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A kind of pharmaceutical composition containing tropisetron compound and preparation method thereof

A tropisetron and composition technology, applied in the field of pharmaceutical compositions of tropisetron compounds and their preparation, can solve problems such as instability of tropisetron, and achieve increasing stability, maintaining stability, and maintaining stability. Good results

Active Publication Date: 2011-12-14
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The object of the present invention is to provide a stable freeze-dried powder preparation of tropisetron for injection and its preparation method, in order to solve the problem that the existing tropisetron for injection is unstable in aqueous solution

Method used

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  • A kind of pharmaceutical composition containing tropisetron compound and preparation method thereof
  • A kind of pharmaceutical composition containing tropisetron compound and preparation method thereof
  • A kind of pharmaceutical composition containing tropisetron compound and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: Tropisetron hydrochloride freeze-dried powder injection

[0028] 1. Composition:

[0029] composition

Proportion (g)

Tropisetron Hydrochloride

1g (calculated as tropisetron)

Mannitol

30g

citric acid

13.1

Sodium citrate

6.9

[0030] 2. Preparation method:

[0031] 1) Add mannitol to 200ml of water for injection, stir to dissolve, then add tropisetron hydrochloride, heat in a water bath at 80°C, and stir to dissolve;

[0032] 2) Add citric acid and sodium citrate to adjust the pH value to 4.5, make up 1000ml of water for injection, filter through a 0.22μm filter membrane, subpackage, and freeze-dry to obtain freeze-dried powder injection.

Embodiment 2

[0033] Embodiment 2: Tropisetron hydrochloride freeze-dried powder injection

[0034] 1. Composition:

[0035] composition

Proportion (g)

Tropisetron Hydrochloride

1g (calculated as tropisetron)

Mannitol

40g

citric acid

13.1

Sodium citrate

6.9

[0036] 2. Preparation method:

[0037] 1) Add mannitol to 250ml of water for injection, stir to dissolve, then add tropisetron hydrochloride, heat in a water bath at 70°C, and stir to dissolve;

[0038] 2) Add citric acid and sodium citrate to adjust the pH value to 5.0, make up 1000ml of water for injection, filter through a 0.22μm filter membrane, subpackage, and freeze-dry to obtain freeze-dried powder injection.

Embodiment 3

[0039] Embodiment 3: Tropisetron hydrochloride freeze-dried powder injection

[0040] 1. Composition:

[0041] composition

Proportion (g)

Tropisetron Hydrochloride

1g (calculated as tropisetron)

Mannitol

50

citric acid

8.2

Sodium citrate

11.8

[0042] 2. Preparation method:

[0043] 1) Add mannitol to 300ml of water for injection, stir to dissolve, then add tropisetron hydrochloride, heat in a water bath at 85°C, and stir to dissolve;

[0044] 2) Add citric acid and sodium citrate to adjust the pH value to 4.5, make up 1000ml of water for injection, filter through a 0.22μm filter membrane, subpackage, and freeze-dry to obtain freeze-dried powder injection.

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PUM

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Abstract

The invention discloses a pharmaceutical composition containing tropisetron compound and a preparation method thereof. The pharmaceutical composition comprises the following ingredients in parts by weight: 1 part of tropisetron or pharmaceutical salt, 30-55 parts of mannitol, 8.2-13.1 parts of citric acid and 6.9-11.8 parts of sodium citrate. The pharmaceutical composition containing tropisetron compound provided by the invention is easy to form freeze-dried injections in preparation and has good stability and high safety after re-dissolution.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of a tropisetron compound and a preparation method thereof. Background technique [0002] Vomiting is the expected consequence of cytotoxic therapy, radiation therapy and postoperative environment, which seriously affects the quality of life of patients after treatment. In recent years, a class of 5-HT has been developed. 3 (5-hydroxytryptamine) receptor antagonist drugs, which interact with 5-HT by antagonizing 3 Receptor-related brain function in the treatment of vomiting. Such drugs include ondansetron, granisetron, alosetron, tropisetron, dolasetron. These 5-HT 3 Antagonists are usually given intravenously shortly before initiation of chemotherapy or radiation therapy and may be given several times during a cycle of chemotherapy or radiation therapy, and they are usually given as tablets or other oral It is also convenient for those ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/46A61K47/12A61P1/08
Inventor 罗诚
Owner 罗诚
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