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A kind of highly stable Oprinone hydrochloride injection composition

A technology of agricultural injection and oprinone, which is applied in the field of medicine, can solve the problems of injection stability, high substance content, large amount of excipients, etc., and achieve low production cost, less amount of excipients, and related substances. The effect of low content

Active Publication Date: 2020-12-08
HEBEI IDEAL & HIGHTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patents CN101919814A and CN101152146A provide some prescriptions and preparation methods of Oprinone Hydrochloride Injection, but the content of related substances is relatively high, and there are certain problems in the stability of the injection
Although the content of related substances in the injection composition is low and the stability is high, the amount of excipients in its prescription is large

Method used

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  • A kind of highly stable Oprinone hydrochloride injection composition
  • A kind of highly stable Oprinone hydrochloride injection composition
  • A kind of highly stable Oprinone hydrochloride injection composition

Examples

Experimental program
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Effect test

Embodiment 1-6

[0059] prescription:

[0060] Example 1 2 3 4 5 6 Oprinone hydrochloride (g) 1 1 1 2 2 2 Sorbitol (g) 10 15 15 15 20 20 Citric acid (g) 0.5 0.8 0.8 1 1 1 Polyethylene glycol (g) 5 7 7 10 10 10 Sodium metabisulfite (g) 2 2.5 3 4 5.5 6 water for injection, added to 1L 1L 1L 1L 1L 1L production 200 sticks 200 sticks 200 sticks 200 sticks 200 sticks 200 sticks

[0061] Preparation Process:

[0062] (1) Add the prescribed amount of sorbitol, citric acid, polyethylene glycol and sodium metabisulfite to an appropriate amount of water for injection, stir to dissolve, add 0.05% activated carbon and stir evenly, let stand for 15 minutes, decarbonize, and use a 0.22μm filter membrane filter.

[0063] (2) Add the prescribed amount of oprinone hydrochloride to the solution obtained in step (1), stir evenly, add water for injection to the full amount, adjust the pH to 3.5-4.5 with an appro...

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Abstract

The invention provides a high-stability olprinone hydrochloride injection composition. Each liter of injection composition comprises 1 to 2 g of olprinone hydrochloride, 10 to 20 g of sorbitol, 0.5 to1 g of citric acid, 5 to 10 g of polyethylene glycol, 1 to 8 g of sodium pyrosulfite and water for injection. The olprinone hydrochloride injection has the advantages of low impurity content, high stability, small use amount of auxiliary materials, high medication safety, suitability for industrial mass production and the like.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a high-stability oprinone hydrochloride injection composition. Background technique [0002] Olprinone Hydrochloride (Olprinone Hydrochloride) is a drug for the treatment of acute heart failure developed by Japan ェ-ザィ Co., Ltd., and its chemical name is 1,2-dihydro-5-imidazo[1,2-a]pyridine-6 -yl-6-methyl-2-oxo-3-pyridinecarbocyanide hydrochloride monohydrate, molecular formula C 14 H 10 N 4 O·HCl·H 2 O. [0003] Chinese patents CN101919814A and CN101152146A provide some prescriptions and preparation methods of Oprinone Hydrochloride Injection, but the content of related substances is relatively high, and there are certain problems in the stability of the injection. [0004] Chinese patent CN201410261301.X provides an injection composition of oxyprinone hydrochloride. Each liter of the injection composition includes 1 g of oxyprinone hydrochloride, 30-60 g of sorbitol, 0.5-1....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/444A61K47/02A61P9/04
CPCA61K9/0019A61K9/08A61K31/444A61K47/02A61P9/04
Inventor 孙建强寻冰玉李岚杨远樊晓燕权颖田读文房振华王月梁擘何雪辉
Owner HEBEI IDEAL & HIGHTECH PHARMA
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