CN100408032C - Stable injection docetaxel - Google Patents
Stable injection docetaxel Download PDFInfo
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- CN100408032C CN100408032C CNB2006100329423A CN200610032942A CN100408032C CN 100408032 C CN100408032 C CN 100408032C CN B2006100329423 A CNB2006100329423 A CN B2006100329423A CN 200610032942 A CN200610032942 A CN 200610032942A CN 100408032 C CN100408032 C CN 100408032C
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- docetaxel
- antioxidant
- citric acid
- injection
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Abstract
A stable Duoxitasai injection is disclosed. It contains a certain quantity of antioxidant to improve its stability.
Description
Technical field
The present invention relates to a kind of stable injection docetaxel, definite a kind of injection docetaxel that contains antioxidant of saying so.Be used for the treatment of cancer.
Background technology
Docetaxel is a kind of anticarcinogen commonly used, and its structural formula is as follows:
Docetaxel injection has commonly been set forth docetaxel injection and preparation method thereof in the United States Patent (USP) 5714512 in the market.But the less stable of present injection docetaxel, generally drug content descends after 9 months to 1 year, and related substance increases, and its curative effect descends, and toxic and side effects increases.
Summary of the invention
The object of the present invention is to provide a kind of stable injection docetaxel.The present invention and existing preparation stability have greatly improved, and effect duration can reach more than 1.5 years.
Preparation of the present invention consists of: the active substance docetaxel; The solvent Tween 80; Antioxidant.Described antioxidant is selected from sodium sulfite, sodium sulfite, ascorbic acid, sodium pyrosulfite, thioglycerol, cysteine hydrochloride, tartaric acid, citric acid, disodium edetate, propyl gallate, tocopherol, lecithin, or any mixture of these antioxidant.The amount of described antioxidant in final products is 0.01% to 3% (weight ratio).The antioxidant optimization citric acid, its content (weight ratio) is preferred 0.1% to 1%, and optimum is 0.5%.
Its preparation method is
1) antioxidant and docetaxel are dissolved in together forms solution in the ethanol;
2) with 1) make alcoholic solution with the polyoxyethylene sorbitan monoleate mix homogeneously;
3) with 2) in make to such an extent that mixture is removed the ethanol packing and got final product.
Preferably under anhydrous condition, implement this method.
The specific embodiment
Mode below by embodiment further specifies the present invention, does not therefore limit the present invention among the described scope of embodiments.
Embodiment 1
Docetaxel 0.4g
Polyoxyethylene sorbitan monoleate 10.0g
Tocopherol 0.03g
Getting the 0.03g tocopherol is dissolved in an amount of dehydrated alcohol, stirring and dissolving, the docetaxel of adding recipe quantity, stirring and dissolving, the polyoxyethylene sorbitan monoleate that adds recipe quantity, mix to clear and bright homogeneous liquid, mixed liquor places Rotary Evaporators, decompression, fling to ethanol, be sub-packed in the cillin bottle, jump a queue, gland.
Implement side 2
Docetaxel 0.4g
Polyoxyethylene sorbitan monoleate 10.0g
Citric acid 0.01g
Getting the 0.01g citric acid is dissolved in an amount of dehydrated alcohol, stirring and dissolving, the docetaxel of adding recipe quantity, stirring and dissolving, the polyoxyethylene sorbitan monoleate that adds recipe quantity, mix to clear and bright homogeneous liquid, mixed liquor places Rotary Evaporators, decompression, fling to ethanol, be sub-packed in the cillin bottle, jump a queue, gland.
Embodiment 3
Docetaxel 0.4g
Polyoxyethylene sorbitan monoleate 10.0g
Citric acid 0.1g
Get the 0.1g citric acid and be dissolved in an amount of dehydrated alcohol, stirring and dissolving, the docetaxel of adding recipe quantity, stirring and dissolving, add the polyoxyethylene sorbitan monoleate of recipe quantity, mix to clear and bright homogeneous liquid, mixed liquor places Rotary Evaporators, decompression, fling to ethanol, be sub-packed in the cillin bottle, jump a queue gland.
Embodiment 4
Docetaxel 0.4g
Polyoxyethylene sorbitan monoleate 10.0g
Citric acid 0.05g
Getting the 0.05g citric acid is dissolved in an amount of dehydrated alcohol, stirring and dissolving, the docetaxel of adding recipe quantity, stirring and dissolving, the polyoxyethylene sorbitan monoleate that adds recipe quantity, mix to clear and bright homogeneous liquid, mixed liquor places Rotary Evaporators, decompression, fling to ethanol, be sub-packed in the cillin bottle, jump a queue, gland.
25 ℃ of stability result such as following table:
After adding especially a certain amount of citric acid of antioxidant as can be known from above experiment, have good stability, extension of validity to 1.5 year is never degenerated.
Claims (6)
1. an injection docetaxel is characterized in that consisting of: the active substance docetaxel; The solvent polyoxyethylene sorbitan monoleate; Antioxidant is selected from sodium sulfite, sodium sulfite, ascorbic acid, sodium pyrosulfite, thioglycerol, cysteine hydrochloride, tartaric acid, citric acid, disodium edetate, propyl gallate, tocopherol, lecithin, or any mixture of these antioxidant.
2. injection docetaxel according to claim 1 is characterized in that described antioxidant is citric acid.
3, as injection docetaxel as described in the claim 1～2, it is characterized in that the amount of described antioxidant in final products is 0.01% to 3% weight ratio.
4. as injection docetaxel as described in the claim 3, it is characterized in that the amount of described antioxidant citric acid in final prescription is 0.1% to 1% weight ratio.
5. as injection docetaxel as described in the claim 4, it is characterized in that the amount of described antioxidant citric acid in final prescription is 0.5% weight ratio.
6. as the described injection docetaxel of claim 1～5, its preparation method is
1) antioxidant and docetaxel are dissolved in together forms solution in the ethanol;
2) with 1) alcoholic solution that makes is with the polyoxyethylene sorbitan monoleate mix homogeneously;
3) with 2) in the mixture that makes remove ethanol and get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100329423A CN100408032C (en) | 2006-01-18 | 2006-01-18 | Stable injection docetaxel |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100329423A CN100408032C (en) | 2006-01-18 | 2006-01-18 | Stable injection docetaxel |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101002761A CN101002761A (en) | 2007-07-25 |
| CN100408032C true CN100408032C (en) | 2008-08-06 |
Family
ID=38702290
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100329423A Expired - Fee Related CN100408032C (en) | 2006-01-18 | 2006-01-18 | Stable injection docetaxel |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100408032C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0600194A (en) | 2006-01-30 | 2007-10-23 | Quiral Quimica Do Brasil S A | docetaxel-containing pharmaceutical compositions and a degradation inhibitor and process for obtaining same |
| CN101716169A (en) * | 2009-11-11 | 2010-06-02 | 山东鲁抗辰欣药业有限公司 | Docetaxel medicinal composition and preparation method thereof |
| CN102871999A (en) * | 2012-11-02 | 2013-01-16 | 济南爱思医药科技有限公司 | Application of 10-monoalkoxy taxad compound derivatives to preparation of antineoplastic drugs |
| CN103169651B (en) * | 2012-12-26 | 2018-01-19 | 辰欣药业股份有限公司 | A kind of injection containing docetaxel and preparation method thereof |
| CN104546694A (en) * | 2013-10-15 | 2015-04-29 | 悦康药业集团有限公司 | Docetaxel injection and preparation method thereof |
| EP3679925A4 (en) | 2017-09-07 | 2021-04-21 | Shenzhen Salubris Pharmaceuticals Co. Ltd | Pharmaceutical composition of docetaxel conjugate and preparation method |
| CN107496352A (en) * | 2017-10-13 | 2017-12-22 | 深圳万乐药业有限公司 | A kind of Docetaxel pharmaceutical composition and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5714512A (en) * | 1991-07-08 | 1998-02-03 | Rhone-Poulenc Rorer, S.A. | Compositions containing taxane derivatives |
-
2006
- 2006-01-18 CN CNB2006100329423A patent/CN100408032C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5714512A (en) * | 1991-07-08 | 1998-02-03 | Rhone-Poulenc Rorer, S.A. | Compositions containing taxane derivatives |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101002761A (en) | 2007-07-25 |
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Granted publication date: 20080806 Termination date: 20200118 |