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Productive technology of docetaxel injection

A docetaxel, production process technology, applied in the direction of pharmaceutical formulations, antineoplastic drugs, drug combinations, etc., to achieve the effect of simple process, reducing the production of related substances, and mild conditions

Inactive Publication Date: 2011-06-01
北京东方协和医药生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the preparation process, such a high viscosity presents a series of difficulties in the production process, mainly reflected in dissolution, sterilization and pyrogen removal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0007] (1) Take 40.0 g of docetaxel raw material and 540 g of Tween 80 solvent into the homogenizer, turn on the homogenizer, and homogenize until all of them pass through an 80-mesh sieve. Wash the homogenizer several times with 540 g Tween 80 solvent.

[0008] (2) Combine the washing solution and the homogenate solution, pour them into an ultrasonically permeable container, such as a glass beaker, and sonicate until it becomes a transparent and uniform solution.

[0009] (3) Add 1.2 g of activated carbon and stir at 40° C. for 30 minutes to remove the pyrogen.

[0010] (4) Under the pressure of 0.3Mpa, the liquid medicine passes through the microporous filter devices of 1.0 micron, 0.45 micron and 0.22 micron in sequence.

[0011] (5) Sterilize by filtration with a 0.22-micron microporous membrane, and fill under aseptic conditions.

[0012] The appearance of the preparation prepared by the method is a light yellow transparent viscous liquid, the pH is between 4.3-5.5, and...

Embodiment approach 2

[0014] (1) Take 40.0 g of docetaxel raw material and 280 g of Tween 80 solvent into the homogenizer, turn on the homogenizer, and homogenize until all of them pass through a 200-mesh sieve. Wash the homogenizer several times with 800 g Tween 80 solvent.

[0015] (2) Combine the washing solution and the homogenate solution, pour them into an ultrasonically permeable container, such as a glass beaker, and sonicate until it becomes a transparent and uniform solution.

[0016] (3) Add 0.12 g of activated carbon and stir at 40° C. for 60 minutes to remove the pyrogen.

[0017] (4) Under the pressure of 0.1Mpa, the liquid medicine passes through the microporous filter devices of 1.0 micron, 0.22 micron and 0.22 micron in sequence.

[0018] (5) Sterilize by filtration with a 0.22-micron microporous membrane, and fill under aseptic conditions.

[0019] The appearance of the preparation prepared by the method is a light yellow transparent viscous liquid, the pH is between 4.3-5.5, an...

Embodiment approach 3

[0021] (1) Take 40.0 g of docetaxel raw material and 800 g of Tween 80 solvent into the homogenizer, turn on the homogenizer, and homogenize until all of them pass through a 200-mesh sieve. Wash the homogenizer several times with 280 g Tween 80 solvent.

[0022] The remaining steps and implementation effects are the same as those in Implementation Scheme 2.

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Abstract

The invention relates to a productive technology of a docetaxel injection, and in particular relates to a common productive process of a thick injection in the market, wherein polysorbate 80 is taken as a primary solvent in the productive process. The main processes of the productive technology are as follows: a docetaxel bulk pharmaceutical chemical (BPC) is dissolved into the polysorbate 80 by ultrasound after homogenate; an ethanol solution of citric acid is utilized to regulate the pH value of the polysorbate 80 solution to 4.3-5.5; a proper amount of activated carbon is added to eliminate pyrogen; the activated carbon is eliminated by multistage millipore filtration; and filling is performed under the condition of sterile operation after millipore filtration sterilization is carried out. The injection prepared by the productive technology meets the requirements in tentative standard YBH10802005 from State Food and Drug Administration (SFDA).

Description

technical field [0001] The invention relates to a production process of a docetaxel preparation, which belongs to the process preparation technology of injections in the technical field of pharmaceutical preparations. Background technique [0002] Docetaxel is an antineoplastic drug mainly used for the treatment of tumor diseases such as breast cancer. The types of preparations on the market are mainly intravenous drip injection products, and its representative product is "Taxotere" of the original research company Aventis. The product has two specifications, 20mg and 80mg, respectively 20mg and 80mg of docetaxel raw material dissolved in 0.5ml and 2.0ml of Tween 80 solution, in addition, the Tween 80 solution also contains less than 2% Anhydrous ethanol and trace amounts of other substances, such as pH regulators. Because the preparation is mainly based on Tween 80, it also has the characteristics of high viscosity of Tween 80, generally up to 350-550mm 2 / s. However, i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/34A61P35/00A61K47/26
Inventor 毛旭马德君柳广尊耿秀欣徐宝玲
Owner 北京东方协和医药生物技术有限公司
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