CN110200953A - Cannboid is preparing the application in inhalation drug - Google Patents
Cannboid is preparing the application in inhalation drug Download PDFInfo
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Abstract
The invention discloses a kind of cannboids to prepare the application in inhalation drug, and the inhalation time of the drug is short, and patient's inhalation time is lower than 1 minute, and drug effect plays rapidly, and peak reaching time of blood concentration is short, and drug bioavailability is high.
Description
Technical field
The invention belongs to biomedicine fields, and in particular to cannboid is preparing the application in inhalation drug.
Background technique
Hemp (scientific name: Cannabis sativa L.) is Moraceae Cannabis plant, is used as drug existing very long
History.In 1997, National Institutes of Health (NIH) delivered report " Workshop on the Medical Utility
Of Marijuana " outlines the useful science data about hemp on treatment use, it is proposed that supports hemp in following medicine
Nausea and vomiting, nerve after the research of potential use in indication: stimulating appetite and/or cachexia, anticancer therapy and
Dyskinesia, pain and glaucoma.Report " Marijuana and Medicine, Assessing were then delivered in 1999
The Science Base " provides the commentary to the reality and potential treatment purposes of cannboid, in addition to this of confirmation hemp
Other than a little medical usages, this report is further highlighted for quick acting, non-smoking formula, safely and reliably cannboid delivery system
Needs.
Cannboid is a distinctive substance in hemp plant, is main active constituent in cannabis plants, it is related it
Research is always the hot spot of hemp research.Main hemp is known as cannabinol (CBN), cannabidiol (CBD), secondary in hemp plant
Cannabidiol (CBDV), cannabigerol (CBG), tetrahydrocannabinol (THCV), tetrahydrocannabinol (THC) etc..Wherein THC can make
People causes unreal habituation, can make drugs, once forbid cultivating within suitable long-term, still, since the economy of hemp, medical value are high, specially
Be referred to as " industrial hemp " for the raw material hemp of industrial use, the THC content in growth period hemp floral leaf less than 3/1000ths,
Do not have extract toxic component tetrahydrocannabinol value or sucked directly as drugs, can legal progresss large-scale planting and
Industrialized developing utilizes.The hemp refers both to industrial hemp in the present invention.Above-mentioned phenolic substances has been shown to have very strong
Pharmacological activity, especially CBD, since it more becomes research hotspot with a variety of pharmacological activity, CBD does not have Nervous toxicity
Property, influence of the THC to nerve system of human body can be hindered, and there is apparent anti-spasm, resisting rheumatoid arthritis, antianxiety etc.
Pharmacological activity has huge industry development value；CBD and THCV can influence lipid and glycometabolism, be likely to become 2 type glycosurias of control
The new selection of patient's blood glucose；CBDV has preferable antiepileptic activity, while some researches show that CBDV can reduce nausea,
Help to treat gastrointestinal problems.
As the pharmacology and physiological activity of cannboid are increasingly paid attention to by common people, the pharmaceutical preparation containing cannboid is obtained extensively
General research.Patent document CN200880106135.9 disclose it is a kind of comprising Cannabinoids tetrahydroquinone diphenol (THCV) and
The pharmaceutical preparation of cannabidiol (CBD), the preparation are tablet, capsule, pulvis, dispersible granula, pill, suspension or cream
Agent etc..In the prior art, contain the drug that cannboid is prepared into inhalable dosage form compared with major general.
Inhalable drug carries out the drug of respiratory tract and systemic therapy by pulmonary administration.Pulmonary administration is relatively injected, thoroughly
Skin and oral administration have many advantages, and drug can be done directly on diseased region, have significant in efficacy, dosage is small,
Quick, few side effects and it is easy to use the advantages that, respiratory tract local drug concentration is high, can avoid or reduces whole body and use medicine
Object has bigger attraction to patient and doctor.
Inhalation mode provides a kind of non-invasive medication, and patient only needs to cooperate, it is ensured that the hair of drug effect
It waves, it has also become a kind of current ideal administration route.Firstly, inhalation can be realized effective lung's targeting medication,
Treatment for relatively common respiratory disease such as asthma, pulmonary emphysema, bronchiectasis and chronic bronchitis；Secondly, inhaling
Enter administration to take effect rapidly, faster than oral or subcutaneous injection close to intravenous injection, this administration mode is conducive to pain, insane
Epilepsy, fear or anxiety attack, hypertensive crisis, allergic reaction and Parkinson's disease treatment；Finally, inhalation replace take orally to
Medicine can to avoid with dissolubility is poor, bioavilability is low, alimentary canal irritation, unnecessary metabolism, food effect and dose-difference
The gastrointestinal problems such as different.
Lung sucks to there are three types of type of preparation at present, and inhalation powder spray sucks water mist agent, inhalation aerosol.Suck powder
Mist agent means a kind of and more than one drugs, enters corresponding portion, lung by special inbalation administration device with dry powder aerosol form
The dosage form of whole body or local action is played in position.Sucking powder advantage is, easy to use, is easy to load.Disadvantage is that dosage is more, partial size
It is unevenly distributed, and part partial size is larger, is not easy to be absorbed by alveolar.This physiological structure of lung, so that only working as drug
The dust cloud particle that grain partial size is 1 to 5 μm gets to bronchus or alveolar.
Inhalation aerosol refers to the mixed liquor for constituting drug solution or suspension and suitable propellant, is divided in together
In the autoclave for possessing particular valve device, pot liquid is sprayed at aerosol form using propellant pressure when use, according to
It is independently sucked by patient, to make drug deposition in lung's corresponding site.Advantage be it is easy to use, it is easy to carry, the disadvantage is that need
Propellant and other auxiliary materials are added, bring added burden to lung, partial size is uneven.
Sucking water mist agent, which is meant, to be dissolved in water for bulk pharmaceutical chemicals or is scattered in respective media, and aqueous solution or suspension are prepared into.
It is atomized to form aerosol with atomizer again, patient actively sucks, to make drug deposition in lung's corresponding site.Suck water mist agent
It is mainly used for treating respiratory disease, in particular asthmatic patient, advantage are that particle is small and uniform, and most partial sizes meet 1-5 μ
M area requirement, be not necessarily to propellant, high dose can be delivered, be not necessarily to special hand-lung cooperation, eupnea, patient make great efforts compared with
It is few, it is suitable for any age patient or first aid.The disadvantage is that a dosage can only be delivered, treatment once needs 20min or so, time
It is long.
U.S. Patent application US20040034108A1 describes a kind of drug system comprising cannboid, solvent and cosolvent
Agent may be used in atomizing pump to be administered, and described can include C1-C4 alcohols with solvent, including as preferred solvent
Ethyl alcohol.Cosolvent includes di-alcohols and glycitols, carbonates and chlorinated hydrocarbons.In order to obtain be suitable for atomizing pump with
The desired partial size of aerosol administration, the viscosity of preparation be it is vital, therefore, solvent: the work model of cosolvent
It encloses and is rather narrow.
Patent document CN200680021401.9 discloses a kind of comprising cannabinoid activity drug ingedient crystalline trans-
The pharmaceutical composition of (±)-Δ 9- tetrahydrocannabinol, including by a effective amount of crystalline trans-(±)-Δ 9- tetrahydrocannabinol and
Pharmaceutically acceptable carrier is mixed to provide composition, the lung of the mammal is delivered to using mechanical device, the machinery
Device preferably is selected from powder inhalator, multi-unit dose inhaler, metered-dose inhaler, atomizing pump and sprayer.
United States Patent (USP) US6747058 describes the composition for Inhalation in Treating, and wherein Δ 9-THC is formulated in semi-aqueous molten
In agent, which contains alcohol, water and the pharmaceutically acceptable dihydric alcohol of " discretion selection " volume ratio, such as 35: 10:
55 ethyl alcohol: water: propylene glycol.
Patent application publication US 20030229027A1 discloses a kind of preparation, and wherein cannabinoid compounds are introduced into
In glassy sugar (sugar glass) or glassy sugar alcohol (sugar alcohol glass), natural cannabinoid compound dissolution
In water-miscible organic solvent, and the sugar is dissolved in the water.Both solution are merged to form mixture, then face it with super
The freeze-drying of boundary's fluid, spray drying, vacuum drying or dry.Freeze-drying generates porous pie, can be processed into powder
Shape object and can be used for tabletting or for pulmonary administration.
United States Patent (USP) US6713048 describes Δ 9-THC solution metered-dose inhaler, contains and casts comprising hydrofluoroalkane
The composition of agent and Δ 9-THC.Suitable propellant includes seven fluorine third of 1,1,1,2- tetrafluoroethane and 1,1,1,2,3,3,3-
Alkane.In addition, said preparation also may include organic solvent (such as ethyl alcohol) so that Δ 9-THC dissolves.
On the basis of existing technology, the present invention provides a kind of cannboid and is preparing the application in inhalation drug, has
It has the advantage that 1) diameter of aspirin particle is uniform, and meets pulmonary administration sucking and require.2) auxiliary material is free of, auxiliary material can be set before sucking
Standby removal.3) administration time is short, and atomized medicine introducing can be completed in several minutes, shorter than with the Conventional nebulizer administration 20min time
Very much, drug effect plays rapidly, and peak reaching time of blood concentration is short, and drug bioavailability is high.
Summary of the invention
The object of the present invention is to provide a kind of cannboids to prepare the application in inhalation drug, when the drug administration
Between be lower than 1 minute；On the other hand, the present invention also provides a kind of composition containing cannboid, also contain medicine in the composition
Object carrier, the composition heat vaporization and/or atomization at 100-400 DEG C；The present invention also provides a kind of applications of cannboid
Method, specifically includes cannboid heating generation gas, and gas is used for inhalation after filtering is cooling.
In a first aspect, cannboid is given preparing the application in inhalation drug, the sucking of the inhalation drug
The medicine time is lower than 1 minute.
Preferably, the inhalation time of the inhalation drug is lower than 10 seconds
Preferably, the inhalation time of the inhalation drug is 1-8 seconds.
It is furthermore preferred that the inhalation drug inhalation time is 1-3 seconds.
The inhalation drug is liquid medicine or solid drugs, it is preferred that the drug is solid drugs, described
Inhalation drug be 100-400 DEG C at can heat vaporize and/or be atomized drug.
It is furthermore preferred that the inhalation drug is the drug that can heat vaporization and/or atomization at 150-300 DEG C.
The solid drugs are the pharmaceutical preparation of following form: tablet, pill, capsule, film, granule.
Grain diameter is 0.1-20 μm after the heated vaporization of the inhalation drug and/or atomization, it is preferred that partial size model
Enclosing is 0.5-15 μm, it is furthermore preferred that particle size range is 0.5-10 μm.Preferably, further include in the drug and cannboid fusing point
Similar pharmaceutical carrier, it is preferred that pharmaceutical carrier differs ± 0-20 DEG C with cannboid fusing point.
It is furthermore preferred that pharmaceutical carrier differs ± 0-10 DEG C with cannboid fusing point.
The pharmaceutical carrier is soluble easily in water, selected from PEG, poloxamer, xylitol, sorbierite, lactitol, isomaltol,
Mannitol, dextrin, starch, gelatin, carragheen, tragacanth, Bletilla glucomannan, melon bean gum, konjac glucomannan, Karaya Gum, pectin, fine jade
The combination of one or more of rouge, Indian gum, tamarind gum, locust bean gum.
Preferably, the pharmaceutical carrier be selected from PEG and/or poloxamer, the PEG be selected from PEG4000, PEG5000,
The combination of one or more of PEG6000, PEG7000, PEG7500, PEG8000.
In a preferred embodiment of the invention, the pharmaceutical carrier is PEG6000.
The mass percent of cannboid is 1-99% in the inhalation drug, it is preferred that big in inhalation drug
The mass percent of numb element is 1-50%, it is furthermore preferred that the mass percent of cannboid is 20% in inhalation drug.
Cannboid of the present invention can be chemosynthesis product, biosynthetic products, plant extracts or use it
He is prepared mode.The cannboid include cannabidiol (CBD), cannabidivarin (CBDV), cannabigerol (CBG),
The combination of one or more of tetrahydrocannabinol (THCV), hemp chromene (CBC), cannabinol (CBN).
Preferably, the mass percent of CBD is not less than 60% in the cannboid, it is preferred that CBD in the cannboid
Mass percent is not less than 90%, and most preferably, the mass percent of CBD is not less than 99.7% in cannboid.
Inhalation drug of the invention be prevent and/or treatment Nausea and vomiting, HIV wasting syndrome, loss of appetite,
Multiple sclerosis, epilepsy, pain, arthritis, dyskinesia, glaucoma, asthma, hypertension, phrenoblabia, is crazy about at spinal cord injury
Slow-witted, systemic inflammatorome, enterogastric diseases, acute stress disorder, depression, anxiety disorder (generalized anxiety disorder, Social Anxiety barrier
Hinder, neurosis, obsessive-compulsive disorder, paranoid fears, posttraumatic stress disorder), premenstrual syndrome, attention deficit disorder, obesity, feed
Flushing, cocaine caused by obstacle, vessel retraction and alcohol addiction, sex dysfunction and related disease, Functional Somatic disorder,
The drug of neurological disorders.
Inhalation drug of the invention equally can be the inhalation drug of non-treatment purpose.
Second aspect, a kind of composition, described pharmaceutical composition include cannboid and pharmaceutical carrier, the pharmaceutical carrier with
Cannboid fusing point is close, it is preferred that pharmaceutical carrier differs ± 0-20 DEG C with cannboid fusing point.
It is furthermore preferred that pharmaceutical carrier differs ± 0-10 DEG C with cannboid fusing point.
Preferably, the mass percent of cannboid is 1-99% in the composition, it is preferred that the quality percentage of cannboid
Than for 1-50%, it is furthermore preferred that the mass percent of cannboid is 20%.
The cannboid includes cannabidiol, cannabidivarin, cannabigerol, tetrahydrocannabinol, hemp chromene, big
The combination of one or more of numb phenol.Preferably, the mass percent of CBD is excellent not less than 60% in the cannboid
Choosing, the mass percent of CBD is not less than 90% in the cannboid, and most preferably, in cannboid the mass percent of CBD is not
Lower than 99.7%.
The pharmaceutical carrier is pharmaceutical carrier soluble easily in water, is selected from PEG, poloxamer, xylitol, sorbierite, lactose
Alcohol, isomaltol, mannitol, dextrin, starch, gelatin, carragheen, tragacanth, Bletilla glucomannan, melon bean gum, konjac glucomannan, thorn Chinese parasol tree
The combination of one or more of paulownia glue, pectin, agar, Indian gum, tamarind gum, locust bean gum.
Preferably, the pharmaceutical carrier be selected from PEG and/or poloxamer, the PEG be selected from PEG4000, PEG5000,
The combination of one or more of PEG6000, PEG7000, PEG7500, PEG8000.
In a preferred embodiment of the invention, the pharmaceutical carrier is selected from PEG6000.
The composition be following form pharmaceutical preparation: tablet, pill, capsule, spray, oily solution, film,
Granula, suspension.
Preferably, the composition is the pharmaceutical preparation of following form: tablet, pill, capsule, film, granule.
In a preferred embodiment of the invention, described pharmaceutical composition is pill.
Preferably, further include antioxidant in the composition, buffer, preservative, lubricant, adhesive, colorant,
The combination of one or more of pH adjusting agent is as excipient substance.
In a preferred embodiment of the invention, the composition is unit preparation, includes appropriate in the unit formulation
The active component cannboid of amount, the amount of active component can be altered or modified between 0.001mg to 1000mg in unit formulation, root
Depending on the pharmaceutical efficacy of cannboid ingredient in unit formulation and the disease of corresponding treatment.
In the present invention, cannabinoid content is 0.1-1000mg in the unit formulation, it is preferred that in the unit formulation
Cannabinoid content is 10-100mg.
The composition can heat vaporization and/or atomization at 100-400 DEG C, it is preferred that pharmaceutical composition is in 150-
Vaporization and/or atomization can be heated at 300 DEG C.Grain diameter is 0.1-20 μm after heating vaporization and/or atomization, it is preferred that partial size
Range is 0.5-15 μm, it is furthermore preferred that particle size range is 0.5-10 μm.
The administration mode of the composition is inhalation, and the inhalation time is lower than 1 minute.
Preferably, the inhalation time of the inhalation drug is lower than 10 seconds
Preferably, the inhalation time of the inhalation drug is 1-8 seconds.
It is furthermore preferred that the inhalation drug inhalation time is 1-3 seconds.
The third aspect, a kind of method of administration of cannboid, including cannboid is heated into vaporization and/or atomization, filtering cooling
After suck, it is preferred that further include the pharmaceutical carrier close with its fusing point in the cannboid.
The pharmaceutical carrier differs ± 0-20 DEG C with cannboid fusing point, it is preferred that pharmaceutical carrier is differed with cannboid fusing point
±0-10℃。
Preferably, a kind of method of administration of cannboid, including cannboid and pharmaceutical carrier are heated into vapour in heating device
Change and/or atomization, gas and/or droplet pass through conveying device and enter filtering cooling device, is filtered to remove pharmaceutical carrier and/or medicine
Object auxiliary material adds thermogenetic gas and/or droplet, and remaining cannboid gas and/or droplet are inhaled by suction apparatus by patient
Enter.
The heating temperature of the heating device is 100-400 DEG C, it is preferred that heating temperature is 150-300 DEG C.
Grain diameter is 0.1-20 μm after cannboid and the heated vaporization of pharmaceutical carrier and/or atomization, it is preferred that partial size model
Enclosing is 0.5-15 μm, it is furthermore preferred that particle size range is 0.5-10 μm.
Preferably, the gas and/or droplet that heating vaporization and/or atomization generate flow through filtered fluid and are filtered cooling, institute
It states filtered fluid and is selected from water, it is furthermore preferred that the coolant-temperature gage is 1-40 DEG C, most preferably, the coolant-temperature gage is 1-25 DEG C.
Cannboid of the present invention includes cannabidiol (CBD), cannabidivarin (CBDV), cannabigerol (CBG), four
The combination of one or more of hydrogen time cannabinol (THCV), hemp chromene (CBC), cannabinol (CBN).Preferably, institute
The mass percent of CBD in cannboid is stated not less than 60%, it is preferred that the mass percent of CBD is not less than in the cannboid
90%, most preferably, the mass percent of CBD is not less than 99.7% in cannboid.
The pharmaceutical carrier is soluble easily in water, selected from PEG, poloxamer, xylitol, sorbierite, lactitol, isomaltol,
Mannitol, dextrin, starch, gelatin, carragheen, tragacanth, Bletilla glucomannan, melon bean gum, konjac glucomannan, Karaya Gum, pectin, fine jade
The combination of one or more of rouge, Indian gum, tamarind gum, locust bean gum.
Preferably, the pharmaceutical carrier be selected from PEG and/or poloxamer, the PEG be selected from PEG4000, PEG5000,
The combination of one or more of PEG6000, PEG7000, PEG7500, PEG8000.
In a preferred embodiment of the invention, the pharmaceutical carrier is PEG6000.
The method can be used for therapeutic purposes or non-treatment purpose.
It is an advantage of the present invention that providing cannboid is preparing the application in inhalation drug, the sucking of the drug
Administration time is short, and patient preferably sucks in 10 seconds, and drug effect plays rapidly, and peak reaching time of blood concentration is short, drug biological utilisation
Degree is high.The preparation containing cannboid can as unit of preparation, unit dosage form it is accurate；Due to pharmaceutical carrier fusing point with
Cannboid fusing point is close, but different solubility of the two in same media, so that can be filled by filtering after vaporization and/or atomization
It sets the gas for generating pharmaceutical carrier to remove, obtains pure cannboid gas for inhalation.
Specific embodiment
The technical scheme in the embodiments of the invention will be clearly and completely described below, it is clear that described implementation
Example is only section Example of the invention, rather than all.Based on the embodiments of the present invention, those of ordinary skill in the art exist
Every other embodiment obtained under the premise of creative work is not made, shall fall within the protection scope of the present invention.
The preparation of pill of the embodiment 1 containing cannboid (20%)
A, by 6,000 80 parts of 20 parts of cannboid (mass percent of CBD is 99.7%), pharmaceutical carrier PEG addition stirrings
In container, it is heated to 65 DEG C while stirring, makes the material melts being added at feed liquid, stirs 30min until uniformly；
Feed liquid injection is shifted to an earlier date in the spherical die that ready diameter is 10mm, is cooled to room temperature molding to it by b；
Mold is sloughed after c, 1h, takes out the spherical pellets of forming.
The preparation of pill of the embodiment 2 containing cannboid (50%)
A, by 6,000 50 parts of 50 parts of cannboid (mass percent of CBD is 99.7%), pharmaceutical carrier PEG addition stirrings
In container, it is heated to 65 DEG C while stirring, makes the material melts being added at feed liquid, stirs 30min until uniformly；
Feed liquid injection is shifted to an earlier date in the spherical die that ready diameter is 10mm, is cooled to room temperature molding to it by b；
Mold is sloughed after c, 1h, takes out the spherical pellets of forming.
The preparation of pill of the embodiment 3 containing cannboid (90%)
A, by 6,000 10 parts of 90 parts of cannboid (mass percent of CBD is 99.7%), pharmaceutical carrier PEG addition stirrings
In container, it is heated to 60 DEG C while stirring, makes the material melts being added at feed liquid, stirs 30min until uniformly；
Feed liquid injection is shifted to an earlier date in the spherical die that ready diameter is 10mm, is cooled to room temperature molding to it by b；
Mold is sloughed after c, 1h, takes out the spherical pellets of forming.
The preparation of pill of the embodiment 4 containing cannboid (90%)
A carries cannboid 90 parts of (mass percent of CBD is 60.6%, CBDV 30.8%, CBN 30.1%), drugs
In 10 parts of addition stirring containers of body poloxamer, it is heated to 60 DEG C while stirring, makes the material melts being added at feed liquid, stirring
30min is until uniformly；
Feed liquid injection is shifted to an earlier date in the spherical die that ready diameter is 10mm, is cooled to room temperature molding to it by b；
Mold is sloughed after c, 1h, takes out the spherical pellets of forming.
The preparation of pill of the embodiment 5 containing cannboid
A, by 4,000 80 parts of 20 parts of cannboid (mass percent of CBD is 99.7%), pharmaceutical carrier PEG addition stirrings
In container, it is heated to 65 DEG C while stirring, makes the material melts being added at feed liquid, stirs 30min until uniformly；
Feed liquid injection is shifted to an earlier date in the spherical die that ready diameter is 10mm, is cooled to room temperature molding to it by b；
Mold is sloughed after c, 1h, takes out the spherical pellets of forming.
The preparation of pill of the embodiment 6 containing cannboid
A holds 80 parts of 20 parts of cannboid (mass percent of CBD is 99.7%), pharmaceutical carrier mannitol addition stirrings
In device, it is heated to 65 DEG C while stirring, makes the material melts being added at feed liquid, stirs 30min until uniformly；
Feed liquid injection is shifted to an earlier date in the spherical die that ready diameter is 10mm, is cooled to room temperature molding to it by b；
Mold is sloughed after c, 1h, takes out the spherical pellets of forming.
The selection of 7 Chinese medical pill object carrier of embodiment
According to preparation method disclosed in embodiment 1 and material ratio, in the case where cannboid is constant, drug load is prepared respectively
Body is the cannboid pill of mannitol, PEG4000, PEG 6000, detects the formability of 3 kinds of pills, surface flatness, and drug carries
Body solubility in water, the indexs such as cannboid rate of transform, the results are shown in Table 1.Cannboid pill is placed in heating device and is risen
Cannboid pill is atomized, the gas for being atomized generation is filtered cooling by filter device, removes medicine by temperature to 300 DEG C of heating
Object carrier adds thermogenetic gas, and filtered fluid is selected from 10 DEG C of water, and detection is filtered cannboid and drug in gas after cooling and carried
The ratio for the gas that body generates, the results are shown in Table 2.
Drug vector selection in the preparation of 1 cannboid pill of table
Drug vector selection in the application of 2 cannboid pill of table
| Pharmaceutical carrier | Filter gas cannabinoid content | Filter carrier gas content |
| Mannitol | 80% | 13% |
| PEG4000 | 90% | 6% |
| PEG6000 | 96% | 1% |
According to testing result as can be seen that when pharmaceutical carrier is mannitol, PEG4000 or PEG6000, cannboid pill
The drug rate of transform it is all the same, since mannitol viscosity is larger, so that pill formability surface flatness is impacted.In addition, medicine
The solubility of object carrier in water, solubility is best in water by PEG6000.The gas of pill heating atomization, generation was passed through
Filter cooling device, through detection pharmaceutical carrier be PEG6000 when, filter gas in cannboid content highest, reach 96%.
The selection of 8 cannboid pill drugloading rate of embodiment
It selects PEG6000 for pharmaceutical carrier, the cannboid of 10%, 20%, 30%, 50% mass is separately added into, according to reality
It applies preparation method disclosed in example 1 and prepares cannboid pill, by stripping result, the examination of pill formability two indices, screening is big
The best drugloading rate of numb vegetable pill agent, the results are shown in Table 3.
The screening of 3 cannboid pill drugloading rate of table
By above-mentioned experimental result we have found that the content of cannboid has a certain impact for the preparation of pill, work as hemp
Cellulose content it is excessively high such as 50% when, stripping result is poor in pill preparation process, and pill is shapeless, when cannabinoid content is 30%
When, pill stripping result and formability are still bad, are able to achieve when cannabinoid content is 20% and demould the forming of smooth and pill
The good maximum drugloading rate of property.
Pill peculiar smell contrast test of the embodiment 9 containing cannboid
Gas odor will be detected after cannboid pill heating atomization prepared by embodiment 1-6, is carried out with cannboid
Control.Above-mentioned cannabinoid formulation is heated in heating device, temperature is 300 DEG C, and smog is filtered through water after atomization, record
The smell generated in heating process, the results are shown in Table 4.
The cannabinoid drugs heated baking experimental result of 4 different dosage forms of table
| Pharmaceutical carrier | Taste | As a result | |
| Embodiment 1 | PEG6000 (80%) | It is tasteless | It is qualified |
| Embodiment 2 | PEG6000 (50%) | It is tasteless | It is qualified |
| Embodiment 3 | PEG6000 (10%) | It is tasteless | It is qualified |
| Embodiment 4 | Poloxamer (10%) | It is tasteless | It is qualified |
| Embodiment 5 | PEG4000 (80%) | It is tasteless | It is qualified |
| Embodiment 6 | Mannitol (80%) | It is tasteless | It is qualified |
| Cannboid | Nothing | It is tasteless | It is qualified |
It can see according to above-mentioned experimental result, compared with DNAcarrier free cannboid, when pharmaceutical carrier is PEG, mannitol
Or when poloxamer, the gas that generates is tasteless after the heating of cannabinoid drugs preparation, and PEG as pharmaceutical carrier content to drug
The smell generated after heating does not influence.
Effect example
1.1 subject's situations
The medical patient 180 of certain sleep section, hospital is randomly selected, the age is 26-45 years old, and the state of an illness duration is 3-14
Month, insomnia factor is the sleep disturbance as caused by anxiety.Subject is randomly divided into cannboid pill group, cannboid spray
Group, placebo, every group 30, male to female ratio is close to 1:1.
1.2 are included in and exclusion criteria
1.2.1 it is included in standard: meeting examining about insomnia in " Chinese Spirit Obstacles classification and diagnostic criteria " third edition
Disconnected standard；All patients sign informed consent form.
1.2.2 exclusion criteria: though it excludes with insomnia, simultaneously with other organic disease persons；Exclude allergy
Constitution patient and to this research institute use drug allergy person；It excludes with the heart, Liver and kidney function obstacle person；Exclude physical disease
Or insomniac caused by psychoactive substance abuse or dependence.
1.3 therapeutic agent
1 group of cannboid pill: the cannboid pill that cannabinoid content prepared by embodiment 1 is 20%, in heating device
300 DEG C are heated to be atomized, gas is filtered cooling by filter device, and subject is sucked by suction apparatus, and every
Subject is 3 seconds the suction medicine time.
2 groups of cannboid pill: the cannboid pill that cannabinoid content prepared by embodiment 1 is 20%, in heating device
300 DEG C are heated to be atomized, gas is filtered cooling by filter device, and subject is sucked by suction apparatus, and every
Subject is 10 seconds the suction medicine time.
3 groups of cannboid pill: the cannboid pill that cannabinoid content prepared by embodiment 1 is 20%, in heating device
300 DEG C are heated to be atomized, gas is filtered cooling by filter device, and subject is sucked by suction apparatus, and every
Subject is 5 minutes the suction medicine time.
4 groups of cannboid pill: the cannboid pill that cannabinoid content prepared by embodiment 1 is 20%, in heating device
300 DEG C are heated to be atomized, gas is filtered cooling by filter device, and subject is sucked by suction apparatus, and every
Subject is 20 minutes the suction medicine time.
Cannboid spray group: it is spraying that the cannboid that cannabinoid content is 20% is prepared according to method disclosed in the prior art
Agent, allowed when needing to be administered patient voluntarily lip-syncing spray into.Cannboid spray is the preparation method is as follows: 20 parts of cannboid, and 80 parts of solvent,
Solvent is ethyl alcohol: cannboid is dissolved in solvent by the mixture of propylene glycol (v/v=1:1), is vortexed and is mixed, liquid subpackage is entered
It is stand-by in the spray bottle of 120ml capacity.
Placebo: blank pill is prepared according to preparation method disclosed in embodiment 1, wherein cannboid is by PEG6000 generation
It replaces, blank pill is heated to 300 DEG C in heating device and is atomized, and gas is filtered cooling by filter device, tested
Person is sucked by suction apparatus, and every subject is 3 seconds the suction medicine time.
1.4 treatment method
Subject needs the 1h self-administration before sleeping every night, 1 times/day, 4mg/ times, continuously takes 7 days.
1.5 efficacy determination
Curative effect determinate standard is as follows, recovery from illness: patient's sleeping time reaches normal condition or Nighttime sleep > after treatment
6h, it is full of vitality after wakeing up；It is effective: patient's sleeping state improving after treatment, increase >=3h before sleeping time relatively treats；It is effective:
Patient's sleep quality makes moderate progress after treatment, increased before sleeping time relatively treatment, but increase time < 3h；It is invalid: treatment
Patient's sleep state does not improve afterwards, or even aggravates.
1.6 statistical procedures
Data to be analyzed using 18.0 statistics software of SPSS, are examined using t, enumeration data uses chi-square criterion, with
P < 0.05 is that difference is statistically significant.
2 test results
Each test group time for falling asleep, sleep time, night awakening number data be shown in Table 5.
The comparison of 5 time for falling asleep of table, sleep time, night awakening number
As can be seen from the above table, the time for falling asleep < 15min person of cannboid pill 1-2 group, sleep time >=6h person,
Night is significantly higher than placebo without awakening person's proportion, and difference has statistical significance (P < 0.05), cannboid spray
Although group also has certain therapeutic effect relative to placebo, effect does not have the cannboid pill group of inhalation to treat
Effect is good.The therapeutic effect of cannboid pill 1-4 group is compared, when the inhalation time is 3 seconds or 10 seconds, the effect of relieving mental strain and helping sleep
Preferably, when the inhalation time long to 20 minutes, therapeutic effect is suitable with spray delivery.Therefore, hemp prepared by the present invention
When the vegetable pill agent inhalation time is 3-10 seconds, inhalation effect effect in terms of tranquilizing and allaying excitement, sleeping, anxiety of releiving
Significantly.
Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Pipe present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: its according to
So be possible to modify the technical solutions described in the foregoing embodiments, or to some or all of the technical features into
Row equivalent replacement；And these are modified or replaceed, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme.
Claims (13)
1. a kind of cannboid is preparing the application in inhalation drug, the inhalation time of the drug was lower than 1 minute.
2. application according to claim 1, which is characterized in that the inhalation drug is liquid medicine or solid medicine
Object.
3. application according to claim 2, which is characterized in that the drug be 100-400 DEG C at can heat vaporize with/
Or the drug of atomization.
4. application according to claim 3, which is characterized in that particle after the heated vaporization of the drug and/or atomization
Diameter is 0.1-20 μm.
5. application according to claim 1 to 4, which is characterized in that further include in the drug and cannboid fusing point phase
Close pharmaceutical carrier, it is preferred that pharmaceutical carrier differs ± 0-20 DEG C with cannboid fusing point.
6. -5 any application according to claim 1, which is characterized in that the pharmaceutical carrier is that drug soluble easily in water carries
Body.
7. application according to claim 6, which is characterized in that the pharmaceutical carrier be selected from PEG, poloxamer, xylitol,
Sorbierite, lactitol, isomaltol, mannitol, dextrin, starch, gelatin, carragheen, tragacanth, Bletilla glucomannan, melon bean gum,
The combination of one or more of konjac glucomannan, Karaya Gum, pectin, agar, Indian gum, tamarind gum, locust bean gum.
8. a kind of composition, the composition includes cannboid and pharmaceutical carrier soluble easily in water, the pharmaceutical carrier and hemp
Plain fusing point is close, it is preferred that pharmaceutical carrier differs ± 0-20 DEG C with cannboid fusing point, and the pharmaceutical composition is in 100-400
Vaporization and/or atomization can be heated at DEG C.
9. composition according to claim 8, which is characterized in that pharmaceutical carrier differs ± 0-10 DEG C with cannboid fusing point,
The mass percent of cannboid is 1-99% in the composition, and the pharmaceutical carrier is selected from PEG and/or poloxamer, described
PEG is selected from the group of one or more of PEG4000, PEG5000, PEG6000, PEG7000, PEG7500, PEG8000
It closes.
10. composition according to claim 8, which is characterized in that the pharmaceutical carrier is selected from: PEG6000, the combination
Object is unit preparation, cannabinoid content 0.1-1000mg.
11. a kind of method of administration of cannboid, cold including the composition heating containing cannboid is vaporized and/or is atomized, is filtered
But it sucks afterwards, it is preferred that further include in the composition and pharmaceutical carrier similar in cannboid fusing point, the pharmaceutical carrier and big
Numb ± 0-20 DEG C of difference of fusing point of element.
12. the method for administration of cannboid according to claim 11, which is characterized in that including by composition in heating device
Middle heating vaporization and/or atomization, gas and/or droplet pass through conveying device and enter filtering cooling device, are filtered to remove drug load
Body, remaining cannboid gas and/or droplet pass through suction apparatus, it is preferred that the filtered fluid is water.
13. the method for administration of any cannboid of 1-12 according to claim 1, which is characterized in that the method for administration
For non-treatment purpose.
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| CN112915121A (en) * | 2019-12-06 | 2021-06-08 | 汉义生物科技（北京）有限公司 | Cannabinoid nano micelle preparation and preparation method thereof |
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