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Preparation method of oxytotin injection

A technology of oxytocin and injection, which is applied in the field of preparation of oxytocin injection, can solve the problems of difficult impurity removal and high impurity content in the production process of oxytocin injection, and achieve remarkable economic benefits, high impurity removal rate, The effect of improving the efficiency and quality of impurity removal

Inactive Publication Date: 2018-12-18
CHENGDU HAITONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to: aim at the above-mentioned existing oxytocin injection production process difficult impurity removal problem, the impurity content is high, the present invention provides a kind of preparation method of oxytocin injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A preparation method of oxytocin injection, comprising the following steps:

[0030] (1) Add hot water for injection into the preparation device 1, then add oxytocin solution, stir evenly, and cool to 30°C;

[0031] (2) Add water for injection at 80°C-85°C into the compounder 2, then add chlorobutanol, and stir evenly;

[0032] (3) transfer the solution in the preparation device 2 to the preparation device 1 after cooling, stir evenly, and use hydrochloric acid to adjust the pH value to 3.4;

[0033] (4) Add water for injection to constant volume, then carry out sterilizing filtration through two stages of 0.22um filter membranes, and measure the impurity content to be 32wt%;

[0034] (5) Refrigerate at 3°C ​​for 20 hours;

[0035] (6) Sterilizing and filtering through two-stage 0.22um filter membranes, the measured impurity content is 14wt%, and the impurity removal rate is 56.25%;

[0036] (7) Potting.

Embodiment 2

[0038] A preparation method of oxytocin injection, comprising the following steps:

[0039] (1) Add hot water for injection into the preparation device 1, then add oxytocin solution, stir evenly, and cool to 30°C;

[0040] (2) Add water for injection at 80°C-85°C into the compounder 2, then add chlorobutanol, and stir evenly;

[0041] (3) transfer the solution in the preparation device 2 to the preparation device 1 after cooling, stir evenly, and use hydrochloric acid to adjust the pH value to 3.5;

[0042] (4) Add water for injection to constant volume, then carry out sterilizing filtration through two stages of 0.22um filter membranes, and determine that the impurity content is 30wt%;

[0043] (5) Refrigerate at 2°C for 24 hours;

[0044] (6) Sterilizing and filtering through two-stage 0.22um filter membranes, the measured impurity content is 15wt%, and the impurity removal rate is 50%;

[0045] (7) Potting.

Embodiment 3

[0047] A preparation method of oxytocin injection, comprising the following steps:

[0048] (1) Add hot water for injection into the preparation device 1, then add oxytocin solution and ascorbic acid, stir evenly, and cool to 30°C; the mass ratio of ascorbic acid to oxytocin solution is 12:1;

[0049] (2) Add water for injection at 80°C-85°C into the compounder 2, then add chlorobutanol, and stir evenly;

[0050] (3) Transfer the solution in the preparation device 2 to the preparation device 1 after cooling, stir evenly, and adjust the pH value to 3.6 with hydrochloric acid;

[0051] (4) Add water for injection to constant volume, then carry out sterilizing filtration through two stages of 0.22um filter membranes, and measure the impurity content to be 29wt%;

[0052] (5) Refrigerate at 5°C for 18 hours;

[0053] (6) Sterilizing and filtering through two-stage 0.22um filter membranes, the measured impurity content is 10wt%, and the impurity removal rate is 65.52%;

[0054] ...

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Abstract

The invention discloses a preparation method of oxytotin injection. The preparation method comprises the following steps: (1) adding hot water for injection into a preparation device 1; then adding anoxytotin solution and uniformly stirring and cooling; (2) adding the hot water for injection into a preparation device 2; then adding a preservative and uniformly stirring; (3) after cooling a solution in the preparation device 2, transferring the solution into the preparation device 1; uniformly stirring and regulating the pH (Potential of Hydrogen) value to be 3.4 to 3.6; (4) adding water for injection and making the volume constant; then removing bacteria and filtering; (5) refrigerating at 2 to 5 DEG C for 16 to 24h; (6) removing bacteria and filtering; (7) filling. According to a new discovery that small molecular active peptide can be precipitated and separated out in a refrigerating process and oxytotin is not precipitated, a refrigerating and impurity removal step is increased inan existing production technology of the oxytotin injection; meanwhile, the corresponding pH, temperature and time are controlled, and the content of impurities in the oxytotin injection can be reduced; the impurity removal rate is 50 to 70 percent.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a preparation method of oxytocin injection. Background technique [0002] Oxytocin, also known as oxytocin, is a peptide hormone secreted by the posterior pituitary gland. It consists of 9 amino acids, and the methionine residues at the "1" and "6" positions are formed in the form of disulfide bonds. A 9-peptide ring structure. Oxytocin is one of the main components of pituitary hormone in mammals and humans, and it is also a commonly used gynecological drug. It is mainly used clinically for induction of labor, postpartum hemorrhage, poor uterine reduction, and promotion of milk discharge. The production of oxytocin was mainly carried out through the tissue extraction of pig and bovine pituitary glands in the past. At present, with the development of polypeptide chemical synthesis methods, it is mainly carried out through chemical synthesis methods. For chemical syn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/11A61K9/08A61K47/22A61P15/04A61P7/04A61K38/095
CPCA61K9/0019A61K9/08A61K47/22A61P7/04A61P15/04
Inventor 史凌洋任军谢雷
Owner CHENGDU HAITONG PHARMA
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