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Esomeprazole sodium composition for injection

A technology for esomeprazole sodium and a composition, which is applied in the field of medicine and medicine manufacturing, can solve the problems of weak esophageal peristalsis and gastric motility, slow release rate of neurotransmitters, and no therapeutic effect, etc. Effects of contents reflux, enhancement of gastric motility, and improved bioavailability

Inactive Publication Date: 2013-09-18
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Studies have found that when esomeprazole treats reflux esophagitis, the release rate of neurotransmitters is slow, the peristalsis of the esophagus and gastric motility are not strong, and the treatment cycle is longer
However, melatonin alone does not have any therapeutic effect on reflux esophagitis

Method used

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  • Esomeprazole sodium composition for injection
  • Esomeprazole sodium composition for injection
  • Esomeprazole sodium composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1, the preparation of esomeprazole sodium composition freeze-dried powder for injection, in 1000

[0020] 1. Prescription

[0021]

[0022] 2. Preparation process

[0023] a) Add 1500ml of water for injection into the liquid preparation tank, add 20g of esomeprazole sodium and 0.75g of edetate disodium into the water for injection and stir to dissolve, then add 0.5g of melatonin and stir well;

[0024] b) Add 1.5g of melatonin and 7.33g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection in another solution, stir at 50°C for 6 hours, and detect that the encapsulation rate of melatonin is greater than 90%. ;

[0025] c) After mixing the solutions of groups a and b above, add NaOH solution to adjust the pH value to 11.0, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates ,...

Embodiment 2

[0027] Embodiment two, the preparation of esomeprazole sodium composition freeze-dried powder for injection, in 1000

[0028] 1. Prescription

[0029]

[0030] 2. Preparation process

[0031] a) Add 1500ml of water for injection into the liquid preparation tank, then add 20g of esomeprazole sodium and 0.83g of edetate disodium into the water for injection and stir to dissolve, then add 1g of melatonin and stir evenly;

[0032] b) Add 3g of melatonin and 14.66g of medium-substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 8 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0033] c) After mixing the solutions of groups a and b above, add NaOH solution to adjust the pH value to 11.0, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to esomepr...

Embodiment 3

[0035] Embodiment three, the preparation of esomeprazole sodium composition freeze-dried powder for injection, in 1000

[0036] 1. Prescription

[0037]

[0038] 2. Preparation process

[0039] a) Add 1500ml of water for injection into the liquid preparation tank, then add 20g of esomeprazole sodium and 0.85g of edetate disodium into the water for injection and stir to dissolve, then add 0.3g of melatonin and stir evenly;

[0040] b) Add 0.9g of melatonin and 4.4g of moderately substituted hydroxypropyl-β-cyclodextrin into 500ml of water for injection, stir at 50°C for 5 hours, and detect that the encapsulation rate of melatonin is greater than 90%;

[0041] c) After mixing the solutions of groups a and b above, add NaOH solution to adjust the pH value to 11.0, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and then filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to...

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Abstract

The invention provides an esomeprazole sodium composition for injection, relating to the field of drugs and drug production technology. The main drug of the composition includes esomeprazole sodium and melatonin, wherein the melatonin comprises a quick release part and a cyclodextrin-inclusion slow release part. The esomeprazole sodium composition for injection is fast in potency and reliable in effect, and applicable to a patient who is not suitable for orally taking medicine, and a drug which is not suitably taken orally; the drug administration design of combining quick release and slow release meets the physiological secretion characteristic of the melatonin, solves the defect of short half life period of the melatonin, and improves the bioavailability of the product; the synergism of the esomeprazole sodium on treating reflux esophagitis can be achieved, gastric dynamics can be enhanced to promote gastric emptying. The coordinated movement of stomach antrum, pylorus and duodenum can be promoted, and the reflux of gastric content can be completely prevented.

Description

Technical field: [0001] The present invention relates to the technical field of medicine and medicine manufacture, in particular to a composition of esomeprazole sodium for injection, more specifically, to a freeze-dried composition for injection containing esomeprazole sodium and melatonin . Background technique: [0002] Esomeprazole, the S-optical isomer of omeprazole, is the world's first isomer proton pump inhibitor (PPI), which reduces gastric acid secretion by specifically inhibiting the proton pump of parietal cells. It has been confirmed by a large number of clinical experiments and drug research: it maintains gastric pH>4 for a longer time, has higher acid suppression efficiency, and has better curative effect than the previous two generations of PPI, with little individual difference. As a new generation of PPI, it has been widely used in clinical treatment of many acid-related diseases. [0003] Proton pump inhibitors (PPIs) are the drug of choice for the tr...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K9/19A61K47/48A61P1/08A61K31/4045A61K47/69
Inventor 汪六一汪金灿郝结兵李彪吴函峰
Owner HAINAN WEI KANG PHARMA QIANSHAN
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