粉末X-射线衍射技术定量测定氨糖美辛肠溶片中吲哚美辛晶型<i>γ</i>的含量

粉末X-射线衍射技术定量测定氨糖美辛肠溶片中吲哚美辛晶型γ的含量

摘要: 目的采用粉末X-射线衍射技术（powder X-ray diffraction，PXRD）对氨糖美辛肠溶片中吲哚美辛晶型γ的含量进行定量分析。方法采用精细扫描方法，扫描范围9~12°，扫描速度5秒/步，步长0.02°。结果氨糖美辛肠溶片中吲哚美辛晶型γ含量线性方程为y=13 728x+1 131（r=0.990 8），检测限为21.2 mg·g^-1（S/N=4.6）。胶囊剂中晶型γ含量为45.73%~50.40%。结论本法操作简单，在辅料没有干扰的情况下可用于氨糖美辛肠溶片中吲哚美辛晶型γ含量的定量分析和快速检测。

Abstract: OBJECTIVE To establish a quantitative analysis of indomethacin crystal type γ content in glucosamine and indometacin enteric-coated tablets by powder X-ray diffraction(PXRD). METHODS The fine scanning method was adopted. The scan range was 9-12°, the scan speed was 5 s per step and the step size was 0.02°. RESULTS The linear equation was y=13 728x+1 131(r=0.990 8). The detection limit was 21.2 mg·g^-1(S/N=4.6). The content of indomethacin crystal type γ in glucosamine and indometacin enteric-coated capsules was 45.73%-50.40%. CONCLUSION The method was simple in operation, which can be used for quantitative analysis of indomethacin crystal type γ content in glucosamine and indometacin enteric-coated tablets while no interference with excipient. It could be a rapid detection method for control crystal type γ content.