Taxol freeze-dried powder preparation process and product

A preparation process and technology for paclitaxel, applied in freeze-drying delivery, powder delivery, drug combination and other directions, can solve the problems of large particle size and complex process of paclitaxel freeze-dried powder, avoid adverse reactions, simplify the preparation process, and achieve blood stability. high effect

Pending Publication Date: 2019-09-06
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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  • Taxol freeze-dried powder preparation process and product
  • Taxol freeze-dried powder preparation process and product
  • Taxol freeze-dried powder preparation process and product

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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] ①Weigh the raw materials (paclitaxel, mPEG-PLA-aspartic acid) according to different feeding ratios. Among them, paclitaxel (CAS33069-62-4) is produced by Xi'an Ruilin Biotechnology Co., Ltd., with a purity greater than 95%. preparation;

[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-containing polymer mixed film.

[0042] ④ Place the above mixed membrane in a water bath at 40-60°C until it becomes transparent, add ultrapure water preheated at th...

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Abstract

The invention belongs to the technical field of medicine preparations, and particularly relates to a taxol freeze-dried powder preparation process and a product. The taxol freeze-dried powder preparation process is simple in route, production cost is low, transportation and storage is simple and convenient, and adverse reaction caused by addition of excipients is avoided. In-vitro stability of taxol micelle freeze-dried powder is higher, redissolved taxol solution is stably kept 12 hours or than at room temperature, and drug treatment requirements are met. Blood stability is higher, grain diameter is small, an EPR effect is more easily played, taxol freeze-dried powder can be redissolved by the aid of common normal saline or glucose injection, and drug administration processes are greatlysimplified.

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): A61K9/19A61K9/107A61K47/34A61K31/337A61P35/00
Inventor 顾晓军滕鑫
Owner POLYMERCHEM
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