Cilostazol oral solid medicine composition

Abstract

The invention relates to a cilostazol oral solid medicine composition. Through research, the inventor obtains an improved cilostazo solid dispersion preparation process and an improved cilostazo soliddispersion with high water solubility as well. In addition, low substituted hydroxypropyl cellulose (of which the water content is less than 5%) of a low water content is selected as a disintegrant of a solid preparation, and the overall water content of the preparation is effectively reduced while a disintegration function is brought into play, so that disintegration caused by the situation thatmoisture in the preparation is absorbed by a raw material medicine can be inhibited. Finally, cilostazol is prepared into a common oral solid preparation. Tests show that the dissolution behavior ofa cilostazol oral solid preparation prepared by using the technique is remarkably improved, and furthermore, the bioavailability of the preparation can be also improved. Meanwhile, because of a low overall water content of auxiliary materials, degradation impurities caused by hydrolysis, of the raw material medicine, can be inhibited, the stability can be improved, and the preparation is simple inprocess, controllable in quality and applicable to industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an oral solid pharmaceutical composition of cilostazol, a preparation method and application thereof. Background technique [0002] Cardiovascular, cerebrovascular and vascular diseases are diseases with high morbidity, great harm, death, and high disability rate. Cardiovascular and cerebrovascular diseases are essentially vascular lesions, and the main cause of vascular lesions is atherosclerotic plaque in arteries And vascular abnormalities caused by atheromatous lipid plaques, which are the main causes of heart and cerebral ischemia and infarction; about the mechanism of atherosclerosis, there are lipid infiltration, smooth muscle hyperplasia, thrombosis, platelet aggregation and arterial intima injury theory, which shows that cardiovascular and cerebrovascular diseases are caused by many factors. important and meaningful. [0003] Cilostazol is a typical intrac...

AI Technical Summary

Problems solved by technology

[0018] However, the drug loading of the solid dispersion thus prepared is small. When the drug specification is small, this technology can significantly increase the drug dissolution rate, but when the drug specification is large, such as tens of milligrams or even Hundreds of milligrams, due to the limitation of the drug loading of this technology itself, in order to achieve the effect of improving the dissolution rate, the final preparation is often too large in volume, for example, the weight of each tablet can reach more than 1g, which seriously reduces the compliance of patients

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