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Middle/long chain triglyceride flurbiprofen axetil injection and preparation method thereof

A technology of triglyceride and flurbiprofen axetil, which is used in pharmaceutical formulations, emulsion delivery, non-central analgesics, etc., to achieve the effects of low toxicity and side effects, significant drug efficacy, and reduced accumulation

Inactive Publication Date: 2012-07-11
GUANGDONG JIABO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present invention is aimed at the defect of existing flurbiprofen axetil fat emulsion injection, and the long-chain triglyceride in the original injection is replaced with a certain proportion of medium / long-chain triglyceride to make medium / long-chain (C6 -C24) flurbiprofen axetil fat emulsion injection, so as to achieve the therapeutic effect of anti-inflammatory and analgesic

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Embodiment 1

[0028] preparation of injection

[0029] Proportion:

[0030] flurbiprofen axetil

[0031] Preparation process: Accurately weigh the materials according to the above proportions, mix flurbiprofen axetil, medium-chain triglycerides, long-chain triglycerides, and lecithin at 40°C-75°C to form a solution, and mix with phosphoric acid Sodium dihydrogen, glycerin, and aqueous solution for injection are mixed at 20°C-40°C, adjusted to pH 4.5 with citric acid, and then passed through a homogenizer to form colostrum. Colostrum continuous high pressure (maintain pressure 500kg / cm 2 -600kg / cm 2 ) homogenized 5 times, filled, sealed and sterilized at 115°C for 30 minutes.

Embodiment 2

[0033] Proportion:

[0034] flurbiprofen axetil

[0035] Preparation process: Accurately weigh the materials according to the above proportions, mix flurbiprofen axetil, medium-chain triglycerides, long-chain triglycerides, and lecithin at 40°C-75°C to form a solution, and mix with phosphoric acid Sodium dihydrogen, glycerin, and aqueous solution for injection are mixed at 20°C-40°C, adjusted to pH 6.0 with citric acid, and then passed through a homogenizer to form colostrum. Colostrum continuous high pressure (maintain pressure 600kg / cm 2 -700kg / cm 2 ) homogenized 7 times, filled, sealed and sterilized at 121°C for 12 minutes.

Embodiment 3

[0037] Proportion:

[0038] flurbiprofen axetil

[0039] Preparation process: Accurately weigh the materials according to the above proportions, mix flurbiprofen axetil, medium-chain triglycerides, long-chain triglycerides, and lecithin at 40°C-75°C to form a solution, and mix with phosphoric acid Sodium dihydrogen, glycerin, and aqueous solution for injection are mixed at 20°C-40°C, adjusted to pH 5.5 with citric acid, and then passed through a homogenizer to form colostrum. Colostrum continuous high pressure (maintain pressure 600kg / cm 2 -700kg / cm 2 ) homogenized 7 times, filled, sealed and sterilized at 115°C for 30 minutes.

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Abstract

The invention provides anti-inflammatory and analgesic flurbiprofen axetil injection and a preparation method thereof. A mixture of 0.1-10 percent (w / v) of flurbiprofen axetil, 10-20 percent (w / v) of middle chain triglyceride (MCT) and 10-20 percent (w / v) of long chain triglyceride (LCT) is contained in the prescription (wherein the proportion of MCT and LCT is 4:1-1:4). The preparation method comprises the following steps: taking 1-5 percent (w / v) of lecithin as an emulsifying agent, taking 1-5 percent (w / v) of glycerol as an isotonic agent, finally adding disodium hydrogen phosphate, citric acid and water for injection and adjusting the pH value to 4-7 to prepare flurbiprofen axetil fat emulsion injection through colostrums, homogeneity and sterilization. The injection has the beneficial effects that the anti-inflammatory and analgesic effect is taken more quickly; the accumulation of fat of a human body can be reduced, and fatty tissues and liver load can be reduced; and the injection is more suitable for critically ill patients and people with poor liver functions and has lower toxic and side effects.

Description

technical field [0001] The present invention relates to a kind of anti-inflammatory analgesic flurbiprofen axetil fat emulsion injection and preparation method thereof, the mixture containing medium-chain triglyceride (MCT) and long-chain triglyceride (LCT) in the injection, Its anti-inflammatory and analgesic effect is rapid onset, and is suitable for anti-inflammatory and analgesic treatment of human body. Background technique [0002] Flurbiprofen axetil (Furbiprofen axetil), also known as: Kaifen, its chemical name is: (±) 2-(2-fluoro-4-biphenyl) propionate-1-acetoxyethyl ester, in 1992 First listed in Japan, in 2004 in my country. Flurbiprofen axetil injection is a non-steroidal intravenous targeted analgesic drug, which has the advantages of long-lasting and clear curative effect, no dependence and preemptive analgesic effect. It has been widely used in clinical practice. Fenate is insoluble in water, and the current dosage form is emulsion injection. Japanese patent...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/222A61K47/14A61K47/44A61P29/00
Inventor 黄健鹏岳峰刘红旗
Owner GUANGDONG JIABO PHARM CO LTD
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