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Medicine composition containing oxytocin

A technology of oxytocin and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of increased impurities and easy degradation, and achieve the effects of reducing impurities, simple preparation method, and simple operation

Inactive Publication Date: 2014-06-04
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the structure of oxytocin contains disulfide bonds and other amide bonds, it is prone to degradation during storage, and the impurities are greatly increased, which has a great risk in clinical use.

Method used

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  • Medicine composition containing oxytocin
  • Medicine composition containing oxytocin
  • Medicine composition containing oxytocin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Embodiment 1: the influence of pH value on the stability of oxytocin solution

[0056] Buffer solutions with pH values ​​of 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, and 9.0 were prepared respectively, and oxytocin solutions of the same concentration were prepared using the buffer solutions, and the stability of the solutions at 60°C was investigated. The results are shown in Table 1 .

[0057] Table 1 Stability data of oxytocin solution under different pH conditions (60°C)

[0058]

[0059] From the results in Table 1, it was found that when the pH value increased from 4.0 to 6.0, the related substances did not change significantly, and when the pH value increased from 6.0 to 7.0, the related substances gradually increased, and when the pH value increased from 7.0 to 9.0, the related substances increased sharply. When the pH value decreased from 4.0 to 3.0, the related substances also increased sharply, indicating that oxytocin had better stability in the range of pH 4.0 to 7....

Embodiment 2

[0060] Embodiment 2: the pharmaceutical preparation containing oxytocin according to the present invention

[0061] formula:

[0062]

[0063]

[0064] Preparation Process:

[0065] Weigh citric acid and sodium citrate according to the prescription, prepare a buffer solution with a certain pH, and set aside. The buffer solution is added with prescribed amount of mannitol, dissolved, mixed evenly, and prepared as auxiliary material liquid. The excipient liquid is ultrafiltered with an ultrafilter to remove heat source. Dissolve oxytocin and add it to the ultrafiltrate of the excipient that has been ultrafiltered and make to volume. Sterile filtration, sub-packaging, and filling with inert gas protection to make injection solution.

Embodiment 3

[0066] Embodiment 3: the pharmaceutical preparation containing oxytocin according to the present invention

[0067] formula:

[0068]

[0069] Preparation Process:

[0070] Weigh the raw and auxiliary materials according to the prescription quantity, and set aside. Dissolve the tartaric acid and mannitol of the prescribed amount, and carry out ultrafiltration to remove pyrogens with an ultrafilter instrument. The oxytocin is dissolved and added to the ultrafiltrate of the ultrafiltered excipient, and water for injection is added to constant volume. Sterile filtration, sub-packaging, freeze-drying by freeze-drying process and filling with inert gas protection to make freeze-dried powder injection.

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PUM

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Abstract

The invention belongs to the field of medicine preparations, and discloses a medicine composition containing oxytocin and a preparation method of the medicine composition. The medicine composition containing the oxytocin comprises oxytocin, a pH adjusting agent with the pH value of 4.0-7.0, an isoosmotic adjusting agent and water. The medicine composition containing the oxytocin is good in stability, the oxytocin is unlikely to have degradation phenomenon in the storage process, impurities caused by oxytocin degradation are greatly reduced, and the security in clinical application of the oxytocin can be effectively improved. The medicine composition containing the oxytocin, which is disclosed by the invention, is simple in operation of a preparation method and applicable to scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable pharmaceutical composition containing oxytocin, a pharmaceutical preparation and a preparation method thereof. Background technique [0002] Oxytocin, also known as oxytocin, is a mammalian hormone that was discovered in 1895. It is mainly secreted by the neurosecretory large cell system of the supraoptic nucleus and paraventricular nucleus of the hypothalamus. It is released from the posterior lobe of the pituitary into Blood, along the blood circulation to reach distant organs to function. [0003] Oxytocin is a biologically active polypeptide product consisting of 9 amino acid residues and having a disulfide bond. The N-terminus and C-terminus of the oxytocin polypeptide are cysteine ​​and glycine respectively, and the seven amino acids in between are connected by peptide bonds to form a primary structure. On this basis, due to the formation of ...

Claims

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Application Information

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IPC IPC(8): A61K38/11A61K47/12A61K47/04A61P15/04A61K38/095
Inventor 陶安进郑春莲马亚平袁建成
Owner HYBIO PHARMA
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