Leurocristine sulfate liposome compositions, and its prepn. method

A technology of vincristine sulfate and composition, which is applied in the directions of liposome delivery, drug combination, and pharmaceutical formulation, and can solve the problems of vincristine sulfate neurotoxicity, bone marrow suppression, tissue necrosis, etc., so as to improve curative effect and Clinical use compliance, reduction of toxic side effects, reduction of neurotoxicity or bone marrow suppression

Active Publication Date: 2005-01-05
诺桥制药(成都)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Vincristine sulfate for injection has greater neurotoxicity and bone marrow suppression, and has a certain degree of irritation. Repeated injections can cause phlebitis, and leakage to the outside of the blood vessel during injection can cause toxic side effects such as local tissue necrosis.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Dissolve 900 grams of phospholipids and 260 grams of cholesterol in 3000 milliliters of absolute ethanol under sterile conditions, pass through a 0.22 μm filter membrane to sterilize, put the filtrate in a container for rotary evaporation, and pump it dry under reduced pressure to form a film.

[0021] Dissolve 80 grams of citric acid and 140 grams of disodium hydrogen phosphate in 6000 ml of 5% glucose injection, sterilize with a 0.22 μm filter membrane, then add the solution to the above container to wash the membrane, and perform high-pressure homogenization.

[0022] Take 4 grams of vincristine sulfate and dissolve it in 5500 ml of 10% glucose injection, and add it to the above solution, stir evenly, pass through a 0.22 μm filter membrane to sterilize, and carry out according to the content of 1 mg and 2 mg of vincristine sulfate in each bottle. Aliquoted and freeze-dried. After freeze-drying, fill it with nitrogen, argon or helium, press the plug, take it out of th...

Embodiment 2

[0025] Under sterile conditions, dissolve 550 grams of phospholipids and 180 grams of cholesterol in 2500 milliliters of absolute ethanol, pass through a 0.22 μm filter membrane to sterilize, put the filtrate in a container for rotary evaporation under reduced pressure, and drain to form a film.

[0026] Dissolve 40 grams of citric acid and 80 grams of disodium hydrogen phosphate in 4000 ml of 5% glucose injection, pass through a 0.22 μm filter membrane to sterilize, then add the solution to the above container to wash the membrane, and perform high-pressure homogenization.

[0027] Take 2.5 grams of vincristine sulfate and dissolve it in 1500 milliliters of 10% glucose injection, and add it to the above solution to sterilize through a 0.22 μm filter membrane. According to each bottle of 1 mg, 2 mg of vincristine sulfate for sub-packaging, freeze-dried. After freeze-drying, fill it with nitrogen, argon or helium, press the plug, take it out of the box, crimp it, and stick a la...

Embodiment 3

[0030] Under sterile conditions, dissolve 400 grams of phospholipids and 125 grams of cholesterol in 2000 milliliters of absolute ethanol, pass through a 0.22 μm filter membrane to sterilize, put the filtrate in a container for rotary evaporation under reduced pressure, and drain to form a film.

[0031] Dissolve 30 grams of citric acid and 60 grams of disodium hydrogen phosphate in 2500 ml of 5% glucose injection, pass through a 0.22 μm filter membrane to sterilize, then add this solution to the above container to wash the membrane, and perform high-pressure homogenization.

[0032] Take 2 grams of vincristine sulfate and dissolve it in 1500 ml of 10% glucose injection, and add it to the above solution to sterilize through a 0.22 μm filter membrane. According to each bottle of 1 mg, 2 mg of vincristine sulfate for sub-packaging, freeze-dried. After freeze-drying, fill it with nitrogen or argon or helium, press the plug, take it out of the box, crimp it, and stick a label.

...

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PUM

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Abstract

A lipid composition of vincristine sulfate in the form freeze dried powder for intravenous injection or drip is prepared from the vincristine sulfate, phosphatide and cholesterin.

Description

technical field [0001] The invention relates to an anticancer drug vincristine sulfate liposome composition and a preparation method thereof. technical background [0002] Vincristine sulfate is an alkaloid sulfate extracted from the vinca flower of the Apocynaceae plant. It is a drug widely used in combination chemotherapy for tumors. It is a cycle-specific drug. Its anti-tumor effect is to prevent microtubule bundles Polymerization and depolymerization caused by affinity with microtubule bundles, vincristine sulfate is commonly used in the treatment of acute and chronic leukemia, malignant lymphoma, small cell lung cancer and breast cancer, and also in the treatment of testicular tumors and ovarian cancer. my country is rich in vincristine resources. [0003] Vincristine sulfate for injection has greater neurotoxicity and bone marrow suppression, and has certain irritation. Repeated injections can cause phlebitis, and leakage to the outside of blood vessels during injecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/475A61P35/00
Inventor 翁帼英庄翌陈文忠程光程培元
Owner 诺桥制药(成都)有限责任公司
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