Preparation of <99m>Tc galactosyl human serum albumin fusion interferon of liver receptor developer and uses thereof

A technology of serum albumin and 99mtc-ghsa-ifn, which is applied in the direction of interferon, peptide preparation, animal/human protein, etc., can solve the serious harm of hepatitis C, achieve convenient clinical application, reduce side effects, pain relieving effect

Inactive Publication Date: 2008-12-31
JIANGSU INST OF NUCLEAR MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The damage of hepatitis C virus to the liver is continuous, hidden and irreversible; the proportion of hepatitis C developing into cirrhosis, liver cancer and liver failure is much higher than that of other hepatitis; since no effective hepatitis C vaccine has been developed yet , making hepatitis C more serious than hepatitis B in a sense

Method used

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  • Preparation of &lt;99m&gt;Tc galactosyl human serum albumin fusion interferon of liver receptor developer and uses thereof
  • Preparation of &lt;99m&gt;Tc galactosyl human serum albumin fusion interferon of liver receptor developer and uses thereof
  • Preparation of &lt;99m&gt;Tc galactosyl human serum albumin fusion interferon of liver receptor developer and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1: 99m Preparation of Tc-GHSA-IFN

[0044] by 99m The preparation of Tc-GHSA-IFN α2b is illustrated as an example 99m Preparation of Tc-GHSA-IFN.

[0045] (1) 0.3mg GHSA-IFNα2b (sugar density is 24) lyophilized product, dissolved with 0.2mol / L buffer solution containing 10mmol / L vitamin C;

[0046] (2) Add 50-100 μg stannous reducing agent freshly prepared with HCl, and mix well;

[0047] (3) Sterilize by filtration with a medical sterile disposable filter containing a 0.22 μm filter membrane;

[0048] (4) Quickly add an appropriate amount (0.3mL) of Na 99m TCO 4 Eluent, reacted for 30 minutes;

[0049] The buffer described in step (1) can be acetic acid-sodium acetate buffer, citric acid-sodium citrate buffer, disodium hydrogen phosphate-citric acid buffer, phthalic acid-hydrochloric acid buffer and glycine-hydrochloric acid buffer etc., the buffer solution pH is 3.0-4.5; the stannous reducing agent described in step (2) comprises the one in stannous fl...

Embodiment 2

[0050] Example 2: Preparation of GHSA-IFNα2b freeze-dried kit

[0051] The kit can be conveniently used in clinical technetium[ 99m Tc] labeled, prepared 99m Tc-GHSA-IFN. The preparation of the freeze-dried kit should be carried out in the radiopharmaceutical factory workshop meeting the GMP standard, and its specific steps are as follows:

[0052] (1) 30mg GHSA-IFN, dissolved in 90mL 0.2mol / L buffer containing 10mmol / L vitamin C;

[0053] (2) Add 8mL, 5-10mg / mL excipient (mannitol) solution and mix well;

[0054] (3) Add 2mL, 5mg / mL stannous reducing agent (freshly prepared with HCl), mix well;

[0055] (4) Sterilize by filtration with a medical sterile disposable filter containing a 0.22 μm filter membrane;

[0056] (5) Aliquot 1 mL of each vial, freeze-dry to make a freeze-dried kit, and store at -20°C. Just before use, just add 0.3mL [99mTc] Sodium Pertechnetate Injection to each bottle of lyophilized kit, and let it stand at room temperature for 30 minutes.

[0057...

Embodiment 3

[0058] Example 3: 99m Tc-GHSA-IFNα2b analysis

[0059] Determination by thin layer chromatography on polyamide-66 thin film chromatography paper 99 Tc m -The radiochemical purity of GHSA-IFNα2b, the development system is 20mmol / L PBS pH7.2: 10% sodium dodecyl sulfate (SDS): acetone (V:V:V)=3:1:1, under this condition Under , the Rf of reduced technetium, hydrolyzed technetium and colloidal technetium are all 0.0, free Na 99m TCO 4 The Rf is 0.4~0.5, 99m The Rf of Tc-GHSA-IFNα-2b is 0.8-1.0. The result shows that its radiochemical purity is 91.8%. After being placed at room temperature for 30 minutes, the radiochemical purity is still greater than 90%, which meets the requirements of clinical use.

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Abstract

Disclosed are a preparation method for hepatic receptor imaging agent 99mTc-galactosyl-human serum albumin fusion interferon and the application of the albumin fusion interferon, belonging to the nuclear medicine technical field. The invention adopts a stannous reduction method for the radioactive technetium tagging of the hepatic receptor imaging agent 99mTc-galactosyl-human serum albumin fusion interferon GHSA-IFN; upon polyamide-66 thin layer chromatography analysis, the radiochemical purity of the prepared 99mTc-GHSA-IFN is more than 90% and can be stabilized for more than 6 hours at room temperature, in line with the requirements of scientific research and clinical use. The distribution in mice and the imaging results of rats show that the 99mTc-GHSA-IFN can be incepted by liver in a specific way, and the liver imaging is very clear within 10-30 minutes which is the best time for liver imaging. Therefore, the 99mTc-GHSA-IFN is a good new liver receptor function SPECT imaging agent and can be used to evaluate the liver receptor functions, diagnose liver diseases and evaluate the liver disease treatment drug efficacy; at the same time, the 99mTc-GHSA-IFN is also used to prepare liver targeted therapy drugs and the treatment drugs for viral hepatitis.

Description

technical field [0001] The invention relates to a novel liver receptor function SPECT imaging agent 99m Tc-galactosylated human serum albumin fusion interferon (Technetium[99mTc]labeled Galactosylated Human SerumAlbumin Interferon Fusion Protein, 99m The preparation method of Tc-GHSA-IFN) and its clinical application belong to the technical field of nuclear medicine. Background technique [0002] my country is a country with a large population, but also a country with a large number of liver diseases, and there are many patients with various liver diseases. The HBV carrier rate in my country is as high as 10% to 13%, and about 50% of them become chronic hepatitis B patients. Among these chronic hepatitis B patients, about 25% to 40% of patients will eventually die of liver cirrhosis or combined liver cancer; HCV infection The rate is 3.2%, about 42 million people. The chronicity rate of HCV infection is extremely high, up to 50% to 85%. After 20 years of infection, about 10...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K19/00C07K14/555C07K1/13A61K51/00A61K49/22A61K38/21A61P1/16A61P31/12A61K103/10
Inventor 张荣军蔡刚明蒋孟军张波周尧远顾晓波谭成周杏琴叶万忠俞惠新曹国宪
Owner JIANGSU INST OF NUCLEAR MEDICINE
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