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In pharmacology, the international unit is a unit of measurement for the amount of a substance; the mass or volume that constitutes one international unit varies based on which substance is being measured, and the variance is based on the biological activity or effect, for the purpose of easier comparison across substances. International units are used to quantify vitamins, hormones, some medications, vaccines, blood products, and similar biologically active substances.
Preparation and value method of alpha-synuclein standard material
The present application relates to the technical field of biometrics and in vitro diagnosis standardization, and particularly relates to a preparation and value determination method of alpha-synuclein solution standard substance, comprising the following steps: cloning a gene coding alpha-synuclein into a prokaryotic expression vector for recombinant expression, purifying the protein raw material with purity greater than or equal to 99% through affinity chromatography and ion exchange chromatography; diluting and sub-packaging the protein raw material for storage to obtain the solution standard substance; determining the value of the standard substance by using an isotope dilution mass spectrometry method based on amino acid analysis, calculating the mass concentration value by measuring the peak area ratio of stable amino acids and isotope-labeled amino acids after hydrolysis, and tracing the value to the international unit system through the amino acid primary standard substance; and performing uniformity testing and stability investigation on the standard substance, solving the problem of lack of standard substance with metrological traceability in the alpha-synuclein detection field, and obtaining the standard substance which can be used for value transmission and detection result standardization among different in vitro diagnosis platforms.
Owner:NATIONAL INSTITUTE OF METROLOGY CHINA