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目的:筛选瘤内注射用替加氟温敏凝胶的最佳处方并考察其体外释放特征。方法:通过细胞毒性试验确定药物剂量,以聚丙交酯-乙交酯-聚乙二醇-聚丙交酯-乙交酯(PLGA-PEG-PLGA)、羟丙基甲基纤维素(HPMC)为基质制备凝胶。以体外释放度为指标,考察不同浓度PLGA-PEG-PLGA和HPMC等因素对凝胶的影响,并以胶凝温度、黏度、pH等评价凝胶质量。结果:凝胶剂的最佳处方为:25%PLGA-PEG-PLGA,1%HPMC,替加氟剂量为1 mg·ml~(-1)。制得凝胶的平均胶凝温度为36.7℃,平均黏度为7 550 m Pa·s,平均pH为7.2。结论:所制备的瘤内注射用替加氟温敏凝胶具有温敏特性和明显的缓释作用,为后续的临床研究提供了试验依据。
OBJECTIVE: To screen the best prescription of tegafur thermosensitive gel for intratumoral injection and investigate its in vitro release characteristics. Methods: The dose of the drug was determined by cytotoxicity test. The effects of PLGA-PEG-PLGA, HPMC Matrix Preparation gel. The effects of different concentrations of PLGA-PEG-PLGA and HPMC on the gel were investigated by in vitro release, and the gel quality was evaluated by the gelation temperature, viscosity and pH. Results: The best prescription of gel was 25% PLGA-PEG-PLGA and 1% HPMC, and the dosage of Tegafur was 1 mg · ml -1. The average gelation temperature of the prepared gel was 36.7 ℃, the average viscosity was 7 550 mPa · s and the average pH was 7.2. CONCLUSION: The prepared tegafur thermosensitive gel for intratumoral injection has thermo-sensitive characteristics and obvious sustained-release effect, which provides the experimental basis for subsequent clinical studies.