Vitamin K1 fat emulsion injection

A vitamin and emulsion technology, applied in the field of medicine

Active Publication Date: 2019-05-28
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 t...

Method used

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  • Vitamin K1 fat emulsion injection
  • Vitamin K1 fat emulsion injection
  • Vitamin K1 fat emulsion injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0100] Preparation Example 1: Preparation of Emulsion Composition

[0101] Composition formula:

[0102]

[0103] Preparation method:

[0104] (1) Weigh vitamin K1, soybean oil (for injection), egg yolk lecithin, glycerin (for injection) according to the prescription, and set aside.

[0105] (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.

[0106] (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.

[0107] (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

[0111] Preparation Example 2: Preparation of Emulsion Composition

[0112] Composition formula:

[0113]

[0114] Preparation method: refer to the method recorded in Preparation Example 1.

preparation example 3

[0115] Preparation Example 3: Preparation of Emulsion Composition

[0116] Composition formula:

[0117]

[0118] Preparation method: refer to the method recorded in Preparation Example 1.

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Abstract

The invention relates to a vitamin K1 fat emulsion injection. Particularly, the emulsion composition comprises a vitamin K1, soybean oil, phospholipid, glycerin and water. The composition is preparedby processes of preparation of a aqueous phase, preparation of an oil phase, preparation of a coarse emulsion, high-pressure emulsification, hot press sterilization and the like. The invention furtherrelates to a method for preparing the emulsion composition and pharmaceutical application of the emulsion composition. The emulsion injection is used for insufficiency of the vitamin K or coagulationdisorder diseases caused by dyssynthesis of coagulation factors II, VII, IX and X, which are generated due to pharmacological intervention interfering the activity of the vitamin K. The emulsion composition disclosed by the invention shows one or various technical effects as shown in the specification. For example, the composition can be used according to a dose of 10mg each time, 1 to 2 times per day and a total dose of 40mg at most in 24 hours, and an administration dosage and frequency are regulated according to prothrombin time response or clinical symptoms; the using mode is intravenousadministration, infusion can directly adopt intravenous injection without dilution, or the vitamin K1 fat emulsion injection is subjected to intravenous dripping after being diluted with 5% glucose injection.

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. 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 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] At present, the 2015 edition of the Chinese Pharmacopoeia contains the raw materials and injections of vitami...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/122A61K47/44A61K47/12A61P7/04
Inventor 傅卫国梁庆王伟
Owner 西安安健药业有限公司
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