Pharmaceutical preparation of dabigatran etexilate mesylate
A technology for dabigatran etexilate mesylate and a pharmaceutical preparation, which is applied in the field of pharmaceutical preparations of direct thrombin inhibitors, can solve problems such as poor stability, and achieve the effects of ensuring curative effect, good dissolution effect, good dissolution and stability
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Embodiment 1
[0042]
[0043]
[0044] Preparation:
[0045] (1) Dabigatran etexilate mesylate, lactose, xanthan gum and guar gum are dispersed in water, spray drying makes dabigatran etexilate mesylate complex, in dabigatran etexilate mesylate The surface of the compound is coated with an isolation coat to obtain the dabigatran etexilate mesylate coating compound, and the dabigatran etexilate mesylate coating compound particle diameter d0.9 is 300 μm;
[0046] (2) The dabigatran etexilate mesylate coating compound was mixed with tartaric acid, and filled into capsules.
Embodiment 2
[0048]
[0049] Preparation:
[0050] (1) dabigatran etexilate mesylate, mannitol, xanthan gum and guar gum are dispersed in 30% ethanol aqueous solution, spray drying makes dabigatran etexilate mesylate complex, in methanesulfonic acid The surface of the dabigatran etexilate complex is coated with an isolation coat to obtain the dabigatran etexilate mesylate coating complex, and the dabigatran etexilate mesylate coating complex particle diameter d0.9 is 250 μm;
[0051] (2) The dabigatran etexilate mesylate coating complex and fumaric acid were mixed, and filled into capsules.
Embodiment 3
[0053]
[0054]
[0055] Preparation:
[0056] (1) Dabigatran etexilate mesylate, lactose, sucrose, xanthan gum, guar gum and sodium lauryl sulfate are dispersed in methylene chloride, and spray drying makes dabigatran etexilate mesylate Composite, coat isolation coat on the surface of dabigatran etexilate mesylate complex, obtain dabigatran etexilate mesylate coating complex, dabigatran etexilate mesylate coating complex particle size d0.9 460μm;
[0057] (2) The dabigatran etexilate mesylate coating compound was mixed with succinic acid, and filled into capsules.
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