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A technology of docetaxel and injection, which is applied in the field of pharmaceutical preparations and achieves the effects of simple preparation method, high biocompatibility and high encapsulation efficiency
Inactive Publication Date: 2012-10-10
灵康药业集团股份有限公司
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[0012] However, the challenge in preparing vesicular phospholipid gels lies in the selection of appropriate phospholipid components and preparation methods
Method used
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Embodiment 1
[0052] Example 1 Preparation of Docetaxel Vesicular Phospholipid Gel Injection
[0053] Prescription: (1000 bottles)
[0054]
[0055] Preparation Process
[0056] (1) Dissolve 20g of docetaxel, 200g of phosphatidylserine and 40g of cholesterol in a mixed solution of chloroform and ethanol, stir and sonicate for 20 minutes, and then perform gradient homogenization at 300bar to 1000bar for 5 times to obtain docetaxel vesicles Type phospholipid gel solution;
[0057] (2) Add 20 g of dextran to the docetaxel vesicular phospholipid gel solution prepared above to dissolve;
[0058] (3) Filter through a 0.22μm microporous membrane, freeze-dry directly at about -35°C, then add 500ml of water for injection to disperse evenly, and then pack into 0.5ml / bottle, that is, docetaxel vesicular phospholipid gel injection .
Embodiment 2
[0059] Example 2 Preparation of Docetaxel Vesicular Phospholipid Gel Injection
[0060] Prescription: (1000 bottles)
[0061]
[0062] Preparation Process
[0063] (1) Dissolve 80g of docetaxel, 960g of phosphatidylserine and 240g of cholesterol in a mixed solution of chloroform and ethanol, stir and sonicate for 20 minutes, and then perform gradient homogenization at 300bar to 1000bar for 7 times to obtain docetaxel vesicles Type phospholipid gel solution;
[0064] (2) Add 160 g of dextran to the docetaxel vesicular phospholipid gel solution prepared above to dissolve;
[0065] (3) Filtrate with a 0.22 μm microporous membrane, freeze-dry directly at about -35°C, add 2000ml of water for injection to disperse evenly, and dispense 2ml / bottle to obtain docetaxel vesicular phospholipid gel injection.
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Abstract
The invention discloses docetaxel vesicle type phospholipid gel injection and a preparation method of the docetaxel vesicle type phospholipid gel injection. The docetaxel vesicle type phospholipid gel injection is prepared from docetaxel, phospholipid, cholesterol and freeze-drying supporting agents according to a specific weight ratio. The docetaxel vesicle type phospholipid gel injection has good preparation stability, the clinical use is convenient, and the vesicle type phospholipid gel maintains good encapsulation rate after long-period storage. The docetaxel vesicle type phospholipid gel injection and the preparation method have the advantages that the quality of the preparation product is improved, the bioavailability of the medicine is improved, the toxic and side effects are reduced, and in addition, the preparation method is simple and is suitable for industrial mass production.
Description
technical field [0001] The invention relates to a novel docetaxel injection and a preparation method thereof, in particular to a docetaxel vesicular phospholipid gel injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Docetaxel (DOC) also known as: Docetaxel, Taxotere , docetaxel anhydrous, docetaxel, chemical name: 5β, 20-epoxy-1, 2α, 4, 7β, 10β, 13α-hexahydroxytaxane-11-en-9-one-4, 10 -Diacetate-2-benzoate-13-[(2'R,3'S)-N-benzoyl-3-phenylisoserine ester. It is white crystalline powder, specific rotation -36° (c=0.74, ethanol). Soluble in ethanol, acetone, ether, benzene and other organic solvents. Relative molecular mass: 807.8792, molecular formula: C 43 h 53 NO 14 ; The structural formula is as follows: [0003] [0004] Docetaxel is a paclitaxel derivative synthesized during the structural modification of paclitaxel, and it is a paclitaxel antineoplastic drug. It plays an a...
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