Medicine urapidil composition for treating senile hypertensive crisis

Abstract

The invention discloses a medicine urapidil composition for treating senile hypertensive crisis, and belongs to the technical field of medicines. The composition comprises urapidil and anhydrous sodium carbonate. The urapidil is crystal, and an X-ray powder diffraction pattern shown in Figure 1 is obtained through Cu-Kalpha radioactive measurement. The new crystalline form of urapidil provided by the invention is different from a crystal structure in the prior art. Experiments show that the composition with the new crystalline form is high in stability and very low in content of an impurity I compared with those in the prior art; the content of all impurities is controlled at a lower range, and the content of the impurities is reduced along with the extension of storage time; the solubility and the flowability of the composition in water are obviously improved compared with those in the prior art; a powder-injection prepared from the composition is high in stability, high in stability after being mixed with a solvent, very low in content of insoluble particles, and very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug urapidil composition for treating hypertensive crisis in the elderly. 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 ta...

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Problems solved by technology

However, because urapidil hydrochloride is easily soluble in water and slightly soluble in organic solvents, urapidil hydrochloride is not easy to be refined by general purification processes such as recrystallization, and the quality of urapidil hydrochloride after refining cannot reach the national standard of China. The requirements of the drug standard WS-(X-116)-2003Z, especially the clarity of which is >No. 2 standard turbidity liquid, 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

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