CN114353444A - Method for reducing impurity B in ornidazole injection - Google Patents
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- CN114353444A CN114353444A CN202210044172.3A CN202210044172A CN114353444A CN 114353444 A CN114353444 A CN 114353444A CN 202210044172 A CN202210044172 A CN 202210044172A CN 114353444 A CN114353444 A CN 114353444A
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Abstract
The invention discloses a method for reducing impurity B in ornidazole injection, which comprises the steps of placing the ornidazole injection after sterilization in an environment of 70-80 ℃ for more than or equal to 15 hours; the preferred scheme is that the ornidazole injection after sterilization is placed in an environment with the temperature of 70 ℃ and the storage time is 15-35 h; placing the ornidazole injection after sterilization in an environment of 80 ℃ for 15-20 h; placing the ornidazole injection after sterilization in an environment of 80 ℃ for 16-20 h; and (3) placing the sterilized ornidazole injection in an environment of 80 ℃ for 16 h. By adopting the method, the impurity B in the ornidazole injection can be reduced to the quality standard range after more than ten hours, even the impurity B cannot be detected, the preparation period of the ornidazole injection is greatly shortened, and the problem of long time consumption of the conventional method for reducing the impurity B in the ornidazole injection is solved; improves the production efficiency of the ornidazole injection.
Description
Technical Field
The invention relates to the technical field of ornidazole injection preparation, in particular to a method for reducing impurity B in ornidazole injection.
Background
Ornidazole (ornidazole) injection was the third generation nitroimidazole drug, originally developed by hoffer. m in the united states, was patented 5/25 in 1969, and was assigned to Hoffmann-LaRoche and Co, switzerland and first marketed in 1977.
In recent years, with the national implementation of the consistency evaluation work of the quality and the curative effect of the medicine, a plurality of domestic medicine enterprises develop the consistency evaluation work of the ornidazole injection. In the process aspect, a terminal sterilization process at 121 ℃ for 15min is selected. On a quality level, the impurity B (1- (2, 3-epoxypropyl) -2-methyl-5-nitroimidazole) can be obviously increased after the product is sterilized to be not in accordance with the limit regulation of the quality standard. After the medicine is stored for more than 3 months at normal temperature, the content of the impurity B can be reduced to be below the limit, and the final product meets the quality standard requirement.
The existing method for reducing the impurity B in the ornidazole injection needs longer time, and the production period is seriously prolonged, so that a new method capable of quickly reducing the impurity B in the ornidazole injection is needed to be designed, the preparation period is shortened, and the production efficiency is improved.
Disclosure of Invention
The invention aims to provide a method for reducing impurity B in ornidazole injection, and aims to solve the problem of long time consumption of the conventional method for reducing impurity B in ornidazole injection.
The invention is realized by the following technical scheme:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 70-80 deg.C for 15 hr or longer.
The existing method for reducing the impurity B in the ornidazole injection is to store the ornidazole injection after sterilization treatment for more than 3 months at normal temperature, and then the content of the impurity B can be reduced to be below the limit, so that the production period is prolonged, the consumed time is long, and the production efficiency is reduced.
The applicant determined that temperature is a key factor affecting the length of time it is stored by analyzing the storage conditions of the sterilized product. According to the design scheme, the samples are stored under different temperature and time conditions and then are inspected, and the result proves that the impurity B and the content of the sample reach the qualified requirement (the peak area of the impurity B is not more than 0.08 times of the main peak area of a control solution, or no peak exists, namely the impurity B is not contained) after the sample is stored in the environment of 70-80 ℃ for 15 hours, and the sample completely meets the quality standard specification.
By adopting the method, the impurity B in the ornidazole injection can be reduced to the quality standard range after more than ten hours, even the impurity B cannot be detected, the preparation period of the ornidazole injection is greatly shortened, and the problem of long time consumption of the conventional method for reducing the impurity B in the ornidazole injection is solved; improves the production efficiency of the ornidazole injection.
Further, placing the sterilized ornidazole injection in an environment of 70-80 ℃ for 15-35 h.
The applicant stores the samples under different temperature and time conditions for investigation, and the results prove that the samples are stored at 70 ℃, the storage time is 10h and 20h, the storage time is 30h and 35h, and the storage time is qualified; the sample is stored at 80 ℃ for 5h and 10h, which are not qualified; the storage time is 15h, 16h and 20 h.
Further, the ornidazole injection after sterilization is placed in an environment with the temperature of 70 ℃ for 15-35 h.
Further, the ornidazole injection after sterilization is placed in an environment with the temperature of 80 ℃ for 15-20 h.
Further, the ornidazole injection after sterilization is placed in an environment with the temperature of 80 ℃ for 16-20 h.
Further, the ornidazole injection after sterilization is placed in an environment with the temperature of 80 ℃ for 16 hours.
The applicant stores the sample under different temperature and time conditions for investigation, and the result proves that the sample is stored at 80 ℃, the impurity B can not be completely detected in the sample after being stored for 16h, wherein the impurity B can not be completely detected even if the storage time is 16h under the environment of 80 ℃, and the storage time is set to 16h under the environment of 80 ℃, so that the optimal configuration of time control and temperature setting is realized.
Further, placing the ornidazole injection after sterilization in a bottle airing chamber, and starting timing when the temperature reaches a set temperature; the bottle airing room has the functions of automatic heating, constant temperature control and automatic heating stop.
The method for reducing the impurity B in the ornidazole injection can utilize the temperature control hot air circulation function of the existing air drying bottle, set the heating temperature to 80 ℃ on the basis of simply drying the outer wall of the ampoule originally, start timing when the temperature of the air return inlet reaches 80 ℃, automatically control the heating time, and automatically stop heating after 16 hours.
Compared with the prior art, the invention has the following advantages and beneficial effects:
1. the method greatly shortens the preparation period of the ornidazole injection and solves the problem of long time consumption of the method for reducing the impurity B in the conventional ornidazole injection; improves the production efficiency of the ornidazole injection.
2. The method is simple and easy to implement, and can utilize the existing bottle airing room without additionally increasing equipment, so that additional production cost cannot be caused.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to examples, and the exemplary embodiments and descriptions thereof are only used for explaining the present invention and are not used as limitations of the present invention.
Example 1:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 70 deg.C, and storing for 30 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 70 ℃, starting timing when the temperature of an air return inlet reaches 70 ℃, automatically controlling the heating time, and automatically stopping heating after 30 hours.
After the ornidazole injection is cooled to room temperature after heating is stopped, detecting impurity B in the ornidazole injection, wherein the detection method comprises the following steps: according to the determination of high performance liquid chromatography of 2020 edition of Chinese pharmacopoeia, octadecylsilane chemically bonded silica is used as a filling agent; the detection result is as follows:
the chromatographic peak of the impurity B is not detected, and the quality standard is met.
Example 2:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 70 deg.C, and storing for 35 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 70 ℃, starting timing when the temperature of an air return inlet reaches 70 ℃, automatically controlling the heating time, and automatically stopping heating after 35 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as the example 1, and the detection result is as follows:
peak free of impurity B.
Example 3:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 80 deg.C, and storing for 15 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 80 ℃, starting timing when the temperature of an air return inlet reaches 80 ℃, automatically controlling the heating time, and automatically stopping heating after 15 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as the example 1, and the detection result is as follows:
the peak area of the impurity B is 0.02 times of the main peak area of the control solution, and the quality standard specification is met.
Example 4:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 80 deg.C, and storing for 16 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 80 ℃, starting timing when the temperature of an air return inlet reaches 80 ℃, automatically controlling the heating time, and automatically stopping heating after 16 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as the example 1, and the detection result is as follows:
peak free of impurity B.
Example 5:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 80 deg.C, and storing for 20 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 80 ℃, starting timing when the temperature of an air return inlet reaches 80 ℃, automatically controlling the heating time, and automatically stopping heating after 20 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as the example 1, and the detection result is as follows:
peak free of impurity B.
Comparative example 1:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 30 deg.C, and storing for 60 days.
The specific operation process is as follows:
and (3) placing the sterilized ornidazole injection in a constant-temperature incubator, setting the temperature to 30 ℃, starting timing when the temperature reaches 30 ℃, and sampling for detection after 60 days.
After sampling, detecting impurity B in the ornidazole injection by the same detection method as that of example 1, wherein the detection result is as follows:
the peak area of impurity B was 0.04 times the main peak area of the control solution.
Comparative example 2:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 30 deg.C, and storing for 50 days.
The specific operation process is as follows:
and (3) placing the sterilized ornidazole injection in a constant-temperature incubator, setting the temperature to 30 ℃, starting timing when the temperature reaches 30 ℃, and sampling for detection after 50 days.
After sampling, detecting impurity B in the ornidazole injection by the same detection method as that of example 1, wherein the detection result is as follows:
the peak area of the impurity B is 0.1 time of the main peak area of the control solution and exceeds the specification of the upper limit of the quality standard.
Comparative example 3:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 50 deg.C, and storing for 30 days.
The specific operation process is as follows:
and (3) placing the sterilized ornidazole injection in a constant-temperature incubator, setting the temperature to 50 ℃, starting timing when the temperature reaches 50 ℃, and sampling for detection after 30 days.
After sampling, detecting impurity B in the ornidazole injection by the same detection method as that of the embodiment 1, wherein the detection result is as follows:
the peak area of the impurity B is 0.02 times of the main peak area of the control solution, and the quality standard specification is met.
Comparative example 4:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 50 deg.C, and storing for 25 days.
The specific operation process is as follows:
and (3) placing the sterilized ornidazole injection in a constant-temperature incubator, setting the temperature to 50 ℃, starting timing when the temperature reaches 50 ℃, and sampling for detection after 25 days.
After sampling, detecting impurity B in the ornidazole injection by the same detection method as that of the embodiment 1, wherein the detection result is as follows:
the peak area of the impurity B is 0.1 time of the main peak area of the control solution and exceeds the specification of the upper limit of the quality standard.
Comparative example 5:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 70 deg.C, and storing for 10 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 70 ℃, starting timing when the temperature of an air return inlet reaches 70 ℃, automatically controlling the heating time, and automatically stopping heating after 10 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.13 times of the main peak area of the control solution and exceeds the specification of the upper limit of the quality standard.
Comparative example 6:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 70 deg.C, and storing for 20 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 70 ℃, starting timing when the temperature of an air return inlet reaches 70 ℃, automatically controlling the heating time, and automatically stopping heating after 20 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.1 time of the main peak area of the control solution and exceeds the upper limit of the quality standard.
Comparative example 7:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 80 deg.C, and storing for 5 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 80 ℃, starting timing when the temperature of an air return inlet reaches 80 ℃, automatically controlling the heating time, and automatically stopping heating after 5 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.14 times of the main peak area of the control solution and exceeds the upper limit of the quality standard.
Comparative example 8:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 80 deg.C, and storing for 10 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 80 ℃, starting timing when the temperature of an air return inlet reaches 80 ℃, automatically controlling the heating time, and automatically stopping heating after 10 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.1 time of the main peak area of the solution and exceeds the upper limit of the quality standard.
Comparative example 9:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 85 deg.C, and storing for 10 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 85 ℃, starting timing when the temperature of an air return inlet reaches 85 ℃, automatically controlling the heating time, and automatically stopping heating after 10 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.14 times of the main peak area of the control solution and exceeds the upper limit of the quality standard.
Comparative example 10:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 85 deg.C, and storing for 5 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 85 ℃, starting timing when the temperature of an air return inlet reaches 85 ℃, automatically controlling the heating time, and automatically stopping heating after 5 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.13 times of the main peak area of the control solution and exceeds the upper limit of the quality standard.
Comparative example 11:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 85 deg.C, and storing for 3 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 85 ℃, starting timing when the temperature of an air return inlet reaches 85 ℃, automatically controlling the heating time, and automatically stopping heating after 3 hours.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.12 times of the main peak area of the control solution and exceeds the upper limit of the quality standard.
Comparative example 12:
a method for reducing impurity B in ornidazole injection comprises placing sterilized ornidazole injection at 85 deg.C, and storing for 1 hr.
The specific operation process is as follows:
placing the ornidazole injection after sterilization in a drying bottle, setting the heating temperature to 85 ℃, starting timing when the temperature of an air return inlet reaches 85 ℃, automatically controlling the heating time, and automatically stopping heating after 1 hour.
After the heating is stopped and the cooling is carried out to the room temperature, detecting the impurity B in the ornidazole injection, wherein the detection method is the same as that of the embodiment 1, and the detection result is as follows:
the peak area of the impurity B is 0.1 time of the main peak area of the control solution and exceeds the upper limit of the quality standard.
The above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (8)
1. A method for reducing impurity B in ornidazole injection is characterized in that the ornidazole injection after sterilization is placed in an environment with the temperature of 70-80 ℃ and the storage time is more than or equal to 15 hours.
2. The method for reducing impurity B in the ornidazole injection as claimed in claim 1, wherein the ornidazole injection after sterilization is placed in an environment of 70-80 ℃ for 15-35 h.
3. The method for reducing impurity B in the ornidazole injection as claimed in claim 2, characterized in that the ornidazole injection after sterilization is placed in an environment of 70 ℃ for 15-35 h.
4. The method for reducing impurity B in the ornidazole injection as claimed in claim 1, wherein the ornidazole injection after sterilization is placed in an environment of 80 ℃ for 15-20 h.
5. The method for reducing impurity B in the ornidazole injection as claimed in claim 4, characterized in that the ornidazole injection after sterilization is placed in an environment of 80 ℃ for 16-20 h.
6. The method for reducing impurity B in the ornidazole injection as claimed in claim 5, wherein the ornidazole injection after sterilization is placed in an environment of 80 ℃ for 16 h.
7. The method for reducing impurity B in the ornidazole injection as claimed in any one of claims 1-6, wherein the ornidazole injection after sterilization is placed in a airing bottle, and when the temperature reaches the set temperature, timing is started.
8. The method for reducing impurity B in ornidazole injection as claimed in claim 7, wherein the bottle drying chamber has the functions of automatic heating, constant temperature control and automatic stop.
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