CN103284945A - Preparation method of pre-filled dexmedetomidine hydrochloride injection - Google Patents
Preparation method of pre-filled dexmedetomidine hydrochloride injection Download PDFInfo
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- CN103284945A CN103284945A CN2013102159380A CN201310215938A CN103284945A CN 103284945 A CN103284945 A CN 103284945A CN 2013102159380 A CN2013102159380 A CN 2013102159380A CN 201310215938 A CN201310215938 A CN 201310215938A CN 103284945 A CN103284945 A CN 103284945A
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Abstract
The invention discloses a preparation method of a pre-filled dexmedetomidine hydrochloride injection. The preparation method of the pre-filled dexmedetomidine hydrochloride injection comprises the following steps of: A, preparing 80% of prescribed dose of water for injection, adding the prescribed dose of dexmedetomidine hydrochloride, stirring to dissolve for 5-8 minutes, then adding the water for injection to full dose, carrying out convection, and stirring and dissolving for 8-10 minutes; B, filtering a solution obtained by step A by virtue of a filter, and detecting an intermediate; and C, carrying out nitrogen filling, prefilling, encapsulation and sterilization on a solution obtained by step B, thus the pre-filled dexmedetomidine hydrochloride injection is obtained. The preparation method of the pre-filled hydrochloric acid dexmedetomidine injection has the advantages that concept is skilful, operation is simple, the problem that the dexmedetomidine hydrochloride injection is polluted in clinical application and inconvenient to use can be effectively solved, and rapidity and safety of an operation process can be guaranteed.
Description
Technical field
The invention belongs to technical field of pharmaceutical chemistry, relate to a kind of preparation method of pre-filled dexmedetomidine hydrochloride injection.
Background technology
Dexmedetomidine hydrochloride, chemical name (+)-4-(S)-[1-(2,3-3,5-dimethylphenyl) ethyl]-the 1H-imidazole hydrochloride, be a kind of α 2-adrenoceptor agonists, have sedation.
The dexmedetomidine hydrochloride injection is the sterile water solution of dexmedetomidine hydrochloride.This product is colourless or almost colourless clear liquid, is applicable to beginning intubate during the Intensive Care Therapy treatment and uses respirator patient's calmness, is applicable to before operation and other operation or ongoing non-tracheal intubation patient's calmness.
At present, the dexmedetomidine hydrochloride injection all adopts the mode of interim preparation before using in clinical use, increased the use link, has the possibility of polluting, and in the part operation, has increased the operating time, fails to embody the characteristics of clinical quick and safe.
Summary of the invention
The objective of the invention is at the deficiencies in the prior art, a kind of preparation method of pre-filled dexmedetomidine hydrochloride injection is provided.This preparation method is skillfully constructed, and is simple to operate, can effectively solve the dexmedetomidine hydrochloride injection and have pollution, awkward problem in clinical use, guarantees quick, safety in the operation process.
For achieving the above object, the technical solution adopted for the present invention to solve the technical problems is:
A kind of preparation method of pre-filled dexmedetomidine hydrochloride injection may further comprise the steps:
A, get the water for injection of recipe quantity 80%, add the dexmedetomidine hydrochloride of recipe quantity, stirring and dissolving 5-8 minute, add to the full amount of water for injection convection current, stirring and dissolving 8-10 minute again;
B, the solution of getting steps A filter through filter, detect intermediate;
C, get step B solution through filling the embedding of nitrogen pre-filled, sterilization, namely get pre-filled dexmedetomidine hydrochloride injection.
As optimal way, in the steps A, the temperature of described water for injection is 60-65 ℃.
As optimal way, among the step B, described filter is the 0.22um filter.
As optimal way, among the step C, described sterilization is pressure sterilizing 15-30min under the 117-121 ℃ of temperature.
The inventor is by a large amount of research, each processing step of the preparation method of dexmedetomidine hydrochloride injection and parameter are improved and optimized, through experiment many times, the discovery that we are surprised: when the processing step that adopts the present invention to put down in writing and parameter, this preparation method is done as a whole, obtained best technique effect, effectively the defective that exists in the prior art that solves is optimized each index of product.
Beneficial effect of the present invention is: the present invention is skillfully constructed, and is simple to operate, can effectively solve the dexmedetomidine hydrochloride injection and have pollution, awkward problem in clinical use, guarantees quick, safety in the operation process.
The specific embodiment
Disclosed all features in this description, or the step in disclosed all methods or the process except mutually exclusive feature and/or step, all can make up by any way.
Embodiment 1:
1, clean liquid mixing system before the dosing: equipment such as Agitation Tank, pipeline wash three times with water for injection before the preparation, and discharging is clean.
2, feed intake, prepare: the water for injection (65 ℃) of 1. getting full dose 80%.2. the dexmedetomidine hydrochloride that adds recipe quantity.3. stirring and dissolving is 5 minutes.4. add to the full amount of water for injection.5. convection current, stirring and dissolving 10 minutes.6. the 0.22um filter filters.7. detect intermediate.
3, intermediate detects: detect by the intermediate quality standard.
4, pre-filled container arrangement.
5, the dosing technology process is as follows: filter, fill nitrogen, fill, fill nitrogen, top plug seals
6, the leak detection of getting on the bus, sterilize
Sterilising temp is 121 ℃, and the time is 15 minutes.
7, Jian Lou vacuum must-more than the 80Kpa, the leak detection time is more than 10 minutes.
8, lamp inspection
Semi-finished product after the sterilization adopt daylight lamp, under black background, look with visual inspection.
Thought is concentrated during lamp inspection, every medicinal liquid up and down gently upset check, can foreign body, outward appearance and other inspection item should be up to specification.
9, packing inspection warehouse-in.
Embodiment 2:
1, clean liquid mixing system before the dosing: equipment such as Agitation Tank, pipeline wash three times with water for injection before the preparation, and discharging is clean.
2, feed intake, prepare: the water for injection (60 ℃) of 1. getting full dose 80%.2. the dexmedetomidine hydrochloride that adds recipe quantity.3. stirring and dissolving is 8 minutes.4. add to the full amount of water for injection.5. convection current, stirring and dissolving 8 minutes.6. the 0.22um filter filters.7. detect intermediate.
3, intermediate detects: detect by the intermediate quality standard.
4, pre-filled container arrangement.
5, the dosing technology process is as follows: filter, fill nitrogen, fill, fill nitrogen, top plug seals
6, the leak detection of getting on the bus, sterilize
Sterilising temp is 117 ℃, time 30min.
7, Jian Lou vacuum must-more than the 80Kpa, the leak detection time is more than 10 minutes.
8, lamp inspection
Semi-finished product after the sterilization adopt daylight lamp, under black background, look with visual inspection.
Thought is concentrated during lamp inspection, every medicinal liquid up and down gently upset check, can foreign body, outward appearance and other inspection item should be up to specification.
9, packing inspection warehouse-in.
Claims (4)
1. the preparation method of a pre-filled dexmedetomidine hydrochloride injection is characterized in that, may further comprise the steps:
A, get the water for injection of recipe quantity 80%, add the dexmedetomidine hydrochloride of recipe quantity, stirring and dissolving 5-8 minute, add to the full amount of water for injection convection current, stirring and dissolving 8-10 minute again;
B, the solution of getting steps A filter through filter, detect intermediate;
C, get step B solution through filling the embedding of nitrogen pre-filled, sterilization, namely get pre-filled dexmedetomidine hydrochloride injection.
2. the preparation method of a kind of pre-filled dexmedetomidine hydrochloride injection as claimed in claim 1, it is characterized in that: in the steps A, the temperature of described water for injection is 60-65 ℃.
3. the preparation method of a kind of pre-filled dexmedetomidine hydrochloride injection as claimed in claim 1, it is characterized in that: among the step B, described filter is the 0.22um filter.
4. the preparation method of a kind of pre-filled dexmedetomidine hydrochloride injection as claimed in claim 1, it is characterized in that: among the step C, described sterilization is pressure sterilizing 15-30min under the 117-121 ℃ of temperature.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013102159380A CN103284945A (en) | 2013-06-03 | 2013-06-03 | Preparation method of pre-filled dexmedetomidine hydrochloride injection |
Applications Claiming Priority (1)
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| CN2013102159380A CN103284945A (en) | 2013-06-03 | 2013-06-03 | Preparation method of pre-filled dexmedetomidine hydrochloride injection |
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| CN103284945A true CN103284945A (en) | 2013-09-11 |
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| CN2013102159380A Pending CN103284945A (en) | 2013-06-03 | 2013-06-03 | Preparation method of pre-filled dexmedetomidine hydrochloride injection |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168122A (en) * | 2015-09-24 | 2015-12-23 | 辰欣药业股份有限公司 | Dexmedetomidine hydrochloride injection and preparation process thereof |
| CN105534891A (en) * | 2016-01-18 | 2016-05-04 | 南京正科医药股份有限公司 | Dexmedetomidine hydrochloride injection |
| CN107028880A (en) * | 2017-06-09 | 2017-08-11 | 安徽赛诺制药有限公司 | A kind of production technology of dexmedetomidine hydrochloride parenteral solution |
| CN108578641A (en) * | 2018-06-29 | 2018-09-28 | 无锡济民可信山禾药业股份有限公司 | A kind of Prefilled preparation of clinical emergency treatment traditional Chinese medicine injection |
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11806429B2 (en) | 2018-06-27 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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| CN101780033A (en) * | 2009-12-21 | 2010-07-21 | 北京凯因科技股份有限公司 | Pre-filled recombinant human interferon injection |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101780033A (en) * | 2009-12-21 | 2010-07-21 | 北京凯因科技股份有限公司 | Pre-filled recombinant human interferon injection |
Non-Patent Citations (3)
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| 徐蓉蓉等: "右美托咪定药代动力学和药效动力学的研究进展", 《广东医学》, vol. 33, no. 8, 30 April 2012 (2012-04-30), pages 1037 - 1040 * |
| 舒成仁等: "盐酸右美托咪定注射液在健康人体的药动学", 《医药导报》, vol. 30, no. 12, 31 December 2011 (2011-12-31), pages 1555 - 1558 * |
| 蔡荣: "预灌装注射器简介", 《上海包装》, no. 2, 31 December 2006 (2006-12-31), pages 19 - 20 * |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168122A (en) * | 2015-09-24 | 2015-12-23 | 辰欣药业股份有限公司 | Dexmedetomidine hydrochloride injection and preparation process thereof |
| CN105168122B (en) * | 2015-09-24 | 2018-11-27 | 辰欣药业股份有限公司 | A kind of dexmedetomidine hydrochloride injection and its preparation process |
| CN105534891A (en) * | 2016-01-18 | 2016-05-04 | 南京正科医药股份有限公司 | Dexmedetomidine hydrochloride injection |
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11839604B2 (en) | 2016-12-31 | 2023-12-12 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11931340B2 (en) | 2016-12-31 | 2024-03-19 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| CN107028880A (en) * | 2017-06-09 | 2017-08-11 | 安徽赛诺制药有限公司 | A kind of production technology of dexmedetomidine hydrochloride parenteral solution |
| US11806429B2 (en) | 2018-06-27 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| CN108578641A (en) * | 2018-06-29 | 2018-09-28 | 无锡济民可信山禾药业股份有限公司 | A kind of Prefilled preparation of clinical emergency treatment traditional Chinese medicine injection |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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Application publication date: 20130911 |