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Levosimendan freeze-dried preparation and preparing method

A technology of freeze-dried preparations and preparations, applied in the field of pharmaceutical preparations, can solve the problems of patient irritation, side effects, complex preparation process, etc., and achieve the effects of reducing related substances, facilitating transportation, good solubility and stability

Inactive Publication Date: 2005-06-15
SHANDONG BESTCOMM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these large amounts of organic solvents are likely to cause irritation and side effects to patients during use, especially for patients who are allergic to alcohol, and it is difficult to use them, and a large amount of organic solvents with high volatility will also make the preparation process more complicated

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Levosimendan 12.5mg

[0026] Mannitol 550mg

[0027] 0.2mol / L disodium hydrogen phosphate 2.5ml

[0028] 0.2mol / L sodium dihydrogen phosphate 0.23ml

[0029] Add water for injection to 5ml

[0030] Take levosimendan (synthesized according to the methods described in WO9212135 and GB2228004), mannitol, add disodium hydrogen phosphate and sodium dihydrogen phosphate solution, stir to completely dissolve (pH≈7.8), add 5 mg of activated carbon, and continue stirring for 30 min. Decarbonize, add water for injection to make up to 5ml, and sterilize by fine filtration with 0.22μm microporous membrane. Under aseptic conditions, the obtained solution is placed in a sterile vial, freeze-dried in a freeze dryer, and sealed. The yellow levosimendan freeze-dried powder preparation A of the present invention was obtained.

Embodiment 2

[0032] Levosimendan 12.5mg

[0033] Mannitol 280mg

[0034] Povidone 50mg

[0035] 0.2mol / L disodium hydrogen phosphate 1.46ml

[0036] 0.2mol / L sodium dihydrogen phosphate 0.14ml

[0037] Add water for injection to 3ml

[0038] Take levosimendan, povidone, and mannitol, add disodium hydrogen phosphate and sodium dihydrogen phosphate solution, stir to dissolve completely (pH≈7.8), add 3 mg of activated carbon, continue stirring for 30 minutes, decarbonize, add water for injection to set Make up to 3ml, sterilize by fine filtration with 0.22μm microporous membrane. Under aseptic conditions, the obtained solution is placed in a sterile vial, freeze-dried in a freeze dryer, and sealed. The yellow levosimendan freeze-dried powder preparation B of the present invention was obtained.

Embodiment 3

[0040] Levosimendan 12.5mg

[0041] Mannitol 190mg

[0042] Hydroxypropyl-β-cyclodextrin 136.8mg

[0043] 0.2mol / L disodium hydrogen phosphate 1.46ml

[0044] 0.2mol / L sodium dihydrogen phosphate 0.14ml

[0045] Add water for injection to 3ml

[0046] Take 12.5 mg of levosimendan, 2-hydroxypropyl-β-cyclodextrin, and mannitol, add disodium hydrogen phosphate and sodium dihydrogen phosphate solution, stir to dissolve completely (pH≈7.8), add 3 mg of activated carbon, continue Stir for 30 minutes, decarbonize, add water for injection to make up to 3ml, and sterilize by fine filtration with 0.22μm microporous membrane. Under aseptic conditions, the obtained solution is placed in a sterile vial, freeze-dried in a freeze dryer, and sealed. The yellow levosimendan freeze-dried powder preparation C of the present invention was obtained.

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Abstract

A freze-dried Zuoximengdan for treating heart failure is prepared from the pharmacologically acceptable pH regulator and water-soluble precipient, and the solution of Zuoximengdan or its pharmacologically acceptable salt through freeze drying. Its advantage is high stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of levosimendan, a drug for treating heart failure, and a preparation method thereof. technical background [0002] Levosimendan, (-)-2-{[4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono} Malononitrile, a positive inotropic drug, enhances myocardial contractility by increasing the sensitivity of cardiomyocytes to calcium ions without increasing the concentration of calcium ions in cardiomyocytes. World Patent WO93 / 21921 describes the use of this compound in the treatment of myocardial ischemia. A large number of clinical studies have confirmed the beneficial effect of levosimendan on heart failure patients. Because the condition of heart failure patients is serious, especially when the patient is in an unconscious state or the intestinal absorption function is weak, it is best to use parenteral administration, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/50A61P9/04
Inventor 孟凡清
Owner SHANDONG BESTCOMM PHARMA CO LTD
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