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Method for improving stability of docetaxel injection

A docetaxel and stability technology, which is applied in the field of preparation of docetaxel injections, can solve the problems of easy oxidative degradation of docetaxel injections, to ensure quality and effectiveness, reduce direct contact, and prevent drug Degradation effect

Pending Publication Date: 2021-10-22
LUOXIN PHARM SHANGHAI CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to provide a method for improving the stability of docetaxel injection in order to overcome the above-mentioned defects in the prior art, and solve the problem that the docetaxel injection in the prior art is prone to oxidative degradation during the preparation process. question

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]A method for improving the stability of docetaxel injection, adopting the following steps:

[0041] (1) Put 20 parts by weight of propylene glycol into the liquid mixing tank, and start stirring.

[0042] (2) Add 1 part by weight of lactic acid into the liquid mixing tank, stir and dissolve; open the vacuum valve to vacuumize the liquid mixing tank, remove the air brought in by adding the above raw materials and the bubbles generated during the stirring and dissolving process, and vacuum the liquid Gas for 5 minutes; open the nitrogen valve, fill the bottom of the batching tank with nitrogen, and return the batching tank to normal pressure, so that the solution is in a hypoxic state before adding the docetaxel raw material.

[0043] (3) Close the nitrogen valve, suspend nitrogen filling, and add 1 part by weight of docetaxel trihydrate into the liquid preparation tank.

[0044] (4) Add 10 parts by weight of propylene glycol, 4 parts by weight of corn oil, and 30 parts b...

Embodiment 2

[0051] A method for improving the stability of docetaxel injection, adopting the following steps:

[0052] (1) Put 14 parts by weight of polyethylene glycol into the liquid mixing tank, and start stirring.

[0053] (2) Add tartaric acid of 0.5 parts by weight into the liquid mixing tank, stir and dissolve; open the vacuum valve to vacuumize the liquid mixing tank, remove the air brought in by adding the above raw materials and the bubbles generated in the stirring and dissolving process, and vacuum out Gas for 5 minutes; open the nitrogen valve, fill the middle of the batching tank with nitrogen, and return the batching tank to normal pressure, so that the solution is in a hypoxic state before adding the docetaxel raw material.

[0054] (3) Close the nitrogen valve, suspend nitrogen filling, and add 1 part by weight of docetaxel trihydrate into the liquid mixing tank.

[0055] (4) Add 7 parts by weight of polyethylene glycol, 3 parts by weight of soybean oil, and 25 parts by ...

Embodiment 3

[0062] A method for improving the stability of docetaxel injection, adopting the following steps:

[0063] (1) Put 18 parts by weight of polypropylene glycol into the liquid mixing tank, and start stirring.

[0064] (2) Add anhydrous citric acid of 0.8 parts by weight into the liquid mixing tank, stir and dissolve; open the vacuum valve to vacuumize the liquid mixing tank, remove the air brought in by adding the above raw materials and the gas produced during the stirring and dissolving process; Bubbles, vacuum degassing; open the nitrogen valve, fill the top of the batching tank with nitrogen, and return the batching tank to normal pressure, so that the solution is in a hypoxic state before adding the docetaxel raw materials.

[0065] (3) Close the nitrogen valve, suspend nitrogen filling, and add 1 part by weight of anhydrous docetaxel into the liquid preparation tank.

[0066] (4) Add 9 parts by weight of polypropylene glycol, 5 parts by weight of medium-chain triglyceride...

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Abstract

The invention relates to a method for improving the stability of a docetaxel injection. The method comprises the following steps: adding part of a first auxiliary material into a mixing tank and stirring; adding a second auxiliary material into the mixing tank, stirring and dissolving, vacuumizing, and introducing nitrogen; adding the docetaxel raw material, the remaining first auxiliary material and other additives into a mixing tank, and stirring for dissolving; carrying out vacuum-pumping treatment on the mixing tank, and filling nitrogen after vacuum degassing is finished; continuously stirring to uniformly mix the liquid medicine; applying nitrogen pressure into the mixing tank, and filtering the liquid medicine into a sterile storage tank; and filling the liquid medicine in the sterile storage tank into a penicillin bottle, pressing a plug, and rolling a cover. Compared with the prior art, the nitrogen is filled in the liquid preparation and / or filling stage, and the nitrogen filling pressure is strictly controlled, so that the direct contact between the medicine and oxygen can be well reduced, the medicine is prevented from being degraded, the medicine stability is improved, and the quality and effectiveness of the medicine are ensured.

Description

technical field [0001] The invention relates to a preparation method of docetaxel injection, in particular to a method for improving the stability of docetaxel injection. Background technique [0002] Oxygen in the air can form peroxygen compounds with drugs, causing oxidative deterioration of drugs, especially in humid air and under the catalysis of light, which will accelerate the oxidation of drugs by air. Some solid medicines exposed in humid air can be oxidized by oxygen; the upper part of the preparation tank of the medicine liquid, the residual air in the upper part of the medicine liquid in the vial, the dissolved oxygen in the medicine solution and water for injection can all cause strong reducibility. oxidation of the drug. Therefore, there is a need to reduce the exposure of drugs to oxygen to improve their stability. [0003] Docetaxel (docetaxel) has the same effect as paclitaxel (PTX). It is an M-phase cycle-specific drug that promotes the polymerization of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/00A61K9/08A61K31/337A61P35/00
CPCA61J3/00A61K31/337A61K9/0019A61P35/00
Inventor 郭红星孙博弘邵长林
Owner LUOXIN PHARM SHANGHAI CO LTD
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