Vitamin K1 injection and preparation method thereof

Abstract

The invention discloses a vitamin K1 injection and a preparation method thereof. The vitamin K1 injection is prepared from an active ingredient vitamin K1, additives and injection water. The preparation method comprises the following steps: adding anhydrous sodium acetate into 80% of formula amount of injection water to obtain a solution A; sequentially weighing and adding formula amount of vitamin K1, HS15 and propylene glycol into a clean and anhydrous container, and uniformly emulsifying to obtain a solution B; slowly adding the solution A into the solution B, adding sodium pyrosulfite, uniformly stirring, and then, adjusting the pH to 5.8-6.2 through glacial acetic acid; supplementing the injection water to the total formula amount, filtering, filling nitrogen, filling and sealing, and carrying out rotary sterilizing at 121 DEG C for 12 minutes to obtain the vitamin K1 injection, or preparing the vitamin K1 injection through an aseptic preparation method. Compared with the commercially available vitamin K1 injection, the vitamin K injection has the advantages that brand new formula and process are adopted, so that the prepared product not only meets the pharmacopoeia criterion of the vitamin K1 injection, and the safety of clinical use of the vitamin K1 injection is greatly improved as well.

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...

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Problems solved by technology

[0004] The patent application with application number 201310345643.5 discloses a vitamin K1 injection and its preparation method. The safety of vitamin K1 injections made of vitamin K1 injections made from esters, referred to as HS15) as a solubilizer is better than that of commercially available vitamin K1 injections, but its clarity is not ideal enough

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