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目的通过制备快速凝胶化的西帕依溃结安灌肠液(简称溃结安)壳聚糖(CS)/β-甘油磷酸钠(β-GP)温敏凝胶,减少药物的损失,明确其释药能力的变化。方法以温敏凝胶为载体,以胶凝时间为指标,通过单因素实验考察β-GP质量浓度、p H值、温度对温敏凝胶的影响。采用扫描电镜(SEM)表征凝胶的形状和表面形态,采用红外光谱仪(FTIR)表征凝胶胶凝前后的结构变化。通过载药温敏凝胶体外释放实验,评估凝胶释药能力。结果溃结安温敏凝胶的胶凝温度为(37.0±4.5)℃,(6.00±0.82)min由液态转变成半固态,对药物的释放速度明显减慢,24 h时累积释放率仅为(67.78±0.35)%(n=3),而等量原料药24 h累积释放率为(90.43±0.62)%(n=3),释药行为接近Weibull模型,释药机制为药物扩散与凝胶溶蚀的双重机制。结论在37.0℃时可实现溃结安溶胶到半固体凝胶的转变,CS/β-GP凝胶体系对溃结安的释放具有缓释性。
OBJECTIVE To prepare a rapidly gelatinized Xipaikuijie An enema solution (nickel-riboned for short) chitosan (CS)/β-glycerophosphate (β-GP) thermosensitive gel to reduce the loss of the drug and clarify its release Changes in drug capacity. Methods The thermosensitive gel was used as carrier and the gelation time was taken as the index. The effect of β-GP mass concentration, p H value and temperature on the temperature sensitive gel was investigated by single factor experiments. Scanning electron microscopy (SEM) was used to characterize the shape and surface morphology of the gel. Infrared spectroscopy (FTIR) was used to characterize the change of gel structure before and after gelation. The in vitro release test of the drug-loaded thermosensitive gel was performed to evaluate the gel release ability. [Results] The gelation temperature of Kuijie Anwenmin gel was (37.0±4.5)°C, (6.00±0.82) min changed from liquid to semi-solid, the release rate of drug was slowed down, and the cumulative release rate at 24 h was only (67.78). (±0.35)% (n=3), while the cumulative release rate of 24 h for the same bulk drug was (90.43±0.62)% (n=3). The drug release behavior was similar to the Weibull model. The drug release mechanism was drug diffusion and gel erosion. The dual mechanism. [Conclusion] At 37.0 °C, the transition from crushed sol to semi-solid gel can be achieved. The CS/β-GP gel system has sustained release of urea.