CN106265539A - A kind of hydrochloride landiolol lyophilized injectable powder and preparation technology thereof - Google Patents
A kind of hydrochloride landiolol lyophilized injectable powder and preparation technology thereof Download PDFInfo
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- CN106265539A CN106265539A CN201610792311.5A CN201610792311A CN106265539A CN 106265539 A CN106265539 A CN 106265539A CN 201610792311 A CN201610792311 A CN 201610792311A CN 106265539 A CN106265539 A CN 106265539A
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- Prior art keywords
- injectable powder
- lyophilized injectable
- hydrochloride landiolol
- landiolol
- hydrochloride
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Abstract
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of hydrochloride landiolol lyophilized injectable powder and preparation technology thereof.Described preparation technology concretely comprises the following steps: dissolved by the mannitol water for injection that boiled of part, lower the temperature after less than 60 DEG C, addition hydrochloride landiolol stirring and dissolving, pH value, benefit water for injection is adjusted to full dose, to add activated carbon stirring and adsorbing by pH adjusting agent, filter, fill, lyophilizing.Compared with prior art, the hydrochloride landiolol lyophilized injectable powder drug effect that the present invention develops according to the various physicochemical properties of hydrochloride landiolol is fast, uses safety, preparation stabilization, and water solublity is good, and preparation technology is simple, easy, is suitable for industrial mass production.
Description
Technical field
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of hydrochloride landiolol lyophilized injectable powder
And preparation technology.
Background technology
Hydrochloride landiolol (Landiolol hydrochloride) is surpassing by Japan little Ye pharmaceutical industries company's exploitation
Fugitive high selectivity beta-blockers, in JIUYUE, 2002 at Japan's Initial Public Offering, tachycardia heart when being used for treating operation
Restrain not normal (auricular fibrillation, atrial flutter and sinus tachycardia), its selectivity ratios similar medicine (Chinese mugwort department to β1receptor
Luo Er and Propranolol) will be strong.Hydrochloride landiolol is as beta blocker, structurally, with the difference of conventional beta blocker
Being: propanol amino side chain and the change of its para-position side-chain structure, amino is morpholino carbonyl amide groups, and the alcohol becoming ester is S-configuration
1,2-ketal glyceryl alcohol；On pharmacologically active, the most prominent 2 are: hydrochloride landiolol is to β 1-adrenoreceptor
High selectivity, the half-life is the shortest simultaneously, in the two structure change with its superiority on pharmacologically active what has
Relation value must study, its result of study can will preferably instruct the design and development of selective beta blocker fugitive, high.
Hydrochloride landiolol is the ultrashort effect after esmolol, high selective β 1-adrenoreceptor blocking-up
Agent, its safety and effectiveness is confirmed, is the good selection solving clinical cardiovascular problem.The appearance of hydrochloride landiolol is given
Patient brings Gospel, can safely and effectively be used in cesarean section, can prevent postoperative atrial fibrillation, reduces medical treatment
Expense etc..During hydrochloride landiolol Clinical practice, after need to dissolving with injection.Intravenous drip 0.9% sodium chloride injection, 5%
Glucose injection, 10% glucose injection, Dextrose and Sodium Chloride Inj. are common infusions liquid.The clinic of Landiolol
Research is the most all continuing, and the impact of various dose and different modes of administration is the most also in the middle of evaluating.
Summary of the invention
For solving above-mentioned technical problem, the invention provides the hydrochloride landiolol that a kind of dissolubility is good, drug effect is safe and freeze
Dry powder injection and preparation technology thereof.
A kind of hydrochloride landiolol lyophilized injectable powder of the present invention, described hydrochloride landiolol lyophilized injectable powder presses matter
Amount part meter, including hydrochloride landiolol and the excipient of 50-80 part of 20-50 part；Described hydrochloride landiolol lyophilized injectable powder
Also include pH adjusting agent and water for injection.
A kind of hydrochloride landiolol lyophilized injectable powder of the present invention, described excipient is mannitol；Described pH regulator
Agent is sodium hydroxide.
A kind of hydrochloride landiolol lyophilized injectable powder of the present invention, described hydrochloride landiolol lyophilized injectable powder presses matter
Amount part meter, also includes that the Herba Leonuri of 0.1-1 part folds olefin(e) acid ester A.
The preparation technology of hydrochloride landiolol lyophilized injectable powder of the present invention, described preparation technology concretely comprises the following steps: will
The mannitol water for injection that boiled of part dissolves, and lower the temperature after less than 60 DEG C, and addition hydrochloride landiolol stirring and dissolving uses pH
Regulator adjusts pH value, benefit water for injection to full dose, to add activated carbon stirring and adsorbing, filter, fill, lyophilizing.
The preparation technology of hydrochloride landiolol lyophilized injectable powder of the present invention, described freeze-drying process includes:
Goods are installed pre-freeze by a: pre-freeze so that product temperature be less than-40 DEG C after insulation about 5 hours.Then cold-trap is given
Refrigeration is to-45 DEG C to-50 DEG C；
B: primary drying starts vacuum pump, and vacuum in freeze drying box is reached about 10Pa, start to set baffle temperature as-
5 DEG C, it is incubated after disappearing to watermark and is incubated 1-2 hour again；In inspection box, pressure and the temperature integrated of condenser decide whether simultaneously
The redrying stage can be entered；
C: redrying, for removing residual moisture, sets baffle temperature as 5 DEG C, 15 DEG C, 25 DEG C of each heat preservation and drynesses 2 hours,
It is ultimately set to 35 degree to terminating；
D: get final product tamponade outlet after pressure recovers pass the test, and carry out cold-trap defrost.
Compared with prior art, the hydrochloride landiolol that the present invention develops according to the various physicochemical properties of hydrochloride landiolol
Lyophilized injectable powder drug effect is fast, uses safety, preparation stabilization, and water solublity is good, and preparation technology is simple, easy, is suitable for industry
Large-scale production.
Detailed description of the invention
Below in conjunction with specific embodiment, hydrochloride landiolol lyophilized injectable powder of the present invention and preparation technology thereof are done
Further illustrate, but protection scope of the present invention is not limited to this.
Embodiment 1
Preparation technology:
Sample:
A: will put in dilute preparing tank according to the load weighted mannitol of prescription, the water for injection stirring adding full dose 60% makes complete
Molten, then solution is lowered the temperature less than 40 DEG C.
B: added immediately in dilute preparing tank by load weighted hydrochloride landiolol, stirring makes the most molten, adds 0.1mol/L hydrogen-oxygen
(after cleaning plastic containers are placed on electronic scale clearing, in container, hydro-oxidation sodium solid is appropriate, then adds to change sodium solution
Water for injection is configured to 0.1mol/L sodium hydroxide solution in right amount) regulation ph be 5.5, then add the water for injection after cooling extremely
Full dose.
C: add and 0.05% (w/v) Actidose prepared is added to material-compound tank, stir 15 minutes decarbonization filterings.So
After open the valve of filtration system, make medicinal liquid pass through 0.5um titanium rod, 0.45 μm and twice 0.22 μm micropore filter filtration cycle.
Semi-finished product content, PH are surveyed in d: sampling, qualified rear for fill
Lyophilizing:
Goods are installed pre-freeze by a: pre-freeze so that product temperature be less than-40 DEG C after insulation about 5 hours.Then cold-trap is given
Refrigeration is to-45 DEG C.
B: primary drying starts vacuum pump, and vacuum in freeze drying box is reached about 10Pa, start to set baffle temperature as-
5 DEG C, it is incubated after disappearing to watermark and is incubated 1 hour again.In inspection box, temperature integrated the deciding whether of pressure and condenser can simultaneously
To enter the redrying stage.
C: redrying, for removing residual moisture, sets baffle temperature as 5 DEG C, and 15 DEG C, 25 DEG C of each heat preservation and drynesses about 2 are little
Time, it is ultimately set to 35 degree to terminating.
D: get final product tamponade outlet after pressure recovers pass the test, and carry out the later stage work such as cold-trap defrost.
Embodiment 2
Preparation technology:
Sample:
A: will put in dilute preparing tank according to the load weighted mannitol of prescription, the water for injection stirring adding full dose 60% makes complete
Molten, then solution is lowered the temperature less than 40 DEG C.
B: added immediately in dilute preparing tank by load weighted hydrochloride landiolol, stirring makes the most molten, adds 0.1mol/L hydrogen-oxygen
(after cleaning plastic containers are placed on electronic scale clearing, in container, hydro-oxidation sodium solid is appropriate, then adds to change sodium solution
Water for injection is configured to 0.1mol/L sodium hydroxide solution in right amount) regulation ph be 6.3, then add the water for injection after cooling extremely
Full dose.
C: add and 0.05% (w/v) Actidose prepared is added to material-compound tank, stir 15 minutes decarbonization filterings.So
After open the valve of filtration system, make medicinal liquid pass through 0.5um titanium rod, 0.45 μm and twice 0.22 μm micropore filter filtration cycle.
Semi-finished product content, PH are surveyed in d: sampling, qualified rear for fill
Lyophilizing:
Goods are installed pre-freeze by a: pre-freeze so that product temperature be less than-40 DEG C after insulation about 5 hours.Then cold-trap is given
Refrigeration is to-50 DEG C.
B: primary drying starts vacuum pump, and vacuum in freeze drying box is reached about 10Pa, start to set baffle temperature as-
5 DEG C, it is incubated after disappearing to watermark and is incubated 2 hours again.In inspection box, temperature integrated the deciding whether of pressure and condenser can simultaneously
To enter the redrying stage.
C: redrying, for removing residual moisture, sets baffle temperature as 5 DEG C, and 15 DEG C, 25 DEG C of each heat preservation and drynesses about 2 are little
Time, it is ultimately set to 35 degree to terminating.
D: get final product tamponade outlet after pressure recovers pass the test, and carry out the later stage work such as cold-trap defrost.
Embodiment 3
Preparation technology:
Sample:
A: will put in dilute preparing tank according to the load weighted mannitol of prescription, the water for injection stirring adding full dose 60% makes complete
Molten, then solution is lowered the temperature less than 40 DEG C.
B: added immediately in dilute preparing tank by load weighted hydrochloride landiolol, stirring makes the most molten, adds 0.1mol/L hydrogen-oxygen
(after cleaning plastic containers are placed on electronic scale clearing, in container, hydro-oxidation sodium solid is appropriate, then adds to change sodium solution
Water for injection is configured to 0.1mol/L sodium hydroxide solution in right amount) regulation ph be 6.3, then add the water for injection after cooling extremely
Full dose.
C: add and 0.05% (w/v) Actidose prepared is added to material-compound tank, stir 15 minutes decarbonization filterings.So
After open the valve of filtration system, make medicinal liquid pass through 0.5um titanium rod, 0.45 μm and twice 0.22 μm micropore filter filtration cycle.
Semi-finished product content, PH are surveyed in d: sampling, qualified rear for fill
Lyophilizing:
Goods are installed pre-freeze by a: pre-freeze so that product temperature be less than-40 DEG C after insulation about 5 hours.Then cold-trap is given
Refrigeration is to-50 DEG C.
B: primary drying starts vacuum pump, and vacuum in freeze drying box is reached about 10Pa, start to set baffle temperature as-
5 DEG C, it is incubated after disappearing to watermark and is incubated 2 hours again.In inspection box, temperature integrated the deciding whether of pressure and condenser can simultaneously
To enter the redrying stage.
C: redrying, for removing residual moisture, sets baffle temperature as 5 DEG C, and 15 DEG C, 25 DEG C of each heat preservation and drynesses about 2 are little
Time, it is ultimately set to 35 degree to terminating.
D: get final product tamponade outlet after pressure recovers pass the test, and carry out the later stage work such as cold-trap defrost.
Embodiment 4
Preparation technology:
Sample:
A: will put in dilute preparing tank according to the load weighted mannitol of prescription, the water for injection stirring adding full dose 60% makes complete
Molten, then solution is lowered the temperature less than 40 DEG C.
B: load weighted hydrochloride landiolol and Herba Leonuri are folded olefin(e) acid ester A and adds immediately in dilute preparing tank, stirring makes the most molten,
Add 0.1mol/L sodium hydroxide solution and (cleaning plastic containers are placed on electronic scale after resetting, hydro-oxidation in container
Sodium solid is appropriate, then injects and is configured to 0.1mol/L sodium hydroxide solution with water in right amount) regulation ph is 6.3, then adds
Water for injection after cooling is to full dose.
C: add and 0.05% (w/v) Actidose prepared is added to material-compound tank, stir 15 minutes decarbonization filterings.So
After open the valve of filtration system, make medicinal liquid pass through 0.5um titanium rod, 0.45 μm and twice 0.22 μm micropore filter filtration cycle.
Semi-finished product content, PH are surveyed in d: sampling, qualified rear for fill
Lyophilizing:
Goods are installed pre-freeze by a: pre-freeze so that product temperature be less than-40 DEG C after insulation about 5 hours.Then cold-trap is given
Refrigeration is to-50 DEG C.
B: primary drying starts vacuum pump, and vacuum in freeze drying box is reached about 10Pa, start to set baffle temperature as-
5 DEG C, it is incubated after disappearing to watermark and is incubated 2 hours again.In inspection box, temperature integrated the deciding whether of pressure and condenser can simultaneously
To enter the redrying stage.
C: redrying, for removing residual moisture, sets baffle temperature as 5 DEG C, and 15 DEG C, 25 DEG C of each heat preservation and drynesses about 2 are little
Time, it is ultimately set to 35 degree to terminating.
D: get final product tamponade outlet after pressure recovers pass the test, and carry out the later stage work such as cold-trap defrost.
Quality verification
Embodiment sample is carried out factors influencing result as follows:
Illustrating that this product steady quality is reliable by factors influencing, the impact of light and high temperature is little.
Claims (5)
1. a hydrochloride landiolol lyophilized injectable powder, it is characterised in that described hydrochloride landiolol lyophilized injectable powder presses quality
Part meter, including hydrochloride landiolol and the excipient of 50-80 part of 20-50 part；Described hydrochloride landiolol lyophilized injectable powder is also
Including pH adjusting agent and water for injection.
A kind of hydrochloride landiolol lyophilized injectable powder the most according to claim 1, it is characterised in that described excipient is sweet
Dew alcohol；Described pH adjusting agent is sodium hydroxide.
A kind of hydrochloride landiolol lyophilized injectable powder the most according to claim 1, it is characterised in that Lip river, described hydrochloric acid orchid ground
That lyophilized injectable powder in parts by mass, also includes that the Herba Leonuri of 0.1-1 part folds olefin(e) acid ester A.
The preparation technology of hydrochloride landiolol lyophilized injectable powder the most according to claim 1, it is characterised in that described preparation work
Skill concretely comprises the following steps: dissolved by the mannitol water for injection that boiled of part, lower the temperature after less than 60 DEG C, Lip river, addition hydrochloric acid orchid ground
That stirring and dissolving, adjusts pH value, benefit water for injection to full dose, to add activated carbon stirring and adsorbing, filter, fill, lyophilizing by pH adjusting agent.
The preparation technology of hydrochloride landiolol lyophilized injectable powder the most according to claim 4, it is characterised in that described lyophilizing
Journey includes:
Goods are installed pre-freeze by a: pre-freeze so that product temperature be less than-40 DEG C after insulation about 5 hours.Then freeze to cold-trap
To-45 DEG C to-50 DEG C；
B: primary drying starts vacuum pump, and vacuum in freeze drying box is reached about 10Pa, starts to set baffle temperature as-5 DEG C,
It is incubated after disappearing to watermark and is incubated 1-2 hour again；In inspection box, pressure and condenser temperature integrated decides whether permissible simultaneously
Enter the redrying stage；
C: redrying, for removing residual moisture, sets baffle temperature as 5 DEG C, 15 DEG C, 25 DEG C of each heat preservation and drynesses 2 hours, finally
It is set as 35 degree to terminating；
D: get final product tamponade outlet after pressure recovers pass the test, and carry out cold-trap defrost.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610792311.5A CN106265539A (en) | 2016-08-31 | 2016-08-31 | A kind of hydrochloride landiolol lyophilized injectable powder and preparation technology thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610792311.5A CN106265539A (en) | 2016-08-31 | 2016-08-31 | A kind of hydrochloride landiolol lyophilized injectable powder and preparation technology thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106265539A true CN106265539A (en) | 2017-01-04 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610792311.5A Pending CN106265539A (en) | 2016-08-31 | 2016-08-31 | A kind of hydrochloride landiolol lyophilized injectable powder and preparation technology thereof |
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| CN (1) | CN106265539A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1652533A1 (en) * | 2003-08-08 | 2006-05-03 | Ono Pharmaceutical Co., Ltd. | HEART-SLOWING DRUG CONTAINING SHORT-ACTING &bgr; BLOCKER AS THE ACTIVE INGREDIENT |
| CN1827109A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Lyophilized injection powder using Lanluodier and its salt as active ingredients and preparing technique therefor |
-
2016
- 2016-08-31 CN CN201610792311.5A patent/CN106265539A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1652533A1 (en) * | 2003-08-08 | 2006-05-03 | Ono Pharmaceutical Co., Ltd. | HEART-SLOWING DRUG CONTAINING SHORT-ACTING &bgr; BLOCKER AS THE ACTIVE INGREDIENT |
| CN1827109A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Lyophilized injection powder using Lanluodier and its salt as active ingredients and preparing technique therefor |
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Application publication date: 20170104 |