Uncertainty analysis model for determining heavy metals in capsules with ICP-MS (inductively coupled plasma mass spectrometry) and establishment method of uncertainty analysis model

Abstract

The invention relates to an uncertainty analysis model for determining heavy metals in capsules with ICP-MS (inductively coupled plasma mass spectrometry) and an establishment method of the uncertainty analysis model, and belongs to the technical field of ICP-MS detection. The method comprises the following steps: data acquisition: designing a recovery rate test, determining the content of heavy metal elements in the recovery test of gelatin hollow capsules with ICP-MS, and collecting data; model establishment: according to the calculation formula of heavy metal element content, analyzing thesource of uncertainty, establishing a measurement model and evaluating and calculating uncertainty. According to the uncertainty analysis model for determining heavy metals in capsules with ICP-MS, bydesigning the recovery rate test, establishing the measurement model, evaluating and calculating uncertainty, factors that can affect test results in the test of determining the content of the heavymetals in the capsules with ICP-MS are analyzed, control of main influencing factors can be enhanced, so that measurement stability is reduced, and reliability of measurement results is guaranteed.

Description

technical field [0001] The invention relates to the technical field of detection by an inductively coupled plasma mass spectrometer, in particular to an uncertainty analysis model for the determination of heavy metals in capsules by an ICP-MS method and a method for establishing the same. Background technique [0002] Gelatin empty capsules are made of medicinal gelatin, which can hold various solids, liquids, etc., are easy to swallow, and dissolve quickly. my country's Drug Administration Law stipulates that gelatin used in capsule production must not use industrial gelatin. However, in recent years, some unscrupulous manufacturers have used industrial gelatin to produce medicinal capsules, and the chromium element in some products exceeds the standard by more than 90 times. Chromium is a heavy metal element that is harmful to the human body, especially hexavalent chromium has a toxic effect of damaging the liver and kidneys. The second part of "Chinese Pharmacopoeia (20...

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Problems solved by technology

[0004] However, due to the current evaluation of ICP-MS for the determination of chromium content in gelatin hollow capsules is less than the evaluation of atomic absorption spectrophotometry, and the sample pretreatment process and determination process of this method are more complicated, and there are many factors affected, therefore, It is urgent to evaluate the uncertainty of the measurement system based on the measurement system analysis and error traceability to reflect the accuracy of the measurement results and provide a scientific basis for judging the accuracy of the test results

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