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Lapatinib injection and preparation method thereof

A lapatinib and injection technology, applied in the field of medicine, can solve problems such as unstable injections and difficult dissolution of lapatinib

Inactive Publication Date: 2009-06-03
李铁军
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, lapatinib listed in the United States has tablets, injections, etc., but because lapatinib is not easily soluble in water, the existing injections are not very stable, so it is urgent to invent a stable, highly soluble, and bioavailable drug. High and cheap lapatinib injection that is convenient for industrialized mass production to provide clinical needs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1 Injection

[0016] Lapatinib 20g

[0017] Sodium sulfite 10mg

[0018] Water for injection to 100ml

[0019] According to the amount of the above prescription, dissolve lapatinib and sodium sulfite in 80ml of water for injection, stir to dissolve, filter, add water for injection to the full amount, seal in a 2ml ampoule, sterilize, and pack.

Embodiment 2

[0020] Example 2 Injection

[0021] Lapatinib 50g

[0022] Sodium sulfite 12.5mg

[0023] Water for injection to 100ml

[0024] Prepared by the same method as in Example 1.

Embodiment 3

[0025] Example 3 Injection

[0026] Lapatinib 1g

[0027] Sodium metabisulfite 12mg

[0028] Water for injection to 100ml

[0029] Prepared by the same method as in Example 1.

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PUM

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Abstract

The invention relates to the field of pharmaceutical technology and discloses a lapatinib injection which has convenient and stable clinical use, high bioavailability, and cheap price and can be used for treating solid tumors. The direct intravenous injection or the intramuscular injection can lead a drug to rapidly achieve the effective therapeutic concentration in vivo, reduce the first pass effect of the drug in liver and improve the bioavailability of the drug in vivo. In order to achieve the purposes, the lapatinib injection mainly contains lapatinib injection liquid or medicinal salt thereof and a solvent for injection; the injection liquid per1ml contains 10-500mg of the lapatinib injection liquid or the medicinal salt thereof, 200-300mg is preferential, and the pH of the injection liquid is 3.0-8.0.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a lapatinib injection capable of treating solid tumors. Background technique [0002] Lapatinib phosphate (fludarabine phosphate, Fudahua) is used for B-cell lymphocytic leukemia (CLL), brain tumors, liver cancer, lung cancer, esophageal cancer, gastric cancer, breast cancer, bladder cancer, testicular cancer, colon cancer and rectal cancer Cancer and other solid tumors have obvious curative effect. [0003] At present, lapatinib listed in the United States has tablets, injections, etc., but because lapatinib is not easily soluble in water, the existing injections are not very stable, so it is urgent to invent a stable, highly soluble, bioavailable High and cheap lapatinib injection that is convenient for industrialized mass production to provide clinical needs. Contents of the invention [0004] In order to solve the above problems, the object of the present invention is to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/506A61P35/00
Inventor 李铁军王宏于凯王跃宽何小娟杨蕊
Owner 李铁军
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