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Jixitabing hydrochloride solution type injection agent

A technology of gemcitabine hydrochloride and injection, applied in the field of solution injection

Inactive Publication Date: 2005-08-10
华润医药商业集团国际贸易有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Has not been reported internationally

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Example 1: (Sodium hydroxide pH is 7.5) Take 114 mg of gemcitabine hydrochloride, dissolve it with 5ml of 0.9% sodium chloride, add 0.5N sodium hydroxide, adjust the pH of the solution to 7.5, and add 0.9% sodium chloride to 10ml. 60℃ for 10 days, the content meets the requirements.

Embodiment 2

[0060] Example 2: (Sodium hydroxide pH is 6) Take 114 mg of gemcitabine hydrochloride, dissolve it with 5ml of 0.9% sodium chloride, add 0.5N sodium hydroxide, adjust the pH of the solution to 6, and add 0.9% sodium chloride to 10ml. 60℃ for 10 days, the content meets the requirements.

Embodiment 3

[0061] Example 3: (Sodium hydroxide pH 3.6) Take 114 mg of gemcitabine hydrochloride, dissolve it with 5 ml of 0.9% sodium chloride, add 0.5N sodium hydroxide, adjust the pH of the solution to 4, and add 0.9% sodium chloride to 10 ml. 60℃ for 10 days, the content meets the requirements.

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PUM

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Abstract

A solution-type injection of Jixitabin hydrochloride features that it contains alkaline substance or weak acid's salt as stabilizer.

Description

Technical field: [0001] The invention relates to a solution injection of medicine, specifically a solution injection containing gemcitabine hydrochloride. The injection contains an alkaline substance as a stabilizer. technical background: [0002] Gemcitabine, English name, Gemcitabine, its chemical name is 2’-deoxy-2’, 2’-difluoroadenosine (β-isomer), and its molecular formula is C 9 H 11 F 2 N 3 O 4 , The molecular weight is 263.1. Its preparation is gemcitabine hydrochloride with molecular formula C 9 H 11 F 2 N 3 O 4 .HCl, the molecular weight is 299.66. [0003] Gemcitabine is an anti-tumor drug produced by Lilly Pharmaceuticals in the United States. In 1996, the US FDA approved it as a first-line treatment for pancreatic cancer, and in 1998 it was approved as a treatment for non-small cell lung cancer. my country approved the import in 1999. The domestic imitation products were approved for clinical trials on June 15, 2000. [0004] The gemcitabine produced at home and abro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7068A61P35/00
Inventor 黄家章
Owner 华润医药商业集团国际贸易有限公司