Calcium dobesilate capsule and preparation method thereof

A technology of calcium dobesilate and capsules, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc., can solve problems such as non-conformity of product dissolution, sticking of calculators, and inability of production to proceed normally.

Inactive Publication Date: 2013-09-18
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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
[0022] 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.

Method used

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  • Calcium dobesilate capsule and preparation method thereof
  • Calcium dobesilate capsule and preparation method thereof
  • Calcium dobesilate capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121]

[0122] The capsules are prepared as follows:

[0123] (1) Weigh each raw and auxiliary material, pass calcium dobesilate and sodium hydroxymethylcellulose through a 100-mesh sieve, and dry at 60±5°C for 1 hour;

[0124] (2) dissolving 2.5-5g polyvinylpyrrolidone with ethanol to prepare adhesive;

[0125] (3) Get 8 / 13 of the binder, add 55% calcium dobesilate and 60% croscarmellose sodium of the prescription amount to it, mix, and make primary granules;

[0126] (4) Put the prepared primary granules into a fluidized bed, add 5 / 13 binding agent and calcium dobesilate of 45% of recipe quantity, croscarmellose sodium of 40% recipe quantity, and further prepare granules until there is no remaining powder, and the whole granules are intermediate granules;

[0127] (5) Add the ethanol solution of magnesium stearate to the intermediate granule spray, mix well, dry, detect the intermediate, fill it in 0# empty capsules after calculating the loading according to the interm...

Embodiment 2

[0129]

[0130] The capsules are prepared as follows:

[0131] (1) Weigh each raw and auxiliary material, pass calcium dobesilate and sodium hydroxymethylcellulose through a 100-mesh sieve, and dry at 65°C for 1 hour;

[0132] (2) dissolving 2.5-5g polyvinylpyrrolidone with ethanol to prepare adhesive;

[0133] (3) Get 8 / 13 of the binder, add 60% calcium dobesilate and 70% croscarmellose sodium of the prescription amount to it, mix, and make primary granules;

[0134] (4) Put the prepared primary granules into a fluidized bed, add 5 / 13 binder and calcium dobesilate of 40% of prescription quantity, croscarmellose sodium of 30% of prescription quantity, and further prepare granules until there is no remaining powder, and the whole granules are intermediate granules;

[0135] (5) Add the ethanol solution of magnesium stearate to the intermediate granule spray, mix well, dry, detect the intermediate, fill in 0# empty capsules after calculating the loading according to the int...

Embodiment 3

[0137]

[0138] The capsules are prepared as follows:

[0139] (1) Weigh each raw and auxiliary material, pass calcium dobesilate and sodium hydroxymethylcellulose through a 100-mesh sieve, and dry at 63°C for 1 hour;

[0140] (2) dissolving 2.5-5g polyvinylpyrrolidone with ethanol to prepare adhesive;

[0141](3) Get 8 / 13 of the binder, add 50% calcium dobesilate and 55% croscarmellose sodium of the prescription amount to it, mix, and make primary granules;

[0142] (4) Put the prepared primary granules into a fluidized bed, add 5 / 13 binder and calcium dobesilate of 50% of recipe quantity, croscarmellose sodium of 45% recipe quantity, and further prepare granules until there is no remaining powder, and the whole granules are intermediate granules;

[0143] (5) Add the ethanol solution of magnesium stearate to the intermediate granule spray, mix well, dry, detect the intermediate, fill in 0# empty capsules after calculating the loading according to the intermediate detect...

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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 croscarmellose sodium 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

technical field [0001] 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 [0002] Calcium dobesilate capsules, English name: Calcium Dobesilate Capsules. The main ingredient of this product is calcium dobesilate, and its chemical name is: 2,5-dihydroxybenzenesulfonate calcium monohydrate. Its structural formula is: [0003] [0004] Molecular formula: C 12 h 10 CaO 10 S 2 ·H 2 O, molecular weight: 436.42. [0005] 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 and Americ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/185A61K47/38A61K47/32A61P3/10A61P9/10A61P27/02A61P9/14A61J3/07
Inventor 马鹰军钟正明
Owner HAINAN JINRUI PHARMA CO LTD
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