Kit for detecting dicysteine related substances

A technology for dicysteine ​​and related substances, which is applied in the field of kits for detecting dicysteine-related substances, can solve the problems of no rapid detection of dicysteine, and achieve low and high detection and quantification limits. System applicability and specificity, the effect of baseline stability

Pending Publication Date: 2022-04-05
无锡市江原实业技贸有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Therefore, the technical problem to be solved by the present invention is that in the prior art there is no reagent kit for rapid detection of related substances in dicysteine, thereby providing a reagent for detecting related substances of dicysteine box

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  • Kit for detecting dicysteine related substances
  • Kit for detecting dicysteine related substances
  • Kit for detecting dicysteine related substances

Examples

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Embodiment 1

[0057] This embodiment provides a kit for detecting dicysteine-related substances, including amino derivative reagent solution, borate buffer, diluent, stop solution, and related substance standard solution, wherein,

[0058] The amino derivatization reagent solution is 1.25 mg / mL of 9-fluorenylmethyl chloroformate solution, the solvent is acetonitrile, 500 μL each;

[0059] The borate buffer solution is 0.1mol / L, pH is 8.5, 250 μL each;

[0060] The diluent is a solution with a volume ratio of acetonitrile and water of 1:1, 500 μL each;

[0061] The stop solution is 20vol% acetic acid solution, and its solvent is 500 μL of the dilution solution.

[0062] The related substance standard solutions are cysteine ​​solutions with concentrations of 0.6, 0.9, 1.2, 1.8, 2.4, 3.6 and 12.0 μg / mL and concentrations of 0.3, 0.45, 0.6, 0.9, 1.2, 1.8 and 6.0 μg / mL tetrahydrothiazole-4-carboxylic acid solution, the solvent of the related substance standard solution is water.

[0063] The...

Embodiment 2

[0072] This embodiment provides a method for detecting related substances in dicysteine, using the kit in Example 1, and the specific steps are as follows:

[0073] (1) Prepare the sample solution to be tested: take 1 bottle of dicysteine ​​for injection (containing 1.5 mg of dicysteine) produced by Jiangyuan Pharmaceutical Factory of Jiangsu Institute of Atomic Medicine, add 1 mL of water to dissolve and mix, and take 400 μl , diluted to 1mL with water, and mixed to obtain the sample solution to be tested;

[0074] (2) Carry out amino derivatization of the sample solution to be tested: take 250 μL of the sample solution to be tested, add a borate buffer solution, mix well, add a solution of amino derivatization reagent, vortex immediately for 120s; add one to stop solution and a diluent, continue to vortex for 120s, and filter through a 0.45μm organic membrane to obtain the derivatized sample to be tested;

[0075] (3) Inject the derivatized sample to be detected into the ma...

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Abstract

The invention discloses a kit for detecting a bis-cysteine related substance, which comprises an amino derivatization reagent solution and a related substance standard solution, and the related substance standard solution comprises a cysteine standard solution. The invention also discloses application and a use method of the kit. Reagents adopted by the kit are simple and easy to obtain, the kit is simple and easy to implement when being used for detecting related substances in bicysteine, the detection result is high in accuracy, precision and stability, meanwhile, the kit has very high system applicability and specificity, and the detection limit and the quantitation limit are low.

Description

technical field [0001] The invention belongs to the technical field of medicinal chemistry, and in particular relates to a kit for detecting substances related to dicysteine. Background technique [0002] Dicysteine ​​for injection and its raw material, dicysteine, are national first-class new drugs and are mainly used to measure effective renal plasma flow, so the quality requirements for their drugs are very high. In 2012, the National Pharmacopoeia Commission issued a notice of supplementary information for the correction of the drug trial standard, suggesting that the relevant substances of this product should be inspected, including stability tests, and included in the quality standards. In the original trial standard, there is no item of "inspection of related substances". "Related substances inspection" item is currently a necessary item in most drug quality standards. In dicysteine, its main related substances are the starting substance cysteine ​​(Cys) and the int...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/72
Inventor 汪洋陈志明邹霈李博齐祥秋代谊彬王刚吴二明高铮凌
Owner 无锡市江原实业技贸有限公司
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