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Meclofenoxate hydrochloride medicinal composition and method for preparing freeze-drying powder injection of meclofenoxate hydrochloride medicinal composition

A technology of meclofenoxate hydrochloride and its composition, which is applied in the field of drug freeze-dried preparations and its preparation, can solve the problems of large adverse reactions and side effects, increase of related substances, increase of adverse reactions, etc., and achieve excellent curative effect, inhibition of hydrolysis, quality Stable and controllable effect

Inactive Publication Date: 2014-06-11
湖北安邦医药有限公司
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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 injections currently on the market have poor stability and relatively large adverse reactions

Method used

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  • Meclofenoxate hydrochloride medicinal composition and method for preparing freeze-drying powder injection of meclofenoxate hydrochloride medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] a. Dissolve 800g of mannitol with 5000ml of water for injection, then add 1000g of meclofenoxate hydrochloride, and adjust the pH value to 4; at room temperature in the dark, add α-cyclodextrin dropwise while stirring, and the stirring time is 5 hours, Make meclofenoxate hydrochloride cyclodextrin saturated solution, the addition of α-cyclodextrin is 5 times of the molar number of meclofenoxate hydrochloride;

[0027] b. In the above solution, add 1000g of reduced glutathione, stir evenly, and then absorb the solution with 0.01% activated carbon, and filter it, the first time with a 0.45um filter membrane, and the second time with a 0.22um filter membrane membrane fine filtration;

[0028] c. Detecting the pH value and content of the filtrate, filling the filtrate after each inspection is qualified, and freeze-drying to obtain the freeze-dried powder injection of the meclofenoxate hydrochloride pharmaceutical composition for injection. The packaging specification is 0....

Embodiment 2

[0029] a. Dissolve 400g of mannitol with 2000ml of water for injection, then add 400g of meclofenoxate hydrochloride, and adjust the pH value to 3; at room temperature in the dark, drop β-cyclodextrin while stirring, and the stirring time is 3 hours to prepare Become meclofenoxate hydrochloride cyclodextrin saturated solution, the addition of β-cyclodextrin is 2 times of the molar number of meclofenoxate hydrochloride;

[0030] b. In the above solution, add 600g of reduced glutathione, stir evenly, and then absorb the solution with 0.01% activated carbon, and filter it, the first time with a 0.45um filter membrane, and the second time with a 0.22um filter membrane membrane fine filtration;

[0031] c. Detecting the pH value and content of the filtrate, filling the filtrate after each inspection is qualified, and freeze-drying to obtain the freeze-dried powder injection of the meclofenoxate hydrochloride pharmaceutical composition for injection. The packaging specification is ...

Embodiment 3

[0033] a. Dissolve 400g of mannitol with 4000ml of water for injection, then add 800g of meclofenoxate hydrochloride, and adjust the pH value to 4; at room temperature in the dark, add γ-cyclodextrin dropwise while stirring, and the stirring time is 4 hours. Make meclofenoxate hydrochloride cyclodextrin saturated solution, the addition of gamma-cyclodextrin is 2 times of the molar number of meclofenoxate hydrochloride;

[0034] b. Add 800g of reduced glutathione to the above solution, stir evenly, then absorb the solution with 0.01% activated carbon, and filter it, the first time with a 0.45um filter membrane, and the second time with a 0.22um filter membrane membrane fine filtration;

[0035] c. Detecting the pH value and content of the filtrate, filling the filtrate after each inspection is qualified, and freeze-drying to obtain the freeze-dried powder injection of the meclofenoxate hydrochloride pharmaceutical composition for injection. The packaging specification is 0.20g...

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Abstract

The invention provides a meclofenoxate hydrochloride medicinal composition and a method for preparing a freeze-drying powder injection of the meclofenoxate hydrochloride medicinal composition. The meclofenoxate hydrochloride medicinal composition comprises the following components in part by weight: 30 to 100 parts of meclofenoxate hydrochloride, 60 to 120 parts of reduced glutathione and 40 to 80 parts of mannitol. The preparation method comprises the following steps of: a) dissolving the mannitol in water for injection, adding the meclofenoxate hydrochloride, and regulating the pH value to be 2-5; b) adding the reduced glutathione, stirring uniformly, adsorbing the solution by using 0.01 percent active carbon and filtering; and c) performing freeze drying to obtain the freeze-drying powder injection. The meclofenoxate hydrochloride medicinal composition has a reasonable formula and a good curative effect, and is high in quality stability, small in side effects and high in safety, and the adverse reaction of patients on medicine is reduced. The method for preparing the freeze-drying powder injection of the meclofenoxate hydrochloride medicinal composition is reasonable, reliable, simple, feasible, and suitable for industrial production.

Description

technical field [0001] The invention relates to a drug freeze-dried preparation and a preparation process thereof, in particular to a meclofenoxate hydrochloride pharmaceutical composition and a preparation method thereof for freeze-dried powder injection. Background technique [0002] The chemical name of meclofenoxate hydrochloride is 2-(dimethylamino)ethyl p-chlorophenoxy acetate hydrochloride, which is a central nervous system stimulant that has been used for many years. Meclofenoxate hydrochloride mainly acts on the cerebral cortex. It can promote the redox of brain cells, regulate the metabolism of nerve cells, increase the utilization of carbohydrates and have an excitatory effect on the inhibited central nervous system. Clinically, it is mostly used for traumatic coma, neonatal hypoxia, infantile dysuria, disturbance of consciousness, senile mental illness, alcoholism, carbon monoxide poisoning, etc. [0003] Because meclofenoxate hydrochloride is extremely unstable...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/221A61K47/20A61K9/19A61P25/26
Inventor 柯少鸿
Owner 湖北安邦医药有限公司
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