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Lansoprazole lipidosome injection

A technology of lansoprazole lipid and lansoprazole, applied in the field of medicine, can solve the problems of low liposome encapsulation rate, difficult to exceed 65%, unstable lansoprazole, etc., and achieves improvement of drug therapeutic index , Improve the stability, reduce the effect of drug side effects

Active Publication Date: 2016-03-02
福安药业集团庆余堂制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The liposome encapsulation efficiency of this formula is not high, it is difficult to exceed 65%
[0005] At present, there is no lansoprazole liposome listed, the main reason is that the encapsulation efficiency of the prior art is not high, easy to leak, resulting in lansoprazole instability, poor finished medicine, difficult to industrialized production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 Lansoprazole liposome freeze-dried powder injection

[0035] Prescription (1000 bottles):

[0036]

[0037] Preparation Process:

[0038] 1) Weighing hydrogenated egg yolk lecithin, soybean lecithin, distearate lecithin and cholesterol and antioxidant are dissolved in 1000ml absolute ethanol, heating and melting, heating and steaming ethanol to obtain a phospholipid film;

[0039] 2) Dissolve the phospholipid film in 5000ml of phosphate buffer solution with a pH value of 6.8, add 30g of sterilized lansoprazole and 5g of vitamin E, and 30g of excipient mannitol, stir and dissolve, ultrasonically disperse, filter, and fill in 1000 bottles of vials;

[0040] 3) Pre-freeze at -35°C for 2 hours, then cool down to -45°C for 1 hour, then dry under reduced pressure and vacuum at -10 to -5°C for 10 hours, and finally dry at 35°C for 6 hours , Delansoprazole liposome freeze-dried powder injection.

Embodiment 2

[0041] Embodiment 2 Lansoprazole liposome freeze-dried powder injection

[0042] Prescription (1000 bottles):

[0043]

[0044]

[0045] Preparation Process:

[0046] 1) Weighing hydrogenated egg yolk lecithin, soybean lecithin, distearate lecithin and cholesterol and antioxidant are dissolved in 1000ml absolute ethanol, heating and melting, heating and steaming ethanol to obtain a phospholipid film;

[0047] 2) Dissolve the phospholipid film in 5000ml of pH value 6.8 phosphate buffer solution, add sterilized lansoprazole 30g and vitamin E1g, excipient mannitol 60g, stir and dissolve, ultrasonically disperse, filter, fill in 1000 In a vial;

[0048] 3) Pre-freeze at -30°C for 1 hour, then cool down to -40°C for 1 hour, then dry under reduced pressure and vacuum at -10 to -5°C for 15 hours, and finally dry at 35°C for 5 hours , Delansoprazole liposome freeze-dried powder injection.

Embodiment 3

[0049] Embodiment 3 Lansoprazole liposome freeze-dried powder injection

[0050] Prescription (1000 bottles):

[0051]

[0052] Preparation:

[0053] 1) Weighing hydrogenated egg yolk lecithin, soybean lecithin, distearate lecithin and cholesterol and antioxidant are dissolved in 1000ml absolute ethanol, heating and melting, heating and steaming ethanol to obtain a phospholipid film;

[0054] 2) Dissolve the phospholipid film in 5000ml of phosphate buffer solution with a pH value of 6.8, add 30g of sterilized lansoprazole, 5g of vitamin E, and 60g of mannitol, stir and dissolve, ultrasonically disperse, filter, and fill in 1000 vials middle;

[0055] 3) Pre-freeze at -35°C for 2 hours, then cool down to -40°C for 1 hour, then dry under reduced pressure and vacuum at -10 to -5°C for 10 hours, and finally dry at 35°C for 5 hours , Delansoprazole liposome freeze-dried powder injection.

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Abstract

The invention discloses a lansoprazole lipidosome injection which comprises 3 parts of lansoprazole, 3 to 6 parts of cholesterol, 6 to 9 parts of phospholipid, 0.1 to 0.5 part of an antioxygen and 3 to 6 parts of an excipient. The phospholipid is composed of HEPC (hydrogenated egg phosphatidylcholine), soya bean lecithin and stearic acid lecithin of which the weight ratio is 3-2 to 3-2 to 1. The lipidosome injection has the advantages of high encapsulation efficiency, low leakage rate, stability and the like, and has a relatively high clinic applicable value.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a lansoprazole liposome and a preparation method thereof. Background technique [0002] Lansoprazole is a proton pump inhibitor, which is mainly used clinically for the treatment of reflux esophagitis, gastric ulcer, and duodenal ulcer. The marketed dosage forms include tablets, capsules and lyophilized powder injections. The most mainstream prescriptions for injections on the market contain lansoprazole, mannitol, meglumine and sodium hydroxide, wherein mannitol is a freeze-drying excipient, meglumine is a stabilizer, and sodium hydroxide is a pH regulator. The disadvantage of the injection is that after being stored for a period of time and used, problems such as a decrease in solution clarity and an increase in insoluble particles are prone to occur, resulting in unqualified product quality and drug safety problems. To solve this problem, people have done many improvement programs, su...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/19A61K31/4439A61K47/24A61P1/04
CPCA61K9/0019A61K9/127A61K9/19A61K31/4439A61K47/24
Inventor 不公告发明人
Owner 福安药业集团庆余堂制药有限公司
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