| 共无定形辛伐他汀-格列齐特的理化性质 |
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| 引用本文： | 陈娟,郭慧慧,张建军,高缘. 共无定形辛伐他汀-格列齐特的理化性质[J]. 中国药科大学学报, 2015, 46(3): 301-308 |
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| 作者姓名： | 陈娟 郭慧慧 张建军 高缘 |
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| 作者单位： | 中国药科大学中药制剂教研室;中国药科大学药剂学教研室;中国药科大学药剂学教研室;中国药科大学中药制剂教研室 |
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| 基金项目： | 江苏省自然科学基金资助项目(No.BK20141351)；江苏高校优势学科建设工程资助项目(PAPD)；江苏省高校“青蓝工程”资助项目 |
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| 摘 要： | 制备共无定形辛伐他汀-格列齐特,对其溶出特性和物理稳定性进行了考察。结果证实产物为单相无定形态,辛伐他汀可能通过O-H与格列齐特磺酰脲基的C=O产生氢键相互作用,使通过常规方法难以制备成无定形的格列齐特实现了无定形化。共无定形物的形成显著提高了格列齐特的溶解度和溶出度,但对辛伐他汀无明显影响。与无定形辛伐他汀相比,该共无定形物的物理稳定性显著提高。
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| 关 键 词： | 辛伐他汀 格列齐特 无定形 共无定形 溶出度 稳定性 |
Physicochemical characteristics of coamorphous simvastatin-gliclazide |
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| CHEN Juan,GUO Huihui,ZHANG Jianjun and GAO Yuan. Physicochemical characteristics of coamorphous simvastatin-gliclazide[J]. Journal of China Pharmaceutical University, 2015, 46(3): 301-308 |
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| Authors: | CHEN Juan GUO Huihui ZHANG Jianjun GAO Yuan |
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| Affiliation: | CHEN Juan;GUO Huihui;ZHANG Jianjun;GAO Yuan;Department of Traditional Chinese Pharmaceutics,China Pharmaceutical University;Department of Pharmaceutics,China Pharmaceutical University; |
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| Abstract: | In this study, coamorphous simvastatin-gliclazide was prepared and characterized. Its single-phase amorphous nature was demonstrated. The hydrogen bond between the O-H group of simvastatin and sulfonylurea C=O group of gliclazide was revealed to be the trigger for the amorphization of gliclazide, which is difficult to form an amorphous state in other methods. Coamorphous simvastatin-gliclazide can significantly enhance the solubility and dissolution of gliclazide, without obvious effect on simvastatin. Compared with amorphous simvastatin, coamorphous simvastatin-gliclazide showed improved physical stability in the cunrent study. |
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| Keywords: | simvastatin gliclazide amorphous coamorphous dissolution stability |
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