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Palonosetron injection and its preparation method

A technology of palonosetron and injection, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of high price, high production cost, and large amount of excipients, etc. , to achieve the effect of low cost, good stability and simple production process

Inactive Publication Date: 2007-10-24
深圳万乐药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the above-mentioned patent application documents, in order to control the stability of palonosetron injection, some auxiliary materials are expensive, such as mannitol and chelating agent, and some auxiliary materials are used in a large amount, such as citric acid and trisodium citrate, so its production The cost is higher

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Specification 10ml: 0.25mg

[0027] Palonosetron Hydrochloride 0.25mg

[0028] Glucose 500mg

[0029] Glycine 10mg

[0030] Water for injection to 10ml

[0031] According to the prescription ratio, weigh the prescribed amount of palonosetron hydrochloride and the required pharmaceutical excipients, add water for injection and stir to dissolve, adjust the pH to 3.7 with hydrochloric acid and sodium hydroxide, and filter through a 0.22um microporous membrane , packed in 10ml vials, filled with nitrogen gas in the bottle, corked and capped.

Embodiment 2

[0033] Specification 10ml: 0.25mg

[0034] Palonosetron Hydrochloride 0.25mg

[0035] Glucose 500mg

[0036] Glycine 20mg

[0037] Water for injection to 10ml

[0038] According to the prescription ratio, weigh the prescribed amount of palonosetron hydrochloride and the required pharmaceutical excipients, add water for injection and stir to dissolve, adjust the pH to 3.7 with hydrochloric acid and sodium hydroxide, and filter through a 0.22um microporous membrane , divided into 10ml vials, filled with carbon dioxide, corked and capped.

Embodiment 3

[0040] Specification 5ml: 0.25mg

[0041] Palonosetron Hydrochloride 0.25mg

[0042] Glucose 250mg

[0043] Glycine 15mg

[0044] Water for injection to 5ml

[0045] According to the prescription ratio, weigh the prescribed amount of palonosetron hydrochloride and the required pharmaceutical excipients, add water for injection and stir to dissolve, adjust the pH to 3.7 with hydrochloric acid and sodium hydroxide, and filter through a 0.22um microporous membrane , packed in 5ml vials, filled with nitrogen gas in the bottle, capped and pressed.

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Abstract

The invention discloses a palonosetron injection and the preparation method. The essential component of the injection comprises: hydrochloric acid palonosetron 0. 01-0. 05 mg / ml, glucose 45-55 mg / ml, aminoacetic acid 0. 2-10 mg / ml. The preparation method comprises following steps: (1) dissolving hydrochloric acid, glucose, and aminoacetic acid in proper amount of water for injection, moderating pH value, adding water for injection to meet the demand; (2) filtering with micro-porous membrane; (3) packing filtered solution, aerating inert gas or carbon dioxide, pressing, covering. The product is characterized by low production cost and good stability.

Description

technical field [0001] The present invention relates to a palonosetron injection, in particular to a stable palonosetron injection formulation for intravenous injection; the present invention also relates to the palonosetron injection formulation method of preparation. Background technique [0002] Palonosetron is a highly efficient and long-lasting serotonin receptor subtype 3 (5-HT) developed by Helsinn Healthcare in Switzerland. 3 ) selective antagonist, clinically used for acute and delayed nausea and vomiting caused by radiotherapy and chemotherapy. Its chemical name is (3aS)-2-[(s)-1-azabicyclo[2.2.2]octyl-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenzene [De]isoquinoline. [0003] U.S. Patent No. 5,202,333 discloses an injection formula of palonosetron hydrochloride in the examples, and the adjuvant that it adopts is glucose, citric acid monohydrate and sodium hydroxide; Chinese patent application CN1758911A discloses palonosetron Agar liquid drug formula, the auxiliary mate...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/473A61K47/16A61K47/26A61P1/08
Inventor 曾嘉铨卓秋琪张汉利宝玉荣
Owner 深圳万乐药业有限公司
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