Tablets for treating vascular hypertension and production method of tablets for treating vascular hypertension

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to tablets for treating vascular hypertension and a production method of the tablets for treatingvascular hypertension. The tablets for treating vascular hypertension contain a solid dispersion produced from azilsartan and polyethylene glycol, a filler, a disintegrant and a lubricant. The tabletsare produced according to the method which comprises the following steps: adding the azilsartan into melted polyethylene glycol, conducting even stirring, adding the obtained mixture into the fillerand the disintegrant, conducting stirring and granulation, adding the lubricant into produced granules, and conducting mixing and tabletting. Compared with the prior art, the production technology issimple, a dissolution rate is high, and the quality is stable and controllable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tablet for treating hypertension and a preparation method thereof. Background technique [0002] Azilsartan is an angiotensin II receptor antagonist drug for the treatment of hypertension. It is mostly used for the treatment of hypertension and is currently the only angiotensin II receptor antagonist (sartan) drug in the late clinical stage. . The drug was launched by Japan's Takeda Pharmaceutical Company in 2012, and its efficacy in the clinical stage is remarkable. [0003] Azilsartan is a poorly soluble drug with a solubility in water of less than 9 μg / ml. The structural formula is as follows: [0004] [0005] The bioavailability of a drug in the body is greatly affected by the dissolution of the drug. Azilsartan is almost insoluble in water and is an insoluble drug. When making pharmaceutical preparations, micronized azilsartan partic...

AI Technical Summary

Problems solved by technology

[0006] CN101528262A discloses a stable and pharmaceutical composition with excellent dissolution properties, which contains low-melting oily substance-free, low-viscosity binders, and its main feature is to use low-viscosity binders to improve the azilsartan Dissolution, but the use of low viscosity binders to enhance in vitro dissolution of azilsartan is often limited

Solved the problem of sharp increase in impurities when preparing azilsartan microparticles by conventional pulverization methods, but the process is more complicated

[0008] CN102895205A discloses a fast-dissolving azilsartan pharmaceutical preparation, the particle size of azilsartan is D90≤20μm, the method improves the dissolution by controlling the particle size, but the dissolution rate still needs to be improved, and the micronized active ingredient is stable sex will drop

[0009] CN102793680A discloses a solid dispersion of azilsartan, a preparation method and a pharmaceutical composition thereof. The solid dispersion system is prepared by using azilsartan and its pharmaceutically acceptable carrier material. The dissolution rate of the tablet prepared by the method is still lower

[0010] CN106333930A discloses a kind of azilsartan micropill tablet and preparation method thereof, and described azilsartan micropill tablet is made

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