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Oxytocin injection and preparation method thereof

A technology for injection and oxytocin is applied in the field of oxytocin injection and its preparation, and achieves the effects of strong curative effect, easy storage and stable quality

Inactive Publication Date: 2020-05-22
厦门紫旭医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there have been clinical applications of combining oxytocin injection and calcium gluconate, they have not been prepared into a compound injection

Method used

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  • Oxytocin injection and preparation method thereof
  • Oxytocin injection and preparation method thereof
  • Oxytocin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Oxytocin injection contains the following ingredients:

[0031] Each 10000ml injection contains:

[0032] Oxytocin solution 100000 units

[0033] Glycinate solution 100000 units

[0034] Calcium Gluconate 10 units

[0035] Add water for injection to 10000ml

[0036] The preparation process of the oxytocin injection comprises the following steps:

[0037] Dissolve the oxytocin solution of the above prescribed amount in water for injection with a total volume of 80%, stir for 15 minutes, slowly add the prescribed amount of glycinate solution, continue stirring for 15 minutes, add the prescribed amount of calcium gluconate, mix well, Use glacial acetic acid to adjust the pH to 3.5, add water for injection to the full amount, and then filter through a sterilizing filter. After the semi-finished product passes the inspection, perform aseptic potting on the obtained solution according to the potting operation procedure, and filter and sterilize the obtained product .

Embodiment 2

[0039] Oxytocin injection contains the following ingredients:

[0040] Each 10000ml injection contains:

[0041] Oxytocin solution 500000 units

[0042] Glycinate solution 500000 units

[0043] Calcium Gluconate 5 units

[0044] Add water for injection to 10000ml

[0045] The preparation process of the oxytocin injection comprises the following steps:

[0046] Dissolve the oxytocin solution of the above prescribed amount in water for injection with a total volume of 80%, stir for 15 minutes, slowly add the prescribed amount of glycinate solution, continue stirring for 15 minutes, add the prescribed amount of calcium gluconate, mix well, Use hydrochloric acid to adjust the pH to 4.2, add water for injection to the full amount, and then filter through a sterilizing filter. After the semi-finished product passes the inspection, the obtained solution is aseptically potted according to the potting operation procedure.

Embodiment 3

[0048] Oxytocin injection contains the following ingredients:

[0049] Each 10000ml injection contains:

[0050] Oxytocin solution 800000 units

[0051] Glycinate solution 800000 units

[0052] Calcium Gluconate 8 units

[0053] Add water for injection to 10000ml

[0054] The preparation process of the oxytocin injection comprises the following steps:

[0055] Dissolve the oxytocin solution of the above prescribed amount in water for injection with a total volume of 80%, stir for 15 minutes, slowly add the prescribed amount of glycinate solution, continue stirring for 15 minutes, add the prescribed amount of calcium gluconate, mix well, Use hydrochloric acid to adjust the pH to 4.2, add water for injection to the full amount, and then filter through a sterilizing filter. After the semi-finished product passes the inspection, the obtained solution is aseptically potted according to the potting operation procedure.

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Abstract

The invention belongs to the technical field of medicinal preparations, and relates to an improved medicine preparation formulation of oxytocin, in particular to an oxytocin injection and a preparation method thereof. The oxytocin injection disclosed by the invention is stable in quality and is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an improved pharmaceutical dosage form of oxytocin, more specifically to an oxytocin injection and a preparation method thereof. Background technique [0002] Oxytocin, also known as oxytocin, is a biologically active polypeptide amino acid product composed of 9 amino acid residues. Oxytocin injection is a polypeptide hormone uterotonic drug, which stimulates the contraction of uterine smooth muscle and simulates the uterine contraction of normal childbirth, resulting in cervical dilatation. The uterine response to oxytocin gradually increases during pregnancy and reaches its peak at full term. . The indications for oxytocin injection are: it is used for uterine bleeding caused by uterine atony, etc. after labor induction, oxytocin, postpartum and post-abortion. Since oxytocin is a special polypeptide structure, it is sensitive to oxygen and variable under hig...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K38/095A61K31/191A61P15/00A61P7/04
CPCA61K9/0019A61K9/08A61K31/191A61K38/08A61K47/183A61P7/04A61P15/00A61K2300/00
Inventor 耿聪聪张慧张春晓赵海峰赵卿霍立茹李战
Owner 厦门紫旭医药科技有限公司