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Compound preparation containing flurbiprofen axetil and preparation method of preparation

A technology of flurbiprofen axetil and compound preparation, applied in the field of medicine, can solve the problems of uncertain drug release time, different drug onset time, etc.

Active Publication Date: 2019-08-13
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the above-mentioned documents, CN200780022230.6 and CN201480033480.X disclose the treatment method for treating gastric damage caused by NSAID drugs, which is aimed at the treatment of gastric damage caused by NSAID drugs. Although the documents CN0180616.3 and CN201410317848.7 are described as compound preparations, they are essentially It is to prepare two different active substances into different small dosage forms. When filling capsules, because there are actually two dosage forms in the capsules, after the patient takes the medicine, the drug release time is uncertain due to the different dosage forms, causing the drug to take effect. Depending on the time, it is difficult to prevent the gastric injury caused by the NSAID drug used. How to develop the compound preparation of the NSAID drug and the proton pump inhibitor into the same dosage form, so that the two drugs can be released at the same time, which can not only achieve the treatment of gastric injury effect, and at the same time can effectively prevent gastric damage, the relevant literature has not yet reported

Method used

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  • Compound preparation containing flurbiprofen axetil and preparation method of preparation
  • Compound preparation containing flurbiprofen axetil and preparation method of preparation
  • Compound preparation containing flurbiprofen axetil and preparation method of preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1 Flurbiprofen axetil and omeprazole fat emulsion

[0042] prescription composition Sample 1 Sample 2 Flurbiprofen axetil 5.0g 5.0g Omeprazole 1.0g 2.0g Soybean oil 17.5g 17.5g egg yolk lecithin 7.5g 7.5g Solutol HS-15 15g 15g Vitamin E 3.0g 3.0g glycerin 12g 12g water Add water to 500ml Add water to 500ml pH 8.1 8.1

[0043] Preparation method: mix the soybean oil and egg yolk lecithin in the recipe amount evenly, adjust the pH with citric acid and sodium dihydrogen phosphate, add the active pharmaceutical ingredients flurbiprofen and omeprazole, and disperse evenly; Solutol HS-15, mix well; add the prescribed amount of glycerin, and then add an appropriate amount of water until the solution volume is 500mL, mix and emulsify, and shear with a high-pressure homogenizer; filter, encapsulate, and sterilize the obtained solution to get .

Embodiment 2

[0044] Example 2 Flurbiprofen axetil and lansoprazole fat emulsion

[0045] prescription composition content Flurbiprofen axetil 5.0g Lansoprazole 3.0g Soybean oil 20g egg yolk lecithin 10g Poloxamer 12g Vitamin E 3.0g glycerin 12g water Add water to 500ml Ph 7.6

[0046] Preparation method: as shown in Example 1.

Embodiment 3

[0047] Example 3 The samples prepared in Examples 1 and 2 were tested for particle size before and after sterilization

[0048] Use a laser scattering particle size analyzer (model: Zetasizer, manufacturer: Malvern) to detect the particle size detection of the samples prepared in Examples 1-9 before and after sterilization, and the results are shown in Table 1 below:

[0049] Table 1

[0050]

[0051] As can be seen from the results in Table 1, the particle size of the milk droplets before and after the sterilization of the fat emulsion prepared by the present invention is relatively stable, thereby further ensuring the stability of the preparation and ensuring the patient's medication safety.

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PUM

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Abstract

The invention discloses a compound preparation containing flurbiprofen axetil. The preparation contains two effective pharmaceutical active ingredients including flurbiprofen axetil and a proton pumpinhibitor, wherein the content of flurbiprofen axetil in unit dosage is 20-100 mg, and the content of the proton pump inhibitor in unit dosage is 5-100 mg. The preparation is preferably a fat emulsionor a lipid microsphere preparation, the blank of a flurbiprofen axetil and proton pump inhibitor compound fat emulsion or a lipid microsphere injection is filled up, the development of the preparation makes a patient treat inflammation or pain by using flurbiprofen axetil and also effectively prevents and / or treats stomach injury caused by inflammation or pain, and therefore side effects on the patient after drug use are further reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a compound preparation containing flurbiprofen axetil, in particular to a compound preparation consisting of flurbiprofen axetil and a proton pump inhibitor and a preparation method thereof. Background technique [0002] Non-steroidal anti-inflammatory drugs (NSAIDs), as a class of drugs with anti-inflammatory, analgesic, antipyretic and reducing platelet adhesion, are widely used in clinical practice, but they have many gastrointestinal side effects and different clinical manifestations. , from asymptomatic, to indigestion, abdominal distension, abdominal pain, ulcers, bleeding, perforation, etc., and even life-threatening in severe cases, and the harm of gastric mucosal damage does not change with the dosage form. Therefore, the active prevention of NSAIDs-induced ulcers and hemorrhage-related gastrointestinal mucosal damage has received more and more clinical attention. [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/222A61K47/24A61K47/14A61K47/10A61K9/00A61P29/00A61P1/00
CPCA61K45/06A61K31/222A61K47/44A61K47/24A61K47/14A61K47/10A61K9/0019A61K2300/00
Inventor 周丽莹陆潇筠刘亚男佟淑文
Owner BEIJING TIDE PHARMA
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