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Gemcitabine hydrochloride injection and preparation method thereof

A technology of gemcitabine hydrochloride and injection, applied in the field of gemcitabine hydrochloride injection and its preparation, can solve the problems of poor stability of gemcitabine hydrochloride, difficult to store, inconvenient to use, etc., and achieve the effects of high clinical application value, good stability and convenient use.

Active Publication Date: 2013-03-06
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Gemcitabine hydrochloride currently on the market is freeze-dried powder injection, the reason is that gemcitabine hydrochloride injection is unstable and cannot be stored for a long time
However, compared with solution preparations, freeze-dried powders have disadvantages such as complex process, high production cost, need to inject solution to dissolve, inconvenient use and increased chance of drug contamination.
[0006] Patent application CN1181829C also provides a kind of injection of gemcitabine hydrochloride, which uses the aqueous solution of water, ethanol, propylene glycol or mannitol as solvent, but the gemcitabine hydrochloride prepared by this application has poor stability and is difficult to preserve

Method used

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  • Gemcitabine hydrochloride injection and preparation method thereof
  • Gemcitabine hydrochloride injection and preparation method thereof
  • Gemcitabine hydrochloride injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0020] Embodiment 1: (1000 bottles)

[0021]

[0022] According to the prescription amount, add gemcitabine hydrochloride to 1000ml of 30% ethanol solution, dissolve and stir evenly, then add sodium chloride and hydroxypropyl-β-cyclodextrin, heat to dissolve, add sodium dihydrogen phosphate to adjust the pH to 6. Dilute to volume with water for injection. The solution was sent to a sterile room, filtered through a 0.22 μm microporous membrane until clarified, filled into 25 ml vials with a volume of 6 ml per bottle, and plugged with a butyl rubber stopper.

Embodiment 2

[0023] Embodiment 2: (1000 bottles)

[0024]

[0025] Add gemcitabine hydrochloride to 1000ml of water for injection according to the prescription amount, dissolve and stir evenly, then add sodium chloride and hydroxypropyl-β-cyclodextrin, heat to dissolve, add sodium dihydrogen phosphate to adjust the pH to 6, Dilute to volume with water for injection. The solution was sent to a sterile room, filtered through a 0.22 μm microporous membrane until clarified, filled into 25 ml vials with a volume of 6 ml per bottle, and plugged with a butyl rubber stopper.

Embodiment 3

[0026] Embodiment 3: (1000 bottles)

[0027]

[0028] According to the prescription amount, add gemcitabine hydrochloride to 1000ml of 30% ethanol solution, dissolve and stir evenly, then add sodium chloride and hydroxypropyl-β-cyclodextrin, heat to dissolve, add sodium dihydrogen phosphate to adjust the pH to 6. Dilute to volume with water for injection. The solution was sent to a sterile room, filtered through a 0.22 μm microporous membrane until clarified, filled into 25 ml vials with a volume of 6 ml per bottle, and plugged with a butyl rubber stopper.

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Abstract

The invention relates to gemcitabine hydrochloride injection and a preparation method of the gemcitabine hydrochloride injection. Specifically, 1ml of gemcitabine hydrochloride injection comprises the following components of 30-70mg of gemcitabine hydrochloride, 1-5mg of NaCl, 10-50mg of hydroxypropyl-beta-cyclodextrin and 1-10mg of pH (Potential of Hydrogen) regulator. The gemcitabine hydrochloride injection provided by the invention is better in stability, simple in preparation and convenient in use, and can reduce the pollution ways of drugs.

Description

technical field [0001] The invention relates to an injection preparation of antineoplastic drugs and a preparation method thereof, in particular to gemcitabine hydrochloride injection and a preparation method thereof. Background technique [0002] Gemcitabine, the English name is Gemcitabine, the chemical name is 2'-deoxy-2',2'-difluoroadenosine (β-isomer), and the molecular formula is C 9 h 11 f 2 N 3 o 4 , the molecular weight is 263.1. Its preparation is gemcitabine hydrochloride, and its molecular formula is C 9 h 11 f 2 N 3 o 4 • HCl, molecular weight 299.66. Gemcitabine hydrochloride is a white to off-white solid, easily soluble in water, slightly soluble in methanol, insoluble in ethanol and polar organic solvents. The structural formula is as follows: [0003] [0004] Gemcitabine is an anti-tumor drug produced by Lilly Company of the United States. It was approved by the FDA in 1996 as a first-line drug for the treatment of pancreatic cancer, and in 1...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7068A61K47/40A61P35/00
Inventor 吕爱锋张春红
Owner JIANGSU HANSOH PHARMA CO LTD
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