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Flurbiprofen axetil structure fat emulsion injection liquid and preparation method thereof

A technology of flurbiprofen axetil and injection, which is applied in the field of flurbiprofen axetil structured fat emulsion injection and its preparation, can solve the problems of increased particle size of emulsion droplets, affecting normal use, ketone body poisoning, etc., and achieves Improve absorption and utilization, clinical use safety, and the effect of small emulsion droplet size

Inactive Publication Date: 2018-05-29
GUANGDONG JIABO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Soybean oil (long-chain triglycerides) is used as the carrier of the currently marketed emulsion prescriptions, but long-chain triglycerides (LCT) can easily lead to hypertriglyceridemia, and the burden of fat metabolism in the liver is heavy, especially not suitable for ester metabolism handicapped patient
Although the use of a mixture of medium-chain triglycerides (MCT) and long-chain triglycerides as a carrier can effectively reduce the disadvantages of using long-chain triglycerides alone, strictly speaking, physically mixed MCT and LCT contain two different lipids. They will interfere with each other's metabolism, and medium-chain fatty acids are not essential fatty acids, which can easily lead to excessive ketone body poisoning after a large amount of intake
At the same time, fat emulsion injection, as a kind of submicroemulsion injection, is a thermodynamically unstable system. As the storage time becomes longer and the storage conditions change, it usually shows phenomena such as increase in particle size of emulsion droplets and flocculation, which affect Normal use

Method used

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  • Flurbiprofen axetil structure fat emulsion injection liquid and preparation method thereof
  • Flurbiprofen axetil structure fat emulsion injection liquid and preparation method thereof
  • Flurbiprofen axetil structure fat emulsion injection liquid and preparation method thereof

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preparation example Construction

[0038] Preparation of structured triglycerides:

[0039] After mixing a certain proportion of long-chain triglycerides and medium-chain triglycerides, the mixture is obtained through the decomposition of lipase and the recombination of fatty acid chains, and finally the lipase is separated and purified to obtain structural triglycerides. The prepared structure Type 2 triglycerides contain 85% (w / w) mixed chain triglycerides, 10% (w / w) medium chain triglycerides and 5% (w / w) long chain triglycerides.

Embodiment 1

[0040] Embodiment 1, flurbiprofen axetil structured fat emulsion injection

[0041]

[0042]

[0043] Preparation method: Accurately weigh the materials according to the above prescription, mix flurbiprofen axetil, structural triglycerides, and lecithin under the protection of nitrogen at high speed at 65°C to form an oil phase; under the protection of nitrogen, dihydrogen phosphate Sodium, glycerin and aqueous solution for injection are mixed at 50°C; under the protection of nitrogen, the above oil phase is mixed with the water phase, and the high-speed shear dispersion is carried out at a shear speed of 5000rpm, and the shear dispersion time is 30 minutes to form colostrum. Citric acid adjusts the pH to 4.5; under the protection of nitrogen, pass the obtained colostrum through a high-pressure homogenizer to form colostrum. , sealed, and sterilized at 115°C for 30 minutes.

Embodiment 2

[0044] Embodiment two, flurbiprofen axetil structured fat emulsion injection

[0045]

[0046] The preparation method refers to Example 1.

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Abstract

The invention relates to the technical field of a medicine preparation, in particular to flurbiprofen axetil structure fat emulsion injection liquid and a preparation method thereof. The flurbiprofenaxetil structure fat emulsion injection liquid is prepared from flurbiprofen axetil, structure triglyceride, emulsifiers, lecithin, disodium hydrogen phosphate, glycerol, citric acid and injection water. The flurbiprofen axetil structure fat emulsion injection liquid provided by the invention has the advantages that the medicine effect is obvious; the toxic and side effects are lower; the stability is high.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a flurbiprofen axetil structured fat emulsion injection and a preparation method thereof. Background technique [0002] Flurbiprofen axetil, its chemical name is: (±) 2-(2-fluoro-4-biphenyl)propanoic acid-1-acetoxyethyl ester [0003] Its structural formula is: [0004] [0005] Molecular formula: C 19 h 19 FO 4 [0006] Molecular weight: 330.35 [0007] Chemical properties: colorless to light yellow transparent oily substance, slightly smelly, bitter taste. Miscible with methanol, ethanol or acetone, insoluble in water. [0008] Flurbiprofen axetil is a prodrug of flurbiprofen, a non-steroidal targeted analgesic. The pharmacological effect is to reduce the synthesis of prostaglandins by inhibiting cyclooxygenase (COX) in the spinal cord and the periphery, and reduce the hyperalgesic state caused by surgical trauma. It can be used for pain relief a...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/14A61K31/222A61P29/00
CPCA61K9/0019A61K9/107A61K31/222A61K47/14
Inventor 谢春燕蔡文坚鲁丹彭创业岳峰
Owner GUANGDONG JIABO PHARM CO LTD
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