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Calcium dobesilate capsule composition and preparation method thereof

A technology of calcium dobesilate and capsules, applied in the field of medicine, can solve the problems of complex process, inconsistency, inconsistency in dissolution curves, etc.

Inactive Publication Date: 2013-08-07
BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] A calcium dobesilate capsule and its preparation method: the multi-step granulation process is complicated; calcium dobesilate capsule and its preparation process, calcium dobesilate sustained and controlled release preparation, nano light calcium dobesilate capsule Or the preparation method and application of compressed tablets, the dissolution curve is inconsistent with the original research; the dissolution of the varieties produced by domestic manufacturers is also inconsistent with the original research

Method used

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Examples

Experimental program
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Embodiment Construction

[0013] Name Raw material Calcium dobesilate / g Added magnesium stearate / g Added starch / g Added pregelatinized starch / g Starch slurry / g HPMC aqueous solution / g Added magnesium stearate / g Example 1 521.5 11.2 21.70 —— 125 —— 5.6 Example 2 521.5 8.4 24.50 —— —— 120 5.6 Example 3 521.5 5.6 27.30 —— 121 —— 5.6 Example 4 521.5 2.8 30.10 —— —— 117 5.6 Example 5 521.5 0.56 32.34 —— 119 —— 5.6 Example 6 521.5 11.2 —— 21.70 123 —— 5.6 Example 7 521.5 8.4 —— 24.50 —— 119 5.6 Example 8 521.5 5.6 —— 27.30 124 —— 5.6 Example 9 521.5 2.8 —— 30.10 —— 120 5.6 Example 10 521.5 0.56 —— 32.34 121 —— 5.6

[0014] Operation method:

[0015] 1. Pass through 80-mesh sieve for raw materials and 80-mesh sieve for excipients, and set aside.

[0016] 2. Prepare 5% starch slurry or 5% HPMC aqueous solution for later use.

[0017] 3. Weigh the raw material and ma...

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PUM

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Abstract

The invention belongs to the technical field of medicines, and concretely discloses a calcium dobesilate capsule composition and a preparation method. Calcium dobesilate is used as a raw material, and the composition also comprises one or a plurality of pharmaceutically acceptable excipients. The preparation method of the composition comprises the following steps: mixing calcium dobesilate with magnesium stearate to obtain a mixture, mixing the mixture with a selectable diluent, adding a proper amount of an adhesive to prepare a soft material, sieving to prepare wet particles, drying the wet particles, sieving for granulation, adding a corresponding lubricant, mixing, and filling to a capsule. The composition has the advantages of simple preparation method, consistency of a dissolution curve with that of reference listed drugs, and guarantee of the effective plasma concentration and the safety. The composition can be used for the diabetic microangiopathy.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of calcium dobesilate, in particular to a capsule and a preparation process of calcium dobesilate, belonging to the technical field of medicine. Background technique [0002] The chemical name of calcium dobesilate is 2,5-dihydroxybenzenesulfonate calcium monohydrate, and the molecular formula is C 12 h 10 CaO 10 S 2 ·H 2 O. [0003] Calcium dobesilate increases permeability, reduces resistance, reduces plasma viscosity, reduces high aggregation of platelets, and prevents thrombus formation by regulating the physiological functions of microvascular walls; indirectly increases lymphatic drainage by improving the flexibility of red blood cells, thereby reducing Edema. For the treatment of retinopathy caused by diabetes and the prevention and treatment of various microvascular diseases. [0004] A calcium dobesylate capsule and its preparation method: the multi-step granulation process is comple...

Claims

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Application Information

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IPC IPC(8): A61K31/185A61K9/48A61P9/00A61P7/02A61P9/10
Inventor 许衬心黄雪任广智
Owner BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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