Quality control product and/or calibration product for simultaneously monitoring 78 neuropsychiatric drugs

A technology of quality control and calibrator, which is applied in the field of simultaneous monitoring of quality control and/or calibrator of 78 kinds of neuropsychiatric drugs and its preparation, which can solve problems such as inability to meet clinical accurate determination and lack of therapeutic drug calibrator , to achieve long storage period, improve indoor precision, and eliminate matrix effect

Active Publication Date: 2022-07-12
SHANGHAI MENTAL HEALTH CENT (SHANGHAI PSYCHOLOGICAL COUNSELLING TRAINING CENT) +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, there is a lack of calibrator and quality control products that cover more than 50 therapeutic drugs and have good interchangeability with patient sample matrices on the market, which cannot meet the needs of clinical accurate determination

Method used

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  • Quality control product and/or calibration product for simultaneously monitoring 78 neuropsychiatric drugs
  • Quality control product and/or calibration product for simultaneously monitoring 78 neuropsychiatric drugs
  • Quality control product and/or calibration product for simultaneously monitoring 78 neuropsychiatric drugs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] This example compares the quality control products and standard products for monitoring 78 kinds of neuropsychiatric drugs when prepared from different serum matrices. The specific preparation method is as follows:

[0049] 1) Accurately weigh 15 kinds of antiepileptic drugs, 23 kinds of antipsychotic drugs, and 40 kinds of antidepressant drugs, and use methanol to dissolve, and obtain each drug standard mother liquor of the concentration shown in Table 1.

[0050] 2) Pipette the volume of each drug standard stock solution in Table 1 and mix it with 55 μL of 50% methanol aqueous solution to obtain a mixed standard solution 1 containing all drugs, wherein the concentration of each drug is shown in Table 1.

[0051] 3) Mix 20 μL of mixed standard solution 1 with 980 μL of 50% methanol aqueous solution to obtain mixed standard solution 2, in which the drug concentrations are shown in Table 1.

[0052] Table 1

[0053]

[0054]

[0055]

[0056] 3) Dilute the mixe...

Embodiment 2

[0078] This example provides a quality control product for monitoring 78 kinds of neuropsychiatric drugs at the same time. The specific preparation method is as follows: according to the method in Example 1, the middle concentration quality control standard solution is horse serum according to the volume of 5%: 90% The ratio is mixed, and the mixed solution containing antioxidants and preservatives is added according to 5% volume ratio, wherein the different antioxidant groups used are shown in Table 5, and the preservatives used are thimerosal with a concentration of 0.002g / ml. volume 100ml) and then freeze-drying (the specific conditions used for freeze-drying are: pre-freezing temperature is set to -50°C, duration 300min; primary drying temperature is set to -30°C, duration is 1200min, and pressure is maintained at 0.2mbar; analytical drying temperature is set to -30 ℃, the duration is 360 min, and the pressure is maintained at 0.3 mbar) to obtain the corresponding quality c...

Embodiment 3

[0090] The present embodiment provides a method for simultaneously monitoring 78 neuropsychiatric drugs, comprising the following steps:

[0091] 1) Using the same method as in Example 2 and adding the antioxidant group 3 in Table 5 as antioxidants, the low-concentration quality control product L (prepared by using the low-concentration quality control mixed standard solution in Example 1) was prepared respectively, Medium-concentration quality control substance M (prepared by using the medium-concentration quality control mixed standard solution in Example 1), and high-concentration quality control substance H (prepared by using the high-concentration quality control mixed standard solution in Example 1).

[0092] 2) Mix the mixed standard solution 1 and mixed standard solution 2 prepared in Example 1 with horse serum in a volume ratio of 5%:90%, respectively, and add to the antioxidant group in Example 2 in a volume ratio of 5%. 3 Mix with the mixed solution of the preservat...

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Abstract

The invention provides a quality control material and/or a calibration material for simultaneously monitoring 78 neuropsychiatric drugs as well as a preparation method and application of the quality control material and/or the calibration material. The quality control material and/or the calibration material comprises the 78 neuropsychiatric drugs, a matrix and an antioxidant, the antioxidant is a combination of ascorbic acid, butylated hydroxytoluene and ethylenediamine tetraacetic acid; the mass content of the antioxidant in the quality control product and/or the calibration product is 0.2-0.5%; the 78 kinds of neuropsychiatric drugs comprise 15 kinds of antiepileptic drugs, 23 kinds of antipsychotic drugs and 40 kinds of antidepressant drugs. The quality control product and/or the calibration product prepared by adding the antioxidant in a specific combination have high stability, effectively eliminate the matrix effect generated in the process of mass spectrometric detection of the neuropsychiatric drugs of the serum sample, and significantly improve the accuracy and indoor precision of mass spectrometric detection; the technical bottleneck is solved for the industrialization and wide application of the technology for detecting the psychotherapy drugs by mass spectrometry.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a detection technology for simultaneously detecting multiple neuropsychiatric drugs, in particular to a quality control product and / or calibrator for monitoring 78 neuropsychiatric drugs simultaneously, and a preparation method and application thereof . Background technique [0002] In September 2017, the Association for Neuropsychopharmacology and Pharmacopsychiatry (AGNP) updated the consensus guidelines for drug testing in neuropsychopharmacology, classifying neuropsychiatric drugs into the following categories: antidepressants, antipsychotics, antiepileptics Drugs, mood stabilizers, anti-anxiety / hypnotic drugs, anti-dementia drugs, drugs for drug dependence-related disorders, anti-Parkinsonian drugs. [0003] Antidepressant drugs refer to a group of psychotropic drugs mainly used to treat psychiatric disorders with prominent symptoms of depression. The difference wit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28C09K15/06C09K15/20G01N30/02G01N30/04G01N30/60G01N30/34G01N27/62
CPCG01N1/28C09K15/06C09K15/20G01N30/02G01N30/04G01N30/6052G01N30/34G01N27/62G01N2030/042G01N2030/047
Inventor 林萍徐一峰李春波杨颖华王华梁胡晓波赵敏余雷黄颖瑜吴洪强
Owner SHANGHAI MENTAL HEALTH CENT (SHANGHAI PSYCHOLOGICAL COUNSELLING TRAINING CENT)
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