Thymopentin (TP-5) drug composition

A composition and drug technology, applied in the field of medicine, can solve the problems of poor stability of peptide bonds, no detection, easy breakage, etc.

Active Publication Date: 2014-01-29
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] It is believed that Asp in the thymopentin molecular chain has poor peptide bond stability and is easily broken in aqueous or acidic solutions, degrading into the corresponding dipeptide Val-Tyr and tripeptide Arg-Lys-Asp
Although the prior art uses the HPLC method to examine the internal quality of thymopentin, such as content and related substances, there is no report on the detection of changes in related impurities in preparation products

Method used

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  • Thymopentin (TP-5) drug composition
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  • Thymopentin (TP-5) drug composition

Examples

Experimental program
Comparison scheme
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preparation example 1

[0123] Preparation Example 1, preparation of compositions (powder injection and water injection) comprising Thymopentin

[0124] formula:

[0125] Thymopentin

1 mg,

Maltose monohydrate

30mg,

pH regulator

Appropriate amount if necessary, adjusted to pH7.0,

Water for Injection

Appropriate amount, add to 1ml.

[0126] Preparation:

[0127] (1) Weigh the main drug and solid excipients (except pH adjuster) of the prescribed amount, place them in a stainless steel bucket, add about 80% of the prescribed amount of water for injection, stir to dissolve, and then add 0.1% (w / v) Activated carbon, stirred for 30 minutes, decarbonized by filtration, and added water for injection to nearly the full amount of the prescription.

[0128] (2) Take a sample of the filtrate, measure the pH value, and adjust to a specified value with a pH regulator if necessary (that is, take an appropriate amount of the filtrate and dilute it with water ...

preparation example 2

[0137] Referring to the method of Preparation Example 1 above, the difference is that the pH value is adjusted to 6.5, 6.8, 7.2, and 7.5, and the numbers of the obtained compositions (powder injection and water injection) are respectively Ex121, Ex122, Ex123, and Ex124;

[0138] Referring to the method of Preparation Example 1 above, the difference is that the amount of water for injection is adjusted to 0.5ml, 0.8ml, 1.2ml, and 1.5ml, and the numbers of the obtained compositions (powder injection and water injection) are respectively Ex125, Ex126, and Ex127 , Ex128.

preparation example 3

[0140] Referring to the method of Preparation Example 1 above, the difference is that 1 / 20, 1 / 15, 1 / 12, 1 / 10, 1 / 8, 1 / 7, 1 / 6 of the amount of maltose monohydrate equivalent to the amount of maltose monohydrate is added , 1 / 5, 1 / 4, 1 / 2, 1, 5 times of mannitol, the numbers of the obtained compositions (powder injection and water injection) are respectively Ex131, Ex132, Ex133, Ex134, Ex135, Ex136, Ex137, Ex138 , Ex139, Ex140, Ex141, Ex142;

[0141] Referring to the method of Preparation Example 1 above, the difference is to add lactose equivalent to 1 / 10, 1 / 7, 1 / 3 times the amount of maltose monohydrate, 1 / 10, 1 / 7, 1 / 3 times dextran, 1 / 10, 1 / 7, 1 / 3 times of glycine, the obtained compositions (powder injection and water injection) numbers are respectively Ex143, Ex144, Ex145, Ex146, Ex147, Ex148, Ex149, Ex150, Ex151.

[0142] Preparation example 2, preparation of compositions (powder injection and water injection) comprising thymopentin

[0143] formula:

[0144] Th...

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Abstract

The invention relates to a thymopentin (TP-5) drug composition and in particular relates to a drug composition. The drug composition comprises 1 part of TP-5, 10-200 parts of sugar and 0-2000 parts of optional water for injection by weight. The TP-5 drug composition can be used for treating chronic viral hepatitis such as chronic hepatitis B, various primary or secondary T cell deficiency diseases such as congenital immunodeficiency diseases in children, some autoimmune diseases such as rheumatoid arthritis and systematic lupus erythematosus, various diseases caused by cellular immune hypofunction and tumors, and can be especially used for adjuvant treatment of tumors.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical preparation, in particular to a thymopentin pharmaceutical composition such as injection or freeze-dried powder injection. Thymopentin pharmaceutical composition of the present invention can be used for the treatment of chronic viral hepatitis such as chronic hepatitis B, for the treatment of various primary or secondary T cell deficiency diseases such as children's congenital immunodeficiency disease, for the treatment of certain Autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus are used to treat various diseases with low cellular immune function, and can also be used to treat tumors, especially for adjuvant therapy of tumors. Background technique [0002] Thymus is the primary lymphoid epithelial tissue, the central immune organ of the body, and the central organ of T-cell development. In addition to providing a microenvironment re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K47/26A61P1/16A61P31/20A61P37/02A61P37/04A61P35/00A61P29/00A61P19/02
Inventor 赵东明贾红军方专罗隽潘旭苟治君
Owner CHENGDU TIANTAISHAN PHARMA
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