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Dianhydrodulcitol lipidosome freeze-dried powder injection and preparation method thereof

A technology of dehydrated dulcitol and freeze-dried powder injection, which is applied in the field of pharmaceutical inventions, can solve the problems of tissue necrosis, difficult remission and treatment of patients, ulcers, etc., and achieves the effects of reducing irritation, improving storage stability, and prolonging circulation time.

Active Publication Date: 2016-06-15
GUANGXI WUZHOU PHARMA GRP
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] At present, the company's product is dulcitol for injection, which is an intravenous injection. The limitation of the dosage form makes it difficult for patients to persist in long-term remission treatment. In addition, if the drug solution leaks out during injection, it may cause local tissue necrosis and form ulcer

Method used

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  • Dianhydrodulcitol lipidosome freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Take 15kg of lecithin, 15kg of cholesterol, 3kg of dulcitol, dissolve in 95% ethanol, evaporate under reduced pressure to form a film, then add 10L of isotonic phosphate buffer solution with pH=6, the two are emulsified, and then removed under reduced pressure Ethanol, and probe-type ultrasound for 3 minutes to obtain liposomes. 15 kg of sucrose is dissolved in liposomes, filtered, subpackaged in vials, freeze-dried, and sealed with a vacuum plug.

Embodiment 2

[0021] Take 120kg of lecithin, 15kg of cholesterol, 3kg of dulcitol, dissolve in 90% ethanol, evaporate under reduced pressure to form a film, then add 10L of isotonic phosphate buffer solution with pH=6, the two are emulsified, and then removed under reduced pressure Ethanol, and probe-type ultrasound for 3 minutes to obtain liposomes. 120kg of sucrose is dissolved in liposomes, filtered, subpackaged in vials, freeze-dried, and sealed with a vacuum stopper.

Embodiment 3

[0023] Take 30kg of lecithin, 15kg of cholesterol, 3kg of dulcitol, dissolve in 95% ethanol, evaporate under reduced pressure to form a film, then add 10L of isotonic phosphate buffer solution with pH=8, emulsify the two, and remove under reduced pressure Ethanol, and probe-type ultrasound for 3 minutes to obtain liposomes. Dissolving 30kg of sucrose in liposomes, filtering, dispensing into vials, freeze-drying, and sealing with a vacuum plug.

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Abstract

The invention relates to the field of medicinal preparations, in particular to a dianhydrodulcitol lipidosome freeze-dried powder injection and a preparation thereof. The weight ratio of dianhydrodulcitol to phospholipids to cholesterol in dianhydrodulcitol lipidosome is 1:(5-40):(2.5-15). The weight ratio of dianhydrodulcitol to phospholipids to cholesterol is preferably 1:(10-30):(5-10). The encapsulation rate of the prepared dianhydrodulcitol lipidosome can be 85% or above, and the grain diameter of the prepared dianhydrodulcitol lipidosome is smaller than 200 nm. After administration, the medicine is rapidly absorbed, takes effect rapidly, and is accurate in quantification and convenient to use, the first-pass effect of the oral medicine is avoided, and the treatment effect and bioavailability are improved.

Description

technical field [0001] The invention relates to the field of medical inventions, in particular to a liposome freeze-dried powder injection with dehydrodungitol as an active ingredient and a preparation method thereof. Background technique [0002] Dehydrodulcitol (chemical name is 1,2,5,6-dianhydrodulcitol, structural formula is as follows) is the bis-epoxide of dibromodungyl hydrogen bromide, which is white columnar, flaky crystal or crystalline Sexual powder, odorless, slightly bitter, soluble in water, soluble in ethanol, acetone, ethyl acetate. Dehydrodulcitol is an antitumor drug, which has a good short-term effect on chronic myelogenous leukemia. [0003] The structural formula of dulcitol: [0004] [0005] From the perspective of antineoplastic drug classification, dulcitol is a typical bioalkylating agent. According to previous clinical data, DAG can inhibit the synthesis of biomacromolecules such as nucleic acids and proteins, and has broad-spectrum anti-tumo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/127A61K31/336A61P35/02
CPCA61K9/127A61K9/19A61K31/336A61K47/26
Inventor 杨北妮刘冠萍郑志远赖树生花世鲜黄源春林艳英
Owner GUANGXI WUZHOU PHARMA GRP
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