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Fat emulsion injection and preparation method thereof

A technology for injection and fat emulsion, which is applied in the field of fat emulsion injection and its preparation, can solve the problems of poor emulsion stability and achieve the effects of improving stability, reducing adverse reactions, and increasing uniformity

Active Publication Date: 2015-07-01
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The above two methods are to add sodium oleate into the water phase and then mix it with the oil phase to homogenize. This method has a wide distribution of emulsion particles, and the content of emulsion particles less than 0.1um is more, so the stability of the emulsion poor

Method used

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  • Fat emulsion injection and preparation method thereof
  • Fat emulsion injection and preparation method thereof
  • Fat emulsion injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0046] Example 1 Preparation of fat emulsion injection of the present invention

[0047] Oil phase preparation: take one or more of soybean oil, olive oil, medium-chain triglycerides and fish oil, heat to 60~85℃, add lecithin, stir and disperse to obtain; water phase preparation: add glycerin In a proper amount of water for injection, stir to dissolve and heat to 60~85℃ to obtain; mix the oil phase and water phase and add the water for injection to the prepared amount. After a two-step high-pressure homogenizer complete the higher pressure homogenization step, the homogenization pressure The first-stage valve is 400-800bar, the second-stage valve is 0-200bar, the number of homogenization is less than 4 times, the homogenization temperature is 50-65℃, add sodium oleate solution and proper amount of sodium hydroxide solution, and use after mixing. The two-step high-pressure homogenizer completes the lower pressure homogenization step, homogenizing once, the homogenizing pressure is...

Embodiment 2

[0048] Example 2 Preparation of fat emulsion injection of the present invention

[0049] Oil phase preparation: take one or more of soybean oil, olive oil, medium-chain triglycerides and fish oil, and heat to 60~85℃ to obtain; water phase preparation: add glycerin to water for injection, stir to dissolve Then heat to 60~85℃, add lecithin, stir and disperse to obtain; mix the oil phase and the water phase, add water for injection to the preparation amount, complete the higher pressure homogenization step through a two-step high-pressure homogenizer, homogenize The pressure is 400-800bar for the primary valve, 0-200bar for the secondary valve, the number of homogenization is less than 4, the homogenization temperature is 50-65℃, add sodium oleate solution and appropriate amount of sodium hydroxide solution, and mix well. Use a two-step high-pressure homogenizer to complete the higher-pressure homogenization step, homogenize once, the homogenization pressure is 120-200bar for the fi...

Embodiment 3

[0050] Example 3 Preparation of fat emulsion injection of the present invention

[0051] Oil phase preparation: take one or more of soybean oil, olive oil, medium-chain triglycerides and fish oil, heat to 60~85℃, add lecithin, stir and disperse to obtain; water phase preparation: add glycerin Mix the oil phase and the water phase and add the water for injection to the prepared amount after mixing and dissolving in an appropriate amount of water for injection. After a two-step high-pressure homogenizer, the homogenization pressure is 400~ 800bar, the secondary valve is 0~200bar, the homogenization frequency is 2~4 times, the homogenization temperature is 50~65℃, and the homogenization pressure is adjusted to 120~200bar for the primary valve and 0~200bar for the secondary valve. 1 time. Add sodium oleate solution and an appropriate amount of sodium hydroxide solution, stir well, fill the emulsion into an infusion bottle / bag, fill with nitrogen, stopper, press the lid, and keep it ...

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Abstract

The invention provides a fat emulsion injection. The fat emulsion injection is prepared from an oil phase, an aqueous phase, a stabilizer and a pH regulator, wherein the oil phase contains one or more of soybean oil, medium chain triglyceride, olive oil and fish oil; in the fat emulsion injection, emulsion particles with particle size more than or equal to 0.1 micron account for more than 80% and emulsion particles with particle size more than or equal to 1.0 micron account for 0%. The invention also provides a method for preparing the fat emulsion injection. The invention can better relieve the problem of relatively narrow emulsion particle distribution, enhance the uniformity of the emulsion particles and improve the stability of the fat emulsion injection; and the adverse reaction of the emulsion agent is reduced and administration safety is enhanced.

Description

Technical field [0001] The invention relates to a fat emulsion injection and a preparation method thereof. Background technique [0002] Fat emulsion injection has developed to the third generation. The first generation is fat emulsion injection (C14-24), and the second generation mainly includes medium / long-chain fat emulsion injection (C6-24) and fish oil fat emulsion injection. And long-chain fat emulsion injection (OO), the latest generation of fat emulsion mainly includes structured fat emulsion injection, multiple oil fat emulsion injection and fish oil medium / long-chain fat emulsion injection. Sodium oleate has been added to the fat emulsion injection from the second generation. Sodium oleate mainly acts as a stabilizer in the emulsion, enhancing the emulsification ability. [0003] The key technology of emulsion preparation: use one oil or several oils to mix and emulsify and homogenize to make stable emulsion particles with an average particle size of 200-500 nanometers ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K36/32A61K35/60A61K36/48A61K31/22A61P3/02
Inventor 孔繁贵赵栋胡思玉王利春王晶翼刘革新刘思川
Owner SICHUAN KELUN PHARMA CO LTD
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