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Tartaric acid vinorelbine powder injection for injection and preparation method thereof

A technology for vinorelbine tartrate and tartaric acid, which is applied to the field of vinorelbine tartrate powder injection for injection and its preparation, can solve the problems of not examining the stability of the preparation, and achieve the effects of excellent appearance and good redissolving behavior

Active Publication Date: 2012-11-14
CSPC MEGALITH BIOPHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in these two patent application documents, the stability of the preparations obtained when these substances are used as fillers are not investigated.

Method used

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  • Tartaric acid vinorelbine powder injection for injection and preparation method thereof
  • Tartaric acid vinorelbine powder injection for injection and preparation method thereof
  • Tartaric acid vinorelbine powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 (vinorelbine tartrate 14%, α-lactose monohydrate 86%)

[0030]

[0031] ①Weigh α-lactose monohydrate, add appropriate amount of water for injection and stir until dissolved, then add water for injection to a sufficient amount; heat the lactose solution to 60±5°C.

[0032] Weigh the activated carbon with 0.25% (w / w) lactose solution, take an appropriate amount of lactose solution to moisten the activated carbon, add it, stir and keep it warm for 20 minutes, then add the second equal amount of activated carbon, stir and keep it warm for 20 minutes, and the adsorption is over.

[0033] The lactose solution is decarbonized and filtered through a filter element, and cooled to room temperature for later use.

[0034] ② Weigh the prescribed amount of vinorelbine tartrate, add appropriate amount of cooled lactose solution and stir until dissolved, make up to the full amount, after stirring evenly, take samples for content, color and other items testing; steriliz...

Embodiment 2

[0038] Embodiment 2 (vinorelbine tartrate 20%, α-lactose monohydrate 80%)

[0039]

[0040] ①Weigh α-lactose monohydrate, add appropriate amount of water for injection and stir until dissolved, then add water for injection to a sufficient amount; heat the lactose solution to 60±5°C.

[0041] Weigh the activated carbon with 0.25% (w / w) lactose solution, take an appropriate amount of lactose solution to moisten the activated carbon, add it, stir and keep it warm for 20 minutes, then add the second equal amount of activated carbon, stir and keep it warm for 20 minutes, and the adsorption is over.

[0042] The lactose solution is decarbonized and filtered through a filter element, and cooled to room temperature for later use.

[0043] ② Weigh the prescribed amount of vinorelbine tartrate, add appropriate amount of cooled lactose solution and stir until dissolved, make up to the full amount, after stirring evenly, take samples for content, color and other items testing; steriliz...

Embodiment 3

[0047] Embodiment 3 (vinorelbine tartrate 25%, α-lactose monohydrate 75%)

[0048]

[0049] ①Weigh α-lactose monohydrate, add appropriate amount of water for injection and stir until dissolved, then add water for injection to a sufficient amount; heat the lactose solution to 60±5°C.

[0050] Weigh the activated carbon with 0.25% (w / w) lactose solution, take an appropriate amount of lactose solution to moisten the activated carbon, add it, stir and keep it warm for 20 minutes, then add the second equal amount of activated carbon, stir and keep it warm for 20 minutes, and the adsorption is over.

[0051] The lactose solution is decarbonized and filtered through a filter element, and cooled to room temperature for later use.

[0052] ② Weigh the prescribed amount of vinorelbine tartrate, add appropriate amount of cooled lactose solution and stir until dissolved, make up to the full amount, after stirring evenly, take samples for content, color and other items testing; steriliz...

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PUM

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Abstract

The invention provides a tartaric acid vinorelbine powder injection for injection. The powder injection for injection is composed of tartaric acid vinorelbine and a filling agent, wherein the filling agent is lactose, preferably alpha-lactose monohydrate; and the weight percentage of the components is as follows: 14-25% of tartaric acid vinorelbine and 75-86% of alpha-lactose monohydrate. The invention also provides a preparation method for the tartaric acid vinorelbine powder injection for injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to vinorelbine tartrate powder injection for injection and a preparation method thereof. Background technique [0002] Vinorelbine, the English name is vinorelbine, and the chemical name is 3',4'-didehydro-4'-deoxy-8'-norvinblastine. [0003] Vinorelbine is a broad-spectrum antineoplastic drug, and it is the first-line treatment drug for advanced non-small cell lung cancer (NSCLC). It is also used for metastatic breast cancer (mammary carcinoma), refractory lymphoma, ovarian cancer and head and neck tumors. treat. It has been included in the "National Basic Medical Insurance Drug Catalog". According to the 2006 ASCO (American Society of Clinical Oncology) consensus, vinorelbine + cisplatin is currently the best adjuvant chemotherapy regimen for NSCLC, and is the first choice chemotherapy drug for recurrent or metastatic breast cancer recommended by the 2006 breast cancer...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/475A61P35/00
Inventor 冯彩霞张素娟郝卫华
Owner CSPC MEGALITH BIOPHARMACEUTICAL CO LTD
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