吡罗昔康原料晶型对片剂溶出度的影响研究

发布时间：2019-01-26 22:09

【摘要】：目的:研究吡罗昔康原料及其在片剂中的晶型特征,并探讨不同晶型对吡罗昔康原料、片剂溶出度的影响。方法:通过差示扫描量热分析(DSC)、傅里叶红外光谱(FTIR)、粉末X射线衍射谱(PXRD)测定吡罗昔康原料的晶型;通过近红外光谱(NIR)使用相关系数模型快速筛查吡罗昔康片的原料晶型;使用光纤溶出仪测定不同晶型原料的固有溶出速率及不同晶型原料片剂的溶出度。结果:目前市场上吡罗昔康原料主要存在2种晶型;不同晶型的吡罗昔康原料固有溶出速率存在差异,不同原料晶型片剂溶出度亦有一定差异。结论:吡罗昔康PⅡ晶型与PⅠ晶型相比,溶出行为更优,晶型的测定为吡罗昔康的质量控制提供了科学依据。
[Abstract]:Objective: to study the characteristics of Piroxicam and its crystal form in tablets, and to study the effect of different crystal forms on dissolution of Piroxicam. Methods: the crystal form of Piroxicam was determined by differential scanning calorimetry (DSC) and X-ray diffraction (PXRD) of (FTIR), powder by (DSC), Fourier transform infrared spectroscopy (FTIR). The crystal forms of Piroxicam tablets were quickly screened by (NIR) using correlation coefficient model, and the inherent dissolution rate of different crystal materials and dissolution rate of different crystal raw materials were measured by optical fiber dissolver. Results: there are two kinds of crystal forms in Piroxicam raw materials in the market at present, and the inherent dissolution rate of Piroxicam raw materials with different crystal forms is different, and the dissolution rates of different raw materials are also different. Conclusion: the dissolution behavior of Piroxicam P 鈪，

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