温度敏感型盐酸川芎嗪腹腔用原位缓释凝胶的制备研究与评价

目的制备以Poloxamer 407为基本材料的温度敏感型盐酸川芎嗪腹腔用原位缓释凝胶,建立温度敏感型盐酸川芎嗪腹腔用原位缓释凝胶的体外评价方法。方法制备Poloxamer 407(P-407)不同浓度溶液,分别测定其相转变温度、绘制黏度-温度曲线及体温下体外释放度测定,选择符合针对腹腔粘连病理特点的盐酸川芎嗪原位缓释凝胶。结果通过体外释放实验发现40%P-407原位凝胶与辅料2%~3%甲基纤维素(MC)结合使盐酸川芎嗪的体外释放度明显延长,最符合实验要求。结论温度敏感型盐酸川芎嗪腹腔用原位缓释凝胶具有良好的体外释放性能、温度敏感黏附性能并且该制剂稳定,方法简单,重现性好。

Evaluation for Preparing Temperature_Sensitive Situ Gel of Ligustrazine

Objective To prepare temperature_sensitive situ gel of Ligustrazine Hydrochloride based on Poloxamer 407,which will be used in abdominal cavity,and establish its evaluation method in vitro.Methods Prepare solution of Poloxamer 407 in different concentrations,measure their phase transition temperature,draw viscosity-temperature curve,determine drug release rate in vitro at the body temperature and choose the proper situ gel formulation according with the pathological characteristic of abdominal cavity adherence.Results The optimizing formulation was Poloxamer 407 situ gel at 40%(w/w) combining with MC at 2%~3%(w/w),which prolonged Ligustrazine Hydrochloride release time in vitro.Conclusion The prepared situ gel posseses favorable drug release performance,temperature sensitivity and viscosity.The method is simple and reproducible.