CN104127373B - Ornidazole injection liquid - Google Patents
Ornidazole injection liquid Download PDFInfo
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- CN104127373B CN104127373B CN201410262380.6A CN201410262380A CN104127373B CN 104127373 B CN104127373 B CN 104127373B CN 201410262380 A CN201410262380 A CN 201410262380A CN 104127373 B CN104127373 B CN 104127373B
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Abstract
The invention provides a preparation method of an ornidazole injection liquid. The preparation method comprises the steps: (1) mixing evenly ornidazole and an organic solvent, wherein the organic solvent is ethanol or is a mixture of ethanol and propylene glycol; (2) carrying out at least two times of heating cooling circulation on the evenly-mixed material, wherein the heating cooling circulation comprises the steps of firstly heating from the temperature of 10-30 DEG C to the temperature of 40-60 DEG C, and then cooling from the temperature of 40-60 DEG C to the temperature of 10-30 DEG C. The invention also provides the ornidazole injection liquid, wherein the ornidazole injection liquid is prepared according to the above method. Through the technical scheme, the storage stability of the ornidazole injection liquid under a condition of relatively low temperatures (-10 DEG C to 20 DEG C) is significantly improved, and irritation is relatively small after injection.
Description
Technical field
The present invention relates to field of pharmaceutical preparations is and in particular to a kind of preparation method of ornidazole injection and this preparation side
The ornidazole injection that method prepares.
Background technology
Ornidazole injection is antibacterials, and the mechanism of action is by the nitro in its molecule, reduces in oxygen-free environment
Becoming amino or by the formation of free radical, interacting with Cell Component, thus leading to the death of microorganism, therefore to anaerobism
The disease that bacterium, infusorian, ameba worm etc. cause has stronger therapeutical effect.
Ornidazole injection in clinical practice extensively, is the choice drug for the treatment of anaerobic infection, can be used for operation consent pre-
Anti- infection and the treatment of Post operation anaerobic infection, also can treat the serious ameba parasitosis of digestive system, such as amebic dysentery,
Amebic liver abscess.But Ornidazole water solublity is bad, existing process adjusts ph value to 1.8～2.3, so that ornidazole injection is existed
Basicly stable during preparation and storage, and relevant material super quality standard limit (singly miscellaneous does not surpass 0.5%, always miscellaneous does not surpass
1.0%), but be obtained ornidazole injection stronger to blood vessel irritation, beyond the tolerance limit of human body, increased defeated simultaneously
Note pain and phlebitic incidence rate, shows according to statistics, and ornidazole injection causes pain and various phlebitic in various degree
Patient is about 59% (Wang Bo, Chinese medical forward position, 2009,4 (24): 69).
Existing document (cn201310000708.2) discloses a kind of ornidazole injection, the ph value of this ornidazole injection
Reach 4.0-7.0, and the good storage-stable of 6 months can be kept in 40 ± 2 DEG C of temperature and under conditions of humidity 75 ± 5%
Property.
But, research finds, the storage under above-mentioned ornidazole injection (- 10 DEG C to 20 DEG C) under relatively low temperature conditionss
, easily the exceeded defect of visible particulate matter in less stable.
Content of the invention
In order to overcome storage stability under ornidazole injection (- 10 DEG C to 20 DEG C) under relatively low temperature conditionss relatively
, easily the exceeded defect of particulate matter in difference, the invention provides a kind of preparation method of ornidazole injection.The present invention
Inventor it was unexpectedly found that, by heat at least twice cooling circulation, ornidazole injection can be significantly increased
Storage stability, resulting in the present invention.
The invention provides a kind of preparation method of ornidazole injection, this preparation method includes: (1) by Ornidazole and has
Machine solvent mix homogeneously；Wherein, described organic solvent is ethanol, or the mixing that described organic solvent is ethanol and propylene glycol
Thing；(2) material after mix homogeneously is heated at least twice cooling circulation；Wherein, described heating cooling circulation includes: first
It is heated to 40-60 DEG C of temperature from 10-30 DEG C of temperature, then the temperature from 40-60 DEG C is cooled to 10-30 DEG C of temperature.
Present invention also offers a kind of ornidazole injection, this ornidazole injection is to be prepared according to method as above
Obtain.
By technique scheme, invention significantly increases ornidazole injection is (- 10 under relatively low temperature conditionss
DEG C to 20 DEG C) under storage stability, and due to can be using less organic solvent, after injection, zest be less.
Other features and advantages of the present invention will be described in detail in subsequent specific embodiment part.
Specific embodiment
Hereinafter the specific embodiment of the present invention is described in detail.It should be appreciated that it is described herein concrete
Embodiment is merely to illustrate and explains the present invention, is not limited to the present invention.
Herein, in the case of not doing contrary explanation, the gas of use and liquid volume numerical value are 20 DEG C, and 101,000
Numerical value under handkerchief.In the present invention, ethanol used is dehydrated alcohol.
The invention provides a kind of preparation method of ornidazole injection, this preparation method includes: (1) by Ornidazole and has
Machine solvent mix homogeneously；Wherein, described organic solvent is ethanol, or the mixing that described organic solvent is ethanol and propylene glycol
Thing；(2) material after mix homogeneously is heated at least twice cooling circulation；Wherein, described heating cooling circulation includes: first
It is heated to 40-60 DEG C of temperature from 10-30 DEG C of temperature, then the temperature from 40-60 DEG C is cooled to 10-30 DEG C of temperature.
Wherein, Ornidazole refers to the material of chemical entitled 1- (3- chloro- 2- hydroxypropyl) -2- 5-nitro imidazole.
Wherein, in the case that described organic solvent is ethanol, the consumption of Ornidazole and ethanol can be ornidazole injection
Conventional consumption, the such as Ornidazole with respect to 1g in preparation field, the usage amount of ethanol can be 3.5-5.5ml；Preferably,
With respect to the Ornidazole of 1g, the usage amount of ethanol is 4-5ml.
Wherein, in the case that described organic solvent is ethanol and the mixture of propylene glycol, the consumption of Ornidazole and ethanol can
Think conventional consumption in ornidazole injection preparation field, the such as Ornidazole with respect to 1g, the usage amount of propylene glycol is permissible
For 0.5-2.5ml, the usage amount of ethanol can be 3.5-5.5ml；Preferably, the Ornidazole with respect to 1g, the use of propylene glycol
Measure as 1-2ml, the usage amount of ethanol is 4-5ml.
Wherein, the material after mix homogeneously in step (1) is heated at least twice cooling circulation；Can be by step
(1) material after mix homogeneously in carry out twice, three times, four times, five times or six times heating cooling circulation；Preferably by step (1)
Material after middle mix homogeneously is heated cooling circulation twice.Wherein, temperature used and change in heating cooling circulation every time
Warm speed can be identical or different.
Wherein it is preferred to, in described heating cooling circulation, it is heated to 45-55 DEG C of temperature from 10-30 DEG C of temperature.
Wherein it is preferred to, in described heating cooling circulation, it is heated to the mistake of 40-60 DEG C of temperature from 10-30 DEG C of temperature
Cheng Zhong, can lower the temperature immediately it is also possible to keep 1-2000s at 40-60 DEG C it is preferable that described add after being heated to 40-60 DEG C
In heat cooling circulation, keep 300-1200s at a temperature of 40-60 DEG C.
Wherein it is preferred to, once in heating cooling circulation, it is heated to the mistake of 40-60 DEG C of temperature from 10-30 DEG C of temperature
The time that journey is experienced is 10-20 minute.
Wherein it is preferred to, once in heating cooling circulation, it is cooled to the mistake of 10-30 DEG C of temperature from 40-60 DEG C of temperature
The time that journey is experienced is 10-20 minute.
Wherein, in order to meet the hygienic requirements of injection, filtration sterilization can be carried out and high pressure is degerming.Used by filtration sterilization
Filter membrane aperture can be less than 0.22 μm.The degerming temperature of high pressure can be 120-122 DEG C.
Present invention also offers a kind of ornidazole injection, this ornidazole injection is to be prepared according to method as above
Obtain.
Further describe the present invention by the following examples.
Embodiment 1
1g Ornidazole is mixed homogeneously with the ethanol of 4.5ml, the temperature of the material after mix homogeneously is 20 DEG C.To mix all
Material after even was heated to 50 DEG C through 15 minutes, maintains 300s, be then cooled to 20 DEG C through 15 minutes, complete first at 50 DEG C
Secondary heating cooling circulation.The material completing the circulation of heating cooling for the first time was heated to 50 DEG C through 15 minutes, ties up at 50 DEG C
Hold 300s, be then cooled to 20 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 2
1g Ornidazole is mixed homogeneously with the ethanol of 4ml, the temperature of the material after mix homogeneously is 15 DEG C.By mix homogeneously
Material afterwards was heated to 45 DEG C through 10 minutes, maintains 600s, be then cooled to 11 DEG C through 10 minutes at 45 DEG C, completed for the first time
Heating cooling circulation.The material completing the circulation of heating cooling for the first time was heated to 45 DEG C through 10 minutes, maintains at 45 DEG C
480s, was then cooled to 28 DEG C through 10 minutes, completed second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 3
1g Ornidazole is mixed homogeneously with the ethanol of 5ml, the temperature of the material after mix homogeneously is 25 DEG C.By mix homogeneously
Material afterwards was heated to 55 DEG C through 20 minutes, maintains 1200s, be then cooled to 28 DEG C through 20 minutes, complete first at 55 DEG C
Secondary heating cooling circulation.The material completing the circulation of heating cooling for the first time was heated to 55 DEG C through 20 minutes, ties up at 55 DEG C
Hold 1200s, be then cooled to 13 DEG C through 20 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 4
1g Ornidazole is mixed homogeneously with the ethanol of 3.5ml, the temperature of the material after mix homogeneously is 20 DEG C.To mix all
Material after even was heated to 42 DEG C through 15 minutes, maintains 1200s, be then cooled to 20 DEG C through 15 minutes at 42 DEG C, completed the
Once heating cooling circulation.The material completing the circulation of heating cooling for the first time was heated to 42 DEG C through 15 minutes, at 42 DEG C
Maintain 240s, be then cooled to 20 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 5
1g Ornidazole is mixed homogeneously with the ethanol of 5.5ml, the temperature of the material after mix homogeneously is 15 DEG C.To mix all
Material after even was heated to 59 DEG C through 15 minutes, maintains 240s, be then cooled to 11 DEG C through 15 minutes, complete first at 59 DEG C
Secondary heating cooling circulation.The material completing the circulation of heating cooling for the first time was heated to 59 DEG C through 15 minutes, ties up at 59 DEG C
Hold 240s, be then cooled to 28 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 6
1g Ornidazole is mixed homogeneously with the ethanol of 4.5ml, the temperature of the material after mix homogeneously is 20 DEG C.To mix all
Material after even was heated to 60 DEG C through 15 minutes, was then cooled to 20 DEG C through 15 minutes, completed to heat cooling circulation for the first time.Will
The material completing the circulation of heating cooling for the first time was heated to 60 DEG C through 15 minutes, was then cooled to 20 DEG C through 15 minutes, completes
Second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Comparative example 1
1g Ornidazole is mixed homogeneously with the ethanol of 4.5ml, the temperature of the material after mix homogeneously is 20 DEG C.To mix all
Material after even was heated to 35 DEG C through 15 minutes, was then cooled to 20 DEG C through 15 minutes, completed to heat cooling circulation for the first time.Will
The material completing the circulation of heating cooling for the first time was heated to 35 DEG C through 15 minutes, maintains 360s, be then cooled at 35 DEG C
20 DEG C, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of this comparative example.
Comparative example 2
1g Ornidazole is mixed homogeneously with the ethanol of 4.5ml, the temperature of the material after mix homogeneously is 20 DEG C.To mix all
The temperature of the material after even is 20 DEG C.The material that have adjusted ph value is heated to 50 DEG C through 15 minutes, at 50 DEG C, maintains 300s,
Then it was cooled to 20 DEG C through 15 minutes, complete once to heat cooling circulation.
By having carried out, the material after once heating cooling circulation is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of this comparative example.
Comparative example 3
1g Ornidazole is mixed homogeneously with the ethanol of 4.5ml, the temperature of the material after mix homogeneously is 20 DEG C.To mix all
Material after even is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare the ornidazole injection of this comparative example.
Testing example 1
According to the method for the regulation in document (Pharmacopoeia of the People's Republic of China two annex of version in 2010), to embodiment
The color of the ornidazole injection of 1-6 and comparative example 1-3, detected about material, bacterial endotoxin, aseptic and osmotic pressure,
Testing result all meets the regulation of the Pharmacopoeia of the People's Republic of China two annex of version in 2010.
According to the method for the regulation in document (Pharmacopoeia of the People's Republic of China two annex of version in 2010), to embodiment
High temperature (40 DEG C) storage stability of the ornidazole injection of 1-6 and comparative example 1-3, room temperature (20 DEG C) storage stability, low temperature
(4 DEG C) storage stability and ice temperature (- 10 DEG C) storage stability are measured.Concrete grammar includes: by embodiment 1-6 and contrast
The ornidazole injection of example 1-3, under 75 ± 5% humidity, stores 200 days at 40 DEG C, 20 DEG C, 4 DEG C and -10 DEG C,
Then carry out particulate matter inspection method (to enter with reference to the Pharmacopoeia of the People's Republic of China two annex annex ix r of version in 2010
Inspection OK), result is as shown in table 1.
Table 1
Visible according to the data of table 1, the ornidazole injection prepared by the method for the present invention can be in relatively low temperature strip
Keep good storage stability under (- 10 DEG C to 20 DEG C) under part, significantly reduce the generation of particulate matter.It is possible former
Because being, the cooling circulation of heating at least twice of the present invention can be effectively facilitated the formation of the solvate of Ornidazole, improves
The storage stability of ornidazole injection.
Embodiment 7
1g Ornidazole is mixed homogeneously with the propylene glycol of 1.5ml and the ethanol of 4.5ml, the temperature of the material after mix homogeneously
For 20 DEG C.Material after mix homogeneously was heated to 50 DEG C through 15 minutes, maintains 300s at 50 DEG C, then lowered the temperature through 15 minutes
To 20 DEG C, complete to heat cooling circulation for the first time.The material completing the circulation of heating cooling for the first time was heated to through 15 minutes
50 DEG C, maintain 300s at 50 DEG C, be then cooled to 20 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 8
1g Ornidazole is mixed homogeneously with the propylene glycol of 1ml and the ethanol of 4ml, the temperature of the material after mix homogeneously is 15
℃.Material after mix homogeneously was heated to 55 DEG C through 10 minutes, maintains 240s at 55 DEG C, be then cooled to 11 through 10 minutes
DEG C, complete to heat cooling circulation for the first time.The material completing the circulation of heating cooling for the first time was heated to 55 DEG C through 10 minutes,
Maintain 300s at 55 DEG C, be then cooled to 28 DEG C through 10 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 9
1g Ornidazole is mixed homogeneously with the propylene glycol of 2ml and the ethanol of 5ml, the temperature of the material after mix homogeneously is 25
℃.Material after mix homogeneously was heated to 45 DEG C through 20 minutes, maintains 600s at 45 DEG C, be then cooled to 28 through 20 minutes
DEG C, complete to heat cooling circulation for the first time.The material completing the circulation of heating cooling for the first time was heated to 45 DEG C through 20 minutes,
Maintain 600s at 45 DEG C, be then cooled to 13 DEG C through 20 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 10
1g Ornidazole is mixed homogeneously with the propylene glycol of 1.5ml and the ethanol of 3.5ml, the temperature of the material after mix homogeneously
For 20 DEG C.Material after mix homogeneously was heated to 60 DEG C through 15 minutes, maintains 360s at 60 DEG C, then lowered the temperature through 15 minutes
To 20 DEG C, complete to heat cooling circulation for the first time.The material completing the circulation of heating cooling for the first time was heated to through 15 minutes
60 DEG C, maintain 300s at 60 DEG C, be then cooled to 20 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 11
1g Ornidazole is mixed homogeneously with the propylene glycol of 2.5ml and the ethanol of 5.5ml, the temperature of the material after mix homogeneously
For 15 DEG C.Material after mix homogeneously was heated to 40 DEG C through 15 minutes, maintains 960s at 40 DEG C, then lowered the temperature through 15 minutes
To 11 DEG C, complete to heat cooling circulation for the first time.The material completing the circulation of heating cooling for the first time was heated to through 15 minutes
40 DEG C, maintain 900s at 40 DEG C, be then cooled to 28 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Embodiment 12
1g Ornidazole is mixed homogeneously with the propylene glycol of 1.5ml and the ethanol of 4.5ml, the temperature of the material after mix homogeneously
For 20 DEG C.Material after mix homogeneously was heated to 50 DEG C through 15 minutes, was then cooled to 20 DEG C through 15 minutes, complete for the first time
Heating cooling circulation.The material completing the circulation of heating cooling for the first time was heated to 50 DEG C through 15 minutes, then through 15 minutes
It is cooled to 20 DEG C, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of the present embodiment.
Comparative example 4
1g Ornidazole is mixed homogeneously with the propylene glycol of 1.5ml and the ethanol of 4.5ml, the temperature of the material after mix homogeneously
For 20 DEG C.Material after mix homogeneously was heated to 34 DEG C through 15 minutes, maintains 1200s at 34 DEG C, then dropped through 15 minutes
Temperature, to 20 DEG C, completes to heat cooling circulation for the first time.The material completing the circulation of heating cooling for the first time was heated through 15 minutes
To 35 DEG C, maintain 1200s at 35 DEG C, be then cooled to 20 DEG C through 15 minutes, complete second heating cooling circulation.
By having carried out, the material after the circulation of heating cooling twice is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of this comparative example.
Comparative example 5
1g Ornidazole is mixed homogeneously with the propylene glycol of 1.5ml and the ethanol of 4.5ml, the temperature of the material after mix homogeneously
For 20 DEG C.Material after mix homogeneously is heated to 60 DEG C, maintains 300s at 60 DEG C, be then cooled to 20 DEG C, complete once
Heating cooling circulation.
By having carried out, the material after once heating cooling circulation is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare
The ornidazole injection of this comparative example.
Comparative example 6
1g Ornidazole is mixed homogeneously with the propylene glycol of 1.5ml and the ethanol of 4.5ml, the temperature of the material after mix homogeneously
For 20 DEG C.Material after mix homogeneously is degerming with the membrane filtration in 0.22 μm of aperture, that is, prepare the nitre difficult to understand of this comparative example
Azoles injection.
Testing example 2
According to the method for the regulation in document (Pharmacopoeia of the People's Republic of China two annex of version in 2010), to embodiment
The color of the ornidazole injection of 7-12 and comparative example 4-6, detected about material, bacterial endotoxin, aseptic and osmotic pressure,
Testing result all meets the regulation of the Pharmacopoeia of the People's Republic of China two annex of version in 2010.
According to the method for the regulation in document (Pharmacopoeia of the People's Republic of China two annex of version in 2010), to embodiment
High temperature (40 DEG C) storage stability of the ornidazole injection of 6-11 and comparative example 4-6, room temperature (20 DEG C) storage stability, low temperature
(4 DEG C) storage stability and ice temperature (- 10 DEG C) storage stability are measured.Concrete grammar includes: by embodiment 7-12 and right
The ornidazole injection of ratio 4-6, under 75 ± 5% humidity, stores 200 at 40 DEG C, 20 DEG C, 4 DEG C and -10 DEG C
My god, then carry out particulate matter inspection method (with reference to the Pharmacopoeia of the People's Republic of China two annex annex ix r of version in 2010
Carry out) inspection, result is as shown in table 2.
Table 2
Visible according to the data of table 2, the ornidazole injection prepared by the method for the present invention can be in relatively low temperature strip
Keep good storage stability under (- 10 DEG C to 20 DEG C) under part, significantly reduce the generation of particulate matter.It is possible former
Because being, the cooling circulation of heating at least twice of the present invention can be effectively facilitated the formation of the solvate of Ornidazole, improves
The storage stability of ornidazole injection.
The preferred embodiment of the present invention described in detail above, but, the present invention is not limited in above-mentioned embodiment
Detail, in the range of the technology design of the present invention, multiple simple variant can be carried out to technical scheme, this
A little simple variant belong to protection scope of the present invention.
It is further to note that each particular technique feature described in above-mentioned specific embodiment, in not lance
In the case of shield, can be combined by any suitable means, in order to avoid unnecessary repetition, the present invention to various can
The compound mode of energy no longer separately illustrates.
Additionally, combination in any can also be carried out between the various different embodiment of the present invention, as long as it is without prejudice to this
The thought of invention, it equally should be considered as content disclosed in this invention.
Claims (10)
1. a kind of preparation method of ornidazole injection it is characterised in that: this preparation method includes:
(1) by Ornidazole and organic solvent mix homogeneously；Wherein, described organic solvent is ethanol, or described organic solvent is
Ethanol and the mixture of propylene glycol；
(2) material after mix homogeneously is heated at least twice cooling circulation；Wherein, described heating cooling circulation includes:
First the temperature from 10-30 DEG C is heated to 40-60 DEG C of temperature, and then the temperature from 40-60 DEG C is cooled to 10-30 DEG C of temperature.
2. preparation method according to claim 1 it is characterised in that: described organic solvent be ethanol, with respect to Austria of 1g
Nitre azoles, the usage amount of ethanol is 3.5-5.5ml.
3. preparation method according to claim 2 it is characterised in that: with respect to the Ornidazole of 1g, the usage amount of ethanol is
4-5ml.
4. preparation method according to claim 1 it is characterised in that: described organic solvent is the mixing of ethanol and propylene glycol
Thing, with respect to the Ornidazole of 1g, the usage amount of propylene glycol is 0.5-2.5ml, and the usage amount of ethanol is 3.5-5.5ml.
5. preparation method according to claim 4 it is characterised in that: with respect to the Ornidazole of 1g, the usage amount of propylene glycol
For 1-2ml, the usage amount of ethanol is 4-5ml.
6. the preparation method according to any one in claim 1-5 it is characterised in that: described heating cooling circulation in,
It is heated to 45-55 DEG C of temperature from 10-30 DEG C of temperature.
7. the preparation method according to any one in claim 1-5 it is characterised in that: described heating cooling circulation in,
300-1200s is kept at a temperature of 40-60 DEG C.
8. the preparation method according to any one in claim 1-5 it is characterised in that: once heating cooling circulation in,
Being heated to the time that the process of 40-60 DEG C of temperature experienced from 10-30 DEG C of temperature is 10-20 minute.
9. the preparation method according to any one in claim 1-5 it is characterised in that: once heating cooling circulation in,
Being cooled to the time that the process of 10-30 DEG C of temperature experienced from 40-60 DEG C of temperature is 10-20 minute.
10. a kind of ornidazole injection is it is characterised in that this ornidazole injection is the method according to claim 4 or 5
Prepare.
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| CN201410262380.6A CN104127373B (en) | 2014-06-12 | 2014-06-12 | Ornidazole injection liquid |
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| CN201410262380.6A CN104127373B (en) | 2014-06-12 | 2014-06-12 | Ornidazole injection liquid |
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| CN104127373B true CN104127373B (en) | 2017-01-25 |
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| CN106309359A (en) * | 2016-08-31 | 2017-01-11 | 北京京科泰来科技有限公司 | Omidazole injection |
| CN110538142A (en) * | 2018-05-29 | 2019-12-06 | 牛涛涛 | Anti-infective drug injection composition |
| CN112220747A (en) * | 2020-10-21 | 2021-01-15 | 山西普德药业有限公司 | Ornidazole injection convenient to store and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101697969A (en) * | 2009-11-03 | 2010-04-28 | 雷绍青 | Ornidazole medicinal composition and preparation method thereof |
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| CN104013571B (en) * | 2014-05-30 | 2017-11-24 | 江苏凌霄科技发展有限公司 | A kind of ornidazole injection and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101697969A (en) * | 2009-11-03 | 2010-04-28 | 雷绍青 | Ornidazole medicinal composition and preparation method thereof |
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