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Production technology of flurbiprofen axetil fat emulsion injection

A flurbiprofen axetil and a production process technology are applied in the field of the production process of flurbiprofen axetil fat emulsion injection, which can solve impurities and pollution, large particle size, and reduce the safety of flurbiprofen axetil fat emulsion injection and other problems to achieve the effect of reducing equipment requirements, product safety, and improving safety

Inactive Publication Date: 2021-10-29
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the prior art, in order to meet the smaller particle size of flurbiprofen axetil fat emulsion injection, micro jet flow is usually used during homogenization. Although the particle size meets the requirements, the equipment requirements are high, and a homogenizer is used for preliminary Although the homogenization treatment of milk does not require high equipment, if the homogenization process cannot be reasonably controlled, it will easily lead to a large particle size, and it is difficult to use the existing technology in the production process of flurbiprofen axetil fat emulsion injection. The pH is controlled at weak acidity, which often requires post-adjustment. Adjusting the pH value in the later stage may introduce impurities and pollution, which reduces the safety of flurbiprofen axetil fat emulsion injection

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Flurbiprofen axetil fat emulsion injection production technology, comprises the following steps:

[0034] S1. Water phase preparation: Glycerin and disodium hydrogen phosphate are prepared into water phase with water for injection, citric acid is used to adjust the pH value of the water phase to 9-10, and the temperature of the water phase is controlled at 70-80°C;

[0035] specifically:

[0036] Add about 25,000 ml of water for injection into the glycerin tank, and put in 1.989Kg of glycerin (for injection) and disodium hydrogen phosphate (Na 2 HPO 4 ) 25.2g and an appropriate amount of citric acid. Close the feeding port, evacuate to below -0.04Mpa, and then fill with nitrogen, repeat this process for more than 4 times, and finally maintain positive pressure with nitrogen. Turn on the glycerin pump, filter the glycerin solution in the glycerin tank to the water phase tank through a cartridge filter (polypropylene filter element, 0.22um), after the glycerin solution...

Embodiment 2

[0054] This embodiment is based on embodiment 1, and the difference with embodiment 1 is:

[0055] In step S1, the temperature of the water phase is controlled at 60-70°C, in step S2, the temperature of the oil phase is controlled at 75-80°C, and the temperature of the emulsion is controlled at 60-70°C.

[0056] The flurbiprofen axetil fat emulsion injection prepared in the present embodiment is detected in particle size and pH value, and the detection results are:

[0057] The particle size is 160-220nm, and the pH value is 6.3-6.6.

[0058] By the data of embodiment 1 and embodiment 2 as can be known:

[0059] The emulsions prepared by the process of the present invention are all weakly acidic, and the human body needs intravenous injection, and the consistency of the emulsion is good (narrow particle size range); under the premise of the temperature control range of the present invention, the lower temperature will not affect The consistency of the emulsion, but the avera...

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Abstract

The invention discloses a production technology of a flurbiprofen axetil fat emulsion injection. The production technology comprises the following steps of: S1, water phase preparation: preparing a water phase from glycerol and disodium hydrogen phosphate by using water for injection, adjusting the pH value of the water phase to 9-10 by using citric acid, and controlling the temperature of the water phase at 60-80 DEG C; S2, oil phase preparation: mixing soybean oil, flurbiprofen axetil and egg yolk lecithin to prepare an oil phase, and heating the oil phase to 75-85 DEG C; S3, primary emulsion preparation: adding the oil phase prepared in the step S2 into the water phase prepared in the step S1 in a stirring state to prepare emulsion, and controlling the temperature of the emulsion at 60-85 DEG C; and S4: homogenizing the emulsion obtained in the step S3 through a homogenizer, dividing homogenization into three stages, wherein the pressure of first homogenization is 160 / 100 bar, the pressure of second to sixth homogenization is 800 / 100 bar, and the pressure of seventh homogenization is 160 / 100 bar. The particle size and the pH value of the flurbiprofen axetil fat emulsion injection prepared by the technology disclosed by the invention can meet the requirements of the human body, and the requirement on equipment is not high.

Description

technical field [0001] The invention relates to the technical field of injection production, in particular to a production process of flurbiprofen axetil fat emulsion injection. Background technique [0002] Flurbiprofen axetil is a non-steroidal intravenous targeted analgesic drug, which is an ester prodrug of flurbiprofen. Compared with flurbiprofen, flurbiprofen axetil can avoid adverse reactions such as gastric mucosal damage caused by oral administration through intravenous injection. It has the advantages of long-lasting effect, strong selectivity, short onset time, and does not affect the recovery of patients. It is widely used It is used in the treatment of clinical inflammatory pain, cancer pain and postoperative pain. [0003] Fat emulsion injection is a heterogeneous liquid preparation, which is a thermodynamically unstable system. During the preparation process, demulsification and stratification may occur due to high temperature sterilization. After demulsific...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/24A61K47/44A61K47/12A61K31/222A61P29/00
CPCA61K9/107A61K9/0019A61K47/24A61K47/44A61K47/12A61K31/222A61P29/00
Inventor 刘思川王云川刘文军谭鸿波郭晓英王亮
Owner SICHUAN KELUN PHARMA CO LTD
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