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Vitamin K1 injection and preparation method thereof

A vitamin and injection technology, which is used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., to achieve the effect of high clinical medicinal safety.

Active Publication Date: 2016-02-03
张蕊 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The patent application with application number 201310416999.3 discloses a vitamin K1 injection and its preparation method. Vitamin K1 injections made of ketone esters (HS15 for short) as solubilizers are safer than commercially available vitamin K1 injections, but as injections, there is still room for further improvement in clarity

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  • Vitamin K1 injection and preparation method thereof

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Effect test

Embodiment 1

[0016] Measure 800ml of water for injection, add 10.0g of anhydrous sodium acetate, dissolve and stir evenly to obtain solution A; successively weigh 10.0g of vitamin K1 (pure), 71.0g of HS15 into a clean anhydrous container, stir to make it completely emulsified and uniform To obtain solution B; slowly add solution A to solution B, and stir while adding, after stirring completely, add 3.0 g of sodium metabisulfite, stir evenly, then adjust the pH to 6.03 with glacial acetic acid; add water for injection to 1000ml, filter , filled with nitrogen and then sterilized by rotation at 121°C for 12 minutes. (Specification: 1ml: 10mg)

Embodiment 2

[0018] Measure 800ml of water for injection, add 10.0g of anhydrous sodium acetate, dissolve and stir evenly to obtain solution A; successively weigh 10.0g of vitamin K1 (pure), 71.0g of HS15 into a clean anhydrous container, stir to make it completely emulsified and uniform To obtain solution B; slowly add solution A to solution B, and stir while adding, after stirring completely, add 3.0 g of sodium metabisulfite, stir evenly, then adjust the pH to 6.03 with glacial acetic acid; add water for injection to 1000ml, filter , filled with nitrogen and sealed, prepared by aseptic method. (Specification: 1ml: 10mg)

Embodiment 3

[0020] Measure 800ml of water for injection, add 10.0g of anhydrous sodium acetate, dissolve and stir evenly to obtain solution A; successively weigh 10.0g of vitamin K1 (pure), 75.0g of HS15 into a clean anhydrous container, stir to make it completely emulsified and uniform To obtain solution B; slowly add solution A to solution B, and stir while adding, after stirring completely, add 3.0 g of sodium metabisulfite, stir evenly, then adjust the pH to 6.00 with glacial acetic acid; add water for injection to 1000ml, filter , filled with nitrogen and then sterilized by rotation at 121°C for 12 minutes. (Specification: 1ml: 10mg)

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Abstract

The invention discloses vitamin K1 injection and preparation method thereof. The vitamin K1 injection is prepared from vitamin K1 which is an active ingredient, auxiliary materials and water for injection. The preparation method comprises the following steps of taking the water for injection accounting for 80% of a formula ratio and adding anhydrous sodium acetate to obtain a solution A; sequentially weighing the vitamin K1 of the formula ratio and HS15 of the formula ratio, feeding the vitamin K1 and the HS15 in a clean container without water and emulsifying evenly to obtain a solution V; slowly adding the solution A in the solution B, then adding sodium pyrosulfite, evenly stirring, and regulating pH with a glacial acetic acid to be 5.8-6.2; and replenishing the water for injection until the water for injection fills up the total formula ratio, filtering, carrying out rotary sterilization for 12 minutes at the temperature of 121 DEG C or sterile preparation after nitrogen filling encapsulation to obtain the vitamin K1 injection. Compared with the existing vitamin K1 injection, the product prepared by the preparation method conforms to a vitamin K1 injection pharmacopoeia criterion, and clarity of the product is greatly improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a vitamin K1 injection and a preparation method thereof. Background technique [0002] Vitamin K1 as: Mixture of trans and cis isomers of 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione . HS-15 is: polyethylene glycol 15-hydroxystearate. Vitamin K1 injection is used for ischemia caused by vitamin K deficiency, such as hemorrhage caused by obstructive jaundice, biliary fistula, chronic diarrhea, etc., hypoprothrombinemia caused by coumarins, sodium salicylate, etc. , neonatal hemorrhage and vitamin K deficiency caused by long-term use of broad-spectrum antibiotics. [0003] Vitamin K1 injection is one of the commonly used clinical drugs. From January 1, 2004 to May 31, 2011, there were 893 serious adverse reactions / event reports of vitamin K1 injection in the case report database of the National Center for Adverse Drug Reaction Monitori...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/34A61K31/122A61P3/02
Inventor 张蕊金洪伟梁加莉
Owner 张蕊
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