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Tropisetron hydrochloride medicament composition for injection

A technology of tropisetron hydrochloride and its composition, which is applied in the field of tropisetron hydrochloride pharmaceutical composition and its preparation, can solve the problems of safety risk, inconvenient use, storage and transportation, etc., achieve good stability and reduce market The effect of risk, method is simple and easy to implement

Inactive Publication Date: 2012-01-04
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0023] The tropisetron hydrochloride injection produced by the prior art has very strict requirements on storage and light protection, and is inconvenient in use, storage and transportation
At the same time, a large number of non-injection-grade pharmaceutical excipients are added, which brings great risks to the safety of clinical applications

Method used

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  • Tropisetron hydrochloride medicament composition for injection
  • Tropisetron hydrochloride medicament composition for injection
  • Tropisetron hydrochloride medicament composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Every 1000 described tropisetron hydrochloride pharmaceutical compositions, its formula consists of:

[0087] Tropisetron hydrochloride 2g (calculated as tropisetron)

[0088] Sodium chloride 18g

[0089] Citric acid 5g

[0090] Add water for injection to 2L

[0091] Preparation process: Take 95% of the prescribed amount of water for injection, at a temperature of 30-40°C, inject carbon dioxide gas until the pH value is in the range of 3.0-4.0, add the prescribed amount of sodium chloride and citric acid, stir and dissolve; add the prescribed amount tropisetron hydrochloride, stirred until completely dissolved; adding medicinal charcoal to the above solution, stirred evenly, and placed; suction filtered, supplemented with water for injection to the full amount, and mixed uniformly; measured the initial pH value, according to the initial pH value, Use 4% sodium hydroxide solution and 10% citric acid solution to adjust the pH value range to 3.0-4.0; fine filter; fill; ...

Embodiment 2

[0093] Every 1000 described tropisetron hydrochloride pharmaceutical compositions, its formula consists of:

[0094] Tropisetron hydrochloride 5g (calculated as tropisetron)

[0095] Sodium chloride 45g

[0096] Citric acid 12.5g

[0097] Add water for injection to 5L

[0098] Preparation process: with embodiment 1.

Embodiment 3

[0100] Every 1000 described tropisetron hydrochloride pharmaceutical compositions, its formula consists of:

[0101] Tropisetron hydrochloride 2g (calculated as tropisetron)

[0102] Sodium chloride 18g

[0103]Citric acid 2.5g

[0104] Add water for injection to 2L

[0105] Preparation process: with embodiment 1.

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Abstract

The invention discloses a tropisetron hydrochloride medicament composition for injection. The medicament composition consists of tropisetron hydrochloride, sodium chloride and citric acid, and is characterized in that the weight ratio of tropisetron hydrochloride to citric acid is 1:(0.001-5). The preparation method of the medicament composition comprises the following steps: taking 95% of prescription amount of water for injection; introducing dioxide at the temperature of 30-40 DEG C until the pH value is at the rang of 3.0-4.0; adding prescription amount of sodium chloride and citric acid, stirring and dissolving; adding prescription amount of tropisetron hydrochloride, and stirring to dissolve completely; adding medicinal charcoal in the solution, and standing after stirring uniformly; filtering in vacuum, supplementing water for injection to full amount, and mixing uniformly; measuring the initial pH value, and regulating the pH value to the range of 3.0-4.0 with 4% sodium hydroxide solution and 10% citric acid solution according to the initial pH value; carrying out fine filtering; filling; sterilizing; carrying out lamp inspection; and warehousing, thus the finished product is obtained. The tropisetron hydrochloride medicament composition has good stability to light, has good stability, and has the obvious advantages for improving the product yield, lowering cost, implementing industrialization, and realizing clinical application better.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a tropisetron hydrochloride pharmaceutical composition with good stability for injection and a preparation method thereof. Background technique [0002] Chemotherapy is an important means of cancer treatment, and nausea and vomiting are the most common adverse reactions during chemotherapy and also have the greatest impact on patients. Acute severe nausea and vomiting may lead to dehydration, nutritional deficiencies, and electrolyte imbalances. In the long run, nausea and vomiting will seriously interfere with the normal life of patients, aggravate their psychological fear of chemotherapy, and reduce their compliance with necessary treatment measures, thereby affecting the therapeutic effect of chemotherapy, increasing treatment costs, and delaying the control of tumors. Timing directly threatens the life of the patient. Therefore, how to prevent and alleviate chemotherapy...

Claims

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Application Information

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IPC IPC(8): A61K31/46A61K9/08A61K47/02A61K47/12
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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