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Midazolam and sodium valproate medical composition and preparation method thereof

A technology of midazolam and sodium valproate, which is applied in the field of pharmacy and pharmacy, can solve the problems of no statistically significant difference in adverse reactions of diazepam and short effective time, so as to improve safety and effectiveness, Fast and easy to use effect

Pending Publication Date: 2020-07-10
浙江美华鼎昌医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to evaluate the effectiveness and safety of midazolam in controlling status epilepticus in children by intranasal administration of midazolam, Zhou Guangyong conducted a Meta-analysis on the treatment of status epilepticus in children by intranasal administration of midazolam. The results showed that midazolam The rapid control effect of intranasal administration is not significantly different from that of diazepam by intravenous administration, but it is better than rectal administration of diazepam, and the effective time is shorter than that of diazepam intravenous administration. academic meaning

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The preparation of the pharmaceutical composition 1 of midazolam and sodium valproate:

[0037] Accurately weigh 50 mg of midazolam, dissolve it in 7 mL of absolute ethanol, add 15 mL of mPEG350 to the above solution, and mix it uniformly by ultrasonication for 2 minutes, then add 18 mL of PEG400, and stir evenly to obtain solution 1; accurately weigh sodium valproate 30.0g, dissolved in 35mL purified water, add 25mL mPEG350 to the above solution, stir to mix evenly to obtain solution 2; add solution 2 dropwise to solution 1 until the solution is clear to obtain midazolam valproate drug combination Object 1.

Embodiment 2

[0039] The preparation of the pharmaceutical composition 2 of midazolam and sodium valproate:

[0040] Accurately weigh 0.5g of midazolam, dissolve it in 7mL of absolute ethanol, add 35mL of mPEG350 to the above solution, ultrasonicate for 2min to mix evenly, then add 18mL of PEG400, stir evenly to obtain solution 1; accurately weigh valproic acid Dissolve 12.5g of sodium in 21mL of purified water, add 19mL of mPEG350 to the above solution, stir to mix evenly to obtain solution 2; add solution 2 dropwise to solution 1 until the solution is clear to obtain midazolam valproate drug Composition 2.

Embodiment 3

[0042] The preparation of the pharmaceutical composition 3 of midazolam and sodium valproate:

[0043] Accurately weigh 1.0g of midazolam, dissolve it in 12mL of absolute ethanol, add 39mL of mPEG350 to the above solution, and ultrasonically mix for 2min to obtain solution 1; accurately weigh 25.0g of sodium valproate, dissolve it in 28mL Add 21 mL of mPEG350 to the above solution in purified water, stir to mix evenly to obtain solution 2; add solution 2 dropwise to solution 1 until the solution is clear to obtain midazolam sodium valproate pharmaceutical composition 3.

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Abstract

The invention relates to a midazolam and sodium valproate medical composition and a preparation method thereof, and belongs to the technical field of pharmaceutical science and pharmaceutics. According to the midazolam and sodium valproate medical composition, main medicines are sodium valproate and midazolam, auxiliary materials are alkoxy polyethylene glycol and medical auxiliary materials, wherein the midazolam can be replaced with midazolam medical salt, and the preparation formulation of the medical composition is aerosol. According to the midazolam and sodium valproate medical composition, two traditional epilepsy treatment medicines including the sodium valproate and the midazolam are combined, and the aerosol is prepared for emergency treatment when epilepsy breaks out; and throughnasal administration, the midazolam and sodium valproate medical composition takes effect quickly and is convenient to use, and safety and validity of separated administration of the sodium valproateand the midazolam can be effectively improved.

Description

technical field [0001] The invention belongs to the technical field of pharmacy and pharmacy, and in particular relates to a pharmaceutical composition of midazolam and sodium valproate and a preparation method thereof. Background technique [0002] The incidence of epilepsy in my country is about 0.03%, and the prevalence is about 0.4-0.8%, of which intractable epilepsy that cannot be controlled by drugs accounts for about 20%. It is estimated that there are about 400,000 new cases in my country each year, and there are about 10 million epileptic patients, and the proportion of patients who die due to epileptic seizures is increasing year by year. Epilepsy refers to the clinical phenomenon caused by the abnormality of brain neurons and excessive hypersynchronized discharge. It is one of the common neurological emergencies. first aid treatment. [0003] Sodium valproate is a traditional antiepileptic drug with a wide range of indications. It is mainly used for single or co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5517A61K31/19A61K9/12A61K47/10A61P25/08
CPCA61K31/5517A61K31/19A61K9/12A61K9/0043A61K47/10A61P25/08
Inventor 杜静贾昕王传跃
Owner 浙江美华鼎昌医药科技有限公司
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