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Paclitaxel mixed micelle preparation, and preparation method thereof

A technology for mixing micelles and paclitaxel, which is applied in the directions of drug combinations, pharmaceutical formulations, and non-active ingredients medical preparations, etc., can solve problems such as allergies, and achieve the effects of ensuring solubility, good stability, and reducing toxic and side effects.

Inactive Publication Date: 2013-04-24
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, polyoxyethylene castor oil is easy to release the plasticizer bis(2-ethylhexyl) phthalate in polyvinyl chloride infusion bags and infusion catheters, causing allergies

Method used

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  • Paclitaxel mixed micelle preparation, and preparation method thereof
  • Paclitaxel mixed micelle preparation, and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0013] Embodiment 1 prepares paclitaxel mixed micelle injection

[0014] Dissolve 250 mg of polyethylene glycol 1000 vitamin E succinate in 0.5 ml of absolute ethanol, then add 6 mg of paclitaxel into the solution and stir to dissolve, filter the above solution with a 0.22 micron microporous membrane, and put it into a vial.

Embodiment 2

[0015] Embodiment 2 prepares paclitaxel mixed micelle injection

[0016] Dissolve 200 mg of polyethylene glycol 1000 vitamin E succinate and 20 mg of lecithin in 0.5 ml of absolute ethanol, then add 6 mg of paclitaxel into the solution and stir to dissolve, use a 0.22 micron microporous membrane to filter the above solution, and pack into the vial.

Embodiment 3

[0017] Embodiment 3 prepares paclitaxel mixed micelle injection

[0018] Dissolve 150 mg of polyethylene glycol 1000 vitamin E succinate and 15 mg of lecithin in 0.5 ml of absolute ethanol, then add 6 mg of paclitaxel into the solution and stir to dissolve, use a 0.22 micron microporous membrane to filter the above solution, and pack into the vial.

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Abstract

The invention discloses a paclitaxel mixed micelle preparation, comprising 100 to 300 milligram of tocopherol polyethylene glycol succinate 1000 (TPGS), 0 to 50 milligram of phosphatide, 0.5 milliliter of anhydrous ethanol and 6 milligram of paclitaxel. The preparation method is as follows: the TPGS is dissolved in the anhydrous ethanol, or the TPGS and the phosphatide are dissolved in the anhydrous ethanol; the paclitaxel is added and dissolved under stirring; the mixture is filtered with a millipore filtration of 0.22 micrometer so as to obtain the paclitaxel mixed micelle preparation. In the invention, the TPGS and the phosphatide are used to form mixed micelles which have good stability and little toxic and side effects; the preparation method is simple and practicable, having a good application prospect. Compared to the prior art, polyoxyethylene castor oil in conventional prescription is substituted in the invention, thereby reducing toxic side effects of paclitaxel injections and greatly enhancing the safety of the injections on condition that solubility is guaranteed.

Description

technical field [0001] The invention relates to a paclitaxel mixed micelle preparation and a preparation method thereof. Background technique [0002] Paclitaxel (paclitaxel, 1) is widely used in the treatment of ovarian cancer, prostate cancer, breast cancer, head and neck cancer, colon cancer, non-small cell lung cancer, thyroid cancer, melanoma and Kaposi sarcoma. The solubility of paclitaxel in water is only 6mg / L, increasing its solubility is the primary problem of paclitaxel preparations. At present, the polyoxyethylene castor oil-ethanol (1:1) injection of paclitaxel is mainly used clinically, and the drug concentration can reach 6 mg / mL, and it is diluted with normal saline or 5% glucose solution before use. However, polyoxyethylene castor oil can easily cause allergic reactions in patients, so anti-allergic treatment should be carried out before use. In addition, polyoxyethylene castor oil is easy to release the plasticizer bis(2-ethylhexyl) phthalate in polyvinyl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/337A61K47/34A61P35/00
Inventor 李凌冰李娜
Owner SHANDONG UNIV
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