【摘要】：目的:研究吡羅昔康原料及其在片劑中的晶型特征,并探討不同晶型對吡羅昔康原料、片劑溶出度的影響。方法:通過差示掃描量熱分析(DSC)、傅里葉紅外光譜(FTIR)、粉末X射線衍射譜(PXRD)測定吡羅昔康原料的晶型;通過近紅外光譜(NIR)使用相關(guān)系數(shù)模型快速篩查吡羅昔康片的原料晶型;使用光纖溶出儀測定不同晶型原料的固有溶出速率及不同晶型原料片劑的溶出度。結(jié)果:目前市場上吡羅昔康原料主要存在2種晶型;不同晶型的吡羅昔康原料固有溶出速率存在差異,不同原料晶型片劑溶出度亦有一定差異。結(jié)論:吡羅昔康PⅡ晶型與PⅠ晶型相比,溶出行為更優(yōu),晶型的測定為吡羅昔康的質(zhì)量控制提供了科學(xué)依據(jù)。
[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，

本文編號：2415961