CN106727443A - Preoperative calm stealthy nose paste preparation of a kind of pediatric anesthesia and preparation method thereof - Google Patents
Preoperative calm stealthy nose paste preparation of a kind of pediatric anesthesia and preparation method thereof Download PDFInfo
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- CN106727443A CN106727443A CN201611119213.1A CN201611119213A CN106727443A CN 106727443 A CN106727443 A CN 106727443A CN 201611119213 A CN201611119213 A CN 201611119213A CN 106727443 A CN106727443 A CN 106727443A
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
- A61K36/575—Magnolia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
Abstract
The invention discloses preoperative calm stealthy nose paste preparation of a kind of pediatric anesthesia and preparation method thereof, nose patch includes elastic biological colloid and the transparent back of the body patch composition that biological skeleton material is made with medicine beta cyclodextrin clathrate.Nose patch is carrier from polymeric biomaterial, and with efficacy stability, compact structure is stealthy, easy to use comfortable, can in acupuncture point target administration, drug effect significantly, the advantages of work rapid.Remarkable result of the invention is, for the infant for preparing row operation, by nose paste preparation being affixed on into fragrant cave or nasal cavity form makes contained downern dexmedetomidine hydrochloride in nose paste preparation be absorbed rapidly through schneiderian membrane, reach calm purpose before anesthesia and do not influence breathing, it is to avoid intramuscular injection or intravenous injection acupuncture are acted on to the bad mental that children bring.
Description
Technical field
The invention belongs to the anaesthetic in field of medicaments, and in particular to a kind of preoperative calm stealthy nose patch of pediatric anesthesia
Preparation and preparation method thereof.
Background technology
The main stream approach of pediatric anesthesia induction induces the suction of gas anesthesia in the world at present, cannot be real in suction induction
When applying, infant must be orally or intramuscular injection some arcotics can just enter operating room and carry out general anaesthesia induction and domestic relative
Fall behind, the scheme of main pediatric anesthesia induction is intramuscular injection or intravenous injection downern, and acupuncture can make to the children for regaining consciousness
Into menticide, increase the incidence of postoperative various complication, oral pediatric anesthesia induction formulation mainly has all kinds of both at home and abroad
The preparation of type syrup mixing sedative, its administering mode is reached after oral administration solid or liquid sedative are equipped with a certain amount of water
To calm purpose, take medicine poor to part children's acceptance, drunk water before anesthesia induction, the risk backflowed and inhale by mistake may be increased.
Dexmedetomidine hydrochloride is an effective, α for high selectivity2Receptor stimulating agent, it is sympathetic with calmness, analgesia, antianxiety, retardance
Neural, thrifty opioid drug etc. is acted on, there is provided unique calm type is " calmness for retaining consciousness ", and patient seems to be in
Sleep state, but easily it is waken up, can be with examiner's exchange and cooperation.
Basic pharmacology and clinical research show that dexmedetomidine hydrochloride nasal membrane organism-absorbing availability is high, rapid-action,
Action time is relatively short, and short sedation is safe.Additionally, it hardly causes respiration inhibition, moreover it is possible to prevention of postoperative nausea
Vomiting and shiver with cold.Yingxiang acupuncture point Cutaneous permeation sticks medicine, it is to avoid the discomfort of schneiderian membrane spray and adverse reaction, and with cave
Position stimulates the double action of dredging the channel and medicine.It is, with Chinese medicine meridian theory as theoretical foundation, to belong to and controlled outside Traditional Chinese Medicine
A kind of important technology of method, is an important component of motherland's medical treasure-house.The i.e. external improvement of the reason inside controlled, inside controls it
Medicine is the outer medicine controlled.Point-application medicine is made without gastro-intestinal administration, the disadvantage of the lossless impairment of the spleen by the stimulation to local acupuncture point
With, penetrated by skin and worked with channels and collaterals conduction etc., and hurtless measure no pain, to the person that fears pin, or the people that be unwilling to be taken medicine, particularly
Suitably.
The content of the invention
The technical problems to be solved by the invention are the deficiency for above-mentioned technology, there is provided a kind of new children are preoperative
Calm nose patch type.The nose is pasted, and is carrier from polymeric biomaterial, and with efficacy stability, compact structure is stealthy, uses
Energy and comfort, can in acupuncture point target administration, drug effect significantly, the advantages of work rapid.
Concrete technical scheme of the invention is as follows：
A kind of preoperative calm stealthy nose patch of pediatric anesthesia, including transparent back of the body patch with fit in it is transparent carry on the back stick containing medicine into
The elastic biological colloid for dividing.
As preference：The transparent back of the body patch is biological fiber rope film；The elastic biological colloid is by biological skeleton material
It is made with medicine Benexate Hydrochloride.
As preference：The biological skeleton material is made up of host material, binder and NMF；The matrix material
Material, binder and NMF are 1 by quality parts ratio：1：1.
As preference：The host material is the mixture of two kinds of gelatin and middle viscosity polyvinyl alcohol；Binder is
Bright matter acid；NMF is glycerine.
As preference：The medicine Benexate Hydrochloride is by the dexmedetomidine hydrochloride of survival dose and the mixing of essential oil
Thing is made up of beta-cyclodextrin inclusion compound technology, volume and the medicine beta-schardinger dextrin of the essential oil and dexmedetomidine hydrochloride mixture
Mass ratio be volume/mass=1：4.
As preference：The essential oil is refined jasmine oil or Rosa Damascana or magnolia essential oil or Lavender.
The present invention also provides a kind of method for preparing the preoperative calm stealthy nose patch of above-mentioned pediatric anesthesia, and step is as follows：
（1）The preparation of medicine Benexate Hydrochloride：Beta-schardinger dextrin is dissolved in by distilled water using saturated water solution method or ultrasonic method
Saturated solution is made, essential oil and dexmedetomidine hydrochloride composition is added, medicine Benexate Hydrochloride is made；
（2）The preparation of elastic biological colloid：The host material that biological skeleton material will be prepared is completely soluble, in temperature 50-60
Binder, NMF and medicine Benexate Hydrochloride are added under the conditions of DEG C, is stirred and is made elastic biological colloid；
（3）Elastic biological colloid is poured into film applicator press-in plastic packaging template, target product is made, is then fitted in back of the body patch material
Together, obtain final product.
As preference：The step（1）Process is：Using ultrasonic method, beta-schardinger dextrin is weighed, be dissolved in 45 DEG C of distilled water
Beta-schardinger dextrin saturated solution is prepared, to the composition that essential oil and Dexmedetomidine are added in beta-schardinger dextrin saturated solution, is mixed, 45
24h is refrigerated in DEG C thermostatic ultrasonic treatment rearmounted refrigerators of 30min, suction filtration is taken out, filtrate is discarded, product is collected, with a little anhydrous second
24h is vacuum dried after alcohol washed product 3 times, Benexate Hydrochloride is obtained final product.
As preference：The step（2）During host material when being the mixture of gelatin and polyvinyl alcohol, matrix material
Material processing method：Gelatin and polyvinyl alcohol are soaked 4-8 hours in water respectively, polyvinyl alcohol is stirred under the conditions of 70 DEG C of water-bath
Solution, is slowly added into gelatin solution when being completely dissolved, and stirring and dissolving completely, is obtained final product.
Compared with prior art, the invention has the advantages that：
1st, with tcm theory as foundation, nose patch medicine contains the natural plant essential oils of special compatibility to the present invention, and essential oil has superpower
Penetrating power, can quickly enter subcutaneous；And its fragrance is easy to be received by children, induce convenient and easy, father and mother's satisfaction is good；
Refined jasmine oil is referred to as " king of essential oil ", there is that alleviating oversensitive, promotion loosens and stop anxiety；Rosa Damascana is praised
It is " liquid golden " effect that fatigue, tranquilizing and allaying excitement and pressure of releiving can be slowed down；Magnolia essential oil has regulation heart Lu, relaxes breathing
The symptom such as rapid, and can calm and lax nerve, mitigate the mood of nervous and anxiety；Lavender be described as essential oil it
Mood is loosened in extraction, decompression of releiving, and treats effect of insomnia；There is Dexmedetomidine unique " retaining the calmness of consciousness " to make
With making patient be in the sleep state that can wake up, and do not influence breathing；
2nd, the present invention is combined by beta-cyclodextrin inclusion compound technology and biological skeleton material, is made the laminating acupuncture point of diameter 5-10mm
Special construction, makes it be discharged in fragrant cave, and Transdermal absorption can not only play massage, the effect of expansion nasal cavity, and hurtless measure without
Pain, to the infant for fearing pin and be unwilling to take medicine, particularly suitably；
3rd, use and special moulding process of the present invention by stealth material, structure is small, and material color is consistent with skin, rises
To stealthy effect, due to patch small volume, the above the average age for marriage infant for cooperation of understanding can also directly be attached to nasal cavity, make
With Energy and comfort and work faster；
4th, the preoperative calm nose patch of pediatric anesthesia of the invention, the tracheae that is drawn to by mistake that can prevent oral administration solid medicament from being brought causes to stop up
Breath；
5th, the preoperative calm nose patch of pediatric anesthesia of the invention does not need special environment and equipment, infant no liquid intake, in stomach
The tolerant suction probability by mistake that backflows is small.
And the present invention is tested by specific safety and proved, nose of the invention pastes not allergy non-stimulated to skin, and drug effect is steady
It is fixed.
Brief description of the drawings
Fig. 1 is the structural representation that nose of the present invention is affixed on fragrant cave；
Fig. 2 is the structural representation that nose of the present invention is affixed on nasal cavity；
Wherein：Transparent back of the body patch 1, elastic biological colloid 2.
Specific embodiment
With reference to embodiment and accompanying drawing, the present invention will be further described.
Embodiment 1：
（1）Using ultrasonic method, beta-schardinger dextrin about 4g is weighed, be dissolved in distilled water（45℃）Prepare saturated solution.Add refined jasmine oil
Mixed with the composition 1ml of Dexmedetomidine, 45 DEG C of thermostatic ultrasonics process 30min, to put and refrigerate 24h in refrigerator, take out suction filtration, used
A little absolute ethanol washing 3 times.24h is dried during powder is put into vacuum desiccator, Benexate Hydrochloride is obtained final product；
（2）Taking gelatin 5g adds the water of meltage to soak 4-8 hours, and polyvinyl alcohol 5g adds the water of meltage to soak 4-8 hours,
Poly-vinyl alcohol solution is stirred under the conditions of 70 DEG C of water-bath, gelatin solution is slowly added into when being completely dissolved, after stirring and dissolving is complete
50 DEG C are reduced the temperature to, hyaluronic acid 10g, glycerine 10g, Benexate Hydrochloride 5g is added, film is poured into after stirring
Machine is pressed into plastic packaging template, packed products.
（3）Mould be made diameter 2-5mm the small semicircle for agreeing with Yingxiang acupuncture point shape is spherical or half elliptic, back of the body patch material
Transparent biological fiber rope film, diameter 5-10mm or 5 × 20mm strip is coated with hydrophily viscous coating, color and skin one
Cause, play the effect of stealth, the colloid plane that will be made sticks in back of the body patch center.
Embodiment 2：
（1）Using ultrasonic method, beta-schardinger dextrin about 4g is weighed, be dissolved in distilled water（45℃）Prepare saturated solution.Add Rosa Damascana
Mixed with the composition 1ml of Dexmedetomidine, 45 DEG C of thermostatic ultrasonics process 30min, to put and refrigerate 24h in refrigerator, take out suction filtration, used
A little absolute ethanol washing 3 times.24h is dried during powder is put into vacuum desiccator, Benexate Hydrochloride is obtained final product.
（2）Taking gelatin 5g adds the water of meltage to soak 4-8 hours, and polyvinyl alcohol 5g adds the water immersion 4-8 of meltage
Hour, poly-vinyl alcohol solution is stirred under the conditions of 70 DEG C of water-bath, gelatin solution is slowly added into when being completely dissolved, stirring and dissolving is complete
50 DEG C are reduced the temperature to after complete, hyaluronic acid 10g, glycerine 10g, Benexate Hydrochloride 5g is added, poured into after stirring
Film applicator is pressed into plastic packaging template, packed products.
（3）Mould be made diameter 2-5mm the small semicircle for agreeing with Yingxiang acupuncture point shape is spherical or half elliptic, back of the body patch material
Transparent biological fiber rope film, diameter 5-10mm or 5 × 20mm strip is coated with hydrophily viscous coating, color and skin one
Cause, play the effect of stealth, the colloid plane that will be made sticks in back of the body patch center.
Embodiment 3：
（1）Using ultrasonic method, beta-schardinger dextrin about 4g is weighed, be dissolved in distilled water（45℃）Prepare saturated solution.Add magnolia essential oil
Mixed with the composition 1ml of Dexmedetomidine, 45 DEG C of thermostatic ultrasonics process 30min, to put and refrigerate 24h in refrigerator, take out suction filtration, used
A little absolute ethanol washing 3 times.24h is dried during powder is put into vacuum desiccator, Benexate Hydrochloride is obtained final product.
（2）Taking gelatin 5g adds the water of meltage to soak 4-8 hours, and polyvinyl alcohol 5g adds the water immersion 4-8 of meltage
Hour, poly-vinyl alcohol solution is stirred under the conditions of 70 DEG C of water-bath, gelatin solution is slowly added into when being completely dissolved, stirring and dissolving is complete
50 DEG C are reduced the temperature to after complete, hyaluronic acid 10g, glycerine 10g, Benexate Hydrochloride 5g is added, poured into after stirring
Film applicator is pressed into plastic packaging template, packed products.
（3）Mould be made diameter 2-5mm the small semicircle for agreeing with Yingxiang acupuncture point shape is spherical or half elliptic, back of the body patch material
Transparent biological fiber rope film, diameter 5-10mm or 5 × 20mm strip is coated with hydrophily viscous coating, color and skin one
Cause, play the effect of stealth, the colloid plane that will be made sticks in back of the body patch center.
Embodiment 4：
（1）Using ultrasonic method, beta-schardinger dextrin about 4g is weighed, be dissolved in distilled water（45℃）Prepare saturated solution.Add lavender essence
The composition 1ml of oil and Dexmedetomidine is mixed, and 45 DEG C of thermostatic ultrasonics process 30min, to be put and refrigerate 24h in refrigerator, takes out suction filtration,
With a little absolute ethanol washing 3 times.24h is dried during powder is put into vacuum desiccator, Benexate Hydrochloride is obtained final product.
（2）Taking gelatin 5g adds the water of meltage to soak 4-8 hours, and polyvinyl alcohol 5g adds the water immersion 4-8 of meltage
Hour, poly-vinyl alcohol solution is stirred under the conditions of 70 DEG C of water-bath, gelatin solution is slowly added into when being completely dissolved, stirring and dissolving is complete
50 DEG C are reduced the temperature to after complete, hyaluronic acid 10g, glycerine 10g, Benexate Hydrochloride 5g is added, poured into after stirring
Film applicator is pressed into plastic packaging template, packed products.
（3）Mould be made diameter 2-5mm the small semicircle for agreeing with Yingxiang acupuncture point shape is spherical or half elliptic, back of the body patch material
Transparent biological fiber rope film, diameter 5-10mm or 5 × 20mm strip is coated with hydrophily viscous coating, color and skin one
Cause, play the effect of stealth, the colloid plane that will be made sticks in back of the body patch center.
Embodiment 4：
（4）Using ultrasonic method, beta-schardinger dextrin about 4g is weighed, be dissolved in distilled water（45℃）Prepare saturated solution.Add lavender essence
The composition 1ml of oil and Dexmedetomidine is mixed, and 45 DEG C of thermostatic ultrasonics process 30min, to be put and refrigerate 24h in refrigerator, takes out suction filtration,
With a little absolute ethanol washing 3 times.24h is dried during powder is put into vacuum desiccator, Benexate Hydrochloride is obtained final product.
（5）Taking gelatin 5g adds the water of meltage to soak 4-8 hours, and polyvinyl alcohol 5g adds the water immersion 4-8 of meltage
Hour, poly-vinyl alcohol solution is stirred under the conditions of 70 DEG C of water-bath, gelatin solution is slowly added into when being completely dissolved, stirring and dissolving is complete
50 DEG C are reduced the temperature to after complete, hyaluronic acid 10g, glycerine 10g, Benexate Hydrochloride 5g is added, poured into after stirring
Film applicator is pressed into plastic packaging template, packed products.
Mould be made diameter 2-5mm the small semicircle for agreeing with Yingxiang acupuncture point shape is spherical or half elliptic, back of the body patch material is saturating
Bright biological fiber rope film, diameter 5-10mm or 5 × 20mm strip is coated with hydrophily viscous coating, and color is consistent with skin,
The effect of stealth is played, the colloid plane that will be made sticks in back of the body patch center.
Local irritation and anaphylaxis evaluation：
1st, reference《Chinese medicine, natural drug excitant and hemolytic investigative technique guideline》2005.3, skin irritation test,
Result shows：This nose is pasted and does not produce excitant to the intact skin and damaged skin of white rabbit, points out nose patch external application not produce thorn
Swash property reaction.
2nd, reference《Chinese medicine, natural drug immunotoxicity（Anaphylaxis, photo sensitive reaction）Technological guidance's principle of research》
2005.3, as a result active skin anaphylactic test shows：This nose patch does not produce anaphylaxis to guinea pig skin, points out the external application of nose patch not
Produce allergic reaction.
The preoperative calm nose paste preparation of pediatric anesthesia manufactured in the present embodiment is divided into level below：
Without pharmaceutically dosage form：Sticked suitable for doctor or father and mother, be used to guide children to stick；
5 μ g (content of Dexmedetomidine in every formulation)：Children suitable for body weight less than or equal to 5kg；
10 μ g (content of Dexmedetomidine in every formulation)：Children suitable for body weight more than 5kg less than or equal to 10kg；
15 μ g (content of Dexmedetomidine in every formulation)：Children suitable for body weight more than 10kg less than or equal to 15kg；
20 μ g (content of Dexmedetomidine in every formulation)：Children suitable for body weight more than 15kg less than or equal to 20kg；
30 μ g (content of Dexmedetomidine in every formulation)：Children suitable for body weight more than 20kg.
The application method of the preoperative calm nose patch of pediatric anesthesia of the invention is as follows：
Nose patch can be affixed in children's fragrant cave or nasal cavity by children father and mother in 1h before surgery, and preoperative half an hour enters operation etc.
Area is treated, and fools it to fall asleep, a general medicament works for about 45-60 minutes, lies against on Operation trolley infant after sleep, then
Pushed by Anesthetist's flatcar（Or embrace）In operation, on operation table the suction such as application Sevoflurane gas routinely induction to certain
After depth of anesthesia, action venipuncture and subsequently anesthesia.
Dexmedetomidine hydrochloride nose paste preparation prepared by the present invention, for the infant for preparing row operation, is made by the way that nose is pasted
Agent is affixed on fragrant cave or nasal cavity form makes contained downern dexmedetomidine hydrochloride in nose paste preparation be inhaled rapidly through schneiderian membrane
Receive, reach calm purpose before anesthesia and do not influence breathing, it is to avoid intramuscular injection or intravenous injection acupuncture to children bring it is bad
Psychological application.
It should be appreciated that the part that this specification is not elaborated belongs to prior art.
It should be appreciated that the above-mentioned description for preferred embodiment is more detailed, therefore can not be considered to the present invention
The limitation of scope of patent protection, one of ordinary skill in the art, will right of the present invention is not departed under enlightenment of the invention
Ask under protected ambit, replacement can also be made or deformed, each fall within protection scope of the present invention, it is of the invention
Scope is claimed should be determined by the appended claims.
Claims (9)
1. a kind of preoperative calm stealthy nose of pediatric anesthesia is pasted, it is characterised in that：Including transparent back of the body patch（1）With fit in the transparent back of the body
Patch（1）On the elastic biological colloid containing drug ingedient（2）.
2. the preoperative calm stealthy nose of pediatric anesthesia as claimed in claim 1 is pasted, it is characterised in that：The transparent back of the body patch（1）
It is biological fiber rope film；The elastic biological colloid（2）It is made up with medicine Benexate Hydrochloride of biological skeleton material.
3. the preoperative calm stealthy nose of pediatric anesthesia as claimed in claim 2 is pasted, it is characterised in that：The biological skeleton material
It is made up of host material, binder and NMF；The host material, binder and NMF are 1 by quality parts ratio：1：1.
4. the preoperative calm stealthy nose of pediatric anesthesia as claimed in claim 3 is pasted, it is characterised in that：The host material is bright
The mixture of two kinds of glue and middle viscosity polyvinyl alcohol；Binder is hyaluronic acid；NMF is glycerine.
5. the preoperative calm stealthy nose of pediatric anesthesia as claimed in claim 2 is pasted, it is characterised in that：The medicine beta-schardinger dextrin
Inclusion compound is made up with the mixture of essential oil of the dexmedetomidine hydrochloride of survival dose of beta-cyclodextrin inclusion compound technology, the essential oil
It is volume/mass=1 with the volume of dexmedetomidine hydrochloride mixture and the mass ratio of medicine beta-schardinger dextrin：4.
6. the preoperative calm stealthy nose of pediatric anesthesia as claimed in claim 5 is pasted, it is characterised in that：The essential oil is jasmine essence
Oil or Rosa Damascana or magnolia essential oil or Lavender.
It is 7. a kind of to prepare the method that the preoperative calm stealthy nose of pediatric anesthesia as claimed in claim 1 is pasted, it is characterised in that：Step
It is rapid as follows：
（1）The preparation of medicine Benexate Hydrochloride：Beta-schardinger dextrin is dissolved in by distilled water using saturated water solution method or ultrasonic method
Saturated solution is made, essential oil and dexmedetomidine hydrochloride composition is added, medicine Benexate Hydrochloride is made；
（2）The preparation of elastic biological colloid：The host material that biological skeleton material will be prepared is completely soluble, in temperature 50-60
Binder, NMF and medicine Benexate Hydrochloride are added under the conditions of DEG C, is stirred and is made elastic biological colloid；
（3）Elastic biological colloid is poured into film applicator press-in plastic packaging template, target product is made, is then fitted in back of the body patch material
Together, obtain final product.
8. preparation method as claimed in claim 7, it is characterised in that：The step（1）Process is：Using ultrasonic method, weigh
Beta-schardinger dextrin, is dissolved in and beta-schardinger dextrin saturated solution is prepared in 45 DEG C of distilled water, to added in beta-schardinger dextrin saturated solution essential oil and
The composition of Dexmedetomidine, is mixed, and 24h is refrigerated in 45 DEG C of thermostatic ultrasonic treatment rearmounted refrigerators of 30min, takes out suction filtration, is discarded
Filtrate, collects product, with 24h is vacuum dried after a little absolute ethanol washing product 3 times, obtains final product Benexate Hydrochloride.
9. preparation method as claimed in claim 7, it is characterised in that：The step（2）During host material be gelatin and
During the mixture of polyvinyl alcohol, host material processing method：Gelatin and polyvinyl alcohol are soaked 4-8 hours in water respectively,
Poly-vinyl alcohol solution is stirred under the conditions of 70 DEG C of water-bath, gelatin solution is slowly added into when being completely dissolved, stirring and dissolving is complete, i.e.,
.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019119292A1 (en) * | 2017-12-20 | 2019-06-27 | 沃康生技股份有限公司 | Pasting structure |
| CN110893186A (en) * | 2018-09-12 | 2020-03-20 | 宜昌人福药业有限责任公司 | Pharmaceutical composition and preparation method and application thereof |
| US11478422B2 (en) | 2018-06-27 | 2022-10-25 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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| CN103191184A (en) * | 2013-04-16 | 2013-07-10 | 王怀伟 | Novel nasal strip gel layer, novel nasal strip and preparation method of nasal strip |
| CN105770071A (en) * | 2016-04-07 | 2016-07-20 | 尹龙飞 | Beauty nasal paste coating |
| CN105796645A (en) * | 2016-05-24 | 2016-07-27 | 中山大学 | Concealed nasal patch capable of reliving rhinobyon and preparation method of concealed nasal patch |
| CN106539778A (en) * | 2016-12-08 | 2017-03-29 | 武汉大学 | Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof |
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| CN103191184A (en) * | 2013-04-16 | 2013-07-10 | 王怀伟 | Novel nasal strip gel layer, novel nasal strip and preparation method of nasal strip |
| CN105770071A (en) * | 2016-04-07 | 2016-07-20 | 尹龙飞 | Beauty nasal paste coating |
| CN105796645A (en) * | 2016-05-24 | 2016-07-27 | 中山大学 | Concealed nasal patch capable of reliving rhinobyon and preparation method of concealed nasal patch |
| CN106539778A (en) * | 2016-12-08 | 2017-03-29 | 武汉大学 | Preoperative buccal oral cavity effervescent tablet of a kind of pediatric anesthesia and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| WO2019119292A1 (en) * | 2017-12-20 | 2019-06-27 | 沃康生技股份有限公司 | Pasting structure |
| US11478422B2 (en) | 2018-06-27 | 2022-10-25 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11497711B2 (en) | 2018-06-27 | 2022-11-15 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11517524B2 (en) | 2018-06-27 | 2022-12-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11559484B2 (en) | 2018-06-27 | 2023-01-24 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11806429B2 (en) | 2018-06-27 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| CN110893186A (en) * | 2018-09-12 | 2020-03-20 | 宜昌人福药业有限责任公司 | Pharmaceutical composition and preparation method and application thereof |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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