Urapidil impurity compound, preparation method and application thereof

A technology of uradil and uradil hydrochloride, applied in organic chemistry, measuring devices, instruments, etc., can solve problems such as inability to carry out effective quality control, and achieve the effects of improved quality standards, high purity, and good product quality
CN112094239APending Publication Date: 2020-12-18燃点(南京)生物医药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
燃点(南京)生物医药科技有限公司
Publication Date
2020-12-18

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Abstract

The invention belongs to the technical field of medicine impurity preparation, and discloses an urapidil impurity compound, a preparation method and application thereof. The preparation method of theurapidil impurity compound comprises the following steps that 1), urapidil is dissolved in a mixed solvent of an organic solvent and water, and after heating dissolution is completed, carbon dioxide is introduced for a pressurization reaction; and 2) after the reaction is finished, the reaction solution isconcentrated and dried under reduced pressure, and purifying is carried out by column chromatography to obtain the urapidil impurity compound. The impurity compound meets the requirements of an impurity reference substance in quality control, can be used for quality control in a urapidil or urapidil hydrochloride synthesis process, can be used as the impurity reference substance for accurate quantitative detection of urapidil or urapidil hydrochloride, and is beneficial to improvement ofquality control of corresponding bulk drugs.
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Description

technical field

[0001] The invention relates to the technical field of pharmaceutical impurity preparation, in particular to an urapidil impurity compound, a preparation method and an application thereof. Background technique

[0002] Urapidil (Urapidil), structural formula II is a highly selective α-receptor blocker with both peripheral and central effects. The peripheral vasodilation effect is mainly to block the post-synaptic α1 receptor, so that the peripheral resistance is significantly reduced, and the central effect is to reduce blood pressure by activating the 5-hydroxytryptamine-1A receptor and reducing the sympathetic feedback regulation of the medullary cardiovascular center. Urapidil preparations have two dosage forms: oral and injection. The raw material used in the oral dosage form is Urapidil, and the raw drug used in the injection is Urapidil Hydrochloride (Urapidil Hydrochloride), with a structural formula such as formula III. Urapidil sustained-release tab...

Claims

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