Calcium dobesilate capsule and preparation method thereof

Abstract

The invention belongs to the technical field of medicine preparation, and in particular relates to a calcium dobesilate capsule composition. The calcium dobesilate capsule composition is characterized by being prepared from the following components in parts by weight: calcium dobesilate, carboxymethyl starch sodium, magnesium stearate, 90 percent of zein and a proper amount of ethanol solution. The long-term stability of the composition is obviously improved.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a stable calcium dobesilate capsule composition. Background technique [0002] Calcium dobesilate, Chinese alias 2,5-dihydroxybenzenesulfonate calcium, English name Calcium Dobesilate, it is white or off-white hygroscopic powder, odorless, bitter taste, perishable when exposed to light, hygroscopic. This product is very soluble in water, easily soluble in ethanol or acetone, very slightly soluble in chloroform or ether. It is an oral vasoprotective agent, which improves the biosynthesis of basement membrane collagen by inhibiting the hyperpermeability caused by vasoactive substances (histamine, serotonin, bradykinin, hyaluronidase, prostaglandin) . It has curative effect on various diseases caused by microvascular circulation disorder (capillary circulation disorder). The therapeutic effect of calcium dobesilate is multifaceted. By reducing the permeability of capillaries a...

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Problems solved by technology

[0004] Calcium dobesilate contains phenolic hydroxyl groups, so there are defects such as hygroscopicity, light instability and easy oxidation. The prior art discloses some preparation prescriptions and processes of calcium dobesilate capsules, such as CN17771927A discloses in order to improve the direct mixing process The defects of uneven loading and dissolution, choosing to use wet granulation and adding glyceryl behenate, only considered the situation at the time of preparation; CN101822648A improved bioavailability by nano-izing the preparation; CN102091055A improved its stability and dissolution The problem is that the method of composition and multi-step granulation is selected, and the process is complicated; CN102416006 uses sodium carboxymethyl starch, magnesium stearate and 95% ethanol to prepare capsules to improve related substances, and does not investigate the long-term stability of the preparation; CN103505438A, CN103271895A , CN103271896A are all related to improving drug stability, such as adopting dry granulation, adding dry ingredients, etc., but they have not investigated long-term stability, and dry granulation has high requirements for equipment and technology

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