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目的制备山苍子杜仲泡腾片,并采用傅里叶红外光谱(FTIR)、X射线衍射(XRD)、扫描电镜(SEM)等方法对其进行表面分析,为该产品工艺与质量提供快速参考。方法 FTIR测试条件为KBr压片处理法,扫描范围400~4000cm-1。XRD测试条件为:Cu靶辐射源,石墨单色器,X光波长λ=0.154nm,辐射管管压为50k V,管流200m A,扫描范围5~60°,扫描速率为0.4°/min,步宽为0.02°。SEM测试条件为用离子溅射仪对材料表面喷金制样,仪器加速电压为5 k V。分别放大4000倍和10000倍进行观察。结果泡腾片需通过制粒,且颗粒大小10~24目表面效果最佳。通过表面分析可知,多酚与绿原酸的结构功能团通过FTIR分析获得体现。XRD结果显示加药泡腾片与空白对比物相改变明显。SEM提示药物呈颗粒状包裹于泡腾片的载体内。结论表面分析方法可作为泡腾片质量控制与工艺验证的辅助手段。
OBJECTIVE To prepare the radix salviae miltiorrhizae effervescent tablets and analyze its surface by Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD) and scanning electron microscopy (SEM), providing a quick reference for the technology and quality of this product . Methods FTIR test conditions KBr tablet processing method, scanning range 400 ~ 4000cm-1. XRD test conditions were: Cu target radiation source, graphite monochromator, X-ray wavelength λ = 0.154 nm, radiation tube pressure 50 kV, tube flow 200 m A, scan range 5 to 60 °, scan rate 0.4 ° / min , Step width of 0.02 °. SEM test conditions for the ion sputter surface material sprayed samples, the instrument acceleration voltage of 5 k V. Magnification of 4000 times and 10,000 times were observed. The results of effervescent tablets to be granulated, and the particle size of 10 to 24 mesh surface best. From the surface analysis, we can see that the functional groups of polyphenols and chlorogenic acids are reflected by FTIR analysis. XRD results showed that the effervescent tablets and blank contrast phase changed obviously. The SEM suggests that the drug is in the form of granules wrapped in the effervescent carrier. Conclusion The surface analysis method can be used as an adjunct to effervescent tablet quality control and process validation.