Solvent system capable of effectively dissolving ornidazole or left-ornidazole and application thereof
A technology for levornidazole and ornidazole, which is applied in the field of ornidazole injection or levoornidazole injection and preparation thereof, can solve the problems of excessive use of propylene glycol, control of impurity growth, low pH value and the like, and achieves the The effect of reducing the amount of solvent, reducing the number of impurities and reducing the amount of solvent
Active Publication Date: 2022-02-15
CHONGQING DIANSUO MEDICAL TECH CO LTD
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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 and application that can dissolve ornidazole or left-ornidazole effectively, solve the impurity growth control that prior art exists, pH value is too low, propylene glycol Excessive use, easy crystallization at low temperature, drug-induced disulfiram reaction, production safety and many other technical problems, in order to meet the clinical safety drug needs to the greatest extent and increase patient drug compliance
Method used
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Experimental program
Comparison scheme
Effect test
Embodiment 1～11
[0057] Embodiment 1~11: Different organic systems are to the solubility of ornidazole or left-ornidazole (1) (room temperature)
[0058] 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.
[0059] Table 1: Examples 1-11
[0060]
Embodiment 27～36
[0077] Embodiment 27~36: low temperature stability test (1)
[0078] Table 5: Examples 27-36
[0079]
Embodiment 37～46
[0080] Embodiment 37~46: low temperature stability test (2)
[0081] Table 6: Examples 37-46
[0082]
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The invention discloses a solvent system capable of effectively dissolving ornidazole or left-ornidazole and its application. The active ingredient is ornidazole or left-ornidazole, and the solvent system is an organic solvent mixed with short-chain polyethylene glycol and propylene glycol; The short-chain polyethylene glycol is preferably polyethylene glycol 300 or / and polyethylene glycol 400. The solvent system can be used in the preparation of ornidazole injection or left-ornidazole injection. The present invention has technical advantages that cannot be achieved by the prior art. The preparation of ornidazole injection or left-ornidazole injection has the advantages of simpler prescription, safer production, more stable preparation, less solvent content, and impurities (especially genes) Toxic impurities) content is lower, low temperature is not easy to crystallize, low incidence of phlebitis, no irritation of low pH infusion, more suitable for patients with sensitive disulfiram reactions, etc., to ensure safer clinical medication and drug compliance of patients better.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a solvent system capable of effectively dissolving ornidazole or left-ornidazole and its application, and provides a safer 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. Y...
Claims
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IPC IPC(8): A61K9/08A61K47/10A61K31/4164A61P31/04A61P33/02
CPCA61K9/08A61K9/0019A61K47/10A61K31/4164A61P31/04A61P33/02
Inventor 刘红潘红春
Owner CHONGQING DIANSUO MEDICAL TECH CO LTD
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