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Thymopoietin for large dosage injection and application thereof for treating severe hepatitis

A hepatitis B, high-dose technology, applied in the field of medicine, can solve the problems of patients' pain in treatment and poor compliance of thymopentin, and achieve the effects of enhancing antiviral efficacy, improving compliance, and facilitating drug administration

Active Publication Date: 2014-01-01
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] Since there is currently only 10mg / bottle of thymopentin, critically ill patients need to be injected 5 times during the injection, which makes the patient very painful during treatment, and the compliance of 10mg / bottle of thymopentin is poor. In order to solve this situation, this The invention provides a high-dose thymopentin for the treatment of severe hepatitis B patients

Method used

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  • Thymopoietin for large dosage injection and application thereof for treating severe hepatitis
  • Thymopoietin for large dosage injection and application thereof for treating severe hepatitis
  • Thymopoietin for large dosage injection and application thereof for treating severe hepatitis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1: the preparation of Thymopentin (50mg) for large dose injection:

[0042] 1), solution preparation:

[0043] 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.

[0044] 2), endotoxin monitoring

[0045] Samples were taken for limulus test, and the endotoxin content per milliliter was less than 2.5 EU.

[0046] 3), content monitoring

[0047] Using high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix Ⅴ D), the content of thymopentin was detected by sampling, the result showed that the content of thymopentin in the sample was 90%~110% of the labeled amount. , indicating that the quality standard is met.

[0048] 4), filter sterilization

[0049] Under Class 100 clean conditions, use a 0.2 μM filter membrane to filter and sterilize.

[0050] 5), filling

[0051]Under the co...

Embodiment 2

[0057] Embodiment 2, the effect detection of Thymopentin (50mg) for large dose injection:

[0058] 1. Check

[0059] 1. pH

[0060] Test method: pH value determination method (Chinese Pharmacopoeia 2010 edition two appendix VI H)

[0061] 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.

[0062] 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.

[0063] Table 1 Determination results of thymopentin alkalinity for injection

[0064]

[0065] 2. Solution clarity and color

[0066] Test method: Take 5 tubes of this product, add 1ml of water to dissolve respectively, the solution should be colorless and clear; if it is turbid, compare it with No. 1 turbidity standard solution...

experiment example 3

[0118] Experimental example 3, hemolysis test of Thymopentin for injection:

[0119] 1. Experimental materials

[0120] 1.1. Test product

[0121] Name: Thymopentin for Injection (Thymopentin for Iniection) prepared in Example 1 of the present invention. Batch number: 20090102. Specifications: 50mg / bottle. Physical and chemical properties: white powder. Stability and storage: airtight, store in a cool and dark place.

[0122] 1.2. Experimental animals

[0123] 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.

[0124] 2. Experimental methods and index testing requirements

[0125] 2.1. Experimental method

[0126] Thymopentin for injection: During the test, 0.9% sodium chloride injection was used to prepare three concentrations of 0.1mg / ml, 1.0mg / ml, and 3.3mg / ml.

[0127] Prepara...

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Abstract

The invention discloses thymopoietin for large dosage injection and an application thereof for treating severe hepatitis, belonging to the technical field of medicine. The specification of the large dosage thymopoietin is 50 mg, and the large dosage thymopoietin used for treating severe hepatitis patients is applied in the preparation of medicine for treating severe hepatitis patients, wherein the specification of the large dosage thymopoietin is 50 mg, and 1 ml is injected each time. The thymopoietin with large dosage of 50 mg of the invention is cooperatively used with adefovir dipivoxil to greatly improve the antiviral treatment effect of adefovir dipivoxil, and the security of the thymopoietin is good, so that the thymopoietin is a medicine for effectively and safely treating severe hepatitis; besides, the medicine is convenient to be delivered to the severe hepatitis patients to improve the compliance of the patient crowd and to satisfy the special demands of the severe hepatitis patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a thymopentin for large dose injection and its application in treating severe hepatitis B. Background technique [0002] 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 [0003] [0004] 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-cell development, it can also produce a variety of thymosin hormones. Thymus hormone can induce the differentiation and maturation of T-cell subsets, and can also enhance the response performance of various T-cells, thereby regulating the function of the entire immune system. [0005] Severa...

Claims

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Application Information

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Patent Type & Authority Patents(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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