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目的制备异烟肼缓释固体分散体,考察其分散状态和体外溶出速率。方法以水不溶性聚合物乙基纤维素为载体,用溶剂法制备异烟肼缓释固体分散体。采用X射线衍射法、差示扫描量热法和红外光谱法鉴别药物在固体分散体中的存在状态,并对其体外释放情况进行研究。结果 X射线衍射法表明异烟肼在固体分散体中有一部分是以分子状态分散,而另一部分可能以微晶体状态分散;差示扫描量热法表明所制备的缓释固体分散体中不存在药物结晶;红外光谱法结果表明异烟肼与乙基纤维素未发生化学反应;溶出度试验结果表明其具有良好的缓释效果。结论采用溶剂法制备的异烟肼缓释固体分散体可以使药物达到高度分散状态,制备的异烟肼缓释固体分散体具有较好的缓释效果。
Objective To prepare isoniazid sustained-release solid dispersion and study its dispersion status and in vitro dissolution rate. Methods The isoniazid sustained-release solid dispersion was prepared by solvent method using water-insoluble polymer ethyl cellulose as carrier. X-ray diffractometry, differential scanning calorimetry and infrared spectroscopy were used to identify the presence of drug in the solid dispersion and to investigate its in vitro release. Results X-ray diffractometry showed that isoniazid partially dispersed in the solid dispersion while the other portion was likely to be dispersed in the microcrystalline state. Differential scanning calorimetry showed that the slow release solid dispersions The crystallization of the drug existed. The results of IR showed no chemical reaction between isoniazid and ethyl cellulose. The result of dissolution test showed that it has a good sustained-release effect. Conclusion The isoniazid sustained-release solid dispersion prepared by solvent method can make the drug reach highly dispersed state. The prepared isoniazid sustained-release solid dispersion has better sustained-release effect.