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Esomeprazole sodium liposome injection

A technology for esomeprazole sodium lipid and injection, which is applied in the field of esomeprazole sodium liposome injection, can solve problems such as poor liposome stability and encapsulation efficiency, and achieves improved product quality, Good stability and remarkable curative effect

Inactive Publication Date: 2013-03-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through the combination of specific excipients, the present invention not only solves the technical problems of poor liposome stability and encapsulation efficiency, but also obtains unexpected preparation effects, thereby providing liposomes with good quality

Method used

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  • Esomeprazole sodium liposome injection
  • Esomeprazole sodium liposome injection
  • Esomeprazole sodium liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of embodiment 1 esomeprazole sodium liposome freeze-dried powder injection

[0033] Prescription (1000 bottles):

[0034]

[0035] Preparation Process:

[0036] (1) Add 120g egg phosphatidylcholine, 20g cholesterol, 4g sphingomyelin and 2g propyl gallate into 600ml of n-butanol and acetonitrile with a volume ratio of 4:1, heat and stir to disperse evenly, and reduce the temperature on a rotary evaporator Remove n-butanol and acetonitrile under pressure to obtain a phospholipid film;

[0037] (2) Adding 600ml of citrate buffer solution with a pH of 6.4, shaking and stirring, makes the phospholipid film fully hydrated, high-speed homogeneous emulsification, and microporous membrane filtration to obtain a blank liposome suspension;

[0038] (3) Dissolve 40g of esomeprazole sodium in water, filter through a microporous membrane, add the filtrate to the blank liposome suspension, keep warm at 45-60°C and stir for 20-40 minutes, then add 100g of sorbitol ...

Embodiment 2

[0040] The preparation of embodiment 2 esomeprazole sodium liposome freeze-dried powder injection

[0041] Prescription (1000 bottles):

[0042]

[0043]

[0044] Preparation Process:

[0045] (1) Add 240g egg phosphatidylcholine, 160g cholesterol, 40g sphingomyelin and 20g propyl gallate into 3000ml of n-butanol and acetonitrile with a volume ratio of 4:1, heat and stir to disperse evenly, and reduce Remove n-butanol and acetonitrile under pressure to obtain a phospholipid film;

[0046] (2) adding 3000mlPH is the citrate buffer solution of 6.4, shakes, stirs, and phospholipid film is fully hydrated, high-speed homogeneous emulsification, microporous membrane filtration, makes blank liposome suspension;

[0047] (3) Dissolve 40g of esomeprazole sodium in water, filter through a microporous membrane, add the filtrate to the blank liposome suspension, keep warm at 45-60°C and stir for 20-40 minutes, then add 300g sorbitol and 300g dextran , stirred to make it dissolve, t...

Embodiment 3

[0050] Prescription (1000 bottles):

[0051]

[0052] Preparation Process:

[0053] (1) Add 160g egg phosphatidylcholine, 80g cholesterol, 20g sphingomyelin and 10g propyl gallate into 1000ml of n-butanol and acetonitrile with a volume ratio of 4:1, heat and stir to disperse evenly, and reduce the temperature on a rotary evaporator Remove n-butanol and acetonitrile under pressure to obtain a phospholipid film;

[0054] (2) adding 1000mlPH is the citrate buffer solution of 6.4, shakes, stirs, and phospholipid film is fully hydrated, high-speed homogeneous emulsification, microporous membrane filtration, makes blank liposome suspension;

[0055] (3) Dissolve 40g of esomeprazole sodium in water, filter through a microporous membrane, add the filtrate to the blank liposome suspension, keep warm at 45-60°C and stir for 20-40 minutes, then add 200g of sorbitol and 200g of dextran , stirred to make it dissolve, then cooled to room temperature to obtain esomeprazole sodium liposo...

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Abstract

The invention discloses an esomeprazole sodium liposome injection. The esomeprazole sodium liposome injection is characterized by being mainly prepared from esomeprazole sodium, phosphatidylcholine, cholesterol, myelin, antioxygen and a protective agent. The prepared liposome injection is high in dissolvability, stability and entrapment rate and is small in a side effect, improves quality of preparation products, reduces toxic and side effects, improves bioavailability, and has an obvious curative effect.

Description

technical field [0001] The invention relates to a new preparation of esomeprazole sodium, in particular to esomeprazole sodium liposome injection and a preparation method thereof. Background technique [0002] Esomeprazole sodium (Esomeprazole), chemical name: 5-methoxy-2-II (4-methoxy-3.5dioxy-2-pyridyl)-1H-benzimidazole sodium, molecular formula: C 17 h 18 N 3 o 3 SNa, molecular weight: 344.1, structural formula: [0003] [0004] Esomeprazole sodium is a proton pump inhibitor that reduces gastric acid secretion by inhibiting H+ / Na+-ATPase in gastric parietal cells. Esomeprazole is the s isomer of omeprazole, the first proton pump inhibitor (ppi) single isomer available for clinical use, which has drugs that omeprazole racemate does not have Compared with omeprazole, esomeprazole has higher and more consistent bioavailability, and the area under the plasma concentration time curve is also larger. The area under the plasma concentration-time curve determines how m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/28A61P1/04
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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