目的 建立右旋酮洛芬氨丁三醇（DKPF）温敏水凝胶的含量测定方法，考察其稳定性和组织相容性。方法 建立紫外分光光度法测定DKPF温敏水凝胶中DKPF含量，并考察方法的专属性、线性关系、定量限、精密度、回收率；应用建立的紫外分光光度法、恒温振荡法测定DKPF温敏水凝胶的释放度，检测高湿、光照、低温条件下的DKPF温敏水凝胶稳定性。随机选取80只昆明小鼠，分别sc 0.2 mL DKPF温敏水凝胶、空白水凝胶、DKPF生理盐水溶液（DKPF浓度同DKPF温敏水凝胶），于给药后1、3、6、9、12 d，每组各取5只脱颈处死，剖开注射部位皮肤观察水凝胶状态，并取皮下组织样本HE染色后光镜下观察，评价DKPF温敏水凝胶组织相容性。结果 DKPF在260 nm处有最大紫外吸收，DKPF质量浓度在1.70~25.56 μg/mL范围内呈良好的线性关系（r=0.999 9），方法学的日间、日内精密度，加样回收率均良好；DKPF温敏水凝胶主要以扩散为主，释放度符合规定，且工艺重现性好；水凝胶在低温、湿度75%条件下稳定性良好，不耐光照，需避光保存。sc给予小鼠水凝胶后，各组小鼠均成活，且水凝胶在皮下逐渐减小直至消失；病理切片结果提示，温敏水凝胶引起轻微炎症反应，随着时间延长逐渐消失，组织相容性良好。结论 本研究所建立的紫外分光光度法方法准确率高，重复性好，可应用于DKPF温敏水凝胶中DKPF含量测定；DKPF温敏水凝胶符合生物材料的安全标准。

Objective To establish a method for determining the content of dexketoprofen trometamol (DKPF) temperature sensitive hydrogels, and to study the stability and histocompatibility of it. Methods The content of DKPF temperature sensitive hydrogels was determined by ultraviolet spectrophotometry, and investigated the specificity, linearity, limit of quantification, precision and recovery rate. The release rate of DKPF thermosensitive hydrogel was determined by ultraviolet spectrophotometry and constant temperature oscillation method. The stability of DKPF thermosensitive hydrogel under high humidity, light and low temperature conditions was determined. Randomly selected 80 male Kunming mice were sc 0.2 mL DKPF temperature sensitive hydrogel, blank hydrogel, DKPF saline solution (the concentration of DKPF with DKPF temperature sensitive hydrogel), after administration of 1, 3, 6, 9, and 12 d, each five rats were sacrificed, cut the skin injection site for hydrogel state observation, and the subcutaneous tissue samples were stained with HE and observed under light microscope to evaluate the histocompatibility of DKPF thermosensitive hydrogels. Results DKPF had the maximum ultraviolet absorption at 260 nm. The linear range of dexketoprofen trometamol was 1.70-25.56 μg/mL (r=0.9999). The precision of intra-and intra-day and the recovery rate of the method were all good. The dissolution of DKPF temperature sensitive hydrogels conformed the rules and it had a good process reproducibility. DKPF temperature sensitive hydrogels had a good stability in low temperature and 75% RH, but it had intolerance of light, should be stored in the dark. After giving hydrogel in mice, mice in all groups survived, and the hydrogel gradually decreased and disappeared. The results of pathological sections showed that the mild inflammatory reaction caused by thermosensitive hydrogel disappeared gradually with time, and the histocompatibility was good. Conclusion This study have established an accurate and repeatable method for dexketoprofen trometamol temperature sensitive hydrogels quality control and the hydrogels meet the safety standards of biological materials.

贵州省科技计划项目（黔科合平台人才[2017]5601；[2016]5613\5677）；贵阳市科技计划项目（筑科合同[20141001]05号/筑科合同[2017]30-29号）