CN104013571A - Ornidazole injection and preparing method thereof - Google Patents
Ornidazole injection and preparing method thereof Download PDFInfo
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- CN104013571A CN104013571A CN201410241439.3A CN201410241439A CN104013571A CN 104013571 A CN104013571 A CN 104013571A CN 201410241439 A CN201410241439 A CN 201410241439A CN 104013571 A CN104013571 A CN 104013571A
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Abstract
The invention discloses an ornidazole injection and a preparing method thereof. The metric injection volume of the ornidazole injection is 1-2 mL. The ornidazole concentration is 0.25-0.5 g/mL. The solvent of the injection is absolute ethyl alcohol or a mixture of absolute ethyl alcohol and glycerol. A finished product of the ornidazole injection is extremely low in impurity content, good in stability and extremely stable in guarantee period. Compared with originally developed ornidazole injections, the ornidazole injection provided by the invention is free of propylene glycol, and is better in clinical using safety, less in medical risk and simpler in preparation process.
Description
Technical field
The present invention relates to medicine manufacture technology field, particularly a kind of ornidazole injection and preparation method thereof.
Background technology
It is the medicine that anaerobe resistant and protozoacide infect for ornidazole (Omidazole), is nitro imidazole derivatives, without disulfiram-like action.Its anti-microbial effect is in oxygen-free environment, to be reduced into amino or by free radical and microbial cell interaction between component by the nitro in its molecule, thereby causes the death of microorganism.Be used for the treatment of the various diseases being caused by infection such as anaerobe, ameba, giardia lamblia, trichomonacides, there is the advantages such as curative effect is high, better tolerance, tissue permeability is good, the interior distribution of body is wide.Succedaneum for metronidazole, tinidazole.The anaerobe resistant that it is good and protozoa resisting (as infusorian etc.) infection effect makes clinical practice increasingly extensive.Ornidazole biological half-life is very long, has good clinical use value.Domestic approved ornidazole injection is produced and is used, but domestic ornidazole injection is after high temperature sterilize, and ornidazole content can occur and declines, and impurity increase is very large, and clinical side effects clearly.And former triturate Tiberal contains a large amount of propylene glycol so that ornidazole injection keeps stable, and the use safety range of propylene glycol is no more than 25mg/kg every day for dosage, in Tiberal, every approximately contains 1.4g propylene glycol, clinical use is first administration ornidazole 1g, 2, to the about 2.8g of propylene glycol, surpass human-body safety scope.There is potential safety hazard.
Summary of the invention
Goal of the invention: for overcoming deficiency of the prior art, the invention provides that a kind of technique is simple, good stability, clinical safe and reliable ornidazole injection and preparation method thereof.
Technical scheme: the present invention is achieved through the following technical solutions:
An ornidazole injection, per unit parenteral solution of preparation volume is 1～2ml, ornidazole concentration is 0.25g/ml～0.5g/ml.
Wherein, the solvent of described ornidazole injection is dehydrated alcohol.
Preferably, the solvent of described ornidazole injection is the mixed liquor of dehydrated alcohol and glycerol, wherein, and dehydrated alcohol: the volume ratio of glycerol is 5: 1～1: 1.
The preparation method that the invention allows for above-mentioned ornidazole injection, comprises the steps:
(1) device processes: high-temperature heat treatment Agitation Tank, pipeline and apparatus, with sterilizing, depyrogenation and moisture, guarantee the anhydrous state of medicinal liquid;
(2) medicinal liquid preparation: first, to the solvent that injects 10～80% formula ratios in Agitation Tank, under agitation the ornidazole of formula ratio is added in Agitation Tank, then adds the solvent that remain formula ratio, sealing, dissolving obtains medicinal liquid;
(3) carbon absorption: add active carbon to carry out remove impurity, depyrogenation in the medicinal liquid obtaining to step (2), stirring and adsorbing, with filtering with microporous membrane, obtains head product;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters, content, the medicinal liquid that obtains being up to the standards; Wherein examination criteria carries out the standard of ornidazole in version the second enlarged edition with reference to < < Pharmacopoeia of People's Republic of China > > for 2010.
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection and subpackage that step (4) is up to the standards.Embedding process, according to the concentration of the ornidazole of the injection of preparation, is selected the volume of per unit parenteral solution of preparation, and scope 1～2ml, so that the content of single medication ornidazole is 1g left and right.
Wherein, in step (1), described high-temperature heat treatment is carried out at 150～250 ℃.The high hot compressed air that to be in particular temperature be 150～250 ℃ passes into Agitation Tank and pipeline after filtering, carries out sterilizing, depyrogenation and except moisture.Meanwhile, all apparatus all pack the high heat sterilization of sterilizing cabinet into.
In step (2), the temperature of heating is 45～55 ℃.
In step (3), the amount of the active carbon adding is: in the injection of every milliliter, add 0005～0.002g.
In step (3), the condition of stirring and adsorbing is: stir speed (S.S.) is 50～100 revs/min, and mixing time is 25～35 minutes.
In step (3), the particle diameter of described microporous filter membrane is 0.1～0.5 μ m.
Beneficial effect: compared with prior art, no matter ornidazole injection of the present invention does not all contain water in the process of preparation or in the raw material of product, and adopts the mixture of pure dehydrated alcohol or dehydrated alcohol and glycerol as solvent, and the finished product impurity of the ornidazole injection of preparation is extremely low thus, have good stability, quality is better than the former product that grinds, and extremely stable, effect duration is long, and not containing propylene glycol, clinical use is safer, and preparation method is simple simultaneously, is suitable for commercial production.
The specific embodiment
Embodiment 1
An ornidazole injection, wherein, ornidazole content is 5000g, and surplus solubilizer makes the about 10000ml of total liquor capacity, and solvent is dehydrated alcohol.
Its preparation method adopts following steps:
(1) device processes: the high hot compressed air of 180 ℃ is passed into Agitation Tank and pipeline after filtering, carry out sterilizing, depyrogenation, dewater, apparatus packs sterilizing cabinet into and carries out high heat sterilization;
(2) preparating liquid: first inject approximately 20% solvent (about 2000ml) in Agitation Tank, under stirring, 5000g ornidazole is added in Agitation Tank, add the solvent of surplus, sealing, is suitably heated to 45～55 ℃ and dissolves to obtain the about 10000ml of medicinal liquid;
(3) carbon absorption: add 20g active carbon in medicinal liquid, 60 revs/min of stirring and adsorbing 30 minutes, with 0.22 micron of filtering with microporous membrane, obtain head product;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters, content, the medicinal liquid that obtains being up to the standards;
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection and packing that step (4) is up to the standards.Embedding process, according to the concentration of the ornidazole of the injection of preparation, is selected the volume of per unit parenteral solution of preparation, and scope 1～2ml, so that the content of single medication ornidazole is 1g left and right.
Examination criteria carries out (following embodiment is identical) to the standard of ornidazole in version the second enlarged edition in 2010 with reference to < < Pharmacopoeia of People's Republic of China > >, and testing result is as shown in table 1:
Table 1
Note: above-mentioned " should be up to specification " refers to the regulation to index of correlation in < < Pharmacopoeia of People's Republic of China > > version the second enlarged edition in 2010, and " should be up to specification " be hereinafter described also like this.
Embodiment 2
An ornidazole injection, containing ornidazole 5000g, surplus solubilizer makes the about 15000ml of total liquor capacity, and solvent is dehydrated alcohol.
The preparation method of above-mentioned ornidazole injection adopts following steps:
(1) device processes: 200 ℃ of high hot compressed airs are passed into Agitation Tank and pipeline after filtering, carry out sterilizing, depyrogenation, remove moisture, apparatus packs the high heat sterilization of sterilizing cabinet into.
(2) preparating liquid: first inject 40% solvent (about 6000ml) in Agitation Tank, under stirring, ornidazole is added in Agitation Tank, add the solvent of surplus, sealing is suitably heated to 45～55 ℃ and dissolves to obtain the about 15000ml of medicinal liquid;
(3) carbon absorption: add 15g active carbon in medicinal liquid, 60 revs/min of stirring and adsorbing 30 minutes, with 0.22 micron of filtering with microporous membrane;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters, content, the medicinal liquid that obtains being up to the standards;
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection, packing that step (4) is up to the standards.
Embedding process, according to the concentration of the ornidazole of the injection of preparation, is selected the volume of per unit parenteral solution of preparation, and scope 1～2ml, so that the content of single medication ornidazole is 1g left and right.
Testing result is as shown in table 2:
Table 2
Embodiment 3
An ornidazole injection, containing ornidazole 5000g, surplus solubilizer makes the about 18000ml of total liquor capacity, and solvent is dehydrated alcohol.
The preparation method of above-mentioned ornidazole injection, adopts following steps:
(1) device processes: the high hot compressed air of 250 ℃ is passed into Agitation Tank and pipeline after filtering, carry out sterilizing, depyrogenation, remove moisture, apparatus packs the high heat sterilization of sterilizing cabinet into.
(2) preparating liquid: first inject 70% (12600ml) about solvent in Agitation Tank, under stirring, ornidazole is added in Agitation Tank, add the solvent of surplus, sealing is suitably heated 45～55 ℃ and dissolved to obtain the about 18000ml of medicinal liquid;
(3) carbon absorption: add 20g active carbon in medicinal liquid, 80 revs/min of stirring and adsorbing 30 minutes, with 0.22 micron of filtering with microporous membrane;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters, content, the medicinal liquid that obtains being up to the standards;
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection, packing that step (4) is up to the standards.
Embedding process, according to the concentration of the ornidazole of the injection of preparation, is selected the volume of per unit parenteral solution of preparation, and scope 1～2ml, so that the content of single medication ornidazole is 1g left and right.
Testing result is as shown in table 3:
Table 3
Embodiment 4
An ornidazole injection, containing ornidazole 5000g, surplus solubilizer makes total liquor capacity to 10000ml, and solvent is dehydrated alcohol: glycerol=5: the mixed solvent of 1 (volume ratio).
The preparation method of this ornidazole injection adopts following steps:
(1) device processes: the high hot compressed air of 250 ℃ is passed into Agitation Tank and pipeline after filtering, carry out sterilizing, depyrogenation, remove moisture, apparatus packs the high heat sterilization of sterilizing cabinet into.
(2) preparating liquid: first inject 60% (about 6000ml) solvent in Agitation Tank, under stirring, ornidazole is added in Agitation Tank, add the solvent of surplus, sealing suitably 45～55 ℃ of heating for dissolving of heating obtains medicinal liquid 10000ml;
(3) carbon absorption: add 20g active carbon in medicinal liquid, 100 revs/min of stirring and adsorbing 30 minutes, with 0.22 micron of filtering with microporous membrane;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters, content, the medicinal liquid that obtains being up to the standards;
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection, packing that step (4) is up to the standards.
Embedding process, according to the concentration of the ornidazole of the injection of preparation, is selected the volume of per unit parenteral solution of preparation, and scope 1～2ml, so that the content of single medication ornidazole is 1g left and right.
Testing result is as shown in table 4:
Table 4
Embodiment 5
An ornidazole injection, containing ornidazole 5000g, surplus solubilizer makes total liquor capacity to 19999ml, and solvent is dehydrated alcohol: glycerol=1: the mixed solvent of 1 (volume ratio).
The preparation method of this ornidazole injection, adopts following steps:
(1) device processes: the high hot compressed air of 200 ℃ is passed into Agitation Tank and pipeline after filtering, carry out sterilizing, depyrogenation, remove moisture, apparatus packs the high heat sterilization of sterilizing cabinet into.
(2) preparating liquid: first inject 50% (about 10000ml) solvent in Agitation Tank, under stirring, ornidazole is added in Agitation Tank, add the solvent of surplus, sealing suitably 45～55 ℃ of heating for dissolving of heating obtains medicinal liquid 19999ml;
(3) carbon absorption: add 20g active carbon in medicinal liquid, 90 revs/min of stirring and adsorbing 30 minutes, with 0.22 micron of filtering with microporous membrane;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters, content, the medicinal liquid that obtains being up to the standards;
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection, packing that step (4) is up to the standards.
Embedding process, according to the concentration of the ornidazole of the injection of preparation, is selected the volume of per unit parenteral solution of preparation, and scope 1～2ml, so that the content of single medication ornidazole is 1g left and right.
Testing result is as shown in table 5:
Table 5
Embodiment 6 stability tests.
The sample of embodiment 1～embodiment 5 is carried out to accelerated test, with reference to < < Pharmacopoeia of People's Republic of China > > 2010 editions, carry out.Each sample is put under 40 ± 2 ℃, the condition of humidity 75 ± 5% and carried out study on the stability 6 months, sampling at the end of month respectively at June after 3 months and sterilizing behind 1 month, sterilizing before sterilizing, after sterilizing and after sterilizing, and contrast with the ornidazole injection (reference preparation) that Roche is produced, detection index is character, related substance, particulate matter, visible foreign matters and content, and result is as shown in table 6.
Table 6
From the above results, the present invention is by stop the use of water completely in preparing the process of ornidazole injection, and adopts the mixture of pure dehydrated alcohol or dehydrated alcohol and glycerol as solvent, and the finished product impurity of the ornidazole injection of preparation is extremely low thus, have good stability, quality is better than the former product that grinds of Roche Group, and quality is extremely stable, and effect duration is long, and owing to not containing propylene glycol, clinical use is safer, and preparation method is simple simultaneously, is suitable for commercial production.
Claims (9)
1. an ornidazole injection, is characterized in that, per unit parenteral solution of preparation volume is 1～2ml, and ornidazole concentration is 0.25g/ml～0.5g/ml.
2. ornidazole injection according to claim 1, is characterized in that, the solvent of described ornidazole injection is dehydrated alcohol.
3. ornidazole injection according to claim 1, is characterized in that, the solvent of described ornidazole injection is the mixed liquor of dehydrated alcohol and glycerol, wherein, and dehydrated alcohol: the volume ratio of glycerol is 5: 1～1: 1.
4. the preparation method of the ornidazole injection described in claims 1 to 3 any one, is characterized in that, comprises the steps:
(1) device processes: high-temperature heat treatment Agitation Tank, pipeline and apparatus, with sterilizing, depyrogenation and moisture, guarantee the anhydrous state of medicinal liquid;
(2) medicinal liquid preparation: first, to the solvent that injects 10～80% formula ratios in Agitation Tank, under agitation the ornidazole of formula ratio is added in Agitation Tank, then adds the solvent that remain formula ratio, seal, heating for dissolving obtains medicinal liquid;
(3) carbon absorption: add active carbon to carry out remove impurity, depyrogenation in the medicinal liquid obtaining to step (2), stirring and adsorbing, with filtering with microporous membrane, obtains head product;
(4) head product check: the head product that testing sequence (3) obtains, inspection item comprise clarity, particulate matter, visible foreign matters and content, the medicinal liquid that obtains being up to the standards;
(5) embedding, packing: medicinal liquid embedding, sterilizing, leak detection, lamp inspection and packing that step (4) is up to the standards.
5. the preparation method of ornidazole injection according to claim 4, is characterized in that, in step (1), described high-temperature heat treatment is carried out at 150～250 ℃.
6. the preparation method of ornidazole injection according to claim 4, is characterized in that, in step (2), the temperature of heating is 45～55 ℃.
7. the preparation method of ornidazole injection according to claim 4, is characterized in that, in step (3), the amount of the active carbon adding is: in the injection of every milliliter, add 0005～0.002g.
8. the preparation method of ornidazole injection according to claim 4, is characterized in that, in step (3), the condition of stirring and adsorbing is: stir speed (S.S.) is 50～100 revs/min, and mixing time is 25～35 minutes.
9. the preparation method of ornidazole injection according to claim 4, is characterized in that, in step (3), the particle diameter of described microporous filter membrane is 0.1～0.5 μ m.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104127373A (en) * | 2014-06-12 | 2014-11-05 | 北京京科泰来科技有限公司 | Ornidazole injection liquid |
| CN107496351A (en) * | 2017-08-17 | 2017-12-22 | 山东华铂凯盛生物科技有限公司 | A kind of ornidazole injection and preparation method thereof |
| CN110917135A (en) * | 2019-12-30 | 2020-03-27 | 西南大学 | Solvent system capable of effectively dissolving ornidazole or levoornidazole and injection thereof |
| CN111265474A (en) * | 2019-07-29 | 2020-06-12 | 南京海融医药科技股份有限公司 | Parthenocinolate injection and preparation method thereof |
| CN111888328A (en) * | 2020-08-21 | 2020-11-06 | 山东致泰医药技术有限公司 | Ornidazole injection with rapid and stable performance and preparation method thereof |
| CN112107539A (en) * | 2020-10-30 | 2020-12-22 | 康普药业股份有限公司 | Ornidazole injection and preparation method thereof |
| CN112569228A (en) * | 2019-09-29 | 2021-03-30 | 扬子江药业集团南京海陵药业有限公司 | Pharmaceutical composition containing ornidazole compounds and preparation method and application thereof |
| CN112569230A (en) * | 2019-09-29 | 2021-03-30 | 扬子江药业集团南京海陵药业有限公司 | Ornidazole pharmaceutical composition with high safety as well as preparation method and application thereof |
| CN113797165A (en) * | 2021-09-30 | 2021-12-17 | 南京瑞捷医药科技有限公司 | Ornidazole injection |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104127373A (en) * | 2014-06-12 | 2014-11-05 | 北京京科泰来科技有限公司 | Ornidazole injection liquid |
| CN107496351A (en) * | 2017-08-17 | 2017-12-22 | 山东华铂凯盛生物科技有限公司 | A kind of ornidazole injection and preparation method thereof |
| CN111265474A (en) * | 2019-07-29 | 2020-06-12 | 南京海融医药科技股份有限公司 | Parthenocinolate injection and preparation method thereof |
| CN111265474B (en) * | 2019-07-29 | 2021-11-09 | 南京海融医药科技股份有限公司 | Parthenocinolate injection and preparation method thereof |
| CN112569228A (en) * | 2019-09-29 | 2021-03-30 | 扬子江药业集团南京海陵药业有限公司 | Pharmaceutical composition containing ornidazole compounds and preparation method and application thereof |
| CN112569230A (en) * | 2019-09-29 | 2021-03-30 | 扬子江药业集团南京海陵药业有限公司 | Ornidazole pharmaceutical composition with high safety as well as preparation method and application thereof |
| CN110917135A (en) * | 2019-12-30 | 2020-03-27 | 西南大学 | Solvent system capable of effectively dissolving ornidazole or levoornidazole and injection thereof |
| CN110917135B (en) * | 2019-12-30 | 2022-01-18 | 西南大学 | Solvent system capable of effectively dissolving ornidazole or levoornidazole and injection thereof |
| CN111888328A (en) * | 2020-08-21 | 2020-11-06 | 山东致泰医药技术有限公司 | Ornidazole injection with rapid and stable performance and preparation method thereof |
| CN111888328B (en) * | 2020-08-21 | 2022-12-30 | 山东致泰医药技术有限公司 | Ornidazole injection with rapid and stable performance and preparation method thereof |
| CN112107539A (en) * | 2020-10-30 | 2020-12-22 | 康普药业股份有限公司 | Ornidazole injection and preparation method thereof |
| CN113797165A (en) * | 2021-09-30 | 2021-12-17 | 南京瑞捷医药科技有限公司 | Ornidazole injection |
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