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A kind of total bufolide liposome injection and preparation method thereof

A technology of total bufalinide and injection, applied in the directions of liposome delivery, antiviral agents, pharmaceutical formulations, etc., can solve the problems of being easily affected by the surrounding environment, drug leakage, unstable liposome properties, etc. , to achieve the effect of prolonging local aggregation, reducing toxicity and reducing vascular irritation

Active Publication Date: 2018-06-19
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, liposomes are unstable in nature, susceptible to the influence of the surrounding environment, and are prone to drug leakage during storage.

Method used

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  • A kind of total bufolide liposome injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The preparation of embodiment 1 total bufolide solid liposome injection

[0029] Dissolve 1g of total bufolide, 20g of soybean lecithin, 5g of cholesterol, and 0.2g of vitamin E in an appropriate amount of acetone and mix well; use a rotary evaporator to remove the organic solvent in the solution under reduced pressure, and form a lipid film on the glass wall ; Add pH7.4 phosphate buffer, stir for 30min, place at room temperature for 2h to make the film imbibition; then stir at room temperature for 2h to obtain a liposome suspension; Or ultrasonic dispersion treatment to homogenize liposomes; centrifuge the obtained total bufolide liposomes at 4000r / min for 15min, collect the supernatant and add isotonic aqueous solution for injection to 1000mL; remove bacteria and heat source through ultrafiltration membrane , potting, each 2mL, steam sterilization for 30 minutes, that is, the total bufolide liposome injection, stored at 0-4 ℃.

[0030] Detection: the vesicle encapsul...

Embodiment 2

[0031] The preparation of embodiment 2 total bufolide solid liposome injection

[0032] Dissolve 1g of total bufolide, 20g of egg yolk lecithin, 5g of cholesterol, and 0.2g of vitamin E in an appropriate amount of acetone and mix well; use a rotary evaporator to remove the organic solvent in the solution under reduced pressure, and form a lipid on the glass wall film; add pH7.4 phosphate buffer, stir for 30min, place at room temperature for 2h to make the film swell; stir at room temperature for 2h to obtain a liposome suspension; the obtained liposome suspension is subjected to high pressure emulsification Homogenize or ultrasonically disperse the liposomes; centrifuge the obtained total bufolide liposomes at 4000r / min for 15min, collect the supernatant and add isotonic aqueous solution for injection to 1000mL; remove bacteria and Heat source, potting, 2mL per vial, steam sterilization for 30min to obtain total bufolide liposome injection, and store at 0-4°C.

[0033] Detect...

Embodiment 3

[0034] The preparation of embodiment 3 total bufolide solid liposome injection

[0035]Dissolve 1 g of total bufolide, 20 g of distearyl phosphatidylglycerol, 5 g of cholesterol, and 0.2 g of vitamin E in an appropriate amount of acetone and mix well; use a rotary evaporator to remove the organic solvent in the solution under reduced pressure, and put it on the glass wall Form a lipid film; add pH 7.4 phosphate buffer, stir for 30 minutes, place at room temperature for 2 hours to make the film imbibition; then stir at room temperature for 2 hours to obtain a liposome suspension; the obtained liposome suspension Homogenize liposomes after high-pressure milk homogenization or ultrasonic dispersion treatment; centrifuge the obtained total bufolide liposomes at 4000r / min for 15min, collect the supernatant and add isotonic aqueous solution for injection to 1000mL; Remove bacteria and heat source, potting, 2mL per vial, sterilize with flowing steam for 30min to obtain total bufolide...

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Abstract

The invention belongs to the field of medicinal preparation and particularly relates to total toad-poison lactone liposome injection and a preparing method thereof. Total toad-poison lactone liposome is basically composed of the treatment effective quantity of total toad-poison lactone, phospholipid, cholesterol, an antioxidant, PBS liquid, organic solvent and water for injection. The liposome injection has the excellent preparation stability, the situation that in the freezing process, due to fusion and ice crystals, the liposome fractures is avoided, and the liposome keeps high encapsulation efficiency as well after being stored for a long term; the solubility of total toad-poison lactone is improved, the quality and the biological availability of preparation products are improved, the total toad-poison lactone can enter the body stably at a constant speed, and can be used in clinic more safely and effectively, and the theoretic foundation is provided for clinic application of the total toad-poison lactone liposome injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a natural active ingredient total bufolide liposome injection and a preparation method. Background technique [0002] Cinobufacin is extracted from the skin of the traditional Chinese medicine Bufo bufo, and it is a traditional Chinese medicine injection that is extracted by water and alcohol. Cinobufacin injection has a significant anti-tumor effect. It has been found through research that cinobufacin injection is rich in water-soluble indole alkaloids (such as 5-hydroxytryptamine, bufotryptamine, toadine, toad sulfur, etc.), amino acids and other components, and the total anti-tumor activity The content of bufolides (bufaxins, bufotoxins) is extremely low. It is clinically believed that cinobufacin local venous irritation, arrhythmia, skin reactions, and asthma are all caused by the pharmacological effects of water-soluble indole alkaloids, and there is no research r...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K9/08A61K35/65A61K47/24A61P35/00A61P1/16A61P31/20
Inventor 张亮亮何勇吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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