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CN103284945A - Preparation method of pre-filled dexmedetomidine hydrochloride injection

Publication number

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

Authority

CN

China

Prior art keywords

injection

filled

dexmedetomidine hydrochloride

preparation

hydrochloride injection

Prior art date

2013-06-03

Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)

Pending

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• 229960002746 dexmedetomidine hydrochloride Drugs 0.000 title claims abstract description 27
• VPNGEIHDPSLNMU-MERQFXBCSA-N dexmedetomidine hydrochloride Chemical compound Cl.C1([C@@H](C)C=2C(=C(C)C=CC=2)C)=CNC=N1 VPNGEIHDPSLNMU-MERQFXBCSA-N 0.000 title claims abstract description 27
• 238000002347 injection Methods 0.000 title claims abstract description 20
• 239000007924 injection Substances 0.000 title claims abstract description 20
• 238000002360 preparation method Methods 0.000 title claims abstract description 18
• XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
• IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims abstract description 14
• 239000008215 water for injection Substances 0.000 claims abstract description 14
• 230000001954 sterilising effect Effects 0.000 claims abstract description 11
• 238000003756 stirring Methods 0.000 claims abstract description 10
• 239000000243 solution Substances 0.000 claims abstract description 8
• 229910052757 nitrogen Inorganic materials 0.000 claims abstract description 7
• 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 7
• 238000000034 method Methods 0.000 abstract description 8
• 229940090044 injection Drugs 0.000 abstract 4
• VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract 2
• 229940005521 dexmedetomidine injection Drugs 0.000 abstract 1
• 238000005538 encapsulation Methods 0.000 abstract 1
• 238000001914 filtration Methods 0.000 abstract 1
• 238000007689 inspection Methods 0.000 description 8
• 239000007788 liquid Substances 0.000 description 5
• 238000001514 detection method Methods 0.000 description 4
• 238000005516 engineering process Methods 0.000 description 3
• 238000013019 agitation Methods 0.000 description 2
• 238000007599 discharging Methods 0.000 description 2
• 235000021050 feed intake Nutrition 0.000 description 2
• 238000002156 mixing Methods 0.000 description 2
• 238000012856 packing Methods 0.000 description 2
• 238000012545 processing Methods 0.000 description 2
• 239000000047 product Substances 0.000 description 2
• 239000011265 semifinished product Substances 0.000 description 2
• 238000011179 visual inspection Methods 0.000 description 2
• JDIIGWSSTNUWGK-UHFFFAOYSA-N 1h-imidazol-3-ium;chloride Chemical compound [Cl-].[NH2+]1C=CN=C1 JDIIGWSSTNUWGK-UHFFFAOYSA-N 0.000 description 1
• 206010039897 Sedation Diseases 0.000 description 1
• 239000000556 agonist Substances 0.000 description 1
• 108020004101 alpha-2 Adrenergic Receptor Proteins 0.000 description 1
• 102000015006 alpha2-adrenergic receptor activity proteins Human genes 0.000 description 1
• 230000009286 beneficial effect Effects 0.000 description 1
• 230000007812 deficiency Effects 0.000 description 1
• 230000002950 deficient Effects 0.000 description 1
• 230000000694 effects Effects 0.000 description 1
• 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
• 238000002474 experimental method Methods 0.000 description 1
• 238000011160 research Methods 0.000 description 1
• 230000036280 sedation Effects 0.000 description 1
• 239000008223 sterile water Substances 0.000 description 1
• 239000000126 substance Substances 0.000 description 1
• 238000002560 therapeutic procedure Methods 0.000 description 1
• 238000002627 tracheal intubation Methods 0.000 description 1

• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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.

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.

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.

• 2013
  • 2013-06-03 CN CN2013102159380A patent/CN103284945A/en active Pending

Application publication date: 20130911

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