Meclofenoxate hydrochloride preparation freeze-drying technique and preparation method thereof

A technology for meclofen axetil hydrochloride and freeze-dried preparations is applied in the field of medicinal preparations and preparations thereof, which can solve the problems of easy hydrolysis of meclofen axetil hydrochloride, inability to solve the problems of moisture absorption in storage, reduced clinical efficacy and the like, and achieves a simple and easy process. The production method is reasonable and reliable, and has no toxic and side effects.

Inactive Publication Date: 2009-06-17
朗美药业(武汉)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the hygroscopicity of meclofenoxate hydrochloride, it is easy to decompose when absorbing moisture, resulting in a decrease in content and an increase in related substances, which will eventually lead to a decrease in clinical efficacy and increase adverse reactions
Meclofenoxate hydrochloride for injection is prepared by aseptic packaging, which has a long production cycle, high cost, and a small batch size, which cannot solve the problem of moisture absorption during storage within the validity period, and the serious increase of related substances limits the wide application of this product in clinical practice. application
Because meclofenoxate is easily hydrolyzed and extremely unstable in water, and lyophilization cannot avoid using water as a solvent, which makes it extremely difficult to make it into a lyophilized preparation
Publication date is July 18th, 2007, and publication number is that the invention patent application of CN100998585A discloses a kind of preparation of meclofenoxate hydrochloride injection and preparation method thereof, although it has improved the stability of meclofenoxate hydrochloride, but It still has the problem that meclofenoxate hydrochloride is easily hydrolyzed, resulting in reduced content and difficult storage

Method used

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  • Meclofenoxate hydrochloride preparation freeze-drying technique and preparation method thereof

Examples

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Effect test

Embodiment 1

[0021] The freeze-dried preparation of meclofenoxate hydrochloride for injection and the preparation process thereof comprise the freeze-dried preparation made of meclofenoxate hydrochloride and mannitol. The parts by weight are 10 parts by weight of meclofenoxate hydrochloride, 17 parts by mannitol, pH is 4.1, and the properties are white or off-white freeze-dried loose block or powder. The preparation process is as follows: take the prescribed amount of mannitol and add water for injection, stir to dissolve; add meclofenoxate hydrochloride to dissolve, add water for injection to constant volume, absorb with 0.01% activated carbon, and filter; use 0.45 μm microporous membrane for primary filtration Then use a 0.22 μm microporous membrane for fine filtration; measure the solution content, and fill each vial with about 2.0ml according to the preparation specifications; freeze-dry, stopper, cap, and pack after passing the quality inspection. The packaging specification is 0.1g. ...

Embodiment 2

[0023] The freeze-dried preparation of meclofenoxate hydrochloride for injection and the preparation process thereof comprise the freeze-dried preparation made of meclofenoxate hydrochloride and mannitol. The parts by weight are 20 parts by weight of meclofenoxate hydrochloride, 10 parts by mannitol, pH is 3.9, and the properties are white or off-white freeze-dried loose block or powder. The preparation process is as follows: take the prescribed amount of mannitol and add water for injection, stir to dissolve; add meclofenoxate hydrochloride to dissolve, add water for injection to constant volume, absorb with 0.01% activated carbon, and filter; use 0.45 μm microporous membrane for primary filtration Then use a 0.22 μm microporous membrane for fine filtration; measure the solution content, and fill each vial with about 2.0ml according to the preparation specifications; freeze-dry, stopper, cap, and pack after passing the quality inspection. The packaging specification is 0.2g. ...

Embodiment 3

[0025] The freeze-dried preparation of meclofenoxate hydrochloride for injection and the preparation process thereof comprise the freeze-dried preparation made of meclofenoxate hydrochloride and mannitol. The parts by weight are 25 parts by weight of meclofenoxate hydrochloride, 10 parts by mannitol, the pH is 4.0, and the properties are white or off-white freeze-dried loose block or powder. The preparation process is as follows: take the prescribed amount of mannitol and add water for injection, stir to dissolve; add meclofenoxate hydrochloride to dissolve, add water for injection to constant volume, absorb with 0.01% activated carbon, and filter; use 0.45 μm microporous membrane for primary filtration Then use a 0.22 μm microporous membrane for fine filtration; measure the solution content, and fill each vial with about 2.0ml according to the preparation specifications; freeze-dry, stopper, cap, and pack after passing the quality inspection. The packaging specification is 0....

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Abstract

The present invention relates to a technique of lyophilized preparation of meclofenxate hydrochloride and a preparing method thereof. According to the invention, mannitol with effective dose of medicament is added with injection water and is dissolved. The meclofenxate hydrochloride with effective dose of medicament is added and mixed to uniform. The pH value is adjusted to 3-5. The obtained preparing is adsorbed with 0.01% of active carbon and is filtered. Then free drying is executed for preparing the lyophilized preparation. The meclofenxate hydrochloride in the invention is enveloped by macromolecule material and greatly reduces the hydrolytic reaction of meclofenxate hydrochloride. Therefore the lyophilized preparation of meclofenxate hydrochloride prepared by the invention has enough stability in water and can totally satisfy the requirement of clinical medicine taking. Furthermore the lyophilized preparation of meclofenxate hydrochloride prepared by the invention can be stably and slowly released. The bioavailability of meclofenxate hydrochloride is increased and transparency after re-dissolving is excellent.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a process of meclofenoxate hydrochloride freeze-dried preparation and a preparation method thereof. Background technique [0002] Meclofenoxate hydrochloride was artificially synthesized by French scientist Professor Thuillier in 1957. Its chemical name is p-chlorophenoxyacetic acid dimethylaminoacetate. It is a central stimulant drug that has been used for many years. Oxygen, neurological disorders, and can control children's enuresis caused by deep sleep and low warning point of deep awakening. In 1996, it was found that it can remove lipofuscin and free radicals in nerve cells, promote body metabolism, protect cell membranes, enhance memory and improve intelligence. It is called an activator of brain cell metabolism, which can promote the utilization of carbohydrates by brain cells. Increase the intake of oxygen to the brain, promote the oxidati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/221A61P25/26
Inventor 柯少鸿
Owner 朗美药业(武汉)有限公司
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