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Melphalan freeze-dried powder injection

A technology of freeze-dried powder injection and melphalan, which is applied in the field of melphalan freeze-dried powder injection and its preparation, can solve the problems of no improvement defects, toxic and side effects, and reduced drug efficacy, and achieve considerable economic and social benefits, related The effect of low substance content and thorough moisture drying

Inactive Publication Date: 2009-11-25
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Melphalan is white to light yellow powder, insoluble in water, unstable to light, heat and humidity, so it can only be made into freeze-dried powder injection, but because melphalan is insoluble in water, during the preparation process Acid needs to be added to make it dissolve into a salt. The common preparation method degrades a large amount of melphalan during the preparation process, which reduces the efficacy of the drug and produces impurities that cause toxic and side effects
Existing known technology also does not improve the suggestion of above defective

Method used

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  • Melphalan freeze-dried powder injection
  • Melphalan freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] prescription

[0026] Melphalan 50g

[0027] tert-butanol 400ml

[0028] Add water for injection to 2000ml

[0029]

[0030] A total of 1000 bottles were made

[0031] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 8°C and keep warm, then add melphalan, stir and add 0.5mol hydrochloric acid dropwise to dissolve, mix evenly and wait for the middle After the physical examination is qualified, it is sent to a sterile room with a peristaltic pump and filtered through a 0.22 μm microporous membrane until it is clear, filled in a brown vial, partially plugged with a butyl rubber stopper, and put into a plate; put it into a plate and wait for freezing Put the dry sample in the freeze-drying box, close the box door, turn on the machine, turn on the circulating pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, when the product temperature...

Embodiment 2

[0033] prescription

[0034] Melphalan 50g

[0035] Mannitol 100g

[0036] tert-butanol 1200ml

[0037] Add water for injection to 4000ml

[0038]

[0039] A total of 1000 bottles were made

[0040] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 6°C and keep warm, then add melphalan and mannitol, stir and add 0.5mol of hydrochloric acid dropwise to dissolve, mix Evenly wait for the intermediate to pass the inspection, send it to a sterile room with a peristaltic pump, filter it through a 0.22 μm microporous membrane until it is clear, fill it in a brown vial, partially plug it with a butyl rubber stopper, and put it on a plate; Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, open the circulating pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and when the product temperature reache...

Embodiment 3

[0042] prescription

[0043] Melphalan 50g

[0044] Mannitol 200g

[0045] tert-butanol 200ml

[0046] Add water for injection to 2000ml

[0047]

[0048] A total of 1000 bottles were made

[0049] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 2°C and keep warm, then add melphalan and mannitol, stir and add 0.5mol hydrochloric acid dropwise to dissolve, mix Evenly wait for the intermediate to pass the inspection, send it to a sterile room with a peristaltic pump, filter it through a 0.22 μm microporous membrane until it is clear, fill it in a brown vial, partially plug it with a butyl rubber stopper, and put it on a plate; Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, open the circulating pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and when the product temperature reaches -...

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Abstract

The invention relates to a melphalan freeze-dried powder injection and a preparing method thereof. The prepared melphalan freeze-dried powder injection is used for treating multiple myeloma, oophoroma, polycythemia vera, local malignant melanoma and soft tissue sarcoma. The melphalan freeze-dried powder injection contains melphalan, utilizes the mixed solvent composed of the tert-butyl alcohol and the injection water in the preparation process, wherein the concentration of the melphalan in the mixed solvents is 10-25 mg / ml; and the volume ratio of the solvents is: 5-50% of tert-butyl alcohol and the balance of injection water. The preparation process comprises the following steps: measuring tert-butyl alcohol, adding injection water, mixing evenly, cooling to 2-15 DEG C, heat preserving, adding melphalan, stirring and dripping 0.5 mol hydrochloric acid to dissolve, filtering, filling, plugging, disking, freeze-drying, pressing plug, out box, tying and packing after quality test qualification.

Description

technical field [0001] The present invention relates to a melphalan freeze-dried powder injection and a preparation method thereof. The melphalan freeze-dried powder injection prepared by the method can be used as a medicine for multiple myeloma, ovarian cancer, polycythemia vera, and local malignant melanin. tumors, and soft tissue sarcomas. Background technique [0002] Melphalan is L-amphalan, its anticancer effect is stronger than that of PAM, its mechanism of action is the same as that of HN2, and it is also a non-specific drug for cell cycle. Oral absorption is sufficient, the plasma reaches the highest level 2 hours after taking the drug, and it remains active in the plasma for about 6 hours. Within 24 hours after taking the drug, 50% of the drug is excreted through urine, of which 13% is the original form, and the metabolites are a hydroxy derivative and a dihydroxy derivative. Hydroxy Derivatives. [0003] The injection is used for the treatment of multiple myelom...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/198A61K47/10A61P35/00
Inventor 叶东戴建国赵俊戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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