Solvent system capable of effectively dissolving ornidazole or levorotatory ornidazole and injection thereof
A technology of levoornidazole and ornidazole, which is applied to the more stable ornidazole injection or levoornidazole injection and the field of preparation thereof, and can solve the problem of excessive use of propylene glycol, control of impurity growth, easy crystallization at low temperature, etc. problem, to achieve the effect of reducing the amount of solvent, easy crystallization, and reducing the amount of solvent
Active Publication Date: 2020-03-27
SOUTHWEST UNIVERSITY +1
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Problems solved by technology
[0015] For the above-mentioned deficiency of prior art, the purpose of the present invention is to provide a kind of solvent system that can dissolve ornidazole or left-ornidazole effectively, solve the impurity growth control that exists in the prior art simultaneously, pH value is too low, propylene glycol excess Use, easy crystallization at low temperature, production safety and many other technical issues, in order to meet the clinical safety drug requirements to the greatest extent, and increase patient drug compliance
Method used
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Experimental program
Comparison scheme
Effect test
Embodiment 1～11
[0062] Embodiment 1~11: Different organic systems are to the solubility of ornidazole or left-ornidazole (1) (room temperature)
[0063] Experimental procedure: first mix various solvents in proportion, then add excess ornidazole or left ornidazole, stir and dissolve at room temperature for 20 minutes, remove undissolved drugs by filtration with a 0.22 micron microporous membrane, and use spectrophotometry ( 318nm) to measure the absorbance of the solution, and calculate the drug solubility according to the standard curve. Note: the amount of each component is parts by weight, the same below.
[0064] Table 1: Examples 1-11
[0065]
Embodiment 27～36
[0081] Embodiment 27~36: low temperature stability test (1)
[0082] Table 5: Examples 27-36
[0083]
Embodiment 37～46
[0084] Embodiment 37~46: low temperature stability test (2)
[0085] Table 6: Examples 37-46
[0086]
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The invention discloses a solvent system capable of effectively dissolving ornidazole or levorotatory ornidazole and an injection thereof, the active component is ornidazole or levorotatory ornidazole, and the solvent system is an organic solvent formed by mixing short-chain polyethylene glycol and ethanol; the short-chain polyethylene glycol is preferably polyethylene glycol 300 or/and polyethylene glycol 400. Wherein the mixed mass fraction ratio of the short-chain polyethylene glycol to the ethanol in the solvent system is (30-100): (0-70). The method has the technical advantages which cannot be achieved by the prior art; the ornidazole injection or levorotatory ornidazole injection has the unique preparation advantages of simpler prescription, safer production, more stable preparation,less solvent amount, lower impurity (particularly genotoxic impurities) content, fewer impurities, low-temperature crystallization difficulty, low phlebitis occurrence rate, no low-pH infusion irritation, no propylene glycol and the like; the clinical medication safety is ensured, and the medication compliance of a patient is better.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a more stable ornidazole injection or left-ornidazole injection and a preparation method thereof. Background technique [0002] Ornidazole and left-ornidazole are the third-generation nitroimidazole broad-spectrum anti-anaerobe and antiprotozoal drugs after metronidazole and tinidazole. They have good curative effect, good tolerance, good tissue permeability, Wide distribution in the body, long biological half-life and other advantages, therefore, ornidazole and left-ornidazole are the first choice drugs for the prevention and treatment of anaerobic infection. [0003] At present, the existing marketed ornidazole injections include small-volume injections and large-volume injections, and left-ornidazole injections only have large-volume injections. Yet existing ornidazole injection and left-ornidazole injection all have following defects: [0004] (1) Ornida...
Claims
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IPC IPC(8): A61K9/08A61K31/4164A61K47/10A61P31/04A61P33/02
CPCA61K31/4164A61K47/10A61K9/08A61K9/0019A61P31/04A61P33/02
Inventor 潘红春刘红郑昌伟
Owner SOUTHWEST UNIVERSITY
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