A kind of vitamin K1 injection and preparation method thereof

A vitamin and injection technology, applied in the field of pharmaceutical preparation technology, to achieve the effect of high clinical medicinal safety

Active Publication Date: 2018-02-16
张蕊 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • A kind of vitamin K1 injection and preparation method thereof

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Experimental program
Comparison scheme
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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PUM

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Abstract

The invention discloses a vitamin K1 injection and a preparation method thereof. It is prepared from active ingredient vitamin K1, auxiliary materials and water for injection. 80% of the water for injection is taken and anhydrous sodium acetate is added to obtain solution A; Take the formula amount of vitamin K1 and HS15 into a clean and anhydrous container, emulsify evenly to obtain solution B; slowly add solution A to solution B, add sodium metabisulfite, stir evenly, and then adjust the pH to 5.8-6.2 with glacial acetic acid; Supplement water for injection to the full amount of the formula, filter, fill with nitrogen and then sterilize by rotation at 121°C for 12 minutes or aseptic preparation method. Compared with the existing vitamin K1 injection, the product prepared by the invention not only complies with the pharmacopeia standard of the vitamin K1 injection, but also greatly improves the clarity of the product.

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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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/14A61K31/122A61P3/02
Inventor 张蕊金洪伟梁加莉
Owner 张蕊
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