三七-茜草宫内缓释硅橡胶棒的制备及体外释放性能的初步评价  

Preparation and in vitro release evaluation of slow releasing intrauterine silicone rubber bar made of Panax notoginseng and Rubia cordifolia

作　　者：徐丽[1] 曹广尚[2] 王信[2] 李文明 师伟[2] 李盼盼[4] 张芳[4] 李彦楠[4] 

机构地区：[1]山东大学附属省立医院,山东济南250021 [2]山东中医药大学附属医院,山东济南250011 [3]山东省药学科学院,山东济南250100 [4]山东中医药大学,山东济南250355

出　　处：《中国中药杂志》2017年第1期113-118,共6页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(81674014);教育部博士点基金新教师类课题(20103731120003);山东省人口和计划生育委员会科技计划项目(2013年第11号)

摘　　要：制备三七-茜草宫内缓释硅橡胶棒并对其进行体外释放性能的初步评价。采用开炼机开练法进行硅橡胶的塑炼。采用正交试验法进行硅橡胶与药物的混炼工艺参数优选。采用单因素试验法进行硅橡胶棒硫化工艺参数的优选。以人参皂苷Rg1、人参皂苷Rb1、三七皂苷R1、羟基茜草素、大叶茜草素为指标,进行体外释放性能的初步评价。结果显示,硅橡胶与药物混炼的最佳工艺参数为:辊距2 mm,速比1∶1.2,前辊温55~60℃,后辊温50~55℃,塑炼时间20 min。硅橡胶棒的最佳硫化工艺参数为:温度90℃,时间60 min。体外释放度试验表明,三七-茜草宫内缓释硅橡胶棒在模拟宫腔液中的药物释放符合Higuchi方程,到90 d,人参皂苷Rg1、人参皂苷Rb1及三七皂苷R1的累积释放度为46.7%,羟基茜草素及大叶茜草素的累积释放度为51.9%。结果表明,三七-茜草宫内硅橡胶棒制备工艺合理可行,具备良好的缓释特性。To prepare the intrauterine slow release silicone rubber bar made of Panax notoginseng and Rubia cordifolia, and finish its preliminary evaluation of in vitro releasing properties. The open mill method was used for plasticating of silicone rubber. The process parameters of the silicone rubber and drugs mixing were optimized by orthogonal test. The parameters of silicone rubber vulcanization was optimized by single factor test. The preliminary evaluation of in vitro release performance of the silicone rubber bar was conducted with ginsenoside Rg1, ginsenoside Rb1 , notoginsenoside Rl , purpurin and rubimaillin as the indexes. The results showed that optimum technologic parameters for silicone rubber and drugs mixing：the roller spacing 2 mm; speed ratio 1： 1.2; front roller temperature 55-60℃ ; rear roll temperature 50-55℃ ; and mixing time 20 min. The optimum parameters for silicone rubber vulcanization ： temperature 90℃, and time 60 min. The studies on release process in vitro revealed that the release process of silicone rubber bar was in line with the Higuchi equations. After 90 days, the cumulative release of ginsenoside Rgl, ginsenoside Rbl and notoginsenoside R1 was 46. 7% , and the cumulative release of purpurin and rubimaillin was 51.9%. The preparation method can be applied to the preparation of sili- cone rubber bar, with slow release characteristics.

关 键 词：三七 茜草 宫内缓释硅橡胶 体外释放 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]