Gemcitabine hydrochloride lyophilized powder injection

A technology for gemcitabine hydrochloride and freeze-dried powder injection, which is applied in the field of gemcitabine hydrochloride freeze-dried powder for injection and its preparation, can solve the problems of lack of improvement, poor stability of gemcitabine hydrochloride, toxic and side effects, etc., and achieves considerable economic and social benefits, moisture drying Thorough, low levels of related substances

Active Publication Date: 2009-10-28
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the poor stability of gemcitabine hydrochloride, it is easy to degrade and produce impurities that

Method used

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  • Gemcitabine hydrochloride lyophilized powder injection
  • Gemcitabine hydrochloride lyophilized powder injection

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0019] Example 1:

[0020] prescription

[0021] Gemcitabine Hydrochloride 228g

[0022] Mannitol 228g

[0023] Sodium acetate 22.8g

[0024] Add water for injection to 6000ml

[0025]

[0026] A total of 1000 bottles were made

[0027] Weigh mannitol and sodium acetate, add 80% water for injection, dissolve and stir evenly, then add gemcitabine hydrochloride, dissolve and stir evenly, adjust pH to 2.7 with 0.1mol / L hydrochloric acid or 0.1mol / L sodium hydroxide solution, After passing the intermediate inspection, add water for injection to make up to full volume. The solution was sent to the sterile room by a peristaltic pump, filtered through a 0.22 μm microporous membrane until it was clear, filled in 25 ml vials with a volume of 6 ml per bottle, partially plugged with butyl rubber stoppers, and placed in a plate. Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circulat...

Example Embodiment

[0028] Example 2:

[0029] prescription

[0030] Gemcitabine Hydrochloride 228g

[0031] Mannitol 114g

[0032] Sodium acetate 11.4g

[0033] Add water for injection to 6000ml

[0034]

[0035] A total of 1000 bottles were made

[0036] Weigh mannitol and sodium acetate, add 80% water for injection, dissolve and stir evenly, then add gemcitabine hydrochloride, dissolve and stir evenly, adjust pH to 3.3 with 0.1mol / L hydrochloric acid or 0.1mol / L sodium hydroxide solution, After passing the intermediate inspection, add water for injection to make up to full volume. The solution was sent to the sterile room by a peristaltic pump, filtered through a 0.22 μm microporous membrane until it was clear, filled in 25 ml vials with a volume of 6 ml per bottle, partially plugged with butyl rubber stoppers, and placed in a plate. Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circulation pum...

Example Embodiment

[0037] Example 3:

[0038] prescription

[0039] Gemcitabine Hydrochloride 228g

[0040] Mannitol 1140g

[0041] Sodium acetate 11.4g

[0042] Add water for injection to 6000ml

[0043]

[0044] A total of 1000 bottles were made

[0045]Weigh mannitol and sodium acetate, add 80% water for injection, dissolve and stir evenly, then add gemcitabine hydrochloride, dissolve and stir evenly, adjust pH to 3.0 with 0.1mol / L hydrochloric acid or 0.1mol / L sodium hydroxide solution, After passing the intermediate inspection, add water for injection to make up to full volume. The solution was sent to the sterile room by a peristaltic pump, filtered through a 0.22 μm microporous membrane until it was clear, filled in 25 ml vials with a volume of 6 ml per bottle, partially plugged with butyl rubber stoppers, and placed in a plate. Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circulatio...

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Abstract

The invention relates to a gemcitabine hydrochloride lyophilized powder injection and a preparation method thereof. The gemcitabine hydrochloride lyophilized powder injection prepared by the method can be used as a therapeutic medicament for treating middle and late non-small cell lung cancer, pancreatic cancer and the like. The gemcitabine hydrochloride lyophilized powder injection is characterized by consisting of gemcitabine hydrochloride, mannitol and sodium acetate, wherein the weight ratio of the gemcitabine hydrochloride to the mannitol is 1:0.5-5, and the weight ratio of the gemcitabine hydrochloride to the sodium acetate is 1:0.01-0.1. The preparation method comprises the following steps: taking the mannitol and the sodium acetate; dissolving the mannitol and the sodium acetate by adding injection water; adding the gemcitabine hydrochloride to the mixture, stirring and dissolving the mixture, and adjusting the pH to between 2.7 and 3.3; fixing the volume; filtering the product by a 0.22 mu m microporous membrane; filling, dishing up, lyophilizing, and compressing; taking the product out of a box, and tying the product with an aluminum-plastic composite cover; and inspecting the quality, and packaging the product after passing the quality inspection to obtain the gemcitabine hydrochloride lyophilized powder injection.

Description

technical field [0001] The invention relates to a gemcitabine hydrochloride freeze-dried powder injection and a preparation method thereof. The gemcitabine hydrochloride freeze-dried powder injection prepared by the method can be used as a therapeutic drug for middle and advanced non-small cell lung cancer and pancreatic cancer. Background technique [0002] Primary bronchial lung cancer is currently one of the most common malignant tumors in the world. In developed countries and developing countries, lung cancer ranks first among malignant tumors. According to the data in recent years, lung cancer has the highest mortality rate in industrialized countries such as Europe and the United States. Almost 80% of lung cancers are non-small cell lung cancers. Data have shown that the incidence rate of lung cancer in my country's large and medium-sized cities such as Shanghai and Beijing ranks first among various malignant tumors. [0003] The International Cancer Research Associat...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7068A61K47/12A61P35/00
Inventor 赵俊戴建国叶东张启杰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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