The invention discloses a pharmaceutical composition containing
dabigatran etexilate
mesylate and a preparation method of the pharmaceutical composition. The
dabigatran etexilate
mesylate composition is prepared from an active substance
dabigatran etexilate
mesylate, a
water dispersible surfactant, a hydrophilic
polymer and other pharmaceutically acceptable auxiliary materials. Wherein the
melting temperature of the
water dispersible surfactant is 40-80 DEG C, and the content of the
water dispersible surfactant is 15-25%; and the
melting temperature of the hydrophilic
polymer is 60-100 DEG C, and the content of the hydrophilic
polymer is 25-35%. The pharmaceutical composition prepared by the invention avoids the use of
organic acid, reduces the stimulation to the
stomach of a patient with excessive
gastric acid secretion, and improves the compliance of the patient. According to the invention, the
dissolution rate of the pharmaceutical composition in an acetate medium with the pH value of 4.5 is improved by using the solubilization effect of the water dispersible surfactant, and the
dissolution amount in 30 minutes can reach 80% or more, so that the
solubility of
dabigatran etexilate mesylate in the
stomach of a patient with
gastric acid deficiency in a relatively high pH value environment is effectively solved, the in-vivo
bioavailability is improved, and the variability among individuals is reduced; and the low hygroscopicity of hydrophilic
polymerization is utilized to improve the stability problem of the pharmaceutical composition in the production and storage processes. The pharmaceutical composition is prepared by adopting a hot-melting stirring
granulation process, water is not contacted and an
organic solvent is not used in the process, the degradation of active substances is effectively reduced, the stability of the pharmaceutical composition is improved, meanwhile, the production process is simple, the period is short, the cost is low, the pharmaceutical composition is green and environment-friendly, and industrial
mass production is easy to realize.