CN105168122A - Dexmedetomidine hydrochloride injection and preparation process thereof - Google Patents
Dexmedetomidine hydrochloride injection and preparation process thereof Download PDFInfo
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- CN105168122A CN105168122A CN201510618411.1A CN201510618411A CN105168122A CN 105168122 A CN105168122 A CN 105168122A CN 201510618411 A CN201510618411 A CN 201510618411A CN 105168122 A CN105168122 A CN 105168122A
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- dexmedetomidine hydrochloride
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- hydrochloride injection
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Abstract
The invention belongs to the technical field of drug preparation, and particularly relates to dexmedetomidine hydrochloride injection and a preparation process thereof. The dexmedetomidine hydrochloride injection comprises main materials and water for injection. The main materials comprise an active component and auxiliary materials. The auxiliary materials comprise an osmotic pressure modifier and a metal ion complexing agent. Dexmedetomidine hydrochloride serves as the active component. Sodium chloride serves as the osmotic pressure modifier. Compared with the prior art, the dexmedetomidine hydrochloride injection has the advantages that pH, content and related substance results of all embodiments are still qualified after the dexmedetomidine hydrochloride injection is subjected to high temperature, illumination and acceleration for 6 months and 24 months, and it is proved that the whole product is stable in quality. In addition, the dexmedetomidine hydrochloride injection is simple in preparation process, low in cost and beneficial to industrial production.
Description
Technical field
The invention belongs to field of medicine preparing technology, specifically, relate to a kind of dexmedetomidine hydrochloride injection and preparation technology thereof.
Background technology
Dexmedetomidine hydrochloride is a kind of α of efficient, high selectivity
2-adrenoceptor agonists, is developed by OrionPharma company of Finland and Abott company of U.S. joint research and development the earliest, this medicine have by acting on two kinds of adrenoreceptors anti-sympathetic, analgesia and sedation, be 8 times of clonidine effect.FDA ratifies it for Intensive Care Therapy a middle or short term (<24 hour) sedation and analgesia medicine, early stage especially after surgery.It acts on two kinds of adrenoreceptors, by exciting presynaptic membrane α
2-receptor, inhibits the release of norepinephrine, and have ceased the conduction of pain signal; In addition, by exciting postsynaptic membrane receptor, dexmedetomidine inhibits sympathetic activity thus causes the decline of blood pressure and heart rate.These two kinds of effects integrate can produce calmness, alleviate anxiety, sympathetic suppression and analgesic acts on.
Dexmedetomidine hydrochloride is the active dextroisomer of medetomidine, in many animals experiment, has no obvious toxic and side effects.This medicine since external listing clinical practice in order, curative effect is good and side effect is little, has unique advantage compared with other downerns.Although at present it is evident in efficacy, sales volume is very large, domestic market vacancy, but occurs the problems such as visible foreign matters increases due to the impact of the easy light of medicine itself and metal ion.Therefore acceleration is caused 6 months when study on the stability and long-term 9 months sample visible foreign matters increase and fail to solve always.
Summary of the invention
For solving the problems of the technologies described above, the invention provides a kind of good stability, being convenient to long storage periods and the dexmedetomidine hydrochloride injection of Clinical practice safety and preparation technology thereof.
A kind of dexmedetomidine hydrochloride injection of the present invention, described dexmedetomidine hydrochloride injection comprises major ingredient and water for injection, and this major ingredient comprises active component and adjuvant; Described adjuvant comprises osmotic pressure regulator and complexing of metal ion agent; Described active component is dexmedetomidine hydrochloride, and described osmotic pressure regulator is sodium chloride.
A kind of dexmedetomidine hydrochloride injection of the present invention, the mass concentration of described dexmedetomidine hydrochloride in injection is 0.01-0.02%; The mass concentration of described sodium chloride in injection is respectively 0.8-1%; The mass concentration of described complexing of metal ion agent in injection is 0.001%-0.005%.
A kind of dexmedetomidine hydrochloride injection of the present invention, described complexing of metal ion agent is selected from one or more in sodium tartrate, disodium edetate, calcium disodium edetate.
A kind of dexmedetomidine hydrochloride injection of the present invention, described complexing of metal ion agent is calcium disodium edetate.
A kind of dexmedetomidine hydrochloride injection of the present invention, the mass concentration of described complexing of metal ion agent in injection is 0.004%.
The preparation method of a kind of dexmedetomidine hydrochloride injection of the present invention, described preparation method is specially: 1) first by major ingredient and solvent formation solution admixed together; 2) add decarburization after activated carbon adsorption, detect semi-finished product after filtration, qualified rear fill.
The preparation method of a kind of dexmedetomidine hydrochloride injection of the present invention, described preparation method is specially: the water for injection 1) getting recipe quantity 95%, cools the temperature to 60 DEG C-70 DEG C after boiling; 2) turn on agitator, adds recipe quantity sodium chloride, stirs and makes it dissolve in 5 minutes; Add dexmedetomidine hydrochloride, stir and within 10 minutes, make it dissolve completely and mix homogeneously; 3) be cooled to 30 DEG C-50 DEG C again, add the complexing of metal ion agent mixture of recipe quantity, stir and make it entirely molten, add the active carbon stirring and adsorbing 15 minutes of major ingredient amount 3% (w/w); 4) benefit adds to the full amount of water for injection, continue to stir lower circulation 15 minutes, after filtering with 0.5 μm of titanium rod and 0.22 μm of microfilter, detect medicinal liquid content and pH value in sample tap sampling, after fluid temperature remains on 30 DEG C-40 DEG C, stop stirring and closing temperature lowering water valve; 5) detect qualified after, through the embedding third level 0.22 μm of microfilter, fill, sealing, in 121 DEG C of sterilizings 15 minutes; 6) lamp inspection, packaging, obtain finished product.
Compared with prior art, dexmedetomidine hydrochloride injection of the present invention high-temperature, illumination and accelerating the ph of each embodiment after June and long-term 24 months, content, related substance result are still qualified, and the steady quality of whole product is described.In addition, the preparation technology of dexmedetomidine hydrochloride injection of the present invention is simple, cost is lower, be convenient to suitability for industrialized production.
Detailed description of the invention
Below in conjunction with specific embodiment, dexmedetomidine hydrochloride injection of the present invention and preparation technology thereof are described further, but protection scope of the present invention is not limited to this.
Embodiment 1
Raw material: dexmedetomidine hydrochloride (in dexmedetomidine) 0.2g, sodium chloride 18g, sodium tartrate 0.08g, inject water to 2000ml, makes 1000.
Preparation method: the water for injection 1) getting recipe quantity 95%, cools the temperature to 60 DEG C after boiling; 2) turn on agitator, adds recipe quantity sodium chloride, stirs and makes it dissolve in 5 minutes; Add dexmedetomidine hydrochloride, stir and within 10 minutes, make it dissolve completely and mix homogeneously; 3) be cooled to 30 DEG C again, add the sodium tartrate of recipe quantity, stir and make it entirely molten, add the active carbon stirring and adsorbing 15 minutes of major ingredient amount 3% (w/w); 4) benefit adds to the full amount of water for injection, continue to stir lower circulation 15 minutes, after filtering with 0.5 μm of titanium rod and 0.22 μm of microfilter, detect medicinal liquid content and pH value in sample tap sampling, after fluid temperature remains on 30 DEG C, stop stirring and closing temperature lowering water valve; 5) detect qualified after, through the embedding third level 0.22 μm of microfilter, fill, sealing, in 121 DEG C of sterilizings 15 minutes; 6) lamp inspection, packaging, obtain finished product.
Embodiment 2
Raw material: dexmedetomidine hydrochloride (in dexmedetomidine) 0.2g, sodium chloride 18g, calcium disodium edetate 0.08g, dihydro coniferyl alcohol γ-O-alpha-L-rhamnoside 0.02g, inject water to 2000ml, make 1000.
Preparation method: the water for injection 1) getting recipe quantity 95%, cools the temperature to 70 DEG C after boiling; 2) turn on agitator, adds recipe quantity sodium chloride, stirs and makes it dissolve in 5 minutes; Add dexmedetomidine hydrochloride, stir and within 10 minutes, make it dissolve completely and mix homogeneously; 3) be cooled to 50 DEG C again, add calcium disodium edetate and the dihydro coniferyl alcohol γ-O-alpha-L-rhamnoside of recipe quantity, stir and make it entirely molten, add the active carbon stirring and adsorbing 15 minutes of major ingredient amount 3% (w/w); 4) benefit adds to the full amount of water for injection, continue to stir lower circulation 15 minutes, after filtering with 0.5 μm of titanium rod and 0.22 μm of microfilter, detect medicinal liquid content and pH value in sample tap sampling, after fluid temperature remains on 40 DEG C, stop stirring and closing temperature lowering water valve; 5) detect qualified after, through the embedding third level 0.22 μm of microfilter, fill, sealing, in 121 DEG C of sterilizings 15 minutes; 6) lamp inspection, packaging, obtain finished product.
Embodiment 3
Raw material: dexmedetomidine hydrochloride (in dexmedetomidine) 0.2g, sodium chloride 18g, calcium disodium edetate 0.08g, inject water to 2000ml, makes 1000.
Preparation method: the water for injection 1) getting recipe quantity 95%, cools the temperature to 70 DEG C after boiling; 2) turn on agitator, adds recipe quantity sodium chloride, stirs and makes it dissolve in 5 minutes; Add dexmedetomidine hydrochloride, stir and within 10 minutes, make it dissolve completely and mix homogeneously; 3) be cooled to 50 DEG C again, add the calcium disodium edetate of recipe quantity, stir and make it entirely molten, add the active carbon stirring and adsorbing 15 minutes of major ingredient amount 3% (w/w); 4) benefit adds to the full amount of water for injection, continue to stir lower circulation 15 minutes, after filtering with 0.5 μm of titanium rod and 0.22 μm of microfilter, detect medicinal liquid content and pH value in sample tap sampling, after fluid temperature remains on 40 DEG C, stop stirring and closing temperature lowering water valve; 5) detect qualified after, through the embedding third level 0.22 μm of microfilter, fill, sealing, in 121 DEG C of sterilizings 15 minutes; 6) lamp inspection, packaging, obtain finished product.
Quality testing
Select the ph and the related substance that detect embodiment 1-3 gained dexmedetomidine hydrochloride injection, to be further elaborated the present invention and to verify.
1, influence factor's test
Embodiment 1,2,3 is respectively got sample segment and be placed in high temperature (60 DEG C ± 5 DEG C), illumination (4500lx ± 500lx), lower 10 days of high humidity (RH92.5%) condition, investigate temperature, illumination to the character of each embodiment injection, pH, clarity of solution and color, related substance and changes of contents.Character, clarity of solution and color all meet the requirements, and pH, related substance and changes of contents are investigated and be the results are shown in Table 1 and table 2.
Table 1: each embodiment is in high temperature, illumination and super-humid conditions ph change in 10 days
| Ph value | When 0 | High temperature (60 DEG C ± 5 DEG C) | Illumination (4500lx ± 500lx) | High humidity (RH92.5%) |
| Embodiment 1 | 5.51 | 5.53 | 5.57 | 5.59 |
| Embodiment 2 | 5.43 | 5.44 | 5.44 | 5.42 |
| Embodiment 3 | 5.37 | 5.32 | 5.34 | 5.38 |
From each embodiment high temperature, illumination, high temperature 10 days results.Various embodiments of the present invention all have higher stability in each condition.
Table 2 each embodiment content related substance testing result
Show from each embodiment content and related substance testing result, each embodiment high temperature 10 days, illumination 10 days and high temperature after 10 days related substance increase less, illustrate that each embodiment stability is high.
3, study on the stability
Each embodiment gained dexmedetomidine hydrochloride injection is put into 40 DEG C ± 2 DEG C, RH75% ± 5% time carry out accelerated test investigate and 25 DEG C ± 2 DEG C, RH60% ± 2% time carries out long term test investigation.Investigation the results are shown in Table 3-8.
Table 3: each embodiment accelerated test ph testing result
| Ph value | When 0 | Accelerate January | Accelerate February | Accelerate March | Accelerate June |
| Embodiment 1 | 5.51 | 5.47 | 5.48 | 5.45 | 5.41 |
| Embodiment 2 | 5.43 | 5.41 | 5.39 | 5.41 | 5.40 |
| Embodiment 3 | 5.37 | 5.33 | 5.35 | 5.29 | 5.35 |
Table 4: each embodiment accelerated test related substance testing result
Table 5: each embodiment accelerated test content detection result
Table 6: each embodiment long term test ph testing result
| Ph value | When 0 | Long-term June | Long-term December | Long-term 24 months |
| Embodiment 1 | 5.51 | 5.49 | 5.47 | 5.48 |
| Embodiment 2 | 5.43 | 5.43 | 5.42 | 5.43 |
| Embodiment 3 | 5.37 | 5.35 | 5.34 | 5.33 |
Table 7: each embodiment long term test related substance testing result
Table 8: each embodiment long term test content detection result
Result is investigated from each embodiment accelerated test and long term test, each embodiment accelerates each embodiment ph after June and long-term 24 months, content, related substance result are still qualified, proves that the dexmedetomidine hydrochloride injection formulation stability according to prescription provided by the invention and preparation method thereof preparation is high.To sum up can illustrate that the present invention is feasible to the detection of each embodiment effect, dexmedetomidine hydrochloride injection that it provides and preparation method thereof has the simple and lower feature being convenient to suitability for industrialized production of cost of good stability, preparation technology.
Claims (7)
1. a dexmedetomidine hydrochloride injection, is characterized in that, described dexmedetomidine hydrochloride injection comprises major ingredient and water for injection, and this major ingredient comprises active component and adjuvant; Described adjuvant comprises osmotic pressure regulator and complexing of metal ion agent; Described active component is dexmedetomidine hydrochloride, and described osmotic pressure regulator is sodium chloride.
2. a kind of dexmedetomidine hydrochloride injection according to claim 1, is characterized in that, the mass concentration of described dexmedetomidine hydrochloride in injection is 0.01-0.02%; The mass concentration of described sodium chloride in injection is respectively 0.8-1%; The mass concentration of described complexing of metal ion agent in injection is 0.001%-0.005%.
3. a kind of dexmedetomidine hydrochloride injection according to claim 1, is characterized in that, described complexing of metal ion agent is selected from one or more in sodium tartrate, disodium edetate, calcium disodium edetate.
4. a kind of dexmedetomidine hydrochloride injection according to claim 1, is characterized in that, described complexing of metal ion agent is calcium disodium edetate.
5. a kind of dexmedetomidine hydrochloride injection according to claim 1, is characterized in that, the mass concentration of described complexing of metal ion agent in injection is 0.004%.
6. a preparation method for dexmedetomidine hydrochloride injection according to claim 1, it is characterized in that, described preparation method is specially: 1) first by major ingredient and solvent formation solution admixed together; 2) add decarburization after activated carbon adsorption, detect semi-finished product after filtration, qualified rear fill.
7. a preparation method for dexmedetomidine hydrochloride injection according to claim 1, it is characterized in that, described preparation method is specially: the water for injection 1) getting recipe quantity 95%, cools the temperature to 60 DEG C-70 DEG C after boiling; 2) turn on agitator, adds recipe quantity sodium chloride, stirs and makes it dissolve in 5 minutes; Add dexmedetomidine hydrochloride, stir and within 10 minutes, make it dissolve completely and mix homogeneously; 3) be cooled to 30 DEG C-50 DEG C again, add the complexing of metal ion agent mixture of recipe quantity, stir and make it entirely molten, add the active carbon stirring and adsorbing 15 minutes of major ingredient amount 3% (w/w); 4) benefit adds to the full amount of water for injection, continue to stir lower circulation 15 minutes, after filtering with 0.5 μm of titanium rod and 0.22 μm of microfilter, detect medicinal liquid content and pH value in sample tap sampling, after fluid temperature remains on 30 DEG C-40 DEG C, stop stirring and closing temperature lowering water valve; 5) detect qualified after, through the embedding third level 0.22 μm of microfilter, fill, sealing, in 121 DEG C of sterilizings 15 minutes; 6) lamp inspection, packaging, obtain finished product.
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Cited By (10)
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| 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 |
| CN107412152A (en) * | 2016-05-24 | 2017-12-01 | 海南合瑞制药股份有限公司 | A kind of dexmedetomidine hydrochloride injecta composition |
| CN108113986A (en) * | 2017-12-28 | 2018-06-05 | 石药银湖制药有限公司 | A kind of raising processing method of dexmedetomidine hydrochloride parenteral solution stability and dexmedetomidine hydrochloride parenteral solution |
| CN111249230A (en) * | 2020-03-18 | 2020-06-09 | 遂成药业股份有限公司 | Preparation process of dexmedetomidine hydrochloride injection |
| CN113116815A (en) * | 2021-06-07 | 2021-07-16 | 辰欣药业股份有限公司 | Preparation method of dexmedetomidine hydrochloride injection |
| CN114983934A (en) * | 2022-06-16 | 2022-09-02 | 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 |
| 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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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105534891A (en) * | 2016-01-18 | 2016-05-04 | 南京正科医药股份有限公司 | Dexmedetomidine hydrochloride injection |
| CN107412152A (en) * | 2016-05-24 | 2017-12-01 | 海南合瑞制药股份有限公司 | A kind of dexmedetomidine hydrochloride injecta composition |
| 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 |
| CN108113986A (en) * | 2017-12-28 | 2018-06-05 | 石药银湖制药有限公司 | A kind of raising processing method of dexmedetomidine hydrochloride parenteral solution stability and dexmedetomidine hydrochloride parenteral solution |
| 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 |
| CN111249230A (en) * | 2020-03-18 | 2020-06-09 | 遂成药业股份有限公司 | Preparation process of dexmedetomidine hydrochloride injection |
| CN113116815A (en) * | 2021-06-07 | 2021-07-16 | 辰欣药业股份有限公司 | Preparation method of dexmedetomidine hydrochloride injection |
| CN114983934A (en) * | 2022-06-16 | 2022-09-02 | 南京正科医药股份有限公司 | Dexmedetomidine hydrochloride injection |
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