Calcium dobesilate dispersible tablet and preparation method thereof

Abstract

The invention provides a calcium dobesilate dispersible tablet and a preparation method thereof. The calcium dobesilate dispersible tablet is prepared from the following components in parts by weight:100 parts of calcium dobesilate, 10-40 parts of microcrystalline cellulose, 50 parts of carboxymethyl starch sodium, 2-25 parts of sodium alginate, 5-80 parts of mannitol, 1-20 parts of magnesium stearate and 1-10 parts of magnesium lauryl sulfate. The invention also provides a preparation method of the dispersible tablet. The prepared calcium dobesilate dispersible tablet has good dispersion uniformity and can be completely disintegrated within 2 minutes. The calcium dobesilate dispersible tablet prepared by the method has high dissolution rate. When dilute hydrochloric acid is used as a dissolution medium, the dissolution rate can reach 95% or more. Moreover, the calcium dobesilate dispersible tablet can better keep the stability of the content of the medicament; and the stability of the content after the medicament is placed for a long time can ensure that the dosage of the medicament active ingredient is not too different from that of the marked ingredient so as to better keep thebioavailability of the medicament. In addition, the validity period of the medicament is prolonged, and the calcium dobesilate dispersible tablet has important significance for storage and use of preparations.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a calcium dobesilate dispersible tablet and a preparation method thereof. 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. ...

AI Technical Summary

Problems solved by technology

At present, calcium dobesilate is on the market at home and abroad and is being accepted by my country's Drug Evaluation Center. The varieties include capsules, tablets, granules and dispersible tablets, among which cefaclor dispersible tablets are more convenient to take and faster to absorb than conventional dosage forms. , early onset, high bioavailability, etc., especially suitable for children, the elderly and patients who have difficulty swallowing solids. However, calcium dobesilate contains unstable phenolic hydroxyl groups, especially unstable to water, so production, During storage and transportation, if the ambient humidity is high or the water content of the preparation is high, it is easily degraded by oxygen, light and other influencing factors to produce related substances, and the appearance also shows easy stains, flowers and other phenomena, so that Reduce drug efficacy or produce adverse reactions

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