Stabilized Parinaudsijones large-capacity injection

A technology of palonosetron and injection, which is applied in the field of large-capacity injection, and can solve the problems of poor compliance, large irritation, and high concentration

Inactive Publication Date: 2007-09-05
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

[0006] Due to the high concentration of the existing palonosetron injection, it is more irritating when used, and the compliance is poor when it is used clinically

Method used

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  • Stabilized Parinaudsijones large-capacity injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Prescription Composition Specifications (30ml: 0.25mg)

[0020] Palonosetron Hydrochloride 0.25mg

[0021] Sodium chloride 240mg

[0022] Sodium bisulfite 1mg

[0023] pH 6.0-8.0

[0024] Water for injection 30ml

[0025] According to the prescription ratio, weigh the prescribed amount of palonosetron hydrochloride and the required pharmaceutical excipients, add water and stir to dissolve, adjust the pH to 6.0-8.0 with hydrochloric acid and sodium hydroxide, apply activated carbon to remove pyrogens, and divide Pack, fill the bottle with nitrogen gas, stopper and press the cap, and steam sterilize at 100°C for 30 minutes.

Embodiment 2

[0027] Prescription Composition Specifications (50ml: 0.25mg)

[0028] Palonosetron Hydrochloride 0.25mg

[0029] Sodium chloride 400mg

[0030] Ascorbic acid 1.5mg

[0031] pH 6.5-7.5

[0032] Water for injection 50ml

[0033] According to the prescription ratio, weigh the prescribed amount of palonosetron hydrochloride and the required pharmaceutical excipients respectively, add water and stir to dissolve, adjust the pH to 6.5-7.5 with hydrochloric acid and sodium hydroxide, apply activated carbon to remove pyrogens, and divide Pack, fill the bottle with nitrogen gas, stopper and press the cap, and steam sterilize at 100°C for 30 minutes.

Embodiment 3

[0035] Prescription Composition Specifications (100ml: 0.25mg)

[0036] Palonosetron Hydrochloride 0.25mg

[0037] Sodium chloride 850mg

[0038] Sodium bisulfite 3mg

[0039] pH 6.5-7.5

[0040] Water for injection 100ml

[0041] According to the prescription ratio, weigh the prescribed amount of palonosetron hydrochloride and the required pharmaceutical excipients respectively, add water and stir to dissolve, adjust the pH to 6.5-7.5 with hydrochloric acid and sodium hydroxide, apply activated carbon to remove pyrogens, and divide Pack, fill the bottle with nitrogen gas, stopper and press the cap, and steam sterilize at 100°C for 30 minutes.

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Abstract

A stable high-capacity injection of Paluonuosiqiong or its medicinal salt for treating the vomiting reaction caused by chemcotherapy or radiotherapy of cancer with low irritation and high compliance is disclosed.

Description

technical field [0001] The invention relates to an injection of palonosetron or a pharmaceutically acceptable salt thereof, especially a stable large-capacity injection, which can be used for vomiting during cancer chemotherapy and radiotherapy. Background technique [0002] Palonosetron is a 5-hydroxytryptamine 3 receptor antagonist developed by Helsinn Healthcare in Switzerland. Its injection (small volume injection, specification: 0.25mg / 5ml) was launched in the United States in September 2003. It is mainly used clinically for Vomiting response to cancer chemotherapy and radiotherapy. [0003] U.S. Patent No. 5,202,333 discloses an oral liquid formulation, an injection formulation and a tablet formulation of palonosetron hydrochloride in its Example 13. In the disclosed injection formulation, the concentration of palonosetron hydrochloride is 10-100 mg / ml, and auxiliary materials such as dextran, citric acid monohydrate and sodium hydroxide are used. [0004] WO20040670...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/473A61K9/08A61P1/08
Inventor 欧阳德方张汉利宝玉荣
Owner 深圳万乐药业有限公司
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