Preparation technology and product of paclitaxel freeze-dried powder

A preparation process, paclitaxel technology, applied in freeze-dried transportation, powder transportation, drug combination, etc., can solve the problems of paclitaxel freeze-dried powder particle size, complex process, etc., to avoid adverse reactions, simplify the preparation process, and reduce production costs Effect

Pending Publication Date: 2019-09-17
POLYMERCHEM
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Jing Xiabin and others disclosed a preparation method of paclitaxel freeze-dried powder in "freeze-dried powder injection of paclitaxel polymer bonded drug and its preparation method" (patent application number 200610016614), and its process is more complicated and needs to add a large amount of Stabilizer and co-solvent, and the obtained paclitaxel freeze-dried powder has a larger particle size after reconstitution, which is 100-150nm

Method used

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  • Preparation technology and product of paclitaxel freeze-dried powder
  • Preparation technology and product of paclitaxel freeze-dried powder
  • Preparation technology and product of paclitaxel freeze-dried powder

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Experimental program
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Embodiment (1-7

[0038] The preparation method of composition among the present invention comprises the following steps:

[0039] ① Weigh paclitaxel and mPEG-PLA-phenylalanine as raw materials according to different feeding ratios (see Table 1 for feeding ratios). Among them, paclitaxel (CAS 33069-62-4) is produced by Xi'an Ruilin Biotechnology Co., Ltd., with a purity greater than 95%, and mPEG-PLA-phenylalanine is produced by the inventor according to the process described in the patent number PCT-CN-2013000453 Self-prepared;

[0040] ②Put the above-mentioned raw materials into a container, and add organic solvents such as ethanol or acetonitrile at a temperature of 15-45°C until they are completely dissolved. The dissolving process can adopt means such as stirring or shaking.

[0041] ③ Rotate the above solution at 30-50°C for 2 hours until the organic solvent evaporates to dryness. Then vacuum drying at 10-40° C. for > 12 hours to remove residual organic solvents to obtain a paclitaxel-...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly discloses a preparation process and product of paclitaxel freeze-dried powder. The preparation process of the paclitaxel freeze-dried powder has the advantages of simple route, low production cost, and easier and more convenient transportation and storage, and avoids adverse reactions caused by adding excipients. The prepared paclitaxel micelle freeze-dried powder has high stability in vitro, and a paclitaxel solution obtained through redissolution of the paclitaxel micelle freeze-dried powder remains stable at room temperature for more than 12 hours and meets the requirements of drug treatment. The paclitaxel freeze-dried powder has higher blood stability, smaller particle size, and is more likely to exert an ERP effect. The paclitaxel freeze-dried powder can be re-dissolved by use of an ordinary physiological saline or glucose injection, and thus the administration process is greatly simplified.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation process and product of paclitaxel freeze-dried powder. Background technique [0002] The molecular formula of paclitaxel is: C 47 h 51 NO 14 , molecular weight 853.9, melting point 213-216 ℃, highly lipophilic, insoluble in water, is a highly efficient, low toxicity, broad-spectrum natural anticancer drug isolated from Taxus genus. It is a complex natural secondary metabolite in Taxus plants, and its molecular structure is shown in the following formula. [0003] [0004] Paclitaxel is a microtubule-specific drug with high anti-cancer activity. Its sales volume ranks first among new anti-tumor drugs all the year round, and is increasing at a rate of 20%. [0005] In 1977, Horwit Z discovered that the anti-cancer mechanism of paclitaxel lies in its ability to bind to tubulin, promote tubulin polymerization and assemble into micr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/337A61K47/34A61K9/107A61P35/00
Inventor 顾晓军滕鑫
Owner POLYMERCHEM
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