VALSARTAN-AMLODIPINE COMPOUND SOLID PREPARATION AND PREPARATION METHOD THEREFOR

摘要

The present invention relates to a compound solid preparation and the preparation method therefor and specifically relates to a valsartan-amlodipine compound solid preparation and the preparation method therefor. The valsartan-amlodipine compound solid preparation comprises valsartan particles and an amlodipine premix. The valsartan particles are prepared by preparing wet valsartan particles from a mixture obtained by mixing valsartan and a pharmaceutic adjuvant with an ethanol aqueous solution as a wetting agent and drying the wet valsartan particles. The amlodipine premix is prepared by mixing amlodipine and a pharmaceutic adjuvant. The valsartan-amlodipine compound solid preparation according to the present invention and the preparation method thereof can prevent the two main ingredients, amlodipine and valsartan, from interfering each other, and the preparation method is relatively simple and suitable for large-scale industrial production.

主权项

1. A valsartan-amlodipine compound solid preparation comprising valsartan particles and an amlodipine premix, wherein,
the valsartan particles are prepared by preparing wet particles from a mixture obtained by mixing valsartan and a pharmaceutic adjuvant with an ethanol aqueous solution as a wetting agent, and drying the wet particles, the amlodipine premix is prepared by mixing amlodipine and a pharmaceutic adjuvant, the weight ratio of valsartan to amlodipine, based on amlodipine free base, ranges from 10:1 to 50:1, wherein the ethanol aqueous solution is one having 5 to 30% by volume of ethanol.