Powder injection of dolasetron and its pharmaceutically acceptable salt, and its preparation method

The technology for dolasetron and preparation is applied in the field of powder injection preparation of dolasetron and its preparation, which can solve the problems of stability of water injection preparation and limitation of transportation and storage conditions, and achieves good stability and long shelf life. , Guaranteed quality effect

Inactive Publication Date: 2006-10-11
CHENGDU XINJIE HIGH TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are injection water injection preparations in the foreign market, which have achieved very good curative effect in clinical practice, but the water injection preparations have certain limitations in stability, transportation and storage conditions

Method used

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  • Powder injection of dolasetron and its pharmaceutically acceptable salt, and its preparation method
  • Powder injection of dolasetron and its pharmaceutically acceptable salt, and its preparation method
  • Powder injection of dolasetron and its pharmaceutically acceptable salt, and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Embodiment 1: Prescription of dolasetron powder injection preparation (calculated as dolasetron)

[0072] Dolasetron 9.25g

[0073] Mannitol 80g

[0074] Add water for injection to 1000ml

[0075] A total of 1000 pieces were made

[0076] Take the following steps to prepare:

[0077] 1) According to the ingredients of the above preparation prescription, add water for injection of 80wt% of the prescription amount to dissolve;

[0078] 2) Add 0.05wt% activated carbon to the above solution for decolorization, and filter to remove carbon;

[0079] 3) dilute to the preparation amount with the above-mentioned solvent, measure the concentration of the medicinal solution, and the pH value of the medicinal solution is 3.0;

[0080] 4) Filter and sterilize through a filter membrane to a liquid storage tank, sub-package, freeze-dry according to a preset temperature, crimp the cap, and pack.

[0081] The present embodiment adopts general freeze-drying machine freeze-drying: ...

Embodiment 2

[0087] Embodiment 2: Prescription of dolasetron powder injection preparation (calculated as dolasetron)

[0088] Dolasetron 74g

[0089] Mannitol 200g

[0090] Add water for injection to 2000ml

[0091] A total of 1000 pieces were made

Embodiment 3

[0092] Embodiment 3: Prescription of dolasetron powder injection preparation (calculated as dolasetron)

[0093] Dolasetron 74g

[0094] Glycine 180g

[0095] Add water for injection to 2000ml

[0096] A total of 1000 pieces were made

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Abstract

The invention relates to an powder injection of Dolasetron and pharmaceutically acceptable salts and its preparing process, wherein the preparation is the combination of one or more of Dolasetron free amine, Dolasetron's mesilates, hydrochlorates, acetates or lactates. The process for preparing the powder injection includes filtering and degerming through microporous filtering film, and low temperation drying.

Description

technical field [0001] The invention relates to a preparation of dolasetron and a preparation method thereof, in particular, a powder injection preparation of dolasetron and a preparation method thereof. technical background [0002] At present, dolasetron is a highly specific and selective 5-hydroxytryptamine subtype 3 (5-HT3) receptor antagonist, which is mainly used for the treatment of postoperative nausea and / or vomiting, Prevention of nausea and vomiting associated with naïve and retreated emetogenic cancer chemotherapy including high-dose cisplatin. At present, there are injection water injection preparations in foreign markets, which have achieved very good clinical efficacy, but the water injection preparations have certain limitations in stability, transportation and storage conditions. Contents of the invention [0003] The object of the present invention is to provide a kind of dolasetron for injection and its medicinal value for the treatment of nausea and / or...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/439A61K9/14A61P1/08
Inventor 蒲洪冯卫王兵沈莹高建
Owner CHENGDU XINJIE HIGH TECH DEV CO LTD
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