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Fat emulsion containing docetaxel and its preparing method

A technology of docetaxel and fat emulsion, which is applied in the field of medicine, can solve the problem of low solubility of docetaxel, and achieve reliable curative effect, high safety and good stability

Inactive Publication Date: 2005-12-21
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] One of main contributions of the present invention is to solve the prior art deficiency that docetaxel has low solubility in water

Method used

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  • Fat emulsion containing docetaxel and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Prepare raw materials, excipients and other components according to the component quantity

[0077] Docetaxel 0.1kg

[0078] Soybean oil for injection 30kg

[0079] Lecithin for injection 1.2kg

[0080] Add water for injection to 100L

[0081] The following steps were all carried out under nitrogen protection. Add 0.1kg of docetaxel to 30kg of soybean oil for injection, stir until the docetaxel is dissolved, heat the solution to 68°C, keep it warm for later use, and obtain solution ①; add 100L of water for injection into high-speed tissue and crush In the machine, add 1.2kg lecithin for injection, stir for 8 minutes, heat the solution temperature to 68°C, keep it warm for later use, and obtain solution ②; add solution ② into the high-speed tissue grinder, and slowly add solution ① into In the stirring solution ②, keep the temperature of the solution at 68°C, stir for 8 minutes, then add water for injection until the total volume of the solution is 100L, adjust the p...

Embodiment 2

[0083] Prepare raw materials, excipients and other components according to the component quantity

[0084] Docetaxel 0.01kg

[0085] Soybean oil for injection 15kg

[0086] Lecithin for injection 1.0kg

[0087] Add water for injection to 100L

[0088] Other steps are the same as in Example 1 to obtain the docetaxel fat emulsion of the present invention.

Embodiment 3

[0090] Prepare raw materials, excipients and other components according to the component quantity

[0091] Docetaxel 0.05kg

[0092] Soybean oil for injection 20kg

[0093] Soy Lecithin for Injection 2.0kg

[0094] Add water for injection to 100L

[0095] Other steps are the same as in Example 1 to obtain the docetaxel fat emulsion of the present invention.

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Abstract

The present invention relates to an infatmul containing docetaxel and its preparation method. Said preparation can be directly used for intravenous injection. At the same time of that it is used as medicine for curing tumor disease said preparation also can provide nutrients for patient. The weight volume concentration range of docetaxel contained by said preparation is 0.1-1.0 mg / ml, and its specification is that 1-500 mg of active component docetaxel is contained. Said infatmul composition includes docetaxel, vegetable oil, phospholipids and injection water, at the same time the components of glycerin and group emulsion, etc. can be added, in which the optimum group emulsion is poloxamer 188. Besides, said invention also provides the concrete steps of its preparation method and its application in preparation of medicine for resisting tumor.

Description

technical field [0001] The invention belongs to the technical field of medicine. Specifically, the invention mainly relates to a fat emulsion containing docetaxel and a preparation method thereof. The invention also relates to the use of the medicine in preparing a medicine for treating tumors. Background technique [0002] Docetaxel is one of the taxane compounds, which has anti-tumor effects and has recently been approved by the US Food and Drug Administration for the treatment of cancer. Docetaxel related patents CN1293570A, CN1490048A, CN1281373A, US5900419, US5880133 are described. Tang Zhiqiang et al found that docetaxel has a good curative effect on advanced breast cancer, advanced ovarian cancer and other cancers (Tang Zhiqiang. New anti-tumor drug-docetaxel. Chinese Journal of Pharmaceutical Sciences, 1999, 34 (2: 134)). [0003] The molecular formula of docetaxel is: C 43 h 53 NO 14 [0004] The structural formula is as follows: [0005] [0006] Docetaxel...

Claims

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Application Information

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IPC IPC(8): A61K31/337
Inventor 杜振新卢秀莲李大涛李红姚洪雷刘同欣王绍同
Owner CISEN PHARMA
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