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Vinca alkaloid nano emulsion injection and preparation method thereof

A vinca alkaloid and nanoemulsion technology, which is applied in emulsion delivery, drug combination, drug delivery, etc., can solve the unsolved problems such as the reconstitution stability of freeze-dried products, improve clinical tolerance, reduce venous Stimulation, the effect of improving the encapsulation rate of the product

Inactive Publication Date: 2010-11-10
SHANGHAI HENGRUI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Publication No. CN1634058A vinorelbine emulsion and freeze-dried emulsion, a freeze-dried product was invented. Although freeze-dried milk is a research hotspot in the field of emulsions, the problem of reconstitution stability of freeze-dried products has not yet been solved

Method used

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  • Vinca alkaloid nano emulsion injection and preparation method thereof
  • Vinca alkaloid nano emulsion injection and preparation method thereof
  • Vinca alkaloid nano emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Vinorelbine 0.05%

[0051] soybean oil 2%

[0052] Yolk Lecithin 1%

[0053] Under the protection of an inert gas, stir 20g of soybean oil for injection to form an oil phase, and add 10g of egg yolk lecithin to 600ml of water for injection, and stir to form a water phase. Under high-speed stirring, mix the oil phase and water phase evenly. And homogenized by a high-pressure homogenizer to make colostrum, add 0.5g of vinorelbine, adjust the pH value to 8.0, add water to set the volume to 1000ml, stir fully, take samples for microscopic inspection, until the average particle size is below 100nm; filling, filling Nitrogen, fusion seal.

Embodiment 2

[0055] The preparation method is the same as in Example 1, except that the dosage of vinorelbine is 50 g, that of soybean oil is 300 g, and that of egg yolk lecithin is 200 g.

Embodiment 3

[0057] Vinorelbine Tartrate 0.05%

[0058] soybean oil 5%

[0059] Yolk Lecithin 5%

[0060] Glucose 5%

[0061] Sodium Oleate 0.1%

[0062] Under the protection of an inert gas, stir 50g of soybean oil for injection to form an oil phase, and add 50g of egg yolk lecithin, 50g of glucose and 1g of sodium oleate into 600ml of water for injection, and stir to form a water phase. The oil phase and the water phase are mixed evenly, and are homogenized by a high-pressure homogenizer to make colostrum, add 0.5g of vinorelbine tartrate, adjust the pH value to 4.0, add water to make it 1000ml, stir well, take a sample for microscopic examination, and reach the average particle size The diameter is below 100nm; filling, filling with nitrogen, and sealing.

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Abstract

The invention provides a nano emulsion injection containing vinca alkaloid, especially vinorelbine, and a preparation method thereof. The nano emulsion injection has the average grain diameter of smaller than 100nm, not only can reduce the pharmaceutical simulation of a vinorelbine injection but also can improve the concentration of the vinorelbine in a product and meanwhile has higher targeted performance.

Description

technical field [0001] The invention relates to a nanoemulsion injection and a preparation method thereof, in particular to a vinca alkaloid nanoemulsion injection and a preparation method thereof. Background technique [0002] Vinorelbine is a semi-synthetic vinblastine drug. As a representative drug of the third generation of vinblastine, it has strong antitumor activity, definite curative effect, and less neurotoxicity than other vinblastine alkaloids such as vinblastine. It is widely used clinically and has many combined drug regimens. It is more effective for non-small cell lung cancer and breast cancer. It is convenient to administer, and the variety is mature, and the market sales are strong. The current marketed product in China is Vinorelbine Tartrate Injection (trade name: Novoribine cover Minno ) and soft capsules, there are no other dosage forms on the market. [0003] Since the common injection currently on the market is an acidic hypertonic solution, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/475A61K47/44A61P35/00
CPCA61K31/475A61K9/1075A61K9/0019A61P35/00
Inventor 仝新勇王海凤崔双进于力
Owner SHANGHAI HENGRUI PHARM CO LTD
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