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Stabilizing medicinal agent containing ciliary nerve nutritive factor analogue

A technology for ciliary nerve nutrition and stabilization of pharmaceuticals, which is applied to medical preparations containing active ingredients, nervous system diseases, and medical preparations with non-active ingredients, etc. It can solve the problems of stability comparison and achieve the effect of convenient transportation

Inactive Publication Date: 2004-07-21
HANGZHOU JIUYUAN GENE ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, as a protein drug, its stability still cannot be compared with conventional chemical drugs (Panayotatos; Nikos, 1998, US 5846935)

Method used

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  • Stabilizing medicinal agent containing ciliary nerve nutritive factor analogue
  • Stabilizing medicinal agent containing ciliary nerve nutritive factor analogue

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] The various stabilizers listed in Table 1 are added to 0.2 mg / ml ciliary neurotrophic factor analogue (its amino acid composition is the same as sequence 1 in the accompanying drawing), containing 10mM pH7.0 phosphate buffer saline in the mixture, without After bacterial filtration, 0.5 ml / cartridge is sealed in a glass vial. Observe its changes under different conditions. Measured by method (A), the results are shown in Table 1. Wherein "activity (%)" represents the remaining ciliary neurotrophic factor analogue activity amount compared with the initial one.

[0070] stabilizer

Embodiment 2

[0072] Several stabilizing agents listed in table 2 are added to 0.2 mg / ml ciliary neurotrophic factor analog (its amino acid composition is the same as sequence 2 in the accompanying drawing), the mixture contains the inorganic salt buffer solution of 10mM different pH, without After bacterial filtration, it is sealed in a bottle at a rate of 0.5 ml / cartridge. Observe its changes under different conditions. Measured by method (B), the results are shown in Table 2.

[0073] stabilizer

Embodiment 3

[0075] The various stabilizers listed in Table 3 are added to 0.2 mg / ml ciliary neurotrophic factor analog (its amino acid composition is the same as sequence 1 in the accompanying drawing), and the mixture contains pH7.0 in 20mM phosphate buffer , after sterile filtration, it is divided into glass vials at 0.5 ml / branch. Then lyophilize according to the following procedure: freeze at -35°C or below -35°C for 4 hours, then perform the first drying for 10 hours, heat from -35°C to -5°C, increase the pressure from 0.015 Torr to 0.2 Torr, and then For the second drying, the temperature is heated from -5°C to 30°C, the pressure is reduced from 0.2 torr to 0.05 torr, and then sterilized dry nitrogen is filled into the inside of the vial to make it reach an atmospheric pressure, and the vial is placed under aseptic conditions. Stoppered and finally sealed with an aluminum cap. Observe its changes under different conditions. Measured by method (B), the results are shown in Table 3....

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Abstract

A high-stability medicine in the form of injection contains the ciliary neurotrophic factor (CNTF) and the substance chosen from medicinal surfactant, protein stabilizer and inorganic salt. Its advantages are high stability and long storage time.

Description

technical field [0001] The present invention relates to a stable medicine containing ciliary neurotrophic factor analogs. More specifically, the present invention relates to a stable preparation containing ciliary neurotrophic factor analogs, suitable for subcutaneous or intravenous administration, for the treatment of neurological diseases or obesity and related diseases. Background technique [0002] CNTF was first discovered in vitro to promote the survival of ciliary ganglion in chick embryos (Manthorpe et al., 1980, J.Neurochem.34:69-75). In the following decades, many more Related biological functions were discovered. Hughes et al. found that it can promote the differentiation of glial progenitor cells in the visual and cranial nerves of perinatal mice (Hughes et al., 1988, Nature 335:70-73), and also found that it can promote the differentiation of dorsal root ganglia in chick embryos. Growth (Skaper and Varon, 1986, Brain Res. 389:39-46). ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K38/18A61K47/14A61K47/34A61K47/36A61K47/42A61P3/04A61P25/00
Inventor 黄岩山裘霁宛邹晔林斌
Owner HANGZHOU JIUYUAN GENE ENG
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