Vinorelbine liposome micro ball injection and its prepn

A technology of vinorelbine and lipid microspheres, which is applied in the field of medicine, can solve the problems of vinorelbine drug instability, inability to achieve vascular stimulating effect, and no provision, so as to reduce systemic toxicity, low irritation, and reduced toxicity Effect

Inactive Publication Date: 2006-05-17
沈阳东星医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0025] The patents of application number 200410065105.1 and application number 200510038178.6 provide a formula and preparation method for preparing vinorelbine emulsion for intravenous injection, but the vinorelbine drug in these patents is not effectively wrapped in the oil phase or interfacial film, Thereby it is impossible to reduce the irritation to blood vessels, improve the curative effect and other purposes; in addition, because vinorelbine is easy to oxidize and degrade, the instability of vinorelbine drug is also an important problem existing in the actual application of vinorelbine drug at present, the above Neither patent provides an effective solution

Method used

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  • Vinorelbine liposome micro ball injection and its prepn
  • Vinorelbine liposome micro ball injection and its prepn

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Prescription 4:

[0163] Oil Phase (Soybean Oil / Medium Chain Fatty Acid Triglyceride=2 / 8) 10%

[0164] Vinorelbine 0.1%

[0165] Lecithin 1.2%

[0166] Glycerin 2.5%

[0167] Sodium Oleate 0.1%

[0168] Tween-80 0.2%

[0169] 10-Hydroxy-2-decenoic acid 0.5%

[0170] Span80 0.1%

[0171] Ascorbic acid 0.1%

[0172] Vitamin E 0.05%

[0173] EDTA0.05%

[0174] Add water for injection to 100mL

[0175] Preparation method 4:

[0176] (1) Mix the prescribed amount of lecithin, Tween-80, glycerin, sodium oleate, ascorbic acid, EDTA with an appropriate amount of water for injection preheated at 70-80°C, transfer to a tissue masher, stir for a few minutes, 5 times , until the ingredients are uniformly dispersed to obtain the water phase; at the same time, add the prescribed amount of vitamin E, 10-hydroxy-2-decenoic acid, and Span80 to the mixed oil phase composed of medium-chain fatty acid triglycerides for injection and soybean oil for injection , heated at 70-80°C...

Embodiment 2

[0178] Prescription 5:

[0179] Soybean oil for injection 10%

[0180] Vinorelbine Tartrate 0.1%

[0181] Soy Lecithin 1.2%

[0182] Glycerin 2.5%

[0183] Tween-80 0.2%

[0184] Sodium Oleate 0.1%

[0185] 10-Hydroxy-2-decenoic acid 0.5%

[0186] Span80 0.1%

[0187] Sodium sulfite 0.2%

[0188] Vitamin E 0.05%

[0189] EDTA0.05%

[0190] Add water for injection to 100ml

[0191] Preparation method 5:

[0192] (1) Mix the prescribed amount of soybean lecithin, Tween-80, sodium oleate, glycerin, sodium sulfite, EDTA with an appropriate amount of water for injection preheated at 70-80°C, transfer to a tissue masher, stir for several minutes, 5 Repeat until the ingredients are uniformly dispersed to obtain the water phase; at the same time, add the prescribed amount of vitamin E, 10-hydroxy-2-decenoic acid, and Span80 to the prescribed amount of soybean oil for injection and heat to dissolve at 70-80°C to obtain the oil phase (2) Add the oil phase to the water phase,...

Embodiment 3

[0194] Prescription 6:

[0195] Oil Phase (Soybean Oil / Medium Chain Fatty Acid Triglyceride=2 / 8) 10%

[0196] Vinorelbine Tartrate 0.1%

[0197] Lecithin 1.2%

[0198] Glycerin 2.5%

[0199] Tween-80 0.2%

[0200] Sodium Oleate 0.1%

[0201] 10-Hydroxy-2-decenoic acid 0.5%

[0202] Span80 0.1%

[0203] L-cysteine ​​0.2%

[0204] Vitamin E 0.05%

[0205] EDTA0.05%

[0206] Add water for injection to 100ml

[0207] Preparation method 6:

[0208] (1) Mix the prescribed amount of lecithin, Tween-80, sodium oleate, glycerin, L-cysteine, EDTA with an appropriate amount of water for injection preheated at 70-80°C, and transfer it into a tissue masher, Stir for several minutes, 5 times, until the ingredients are evenly dispersed to obtain a water phase; at the same time, add the prescribed amount of vitamin E, 10-hydroxy-2-decenoic acid, and Span80 to the prescribed amount of soybean oil for injection and medium-chain fatty acid for injection Heat and dissolve the triglyce...

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Abstract

The present invention relates to one kind of vinorelbine liposome micro ball injection and its preparation process. The present invention has vinorelbine medicine in 90-98 % coated inside the oil phase and oil-water interface of liposome micro ball, reduces the clinical toxicity and irritation of vinorelbine greatly and raises its antitumor effect. The preparation of the present invention as one kind of antitumor injection has low irritation, low toxicity and high curative effect.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a vinorelbine lipid microsphere injection and a preparation method thereof. Background technique [0002] With the development and progress of medical technology, human beings have basically controlled the infectious diseases that threatened human health in the past, while non-communicable diseases such as tumors and cardiovascular and cerebrovascular diseases have gradually become the main enemy of human health. According to the report of the World Health Organization in 1997, in 1996, among the 5.8 billion people in the world, about 6.3 million people died of cancer, accounting for about 12% of the total number of deaths, of which nearly 60% died of lung cancer, gastric cancer, breast cancer, colorectal cancer, Oral cancer, liver cancer, cervical cancer and esophageal cancer are the second leading causes of death after cardiovascular disease. Since 1996, more than 10.3 millio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/475A61K9/127A61K9/16A61P35/00
Inventor 唐星赵少春漆新国
Owner 沈阳东星医药科技有限公司
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