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

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Problems solved by technology

[0017] This makes the application of the pharmaceutical c

Method used

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  • Medicine composition containing taxol substance and its preparation method

Examples

Experimental program
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Example Embodiment

[0048] Example 1: Preparation of Reconstituted, Solid Paclitaxel / Acetyl-γ-Cyclodextrin Compositions by Drying Process:

[0049] Dissolve 500 mg of acetyl-γ-cyclodextrin, 3 mg of citric acid, and 1.5 mg of sodium citrate in 2.5 ml of water, add 3 mg of paclitaxel (or dissolve paclitaxel in 0.25 ml of ethanol first), 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 obtain clear solutions with paclitaxel contents of 0.99 mg / ml, respectively. The reconstituted solution was stored in a sealed glass container at 35° C. for 6 hr. The results of HPLC analysis are shown in Table 8.

[0051] Final concentration of paclitaxel: 0.99mg / ml

Example Embodiment

[0052] Example 2: Dry Preparation of Reconstituted, Solid Paclitaxel / Acetyl-γ-Cyclodextrin Compositions:

[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 dissolve paclitaxel in 0.25 ml of ethanol first), stir until a clear solution is obtained, and freeze-dry to obtain a solid substance.

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

[0055] Final concentration of paclitaxel: 0.49mg / ml

Example Embodiment

[0056] Example 3: Dry Preparation of Reconstituted, Solid Docetaxel / HP-β-CD Compositions:

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

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

[0059] Docetaxl final concentration: 1.00mg / ml

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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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