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A kind of paclitaxel injection and preparation method thereof

A technology for paclitaxel and injection, which is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. The effect of mature production technology route

Active Publication Date: 2020-01-07
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to provide a kind of paclitaxel injection and preparation method thereof, to solve adverse reactions such as allergies in traditional paclitaxel injection in clinical use and poor stability in injections in which it is dissolved in sodium chloride or glucose question

Method used

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  • A kind of paclitaxel injection and preparation method thereof
  • A kind of paclitaxel injection and preparation method thereof
  • A kind of paclitaxel injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) Weigh 3g of paclitaxel, 20g of castor oil polyoxyl ester (35), 6g of vitamin E, 10g of Tween 80, 200g of absolute ethanol and an appropriate amount of pH regulator (anhydrous citrate and sodium citrate according to Mixed solution with a mass ratio of 2:1);

[0023] (2) Add castor oil polyoxyl ester (35) and Tween 80 into 120g of absolute ethanol to dissolve at a temperature of 35°C, and stir evenly to obtain a mixed solution A;

[0024] (3) Dissolve vitamin E in the remaining 80 g of absolute ethanol, then slowly add paclitaxel into the ethanol solution of vitamin E under stirring, and stir evenly to obtain mixed solution B;

[0025] (4) Mix the mixed solution A with the mixed solution B, and then add the pH adjuster dropwise under the condition of stirring, adjust the pH value of the mixed solution to 4.0 and stop the dropwise addition;

[0026] (5) Stir the mixed solution with a pH value of 4.0 at a temperature of 35°C for 90 minutes (stirring speed is 50r / min), ...

Embodiment 2

[0028] (1) Weigh 3g of paclitaxel, 80g of castor oil polyoxyl ester (35), 6g of vitamin E, 25g of Tween 80, 500g of absolute ethanol and an appropriate amount of pH regulator (anhydrous citrate and sodium citrate according to Mixed solution with a mass ratio of 2:1);

[0029] (2) Add castor oil polyoxyl ester (35) and Tween 80 into 300g of absolute ethanol to dissolve at a temperature of 35°C, and stir evenly to obtain a mixed solution A;

[0030] (3) Dissolve vitamin E in the remaining 200g of absolute ethanol, then slowly add paclitaxel into the ethanol solution of vitamin E under stirring, and stir evenly to obtain mixed solution B;

[0031] (4) Mix the mixed solution A with the mixed solution B, and then add the pH adjuster dropwise under the condition of stirring, adjust the pH value of the mixed solution to 4.0 and stop the dropwise addition;

[0032] (5) Stir the mixed solution with a pH value of 4.0 at a temperature of 35°C for 90 minutes (stirring speed is 50r / min), ...

Embodiment 3

[0034] (1) Weigh 3g of paclitaxel, 60g of castor oil polyoxyl ester (35), 10g of vitamin E, 25g of Tween 80, 500g of absolute ethanol and an appropriate amount of pH regulator (anhydrous citrate and sodium citrate according to Mixed solution with a mass ratio of 2:1);

[0035] (2) Add castor oil polyoxyl ester (35) and Tween 80 into 300g of absolute ethanol to dissolve at a temperature of 35°C, and stir evenly to obtain a mixed solution A;

[0036] (3) Dissolve vitamin E in the remaining 200g of absolute ethanol, then slowly add paclitaxel into the ethanol solution of vitamin E under stirring, and stir evenly to obtain mixed solution B;

[0037] (4) Mix the mixed solution A with the mixed solution B, and then add the pH adjuster dropwise under the condition of stirring, adjust the pH value of the mixed solution to 4.0 and stop the dropwise addition;

[0038] (5) Stir the mixed solution with a pH value of 4.0 at a temperature of 35°C for 90 minutes (stirring speed is 50r / min),...

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Abstract

The invention discloses a paclitaxel injection, which, in proportion by weight, comprises: paclitaxel, polyoxyethylene 35 castor oil, vitamin E, Tween 80, absolute ethanol and a pH regulator; the pH regulator injects paclitaxel into The pH of the solution was adjusted to 3.0 to 5.0. At the same time, a preparation method of paclitaxel injection is also disclosed: adding polyoxyethylene 35 castor oil and Tween 80 into part of absolute ethanol to dissolve to obtain mixed solution A; dissolving vitamin E in the remaining absolute ethanol, and then adding Add paclitaxel to the ethanol solution of vitamin E to obtain mixed solution B; mix mixed solution A and mixed solution B, adjust the pH value, and filter to obtain. The paclitaxel injection prepared by the invention has good stability, and the usage amount of polyoxyethylene 35 castor oil in the formula is small, which overcomes the problem that the traditional paclitaxel injection easily causes allergies to patients, has high clinical drug safety, and is suitable for industrial production and popularization and application. .

Description

technical field [0001] The invention relates to an antitumor drug preparation and a preparation method thereof, in particular to a paclitaxel injection and a preparation method thereof. Background technique [0002] In recent years, the mortality rate of cancer has increased year by year, which has seriously threatened human health and life. Therefore, the prevention and treatment of tumors has become a very difficult task in medical treatment. Paclitaxel, a tetracyclic diterpenoid compound isolated from Pacific yew bark by American chemists Professor Wall and Wani in 1966, is one of the first-choice anticancer drugs. Paclitaxel is an anti-microtubule drug with a very novel mechanism of action. It can promote tubulin polymerization and inhibit its depolymerization, and then block cell mitosis to achieve the purpose of anti-cancer. It has been widely used in breast cancer, ovarian cancer, head and neck cancer, etc. It is one of the most potential anti-tumor drugs in the exis...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/44A61K47/10A61K47/22A61K31/337A61P35/00
CPCA61K9/0019A61K9/08A61K31/337A61K47/10A61K47/22A61K47/44
Inventor 毛欣怡刘树林张天兵张志江郭慧娟王燕燕张娴刘超梁冉
Owner NORTH CHINA PHARMA COMPANY
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