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Taxol injection and preparation method thereof

A technology for paclitaxel and injection, which is applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as allergic stability, and achieves a simple and feasible preparation process and is suitable for industrial production. And the effect of promotion and application, excellent dissolution uniformity and stability

Active Publication Date: 2017-06-23
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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  • Taxol injection and preparation method thereof
  • Taxol injection and preparation method thereof
  • Taxol 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 taxol injection. The taxol injection is prepared from the following components in parts by weight: taxol, cremophor el 35, vitamin E, Tween 80, absolute ethyl alcohol, and a pH (potential of hydrogen) value regulator, wherein the pH value regulator is used for regulating the pH value of the taxol injection to 3.0-5.0. The invention also discloses a preparation method of the taxol injection. The preparation method comprises the following steps of adding the cremophor el 35 and the Tween 80 into one part of absolute ethyl alcohol, and dissolving, so as to obtain a mixed solution A; dissolving the vitamin E into the remaining absolute ethyl alcohol, and adding the taxol into the ethyl alcohol solution containing the vitamin E, so as to obtain a mixed solution B; mixing the mixed solution A and the mixed solution B, regulating the pH value, and filtering, so as to obtain the taxol injection. The prepared taxol injection has the advantages that the stability is good, the usage amount of cremophor el 35 in the formula is small, the disturbance of easiness in allergy of a patient by the traditional taxol injection is overcome, the safety in clinical application is high, and the taxol injection is suitable for industrialized production, 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 Applications(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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