Flurbiprofen axetil microsphere injection and preparation method thereof

A technology of flurbiprofen axetil and injection, which is applied in the field of medicine and its preparation, can solve the problems of gastrointestinal disturbance, long duration of drug effect, difficulty in injecting dosage forms, etc. Effect

Inactive Publication Date: 2015-07-22
EAST CHINA UNIV OF SCI & TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Flurbiprofen (Flurbiprofen, FP) is a kind of non-steroidal anti-inflammatory drug widely used clinically, because flurbiprofen is insoluble in water, it is difficult to make injection dosage form, the preparation on the market is mostly oral dosage form at present, It is easy to cause adverse reactions such as gastrointestinal disturbances. For the treatment of pain caused by cancer or postoperative pain, because many patients cannot take drugs orally, and the injection form takes effect quickly and the drug effect lasts for a long time, so non-oral administration is required, especially IV route of administration

Method used

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  • Flurbiprofen axetil microsphere injection and preparation method thereof
  • Flurbiprofen axetil microsphere injection and preparation method thereof
  • Flurbiprofen axetil microsphere injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The specific prescription and technology of flurbiprofen axetil lipid microsphere injection of the present invention are as follows:

[0033] (1) Prescription

[0034] flurbiprofen axetil

1g

Main drug

Refined soybean oil

10g

oil phase

egg yolk lecithin

1.2g

Emulsifier

Glycerin

2.3g

Isotonic agent

Disodium phosphate

0.068g

buffer

citric acid

Appropriate amount

pH regulator

[0035] Water for Injection

Add to 100mL

medium

[0036] (2) Preparation process

[0037] Add flurbiprofen axetil and lecithin to refined soybean oil according to the above prescription, heat to 75°C and keep warm; add glycerin and disodium hydrogen phosphate to water for injection, heat to 75°C and keep warm; It was added to the water phase in the state, the temperature was controlled at 75°C, the speed of the high-shear emulsifier was 8000r / min, and the colostrum was formed ...

Embodiment 2

[0039] The specific formula and process of flurbiprofen axetil lipid microsphere injection of the present invention are as follows:

[0040] (1) Prescription

[0041]

[0042] (2) Preparation process

[0043] According to the above prescription, add flurbiprofen axetil and lecithin to refined soybean oil, heat to 65°C and keep warm; add glycerin, F68, disodium hydrogen phosphate to water for injection, heat to 65°C and keep warm; It was added to the water phase in the cut state, the temperature was controlled at 65°C, the speed of the high-shear emulsifier was 20000r / min, and the colostrum was formed by shearing for 8 minutes. Nitrogen was filled during the preparation of the colostrum. The volume of the colostrum was adjusted and the pH was adjusted to 7-9. Homogenize 6 times by a high-pressure homogenizer, and the homogenization pressure is 1000 bar to obtain the final milk. The final milk was melt-sealed and filled into 5mL ampoules, sterilized by autoclaving, and ste...

Embodiment 3

[0045] The specific formula and process of flurbiprofen axetil lipid microsphere injection of the present invention are as follows:

[0046] (1) Prescription

[0047] flurbiprofen axetil

1g

Main drug

Refined soybean oil

10g

oil phase

egg yolk lecithin

1.2g

Emulsifier

sodium oleate

0.05g

stabilizer

Glycerin

2.3g

Isotonic agent

Disodium phosphate

0.068g

buffer

citric acid

Appropriate amount

pH regulator

Water for Injection

Add to 100mL

medium

[0048] (2) Preparation process

[0049] According to the above prescription, add flurbiprofen axetil and lecithin to refined soybean oil, heat to 65°C and keep warm; add glycerin, F68, disodium hydrogen phosphate to water for injection, heat to 65°C and keep warm; It was added to the water phase in the cut state, the temperature was controlled at 65°C, the speed of the high-shear emulsifier was 20000r / min, a...

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Abstract

The invention relates to a flurbiprofen axetil microsphere injection and a preparation method thereof. The flurbiprofen axetil microsphere injection is composed of a main drug, long chain oil for injection, one or more emulsifier, a stabilizer, an isotonic agent, a pH adjusting agent and water for injection. The one or more emulsifier is / are safe nontoxic and has good biocompatibility, such as lecithin and F68, and sodium oleate is added as the stabilizer to guarantee the stability of physical and chemical properties before and after disinfection. The particle size of the flurbiprofen axetil microsphere injection is stable and uniform, and is 180-200nm concretely, and the flurbiprofen axetil microsphere injection is mainly used for cancer pain easing and postoperative pain relieving, and is suitable for being widely clinically applied.

Description

【Technical field】 [0001] The invention belongs to the field of medicines and preparations thereof, and in particular relates to a lipid microsphere injection for flurbiprofen axetil injection and a preparation method thereof. 【Background technique】 [0002] Nonsteroidal anti-inflammatory drugs (Nonsteroida1 Anti-inflammatory Drugs, NSAIDs) are a class of anti-inflammatory drugs that do not contain a steroidal structure, have antipyretic, anti-inflammatory, and analgesic effects, and are widely used in pain and inflammatory diseases. treat. Its main principle of action is to reduce the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase in the cascade of arachidonic acid. At present, NSAIDs are one of the most used drugs in the world, and there are about 30 million people in the world using them. Flurbiprofen (Flurbiprofen, FP) is a kind of non-steroidal anti-inflammatory drug widely used clinically, because flurbiprofen is insoluble in water, it is dif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/34A61K47/12A61K31/216A61P29/00
Inventor 高峰付爱玲楼开炎陈彦佐屠祎惺叶亚婧秦冬冬姚芳金玉谢木青王云陆益奔黄小音
Owner EAST CHINA UNIV OF SCI & TECH
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