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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。
Preparation of Panax Notoginseng - rubella intrauterine sustained - release silicone rubber stick and in vitro release of preliminary evaluation. Using open mill practice method for plastic molding silicone rubber. Orthogonal test method for silicone rubber and drug mixing process parameters preferred. The single factor experiment method is adopted to optimize the process parameters of vulcanization of silicone rubber rod. Ginsenoside Rg1, ginsenoside Rb1, notoginsenoside R1, phorbol myristin, macrophylla glycosides as an indicator of initial release in vitro performance evaluation. The results showed that the optimal process parameters of silicone rubber and drug mixing were: roll distance 2 mm, speed ratio 1: 1.2, front roll temperature 55 ~ 60 ℃, post roll temperature 50 ~ 55 ℃, mastication time 20 min. The optimum curing process parameters of silicone rubber rods: temperature 90 ℃, time 60 min. In vitro release test showed that the release of intragastric Parmigianao rubber stick in simulated uterine fluid was consistent with the Higuchi equation. At 90 days, the cumulative release of ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 Was 46.7%. The cumulative release of phorbol myristate and macrophylla was 51.9%. The results showed that the preparation process of Panax notoginseng-Rubia intrauterine silastic was reasonable and feasible, and had good slow-release properties.