Method of evaluating uncertainty of test results of drug components by working curve method

A technology of component content and degree of certainty, which is applied in the field of evaluation of the uncertainty of drug component content test results by the external standard method, and can solve problems such as deviation from the true value

CN107169292AInactive Publication Date: 2017-09-15INST OF FORENSIC SCI OF MIN OF PUBLIC SECURITY
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2017-09-15
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention discloses a method of evaluating uncertainty of test results of drug components by a working curve method. The method comprises following steps: establishment of measurement result calculating formulas and mathematics models, analysis of uncertainty source, quantification of uncertainty components, calculation of synthesis standard uncertainty, calculation of expanded uncertainty and expression of measurement results. By means of the method in the invention, the main source affecting uncertainty can be accurately reflected so as to provide more reliable examination determination results.
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Description

technical field

[0001] The invention belongs to the field of forensic science drug analysis, and relates to an evaluation method for evaluating the uncertainty of drug component content test results calculated by an external standard method. It is suitable for the analysis of the uncertainty of the results of the measurement of drug content by liquid chromatography and gas chromatography. Background technique

[0002] At present, the increasingly serious drug problem has become a global disaster. The proliferation of drugs directly endangers people's physical and mental health, and poses a huge threat to economic development and social progress. Therefore, establishing a forensic scientific drug detection quantity traceability system, improving the measurement technology of drug components, ensuring the reliability and comparability of measurement results, establishing the sharing and mutual recognition of measurement data, and providing accurate and reliable evidence for c...

Examples

Embodiment 1

[0036] The drug components in the test materials of drug-related cases are extracted with solvents, analyzed by gas chromatography (GC) or liquid chromatography (HPLC), and quantified by the standard curve method.

[0037] Calculation formula of measurement results and establishment of mathematical model

[0038] The quantitative mathematical model for determining the content of drug components in drug samples by gas chromatography or liquid chromatography is:

[0039]

[0040] In the formula: w—the percentage of drug components in the sample, %;

[0041] V 1 - the volume of the sample solution initially fixed to volume, mL;

[0042] V2 - from V 1 The volume of the sample solution pipetted in, mL;

[0043] V 3 - put V 2 The volume of solvent added during dilution, mL;

[0044] C—concentration of drug components in the sample solution, mg / mL;

[0045] m—the weighing weight of the drug sample used for determination, mg.

[0046] Uncertainty source analysis

[0047] ...

Embodiment 2

[0154] An evaluation method for calculating the uncertainty of drug component content test results by a standard curve method, including

[0155] Next steps:

[0156] Step one, establish gas chromatography or liquid chromatography to determine the content of drug components in drug samples

[0157] The quantitative mathematical model is:

[0158]

[0159] In the formula: w—the percentage of drug components in the sample, %;

[0160] V 1 - The volume of the sample solution to be fixed for the first time, 20mL;

[0161] V 2 - from V 1 Pipette the sample solution volume, 1mL;

[0162] V 3 - put V 2 Add solvent volume when diluting, 20mL;

[0163] C - the concentration of drug components in the sample solution, 0.164, 0.166mg / mL;

[0164] m——Weighing weight of the drug sample used for determination, 99.50, 100.50 mg.

[0165] Step 2, analyzing sources of uncertainty includes: measuring the uncertainty u introduced by repeatability 0 , derived from the uncertainty u(...