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Injection packaging preparation of thymosin pha1 microspheres

A thymosin, subpackaging technology, applied in the direction of peptide/protein components, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., to achieve the effect of ensuring accuracy and effectiveness

Active Publication Date: 2010-07-07
CHENGDU DIAO JIUHONG PHARMA FAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] There is no report about the injection solution of thymosin α1 microspheres in the existing literature

Method used

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  • Injection packaging preparation of thymosin pha1 microspheres
  • Injection packaging preparation of thymosin pha1 microspheres
  • Injection packaging preparation of thymosin pha1 microspheres

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation of Thymosin α1 Microsphere Injection Packing Preparation

[0033] (1) Preparation of special injection solvent

[0034] (1) Prescription

[0035] CMC-Na (molecular weight 300-800) 5g

[0036] Mannitol 25g

[0037] Add water for injection to 1000ml

[0038] (2) Accurately weigh each auxiliary material according to the prescription quantity;

[0039] (3) Take the required mannitol in a suitable container between the ingredients under 100-level laminar flow, add about 900ml of sterilized water for injection to dissolve, stir, and mix evenly, and measure the required carboxymethyl alcohol according to the amount of feed Sodium cellulose, slowly add to the container while stirring, continue to stir until the solution is clear, add water for injection to 1000ml.

[0040] (4) Filter the prepared medicinal solution and wait for subpackaging.

[0041] (5) Before subpackaging, use sterile water for injection to adjust the dosage according to 5.0ml per vi...

Embodiment 2

[0046] Example 2 Preparation of Thymosin α1 Microsphere Injection Packing Preparation

[0047] (1) Preparation of special injection solvent

[0048] (1) Prescription

[0049] CMC-Na (molecular weight 800-1200) 2.5g

[0050] Mannitol 25g

[0051] Add water for injection to 1000ml

[0052] (2) Accurately weigh each auxiliary material according to the prescription quantity;

[0053] (3) Take the required mannitol in a suitable container between the ingredients under 100-level laminar flow, add about 900ml of sterilized water for injection to dissolve, stir, and mix evenly, and measure the required carboxymethyl alcohol according to the amount of feed Sodium cellulose, slowly add to the container while stirring, continue to stir until the solution is clear, add water for injection to 1000ml.

[0054] (4) Filter the prepared medicinal solution and wait for subpackaging.

[0055] (5) Before dispensing, use sterile water for injection to adjust the dosage according to 3.0ml per...

Embodiment 3

[0060] Example 3 Preparation of Thymosin α1 Microsphere Injection Packing Preparation

[0061] (1) Preparation of special injection solvent

[0062] (1) Prescription

[0063] Carbomer 2g

[0064] Mannitol 25g

[0065] Add water for injection to 1000ml

[0066] (2) Accurately weigh each auxiliary material according to the prescription quantity;

[0067] (3) Take the required mannitol in a suitable container between the ingredients under 100-level laminar flow, add about 900ml of sterilized water for injection to dissolve, stir, and mix evenly, and measure the required carbomer according to the amount of feed , slowly add to the container while stirring, continue to stir until the solution is clear, add water for injection to 1000ml.

[0068] (4) Filter the prepared medicinal solution and wait for subpackaging.

[0069] (5) Before dispensing, use sterile water for injection to adjust the dosage according to 2.0ml per vial, stopper and cap. After capping, the aluminum cove...

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Abstract

The invention provides an injection packaging preparation of thymosin pha1 microspheres, comprising thymosin pha1 PLGA buffer microspheres and injection solvent which are separately packaged, wherein, the volume of the injection solvent is 1-500ml, and the dose of the thymosin pha1 buffer microspheres is 1-5000mg; the injection solvent is prepared by the excipients according to the following weight ratio: 0.5-50 parts of thickener, 5-200 parts of protective agent, 0-50 parts of pH regulator, 0-50 parts of iso-osmotic / isotonic regulator, 0-50 parts of solubilizer or cosolvent, 0-20 parts of antioxidant, 0-10 parts of local pain relief agent, and 0-1000 parts of water for injection. The special injection solvent provided by the invention can suspend and disperse the thymosin pha1 microspheres evenly, without reacting with the thymosin pha1 microspheres, and bonding or complexing; moreover, the nature of the microspheres or the thymosin pha1 can maintain stable, thereby ensuring accuracy and effectiveness of the treatment; additionally, the solvent per se is very stable, therefore, the invention provides a novel thymosin pha1 clinical preparation.

Description

technical field [0001] The invention relates to a thymosin α1 microsphere injection subpackage preparation, which belongs to the field of medicines. Background technique [0002] Thymosin α1 (thymosin alpha1, referred to as Tα1) is a polypeptide with immune function, which is mostly used clinically for immune enhancement or treatment of viral hepatitis. Its amino acid sequence is: [0003] A C-Ser-Asp-Alα-Alα-Vαl-Asp-Thr-Ser-Ser-Glu-Ile-Thr-Thr-Lys-Asp-Leu-lys-Glu-Lys-Lys-Glu-Vαl-Vαl-Glu -Glu-Alα-Glu-Asn_-OH [0004] Molecular formula: C 129 h 215 N 33 o 55- , molecular weight: 3108.37 [0005] Thymosin α1 (Tα1) is a polypeptide containing 29 amino acid residues with active physical and chemical properties. Due to the short half-life of the existing thymosin α1 preparations and long treatment time, frequent administration is required, which has the disadvantages of poor patient compliance and low bioavailability. The microsphere preparation encapsulates thymosin α1 i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/17A61K9/10A61K47/32A61K47/34A61K47/36A61K47/38A61K47/42A61K47/44A61P1/16A61P31/14A61P31/20A61P37/04
Inventor 叶兵黄梅鲍锐武勇
Owner CHENGDU DIAO JIUHONG PHARMA FAB
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