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Vitamin K1 injection and preparation method thereof

A technology for vitamins and injections, applied in anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., can solve the problems of poor stability, easy decomposition, and darkening of vitamin K1, and is suitable for industrial scale-up production, improving solubility, The effect of simple process

Active Publication Date: 2020-03-13
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the reasons for the adverse reactions caused by vitamin K1 injection may be related to the following: vitamin K1 itself has poor stability, it is easily decomposed when exposed to light, the color will deepen after long-term storage, and impurities will be generated when it is degraded; the auxiliary materials of vitamin K1 injection preparations contain Tween- 80. Propylene glycol, etc.
Among them, Tween-80 is a surfactant with relatively large side effects

Method used

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  • Vitamin K1 injection and preparation method thereof
  • Vitamin K1 injection and preparation method thereof
  • Vitamin K1 injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Example 1 Preparation of Vitamin K1 Mixed Micelle Solution and Injection

[0068] The specification of the injection to be prepared in this example is 1mL / bottle, each containing 10mg of the main drug vitamin K1, calculated on the basis of 1000 injections, the composition is as follows:

[0069]

[0070] The specific operation process is as follows:

[0071] (1) Weigh each component according to the stated ratio, put it in a beaker, add an appropriate amount of ethanol, put it in a water bath magnetic stirrer, heat to 40°C ± 2°C, stir, and dissolve until clear;

[0072] (2) heat the solution obtained in step (1) at 40°C ± 2°C, keep it away from light, pass nitrogen gas for 1-2 hours, and volatilize to remove ethanol to obtain a semi-solid mixture;

[0073] (3) Add 80% of the prescribed amount of water for injection to the semi-solid mixture obtained in step (2), adjust the pH to 5.4, continue to stir until clarified, make up the amount of water for injection to the ...

Embodiment 2

[0075] The physicochemical property test of embodiment 2 micelle solution

[0076] (1) Particle size and Zeta potential measurement

[0077] The solution containing vitamin K1 mixed micelles prepared in Example 1 was diluted to 0.5 mg / mL, and the average particle size of the micelles was measured by MalvernNano ZS90 Zetasizer, and the average particle size of the micelles was 9.7±2.0 nm.

[0078] (2) Morphological investigation

[0079] The diluted mixed micelle solution was added dropwise to the copper grid, counterstained with 2% sodium phosphotungstate solution, observed and photographed under a transmission electron microscope (TEM). The prepared mixed micelles are evenly distributed quasi-spherical entities (such as Figure 7 shown).

[0080] (3) Solution light transmittance test

[0081] Take the mixed micelle solution, and measure its light transmittance (%) at 600 nm by using a UV-visible spectrophotometer. The light transmittance of the solution was measured to b...

Embodiment 3

[0090] The 2-year stability study of embodiment 3 injection

[0091] The sterilized injection was prepared according to the method of Example 1, and a 2-year stability study was carried out, and the results are shown in Table 1.

[0092] Table 1 Stability data of vitamin K1 phospholipid / bile salt mixed micelles sterilized injection

[0093]

[0094] As can be seen from Table 1, the injection solution of the present invention has good stability, and the storage period can reach more than 2 years.

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Abstract

The invention relates to the field of medicines, and relates to a vitamin K1 injection and a preparation method thereof. In particular, the invention relates to a micelle solution and a preparation method thereof, and also relates to an injection containing the micelle solution and a preparation method thereof.

Description

technical field [0001] The invention relates to the field of medicine, in particular to the field of injection preparations. Background technique [0002] The chemical name of vitamin K1 is 2-methyl-3-(3,7,11,15-tetramethylhexade-2-enyl)-1,4-naphthoquinone, and the molecular formula is C 31 h 46 o 2 , the molecular weight is 450.71, and its structural formula is shown in the following formula. [0003] [0004] Vitamin K1 is a yellow to orange-yellow, transparent and viscous liquid with an odorless or almost odorless odor. It is extremely unstable under light conditions and easily decomposed. Vitamin K1 is easily soluble in solvents such as chloroform, ether or vegetable oil, slightly soluble in ethanol, almost insoluble in water, and its refractive index is 1.525-1.528. [0005] Vitamin K1 is an essential substance for the liver to synthesize prothrombin, and when it is deficient, it can cause coagulation disorders. When human blood lacks prothrombin, blood coagulat...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/28A61K47/24A61K31/122A61P7/04A61P29/00A61P1/06
CPCA61K9/1075A61K9/0019A61K47/28A61K47/24A61K31/122A61P7/04A61P29/00A61P1/06Y02A50/30
Inventor 全东琴王永安王涛王亚男李海燕申辽张亚丹
Owner ACADEMY OF MILITARY MEDICAL SCI
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