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Anti-tumor pharmaceutical composition as well as preparation method and application thereof

A composition and drug technology, applied in the field of anti-tumor drugs, can solve problems such as difficult to effectively control adverse reactions of products, high risk of clinical drug safety, and poor drug compliance of patients, so as to improve drug safety and prevent the occurrence of serious adverse drug reactions The effect of reducing the rate and reducing serious adverse reactions

Active Publication Date: 2018-04-20
JIANGSU JIUXU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to reduce and avoid adverse reactions, the quality control of polyoxyethylene castor oil products has been strengthened at home and abroad. The product standards have been included in the pharmacopoeias of the United States, Europe, and China. The quality standard is difficult to effectively control the occurrence of adverse reactions of the product, the toxicity of related impurities is unknown, the safety risk of clinical medication is high, and the patient's medication compliance is very poor

Method used

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  • Anti-tumor pharmaceutical composition as well as preparation method and application thereof
  • Anti-tumor pharmaceutical composition as well as preparation method and application thereof
  • Anti-tumor pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0046] Embodiment 1 polyoxyethylene castor oil refining method

[0047] Take 1 part by weight of polyoxyethylene castor oil and add 1.4 parts by weight of acetonitrile to dissolve it, add 1.4 parts by weight of cyclohexane to extract, stir at 150r / min for 15min, put it in a water bath at 30°C, and let it stand for stratification to obtain the acetonitrile solution of the lower layer; Acetonitrile solution, adding 1.4 parts by weight of cyclohexane for extraction, stirring at 150r / min for 15min, standing in a water bath at 60°C for stratification to obtain the lower layer of acetonitrile solution; repeated extraction with cyclohexane for 4 times, the final acetonitrile extract in In a water bath at 40°C, acetonitrile was removed by rotary evaporation to obtain refined polyoxyethylene castor oil.

Embodiment 2

[0048] Embodiment 2 polyoxyethylene castor oil refining method

[0049] Take 1 part by weight of polyoxyethylene castor oil and add 1.6 parts by weight of acetonitrile to dissolve it, add 1.6 parts by weight of cyclohexane to extract, stir at 150r / min for 15min, put it in a water bath at 55°C, and let it stand for stratification to obtain the acetonitrile solution of the lower layer; Acetonitrile solution, adding 1.6 parts by weight of cyclohexane for extraction, stirring at 150r / min for 15min, standing in a water bath at 55°C for stratification to obtain the lower layer of acetonitrile solution; repeated extraction with cyclohexane for 3 times, and the final acetonitrile extract in In a water bath at 55°C, remove acetonitrile by rotary evaporation to obtain refined polyoxyethylene castor oil.

Embodiment 3

[0050] Embodiment 3 polyoxyethylene castor oil refining method

[0051] Take 1 part by weight of polyoxyethylene castor oil and add 1.8 parts by weight of acetonitrile to dissolve it, add 1.8 parts by weight of cyclohexane to extract, stir at 150r / min for 15min, put it in a water bath at 60°C, and let it stand for stratification to obtain the acetonitrile solution of the lower layer; Acetonitrile solution, adding 1.8 parts by weight of cyclohexane for extraction, stirring at 150r / min for 15min, standing in a water bath at 30°C, standing for stratification to obtain the lower layer of acetonitrile solution; repeating the extraction with cyclohexane for 3 times, the final acetonitrile extract in In a water bath at 60°C, remove acetonitrile by rotary evaporation to obtain refined polyoxyethylene castor oil.

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Abstract

The invention relates to the technical field of anti-tumor drugs and particularly relates to an anti-tumor pharmaceutical composition as well as a preparation method and application thereof. By utilizing the anti-tumor pharmaceutical composition prepared from refined polyoxyethylated castor oil, the occurrence rate of serious untoward effects of a taxol injection is decreased, and the pharmaceutical safety and the pharmaceutical compliance of a patient are improved. The comparison of impurities before and after the polyoxyethylated castor oil is refined shows that the contents of polyoxyethylated castor oil impurities at relative retention time 0.6 and 1.2 in a related substance related substance of the taxol injection are remarkably reduced, and the safety of the refined polyoxyethylatedcastor oil is obviously improved.

Description

technical field [0001] The invention relates to the technical field of anti-tumor drugs, in particular to an anti-tumor pharmaceutical composition and its preparation method and application. Background technique [0002] Paclitaxel is a tetracyclic diterpene amide compound, a secondary metabolite first extracted from the bark of Taxus chinensis. It is a natural anticancer drug with strong spectrum and activity. The injection Taxol developed by Bristol-Myers Squibb at the end of the 20th century was first used in clinical practice. Tubulin assembles into microtubules, but inhibits the depolymerization of microtubules and stabilizes microtubules, which leads to abnormal arrangement of microtubules, makes the pituitary gland lose its normal function and leads to cell death, and has outstanding curative effect on breast cancer and ovarian cancer. In addition, It also has a certain effect on liver cancer, lung cancer, esophageal cancer, head and neck cancer and prostate cancer, ...

Claims

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Application Information

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IPC IPC(8): A61K47/44A61K9/08A61K31/337A61K31/704A61K31/555A61P35/00
CPCA61K9/0019A61K9/08A61K31/337A61K31/555A61K31/704A61K47/44
Inventor 刘新红张明明于自勋毛黎静吴杰
Owner JIANGSU JIUXU PHARMA
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