A kind of 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, increasing uniformity, and reducing adverse reactions

Active Publication Date: 2017-10-27
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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  • A kind of fat emulsion injection and preparation method thereof
  • A kind of fat emulsion injection and preparation method thereof
  • A kind of fat emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The preparation of embodiment 1 fat emulsion injection of the present invention

[0047] Preparation of oil phase: Take one or more of soybean oil, olive oil, medium-chain triglycerides and fish oil, heat to 60-85°C, add lecithin, stir and disperse to obtain; water phase preparation: Take glycerin and add Add an appropriate amount of water for injection, stir to dissolve, and then heat to 60-85°C; mix and stir the oil phase and water phase, add water for injection to the prepared amount, and complete the higher-pressure homogenization step through a two-step high-pressure homogenizer. The first-stage valve is 400-800 bar, the second-stage valve is 0-200 bar, the number of homogenization is within 4 times, and the homogenization temperature is 50-65 ° C. Add sodium oleate solution and appropriate amount of sodium hydroxide solution, mix well before use The two-step high-pressure homogenizer completes the lower-pressure homogenization step, homogenizing once, the homogeni...

Embodiment 2

[0048] The preparation of embodiment 2 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 it to 60-85°C to get ready; water phase preparation: add glycerin to an appropriate amount of water for injection, stir to dissolve After heating to 60-85°C, add lecithin, stir and disperse to obtain; mix and stir the oil phase and water phase, add water for injection to the prepared amount, and complete the higher-pressure homogenization step through two steps of high-pressure homogenizer, homogenization The pressure is 400-800bar for the first-stage valve, 0-200bar for the second-stage valve, the number of homogenization is within 4 times, and the homogenization temperature is 50-65°C. Add sodium oleate solution and appropriate amount of sodium hydroxide solution, mix well and then Use a two-step high-pressure homogenizer to complete the higher-pressure homogenizati...

Embodiment 3

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

[0051] Preparation of oil phase: Take one or more of soybean oil, olive oil, medium-chain triglycerides and fish oil, heat to 60-85°C, add lecithin, stir and disperse to obtain; water phase preparation: Take glycerin and add Add an appropriate amount of water for injection, stir to dissolve and then heat to 60-85°C; mix and stir the oil phase and water phase, add water for injection to the prepared amount, and pass through a two-step high-pressure homogenizer, the homogenization pressure is 400-400 °C for the first-stage valve 800bar, the secondary valve is 0-200bar, the number of homogenization is 2-4 times, the homogenization temperature is 50-65°C, and then adjust the homogenization pressure to be 120-200bar for the first-stage valve, and 0-200bar for the second-stage valve 1 time. Add sodium oleate solution and an appropriate amount of sodium hydroxide solution, stir well, fill the emulsi...

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Abstract

The invention provides a fat emulsion injection, which is prepared from raw materials including an oil phase, a water phase, a stabilizer and a pH regulator, the oil phase contains soybean oil, medium-chain triglycerides One or more of , olive oil and fish oil; in the fat emulsion injection, the content of emulsion particles with a particle size ≥ 0.1um is more than 80%, and the content of emulsion particles with a particle size ≥ 1.0um is 0%. The invention also provides a method for preparing the fat emulsion injection. The invention can well reduce the problem of wide distribution of emulsion particles, increase the uniformity of emulsion particles, improve the stability of fat emulsion injection, reduce the adverse reaction of emulsion, and increase the safety of medication.

Description

technical field [0001] The invention relates to a fat emulsion injection and a preparation method thereof. Background technique [0002] Fat emulsion injection has been developed to the third generation so far, the first generation is fat emulsion injection (C14-24), the second generation mainly includes medium / long chain fat emulsion injection (C6-24), fish oil fat emulsion injection and long-chain fat emulsion injection (OO), the latest generation of fat emulsion mainly includes structured fat emulsion injection, various oil fat emulsion injection and fish oil medium / long-chain fat emulsion injection. Sodium oleate has been added to fat emulsion injections since the second generation. Sodium oleate mainly acts as a stabilizer in the emulsion and enhances the emulsifying ability. [0003] The key technology of the preparation of the emulsion: use one oil or several oils to mix and emulsify and homogenize to make stable emulsion particles with an average particle size of 2...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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