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Immunomodulator thymopentin powder injection pharmaceutical composition and quality control method

A technology of composition and acid-base regulator, which is applied in the field of medicine and can solve problems such as unqualified clarity and color of solutions

Active Publication Date: 2017-08-11
北京元延医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(2) Secondary immunodeficiency: 50 mg once, 3 times a week, for 3 to 6 consecutive weeks
[0020] However, when the inventors developed 1mg and 10mg thymopentin powder for injection, the solution before freeze-drying was 1ml; even if the 1mg specification was subjected to long-term storage tests, it was carried out according to the "Chinese Pharmacopoeia". The clarity and color of the solution meet the requirements, but the prepared 10mg specifications show that the clarity and color of the solution are gradually becoming unqualified during long-term storage.

Method used

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  • Immunomodulator thymopentin powder injection pharmaceutical composition and quality control method
  • Immunomodulator thymopentin powder injection pharmaceutical composition and quality control method
  • Immunomodulator thymopentin powder injection pharmaceutical composition and quality control method

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0119] Preparation example 1. Preparation of powder injection composition containing thymopentin

[0120] formula:

[0121] Thymopentin 1mg, Mannitol 50mg, pH regulator If necessary, adjust to pH7.0, Water for Injection A proper amount is added to the total weight of the material to be 1.0g.

[0122] Preparation:

[0123] (a) Weigh the prescribed amount of thymopentin and dissolve it in 0.1ml of water for injection;

[0124] (b) Add 0.1% (w / v) activated carbon according to the volume of the solution under the temperature of 30℃, stir evenly, add an appropriate amount of acid-base regulator to make the pH of the solution 9.0, stir for 15 minutes to absorb, and then drop Add an appropriate amount of acid-base regulator to make the pH of the solution 7.0, stir for 10 minutes to absorb, and then filter with a 1μm titanium rod to remove carbon;

[0125] (c) Weigh mannitol and dissolve it in 0.45ml of water for injection, add 0.1% (w / v) activated carbon according to the volume of the...

preparation example 2

[0129] Preparation example 2. Preparation of powder injection composition containing thymopentin

[0130] formula:

[0131]

[0132]

[0133] Preparation:

[0134] (a) Weigh the prescribed amount of thymopentin and dissolve it in 0.12ml of water for injection;

[0135] (b) Add 0.08% (w / v) activated carbon according to the volume of the solution under the temperature of 30℃, stir evenly, add an appropriate amount of acid-base regulator to make the pH of the solution 9.3, stir for 15 minutes to absorb, then drop Add an acid-base regulator (glacial acetic acid is used in this preparation example) to make the pH of the solution 7.3, stir for 10 minutes, and then filter and decarbonize with a 1μm titanium rod;

[0136] (c) Weigh 100 mg of mannitol and dissolve it in 0.5 ml of water for injection, add 0.15% (w / v) activated carbon according to the volume of the solution under the condition of holding at 50 to 60°C, stir well, and keep holding for 15 minutes. Then filter and remove the carbo...

preparation example 3

[0140] Preparation Example 3. Preparation of powder injection composition containing thymopentin

[0141] formula:

[0142] Thymopentin 1mg, Mannitol 20mg, pH regulator If necessary, adjust to pH6.5, Water for Injection A proper amount is added to the total weight of the material to be 0.8g.

[0143] Preparation:

[0144] (a) Weigh the prescribed amount of thymopentin and dissolve it in 0.08ml of water for injection;

[0145] (b) Add 0.15% (w / v) activated carbon according to the volume of the solution under the temperature of 30℃, stir evenly, add an appropriate amount of acid-base regulator to make the pH of the solution 9.5, stir for 15 minutes to absorb, and then drip Add an appropriate amount of acid-base regulator to make the pH of the solution 6.7, stir for 10 minutes to adsorb, and then filter with a 1μm titanium rod to remove carbon;

[0146] (c) Weigh 20mg of mannitol, dissolve it in 0.4ml of water for injection, add 0.08% (w / v) activated carbon according to the volume...

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Abstract

The invention relates to an immunomodulator thymopentin powder injection pharmaceutical composition and a quality control method. The immunomodulator thymopentin powder injection pharmaceutical composition comprises thymopentin, mannitol and an optional acid or alkali modulator, wherein the mannitol is 20-100 parts by weight on the basis of each 100 parts by weight of thymopentin. The thymopentin pharmaceutical composition can be used for treating chronic viral hepatitis, such as chronic hepatitis B and can be used for treating various primary or secondary T cell defects such as congenital immunodeficiency in children. In addition, the immunomodulator thymopentin powder injection pharmaceutical composition can be used for treating a few of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus, can be used for treating various diseases caused by a low cellular immune function, and can also be used for tumor treatment, especially adjuvant treatment of tumors. The immunomodulator thymopentin powder injection pharmaceutical composition has an excellent technical effect.

Description

Technical field [0001] The present invention belongs to the technical field of medicine, and relates to a pharmaceutical composition of an immunomodulator, in particular to a pharmaceutical composition of an immunomodulator such as thymopentin, such as its freeze-dried powder injection. The 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 defects such as childhood congenital immunodeficiency; in addition, the present invention The immunomodulator thymopentin powder injection pharmaceutical composition can also be used to treat certain autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus, to treat various diseases with low cellular immune function, and to treat tumors. It is used for adjuvant treatment of tumors. The immunomodulator thymopentin powder injection drug combination of the present in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/08A61K47/26A61K47/12A61K47/02A61P37/02A61P19/02A61P29/00A61P31/20A61P1/16A61P35/00G01N21/78
CPCA61K38/08A61K47/02A61K47/12A61K47/26G01N21/78A61K9/0019A61K9/19
Inventor 王立强李明
Owner 北京元延医药科技股份有限公司
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