目的制备注射用新藤黄酸温敏原位凝胶剂。方法运用星点设计一效应面优化法确定注射用新藤黄酸温敏原位凝胶剂的最佳处方,并采用高效液相法对其体外释放进行含量测定。结果最佳处方为0.2%新藤黄酸+18.26%泊洛沙姆407(F127)+7.4%泊洛沙姆188(F68)+0.59/6苯甲醇,胶凝温度为35.4℃。新藤黄酸温敏原位凝胶的体外释放方程为Y=0.9835X+4.028,R=0.9993,符合零级释药。结论星点设计一效应面优化法能很好地优化该制剂处方,优化后处方的体外释药稳定,达到预期要求。
Objective To prepare the injectable temperature-responsive in situ gel of neogambogic acid. Methods The central composite design-response surface methodology (CCI-RSM) was used to determine the best formula of injectable temperature-responsive in situ gel of neogambogic acid. High-performance liquid chroma- tography was used to determine the in vitro release of neogambogic acid. Results The best formula was 0.2 neogambogic acid+18.26% poloxamer 407 (F127)+7.4% poloxamer 188 (F68)+0.5% benzyl alcohol, with a gel temperature of 35.4 ℃. The fitting equation for in vitro release of neogambogic acid was Y: 0. 983 5X+ 4. 028, R:0. 999 3, suggesting zero-order release kinetics: Conclusion "CCD-RSM can optimize the formula of injectable temperature-responsive in situ gel of neogambogic acid and enable stable in vitro drug release.