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Fat emulsion injection for supplementing fat-soluble vitamins

A technology for vitamins and injections, applied in the fields of fat-soluble vitamin injections, medicine box products, emulsion-type injections, and preservation of the fat-soluble vitamin injections, which can solve the problems of increasing costs

Active Publication Date: 2013-04-17
西安安健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Now these drugs have stricter storage conditions after they are put on the market. For example, the fat-soluble vitamin injection (I) and the fat-soluble vitamin injection (II) produced by Wuxi Huarui Pharmaceutical Co., Ltd. above are stipulated to be stored at "2-10°C". Preservation and / or storage in a "cold place", this stricter storage condition will invisibly increase a lot of costs for this clinical routine drug

Method used

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  • Fat emulsion injection for supplementing fat-soluble vitamins
  • Fat emulsion injection for supplementing fat-soluble vitamins
  • Fat emulsion injection for supplementing fat-soluble vitamins

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0095] Preparation Example 1: Preparation of emulsion type injection of the present invention (Type I)

[0096] Ingredients in 10ml bottle

[0097] Vitamin A

0.69mg

Vitamin D2

10μg

Vitamin E

6.4mg

Vitamin K1

0.2mg

Soybean Oil for Injection

1g

Lecithin for Injection

0.12g

Glycerin

0.22g

sodium hydroxide

Appropriate amount, adjust the pH value to 8.0±0.2

Water for Injection

Appropriate amount, add to 10ml.

[0098] Wherein the vitamin A is fed in the form of vitamin A palmitate, and the dosage of each bottle calculated by vitamin A in the formula table is 0.69mg, and the context of the present invention has the same meaning as this.

[0099] Preparation Process:

[0100] (1) Weigh vitamin A palmitate, vitamin D2, vitamin E, and vitamin K according to the prescription amount 1 , soybean oil (for injection), egg yolk lecithin, glycerin (for injection), spare;

[0101] ...

preparation example 2

[0108] Preparation Example 2: Preparation of Emulsion Injection (Type II) of the present invention

[0109] Ingredients in 10ml bottle

[0110] Vitamin A

0.99mg

Vitamin D2

5μg

Vitamin E

9.1mg

Vitamin K1

0.15mg

Soybean Oil for Injection

1g

Lecithin for Injection

0.12g

Glycerin

0.22g

sodium hydroxide

Appropriate amount, adjust the pH value to 8.0±0.2

Water for Injection

Appropriate amount, add to 10ml.

[0111] Wherein vitamin A is fed in the form of vitamin A palmitate, and its every feeding amount calculated by vitamin A palmitate is 1.815mg (equivalent to vitamin A being 0.99mg), and the context of the present invention has the same meaning as this.

[0112] Preparation method is the same as embodiment 1. The above formula and process produced three batches in total, the batch numbers are: II-101, II-102, and II-103.

preparation example 3

[0113] Preparation Example 3: Preparation of emulsion type injection of the present invention

[0114] Ingredients in 10ml bottle

[0115] Vitamin A

[0116] sodium hydroxide

[0117] Preparation method is the same as embodiment 1. After inspection / determination, the content of active ingredients in the emulsion type injection is within the range of 95-105% of the labeled amount, and various physical properties such as emulsion particle size, appearance, pH value, etc. are in line with general emulsions, especially fat-soluble ones. The standards for vitamin injection (I) or (II) stipulate that, for example, the product is a milky white emulsion with a pH value of 7.5 to 8.5, measured by light scattering method, no more than 4% of the milk particles larger than 1 μm, and no inspection Produce milk particles larger than 5 μm.

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Abstract

The invention relates to fat emulsion injection for supplementing fat-soluble vitamins. The injection is emulsion type injection, wherein the injection comprises four lipophilic vitamins. The invention further relates to a method for treating the emulsion type injection. According to the fat emulsion injection for supplementing fat-soluble vitamins, the method for supplementing fat-soluble vitamins is beneficial to clinical medication.

Description

technical field [0001] The invention relates to a fat emulsion injection for supplementing fat-soluble vitamins, in particular to a fat-soluble vitamin injection, in particular to an emulsion containing four fat-soluble vitamins: vitamin A, vitamin D2, vitamin E and vitamin K1 type injection. The invention also relates to a method for preserving the fat-soluble vitamin injection and a medicine box product comprising the fat-soluble vitamin injection. Background technique [0002] The fat-soluble vitamin injections that have been used clinically in China to supplement the daily physiological needs of fat-soluble vitamin A, vitamin D2, vitamin E, and vitamin K1 mainly include fat-soluble vitamin injection (I) and fat-soluble vitamin injection Liquid (II). For example, Wuxi Huarui Pharmaceutical Co., Ltd. produces fat-soluble vitamin injection (I) (National Medicine Approval H32023003), which is mainly suitable for children under 11 years old and infants, and is used to meet ...

Claims

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Application Information

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IPC IPC(8): A61K31/592A61K31/355A61K31/122A61K31/07A61K9/107A61P3/02
Inventor 曾韶辉傅卫国周丽梅黄伟静贺立泽
Owner 西安安健药业有限公司
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