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Stable chloral hydrate solution and preparation method and application thereof

A chloral hydrate solution technology, which is applied in the field of chloral hydrate solution and sedative hypnotic drug preparations, can solve problems such as poor compliance, increased children's fear and pain, and large toxic and side effects, and achieve the effect of increasing the concentration

Active Publication Date: 2019-08-23
TEFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, effectively improving the stability of chloral hydrate oral solution becomes a difficult problem, and there is no effective method report always
In addition, hospital preparations are limited to the use of this preparation in hospitals and are not allowed to be sold externally. For the large number of small and medium-sized hospitals and grass-roots hospitals that do not have the preparation conditions, it is difficult to obtain chloral hydrate preparations. Clinicians often have to choose phenobarbital with severe side effects Drugs such as sodium, propofol, and ketamine injections
Compared with oral medicines, injections require professional administration, are inconvenient to use, increase children’s sense of fear and pain, and have poor compliance

Method used

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  • Stable chloral hydrate solution and preparation method and application thereof
  • Stable chloral hydrate solution and preparation method and application thereof
  • Stable chloral hydrate solution and preparation method and application thereof

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preparation example Construction

[0032] In some embodiments, the present invention provides the preparation method of chloral hydrate solution, it is characterized in that: its preparation step comprises:

[0033] 1) mixing a pharmaceutically acceptable acid with water, stirring and dissolving to obtain an acid solution with a pH value of 1.0-2.9; and

[0034] 2) Add chloral hydrate to the acid solution while stirring, and stir until completely dissolved to obtain the chloral hydrate solution, wherein the mass concentration of chloral hydrate is 40%-80% (such as 44%-80% %, 44%-70%, 44%-60% or 44%-50%).

[0035] In a preferred embodiment, the pH of the acid solution prepared in step 1) of the method is 1.0-2.0, preferably 1.2-1.6.

[0036] In a preferred embodiment, the pH of the acid solution prepared in step 1) of the method is 1.31-2.0.

[0037] In a preferred embodiment, the pH of the acid solution prepared in step 1) of the method is 1.61-2.0.

[0038] In other embodiments, the present invention provid...

Embodiment 1

[0056] Add 12g of anhydrous citric acid and a certain amount of purified water into a glass beaker, stir and dissolve to obtain a citric acid solution with a pH value of 1.64, then add 738g of chloral hydrate (14-24 mesh) while stirring, Stir under the rotating speed of / min until dissolving completely, obtain the chloral hydrate solution that mass concentration is 44%.

Embodiment 2

[0058] Add 12g of anhydrous citric acid and a certain amount of purified water into a glass beaker, stir and dissolve to obtain a citric acid solution with a pH value of 1.61, then add 1007g of chloral hydrate (14-24 mesh) while stirring, Stir under the rotating speed of / min until completely dissolving, obtain the chloral hydrate solution that mass concentration is 60%.

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Abstract

The invention discloses a chloral hydrate solution. The chloral hydrate solution comprises chloral hydrate, pharmaceutically-acceptable acid and water, wherein the mass concentration of the chloral hydrate is 40-80%, and the pH value of the chloral hydrate solution is preferably 1.0-2.9. Particularly, the invention relates to a stable chloral hydrate solution. The stable chloral hydrate solution comprises chloral hydrate, monohydrate or anhydrous citric acid and purified water, wherein the mass concentration of the chloral hydrate is 44-80%, and the pH value of the chloral hydrate solution ispreferably 1.0-2.9. The invention further relates to a preparation method and application of the chloral hydrate solution.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a sedative-hypnotic pharmaceutical preparation, and more specifically to a diluted chloral hydrate solution suitable for oral use by children. In addition, the present invention also relates to a preparation method of the chloral hydrate solution and the use of the chloral hydrate solution in the preparation of sedative and hypnotic drugs. Background technique [0002] Diagnosis and treatment of childhood illnesses often require multiple medical tests such as MRI, CT, EKG, EEG, eye exams, dental exams, etc. As a special group, children have immature psychological development, and their ability to control their own emotions and behaviors in the process of diagnosis and treatment is far inferior to that of adults. The process is difficult. Once disease diagnosis and treatment cannot be carried out normally, it will often affect the quality of diagnosis and tre...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/11A61K47/12A61P25/20
CPCA61K31/11A61K9/0095A61K47/12A61P25/20A61K9/08A61K31/047
Inventor 云琦陶亮张蓉郑永刚姚丽华李月荣石志金唐城李雅娟孙媛媛袁子惠焦依杨何景景金凡
Owner TEFENG PHARM CO LTD
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