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Flurbiprofen axetil fat emulsion concentrate and preparation method and use thereof

A flurbiprofen axetil and fat emulsion technology, applied in the field of flurbiprofen axetil fat emulsion concentrate, can solve the problems of unstable process, uneven milk particles, complicated preparation process and the like

Inactive Publication Date: 2015-06-17
天津迈迪瑞康生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Flurbiprofen axetil fat emulsion preparations, like common fat emulsion preparations, have the disadvantages of poor stability and complex preparation process: those skilled in the art understand that fat emulsion preparations such as flurbiprofen axetil fat emulsion preparations appear in appearance It is an opaque milky white liquid, which cannot be tested for clarity; oil-water stratification, coagulation, flocculation, etc. are prone to occur during product storage; the preparation process involves colostrum preparation, high-pressure homogenization, and the process is unstable. Temperature, emulsification time and The production equipment affects the product quality, resulting in uneven milk grains; moreover, the existing fat emulsion requires special equipment to be sterilized under high pressure

Method used

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  • Flurbiprofen axetil fat emulsion concentrate and preparation method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0166] Embodiment 1: the preparation of flurbiprofen axetil fat emulsion concentrate sample 1

[0167] Its composition is as follows:

[0168] Flurbiprofen axetil 7g

[0169] soybean oil 5 grams

[0170] Medium chain fatty acid triglycerides (Crodamol GTCC) 60g

[0171] 1,2-Propanediol 8g

[0172] Soy lecithin (Epikuron 170, Degussa) 7.5 grams

[0173] Tween 80 4g

[0174] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 8.2 g

[0175] Vitamin E 0.3g

[0176] The preparation method of the flurbiprofen axetil fat emulsion concentrate is as follows:

[0177] 1) Add the above-mentioned weight of soybean lecithin into medium-chain fatty acid glycerides and soybean oil at 20°C, and stir at 20,000 rpm until a transparent and clear solution is formed;

[0178]2) Add the above-mentioned weight of flurbiprofen axetil to the product of step 1) at 20°C, and keep stirring at 200rpm until the whole system is transparent;

[0179] 3) Add the above-mentioned we...

Embodiment 2

[0181] Embodiment 2: the preparation of flurbiprofen axetil fat emulsion concentrate sample 2

[0182] Its composition is as follows:

[0183] Flurbiprofen axetil 4.5g

[0184] soybean oil 29 grams

[0185] Glyceryl caprylate (Miglyol 812, SASOL) 29g

[0186] 1,2-Propanediol 7g

[0187] Soy Lecithin (Epikuron 170, Degussa) 11g

[0188] Polyglyceryl Oleate 4g

[0189] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 11 g

[0190] Tween 80 4g

[0191] Vitamin E 0.3g

[0192] Oleic acid 0.2g

[0193] The preparation method of the flurbiprofen axetil fat emulsion concentrate is as follows:

[0194] 1) At 45°C, add the above-mentioned weight of soybean lecithin and polyglyceryl oleate into caprylic capric glyceride and soybean oil, and stir at 2000rpm until a transparent and clear solution is formed;

[0195] 2) Add the above-mentioned weight of flurbiprofen axetil to the product of step 1) at 35°C, and keep stirring at 1000rpm until the whole system is tr...

Embodiment 3

[0198] Embodiment 3: the preparation of flurbiprofen axetil fat emulsion concentrate sample 3

[0199] Its composition is as follows:

[0200] Flurbiprofen axetil 5.5g

[0201] 47.5 grams soybean oil

[0202] 1,2-propanediol 9 grams

[0203] Soy Lecithin (Epikuron 170, Degussa) 12g

[0204] Polyglyceryl Oleate 2.6g

[0205] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 13 g

[0206] Tween 80 10g

[0207] Vitamin E 0.35g

[0208] Oleic acid 0.05g

[0209] The preparation method of the flurbiprofen axetil fat emulsion concentrate is as follows:

[0210] 1) At 30°C, add the above-mentioned weight of soybean lecithin and polyglycerol oleate into soybean oil, and stir at 10,000 rpm until a transparent and clear solution is formed;

[0211] 2) Add the above-mentioned weight of flurbiprofen axetil to the product of step 1) at 45°C, and keep stirring at 2000rpm until the whole system is transparent;

[0212] 3) At 45°C, add the above-mentioned weight of 1,...

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Abstract

The invention relates to a flurbiprofen axetil fat emulsion concentrate and a preparation method and use thereof, and belongs to the field of medicine and pharmacy. The flurbiprofen axetil fat emulsion concentrate overcomes the defects of complex traditional fat milk preparation process and poor product stability. The flurbiprofen axetil fat emulsion concentrate is simple in preparation process only needing simple physical mixing without homogenization process. The product can be sterilized through a 0.22 mum millipore filter film, can spontaneously emulsify during clinical use by dilution with normal saline or glucose solution and other water solutions and slight oscillation, under the optimal conditions, emulsified average particle size is about 0.2 mum, and fully shows injection fat milk properties. The flurbiprofen axetil fat emulsion concentrate product has good liquidity, and may not be hung on the wall, the appearance is single-phase, transparent and clear, clarity detection is acceptable, and after repeated freezing and thawing, preparation stratification phenomenon does not occur. The flurbiprofen axetil fat emulsion concentrate product is used for postoperative and cancer analgesia and other clinical application.

Description

technical field [0001] The invention belongs to the field of pharmacy and pharmacy, and relates to a flurbiprofen axetil fat emulsion concentrate, a preparation method and application thereof. Background technique [0002] Flurbiprofen axetil (Flurbiprofen Axet), the prodrug of flurbiprofen, is rapidly hydrolyzed by carboxyl esterase in the body to generate flurbiprofen, and exerts analgesic and anti-inflammatory effects by inhibiting the synthesis of prostaglandins through flurbiprofen. Inflammation and antipyretic effect. Its anti-inflammatory effect is 250 times that of acetylsalicylic acid, and its analgesic effect is 50 times that of acetylsalicylic acid. Flurbiprofen axetil is a non-steroidal targeted analgesic, which reduces the synthesis of prostaglandins by inhibiting cyclooxygenase (COX) in the spinal cord and the periphery, reduces the hyperalgesia state caused by surgical trauma, and has a positive effect on the central nervous system. No inhibitory effect. Fl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/222A61K9/107A61P29/00
Inventor 杨杰其他发明人请求不公开姓名
Owner 天津迈迪瑞康生物医药科技有限公司
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