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Two-step <99m>Tc-ECD marking process with high radiochemical purity and <99m>Tc-ECD solution

A 99mtc-ecd, radiochemical purity technology, applied in the directions of liquid transportation, radioactive carrier, radioactive physical shape, etc., can solve the problems of many impurities, high background, difficult clinical diagnosis, etc., and achieve the effect of clear imaging

Pending Publication Date: 2020-11-24
北京森科医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

After the pharmacopoeia test, the solution prepared with the volume ratio of methanol:dichloromethane:water as 80:15:5 is used as the developer, and the polyamide-6 film is developed with low radiochemical purity, and the clinical imaging effect is very good. Poor, many impurities, high background, difficult clinical diagnosis

Method used

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  • Two-step &lt;99m&gt;Tc-ECD marking process with high radiochemical purity and &lt;99m&gt;Tc-ECD solution
  • Two-step &lt;99m&gt;Tc-ECD marking process with high radiochemical purity and &lt;99m&gt;Tc-ECD solution
  • Two-step &lt;99m&gt;Tc-ECD marking process with high radiochemical purity and &lt;99m&gt;Tc-ECD solution

Examples

Experimental program
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Effect test

Embodiment 1

[0030] This embodiment provides a two-step method with high radiochemical purity 99m The Tc-ECD marking process specifically includes the following steps:

[0031]S1. Preparation of stannous glucoheptonate sodium solution: Mix 5 μg of stannous chloride and 3.1 mg of sodium glucoheptonate, mix well, dissolve in 5 mL of 0.9% chloride at room temperature Add phosphate buffer to the sodium solution to adjust the pH of the solution to 5.5-6.0, and then prepare a stannous glucoheptonate sodium solution (ie, GH solution) for future use. Among them, the phosphate buffer is NaH 2 PO 4 and Na 2 HPO 4 Mixture of solutions, NaH 2 PO 4 NaH in solution 2 PO 4 Concentration is 0.2mol / L, Na 2 HPO 4 Na in solution 2 HPO 4 The concentration is 0.2mol / L, NaH in phosphate buffer 2 PO 4 solution and Na 2 HPO 4 The volume ratio of the solution is 12.3:87.7, so that the pH of the solution can be kept in the range of 5.5-6.9. In this embodiment, the pH of the solution is 6.3.

[0032...

Embodiment 2-7

[0035] The difference between Examples 2-7 and Example 1 is that the consumption of each raw material is different, see Table 1 for details, and the others are the same as Example 1.

[0036] The preparation of table 1 embodiment 1-7 99m Raw material composition and dosage of Tc-ECD solution

[0037]

Embodiment 8

[0039] The difference between this example and Example 3 is that the reaction conditions in step S3 are different, specifically reacting at 90°C for 20 minutes to obtain the marker 99m Tc-ECD solution.

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Abstract

The invention discloses a two-step <99m>Tc-ECD marking process with high radiochemical purity and a <99m>Tc-ECD solution, relates to the technical field of imaging, and solves the problems of many clinical imaging impurities and difficulty in clinical diagnosis. The marking process comprises the following steps: S1, preparation of a GH solution: mixing stannous chloride and sodium glucoheptonate,and dissolving the mixture in a sodium chloride solution at normal temperature for later use; S2, adding a sodium pertechnetate [<99m>Tc] solution to enable stannous chloride to completely react, shaking up, and performing standing to obtain a 99mTc-GH solution; and S3, adding the <99m> Tc-GH solution into ECD, uniformly mixing, and performing heating to react, so as to obtain a marker <99m> Tc-ECD solution. The <99m> Tc-ECD solution provided by the invention is obtained by the marking process. The <99m>Tc-ECD solution disclosed by the invention is high in radiochemical purity, good in imagingeffect, low in background and clear in image when being used for brain imaging.

Description

technical field [0001] This application relates to the technical field of single photon emission computed tomography (SPECT) imaging, more specifically, it relates to a two-step method with high radiochemical purity 99m Tc-ECD marking process and 99m Tc-ECD solution. Background technique [0002] SPECT cerebral blood flow 99m Tc-ECD is a tomographic imaging technology in which a physiological imaging agent is distributed in the brain. It is a physiological imaging of a living body. External stimulation or disease will change the pixel density value of the relevant area; therefore, the analysis of the functional area The situation of the pixel, especially for cognitive research and disease diagnosis are of great significance. [0003] And currently, 99m The Tc-ECD labeling process is divided into two types, namely one-step method and two-step method. [0004] The specific operation of the one-step method is: mix stannous chloride, sodium glucoheptonate, phosphate buffer ...

Claims

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Application Information

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IPC IPC(8): A61K51/12A61K51/04A61K103/10
CPCA61K51/0478A61K51/121
Inventor 王亚敏张志永陈敏
Owner 北京森科医药有限公司
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