近红外光谱法测定三七通舒胶囊粉末的混合均匀度

目的 利用近红外光谱法对三七通舒胶囊粉末混合过程进行质量控制研究.方法 利用校正集真值与近红外光谱数据建立模型,筛选考察指标、预处理方法及光谱范围.结果 矢量归一化法和一阶导数+矢量归一化法对模拟样品数据进行处理所得预示集回收率分别为99.80％、99.96％、99.82％、100.54％、100.57％、100.98％,RSD分别为5.77％、4.89％、5.12％、6.68％、9.92％、6.52％,光谱范围分别为7502.1 ～4246.7 cm-1和6102.0 ～4246.7 cm-1,最佳评价指标为人参皂苷Rg1.结论 近红外光谱法基本可以满足药品生产过程中粉末混合均匀度的测定要求.

Determination of the powder blending uniformity of Sanqi Tongshu capsule by near infrared spectrometry

OBJECTIVE To establish a near infrared spectrometry（NIRS） method for determination of the powder blending uniformity of Sanqi Tongshu capsule.METHODS The true values of calibration set and the data of NIR spectrum were used to establish calibration model.The investigation index,pretreatment method and NIR wavelength range were tested.RESULTS The recoveries of prediction set obtained by vector normalization method and first-order derivate+vector normalization method were 99.20%,99.96%,99.02%,100.54%,100.57% and 100.98%.The RSD were 5.77%,4.89%,5.12%,6.68%,9.92% and 6.52%,respectively,and the optimum NIR wavelength ranges were 7502.1-4246.7 cm^-1 and 6102.0-4246.7 cm^-1.The optimum evaluation index was Rg₁.CONCLUSION NIRS could fulfil the requirements for determination of powder blending uniformity in the process of drug production.