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Kit for detecting drug concentration of nilotinib in dried blood spots, and detection method implemented by kit

A technology of nilotinib and drug concentration, applied in the field of kits for the detection of nilotinib drug concentration, can solve the problems of time-consuming and laborious development, affecting accuracy, large sampling volume, etc. Inaccurate sampling, the effect of ensuring accuracy

Inactive Publication Date: 2019-07-23
上海药明傲喆医学检验所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the continuous advancement of new technologies and the new needs of patients for medical diagnosis, traditional samples continue to show certain shortcomings in use: 1. Traditional samples have a large amount of sampling, and the detection of whole blood, plasma, and serum samples requires a large number of samples. ml, and the serum and plasma need to be separated again
2. The stability of liquid samples is poor, and various physical, chemical, and biological factors will lead to the accuracy of the analysis results, such as light, PH, enzyme effects, etc., and samples from patients in remote areas need to be transported to regional testing centers by cold chain. higher cost
3. Liquid matrix samples are more likely to cause occupational exposure and pathogen infection
4. Traditional samples need to accurately measure the sampling volume, otherwise it will affect the accuracy of quantification
Most of the detection items in the LDT mode lack quality control, and the instability of analysis batches and reagent batches will cause a huge risk of reproducibility, and the accuracy, precision, and reliability of experimental data are difficult to guarantee
The development of LDT mode projects is time-consuming and laborious, and the convenience is poor. Reagent preparation, method establishment, instrument parameters, etc. need professional and responsible staff to ensure

Method used

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  • Kit for detecting drug concentration of nilotinib in dried blood spots, and detection method implemented by kit
  • Kit for detecting drug concentration of nilotinib in dried blood spots, and detection method implemented by kit
  • Kit for detecting drug concentration of nilotinib in dried blood spots, and detection method implemented by kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1: kit composition

[0046] A kit for detecting the drug concentration of nilotinib in dried blood spots, comprising: an internal standard extraction reagent, a dried blood spot calibration product and a dried blood spot quality control product. in,

[0047] The internal standard extraction reagent uses D6-nilotinib as the internal standard, and the solvent of the internal standard extraction reagent is a mixture of organic solvent and water; the organic solvent is methanol, or acetonitrile, or a mixture of methanol and acetonitrile, and the organic solvent and water The volume ratio is (1.5~4.0):1.

[0048] The nilotinib dried blood spot calibration product is a group of dried blood spot samples of nilotinib with different concentration gradients, the number of the dried blood spot samples is at least 6, and the dried blood spot samples are fixed on the blood spot Acquisition card; the concentration range of the concentration gradient is 50-4000ng / mL. Suc...

Embodiment 2

[0076] Embodiment 2: Nilotinib DBS spotting volume to the research of detection result

[0077] The LC-MS / MS method was used to detect the concentration of nilotinib in dried blood slices, and the influence of sample volume on the detection results was studied.

[0078] Whole blood with an HCT value of 40% was used to prepare a high-concentration sample (high) and a low-concentration sample (low), and the sample concentration was the same as that of HQC and LQC.

[0079] Preparation of volume effect blood spot card: Take the above HQC and LQC samples, and put 10uL, 15uL, 20uL, 40uL on the DBS card respectively. Each sample was repeated three times and dried at room temperature for later use.

[0080] Experimental results:

[0081]

[0082] Acceptable standard: Investigate the detection concentration when the sample volume is 10μL, 15μL, 20μL, 30ul or 40μL. When the CV≤15%, the deviation from the theoretical value is ≤±20%, it is considered that the volume effect has no i...

Embodiment 3

[0085] Embodiment 3: Nilotinib DBS accelerated stability test

[0086] Using the preparation method and detection method of the kit described in the above examples, the samples are preserved in an environment more severe than daily operation (high temperature 40°C and high humidity 75%), and the storage stability of the samples is tested in a shorter time.

[0087] Statistics of experimental results: refer to the statistical method of long-term stability of EP25-A, take time as the abscissa, and the average concentration detected at each time point as the ordinate to make a scatter plot, and use linear regression analysis to obtain the regression equation Y=bX+a .

[0088] 1) Make a t-test between the slope b and 0, if there is no significant difference (P>0.05), the sample remains stable during the detection period.

[0089] 2) If the slope b is significantly different from 0 (P<0.05), then draw the 95% one-sided confidence line of the regression line, which is parallel to X...

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Abstract

The invention discloses a kit for detecting the drug concentration of nilotinib in dried blood spots. The kit comprises an internal standard extraction reagent, and dried blood spot calibrators, wherein the internal standard extraction reagent adopts isotopically substituted nilotinib as an internal standard substance, and a solvent for the internal standard extraction reagent is a mixture of an organic solvent and water; the nilotinib dried blood spot calibrators are a group of nilotinib dried blood spot samples with different concentration gradients, the number of the dried blood spot samples is equal to or larger than 6, and the dried blood spot samples are fixed on a dried blood spot collection card; and the concentration range of the concentration gradients is between 50 ng / mL and 4,000 ng / mL. The invention further discloses a detection method implemented by the kit. The kit and the detection method provided by the invention have the advantages of small sampling volume, high sample stability, and high accuracy of detection results.

Description

technical field [0001] The invention belongs to the field of biological detection, and in particular relates to a kit and a method for detecting the drug concentration of nilotinib in a dried blood spot sample. Background technique [0002] Nilotinib (Nilotinib), the molecular formula is C 28 h 22 f 3 N 7 O, with a molecular weight of 529.51600, was developed by Swiss Novartis in 2007. Nilotinib has stronger selectivity for BCR-ABL kinase activity, and its inhibitory effect on tyrosine kinase is 30 times stronger than that of imatinib, which can inhibit the BCR-ABL mutant that is resistant to imatinib. Kinase activity, clinically mainly used to treat chronic myelogenous leukemia resistant to Gleevec (imatinib). [0003] Therapeutic drug monitoring (TDM) is to measure the drug concentration in blood or other body fluids of drugs with narrow therapeutic index, strong toxicity and large individual differences, and formulate individual dosage regimens based on pharmacokinet...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/045
Inventor 朱磊李宇
Owner 上海药明傲喆医学检验所有限公司
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