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Preparation of antineoplastic drug docetaxel injection

A technology of docetaxel and preparation process, which is applied in the directions of antitumor drugs, medical preparations containing active ingredients, and drug delivery, etc. Instability and other problems, to achieve the effect of scientifically novel conception, low production cost and easy acceptance

Inactive Publication Date: 2009-01-14
辽宁嘉事堂药业有限公司
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  • Summary
  • Abstract
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  • Claims
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AI Technical Summary

Problems solved by technology

The problems that this method exists are: a, bacteria and heat source treatment are not thorough; B, relevant material and ethanol content are unstable; unstable

Method used

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Embodiment Construction

[0012] Its product preparation technology is, accurately weighs 22 grams of docetaxel of the prescribed amount, adds 2500 milliliters of absolute ethanol, stirs to make it dissolve completely, adds 500 milliliters of sterilized polysorbate 80 in the prescribed amount, stirs and mixes until Clarify, under sterile conditions, use microporous membrane and filter for sterilization and pyrogen removal twice to ensure sterility and no pyrogens, then quantitatively dispense into vials, half-gland on-line, set temperature, vacuum Dry under vacuum at high temperature and time, remove ethanol, seal tightly, and roll the cap.

[0013] Clinical report on the preparation process of antineoplastic drug docetaxel injection: Docetaxel is a semi-synthetic taxane antineoplastic drug, which fundamentally "freezes" the intracellular skeleton composed of microtubules, thereby inhibiting cancer cells Split. Microtubules polymerize and then depolymerize during a cell cycle, and docetaxel promotes m...

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Abstract

The invention relates to a preparation process of anticancer drug docetaxel injecta, which is applied to the field of chemical medicine. The product preparation process comprises that 20g to 25g of docetaxel is weighed precisely according to the formula dosage and is added into 2000ml to 3000ml of absolute ethyl alcohol to be stirred till being dissolved completely, and then 500ml to 800ml sterilized polysorbate 80 is added to be stirred for mixing till clarification; the mixture is filtered two times with a microporous filtering film and a degermation and heat-extraction filter under the aseptic condition, and then is subpackaged in vials after is in sure of asepsis and no heat source, and the half cap-pressing is carried out on line; the mixture is dried in vacuum under the prescriptive temperature, vacuum degree and time and then is sealed after the ethanol is removed, and finically the cap is pressed. The process has complete sterilization, simple heat-extraction preparation flow and low cost, is easy to be accepted by the patients, alleviates the pain of the patients, and has obvious healing efficacy and safe and reliable medication.

Description

Technical field: [0001] The invention relates to a preparation process of an antineoplastic drug docetaxel injection in the field of chemical preparations. Background technique: [0002] At the 18th International Anti-Cancer Union Conference, a research report published by the World Health Organization showed that the global cancer situation will become increasingly serious, and the number of new patients will increase from the current 10 million to 15 million per year in the next 20 years. The number of people will also increase from 6 million to 10 million per year. In response to the above severe situation, the report calls on all countries to formulate national anti-cancer plans and specific implementation plans, and particularly emphasizes the importance of cancer prevention, early detection and early treatment. According to the report, if countries can make full use of the existing knowledge and technology in the world and implement the best possible means of cancer p...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/337A61P35/00
Inventor 任乃华
Owner 辽宁嘉事堂药业有限公司
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