出机制,寻找一种可保证水飞蓟素中多组分同步缓释的制备技术,使得水飞蓟素中5种有效成分可以达到同步缓慢释放。方法:使用熔融法制备水飞蓟素固体分散体并确定最终剂型为滴丸,采用正交实验法对滴丸的制备工艺进行优化:以载药量、单硬脂酸甘油酯(GMS)质量分数、硬脂酸(SA)质量分数为考察因素,以“释放区间”值为指标,采用Doehlert 设计-相应曲面优化法对水飞蓟素同步缓释滴丸的处
【机 构】
:
南京军区福州总医院药学科,福建 福州 350025 南京军区福州总医院药学科,福建 福州 3500
【出 处】
:
2012转化医学与中药现代化高峰论坛
论文部分内容阅读
目的:基于载体控制型的溶出机制,寻找一种可保证水飞蓟素中多组分同步缓释的制备技术,使得水飞蓟素中5种有效成分可以达到同步缓慢释放。方法:使用熔融法制备水飞蓟素固体分散体并确定最终剂型为滴丸,采用正交实验法对滴丸的制备工艺进行优化:以载药量、单硬脂酸甘油酯(GMS)质量分数、硬脂酸(SA)质量分数为考察因素,以“释放区间”值为指标,采用Doehlert 设计-相应曲面优化法对水飞蓟素同步缓释滴丸的处方进行优化,拟合各组分体外释药规律。结果:制得的滴丸粒度均匀圆整,外观良好。优化的处方为载药量13%,GMS质量分数为31%,SA质量分数为6%。体外溶出实验证明水飞蓟素中5种有效成分释放行为相似因子(f2)均符合同步要求,且具备缓释特性。结论:优化的水飞蓟素同步缓释滴丸能够实现各组分的同步缓慢释放,其释放机制以溶蚀为主。
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