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Lafutidine lyophilized powder injection and preparing method thereof

A technology for freeze-dried powder injection and lafutidine, which is applied in the field of lafutidine freeze-dried powder for injection, can solve the problems of increasing the irritation of injections, unable to prepare injections, and no improvement is proposed, and achieves low difficulty in rejecting waste, Excellent dissolving performance and manpower saving effect

Inactive Publication Date: 2010-09-15
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Existing lafutidine preparations are all oral preparations. Because lafutidine is insoluble in water, its oral onset is slow and its bioavailability is low. Making injections can greatly improve the bioavailability of lafutidine
And rapid onset, but lafutidine is insoluble in water and cannot be prepared into injections by common methods
Chinese patent 02135960.1 adopts the method of adding surfactants and organic solvents to prepare injections. Since most surfactants and organic solvents have certain hemolytic properties, they will increase the irritation of the injections to the human body, and some will cause severe Allergic reactions have defects, and other known technologies have not proposed suggestions for improving these defects

Method used

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  • Lafutidine lyophilized powder injection and preparing method thereof
  • Lafutidine lyophilized powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] prescription

[0022] Lafutidine 10g

[0023] Mannitol 100g

[0024] Add water for injection to 10000ml

[0025] A total of 1000 bottles were made

[0026] Take the prescribed amount of lafutidine and put it in a sterile container, add water for injection, heat to 70°C to dissolve, then add the prescribed amount of mannitol, stir to dissolve and mix evenly, measure the content of the intermediate, and test it under sterile conditions Next, filter with a 0.22 μm microporous membrane until clear, fill the filtrate in a sterile 25ml vial, partially plug it with a butyl rubber stopper, put it in a plate, turn on the freeze dryer in advance, and use heat transfer oil to cool the plate layer. Until the plate temperature reaches -40~-45°C, quickly send the lafutidine solution filled in the sterile cillin bottle into the freeze dryer, close the door, and keep the plate temperature at -40~-45°C for The temperature of the product drops. When the sample reaches -40°C, stop pla...

Embodiment 2

[0029] prescription

[0030] Lafutidine 10g

[0031] Mannitol 1000g

[0032] Sodium chloride 20g

[0033] Add water for injection to 10000ml

[0034] A total of 1000 bottles were made

[0035] Take the prescribed amount of lafutidine and put it in a sterile container, add water for injection, heat to 70°C to dissolve, then add the prescribed amount of mannitol and sodium chloride, stir to dissolve and mix evenly, measure the content of intermediates, after passing the Under sterile conditions, filter with a 0.22 μm microporous membrane until clear, fill the filtrate into a sterile 25ml vial, partially plug it with a butyl rubber stopper, put it in a plate, turn on the freeze dryer in advance, and use heat transfer oil to heat the plate. Layer refrigeration until the temperature of the layer reaches -40~-45℃, quickly send the lafutidine solution filled in the aseptic penicillin bottle into the freeze dryer, close the door, and keep the temperature of the layer at -40~- 45°...

Embodiment 3

[0038] prescription

[0039] Lafutidine 10g

[0040] Mannitol 200g

[0041] Sodium chloride 5g

[0042] Add water for injection to 10000ml

[0043] A total of 1000 bottles were made

[0044] Take the prescribed amount of lafutidine and put it in a sterile container, add water for injection, heat to 70°C to dissolve, then add the prescribed amount of mannitol and sodium chloride, stir to dissolve and mix evenly, measure the content of intermediates, and pass the test Under sterile conditions, filter with a 0.22 μm microporous membrane until clear, fill the filtrate in a sterile 25ml vial, partially plug it with a butyl rubber stopper, put it in a plate, turn on the lyophilizer in advance, and use heat transfer oil to Refrigerate the plate until the temperature of the plate reaches -40~-45℃, quickly send the lafutidine solution filled in the sterile pencil bottle into the freeze dryer, close the door, and keep the temperature of the plate at -40~ -45°C lowers the temperatur...

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Abstract

The invention relates to lafutidine freeze-dried injection, which can treat gastric ulcer, duodenal ulcer and ulcer on the anastomosed part. The lafutidine freeze-dried injection is composed of lafutidine and mannitol, wherein, the mass ratio of the lafutidine and the mannitol is 1 : 10 to 100; the preferable mass ratio is 1 : 20 to 50; and one or the mixture of sodium chloride and citrate can be added into the lafutidine freeze-dried injection so as to prevent the medicine bottle from exploding in the process of freeze-drying the lafutidine freeze-dried injection. The preparation processes are as following: the lafutidine is taken to be placed inside the aseptic container, and then the water for injection is added to be heated until the temperature reaches 70 DEG C so that the lafutidine can be dissolved in the water for injection; and then the mannitol is added to be mixed so that the mannitol can be dissolved and is mixed evenly; the content of the intermediate is measured; after the content of the intermediate is qualified, in the aseptic condition, the solution is filtered until to be clear by microporous membrane of 0.22 microns; the filtrate is filled inside the aseptic silin bottle; and part of the silin bottle is plugged by butyl rubber closure, with the posterior steps of tray filling, freeze-drying in the freeze dryer, tamponing, unpacking, mouth rolling, quality inspecting and packaging.

Description

technical field [0001] What the present invention relates to is a kind of lafutidine freeze-dried powder injection, the lafutidine freeze-dried powder injection prepared by the technical scheme of the present invention can be used as the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer; can improve Acute gastritis, mucosal lesions (such as erosion, bleeding, redness) in the acute malignant transformation of chronic gastritis; it can also be used for administration before anesthesia. Background technique [0002] Peptic ulcer is a common disease, frequently-occurring disease, and the incidence rate accounts for about 10% of the total population. According to the statistics of "National Medical Medication Situation in 1998", the amount of drugs used in hospitals that act on the digestive system increased by 74% in 1998 compared with 1997, and the total amount reached 7.25 billion yuan. [0003] Lafutidine (lafutidine, 1) is an H2 receptor antagonist jointly devel...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4545A61K9/19A61K47/10A61P1/04
Inventor 李晓昕叶东盛琼波戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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