Unlock instant, AI-driven research and patent intelligence for your innovation.

Nizatidine injection

A technology for nizatidine and injection, which is applied in the field of injectable drugs, can solve problems such as hidden dangers of drug safety, instability, and influence on widespread use.

Inactive Publication Date: 2010-05-12
成都摩尔生物医药有限公司
View PDF3 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] It is not difficult to find out from the structure of formula (I), that nizatidine is a thiazole compound containing amino group, so it is extremely unstable in aqueous solution, even if it is placed at room temperature, it is easy to produce a large amount of impurities, and the safety of drug administration is limited. to hidden danger
Although nizatidine freeze-dried powder preparations have been reported, due to its relatively high cost and price, it has become an unfavorable factor affecting its widespread use

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Nizatidine injection
  • Nizatidine injection
  • Nizatidine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Get 1600ml of propylene glycol and 200ml of ethanol and mix them with 2000ml of water for injection, add 100g of nizatidine and stir to dissolve, add 0.15% (w / v) activated carbon for needles, stir evenly, keep it warm, filter to remove the activated carbon, and use 10 % hydrochloric acid to adjust the pH to 7.0-7.5, add water for injection to 4000 ml, and then sterilize and filter with 0.45um and 0.22um filter membranes respectively, and fill and seal in ampoules, each 4ml.

Embodiment 2

[0016] Dissolve 12 g of poloxamer in 800 ml of water for injection, add 800 ml of propylene glycol and 100 ml of ethanol, add 100 g of nizatidine under stirring to dissolve, add 0.2% (w / v) activated carbon for needles, stir well, and then keep it warm , filter to remove activated carbon, adjust the pH of the solution to 7.0-7.5 with 10% hydrochloric acid, add water for injection to 2000 ml, filter through a 0.45um filter membrane, fill in ampoules, 2ml each, and sterilize at 100°C for 30 minutes.

Embodiment 3

[0018] Get 1600ml of propylene glycol and 200ml of ethanol and mix them with 2000ml of water for injection, add 100g of nizatidine and stir to dissolve, add 0.15% (w / v) activated carbon for needles, stir evenly, keep it warm, filter to remove the activated carbon, and use 10 % hydrochloric acid to adjust the pH to 7.0-7.5, add water for injection to 4000 ml, filter through a 0.45um filter membrane, fill and seal in ampoules, 4ml each, and sterilize at 100°C for 30 minutes.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The nizatidine injection contains nizatidine in 10-100 mg / ml, stabilizer in 5-80 vol% and at least one of pharmaceutically acceptable solubilizer and / or cosolvent in 0-5 vol%, except solvent includingwater for injection, with the stabilizer being at least one of ethanol, propylene glycol, glycerin and other lower alcohol. Test shows that the injection has high stability and safety in production and clinical application.

Description

technical field [0001] The present invention relates to an injection-type medicine, specifically a kind of nizatidine injection, which is a kind of nizatidine injection which has H2 receptor antagonism and can be used for treating and / or preventing benign active gastric ulcer and active duodenal ulcer. Medicines for conditions such as ulcers, esophagitis (including erosive and ulcerative esophagitis), and heartburn associated with GERD. Background technique [0002] As reported in US Pat. No. 4,375,547, nizatidine having a structure represented by formula (I) may have excellent pharmaceutical activity. As a drug with H2 receptor antagonistic effect, it can be used for the treatment and / or prevention of benign active gastric ulcer, active duodenal ulcer, esophagitis (including erosive and ulcerative esophagitis) and GERD-related Diseases such as heartburn. At present, the intravenous administration of nizatidine is mainly used for emergencies such as bleeding gastric ulcer....

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/426A61K9/08A61K47/10A61K47/34A61P1/04
Inventor 张留安丰禹华丽
Owner 成都摩尔生物医药有限公司