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Valproic acid drug concentration detection kit and application thereof

A technology for detecting the concentration of kits and drugs, which is applied in the field of medical testing and can solve problems such as high requirements for storage and transportation conditions, large sample volume, and endogenous interference.

Pending Publication Date: 2020-10-23
WUXI APPTEC ZK SUZHOU BIOSCIENCE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to provide a novel valproic acid drug concentration detection kit, which can be used for the detection of valproic acid drug concentration in dried blood spots, so as to solve the lack of valproic acid drug concentration based on chromatography in the prior art. The technical problems of the valeric acid drug concentration detection kit can overcome the defects of derivatization pretreatment, inaccurate quantitative results of immunoassay detection, large sample volume required, high requirements for storage and transportation conditions, and large endogenous interference.

Method used

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  • Valproic acid drug concentration detection kit and application thereof
  • Valproic acid drug concentration detection kit and application thereof
  • Valproic acid drug concentration detection kit and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Such as figure 1 Shown is a schematic diagram of the three-dimensional structure of a specific embodiment of the kit of the present invention. The valproate concentration detection kit includes: a box body 1, a first container 2, a calibrator card 3 and a quality control card 4. Wherein, the first container 2 , the calibration product card 3 and the quality control product card 4 are placed in the box body 1 .

[0080] figure 1 The reagent box shown in also includes a box cover 5, and the box cover 5 cooperates with the box body 1 to realize the function of closing or opening the reagent box. figure 1 In the above, the box cover 5 is connected with the box body 1 and is integrated; in other embodiments, the box cover 5 and the box body 1 can also be independent of each other, which is a separate type. When the box cover 5 cooperates with the box body 1 to close, the reagent box can be kept in a sealed state.

[0081] figure 1 The kit shown in , also includes a fixa...

Embodiment 2

[0096] Example 2 The preparation process of the kit

[0097] (1) Preparation of standard solution

[0098] Accurately weigh 30 mg of valproic acid compound, place it in a 10 mL volumetric flask, dissolve in pure methanol, and set the volume to 10 mL to obtain a stock solution with a valproic acid concentration of 3 mg / mL.

[0099] (2) Preparation of sample extract

[0100] Take 20 μL of valproic acid internal standard (VPA-D6) stock solution (1mg / mL), dilute to 40mL with 80% methanol, and prepare the sample extraction solution containing internal standard (VPA-D6) concentration of 0.5 μg / mL 80 % methanol solution.

[0101] (3) Calibration sample card and quality control sample card preparation

[0102] 1) After mixing the freshly collected blood from 6 rabbits, measure the mixed rabbit hematocrit (HCT) according to the laboratory "Hematocrit Measurement and Adjustment Standard Operating Procedures" (SD1-S-M3008), and finally adjust the mixed blood The HCT value of rabbit b...

Embodiment 3

[0130] Embodiment three: use the test kit of the present invention to carry out the feasibility study of valproic acid method (linear experiment, specificity experiment)

[0131] 1. Sample preparation

[0132] Sample preparation was carried out according to the methods of "(1) preparation of standard solution", "(2) preparation of sample extract", "(3) preparation of calibration sample card and quality control sample card" in Example 2.

[0133] The blood sample is directly collected on a specific filter paper to form a dried blood spot sample that meets the requirements, and a small blood spot disc of an appropriate size is punched from the center of the dried blood spot with a puncher and placed in a 96-well plate; Valproic acid-D6 internal standard solution with a concentration of 0.5 μg / mL was vortexed for 10 minutes to complete the extraction and precipitation process; solid impurities were removed by centrifugation, and an appropriate amount of supernatant was added to a...

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Abstract

The invention discloses a kit for detecting valproic acid drug concentration in dry blood spots. The kit comprises a kit body, a first container, a calibrator card and a quality control card, whereinthe calibrator card is a blood spot collection card fixed with a group of valproic acid dry blood spot samples as dry blood spot calibration points, and the number of the dry blood spot calibration points is at least six, the quality control material card is a blood spot collection card fixed with at least one group of valproic acid dry blood spot samples as dry blood spot quality control points,the number of each group of dry blood spot quality control points is at least three, the first container is filled with an internal standard extracting solution, and an internal standard adopts isotopic substituted valproic acid. The invention further discloses a detection method of the kit. The kit provided by the invention has advantages of simple preparation of reagents, less required amount ofsamples, convenience in storage and transportation, rapid pretreatment, short analysis period, lower cost and the like, and is suitable for popularization in clinical conventional detection.

Description

technical field [0001] The invention relates to the field of medical testing, in particular to a kit for detecting the drug concentration of valproic acid in dried blood spot samples. Background technique [0002] Valproic acid (VPA) is currently the first-line broad-spectrum antiepileptic drug in clinical application. Treatment of epilepsy, especially infantile spasms has a significant effect. The results of a large number of clinical trials have shown that among all antiepileptic drugs for the treatment of epilepsy in children and adults, valproic acid may have the widest range of antiepileptic activity. In addition to treating partial and generalized seizures, studies have shown that valproic acid is also effective in controlling very difficult epilepsy syndromes, such as Lennox-Gastaut syndrome and West syndrome. Therefore, valproic acid has a very prominent advantage in the treatment of patients with complex types of epileptic seizures whose symptoms are difficult to ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/72G01N30/86B65D25/10
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/72G01N30/8675B65D25/10G01N2030/324G01N2030/626
Inventor 罗稳沈敏李晓芳
Owner WUXI APPTEC ZK SUZHOU BIOSCIENCE CO LTD
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