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PLGA and ethyl alcohol compound used for biological polypeptide preparation

A technology of complex and ethanol, applied in the field of complex of PLGA and ethanol, can solve problems such as easy loss and reduced activity

Active Publication Date: 2014-03-12
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a complex of PLGA and ethanol used in biological polypeptide preparations, which can solve the problem that biological polypeptide drugs are easily lost or reduced in activity when heated by hot-melt extrusion

Method used

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  • PLGA and ethyl alcohol compound used for biological polypeptide preparation
  • PLGA and ethyl alcohol compound used for biological polypeptide preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] PLGA has the following characteristics: the intrinsic viscosity measured in chloroform at 25°C is 0.10dl / g, the molar ratio of lactide and glycolide is 50 / 50, and the PLGA is dried and evaporated in a vacuum drying oven at 40°C to Moisture is less than 0.5%, reserve;

[0043] Absolute ethanol and acetone, treated with a good molecular sieve, mixed according to the ratio, set aside;

[0044] Take PLGA dissolved in a mixed solvent of 10 times of acetone and ethanol (9:1), heat to 56 degrees Celsius and stir, evaporate the acetone, and pulverize at low temperature (-20 degrees Celsius) to obtain a compound of PLGA and ethanol;

Embodiment 2

[0046] PLGA has the following characteristics: the intrinsic viscosity measured in chloroform at 25°C is 0.50dl / g, and the molar ratio of lactide and glycolide is 70 / 30. Moisture is less than 0.5%, reserve;

[0047] Absolute ethanol and acetone, treated with a good molecular sieve, mixed according to the ratio, set aside;

[0048] Take PLGA dissolved in a mixed solvent of 10 times of acetone and ethanol (8:2), heat to 56 degrees Celsius and stir, evaporate the acetone, and pulverize at low temperature (-20 degrees Celsius) to obtain a compound of PLGA and ethanol;

Embodiment 3

[0050] The complex of PLGA and ethanol obtained in Example 1-2 was uniformly mixed with recombinant human thymosin β4 (rh-Tβ4) at a total ratio of 5:1, and extruded at 40°C to obtain a column. For implantation under the skin.

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Abstract

The invention relates to a PLGA and ethyl alcohol compound used for a biological polypeptide preparation. The compound is a physical compound of PLGA and physical compound and can serve as a sustained-release material for the biological polypeptide preparation.

Description

technical field [0001] The invention relates to a complex of PLGA and ethanol, which can be used for hot-melt extrusion at a relatively low temperature, avoids the use of organic solvents, and prepares sustained-release preparations of biological polypeptides for use in the technical field of medicine. Background technique [0002] PLGA is a lactide-glycolide copolymer, and different proportions and degrees of polymerization of PLGA are formed by polymerizing lactide and glycolide in different proportions. PLGA is hydrolyzed into lactic acid in the body, and then undergoes energy metabolism through the tricarboxylic acid cycle. It has good biocompatibility, non-toxicity, good capsule-forming and film-forming properties, and is widely used in pharmaceuticals, medical engineering materials and modern industrial fields . In the United States, PLGA passed the FDA certification and was officially included in the United States Pharmacopoeia as a pharmaceutical excipient. At pres...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/34A61K47/10A61K38/22A61K38/08
Inventor 尚丽霞牟昳
Owner NKD PHARMA CO LTD