Solvent system capable of effectively dissolving ornidazole or left-ornidazole and injection thereof
A technology of levoornidazole and ornidazole, which is applied to the more stable ornidazole injection or levoornidazole injection and the preparation field thereof, and can solve the problem of excessive use of propylene glycol, control of impurity growth, and low pH value. and other problems, to achieve the effect of reducing the amount of solvent, the number of impurities, and reducing the amount of solvent
Active Publication Date: 2022-01-18
SOUTHWEST UNIV +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
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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 left-ornidazole and an injection thereof, the active ingredient is ornidazole or left-ornidazole, and the solvent system is a mixture of short-chain polyethylene glycol and ethanol The organic solvent of short-chain polyethylene glycol is preferably polyethylene glycol 300 or / and polyethylene glycol 400. The mixed mass fraction ratio of short-chain polyethylene glycol and ethanol in the solvent system is 30-100:0-70. The present invention has technical advantages that cannot be achieved by the prior art. The ornidazole injection or left-ornidazole injection has the advantages of simpler prescription, safer production, more stable preparation, less solvent content, and impurities (especially genotoxic impurities). ) content is lower, the number of impurities is less, low temperature is not easy to crystallize, the incidence of phlebitis is low, no low pH infusion irritation, no propylene glycol and other unique preparation advantages ensure safer clinical medication and better drug compliance of patients.
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 UNIV
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