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Novel crystal form of midazolam hydrochloride and preparation method thereof

A technology for midazolam hydrochloride and its crystal form, which is applied in the field of new crystal forms of midazolam hydrochloride and its preparation, and can solve the problems of poor chemical stability, purity change, and deliquescence of midazolam hydrochloride crystal form

Active Publication Date: 2021-06-01
NHWA PHARMA CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the midazolam hydrochloride obtained by this method not only has poor crystal form chemical stability, but also has strong water absorption and is prone to deliquescence.
Generally speaking, raw materials are generally stored for a long time, so the deliquescence during storage is easy to change the purity, resulting in impurity content that does not meet the pharmacopoeia standards
In addition, the preparation method disclosed in the above-mentioned patent has a complicated preparation process and requires the mixed preparation of two compounds, which is not suitable for large-scale pharmaceutical industrial production
[0005] At present, no other reports of new crystal forms of midazolam hydrochloride have been found, and no other simpler and economical industrial production processes have been disclosed. Therefore, the new crystal forms of midazolam hydrochloride are worthy of further research

Method used

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  • Novel crystal form of midazolam hydrochloride and preparation method thereof
  • Novel crystal form of midazolam hydrochloride and preparation method thereof
  • Novel crystal form of midazolam hydrochloride and preparation method thereof

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Embodiment Construction

[0073] In the specification and claims of the present application, unless otherwise specified, the scientific and technical terms used herein have the meanings commonly understood by those skilled in the art. However, for a better understanding of the present invention, definitions and explanations of some related terms are provided below. In addition, when the definitions and explanations of terms provided in this application are inconsistent with the meanings commonly understood by those skilled in the art, the definitions and explanations of terms provided in this application shall prevail.

[0074] The "ether" in the present invention refers to a chain compound or a cyclic compound containing an ether bond -O- and having 1 to 10 carbon atoms. Specific examples include but are not limited to: diethyl ether, diisopropyl ether, Propylene glycol methyl ether, tetrahydrofuran, methyl tert-butyl ether or 1,4-dioxane.

[0075] The "ketones" mentioned in the present invention ref...

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Abstract

The invention relates to a crystal form A and crystal B of midazolam hydrochloride and a preparation method thereof. The crystal form A and crystal B of midazolam hydrochloride obtained in the present invention have good crystal form stability and chemical stability Sex, can be better used in clinical treatment,

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a new crystal form of midazolam hydrochloride and a preparation method thereof. Background technique [0002] Midazolam hydrochloride is a commonly used drug for anesthesia and sedation, its chemical name is 1-methyl-8-chloro-6-(2-fluorophenyl)-4H-imidazo[1,5-a][1, 4]-Benzodiazepine Monohydrochloride, which is currently on the market in China, is used for administration before anesthesia, induction and maintenance of general anesthesia, adjuvant medication for spinal anesthesia and local anesthesia, patient sedation during diagnostic or therapeutic operations, and ICU patient sedation; its specific The chemical structure is shown below: [0003] [0004] US4280957A and CN102241679B disclose the preparation method of midazolam hydrochloride crystals; both are prepared by mixing the ethanol solution of midazolam and the ethanol suspension of dihydrochloride. However, the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D487/04A61K31/5517A61P23/00A61P25/20
CPCA61P23/00A61P25/20C07B2200/13C07D487/04
Inventor 杨盼段衬李超王伟许向阳
Owner NHWA PHARMA CORPORATION
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