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Preservative-free oxytocin composition as well as preparation method and application thereof

A technology of oxytocin and composition, applied in the field of oxytocin composition and its preparation, to achieve the effects of avoiding aggregation, enhancing interaction and stable properties

Pending Publication Date: 2022-07-22
CHENGDU SINTANOVO BIOTECHNOLOGV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, almost all oxytocin drugs on the domestic and foreign markets are injections, and clinical adverse reactions caused by preservatives frequently occur

Method used

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  • Preservative-free oxytocin composition as well as preparation method and application thereof
  • Preservative-free oxytocin composition as well as preparation method and application thereof
  • Preservative-free oxytocin composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Injection containing oxytocin pharmaceutical composition (batch number 210501, batch of 70,000 pieces).

[0035] Described pharmaceutical composition, according to potency conversion, contains oxytocin 583mg (equivalent to 350000 units), monohydrate citric acid 192.7g, dihydrate trisodium citrate 142.1g, sodium chloride 630g, water for injection is added to 70kg, pH The value regulator is 1 mol / L citric acid / trisodium citrate solution, and the pH is adjusted to 3.5-4.5.

[0036] Preparation:

[0037] (1) Put the medium borosilicate glass ampoule bottle into the ultrasonic bottle washer for cleaning according to the procedure, and transfer it to the hot air circulation tunnel oven for drying and sterilization.

[0038] (2) Weighing: Weigh each raw and auxiliary material in the prescribed amount for use. Among them, the raw material drug should be pure, and the actual feeding amount = the process prescription amount / the raw material potency.

[0039] (3) Cool the water...

Embodiment 2

[0050] Injection containing oxytocin pharmaceutical composition (batch number 210502, batch of 70,000 pieces).

[0051] Described pharmaceutical composition, according to potency conversion, contains oxytocin 1166mg (equivalent to 700000 units), trihydrate sodium acetate 47.6g, sodium chloride 1260g, water for injection is added to 70kg, pH regulator is 1mol / L acetic acid or 1mol / L sodium acetate solution, adjust the pH to 3.5~4.5.

[0052] Preparation:

[0053] (1) Put the borosilicate controlled injection bottle and bromobutyl rubber stopper into the ultrasonic bottle washer for cleaning according to the procedure, and then transfer to the hot air circulation tunnel oven for drying and sterilization.

[0054] (2) Weighing: Weigh each raw and auxiliary material in the prescribed amount for use. Among them, the raw material drug should be pure, and the actual feeding amount = the process prescription amount / the raw material potency.

[0055] (3) Cool the water for injectio...

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Abstract

The invention provides a preservative-free oxytocin composition which is characterized by comprising oxytocin, buffer salt, a pH regulator and sodium chloride. The oxytocin-containing pharmaceutical composition and injection provided by the invention do not contain preservatives, have stable properties, can significantly reduce the occurrence rate of adverse reactions caused by the preservative trichlorobutanol in the product, have high safety, have important clinical significance, and are simple and feasible in preparation method and low in cost.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preservative-free oxytocin composition and a preparation method and application thereof. Background technique [0002] Oxytocin, also known as oxytocin, chemical composition is N-benzyloxycarbonyl-S-benzylcysteinyl-tyrosyl-isoleucyl-glutamyl-asparaginyl-(S-benzyl base) cysteinyl-prolyl-leucyl-glycinamide, is a uterine contraction drug, which can be extracted or chemically synthesized from the posterior pituitary gland, and is now mainly obtained by chemical synthesis. The chemically synthesized oxytocin does not contain vasopressin, has no blood pressure raising effect, and has a selective excitatory effect on uterine smooth muscle. The uterus before labor is the most sensitive to oxytocin (the secretion of estrogen increases), and the immature uterus has no effect on this product. Responsiveness: The uterus is less responsive to oxytocin in the first or second trimester of p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/095A61K9/08A61K47/02A61K47/12A61P15/04
CPCA61K38/095A61K9/08A61K9/0019A61K47/02A61K47/12A61P15/04
Inventor 邓学鹏黄波李元波袁瑜罗敏徐杰
Owner CHENGDU SINTANOVO BIOTECHNOLOGV CO LTD
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