Preparation method of stable calcium dobesilate

A calcium dobesilate, stable technology, applied in the field of medicine, can solve the problems of reducing drug efficacy, adverse reactions, and easy staining on the appearance, and achieve the effect of improving stability, ensuring effectiveness and safety

Inactive Publication Date: 2013-09-04
南京先宇科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Calcium dobesilate has been widely used clinically as an effective drug for diabetic complications. However, due to its special structure, it contains unstable phenolic hydroxyl groups, especially unstable to water, so production, storage, During 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. effect or adverse reaction

Method used

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  • Preparation method of stable calcium dobesilate
  • Preparation method of stable calcium dobesilate
  • Preparation method of stable calcium dobesilate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Preparation of calcium dobesilate tablets by dry method and direct compression

[0038] prescription

[0039]

[0040]

[0041] Preparation Process

[0042] The raw and auxiliary materials are dried (when the moisture content is less than 2%), weighed according to the prescription, respectively passed through a 100 mesh sieve, mixed evenly, passed through an 80 mesh sieve 3 times, directly added to the hopper, the environmental humidity is not more than 65% , Use a flat concave head with a diameter of 9-11mm to punch the tablet, and control the radial pressure of the compressed tablet to 6-10kg.

Embodiment 2

[0044] Preparation of calcium dobesilate film-coated tablets by dry compression and granulation

[0045] prescription:

[0046]

[0047] Preparation Process:

[0048] Weigh the raw and auxiliary materials (except micro-powder silica gel) according to the prescribed amount, respectively pass through a 100-mesh sieve, mix well, pass through an 80-mesh sieve 3 times, and directly add to the hopper. The ambient humidity is not more than 65%, and a flat concave head with a diameter of more than 12mm is used. For punching tablets, the radial pressure of the compressed tablets is controlled at 3~5kg.

[0049] Crush the pressed large tablets into uniform particles, pass through an 18-mesh sieve, add the prescription amount of fine silica gel, mix evenly, add to the hopper, adjust the pressure to 6-10kg, and press the tablets with a punch with a diameter of 9-11mm.

[0050] The compressed tablets are made into a coating material with an anhydrous ethanol solution of polyvinyl dialdehyde diethyl...

Embodiment 3

[0052] Preparation of Calcium Dobesilate Capsules by Dry Compression and Granulation

[0053] prescription:

[0054]

[0055]

[0056] Preparation Process:

[0057] Weigh the raw and auxiliary materials (except magnesium stearate) according to the prescribed amount, respectively pass through a 100-mesh sieve, mix well, pass through an 80-mesh sieve 3 times, and directly add to the hopper. The ambient humidity is not more than 65%. Use a flat with a diameter of more than 12mm. With concave head punching tablets, the radial pressure of the compressed tablets is controlled at 3~5kg.

[0058] The crushed large tablets are crushed into uniform particles, passed through an 18-mesh sieve, and the prescription amount of finely powdered silica gel is added, and after mixing uniformly, the capsules are filled to obtain the product.

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Abstract

The invention provides a preparation method of stable calcium dobesilate and overcomes the defect in the prior art. According to the invention, a dry granulating method is used for controlling water content in the preparation process, and obviously reducing degradation and increasing stability. Acceptable carrier or excipients and other pharmaceutic adjuvants are added into the prescription for preparing common tablet, oral disintegrating tablet, chewing tablet, film coated tablet, effervescent tablet, particulate agent, capsule, electuary, powder, suspension or sustained release agent.

Description

Technical field [0001] The invention relates to a preparation method of a medicine for preventing and treating retinal fundus diseases and microcirculation disorders in diabetic patients, such as various varicose veins and hemorrhoids, ulcerated legs, and pruritic dermatitis, and belongs to the technical field of medicine. Background technique [0002] Diabetes is a common and frequently-occurring disease. With the continuous improvement of people's living standards, the population is aging and the incidence of obesity is increasing. At present, the incidence of diabetes is increasing in all countries in the world. The incidence in Western European countries is about 2%; the incidence in American adults is as high as 6%. The increase in the incidence of diabetes in some developing countries has significantly exceeded that in developed countries. Diabetes has become another chronic disease threatening people's health after cardiovascular and cerebrovascular diseases, tumors, and ...

Claims

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Application Information

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IPC IPC(8): A61K31/185A61P9/14A61P27/02A61P17/02A61P29/00
Inventor 李明李雨先吴琦
Owner 南京先宇科技有限公司
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