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目的:制备纳米雄黄固体分散体以提高纳米雄黄的稳定性及体外溶出度。方法:分别以聚乙二醇6000(PEG6000)、泊洛沙姆188(F68)为载体,采用熔融法制备纳米雄黄固体分散体并用X-射线衍射法、显微观察鉴别药物在载体中的存在状态。采用二乙基二硫代氨基甲酸银分光光度法对As203进行含量测定并进行稳定性考察试验,采用氢化物原子吸收分光光度法进行含量测定,对固体分散体中砷的体外溶出进行考察。结果:X-射线衍射和显微观察结果显示,纳米雄黄以无定型状态存在于固体分散体中,2种载体的固体分散体均能增加纳米雄黄中砷的溶出量和溶出速度并减少纳米雄黄的团聚和As203的含量。结论:以F68为载体制备的固体分散体能显著提高纳米雄黄的稳定性和体外溶出度。
OBJECTIVE: To prepare nano-realgar solid dispersion to improve the stability of nano-realgar and the dissolution in vitro. Methods: The solid dispersions of nano-realgar were prepared by PEG6000 and poloxamer 188 (F68) respectively. The solid dispersions of nano-realgar were prepared by X-ray diffraction. The drug was identified in the carrier by microscopic observation status. The content of As203 was determined by silver diethyldithiocarbamate spectrophotometry and the stability test was carried out. The content of As2O3 was determined by hydride atomic absorption spectrophotometry, and the in vitro dissolution of arsenic in solid dispersion was investigated. Results: The results of X-ray diffraction and microscopic observation showed that nano-realgar existed in the amorphous state in the solid dispersion. The solid dispersion of the two kinds of carriers could increase the dissolution and dissolution rate of arsenic in nano-realgar and reduce the nano-realgar Reunion and As203 content. Conclusion: The solid dispersion prepared with F68 can significantly improve the stability of nano-realgar and the dissolution in vitro.