Method for treating coagulation disorders by adopting vitamin K1 fat milk injection

A vitamin and fatty acid technology, applied in the field of medicine

Active Publication Date: 2019-05-17
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

Although vitamin K1 cannot directly act on pathogenic bacteria, it can enhance the effect of certain antibiotics, thereby inhibiting the growth of pathogenic bacteria

Method used

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  • Method for treating coagulation disorders by adopting vitamin K1 fat milk injection
  • Method for treating coagulation disorders by adopting vitamin K1 fat milk injection
  • Method for treating coagulation disorders by adopting vitamin K1 fat milk injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0178] Preparation Example 1: Preparation of Emulsion Composition

[0179] Composition formula:

[0180]

[0181] Preparation method:

[0182] (1) Weigh vitamin K1, soybean oil (for injection), egg yolk lecithin, glycerin (for injection) according to the prescription, and set aside.

[0183] (2) Preparation of the water phase: add about 80% of the water for injection into a stainless steel tank, and add glycerin (for injection) in the prescribed amount while stirring.

[0184] (3) Preparation of the oil phase: Add the prescribed amount of soybean oil (for injection) into another stainless steel tank, feed nitrogen flow, add the prescribed amount of vitamin K1 and egg yolk lecithin, and stir until the egg yolk lecithin is dissolved.

[0185] (4) Preparation of colostrum: Feed into the nitrogen stream, slowly add the oil phase to the high-speed stirring water phase, continue high-speed stirring for at least 5 minutes, adjust the pH value of the solution to the specified v...

preparation example 2

[0189] Preparation Example 2: Preparation of Emulsion Composition

[0190] Composition formula:

[0191]

[0192] Preparation method: refer to the method recorded in Preparation Example 1.

preparation example 3

[0193] Preparation Example 3: Preparation of Emulsion Composition

[0194] Composition formula:

[0195]

[0196] Preparation method: refer to the method recorded in Preparation Example 1.

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Abstract

The invention relates to a method for treating coagulation disorders by adopting a vitamin K1 fat milk injection. Particularly, an emulsion composition is prepared from vitamin K1, soybean oil, phospholipid, glycerinum and water. The emulsion composition is prepared through technologies of preparing a water phase, preparing an oil phase, preparing crude milk, performing high pressure emulsifying,performing hot-pressing sterilizing and the like. The method further comprises the step of detecting related substances, in particular to an impurity B on the emulsion composition obtained after hot-pressing sterilizing. The invention further relates to pharmaceutical application of the emulsion composition for treating coagulation disorders caused by dyssynthesis of coagulation factors II, VII, IX and X caused by medicine intervention of vitamin K deficiency or vitamin K activity interference. The invention further relates to a method for determining related substances, particularly the impurity B in the vitamin K1 composition through an HPLC method. The emulsion composition has one or more technical effects shown in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a fat emulsion injection, in particular to a fat emulsion injection containing vitamin K1. The present invention further relates to the method for preparing the fat emulsion injection of the present invention. The present invention further relates to the use of the prepared vitamin K1 fat emulsion injection, especially for coagulation disorders caused by vitamin K deficiency or drug intervention that interferes with the activity of vitamin K and coagulation factors II, VII, IX and X. . Further, the present invention relates to a method for quality testing of the vitamin K1 fat emulsion injection. Background technique [0002] Vitamin K1 (Vitamin K1, Phytonadione) 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 inso...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/44A61K47/24A61K47/10A61K47/12A61K31/122A61P7/04G01N30/02G01N30/06
Inventor 傅卫国梁庆王伟
Owner 西安安健药业有限公司
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