Irbesartan and hydrochlorothiazide pharmaceutical composition and preparation method thereof

Abstract

The invention relates to a medicinal composite of Irbesartan hydrochlorothiazide. The medicinal composite is composed of 150 portions of Irbesartan, 12.5 portions of hydrochlorothiazide, 20 portions to 60 portions of microcrystalline cellulose, 20 portions to 60 portions of lactose monohydrate, 15 portions to 25 portions of crosslinked sodium carboxymethyl cellulose, 1 portion to 10 portions of hydroxypropylmethyl cellulose, 2 portions to 7 portions of SiliciiDoxydum, 1 portion to 3 portions of magnesium stearate. The major medicinal ingredients are mixed with part of the crosslinked sodium carboxymethyl cellulose and the microcrystalline cellulose, and the mixture is crushed down and then added with the lactose monohydrate for mixing; the mixture obtained from the former step is added with 50 percent of ethanol solvent containing 2 percent of hydroxypropylmethyl cellulose for even mixing, then the mixture is screened, made into integral grains which are then dried; the dry grains are mixed with the SiliciiDoxydum, the magnesium stearate and the residual crosslinked sodium carboxymethyl cellulose, and the mixture then undergoes tabletting and coating so as to obtain the medicinal composite. The prescription of the medicinal composite of the invention is reasonable, the quality is stable and reliable, and the medicinal composite has a satisfactory dissolution rate.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating hypertension and a preparation method thereof, more specifically an irbesartan hydrochlorothiazide medicinal composition and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases that endanger human health and is a major public health problem worldwide. At present, the control rate of hypertension in major countries in the world is not high. The National Nutrition and Health Status Survey released by the Ministry of Health of China in 2002 showed that there were nearly 160 million hypertensive patients in China, and the control rate of blood pressure was only 6.16%. A large number of evidence-based medical studies have confirmed that with the increase of blood pressure, the risk of cardiovascular events will increase significantly, so improving the control rate of blood p...

AI Technical Summary

Problems solved by technology

The analysis may show that irbesartan raw material drug has low density and poor fluidity, and the scheme disclosed in this patent uses an unreasonable prescription ratio, so that qualified tablet products cannot be obtained

[0008] Chinese patent application 200510097977 discloses another dispersible tablet solution of the pharmaceutical composition, in which mannitol is used as a filler, and when mannitol is used to prepare tablets, the problem of drug tablet breakage often occurs

After testing, it is found that although this method can obtain tablets with good appearance and moderate hardness, the results in the dissolution test are not very satisfactory. The analysis may be due to the low density of irbesartan, which makes it difficult to mix uniformly.

[0010] To sum up, most of the current existing technologies use pharmaceutical excipients with certain toxic and side effects to produce irbesartan-hydrochlorothiazide tablets, and the prescription dosage is also extremely unreasonable

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