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Application of thymopentin in preparation of drug for treating patient with severe hepatitis b

A technology for thymus and severe disease, applied in the field of medicine, can solve the problems of lack of 50mg product specification, restricted application, etc., to achieve the effect of facilitating administration, improving compliance, and meeting special needs

Inactive Publication Date: 2014-03-26
THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The lack of 50mg product regulations in clinical liver disease restricts the clinical application of this product in liver disease

Method used

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  • Application of thymopentin in preparation of drug for treating patient with severe hepatitis b
  • Application of thymopentin in preparation of drug for treating patient with severe hepatitis b
  • Application of thymopentin in preparation of drug for treating patient with severe hepatitis b

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Example 1: Preparation of Thymopentin (50 mg) for large dose injection:

[0044] 1), solution preparation:

[0045] In a class 10,000 clean room, take the prescribed amount of thymopentin 50,000mg and mannitol 50,000mg, add it to about 900ml of water for injection, shake well, and dilute to 1,000ml to get ready.

[0046] 2), endotoxin monitoring

[0047] Samples were taken for limulus test, and the endotoxin content per milliliter was less than 2.5 EU.

[0048] 3), content monitoring

[0049]Using high performance liquid chromatography (Chinese Pharmacopoeia 2010 Edition, Appendix ⅤD), samples were taken to detect the content of thymopentin, and the results showed that the content of thymopentin in the sample was 90% to 110% of the labeled amount. , indicating that the quality standard is met.

[0050] 4), filter sterilization

[0051] Under Class 100 clean conditions, use a 0.2 μM filter membrane to filter and sterilize.

[0052] 5), filling

[0053] Under the ...

Embodiment 2

[0059] Example 2, detection of the effect of Thymopentin (50 mg) for large dose injection:

[0060] 1. Check

[0061] 1. pH

[0062] Test method: pH value determination method (Chinese Pharmacopoeia 2010 edition two appendix VI H)

[0063] Measuring process: 3 batches of 50 mg thymopentin prepared in Example 1 were randomly taken, and the batch numbers were named 20090102, 20090103 and 20090104, each was dissolved with 5 ml of water, and the pH value of the solution was measured according to the law.

[0064] Results: The pH values ​​of the three batches of test samples were all between 6.0 and 8.0. The measurement data are shown in Table 1.

[0065] Table 1 Thymopentin Alkalinity Determination Results for Injection

[0066]

[0067] 2. Solution clarity and color

[0068] Test method: Take 5 tubes of this product, add 1ml of water to dissolve, the solution should be colorless and clear; if it is cloudy, compare it with the No. 1 turbidity standard solution (Appendix ...

Embodiment 3

[0120] Embodiment 3, the hemolysis test of Thymopentin for injection:

[0121] 1. Experimental materials

[0122] 1.1. Test product

[0123] Name: Thymopentin for injection prepared in Example 1 of the present invention (Thymopentin for Iniection). Batch number: 20090102. Specifications: 50mg / bottle. Physical and chemical properties: white powder. Stability and storage: airtight, store in a cool and dark place.

[0124] 1.2. Experimental animals

[0125] Species: Rabbit. Department: Big-eared White Rabbit. Gender and number: female, 1 only. Animal age: 16 weeks. Animal weight: 2.5 kg. Animal source: Beijing Keyu Animal Breeding Center. Animal certificate number: SCXK (Beijing) 20070003.

[0126] 2. Experimental methods and index testing requirements

[0127] 2.1. Experimental method

[0128] Thymopentin for injection: During the test, 0.9% sodium chloride injection was prepared into 3 concentrations of 0.1mg / ml, 1.0mg / ml, and 3.3mg / ml.

[0129] Preparation of bl...

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Abstract

The invention discloses an application of thymopentin in preparation of a drug for treating a patient with severe hepatitis B, and belongs to the technical field of a medicine. According to application of the thymopentin in preparation of the drug for treating the patient with severe hepatitis B, the dose of the thymopentin is 50mg. The thymopentin with a large dose of 50mg disclosed by the invention can significantly enhance the antiviral efficacy of adefovir dipivoxil when being combined with the adefovir dipivoxil, is good in safety, and is an effective and safe drug for treating the severe hepatitis B, administration on the patient with the severe hepatitis B is facilitated, the compliance of the patient population is improved, and special requirements of the patient with the severe hepatitis B are met.

Description

[0001] The patent application of the present invention is the application number "201110417354.2", the application date is "December 14, 2011", and the title is "a large dose of Thymopentin for injection and its application in the treatment of severe hepatitis B". Application technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to the application of thymopentin in the preparation of medicine for treating severe hepatitis B patients. Background technique [0003] Thymopentin, the English full name is Thymopoietin or Timunox, and the English abbreviation is TP-5. It is composed of five amino acids including arginine, lysine, aspartic acid, valine and tyrosine. The chemical structure formula is [0004] [0005] The thymus is the primary lymphoid epithelial tissue, the primary central immune organ of the human body, and the central organ of T-cell development. In addition to providing a microenvironment required for T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61P1/16A61P31/20
Inventor 韩晋袁海龙丁晋彪周旭谢进
Owner THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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