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Orally taken vitamin K1 lipid emulsion

A vitamin and emulsion technology, applied in the field of medicine, can solve problems such as difficulty in compliance and inapplicability to infants and young children swallowing patients.

Active Publication Date: 2012-09-19
广东安健医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] However, the existing route of administration of vitamin K1 mainly focuses on injection, which is more difficult for patients to comply with than oral administration, but oral administration makes people more difficult in terms of drug bioavailability. face the challenge
In addition, although VK1 tablets have been used clinically, this kind of tablet is suitable for some adults, but it is not suitable for infants and patients who have difficulty swallowing

Method used

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  • Orally taken vitamin K1 lipid emulsion
  • Orally taken vitamin K1 lipid emulsion
  • Orally taken vitamin K1 lipid emulsion

Examples

Experimental program
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Effect test

preparation example Construction

[0110] In the emulsion compositions prepared by the following preparation examples and comparative examples of the present invention, if not otherwise stated, parameters such as the number of times and time of homogenization of the homogenizer are adjusted so that the particle size of the final milk (before sterilization) is controlled. In the following range: more than 90% of the emulsion particles have a particle size between 0.1 and 2.0 μm, and among the total number of emulsion particles with a particle size greater than or equal to 1 μm, less than 10% of the emulsion particles have a particle size greater than 5 μm (light scattering method, wet method).

[0111] A, composition preparation example part: prepare the emulsion composition of the present invention

preparation example 1

[0112] Preparation Example 1: Preparation of the emulsion composition of the present invention

[0113] Composition formula:

[0114] Vitamin K1 1.0g,

[0115] soybean oil 10g,

[0116] Egg yolk lecithin 1.2g,

[0117] Glycerin 2.2g,

[0118] Mannitol 2.5g,

[0119] pH adjuster Appropriate amount, adjust the pH value to 6.5,

[0120] Appropriate amount of water, add to 100ml.

[0121] Preparation method:

[0122] (1) Take vitamin K1, soybean oil, egg yolk lecithin, glycerin, and mannitol according to the prescription amount, and set aside.

[0123](2) Preparation of the water phase: add about 80% of the water for injection into a stainless steel tank, and add glycerin in the prescribed amount while stirring.

[0124] (3) Preparation of the oil phase: Add the prescribed amount of soybean oil into another stainless steel tank, pass through nitrogen flow, add the prescribed amount of vitamin K1 and egg yolk lecithin, and stir until the egg yolk lecithin is dissolved.

...

preparation example 2

[0129] Preparation Example 2: Preparation of the emulsion composition of the present invention

[0130] Composition formula:

[0131] Vitamin K1 1.0g,

[0132] soybean oil 10g,

[0133] Egg yolk lecithin 1.2g,

[0134] Propylene glycol 2.5g,

[0135] Mannitol 2.5g,

[0136] Appropriate amount of pH adjuster, adjust the pH value to 5,

[0137] Appropriate amount of water, add to 100ml.

[0138] Preparation method: refer to the method recorded in Preparation Example 1.

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Abstract

The invention relates to an orally taken vitamin K1 lipid emulsion, in particular to an emulsion compound. The orally taken vitamin K1 lipid emulsion comprises 0.5-2 percent of vitamin K1, 5-15 percent of soybean oil, 0.5-2 percent of phospholipid, 1-5 percent of low alcohol, 1-5 percent of saccharides and water. The invention also relates to a method for preparing the emulsion compound. The vitamin K1 emulsion compound provided by the invention meets the properties of common pharmaceutics, can be orally administered, is enough in bioavailability and can be suitable for a wider range of people including infants.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a fat emulsion, in particular to a vitamin K1 fat emulsion which can be used orally. The present invention further relates to a method for preparing the fat emulsion of the present invention. Background technique [0002] Vitamin K1 is a yellow to orange clear viscous liquid, odorless or almost odorless, easy to decompose when exposed to light. Vitamin K1 is easily soluble in chloroform, ether or vegetable oil, slightly soluble in ethanol, and insoluble in water. The chemical name of vitamin K1 is: trans and cis isomerization of 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione A mixture of solids, its molecular formula: C31H46O2, molecular weight: 450.71, and its structural formula is: [0003] [0004] Vitamin K1 is a fat-soluble vitamin widely found in green plants in the form of phylloquinone, which can also be synthesized artificially. Vitamin K1 was...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/122A61K47/44A61P1/16A61P7/04A61P11/00A61P17/16A61P19/10A61P21/02A61P35/00
Inventor 傅卫国周丽梅梅丹王伟
Owner 广东安健医药有限公司
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