Production of high-concentration thymic peptide solution and large-specification thymic peptide preparation

A high-concentration technology of thymosin, which is applied in the field of preparation of thymosin, can solve the problems of easy pollution, waste of pharmaceutical packaging material resources, environmental protection burden, etc., and achieve the effect of simple method, inhibition of microbial reproduction, and maintenance of biological activity

Active Publication Date: 2008-07-16
BEIJING SAISHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, due to the low content of the thymosin solution obtained by the general extraction process (less than 10 mg / ml), only low-spec preparations of 5 mg, 10 mg and 20 mg can be prepared, and it is difficult to prepare large-scale preparations of 50 mg and 100 mg in a small volume; and Low-specification preparations have many disadvantages for large-dose use. For example, if you use multiple bottles at a time, you need to open and dissolve one by one. Not only is the operation time-consuming, but it is also easy to cause pollution; waste, and a burden to the environment

Method used

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  • Production of high-concentration thymic peptide solution and large-specification thymic peptide preparation
  • Production of high-concentration thymic peptide solution and large-specification thymic peptide preparation
  • Production of high-concentration thymic peptide solution and large-specification thymic peptide preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Get 100Kg of quick-frozen calf thymus and put it in a special water tank to thaw, remove the fat and outer membrane, and get a net weight of 85Kg. The extracted thymus was first washed 3 times with drinking water, and then 3 times with water for injection. After mincing with a meat grinder, add 85L of cold water for injection, and use a colloid mill to homogenize for 2 minutes. The homogenate was frozen at -30°C for 48 hours. After taking it out, it was melted in a water bath at 20°C. It was rapidly heated to 90°C and kept for 3 minutes, and then quickly cooled to room temperature. Centrifuge at 3000rpm for 20 minutes, take the supernatant and filter, and then ultrafilter the filtrate with an ultrafilter with a molecular weight cut-off of 10,000 Daltons, and aseptically collect the permeate, which is the thymosin solution.

[0029] According to the national drug standard WS of thymosin solution 1 -XG-042-2000-2003 detection, the content is 5.9mg / ml, thymosin α 1 Acco...

Embodiment 2

[0031] Get 100Kg of quick-frozen calf thymus and put it in a special water tank to thaw, remove the fat and outer membrane, and get a net weight of 80Kg. The extracted thymus was first washed 3 times with drinking water, and then 3 times with water for injection. After mincing with a meat grinder, add 60L of cold water for injection, and homogenize with a colloid mill for 2 minutes. The homogenate was frozen at -30°C for 24 hours, taken out in a 25°C water bath the next day and thawed, and repeated 3 times. After the third thaw, it was rapidly heated to 80°C and kept for 10 minutes, and then rapidly cooled to room temperature. Centrifuge at 3000rpm for 20 minutes, take the supernatant and filter, and then ultrafilter the filtrate with an ultrafilter with a molecular weight cut-off of 10,000 Daltons, and aseptically collect the permeate, which is the thymosin solution.

[0032] According to the national drug standard WS of thymosin solution 1 -XG-042-2000-2003 detection, the ...

Embodiment 3

[0034] Get 100Kg of quick-frozen calf thymus and put it in a special water tank to thaw, remove the fat and outer membrane, and get a net weight of 83Kg. The extracted thymus was first washed 3 times with drinking water, and then 3 times with water for injection. After mincing with a meat grinder, add 40L of cold water for injection, and homogenize with a colloid mill for 2 minutes. The homogenate was frozen at -30°C for 24 hours, taken out in a 30°C water bath the next day and thawed, and repeated 5 times. After the fifth thaw, it was rapidly heated to 85°C for 5 minutes, and then quickly cooled to room temperature. Centrifuge at 3000rpm for 20 minutes, take the supernatant and filter, and then ultrafilter the filtrate with an ultrafilter with a molecular weight cut-off of 10,000 Daltons, and aseptically collect the permeate, which is the thymosin solution.

[0035] According to the national drug standard WS of thymosin solution 1 -XG-042-2000-2003 detection, the content is...

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Abstract

A process for preparing the high-concentration thymopeptide solution features use of physical freezing technology to concentrate the low-concentration one for making the content of thymopeptide reach more than 50 mg / ml. A large-dosage (50 mg and 100 mg) thymopeptide injection prepared from it is also disclosed.

Description

technical field [0001] The invention relates to a preparation method of thymosin, more specifically, to a preparation method of a high-concentration thymosin solution. [0002] The present invention also relates to a large scale thymosin preparation prepared by the method of the present invention. Background technique [0003] Thymosin is an immunomodulatory drug. It has the function of regulating and enhancing the immune function of human cells, and can promote the maturation of T-lymphocytes. It is mainly used for the treatment of various primary or secondary T cell deficiency diseases, certain autoimmune diseases, various diseases with low cellular immune function and adjuvant treatment of tumors. Including: 1. Various types of severe hepatitis, chronic activity 2. Herpes zoster, genital herpes, condyloma acuminatum, etc.; 3. Bronchitis, bronchial asthma, tuberculosis, prevention of upper respiratory tract infection, etc.; 4. Early stages of various malignant tumors and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/17A61K9/19A61P37/02A61P1/16A61P31/12A61P11/00A61P31/18A61P35/00A61P29/00A61P19/00
Inventor 马骉王天燕
Owner BEIJING SAISHENG PHARMA
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