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Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof

A technology of ramosetron hydrochloride and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of ramosetron hydrochloride and its preparation, can solve problems such as poor stability, and achieve high stability, loose appearance, and easy forming Effect

Active Publication Date: 2013-07-24
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the problem of poor stability of ramosetron hydrochloride solution, the object of the present invention is to provide a ramosetron hydrochloride for injection that is easy to shape when freeze-dried, and has good shape, loose product appearance, low water content, rapid reconstitution and high stability. Freeze-dried formulation of mosetron

Method used

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  • Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof
  • Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof
  • Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0024] Example 1 Preparation of Ramosetron Hydrochloride for Injection

[0025] The prescription consists of

[0026] Ramosetron Hydrochloride 0.3g

[0027] Lactose 80g

[0028] Water for injection 2L

[0029] making process

[0030] Weigh the lactose according to the prescription amount, put it in a sterile batching tank, add 95% water for injection (water temperature not exceeding 60°C), stir to dissolve, adjust the pH value to 4.0-6.0, and add water for injection to the full amount.

[0031] Adding medicinal activated carbon with a concentration of 0.05% (W / V) and stirring for adsorption for 20 minutes, decarbonizing and filtering, adding prescription amount of ramosetron hydrochloride, stirring to dissolve.

[0032] After checking the pH value, bacterial endotoxin and content of the coarse filtrate to pass the test, the filter can be sterilized, and the initial filtrate can only be filtered after the foreign matter is found to meet the requirements.

[0033] The fill...

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Abstract

The invention discloses a ramosetron hydrochloride freeze-dried powder injection and a preparation method thereof. Under illumination, the solution of the existing ramosetron hydrochloride has poor stability, poordrug effects and high drug adverse effects; and the solids of the existing ramosetron hydrochloride have good stability. Therefore, the ramosetron hydrochloride freeze-dried powder injection improves product stability and safety. A preclinical research shows that an antagonistic activity of ramosetron hydrochloride to 5-HT3 acceptors is stronger and more stable than that of the existing 5-HT3 acceptor antagonist; and ramosetron hydrochloride has stronger effect of treatment on chemotherapeutic drug-caused emesis. Therefore, ramosetron hydrochloride is clinically used for preventing and treating digestive tract symptoms such as nausea and emesis caused by cancer-resistant drugs.

Description

technical field [0001] The invention relates to the field of medical technology and application, in particular to a freeze-dried powder injection of ramosetron hydrochloride and a preparation method thereof. Background technique [0002] This product is freeze-dried powder injection, the main ingredient is ramosetron hydrochloride. Ramosetron hydrochloride chemical name: (-)-5-(R)-(1-methylindole 3 carbonyl 4,5,6,7-tetrahydro-benzimidazole hydrochloride, molecular formula: C17H17N30. HCl, molecular weight: 315.80; its chemical structural formula is: [0003] Ramosetron Hydrochloride [0004] [0005] Preclinical studies have shown that ramosetron hydrochloride has stronger and more stable antagonistic activity on 5-HT3 receptors than existing 5-HT3 receptor antagonists, and it has a stronger therapeutic effect on vomiting caused by chemotherapy drugs. Therefore, it is clinically used to prevent and treat gastrointestinal symptoms such as nausea and vomiting caused by a...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4184A61P1/08
Inventor 吕旭幸王丽云冯超敏戴兴祥王一升
Owner ZHEJIANG YATAI PHARMA
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