胸腺五肽缓释微球的制备及其质量评价

Preparation and Quality Evaluation of the Thymopentin Sustained Release Microspheres

关键词:  胸腺五肽  缓释微球  质量评价

Key words:  thymopentin  sustained release microspheres  quality evaluation

摘要:

目的 确立胸腺五肽(TP-5)微球的制备及质量评价方法。方法 以聚乳酸-羟基乙酸(PLGA)为载体材料，采用复乳法(w/o/w)制备TP-5长效缓释注射微球，考察其粒径大小、外观、包封率等理化性质；采用HPLC测定微球中TP-5的含量。结果 TP-5微球球形圆整，包封率在80%以上，平均粒径为67.8 mm，27 d体外累积释放百分率在80%以上。结论 TP-5微球的制备工艺合理，评价方法简便、快速、准确。

Abstract:

OBJECTIVE To establish the process of preparation and the quality evaluation method of thethymopentin microspheres (TP-5). METHODS TP-5 loaded microspheres were prepared with poly (lactic-co-glyeolic acid) (PLGA) as carrier material by double emulsion(w/o/w)，to investigate the size, outside appearance and drug entrapment efficiency of the microspheres. HPLC method was used to determine the content of the TP-5 microspheres. RESULTS Microspheres with good shape were prepared by this method．The drug entrapment efficiency was more than 80%. Mean particle size was 67.8 mm. Under the release condition in vitro, cumulative drug release of microspheres was above 80% within 27 d. CONCLUSION The process of preparation of TP-5 microspheres is reasonable．The evaluation method is simple，rapid，accurate and suitable for the quality control of TP-5 microspheres.