Freeze drying preparation of amifostine, and preparation method

A technology of freeze-dried preparations and amifostine, which is applied in freeze-dried transportation, pharmaceutical formulations, medical preparations containing active ingredients, etc., to achieve the effects of convenient transportation and storage, convenient use, and large-scale production

Active Publication Date: 2007-03-21
深圳市资福药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the method is publicly available using the C 1 ~C 5 The solution of alcohol and water is a solvent, and the temperature range of freezing and drying is very wide, but only ethanol is as the embodiment of solvent in the embodiment

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Take 250.0 g of commercially available amifostine (trihydrate), add 1150 ml of water for injection, and stir to completely dissolve. Slowly add 200.0ml of acetone dropwise to the solution under stirring. At this time, the solution is a clear liquid. Add water for injection to 2000.0ml. Add 0.1% activated carbon for needles while stirring, keep at 25°C for 30 minutes, decarbonize and filter, continue the filtrate Filter through a 0.22 μm microporous membrane until clear. Fill in aseptically treated vials, 2.0ml per bottle, freeze-dry according to the method of Example 7 in a freeze dryer, and aseptically seal to obtain the preparation A of the present invention.

Embodiment 2

[0034] Preparation B of the present invention was prepared according to the method of Example 1, except that 100.0 g of mannitol (Shandong Jiejing Group) was added to the amifostine-containing solution, and freeze-dried according to the method of Example 7.

Embodiment 3-5

[0036] Preparations C, D, and E of the present invention were prepared according to the method of Example 2, except that each milliliter of solution contained 60 mg, 150 mg, and 280 mg of amifostine, 0.075 ml, 0.1 ml, and 0.15 ml of acetone, and contained no excipients and lactose. 100mg, containing 180mg of glycine, and adding activated carbon according to the dosage of 0.06%, 0.5%, 2.5% (g / ml) respectively, stirring at 20, 25, and 30°C for 30, 20, and 10 minutes, decarbonizing and filtering, according to the implementation Freeze drying by the method of Example 7.

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PUM

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Abstract

A freeze-dried amifostine is prepared from amifostine, acetone and the solution of pharmacologically acceptable excipient through prefreezing, sublimated drying, and drying again.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried amifostine preparation and a preparation method thereof. Background technique [0002] Amifostine is an alkyl phosphorothioate compound (dihydrogen phosphorothioate S-2-(3-aminopropylamino) ethyl ester), it is a broad-spectrum selective cell protector, the main function is to protect Hematopoietic stem cells have obvious protective effects on red and white blood cells and platelets, and can reduce the toxic and side effects of radiotherapy and chemotherapy on the liver, kidney, heart, and nervous system. It is mainly suitable for the adjuvant treatment of tumor radiotherapy or cytotoxic chemotherapy. On the other hand, the combination of amifostine and radiotherapy or cytotoxic antineoplastic drugs can enhance the patient's tolerance to antitumor treatment, which is conducive to increasing the treatment dose and shortening the treatment period...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/661A61K9/19A61P35/00
Inventor 吴良信邵梅
Owner 深圳市资福药业有限公司
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