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目的:应用粉末X-射线衍射法对甘氨酸原料药中α晶型的含量进行定量分析,为多晶型研究提供实验依据.方法:分别选择α晶型的特征衍射峰2θ=19. 1°与γ晶型特征衍射峰2θ=25. 4°的峰强度比值为定量参数,建立标准曲线,测定α晶型的含量.结果:获得甘氨酸α晶型与γ晶型的表征图谱,α晶型的线性范围为1% ~99% (r=0.996 7),平均回收率为102. 8% (RSD=4. 0% ,n=9).结论:所建方法准确可靠,快速简便,可用于甘氨酸原料药中α晶型的定量分析.“,”Objective: To determine the content of crystal type α in glycine by X-ray power diffraction technique to provide evi-dence for the polymorphic research. Methods: A calibration curve was established by using the characteristic peak ratio of glycine form α at 2θ=19. 1° to form γ at 2θ=25. 4° as the quantitative parameter to determine the content of crystal type α. Results: The charac-terization figures of form α and form γ were obtained. The linear range of form α was 1%-99% (r=0. 996 7), and the average recov-ery was 102. 8% with the RSD of 4. 0% (n=9). Conclusion: X-ray powder diffraction method is a feasible analytical method for the quantitative determination of form α and form γ of glycine with simple,sensitive and accurate properties.