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目的:研究羟丙基-β-环糊精(HP-β-CD)包合对难溶性药物格列齐特(GZ)溶解度和溶出度的增强作用。方法:分别采用研磨法、超声法和冷冻干燥法制备GZ的HP-β-CD包合物,测定其溶解度和溶出度,并与GZ原料药,GZ与HP-β-CD的物理混合物进行比较。用差热扫描量热法,红外光谱对包合物进行物相鉴别。结果:HP-β-CD与GZ形成包合物使其溶解度提高6.8倍。结论:HP-β-CD能大幅度地提高GZ的溶解度和溶出度。
OBJECTIVE: To study the effects of inclusion of hydroxypropyl-β-cyclodextrin (HP-β-CD) on the solubility and dissolution of the insoluble drug Gliclazide (GZ). Methods: HP-β-CD inclusion complex of GZ was prepared by grinding method, ultrasonic method and freeze-drying method respectively. The solubility and dissolution of GZ were measured and compared with the physical mixture of GZ drug substance, GZ and HP-β-CD . Differential scanning calorimetry, infrared spectroscopy of inclusions phase identification. Results: The inclusion complex formed by HP-β-CD and GZ increased its solubility by 6.8 times. Conclusion: HP-β-CD can significantly improve the solubility and dissolution of GZ.