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Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating senile dementia

A technology of meclofen axetil hydrochloride and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of low bioavailability and high incidence of side reactions, and achieves low side reaction rate, low moisture and impurity content, and good stability. 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 senile dementia
  • Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating senile dementia
  • Medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating senile dementia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: the preparation of meclofenoxate hydrochloride crystal

[0028] (1) Grind the crude product of meclofenoxate hydrochloride, pass it through an 80-mesh sieve, then add it to deionized water whose volume is 6 times the weight of meclofenoxate hydrochloride, and stir at 130 rpm for 10 minutes;

[0029] (2) Add dichloroethane whose volume is 4 times the weight of meclofenoxate hydrochloride under stirring at 90 rpm, and raise the temperature to 35°C at the same time;

[0030] (3) After the solution is added, let it stand for 3 hours, and add dropwise a mixed solution of diethyl ether and carbon tetrachloride whose volume is 8 times the weight of meclofenoxate hydrochloride at 0°C under the condition of stirring at 150 rev / min. The volume ratio of carbon chloride is 3:2, and the uniform dropwise addition is completed within 2 hours;

[0031] (4) After the dropwise addition was completed, the temperature was lowered to -5°C, and the stirring was continued for 2...

Embodiment 2

[0033] Embodiment 2: the preparation of meclofenoxate hydrochloride freeze-dried powder injection

[0034] Prescription: in parts by weight, 3 parts of meclofenoxate hydrochloride crystalline compound prepared in Example 1, and 8 parts of trehalose.

[0035] Preparation method: take the meclofenoxate hydrochloride compound of the present invention, stir with water for injection, add trehalose in the prescribed amount, adjust the pH value to 4.0-5.0, then stir until the pH remains constant, then add water for injection until the volume of the solution becomes hydrochloric acid 100 times the weight of meclofenoxate, then coarsely filter with activated carbon, pass through 1.0μm, 0.45μm, 0.22μm microporous membranes in turn to sterilize and filter, filter into the sterile room, measure the pH and content after passing the filling, Press half the stopper, put it into a freeze-drying box that has been cooled to -25°C, freeze-dry at low temperature, press the stopper out of the box,...

Embodiment 3

[0040] Embodiment 3: the preparation of meclofenoxate hydrochloride freeze-dried powder injection

[0041] Prescription: in parts by weight, 3 parts of meclofenoxate hydrochloride crystalline compound prepared in Example 1, and 9 parts of trehalose.

[0042] Preparation method: take the meclofenoxate hydrochloride compound of the present invention, stir with water for injection, add trehalose in the prescribed amount, adjust the pH value to 4.0-5.0, then stir until the pH remains constant, then add water for injection until the volume of the solution becomes hydrochloric acid 100 times the weight of meclofenoxate, then coarsely filter with activated carbon, pass through 1.0μm, 0.45μm, 0.22μm microporous membranes in turn to sterilize and filter, filter into the sterile room, measure the pH and content after passing the filling, Press half the stopper, put it into a freeze-drying box that has been cooled to -25°C, freeze-dry at low temperature, press the stopper out of the box,...

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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 senile dementia. The medicinal meclofenoxate hydrochloride composition freeze-dried powder injection for treating senile dementia comprises meclofenoxate hydrochloride and an excipient. The excipient is trehalose, the meclofenoxate hydrochloride is a novel crystal complex, and an X-ray powder diffraction pattern measured by adopting Cu-Ka rays is shown as Figure 1. The novel crystal structure of the meclofenoxate hydrochloride is different from the prior art, the experimental verification shows that compared with the prior art, the moisture absorption performance and mobility of the meclofenoxate hydrochloride crystal complex are obviously improved, the content of moisture and impurities is relatively low, the stability is better, and convenience is brought to the preparation of a formulation; the bioavailability is higher, and the adverse reaction is reduced. Compared with the prior art, the freeze-dried powder injection prepared by using the meclofenoxate hydrochloride crystal 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 senile dementia, 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 bra...

Claims

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Application Information

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