【摘要】 目的对中国药典中蒙脱石散的方英石及其他杂质检查法进行研究优化。方法本文开展了蒙脱石散中方英石与其他杂质的专属性试验、样品预处理过程方法耐用性试验(不同干燥时间、不同饱和时间、不同饱和温度)以及测试方法的重复性、重现性、耐用性(不同扫描步长、不同扫描时间)试验,并比较了不同基线处理方式的处理结果。结果中国药典方法的专属性、重复性、重现性、耐用性等均符合要求,该方法适用于本品检测。采用线性拟合法、抛物线拟合法、三次样条函数法等三种基线处理方法,其中线性拟合法所得检测结果更高。结论中国药典2020年版中蒙脱石散的方英石及其他杂质检查法适用于本品检测,为更严格控制产品质量,选用线性拟合法确定基线进行处理,计算杂质结果。更多还原

【Abstract】 OBJECTIVE To research and optimize the cristobalite and other impurity inspection methods of montmorillonite powder in the ChP.METHODS In this paper, the analytical method of aragonite and other impurities in montmorillonite powder was verified.The validation of analytical method are about the specificity, the robustness of sample preparation, such as drying time, saturation time, saturation temperature, the repeatability, reproducibility, and the robustness(scan step length and scan time).Two kinds of baseline processing methods are also compared.RESULTS The specificity, repeatability, reproducibility, and durability of the Chinese Pharmacopoeia method met the requirements, and this method was suitable for the detection of this product.Three baseline processing methods, including linear fitting method, parabolic fitting method, and cubic spline function method, were used, among which the linear fitting method had higher detection results.CONCLUSION The cristobalite and other impurity inspection method of montmorillonite powder in the ChP 2020 is applicable to the test of this product.In order to more strictly control the product quality, the linear fitting method is used to determine the baseline for processing and calculate the impurity results.更多还原