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Medicine composition containing taxol substance and its preparation method

A composition, paclitaxel technology, applied in the direction of drug combination, antineoplastic drugs, etc.

Inactive Publication Date: 2004-10-13
齐鲁制药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] This makes the application of the pharmaceutical composition problematic at ambient temperatures above 25°C

Method used

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  • Medicine composition containing taxol substance and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Example 1: Preparation of a reconstitutable, solid paclitaxel / acetyl-γ-cyclodextrin composition by dry method:

[0049] Dissolve 500mg of acetyl-γ-cyclodextrin, 3mg of citric acid, and 1.5mg of sodium citrate in 2.5ml of water, add 3mg of paclitaxel (or first dissolve paclitaxel in 0.25ml of ethanol), stir until a clear solution is obtained, and freeze-dry to obtain solid matter.

[0050] 100 mg of this solid was easily dissolved in 1 ml of 0.9% NaCl (or 5% G) aqueous solution to give clear solutions with a paclitaxel content of 0.99 mg / ml, respectively. The reconstituted solution was stored in a sealed glass container at 35° C. for 6 hours, and the HPLC analysis results are shown in Table 8.

[0051] Paclitaxel final concentration: 0.99mg / ml

Embodiment 2

[0052] Example 2: Preparation of a reconstitutable, solid paclitaxel / acetyl-γ-cyclodextrin composition by dry method:

[0053] Dissolve 500 mg of acetyl-γ-cyclodextrin and 3 mg of tartaric acid in 2.5 ml of water, add 3 mg of paclitaxel (or first dissolve paclitaxel in 0.25 ml of ethanol), stir until a clear solution is obtained, and freeze-dry to obtain a solid substance.

[0054] 100 mg of this solid was readily dissolved in 2 ml of 0.9% NaCl (or 5% G) aqueous solution to give clear solutions with a paclitaxel content of 0.49 mg / ml, respectively. The reconstituted solution was stored in a sealed glass container at 35° C. for 6 hours, and the HPLC analysis results are shown in Table 9.

[0055] Paclitaxel final concentration: 0.49mg / ml

Embodiment 3

[0056] Example 3: Preparation of reconstitutable, solid Docetaxel / HP-β-CD compositions by dry method:

[0057] Dissolve 420mg of HP-β-CD, 6mg of lactic acid, and 2mg of sodium lactate in 2.5ml of water, add 6mg of Docetaxel (or first dissolve Docetaxel in 0.15ml of ethanol), stir until a clear solution is obtained, and freeze-dry to obtain a solid substance.

[0058] 70 mg of this solid was readily dissolved in 1 ml of 0.9% sodium chloride (or 5% dextrose) aqueous solution to give clear solutions with a Docetaxel content of 1.00 mg / ml, respectively. The reconstituted solution was stored in a sealed glass container at 35° C. for 6 hours, and the HPLC analysis results are shown in Table 10.

[0059] Docetaxl final concentration: 1.00mg / ml

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PUM

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Abstract

The present invention relates to a medicine composition containing taxol-like substance. Its composition contains (by weight portion) 1 portion of taxol-live substance, 0.05-10 portions of organic acid, 0-10 portions of organic acid salt and proper quantity of cyclodextrin. Under the condition of that environmental temp. is not higher than 35 deg.C said invented medicine composition stability can be relained for above 6 hr, and can meet the requirements for intravenous drip therapy.

Description

Technical field: [0001] The present invention relates to a pharmaceutical composition containing paclitaxel, and relates to the improvement technology of a water-soluble solid pharmaceutical composition and its solution in an aqueous solvent. Background technique: [0002] The following definitions apply throughout the specification and claims: [0003] paclitaxel = paclitaxel (taxoL) A; [0004] docetaxel=[N-debenzylation-N-tert-butoxycarbonyl]-10-deacetyl-paclitaxel; [0005] CD = cyclodextrin [0006] HP-β-CD = hydroxypropyl-β-cyclodextrin (about 2 to 8 hydroxypropyl groups per CD unit); [0007] G = Glucose [0008] NaCI = sodium chloride [0009] Paclitaxel is a class of compounds known to have significant anticancer activity by enhancing tubulin polymerization and inhibiting microtubule depolymerization, leading to the formation of stable non-functional microtubule bundles, thereby disrupting mitosis and cell proliferation . [0010] Such substances are known to...

Claims

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Application Information

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IPC IPC(8): A61K31/337A61P35/00
Inventor 杨清敏李霞边红唐伟徐先艳
Owner 齐鲁制药厂
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