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Paclitaxel injection and preparation method thereof

A technology for paclitaxel and injection, applied in the field of paclitaxel injection and its preparation, can solve the problems of poor water solubility, low bioavailability and high technical difficulty of paclitaxel, and achieve the effect of low cost, simple preparation method and good solubility

Active Publication Date: 2020-03-17
海南紫杉园制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, paclitaxel is extremely poor in water solubility, hardly soluble in water, and has low bioavailability, so it is very difficult to prepare it into preparations for intravenous injection or infusion.

Method used

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  • Paclitaxel injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A kind of paclitaxel injection, is made up of paclitaxel, dehydrated alcohol, castor oil polyoxyl ester (35) and pH adjusting agent, and the content of each composition is:

[0034] Paclitaxel 28.5g

[0035] Absolute ethanol 2375ml

[0036] Castor Oil Polyoxylate (35) 2375ml.

[0037] The pH regulator is acetic acid ethanol solution, which is prepared from acetic acid and absolute ethanol at a volume ratio of 1:2.

[0038] A method for preparing paclitaxel injection, comprising the steps of:

[0039] S1, weigh according to the content of each component, set aside;

[0040] S2, taking 1 / 3 of the total amount of absolute ethanol to dissolve paclitaxel;

[0041] S3, adding castor oil polyoxyl ester (35) and remaining absolute ethanol to the solution obtained by dissolving S2, and mixing;

[0042] S4, adding a pH regulator, wherein the pH regulator is acetic acid ethanol solution, adding the pH regulator until the pH of the solution is 3;

[0043] S5, sterile filtrati...

Embodiment 2

[0046] A kind of paclitaxel injection, is made up of paclitaxel, dehydrated alcohol, castor oil polyoxyl ester (35) and pH adjusting agent, and the content of each composition is:

[0047] Paclitaxel 31.5g

[0048] Absolute ethanol 2625ml

[0049] Castor Oil Polyoxylate (35) 2625ml.

[0050] The pH regulator is acetic acid ethanol solution, which is prepared from acetic acid and absolute ethanol at a volume ratio of 1:2.

[0051] A method for preparing paclitaxel injection, comprising the steps of:

[0052] S1, weigh according to the content of each component, set aside;

[0053] S2, taking 1 / 4 of the total amount of absolute ethanol to dissolve paclitaxel;

[0054] S3, adding castor oil polyoxyl ester (35) and remaining absolute ethanol to the solution obtained by dissolving S2, and mixing;

[0055] S4, adding a pH regulator, wherein the pH regulator is acetic acid ethanol solution, adding the pH regulator until the pH of the solution is 5;

[0056] S5, sterile filtrati...

Embodiment 3

[0059] A kind of paclitaxel injection, is made up of paclitaxel, dehydrated alcohol, castor oil polyoxyl ester (35) and pH adjusting agent, and the content of each composition is:

[0060] Paclitaxel 30g

[0061] Absolute ethanol 2500ml

[0062] Castor Oil Polyoxylate (35) 2500ml.

[0063] The pH regulator is acetic acid ethanol solution, which is prepared from acetic acid and absolute ethanol at a volume ratio of 1:2.

[0064] A method for preparing paclitaxel injection, comprising the steps of:

[0065] S1, weigh according to the content of each component, set aside;

[0066] S2, taking 1 / 4 of the total amount of absolute ethanol to dissolve paclitaxel;

[0067] S3, adding castor oil polyoxyl ester (35) and remaining absolute ethanol to the solution obtained by dissolving S2, and mixing;

[0068] S4, adding a pH regulator, wherein the pH regulator is acetic acid ethanol solution, adding the pH regulator until the pH of the solution is 4;

[0069] S5, sterile filtration...

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Abstract

The invention discloses a paclitaxel injection and a preparation method thereof, which belong to the technical field of biological medicines. The paclitaxel injection is composed of paclitaxel, absolute ethyl alcohol, castor oil polyalkoxy ester (35) and a pH regulator. 250ml + / -5% of absolute ethyl alcohol and 250 ml + / -5% of castor oil polyalkoxy ester (35) need to be added to every 3g + / -5% ofpaclitaxel in a matched manner. The paclitaxel injection disclosed by the invention has the advantages of good solubility, uniform concentration, low content of related substances and stable quality.The preparation method is simple, easy to control and high in production efficiency.

Description

technical field [0001] The invention relates to paclitaxel injection and a preparation method thereof, belonging to the technical field of biomedicine. Background technique [0002] Paclitaxel, English name Paclitaxel, chemical name 5β, 20-epoxy-1, 2α, 4, 7β, 10β, 13α-hexahydroxytaxane-11-en-9-one-4,10-diacetate- 2-Benzoate-13[(2'R,3'S)-N-benzoyl-3-phenylisoserine ester], molecular weight 853.92, molecular formula C 47 h 51 NO 14 . [0003] Paclitaxel is a natural plant extract anti-tumor drug that can effectively treat various cancers. It is widely used in the treatment of ovarian cancer, breast cancer, lung cancer and other tumors. Cancer, head and neck cancer and prostate cancer also have a certain curative effect, and when combined with other commonly used anti-tumor drugs, the curative effect can be further improved, because the unique anti-cancer mechanism is widely used in clinical practice. However, paclitaxel is extremely poor in water solubility, hardly solubl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/44A61P35/00
CPCA61K9/0019A61K9/08A61K31/337A61K47/44A61P35/00
Inventor 陈琼
Owner 海南紫杉园制药有限公司
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