Prescription and preparation method of docetaxel injection

A technology of docetaxel and injection, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of unqualified substances and unstable preparations, and achieve the goal of preparing Convenience, good stability effect

Inactive Publication Date: 2012-05-16
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, in the preparation process of docetaxel injection, it is mostly prepared by mixing docetaxel with solubilizer Tween-80 and ethanol and then filtering. qualified

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Docetaxel 20g

[0021] Sodium chloride 10g

[0022] Tween-80 1000g

[0023] Add absolute ethanol to 1000ml

[0024]

[0025] Made 1000 pieces

[0026] Weigh the prescribed amount of docetaxel, sodium chloride and 40% absolute ethanol of the prescribed amount, mix and stir to dissolve. Then add the prescribed amount of Tween-80, stir to dissolve and set the volume to 1000ml, add activated carbon, stir and filter for decarbonization, and filter the filtrate with a 0.22 μm microporous membrane filter to sterilize; take the filtrate and fill it in a 5ml vial, press Half stopper, put it in a freeze-drying box, volatilize under reduced pressure at 40°C, remove ethanol, press the stopper and cover.

Embodiment 2

[0028] Docetaxel 20g

[0029] Citric acid 50g

[0030] Tween-80 600g

[0031] Add absolute ethanol to 1000ml

[0032]

[0033] Made 1000 pieces

[0034] Weigh the prescribed amount of docetaxel, citric acid and 40% absolute ethanol of the prescribed amount, mix and stir to dissolve. Then add the prescription amount of Tween-80, stir to dissolve and set the volume to 1000ml, add activated carbon, stir and filter for decarbonization, and filter the filtrate with a 0.22μm microporous membrane to filter the bacteria; take the filtrate and fill it in a 5ml vial, press Half stopper, put it in a freeze-drying box, volatilize under reduced pressure at 40°C, remove ethanol, press the stopper and cover.

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PUM

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Abstract

The invention provides a prescription and a preparation method of an anti-tumor medicament docetaxel injection which is used for early chemotherapy failure or metastatic breast cancer, late cisplatin chemotherapy failure or metastatic small cell carcinoma in the field of pharmacy. The preparation is an injection prepared by using docetaxel as an active component and adding injection auxiliary materials through heat source removing, degerming and alcohol volatilization. Aiming at the overcoming the defect of a medicinal preparation using docetaxel as the active component, the invention provides the prescription and preparation method of the docetaxel injection. The preparation prepared by virtue of the method is excellent in stability and convenient in preparation, so that the medicament safety and the patient adaptability are improved.

Description

Technical field: [0001] The invention relates to the field of pharmacy, in particular to the prescription and preparation method of the antitumor drug docetaxel injection for advanced chemotherapy failure or metastatic breast cancer, cisplatin chemotherapy failure advanced or metastatic small cell carcinoma . Background technique: [0002] Docetaxel, also known as docetaxel, is a semi-synthetic antitumor drug that has strong antitumor activity against a variety of solid tumors. The mechanism of action of this product is to strengthen the polymerization of tubulin and inhibit the depolymerization of microtubules, resulting in the formation of stable non-functional microtubule bundles, thus destroying the mitosis of tumor cells. In vitro tests suggest that this product can inhibit the growth of SPC-A1 lung cancer cells, and the inhibitory effect is enhanced with the increase of the dose; it has radiosensitizing effects on various tumors, and does not aggravate the radiation d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/34A61P35/00A61P35/04
Inventor 魏雪纹李强胡泉忠
Owner 双鹤药业(海南)有限责任公司
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