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Troxerutin for injection and preparation method thereof

A technology for troxerutin and injection, which is applied in the field of medicine and can solve the problems of sensitive pH value changes, decreased troxerutin content, poor stability of troxerutin, etc.

Active Publication Date: 2019-10-18
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Troxerutin has a wide range of clinical applications, and the commonly used dosage forms include tablets, injections, freeze-dried powder injections, etc. Among them, injections are more widely used in clinical practice because of their high bioavailability and fast onset of action, but troxerutin has poor stability. It is sensitive to the change of pH value, and the stability of troxerutin injection prepared at present is still relatively poor, and the content of troxerutin decreases significantly after being placed for a long time, which is not conducive to the clinical application of troxerutin

Method used

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  • Troxerutin for injection and preparation method thereof
  • Troxerutin for injection and preparation method thereof
  • Troxerutin for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Preparation of Troxerutin for Injection (Specification: 0.3g)

[0040] prescription:

[0041]

[0042] The preparation method of troxerutin for injection of the present invention comprises the following steps:

[0043] (1) Add the prescribed amount of sodium citrate and troxerutin into 1200ml of water for injection and stir to dissolve, add water for injection to 2000ml, and stir evenly;

[0044] (2) Filter the solution in step (1) through a 0.22 μm microporous membrane, measure the pH value and content of the filtrate, determine the filling volume according to the specifications, and divide into half-stoppered liquid;

[0045] (3) Freeze-drying:

[0046] ①Pre-freezing: put the aliquoted solution in a freezer that has been cooled to -30°C in advance, and keep it for 2 hours;

[0047] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree to 17Pa, raise the temperature at a constant speed (2.5°C / h) to -10°C, and keep at this temperature for 8 h...

Embodiment 2

[0049] Example 2 Preparation of Troxerutin for Injection (Specification: 0.3g)

[0050] prescription:

[0051]

[0052] The preparation method of troxerutin for injection of the present invention comprises the following steps:

[0053] (1) Add the prescribed amount of sodium citrate and troxerutin into 1200ml of water for injection and stir to dissolve, add water for injection to 2000ml, and stir evenly;

[0054] (2) Filter the solution in step (1) through a 0.22 μm microporous membrane, measure the pH value and content of the filtrate, determine the filling volume according to the specifications, and divide into half-stoppered liquid;

[0055] (3) Freeze-drying:

[0056] ①Pre-freezing: put the aliquot in a freezer that has been cooled to -20°C in advance, and keep it for 3 hours;

[0057] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree to 17Pa, raise the temperature at a constant speed (3.0°C / h) to -6°C, and keep at this temperature for 8 hours;

[00...

Embodiment 3

[0059] Example 3 Preparation of Troxerutin for Injection (Specification: 0.3g)

[0060] prescription:

[0061]

[0062] The preparation method of troxerutin for injection of the present invention comprises the following steps:

[0063] (1) Add the prescribed amount of sodium citrate and troxerutin into 1200ml of water for injection and stir to dissolve, add water for injection to 2000ml, and stir evenly;

[0064] (2) Filter the solution in step (1) through a 0.22 μm microporous membrane, measure the pH value and content of the filtrate, determine the filling volume according to the specifications, and divide into half-stoppered liquid;

[0065] (3) Freeze-drying:

[0066] ① Pre-freezing: place the aliquot in a freezer at -25°C in advance and keep it for 2.5 hours;

[0067] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree to 17Pa, raise the temperature at a constant speed (2.8°C / h) to -8°C, and keep at this temperature for 8 hours;

[0068] ③Drying: rais...

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PUM

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Abstract

The invention relates to troxerutin for injection and a preparation method thereof. The troxerutin for injection has good quality and high stability, and greatly improves the effectiveness and safetyof clinical use of troxerutin for injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to troxerutin for injection and a preparation method thereof. Background technique [0002] Troxerutin is a semi-synthetic flavonoid compound produced by hydroxyethylation of rutin. It can inhibit the aggregation of red blood cells and platelets, prevent thrombus formation, increase the oxygen content in the blood, improve microcirculation, and promote the formation of new blood vessels. Improve collateral circulation. It has a protective effect on endothelial cells, can resist vascular damage caused by serotonin and bradykinin, increase the resistance of capillaries, reduce the permeability of capillaries, and prevent edema caused by increased vascular permeability It has anti-radiation damage, anti-inflammation, anti-allergic, anti-ulcer effects. Troxerutin has a wide range of clinical applications, and the commonly used dosage forms include tablets, injections, fre...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/12A61K31/7048A61P7/02A61P9/14
CPCA61K9/0019A61K9/19A61K31/7048A61K47/12A61P7/02A61P9/14
Inventor 胡成忠
Owner 湖北美林药业有限公司
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