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Preparation method of troxerutin injection

A troxerutin and injection technology, applied in the field of preparation of troxerutin injection, can solve the problems of hydroxyethylrutin derivative allergy, poor drug stability and the like, achieve improved clarity, good stability, A stable effect

Inactive Publication Date: 2006-09-13
诺氏制药(吉林)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Troxerutin injection currently on the market has poor drug stability, and there is a phenomenon of hypersensitivity to other hydroxyethyl rutin derivatives, which are ineffective ingredients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A) Take 20% fresh water for injection at 80°C, cool down to 20°C, add troxerutin in the prescription, stir well to dissolve completely, adjust the pH value to 5.8, pass through cation exchange resin and anion exchange resin respectively, and collect Troxerutin liquid medicine.

[0025] B) Take the above-mentioned troxerutin medicinal solution, add 0.02% activated carbon, heat and boil for 30 minutes, circulate and cool the medicinal solution to 45° C., decarbonize and filter.

[0026] C) The medicinal liquid is fixed to volume, adjusted to pH 5.8, the medicinal liquid is filtered and filled into ampoules, sterilized, inspected by light, and packaged to obtain the finished preparation.

Embodiment 2

[0028] A) Take 30% fresh water for injection at 85°C, cool down to 25°C, add troxerutin in the prescription, stir well to dissolve completely, adjust the pH value to 6.0, pass through cation exchange resin and anion exchange resin respectively, and collect Troxerutin liquid medicine.

[0029] B) Take the above-mentioned troxerutin medicinal liquid, add 0.3% activated carbon, heat and boil for 20 minutes, cool down the medicinal liquid to 48° C., decarbonize and filter.

[0030] C) The medicinal solution is fixed to volume, adjusted to pH 6.0, the medicinal solution is filtered and filled into ampoules, sterilized, inspected by lights, and packaged to obtain the finished preparation.

Embodiment 3

[0032] A) Take 40% fresh water for injection at 86°C, cool down to 30°C, add troxerutin in the prescription, stir well to dissolve completely, adjust the pH value to 6.5, pass through cation exchange resin and anion exchange resin respectively, and collect Troxerutin liquid medicine.

[0033] B) Take the above-mentioned troxerutin medicinal solution, add 0.08% activated carbon, heat and boil for 27 minutes, cool down the medicinal solution to 46° C., decarbonize and filter.

[0034] C) The medicinal solution is fixed to volume, adjusted to pH 6.5, the medicinal solution is filtered and filled into ampoules, sterilized, inspected by lights, and packaged to obtain the finished preparation.

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PUM

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Abstract

An injection of troxerutin for treating obliterative syndrome, thrombophlebitis, capillary hemorrhage is prepared through ion exchange of troxerutin, mixing with the water for injection, pouring in containers, sterilizing, and lamp examining.

Description

technical field [0001] The invention discloses a preparation method of troxerutin injection, which contains troxerutin obtained through hydroxyethylation of rutin and water for injection. The preparation is treated with ion exchange technology to obtain troxerutin medicinal liquid, which is prepared together with water for injection, filled, sterilized, lamp-inspected and packaged to make a finished product. This process is treated with ion exchange technology to ensure that more than 99.99% of the metal ions are completely removed, ensuring that the inspection of metal ions in the preparation meets the regulations; at the same time, most of the other hydroxyethyl rutin derivatives are also removed, ensuring the hydroxy The ethyl rutin derivatives are checked to meet the regulations, and the prepared preparations have good stability, small irritation, stable curative effect, and improved clarity. For obliteration syndrome, thrombophlebitis, capillary hemorrhage, etc. Backgr...

Claims

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Application Information

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IPC IPC(8): A61K31/352A61K9/08A61P9/14A61P7/02
Inventor 郭智华
Owner 诺氏制药(吉林)有限公司
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