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将复方制剂诸组分的纯品按标示量的100%,100±15%,100士10%和100±15%进行交叉组合,制备合成样品(习称模拟样品),绘制其溶液的UV-VIS吸收光谱,选择组分含量对吸收度影响大的若干灵敏波长,读出对应的吸收度,并用逐步回归法构造反映该复方制剂在灵敏波长吸收度一组分含量关系的数学模型;根据所构造的数学模型,在计算机上算出诸组分含量在标示量100士15%范围内详尽组合(以标示量的0.1%或其它含量单位系统增减)的模拟样品溶液的吸收度;对未知样品采用全组合法寻优,即可求出组分的含量。本研究是通过建立测定脑清片(二组分)组分含量的统计模拟分光光度法完成的,并对含量测定结果进行方差分析,均得到今人满意的结果。
Synthetic samples were prepared by cross-combining 100%, 100 ± 15%, 100 ± 10% and 100 ± 15% of the indicated amount of the pure product of the compound preparation, and the UV- VIS absorbance spectrum, the sensitivity of the selected component content to the absorbance of a number of sensitive wavelength, read the corresponding absorbance, and step by step regression method to construct the complex formulation reflects the sensitivity of wavelength absorbance of a component of the relationship between the mathematical model; The mathematical model of the structure, calculated on the computer components of the amount of 100% in the marked amount of 15% range of combinations (0.1% of the marked amount or other content units of the system increase or decrease) of the simulated sample solution absorbance; Unknown sample using the whole group optimization method, you can find the content of the components. This study was accomplished by establishing a statistical simulation spectrophotometric method for determining the content of cerebrum tablets (two components), and the results of variance analysis were carried out.