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Anti-hypertension urapidil medicine compound

A technology of urapidil and anti-hypertension, applied in the field of medicine, can solve the problems of patients with toxicity, affect the quality of drugs, and poor stability, and achieve the effect of improving fluidity, improving drug efficacy, and good stability

Inactive Publication Date: 2015-12-02
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because urapidil hydrochloride is easily soluble in water and slightly soluble in organic solvents (such as ethanol), urapidil hydrochloride is not easy to be refined by general purification processes such as recrystallization, and the quality of urapidil hydrochloride after refining It cannot meet the requirements of the Chinese National Drug Standard WS-(X-116)-2003Z, especially the clarity>No. 2 standard turbidity liquid, and the quality cannot meet the purity requirements of injection drugs. Therefore, the purification of urapidil is particularly important
[0006] Urapidil in the prior art has disadvantages such as poor stability, easy decomposition and deterioration, and difficult storage under special circumstances (such as high temperature and light), which are largely limits the wide application of the drug
Find that there is a certain amount of oxidative degradation product I in the urapidil in the prior art through a large number of experimental studies simultaneously, as impurity, it shows the risk that has toxicity to patient or is harmful in other respects, has had a strong impact on the quality of medicine, increases patient risk
The existing technology solves the problems of water solubility and stability by changing the excipients and preparation methods of the preparation. It must rely on specific prescriptions and processes to achieve its stable effect, which brings certain limitations to the preparation of preparations and the selection of excipients. sex

Method used

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  • Anti-hypertension urapidil medicine compound
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  • Anti-hypertension urapidil medicine compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: Preparation of urapidil crystal compound

[0023] (1) Add the crude urapidil to a mixed solution of chloroform and propanol whose volume is 4 times the weight of urapidil, the volume ratio of chloroform and propanol is 3:1, heat up to 30°C, and stir until completely dissolved;

[0024] (2) In a sound field with a frequency of 30KHz and an output power of 45W, add a mixed solution of ether, acetone, and cyclohexane whose volume is 8 times the weight of urapidil while stirring, and the volume ratio of ether, acetone, and cyclohexane It is 4:1:1, the stirring speed is 150 rpm, and the adding speed is 100 ml / min;

[0025] (3) After adding the mixed solution of ether, acetone, and cyclohexane, under a sound field with a frequency of 25KHz and an output power of 40W, cool down to -10°C at 10°C / hour, grow crystals for 2 hours, wash, and dry in vacuum , to obtain urapidil compound.

[0026] The X-ray powder diffraction pattern obtained by measuring the compound...

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Abstract

The invention discloses an anti-hypertension urapidil medicine compound, and belongs to the technical field of medicine. X-ray powder diffraction patterns of the anti-hypertension urapidil medicine compound measured by Cu-Ka rays are shown as a figure 1. Compared with the prior art, the anti-hypertension urapidil medicine compound has the advantages that the anti-hypertension urapidil medicine compound which is a urapidil crystal-form compound is good in stability and rarely contains impurities I, and the total impurity content of the anti-hypertension urapidil medicine compound is within a narrow range under the control and rarely changes along with extension of the storage time; the solubility and the flowability of the urapidil crystal-form compound in water are obviously improved, accordingly, the anti-hypertension urapidil medicine compound brings convenience for preparing preparations, and the efficacy of the anti-hypertension urapidil medicine compound can be greatly improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an antihypertensive drug urapidil compound. Background technique [0002] Hypertension is a kind of common disease, frequently-occurring disease. With the improvement of people's living standards, the number of hypertensive patients is increasing day by day, especially the number of hypertensive crisis and severe hypertensive patients is constantly increasing, but there are few safe and effective injection drugs clinically used for this type of disease. High blood pressure affects work and life, and high blood pressure is the most important risk factor for coronary heart disease and cerebrovascular disease. 50% of myocardial infarction patients are hypertensive patients, and 76% of stroke patients have a history of hypertension. Therefore, the risk of high blood pressure is sudden death or disability. Hypertensive patients should learn how to take care of life and early treat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D239/545
CPCC07D239/545
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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