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Nedaplatin-containing freeze-drying composition as well as application and preparation method thereof

A technology of a composition and nedaplatin, which is applied in the field of freeze-dried compositions containing nedaplatin, can solve problems such as longer freeze-drying time, increased viscosity parameters, and difficulty in water sublimation, and achieves good freeze-drying effect and free related substances Low, low residual moisture effect

Active Publication Date: 2013-09-25
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, with the increase of the average molecular weight of dextran itself, its viscosity parameter increases; at the same time, with the increase of the amount of dextran in the powder injection preparation process, the viscosity of the solution also increases. Therefore, after using dextran as a stabilizer, water sublimation becomes difficult. , longer freeze-drying time

Method used

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  • Nedaplatin-containing freeze-drying composition as well as application and preparation method thereof
  • Nedaplatin-containing freeze-drying composition as well as application and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Nedaplatin 10g

[0055] Dextran-40 30g

[0056] tert-butanol 125mL

[0057] Add water for injection to 2500mL

[0058] Add 1.25L of water for injection and 125mL of tert-butanol into the batching tank, stir, add 30g of dextran-40 into the batching tank, stir to dissolve completely. Add wetted activated carbon into the batching tank, stir at 80°C for 30 minutes, use a circulating pump or compressed air as the power, decarbonize the auxiliary material solution through a titanium rod to obtain a filtrate. Add water for injection to the filtrate to about 2.25L, stir, and use circulating refrigerant to cool the solution below 30°C, then add 10g of nedaplatin to the batching tank, stir for about 15 minutes to completely dissolve, add water for injection to 2.5L, Stir for 10 minutes. After filtering through a 0.22 μm microporous membrane, it was divided into 1000 vials, each containing 10 mg of nedaplatin; it was freeze-dried according to the following freeze-drying curve. ...

Embodiment 2

[0062] Nedaplatin 50g

[0063] Dextran-40 150g

[0064] tert-butanol 300mL

[0065] Add water for injection to 10L

[0066] Add 4L of water for injection and 400mL of tert-butanol into the batching tank, stir, add 150g of dextran-40 into the batching tank, stir to dissolve completely. Add wetted activated carbon into the batching tank, stir at 80°C for 30 minutes, use a circulating pump or compressed air as the power, decarbonize the auxiliary material solution through a titanium rod to obtain a filtrate. Add water for injection to the filtrate to about 9L, stir, and use circulating refrigerated liquid to cool the solution below 30°C, add 50g of nedaplatin to the batching tank, stir for about 15 minutes to dissolve completely, add water for injection to 10L, and stir for 10 minute. After filtering through a 0.22 μm microporous membrane, it was divided into 1000 vials, each containing 50 mg of nedaplatin; it was freeze-dried according to the following freeze-drying curve. ...

Embodiment 3

[0070] Nedaplatin 50g

[0071] Dextran-40 150g

[0072] tert-butanol 300mL

[0073] Add water for injection to 10L

[0074] Add 4L of water for injection and 300mL of tert-butanol into the batching tank, stir, add 150g of dextran-40 into the batching tank, stir to dissolve completely. Add wetted activated carbon into the batching tank, stir at 80°C for 30 minutes, use a circulating pump or compressed air as the power, decarbonize the auxiliary material solution through a titanium rod to obtain a filtrate. Add water for injection to the filtrate to about 9L, stir, and use circulating refrigerated liquid to cool the solution below 30°C, add 50g of nedaplatin to the batching tank, stir for about 15 minutes to dissolve completely, add water for injection to 10L, and stir for 10 minute. After filtering through a 0.22 μm microporous membrane, it was divided into 500 vials, each containing 100 mg of nedaplatin; it was freeze-dried according to the following freeze-drying curve. ...

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Abstract

The invention provides a novel nedaplatin-containing freeze-drying composition as well as an application and preparation method thereof. The nedaplatin-containing freeze-drying composition provided by the invention has the advantages of attractive product appearance and low residual water content. The preparation method of nedaplatin-containing freeze-drying powder provided by the invention has the advantages that time consumption is little, industrialization is easily carried out and few relevant substances in the preparation process are generated. The nedaplatin-containing freeze-drying composition provided by the invention is prepared by freezing and drying a water solution of nedaplatin and dextranum-40 in the mass ratio of 1:3, wherein the water solution contains 1-5% of tertiary butanol according to the volume percentage.

Description

[0001] technical field [0002] The invention relates to the field of medicine, and more specifically relates to a freeze-dried composition containing nedaplatin, its application and its preparation method. [0003] Background technique [0004] Nedaplatin (Nedaplatin) is another platinum-based antitumor drug following cisplatin and carboplatin; it was first developed and marketed by Shionogi Company in Japan under the trade name Aqupla in June 1995. The chemical structure of nedaplatin is shown in formula-I, and it is mainly used clinically for the treatment of head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer, ovarian cancer and other solid tumors. Nedaplatin has the characteristics of broad anti-tumor spectrum, wide range of combined chemotherapy, synergistic effect of combined chemotherapy, no cross-resistance with cisplatin, and low adverse reactions. [0005] Formula-I [0006] Nedaplatin is slightly soluble in water, alm...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/36A61K31/282A61P35/00
Inventor 陈庆财吉同琴赵霞
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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