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Polygeline dextran composition

A technology of polygelatin peptide and plasma replacement, which is applied in the field of medicine, can solve problems such as potential safety hazards, and achieve the effects of high safety, accurate electrolyte control, and reliable product quality

Active Publication Date: 2013-08-07
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The polygelatin peptide preparation technology disclosed by the patent application number CN201010271416.9 requires higher temperature and uses the organic solvent acetone, and acetone has strong toxicity. Although this technology has a step of removing acetone, there will still be big security risk

Method used

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  • Polygeline dextran composition
  • Polygeline dextran composition
  • Polygeline dextran composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1. Dissolve 190g of commercially available bovine bone gelatin (32g in terms of nitrogen content) with 2250ml of water for injection at 60°C, adjust the pH value to 5.0 with hydrochloric acid solution or sodium hydroxide, place the gelatin solution at a power of 0.8KW, and a frequency of Under the ultrasonic field of 40KHz, the temperature was raised to 78°C, and the temperature was maintained. When the relative viscosity reached 1.65, the ultrasonic was stopped, cooled to 25°C, and the gelatin degradation solution was obtained;

[0030] 2. Use sodium hydroxide to adjust the pH of the degradation solution to 7.6, add 2g of glutaraldehyde at 25°C, stir continuously, crosslink for 1 hour, adjust the pH to 9.5 with sodium hydroxide, and add 2g of glutaraldehyde at 32°C Add 1.8g of trimethylolpropane, stir continuously, and cross-link for 1.5 hours; adjust the pH value to 11.0 with sodium hydroxide, and stir continuously at 29°C, and cross-link for 0.8 hours;

[0031] 3. Ad...

Embodiment 2

[0034] 1. Dissolve 205g of commercially available bovine bone gelatin (32g in terms of nitrogen content) in 2250ml of water for injection at 70°C, adjust the pH value to 6.0 with hydrochloric acid solution or sodium hydroxide, place the gelatin solution at a power of 0.8KW, and a frequency of Under the ultrasonic field of 40KHz, the temperature was raised to 75°C, and the temperature was maintained until the relative viscosity reached 1.80, the ultrasonic was stopped, cooled to 25°C, and the gelatin degradation solution was obtained;

[0035] 2. Use sodium hydroxide to adjust the pH of the degradation solution to 8.6, add 2.2g of glutaraldehyde at 30°C, stir continuously, crosslink for 1 hour, adjust the pH to 10.5 with sodium hydroxide, and add 2.2g of glutaraldehyde at 37°C Add 2.1 g of trimethylolpropane, stir continuously, and cross-link for 1 hour; adjust the pH value to 11.5 with sodium hydroxide, and stir continuously at 34°C, and cross-link for 1 hour;

[0036] 3. Add ...

Embodiment 3

[0039] 1. Dissolve 210g of commercially available pork bone gelatin (32g in terms of nitrogen content) in 2250ml of water for injection at 62°C, adjust the pH value to 5.8 with hydrochloric acid solution or sodium hydroxide, place the gelatin solution at a power of 0.8KW, and a frequency of Under the ultrasonic field of 40KHz, the temperature was raised to 80°C, and the temperature was maintained, and when the relative viscosity reached 1.75, the ultrasonic was stopped, cooled to 26°C, and the gelatin degradation solution was obtained;

[0040] 2. Use sodium hydroxide to adjust the pH of the degradation solution to 8.4, add 2.3g of glutaraldehyde at 28°C, stir continuously, crosslink for 1 hour, adjust the pH to 10.0 with sodium hydroxide, and add 2.3g of glutaraldehyde at 37°C 2.2 g of trimethylolpropane was added under constant stirring, and cross-linked for 1 hour; the pH value was adjusted to 11.2 with sodium hydroxide, and at 32° C., stirred continuously, and cross-linked ...

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Abstract

The invention relates to a polygeline dextran composition which is extracted from beef bone or pig bone gelatin, contains substances such as polypeptide and amino acid and is used for injection. The composition is prepared from 32g of gelatin, 36-39g of sodium chloride, 0.9-1.3g of potassium chloride, 0.2-0.6g of calcium chloride and 5000ml of water for injection. The preparation method comprises the following steps of: 1, ultrasonic degradation of gelatin; 2, crosslinking; 3, electrolyte adjustment; and 4, filtering, encapsulating, sterilizing and packaging. According to the polygeline dextran composition, high-temperature degradation is not required, so that the phenomena that the crosslinking difficulty and the potential risk are increased caused by the factor that a great amount of micromolecule substances such as amino acid and small molecule peptide as well as unknown substances are generated as a result of intense high-temperature degradation reaction condition are avoided; the crosslinking quality controllability is high; no organic solvent is added; the safety is high; the electrolyte control is accurate and meets the national standard requirement; and the quality of products is reliable. A test proves that the injection of the polygeline dextran composition prepared by the invention meets the national standard requirement.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a polygelatin peptide substitute plasma composition for injection containing polypeptide, amino acid and other substances extracted from bovine bone or pig bone gelatin. Background technique [0002] Gelatin peptide is used for patients with hemorrhagic shock caused by trauma; patients with fluid loss shock caused by severe burns, sepsis, pancreatitis, etc. This product can also be used to prevent hypotension that may occur before major operations, as well as for extracorporeal circulation and volume supplementation during hemodialysis, and has become a common substitute for plasma. At present, there are some deficiencies in the production technology of this product. For example, the Chinese patent application number CN02115961.0 discloses a preparation process of polygelatin injection. It is prepared from bovine bone, pork bone or other gelatin through sol, thermal degradation, ...

Claims

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Application Information

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IPC IPC(8): A61P7/08A61K38/17A61K9/08
Inventor 李美林胡成忠
Owner 湖北美林药业有限公司
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