减免随机性方法误差对含量均匀度检查的影响
STUDIES ON ELIMINATING THE INFLUENCE OF RANDOM ERRORS OF ANALYTICAL METHODS ON THE CONTENT UNIFORMITY TEST
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摘要: 在含量均匀度检查中,结果受随机性方法误差的影响。理论上,采用根据统计参数制定的计量型方案时,这种误差可按误差叠加原理减免。本文从理论与实践的结合上阐明了这种误差如何影响含量均匀度检查的结果,首次在所制定的含量均匀度计量型检查方案中进行了减免这种误差影响的研究,进一步提高了含量均匀度检查结果的准确性,更充分体现了计量型检查方案的优越性。Abstract: The conclusion drawn from the content uniformity test for a batch of solid dosage forms is influenced by the random error of the analytical method(random methodic error for short) used. Theoretically, the test by variables based on the statistical parameters of the sample has the merit of eliminating the influence of the random methodic error acccording to the principle of superposition of errors. In this paper, random methodic errors of some analytical methods were obtained by experiment and then used to eliminate the influence of random methodic errors on the content uniformity test by variables devised by us. Thus, the accuracy of the test is further improved.
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