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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67.8μm,27d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。
Objective To establish the preparation and quality evaluation of thymopentin (TP-5) microspheres. Methods Poly (lactic-co-glycolic acid) (PLGA) was used as carrier material to prepare TP-5 long-acting slow release microspheres by double emulsion method (w / o / w) The content of TP-5 in the microspheres was determined by HPLC. Results The spheroids of TP-5 microspheres were round and the entrapment efficiency was above 80%. The mean particle size was 67.8μm. The cumulative release percentage of TP-5 microspheres was above 80% in 27 days. Conclusion TP-5 microspheres preparation process is reasonable, evaluation method is simple, fast and accurate.