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Pharmaceutical composition containing water-soluble vitamins for injection, fat-soluble vitamins for injection and medium/long-chain fat emulsion injection

A fat-soluble vitamin and water-soluble vitamin technology, applied in the field of medicine, can solve the problems of inability to use patients, instability of soybean oil and lecithin, insufficient synthesis amount and the like

Inactive Publication Date: 2015-03-11
海南顿斯医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

③ Most of the vitamins cannot be synthesized by the body or the amount of synthesis is insufficient to meet the needs of the body and must be obtained from food frequently
④The human body has very little requirement for vitamins, and the daily requirement is often calculated in milligrams (mg) or micrograms (μg), but once it is deficient, it will cause corresponding vitamin deficiency and cause damage to human health
[0009] However, the common fat emulsion injection used in the pharmaceutical composition in the above-mentioned patent documents has only soybean oil, lecithin and glycerin, which can only provide parenteral nutrition energy and essential fatty acids, and the energy supply is relatively slow. It cannot be used for those patients who lack or reduce the activity of carnitine transport enzyme, and the soybean oil and lecithin are unstable due to the ingredients, and the curative effect is not good

Method used

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  • Pharmaceutical composition containing water-soluble vitamins for injection, fat-soluble vitamins for injection and medium/long-chain fat emulsion injection
  • Pharmaceutical composition containing water-soluble vitamins for injection, fat-soluble vitamins for injection and medium/long-chain fat emulsion injection
  • Pharmaceutical composition containing water-soluble vitamins for injection, fat-soluble vitamins for injection and medium/long-chain fat emulsion injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Example 1 Preparation of fat-soluble vitamin (I) for injection

[0089] (1) Weigh 0.69g vitamin A, 6.4g vitamin E, 10mg vitamin D 2 , 0.2g Vitamin K 1 , 150g Tween 80, 50g Tween 20 and 80g absolute ethanol, stir and mix until the main ingredient is completely dissolved, then add 1800ml of water for injection, stir well, add 160g of mannitol, stir to dissolve, add water for injection up to 2000ml;

[0090] (2) Adjust the pH value to 6.0 with 1mol / L sodium hydroxide solution, add 0.61g of activated carbon to stir for adsorption, and filter for decarbonization;

[0091] (3) Fine filtration, sub-packaging, 2ml / bottle;

[0092] (4) Freeze drying,

[0093] a. Pre-freezing: Cool down the packaged medicinal solution to -40°C at a rate of 2°C / min, and keep it warm for 3 hours;

[0094] b. Sublimation: Vacuumize the pre-frozen drug to 15Pa, then slowly raise the temperature to -20°C within 8 hours at a uniform rate, keep it warm for 2 hours, and then raise the temperature ...

Embodiment 2

[0096] Example 2 Preparation of fat-soluble vitamin (II) for injection

[0097] (1) Weigh 0.99g vitamin A, 9.1g vitamin E, 5mg vitamin D 2 , 0.15g Vitamin K 1 , 200g Tween 80, 60g Tween 20 and 120g absolute ethanol, stir and mix until the main ingredient is completely dissolved, then add 1800ml of water for injection, stir well, add 160g of mannitol, stir to dissolve, add water for injection up to 2000ml;

[0098] (2) Use 1mol / L sodium hydroxide solution to adjust the pH to 6.1, add 0.60g of activated carbon to stir for adsorption, and filter for decarbonization;

[0099] (3) Fine filtration, sub-packaging, 2ml / bottle;

[0100] (4) Freeze drying,

[0101] a. Pre-freezing: Cool down the packaged medicinal solution to -40°C at a rate of 2°C / min, and keep it warm for 3 hours;

[0102] b. Sublimation: Vacuumize the pre-frozen drug to 15Pa, then slowly raise the temperature to -20°C within 8 hours at a uniform rate, keep it warm for 2 hours, and then raise the temperature to...

Embodiment 3

[0104] Example 3 Preparation of Sterile Powder Injection of Water-Soluble Vitamins for Injection

[0105] (1) Weigh vitamin B respectively 1 3.1g, vitamin B 2 4.9g, Niacinamide 40g, Vitamin B 6 4.9g, sodium pantothenate 16.5g, vitamin C sodium 113g, biotin 60mg, folic acid 0.4g, vitamin B 12 5mg, 300g of glycine, 0.5g of disodium edetate, 0.5g of methyl p-hydroxybenzoate, add 2400ml of water for injection, stir well, adjust the pH value to 6.2 with 1mol / L sodium hydroxide solution or hydrochloric acid solution, The raw and auxiliary materials are completely dissolved, add water for injection to 3000ml, add 0.9g of activated carbon for adsorption, and filter for decarbonization;

[0106] (2) Fine filtration, sub-packaging, 3ml / bottle;

[0107] (3) Freeze drying:

[0108] a. Pre-freezing: Cool down the packaged medicinal solution to -40°C at a rate of 2°C / min, and keep it warm for 3 hours;

[0109] b. Sublimation: Vacuumize the pre-frozen drug to 15Pa, then slowly raise ...

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Abstract

The invention relates to a pharmaceutical composition containing water-soluble vitamins for injection, fat-soluble vitamins for injection and a medium / long-chain fat emulsion injection, particularly a combined applied package, which comprises water-soluble vitamins for injection, fat-soluble vitamins for injection and a medium / long-chain fat emulsion injection. When in use, the water-soluble vitamins for injection and fat-soluble vitamin aseptic powder injection for injection are dissolved and transferred into the medium / long-chain fat emulsion injection for intravenous infusion. The combined applied package comprehensively supplements vitamins and essential fatty acids required by the human body, avoids the defect due to use of a single vitamin and fatty acid, and greatly enhances the treatment effect.

Description

technical field [0001] The invention relates to a pharmaceutical composition of vitamins and fat emulsion, in particular to a pharmaceutical composition of water-soluble vitamins for injection, fat-soluble vitamins for injection and medium / long-chain fat emulsion injection, belonging to the technical field of medicine. Background technique [0002] Vitamins are a type of trace organic substances necessary for humans and animals to maintain normal physiological functions. They play an important role in the growth, metabolism, and development of the human body. When humans and animals lack vitamins, they cannot grow normally and develop specific lesions. The so-called vitamin deficiency. [0003] Vitamins are also known as vitamins. Generally speaking, they are life-sustaining substances. They are a type of organic substances necessary to maintain human life activities, and are also important active substances to maintain human health. Vitamins are present in small amounts in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/714A61K9/107A61P3/02A61K31/07A61K31/51A61K31/525A61K31/455A61K31/4415A61K31/197A61K31/375A61K31/4188A61K31/519A61K31/592A61K31/355A61K31/122
Inventor 王平
Owner 海南顿斯医药科技有限公司
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