Vitamin K1 injection and preparation method thereof
What is Al technical title?
Al technical title is built by PatSnap Al team. It summarizes the technical point description of the patent document.
A vitamin and injection technology, which can be applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as unsatisfactory clarity.
Active Publication Date: 2013-12-25
成都原研医药科技有限公司
View PDF4 Cites 5 Cited by
Summary
Abstract
Description
Claims
Application Information
AI Technical Summary
This helps you quickly interpret patents by identifying the three key elements:
Problems solved by technology
Method used
Benefits of technology
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 ...
Method used
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more
Image
Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
Click on the blue label to locate the original text in one second.
Reading with bidirectional positioning of images and text.
Smart Image
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0014] Measure 800ml of water for injection, add 10.0g of anhydrous sodium acetate, dissolve and stir evenly to obtain solution A; sequentially weigh 10.0g of vitamin K1 (converted pure), 50.0g of HS15 and 20g.0g of propylene glycol into a clean anhydrous container, stir, 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 3.0g of sodium metabisulfite, stir well, then adjust the pH to 6.01 with glacial acetic acid; add water for injection to 1000ml, filtered, filled with nitrogen, sealed, and sterilized by rotation at 121°C for 12 minutes. (Specification: 1ml: 10mg)
Embodiment 2
[0016] Measure 800ml of water for injection, add 10.0g of anhydrous sodium acetate, dissolve and stir evenly to obtain solution A; sequentially weigh 10.0g of vitamin K1 (converted pure), 50.0g of HS15 and 20g.0g of propylene glycol into a clean anhydrous container, stir, 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 3.0g of sodium metabisulfite, stir well, then adjust the pH to 6.01 with glacial acetic acid; add water for injection To 1000ml, filtered, filled with nitrogen, potted, and prepared by aseptic method. (Specification: 1ml: 10mg)
Embodiment 3
[0018] Measure 800ml of water for injection, add 10.0g of anhydrous sodium acetate, dissolve and stir evenly to obtain solution A; sequentially weigh 10.0g of vitamin K1 (converted pure), 70.0g of HS15 and 20g.0g of propylene glycol into a clean anhydrous container, stir, 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 3.0g of sodium metabisulfite, stir well, then adjust the pH to 6.08 with glacial acetic acid; add water for injection to 1000ml, filtered, filled with nitrogen, sealed, and sterilized by rotation at 121°C for 12 minutes. (Specification: 1ml: 10mg)
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more
PUM
Login to view more
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...
Claims
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more
Application Information
Patent Timeline
Application Date:The date an application was filed.
Publication Date:The date a patent or application was officially published.
First Publication Date:The earliest publication date of a patent with the same application number.
Issue Date:Publication date of the patent grant document.
PCT Entry Date:The Entry date of PCT National Phase.
Estimated Expiry Date:The statutory expiry date of a patent right according to the Patent Law, and it is the longest term of protection that the patent right can achieve without the termination of the patent right due to other reasons(Term extension factor has been taken into account ).
Invalid Date:Actual expiry date is based on effective date or publication date of legal transaction data of invalid patent.
Login to view more 
Login to view more