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Preparation method of paclitaxel injection

A paclitaxel and injection technology, applied in the field of pharmaceutical preparations, can solve problems such as low pH and stability, and achieve the effects of increasing compliance and safety, reducing adverse reactions, and increasing stability

Active Publication Date: 2022-04-15
BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a preparation method of paclitaxel injection with stable properties, in order to solve the problems of low pH and stability in the preparation process of paclitaxel injection in the prior art

Method used

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  • Preparation method of paclitaxel injection
  • Preparation method of paclitaxel injection
  • Preparation method of paclitaxel injection

Examples

Experimental program
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Effect test

Embodiment 1

[0018]

[0019] 1) Weigh 375g of cation exchange resin, fill it in a clean glass tube packed column, moisten it with 500ml water for injection, press filter to remove excess water, then rinse with 500ml of 4% sodium hydroxide solution in sequence, and then use 500ml of injection Rinse the resin-packed column with water and 1000ml of 5% hydrochloric acid solution, cycle twice, and finally rinse with 500ml of water for injection and press filter to remove excess water;

[0020] 2) Take out the resin in the packed column, place it in an oven at 60°C and dry it to a constant weight, then soak the dried resin in an equal volume of absolute ethanol for 30 minutes, and dry it;

[0021] 3) Stir and mix 2.5L polyoxyethylene 35 castor oil (imported from BASF) and 2.5L absolute ethanol, add resin, and stir at about 20°C for 2 hours. Stirring was stopped, the mixed solution was allowed to stand for stratification, and the supernatant was filtered through a 1.2 μm polytetrafluoroethylen...

Embodiment 2

[0028]

[0029] 1) Weigh 375g of cation exchange resin, fill it in a clean glass tube packed column, moisten it with 500ml water for injection, press filter to remove excess water, then rinse with 500ml of 4% sodium hydroxide solution in sequence, and then use 500ml of injection Rinse the resin-packed column with water and 1000ml of 5% hydrochloric acid solution, cycle 4 times, and finally rinse with 500ml of water for injection and press filter to remove excess water;

[0030] 2) Take out the resin in the packed column, place it in an oven at 60°C and dry it to a constant weight, then soak the dried resin in an equal volume of absolute ethanol for 30 minutes, and dry it;

[0031] 3) Stir and mix 2.5L polyoxyethylene 35 castor oil and 2.5L absolute ethanol, add resin, and stir at about 25°C for 4 hours. Stirring was stopped, the mixed solution was allowed to stand for stratification, and the supernatant was filtered through a 0.22 μm polytetrafluoroethylene filter element; ...

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Abstract

According to the preparation method of the paclitaxel injection with the stable property, the blank auxiliary materials are pretreated, carboxylate anions in the auxiliary materials are reduced, degradation of main components is inhibited, and the stability of the paclitaxel injection in the storage period is improved; meanwhile, introduction of a pH regulator is avoided, the pH value of the obtained preparation is 4-6, in the pH value range of infusion tolerable by the human body, adverse reactions can be reduced, and the compliance and safety of the medicine in the clinical use process are improved. Besides, finished products which are prepared from domestic and imported polyoxyethylene 35 castor oil and have obvious difference in quality can achieve similar stability, are consistent with related substances of a reference preparation in level and are good in stability, and the safety of the products in the using process can be effectively guaranteed.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of paclitaxel injection. Background technique [0002] Paclitaxel is a new type of anti-microtubule drug, which promotes tubulin polymerization and inhibits depolymerization, keeps tubulin stable, and inhibits cell mitosis. In vitro experiments have shown that paclitaxel has a significant radiosensitizing effect, which may cause cells to stop in the G2 and M phases that are sensitive to radiotherapy. In clinical practice, it is mainly used for ovarian cancer and breast cancer, and it also has a certain effect on lung cancer, colorectal cancer, melanoma, head and neck cancer, lymphoma and brain tumor. Paclitaxel injection was originally developed by the NCI Cancer Research Center in the United States. In 1991, Bristol-Myers Squibb obtained the authorization, and HQ Specialty Pharma. obtained the authorization to sell the product in the Uni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/44A61K31/337A61P35/00
CPCY02A50/30
Inventor 杨振磊赵德千
Owner BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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