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Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma

A technology of meclofenoxate hydrochloride and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of high incidence of side reactions and low bioavailability, and achieve low water and impurity content, low side reaction rate, and high bioavailability degree of effect

Inactive Publication Date: 2016-02-03
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present invention also provides a composition preparation whose active ingredient is the meclofenoxate hydrochloride compound described in the present invention and a preparation method thereof. The preparation that can be prepared according to the content of the present invention maintains extremely high stability, which is obviously better than the commercially available variety, greatly improving the safety and effectiveness of meclofenoxate hydrochloride use, but its bioavailability is low and the incidence of side effects is high

Method used

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  • Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma
  • Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma
  • Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: the preparation of meclofenoxate hydrochloride crystal

[0026] (1) Prepare water, N,N-dimethylformamide as a mixed solvent, and the volume ratio of water and N,N-dimethylformamide is 2:1;

[0027] (2) Take the meclofenoxate hydrochloride raw material, dissolve it in the mixed solvent of water and N,N-dimethylformamide whose volume is 6 times the weight of meclofenoxate hydrochloride in step (1), and heat up to 35 ℃, stirred until completely dissolved to obtain meclofenoxate hydrochloride solution;

[0028] (3) Under the condition of a stirring speed of 560r / min, add the meclofenoxate hydrochloride solution in step (2) into methyl propyl ether whose volume is 5 times the weight of meclofenoxate hydrochloride, and mix to form a mixed Cool the suspension to -10°C at a rate of 10°C / min;

[0029] (4) Perform suction filtration, wash the filter cake, and then vacuum-dry the filter cake to obtain a crystalline powder, which is the meclofenoxate hydrochloride...

Embodiment 2

[0031] Embodiment 2: the preparation of meclofenoxate hydrochloride freeze-dried powder injection

[0032] Prescription: in parts by weight, 3 parts of meclofenoxate hydrochloride crystalline compound and 1.5 parts of low molecular weight dextran prepared in Example 1.

[0033] Preparation method: take the meclofenoxate hydrochloride compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of low-molecular dextran, adjust the pH value to 4.0-5.0, then stir until the pH remains constant, then add water for injection to The volume of the solution is 150 times the weight of meclofenoxate hydrochloride, and then coarsely filtered with activated carbon, sterilized and filtered through 1.0 μm, 0.45 μm, and 0.22 μm microporous membranes in turn, and then filtered into a sterile room. After the pH and content are qualified , fill, press half of the stopper, put it into a freeze-drying box that has been cooled to -35°C, freeze-dry at...

Embodiment 3

[0036] Embodiment 3: the preparation of meclofenoxate hydrochloride freeze-dried powder injection

[0037] Prescription: in parts by weight, 3 parts of meclofenoxate hydrochloride crystalline compound and 2.25 parts of low molecular weight dextran prepared in Example 1.

[0038] Preparation method: take the meclofenoxate hydrochloride compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of low-molecular dextran, adjust the pH value to 4.0-5.0, then stir until the pH remains constant, then add water for injection to The volume of the solution is 150 times the weight of meclofenoxate hydrochloride, and then coarsely filtered with activated carbon, sterilized and filtered through 1.0 μm, 0.45 μm, and 0.22 μm microporous membranes in turn, and then filtered into a sterile room. After the pH and content are qualified , fill, press half of the stopper, put it into a freeze-drying box that has been cooled to -35°C, freeze-dry a...

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Abstract

The invention belongs to the technical field of medicine, and relates to a medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma. The medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma comprises meclofenoxate hydrochloride and an excipient. The excipient is a low-molecular dextran, the meclofenoxate hydrochloride is a novel crystal complex, an X-ray powder diffraction pattern measured by using Cu-Ka rays is shown as figure 1, and the meclofenoxate hydrochloride is the meclofenoxate hydrochloride different from that reported in the prior art. The experiment shows that compared with the prior art, the moisture absorption performance and mobility of the meclofenoxate hydrochloride novel crystal complex are obviously improved, the content of moisture and impurities is extremely low, the stability is better, and convenience is brought to the preparation of a formulation; moreover, the bioavailability is higher, and adverse reaction is reduced. Compared with the prior art, the freeze-dried powder injection prepared by using the novel complex is good in stability, extremely low in moisture and impurity content, low in adverse reaction, good in stability after being compounded with solvent, extremely low in content of insoluble micro-particles and very suitable for the clinical application.

Description

technical field [0001] The invention relates to a meclofenoxate hydrochloride composition freeze-dried powder injection for treating traumatic coma, which belongs to the technical field of medicine. Background technique [0002] The chemical name of meclofenoxate hydrochloride is 2-(dimethylamino)ethyl p-chlorophenoxy acetate hydrochloride, which is a central nervous system stimulant and brain neurotrophic drug, which can improve the central nervous system Functions, including causing awakening, invigorating the spirit, exciting breathing, improving nerve reflexes and increasing free activities, it can promote protein assimilation, and can be used as raw materials for the synthesis of choline and acetylcholine in the body, and then synthesize lecithin, thereby changing the neurotransmitter of the central nervous system content, increase the amount of acetylcholine in the brain, have an anti-hypoxic effect, promote the oxidation-reduction reaction of brain cells, promote brai...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/216A61P25/26A61P25/28C07C219/06C07C213/10
Inventor 尹连妮赵晨曲
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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