Stabilized oil-in-water emulsion of vinca alkaloids for vein and production thereof

A vinca alkaloid and oil-in-water emulsion technology, which is applied to medical preparations containing active ingredients, drug combinations, and pharmaceutical formulas, and can solve the problems of not being able to contact the skin, easily causing vasculitis, and inconvenient clinical application , to achieve the effect of less toxicity, less adverse reactions, and reduce the stimulation of blood vessels

Inactive Publication Date: 2005-10-12
JIANGSU QINGJIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Currently commercially available vinorelbine preparations include small injections and powder injections. However, for a long time, vinorelbine has serious adverse reactions in clinical application, which can easily cause vasculitis and cannot be in contact with the skin; there are also many inconveniences in clinical application.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Under the protection of nitrogen, weigh 50g of soybean oil for injection and heat it to 70°C. Under high-speed stirring, add 5g of egg yolk lecithin and 0.1g of vinorelbine bitartrate, stir evenly as the oil phase; add 10g of glycerin for injection into 600ml injection In water, mix well and filter with a 0.45 μm filter membrane as the water phase. Add the oil phase to the water phase under high speed stirring to make colostrum. Measure the pH value to 6.0, add water for injection to 1000ml, homogenize repeatedly through a high-pressure homogenizer, and check the size of the milk particles. The particle size of all particles is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, sealed, and sterilized by rotary steam. After cooling, vinorelbine bitartrate emulsion injection was obtained after passing the inspection.

Embodiment 2

[0030]Under the protection of nitrogen, weigh 300g of soybean oil for injection and heat it to 80°C. Under high-speed stirring, add 30g of egg yolk lecithin, 3g of vinblastine, and 50g of benzyl alcohol, and stir evenly as the oil phase; add 50g of glycerin for injection into 600ml injection In water, mix well and filter with a 0.45 μm filter membrane as the water phase. Add the oil phase to the water phase under high speed stirring to make colostrum. Measure the pH value to be 8.0, add water for injection to 1000ml, homogenize repeatedly through a high-pressure homogenizer, and check the size of the milk particles. The particle size of all particles is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, sealed, and sterilized by rotary steam. After cooling, the vinblastine emulsion injection was obtained.

Embodiment 3

[0032] Under nitrogen protection, weigh 100g of soybean oil for injection and heat it to 75°C. Under high-speed stirring, add 12g of egg yolk lecithin, 1g of vinorelbine, and 10g of benzyl alcohol, and stir evenly as the oil phase; add 22.5g of glycerin for injection 600ml water for injection, mix well and filter with a 0.45μm filter membrane as the water phase. Add the oil phase to the water phase under high speed stirring to make colostrum. Measure the pH value to 5.0, add water for injection to 1000ml, homogenize repeatedly through a high-pressure homogenizer, and check the size of the milk particles. The particle size of all particles is less than 1 μm. After the emulsion is filtered, it is filled with nitrogen, sealed, and sterilized by rotary steam. After cooling, vinorelbine emulsion injection was obtained.

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PUM

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Abstract

A stable oil-in-water emulsion of vinorelbine for intravenous injection is prepared from vinorelbine, the oil for injection, emulsifier, and the water for injection. Its advantages are high tageting function, low poison, and high safety.

Description

technical field [0001] The invention relates to an emulsion and a preparation method thereof, in particular to a stable oil-in-water emulsion of vinca alkaloid (vinorelbine) for intravenous infusion and a preparation method thereof. Background technique [0002] Vinorelbine (NVB) is a kind of alkaloid extracted from periwinkle, semi-synthesized tartrate of Vinca alkaloid, is a new broad-spectrum anticancer drug. Its mechanism of action is basically the same as that of vinblastine (VLB) and vincristine (VCR), mainly by blocking the formation of microtubules in the process of cell mitosis, so that cell division stops in the metaphase of mitosis, and it is a cell cycle specific drug. Like other vinblastines, vinorelbine also inhibits amino acid back-and-forth cycling and glutathione metabolism. The main function of vinorelbine is to bind to tubulin, thus making the formation of microtubules in cells during mitosis difficult. NVB is a cycle-specific drug, its effect is similar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/475A61P35/00
Inventor 张喜全晏彩霞蔡紫阳张来芳
Owner JIANGSU QINGJIANG PHARMA
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