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Pharmaceutical composition injection of compound liposoluble vitamin and preparation method thereof

A fat-soluble vitamin and composition technology, which is applied in the field of fat-soluble vitamin injection and its preparation, and achieves the effects of highlighting substantive characteristics, making significant progress, and avoiding adverse effects.

Inactive Publication Date: 2013-10-16
刘时灵
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the ingredients contained in fat-soluble vitamins are sticky and difficult to dissolve, especially insoluble in water, K-type vitamins are resistant to heat and water, and are easily oxidized and damaged by light (ultraviolet rays). General additives such as co-solvents cannot help them Dissolved in water to form a clear solution, the antioxidant effect of antioxidants is not satisfactory. Therefore, when fat-soluble vitamins are prepared into injections, the solubility should be improved, no additional excipients should be added, and the stability of oxidized components should be maintained. The stability of the clear solution after placement is an important issue that needs to be solved

Method used

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  • Pharmaceutical composition injection of compound liposoluble vitamin and preparation method thereof
  • Pharmaceutical composition injection of compound liposoluble vitamin and preparation method thereof
  • Pharmaceutical composition injection of compound liposoluble vitamin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] A pharmaceutical composition injection of compound fat-soluble vitamins, the raw material is composed of:

[0083]

[0084]

[0085] and the remaining amount of water for injection;

[0086] The obtained product is 1000ml injection.

[0087] The preparation method includes (total dispensing volume is 1000ml):

[0088](1) Measure 50-80% of the total dosage of water for injection, and prepare 150-200ml of 95% ethanol solution;

[0089] (2) Dissolve vitamin D2 and fat-soluble antioxidant in an appropriate amount of (1) ethanol solution, pour into melted Solutol Hs15 and mix well;

[0090] (3) Melt vitamin A palmitate by ultrasonic, then add the melted A palmitate, vitamin E and vitamin K1 to the solution obtained in (2), and stir until it becomes a clear solution;

[0091] (4) Add the water for injection of (1) into the clear solution obtained in (3) at least twice, and mix well; the water for injection is added in a way that the amount of water for injection is i...

Embodiment 2

[0095] A pharmaceutical composition injection of compound fat-soluble vitamins, the raw material is composed of:

[0096]

[0097] The above-mentioned composition also includes the remaining amount of water for injection, and the obtained product is 1000ml injection.

[0098] The preparation method includes (total dispensing volume is 1000ml):

[0099] (1) Measure 50-80% of the total dosage of water for injection, and prepare 150-200ml of 95% ethanol solution;

[0100] (2) Dissolve vitamin D2 and fat-soluble antioxidant in an appropriate amount of (1) ethanol solution, pour into melted Solutol Hs15 and mix well;

[0101] (3) Add vitamin A palmitate, vitamin E and vitamin K1 to the solution of (2), add the remaining amount of ethanol, and stir until it is clear;

[0102] (4) Add the water for injection of (1) to the clear solution obtained in (3), and mix well;

[0103] (5) adding activated carbon to the solution obtained in (4), then decarburizing and filtering;

[0104...

Embodiment 3

[0106] A pharmaceutical composition injection of compound fat-soluble vitamins, the raw material is composed of:

[0107]

[0108] The above-mentioned composition also includes the remaining amount of water for injection, and the obtained product is 1000ml injection.

[0109] The preparation method (total dispensing volume is 1000ml) is the same as in Example 1.

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PUM

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Abstract

The invention provides composite fat-soluable vitamin injection which is composed of the following raw materials: 0.5-1g of vitamin A palmitate, 0.001-0.005g of vitamin D2, 5-10g of vitamin E, 1.0+ / -0.1g of vitamin K1, 50-80g of Solutol Hs 15 and proper amount of fat-soluable antioxygen. The fat-soluable vitamin injection can be totally placed under the normal-temperature and normal environment, can be always kept to be clear within the shelf life of the injection, and has no particles or phenomena of turbidity, layering and other unstable states.

Description

technical field [0001] The invention relates to a pharmaceutical composition injection of compound fat-soluble vitamins and a preparation method, in particular to a fat-soluble vitamin injection and a preparation method thereof. Background technique [0002] Vitamins are trace amounts of low-molecular-weight organic compounds necessary to maintain the body's life activities. There are many types and different chemical structures. It is neither the main raw material for various tissues nor the source of energy in the body. However, it plays a very important role in the reaction of energy production and the regulation of the body's metabolism. effect. [0003] According to different solubility, vitamins are divided into two categories: water-soluble and fat-soluble. Fat-soluble vitamins refer to vitamins that are insoluble in water and can be stored in the body after absorption. Fat-soluble vitamins include vitamin A (retinol), vitamin D, vitamin E, and vitamin K. The charac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/592A61K47/34A61K9/08A61P3/02A61K31/23A61K31/355A61K31/122
Inventor 李静李慧
Owner 刘时灵
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