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Gemcitabine hydrochloride lyophilized preparation

A gemcitabine hydrochloride and freeze-dried preparation technology, which is applied in the field of gemcitabine hydrochloride freeze-dried preparations, can solve the problems of inability to reduce the risk of patients, achieve the effects of reducing drug risk, solving stability problems, and ensuring product quality

Active Publication Date: 2012-01-04
SHANGHAI ACEBRIGHT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the existing freeze-dried preparations of gemcitabine hydrochloride still have stability and safety problems, and it is still unable to reduce the risk of patients taking this drug.

Method used

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  • Gemcitabine hydrochloride lyophilized preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] formula:

[0019] Preparation: First, dissolve the prescribed amount of antioxidant in an enamel or glass container with an appropriate amount of water for injection, filter and add the prescribed amount of gemcitabine hydrochloride, lyoprotectant and appropriate amount of water for injection, stir to dissolve completely, and then add injection Use water to make the total volume 1000ml, then stir to make the mixture even, and finally filter, sub-package, and freeze-dry to obtain.

[0020] Stability test: place the finished gemcitabine hydrochloride freeze-dried preparation for 12 months under the conditions of 25°C and relative humidity of 60±5%. , the content of gemcitabine hydrochloride and the content of the single largest / total impurity in the sample were detected every 3 months. The test data are shown in Table 1.

Embodiment 2

[0022] formula:

[0023] The rest of the content is the same as described in Example 1.

Embodiment 3

[0025] formula:

[0026] The rest of the content is the same as described in Example 1.

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PUM

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Abstract

The present invention discloses a gemcitabine hydrochloride lyophilized preparation. The lyophilized preparation comprises, by weight, 20-70 parts of gemcitabine hydrochloride, 15-60 parts of a lyoprotectant and 0.005-0.5 parts of an antioxidant. Compared to the prior art, with the gemcitabine hydrochloride lyophilized preparation provided by the present invention, the problem of the stability ofthe gemcitabine hydrochloride is solved; the product quality is ensured; the risk of drug using is reduced; the preparation process is simple, the cost is low; and the preparation is suitable for theindustrial production, and has practical value.

Description

Technical field [0001] The invention relates to a gemcitabine hydrochloride freeze-dried preparation and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Gemcitabine hydrochloride is a new type of synthetic difluoronucleoside anti-metabolite anti-tumor drug. Its chemical name is 2-deoxy-2,2-difluorodeoxycytidine hydrochloride (β-isomer). It was developed by Eli Lilly and Company It was developed and approved for marketing in South Africa, Sweden, the Netherlands, Australia and other countries in 1995. It was also approved by the US FDA in 1996 for clinical use in the first-line treatment of non-small cell lung cancer and pancreatic cancer. [0003] This product is a cell cycle-specific anti-metabolite drug that mainly acts on tumor cells in the DNA synthesis phase, that is, S phase cells. Under certain conditions, it can prevent the progression from G1 phase to S phase; it is used for various cultured human and Mouse tumors have o...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7068A61P35/00
Inventor 安晓霞张静李小强马素伟
Owner SHANGHAI ACEBRIGHT PHARMA CO LTD
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