Fat emulsion injection and production method thereof

A production method and injection technology, which are applied in the field of fat emulsion injection and its production, can solve the problems of high content of methoxyaniline, affecting output, production capacity, and large emulsion particles of the drug solution, so as to reduce the value of methoxyaniline , Improve production capacity, reduce the effect of milk particle size

Active Publication Date: 2010-05-05
ANHUI FENGYUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current production process has many times of homogenization, large liquid emulsion, high content of methoxyaniline which is harmfu

Method used

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  • Fat emulsion injection and production method thereof
  • Fat emulsion injection and production method thereof
  • Fat emulsion injection and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Fat emulsion injection production method of the present invention:

[0016] Under the protection of nitrogen, add the prescription amount of soybean oil into the container, heat it in a water bath to 65-70°C, add lecithin and oleic acid, and disperse it by high-speed shearing for 10 minutes to prepare an oil phase; in addition, appropriate amount of water for injection (60 ~65°C) in the container, add the prescribed amount of glycerin (for injection) and stir to make a water phase, add an appropriate amount of 1mol / L sodium hydroxide solution, and circulate and filter through a 0.45μm filter membrane for 15 minutes to make water Mutually. Mix the oil phase and the water phase in a certain proportion through a high-speed shearing machine, add water for injection to the full amount, and then pass through the high-speed shearing machine for 10 minutes of shearing cycle, stir well to form the initial emulsion, and the temperature of the initial emulsion is controlled at 50-...

Embodiment 2

[0018] Effects of different oleic acid dosages on emulsion stability:

[0019] Experimental method: Taking the pH value of the emulsion, the particle size of the emulsion, the zeta potential, and the appearance (floating oil) as the evaluation indicators, the German lecithin (Lipoid-E80) was selected as the emulsifier, and different amounts of oleic acid were added as the co-emulsifier , according to the above-mentioned new process preparation fat emulsion injection, the gained sample is placed under light (4500 ± 500lx) and 60 ℃ conditions respectively for 10 days, investigates the change of each index, the results are shown in Table 1.

[0020] Table 1 Effect of different amounts of oleic acid on the stability of milk particles

[0021]

[0022]

[0023] Note: *Floating oil "+" means there is floating oil, "+" means the degree of floating oil, "-" means no floating oil

[0024] Results and discussion: After the prepared samples were subjected to light or accelerated a...

Embodiment 3

[0028] Effect of different colostrum temperature on emulsion stability:

[0029] The colostrum preparation temperature of fat emulsion injection is closely related to the quality and stability of the product. Therefore, we used pH, acid value, peroxide value, lysophospholipid, appearance, and milk particle size as evaluation indicators to investigate different See Table 2 for the effects of colostrum temperature (50, 60, 70°C) on the stability of fat emulsion injection.

[0030] Sample batch number: 080721-1 (colostrum temperature 50°C), 080721-2 (colostrum temperature 60°C), 080721-3 (colostrum temperature 70°C).

[0031] Table 2 Effect of different colostrum temperature on the stability of fat emulsion injection

[0032]

[0033] Note: *DV50 means the average particle size

[0034] *Floating oil "+" means there is floating oil, "+" means the degree of floating oil, "-" means no floating oil

[0035] The results in Table 2 show that different colostrum preparation tempe...

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Abstract

The invention relates to a fat emulsion injection and a manufacture method thereof. As the fat emulsion injection contains oleic acid, the fat emulsion injection can provide enough and stable emulsion particles when used as the auxiliary emulsifier so as to overcome the defects of oil floating, enlarged emulsion particles and the like of the emulsion. The method for manufacturing the fat emulsion injection adjusts the production technology in the production process by adding oleic acid in oil phase so as to improve the emulsifying capability, reduce the grain size of the emulsion particles, improve the stability of emulsion particles, reduce the value of methoxyaniline, reduce the number of homogenization, and improve the production yield.

Description

technical field [0001] The invention relates to a fat emulsion injection and a production method thereof, in particular to a fat emulsion injection with improved stability and a production method thereof. Background technique [0002] Fat emulsion injection is a compound preparation, which is a sterilized milky liquid made of soybean oil for injection emulsified by lecithin for injection and added glycerin for injection, which provides energy and essential fatty acids for the body, and prevents and treats essential fatty acid deficiency in humans. [0003] However, the stability of the existing fat emulsion injection is low, and large fat particles will appear as time and temperature change during heat sterilization and storage. On the other hand, various infusion medicaments are usually mixed and used, but the mixing during use has the problem of complicated operation and easy to be contaminated by bacteria. Therefore, the subject of research and development of pre-mixed fa...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/12A61K36/48A61P3/02A61K31/685
Inventor 方加林
Owner ANHUI FENGYUAN PHARM CO LTD
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