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A kind of long-chain fat emulsion injection containing olive oil and preparation method thereof

A technology for long-chain fat emulsion and injection, which can be used in medical preparations containing active ingredients, emulsion delivery, and medical preparations with non-active ingredients, etc. Guarantee, easy oxidation of oil phase components, etc., to achieve the effect of convenient nitrogen filling, excellent long-term stability, and increased drug safety

Inactive Publication Date: 2018-11-30
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Regarding the long-chain fat emulsion injection, CN103690478 discloses a long-chain fat emulsion injection containing olive oil and a preparation method thereof. Specifically, the oil phase components are stirred and mixed, and after stirring with the water phase to form colostrum, the homogenized Obtain liquid medicine, fill, seal and then sterilize to obtain the finished product; in this technology, adopt 30-60 ℃ temperature and the mode of stirring to prepare the oil phase, and obtain the colostrum with the mode of stirring, find through the experiment of the technician of the present invention, ①In the oil phase preparation process, the temperature of 30-60°C is used, and the lecithin is difficult to dissolve; in addition, the colostrum is prepared by stirring, and the stirring force is not enough, resulting in poor stability of the colostrum in the later stage, and the oil floating phenomenon of the finished product is obvious, and the long-term stability Poor, safety of medication can not be fully guaranteed; 2. oil phase component is easily oxidized in this prescription, and finished product oxidation impurity is high, and medication safety is low; CN104739764A discloses a kind of fat emulsion injection and preparation method thereof, in this method The oil phase and the water phase are subjected to high-pressure homogenization to obtain an emulsion. The high-pressure homogenization of this technology needs to be carried out in different liquid mixing tanks, which is not conducive to the nitrogen filling operation, and the finished product has high oxidation impurities. On the other hand, the emulsion product prepared by this method There is oil floating phenomenon, poor long-term storage stability, and low drug safety

Method used

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  • A kind of long-chain fat emulsion injection containing olive oil and preparation method thereof
  • A kind of long-chain fat emulsion injection containing olive oil and preparation method thereof
  • A kind of long-chain fat emulsion injection containing olive oil and preparation method thereof

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Effect test

Embodiment 1

[0028] (1) Prescription

[0029]

[0030] (2) Preparation process

[0031] ①Preparation of the water phase: Weigh the prescribed amount of glycerin and add it to the water for injection, stir to dissolve, add sodium hydroxide dropwise to adjust the pH value of the water phase, place it in a water bath at 70°C and fill it with nitrogen to keep it warm, and set aside;

[0032] ②Preparation of the oil phase: Put the oil phase components, including olive oil, soybean oil, oleic acid, egg yolk lecithin, Pluronic F68, and ascorbyl palmitate into a beaker, shear at high speed for 10 minutes, and then place it in Stir with nitrogen in a water bath at 70°C until a homogeneous transparent liquid is obtained;

[0033] ③ In a 70°C water bath, the oil phase and the water phase are mixed evenly under the protection of nitrogen flow through high-speed shearing to obtain colostrum;

[0034] ④ Place the obtained colostrum in an ultrasonic emulsification machine for emulsification under th...

Embodiment 2

[0037] (1) Prescription

[0038]

[0039] (2) Preparation process

[0040] ①Preparation of the water phase: Weigh the prescribed amount of glycerin and add it to the water for injection, stir to dissolve, add sodium hydroxide and hydrochloric acid dropwise to adjust the pH value of the water phase, place it in a water bath at 60°C and fill it with nitrogen to keep warm, and set aside;

[0041] ②Preparation of the oil phase: Put the oil phase components, including olive oil, soybean oil, oleic acid, egg yolk lecithin, Pluronic F68, and ascorbyl palmitate into a beaker, shear at high speed for 10 minutes, and then place it in Stir with nitrogen in a water bath at 60°C until a homogeneous transparent liquid is obtained;

[0042] ③ In a 60°C water bath, the oil phase and the water phase are mixed evenly under the protection of nitrogen flow through high-speed shearing to obtain colostrum;

[0043] ④ Place the obtained colostrum in an ultrasonic emulsification machine for emul...

Embodiment 3

[0046] (1) Prescription

[0047]

[0048]

[0049] (2) Preparation process

[0050] ①Preparation of the water phase: Weigh the prescribed amount of glycerin and add it to the water for injection, stir to dissolve, add sodium citrate and sodium malate dropwise to adjust the pH value of the water phase, place it in a water bath at 80°C and fill it with nitrogen to keep it warm. spare;

[0051] ②Put the oil phase components, including olive oil, soybean oil, oleic acid, egg yolk lecithin, Pluronic F68, ascorbyl palmitate, and ascorbyl acetate into a beaker, shear at high speed for 15 minutes, and then place it at 80 ℃ in a water bath filled with nitrogen and stirred until a homogeneous transparent liquid was obtained;

[0052] ③In a water bath at 80°C, the oil phase and the water phase are mixed evenly under the protection of nitrogen flow through high-speed shearing to obtain colostrum;

[0053] ④ place the obtained colostrum in an ultrasonic emulsification machine and ...

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Abstract

The invention belongs to the field of pharmaceutical preparations, in particular to a long-chain fat emulsion injection containing olive oil and a preparation method thereof. The fat emulsion comprises an oil phase composed of olive oil, soybean oil and an emulsifier, an aqueous phase composed of water for injection and glycerin, an oleic acid stabilizer, a pH regulator and a fat-soluble antioxidant; the fat emulsion injection consists of water The phase and the oil phase are prepared by ultrasonic emulsification, and the average particle size is about 280±20nm. The invention solves the problems of uneven particle size distribution and oil floating in fat emulsion, greatly reduces the residual oxygen in the emulsion and the oxidation degree of oil phase components, increases the long-term stability of fat emulsion injection, and reduces the adverse effects of patients. reaction, increasing drug safety.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a long-chain fat emulsion injection containing olive oil and a preparation method thereof. Background technique [0002] Long-chain fat emulsion injection (OO) was first launched in Europe in 1996, and then successively launched in Portugal, Germany, Australia, the United Kingdom, Israel, Canada and other countries. In 2006, it was approved for import in my country. (Clinnuo)". The fat emulsion injection is made by mixing olive oil and soybean oil in a certain ratio, which provides essential fatty acids for human body, and is an important part of parenteral nutrition support and an important source of energy. [0003] Regarding the long-chain fat emulsion injection, CN103690478 discloses a long-chain fat emulsion injection containing olive oil and a preparation method thereof. Specifically, the oil phase components are stirred and mixed, and after stirring with the wat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/24A61K47/10A61K47/22A61K36/63A61P3/02
CPCA61K9/0029A61K9/107A61K36/63A61K47/10A61K47/22A61K47/24
Inventor 张颖杨春芬李鹏赫红曲延伟
Owner JINAN KANGHE MEDICAL TECH
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