王玺, 周炬, 毕开顺, 杜立颖, 罗旭. 统计模拟分光光度法及其在复方制剂组分含量测定中的应用J. 药学学报, 1995, 30(5): 378-383.
引用本文: 王玺, 周炬, 毕开顺, 杜立颖, 罗旭. 统计模拟分光光度法及其在复方制剂组分含量测定中的应用J. 药学学报, 1995, 30(5): 378-383.
X Wang, J zhuo, KS Bi, LY Du , X Luo, . STATISTICAL SIMULATION SPECTROPHOTOMETRY AND ITS APPLICATION TO THE ASSAY FOR INDIVIDUAL MELICAMENTS IN A COMPOUND FORMULATIONJ. Acta Pharmaceutica Sinica, 1995, 30(5): 378-383.
Citation: X Wang, J zhuo, KS Bi, LY Du , X Luo, . STATISTICAL SIMULATION SPECTROPHOTOMETRY AND ITS APPLICATION TO THE ASSAY FOR INDIVIDUAL MELICAMENTS IN A COMPOUND FORMULATIONJ. Acta Pharmaceutica Sinica, 1995, 30(5): 378-383.

统计模拟分光光度法及其在复方制剂组分含量测定中的应用

STATISTICAL SIMULATION SPECTROPHOTOMETRY AND ITS APPLICATION TO THE ASSAY FOR INDIVIDUAL MELICAMENTS IN A COMPOUND FORMULATION

  • 摘要: 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。

     

    Abstract: It is well known that the absorbance-concentration relationship of a chemicalcomponent may deviate from Beer's law with certain chemical cause, and errors of aborhancemeasurement propagate and multiply in mathematical operation. But there are difficulties in carryingout experiments on large systems of chemical components to ascertain the real relationship , andstatistical simulation spectrophotometry-SSS for short ,or Monte Carlo simulation spectropho-tometry——has been developed for the assay of medicaments in compound formulations.The keystep of SSS is to build a model based on a collection of limited but sufficient actual data , then themodel will provide the numerical imitation——giving simulation data——of the real sum-upabsorbance-concentration relationship of individual medicaments at several sensitive wavelengths.The method of stepwise regression has been used in the present study on Naoqingpian tablets,acompound formulation of two medicaments.For the reliability of this SSS ,an analysis of variance hasbeen performed on the assay data of cross- classification to separate and estimate the variationsassociated with instrument and operator. SSS is accurate , rapid and practicable ,and promises well tobe adopted as an official assay method of some compound formulations.

     

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