甲磺酸加贝酯温敏原位凝胶的制备及质量评价

摘要

目的：制备甲磺酸加贝酯温敏原位凝胶，并建立其质量控制方法。方法以泊洛沙姆作为基质制备甲磺酸加贝酯温敏原位凝胶，采用胶凝温度、胶凝时间、体外成胶能力和相变动力学作为评价指标筛选处方，建立RP-HPLC测定甲磺酸加贝酯温敏原位凝胶的含量测定方法。结果制备得到的甲磺酸加贝酯温敏原位凝胶胶凝温度为31℃，胶凝时间为（1.8±0.2）min，达31℃时黏度明显增大，体外成胶能力良好，HPLC测定方法线性范围为10～350μg／ml，平均回收率为99.63％， RSD为0.88％。结论该制备方法简单易行，质量可控；含量测定方法准确、可靠。%Objective To prepare thermosensitive in situ hydrogels (ISG) of gabexate mesilate and establish quality control method.Methods ISGs were prepared using PF127 and PF68 as matrix, evaluated by gelling temperature , gelling time, gelling ca-pacity in vitro, and determinated by HPLC.Results The gelling time of ISG was (1.8 ±0.2)min, with gelling temperature at 31℃. When the gel temperature rose to 31℃, the viscosity of ISG increased dramatically .The linear range of HPLC determination curve was 10-350 μg/ml, with an average recovery of 99.63%( RSD=0.88%) .Conclusion Preparation of the gel with controllable quality is simple and easy .The determination method is reliable for gabexate mesilate thermosensitive in situ hydrogels .