Calcium dobesilate capsule and preparation method thereof

Abstract

The invention discloses a calcium dobesilate capsule and a preparation method thereof. The calcium dobesilate capsule is prepared from calcium dobesilate, croscarmellose sodium, magnesium stearate and polyvinyl pyrrolidone, wherein every 1000 calcium dobesilate capsules contain 500g of calcium dobesilate, 20-50g of croscarmellose sodium and 2-6g of magnesium stearate. In addition, a traditional preparation method is improved in the invention, and the improved method comprises the following steps: on the basis of taking the croscarmellose sodium as a disintegrating agent and taking the magnesium stearate as a lubricating agent, adding a proper amount of the polyvinyl pyrrolidone to prepare a bonding agent; preparing the bonding agent and the calcium dobesilate as well as the croscarmellosesodium into granules by a multi-step granulation method; and spraying the ethanol solution of the magnesium stearate onto the surfaces of the granules to obtain calcium dobesilate capsules with stable quality, high dissolution rate and small content uniformity.

Description

A kind of calcium dobesilate capsule and preparation method thereof technical field The invention relates to the field of pharmaceutical preparations, more specifically the invention provides a calcium dobesilate capsule and a preparation method thereof. Background technique Calcium dobesilate capsules, English name: CalciumDobesilateCapsules. The main ingredient of this product is calcium dobesilate, and its chemical name is: 2,5-dihydroxybenzenesulfonate calcium monohydrate. Its structural formula is: Molecular formula: C12H10CaO10S2 H2O, molecular weight: 436.42. In recent years, with the continuous improvement of living standards. The number of diabetics known as the disease of the rich is increasing year by year. Many complications caused by diabetes. It has become one of the major factors endangering people's health. Diabetic retinopathy (DR) is one of the serious complications of diabetes. It ranks first among the four major blindness diseases in European...

AI Technical Summary

Problems solved by technology

1. Using directly mixed particles, the fluidity is related to the nature of the raw material itself. During the filling process, the filling capacity is often unstable and the filling capacity varies greatly due to the poor fluidity of the raw material itself.

And it is easy to cause the sticking of the punch and calculation disc of the capsule filling machine, resulting in the failure of normal production

2. Magnesium stearate is a lubricant in this formula, and it needs to be mixed for 50 rotations (15 minutes) to fully mix evenly during the total mixing, but the dissolution rate of the product does not meet the requirements of the standard under this process condition

However, there is still a lot of room for improvement in the stability and disintegration performance of the prepared capsules.

Images