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Method for quantitative determination of prostaglandin in biological sample

A biological sample and prostaglandin technology, which is applied in the field of drug analysis and research, can solve problems such as unsatisfactory analysis requirements and unreachable sensitivity of injection volume, and achieve the effects of shortening sample analysis time, increasing throughput, and reducing separation difficulty

Inactive Publication Date: 2018-01-19
JILIN UNIV
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Problems solved by technology

At present, the analysis method that can meet the LLOQ of limaprostaglandin pharmacokinetics is two-dimensional liquid chromatography-tandem mass spectrometry (2D-LC-MS / MS). The problems of this method are: (1) In order to improve the analysis method in Selectivity in biological samples, MRM monitors the reaction ion pair with strong specificity and weak signal (m / z 379→m / z 233), which leads to the failure to achieve LLOQ sensitivity with conventional injection volume (10-20μL) , the method had to use a very large injection volume of 100 μL
For this reason, the chromatographic separation of this method uses two-dimensional chromatographic separation, and the analysis time of each sample is as long as 50 minutes, which cannot meet the analysis requirements of thousands of samples in the bioequivalence (BE) test of this product.

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  • Method for quantitative determination of prostaglandin in biological sample
  • Method for quantitative determination of prostaglandin in biological sample
  • Method for quantitative determination of prostaglandin in biological sample

Examples

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Embodiment 1

[0059] In this example, Limaprostaglandin in plasma was specifically determined.

[0060] Healthy volunteers took 5 μg of test preparation limaprostaglandin tablets orally on an empty stomach, before administration 0h (within 30 minutes before administration) and after administration 10min, 15min, 20min, 25min, 30min, 40min, 1h, 1.5h, Venous blood was collected at 13 time points of 2h, 3h, 4h, and 6h. Each time, 14mL of blood (2 tubes in total) was collected, and slowly placed in an anti-adsorption test tube treated with sodium heparin, and centrifuged at 1800g for 5min in a 4°C centrifuge. . After centrifugation, the plasma was transferred to anti-adsorption cryovials. Determination of the content of limaprostaglandin in plasma, plasma drug concentration-time curve see Figure 4 .

[0061] The main steps are as follows:

[0062] A. Treatment of biological samples to be tested:

[0063] Take 3 mL of plasma sample, put it in a 10 mL anti-adsorption glass tube, add 100 μL o...

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Abstract

The invention discloses a method for quantitative determination of prostaglandin in a biological sample. An ultra performance liquid chromatography-differential mobility spectrometry-tandem mass spectrometry (UPLC-DMS-MS / MS) detection system is employed to determine prostaglandin in the biological sample, and a DMS pool is added between the high performance liquid chromatogram and the mass spectrum. According to the invention, the DMS pool is mounted between an ion source of the mass spectrum and a first quadrupole, the interference of limaprost in blood plasma is further removed by DMS, thusreducing the liquid chromatogram separation difficulty, changing two-dimensional chromatogram to one-dimensional chromatogram, greatly shortening the sample analysis time, and improving the sample analysis flux.

Description

technical field [0001] The invention belongs to the technical field of drug analysis and research, and relates to a biological mass spectrometry quantitative analysis method for determining prostaglandins in biological samples, and is especially suitable for determining lima prostaglandins. Background technique [0002] Limaprostaglandin is a synthetic analogue of prostaglandin E1. It was jointly developed by Ono Pharmaceutical Co., Ltd. and Dainippon Pharmaceutical Co., Ltd. in Japan. In 1988, it was listed under the trade names OPALMON and PRORENAL respectively. Its chemical structure is (E)-7 -[(1R,2R,3R)-3-Hydroxy-2-[(3S,5S)-(E)-3-Hydroxy-5-methyl-1-nonenyl-5-oxocyclopentyl] -2-heptanoic acid (see figure 1 ), molecular formula C22H36O5, molecular weight is 380.5Da [0003] Due to the destruction of digestive enzymes, traditional prostaglandin drugs are easily catabolized and generally ineffective when taken orally. However, lima prostaglandin can exert pharmacological ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 顾景凯孟祥骏赵式樱张琪僮金尹磊
Owner JILIN UNIV
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