CN107951869A - Pharmaceutical preparation and its application containing cannabidiol - Google Patents

Pharmaceutical preparation and its application containing cannabidiol Download PDF

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Publication number
CN107951869A
CN107951869A CN201610893569.4A CN201610893569A CN107951869A CN 107951869 A CN107951869 A CN 107951869A CN 201610893569 A CN201610893569 A CN 201610893569A CN 107951869 A CN107951869 A CN 107951869A
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CN
China
Prior art keywords
pharmaceutical preparation
cannabidiol
application described
cbd
depression
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CN201610893569.4A
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Chinese (zh)
Inventor
张可
谭盺
常坦然
金倩
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Han Yi Biotechnology (beijing) Co Ltd
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Han Yi Biotechnology (beijing) Co Ltd
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Priority to CN201610893569.4A priority Critical patent/CN107951869A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols

Abstract

The present invention provides a kind of application of cannabidiol (CBD) with low dosage or its pharmaceutically acceptable salt in the pharmaceutical preparation for preparing prevention and/or treatment depression.

Description

Pharmaceutical preparation and its application containing cannabidiol
Technical field
The present invention relates to field of medicaments, and in particular to a kind of cannabidiol of low dosage is preparing prevention and/or treatment suppression Application in strongly fragrant pharmaceutical preparation.
Background technology
Depression is a kind of global common disease, and estimation shares 3.5 hundred million patients.Depression is different from common mood swing With the of short duration emotional reactions to challenging generation in daily life.Especially, long-term moderate or major depressive disorder are likely to become one A serious illness.Patient may be performed poor by extreme influence in work and in school and family life.Most serious When, depression can be led to suicide.Every year because its committed suicide Population size estimation is up to 1,000,000 people.
There is various active material to can be used for treating depression, such as serotonin reuptake inhibitors (SRI), noradrenaline Plain reuptaking inhibitor (NERI), serotonin-norepinephrine reuptake double inhibitor (SNRI), monoamine oxidase suppress Agent (MAQI), phosphodiesterase-4 (PDE4) inhibitor etc..But existing medicine to many patients still without therapeutic effect or Therapeutic effect is bad.In addition, one more important question is that there may be side effect, such as sexual function to hinder for traditional medicine Hinder, gastrointestinal disturbance, excitement, insomnia, weight gain, diabetes onset, heart rate correction interval prolongation etc..These side effects are usually Patient is hindered to be treated using medicine.Accordingly, it is determined that the minimum effective dose of antidepressants is need to continue the important of solution to ask Topic.
TV ZanelatiDeng(Antidepressant-like effects of cannabidiol in mice: possible involvement of 5-HT1A receptors, British journal of pharmacology, 2010)It was found that cannabidiol (CBD) can be by activating 5-HT1AReceptor-inducible antidepression sample acts on, it is believed that cannabidiol (CBD) With the antidepressant activity in mouse.But they think only 30 mgkg-1Dosage just have significant antidepression effect Fruit, does not all have effect below or above this dosage.
Patent CN101939017A discloses plant cannabinoids and is used to prevent or control with one or more antipsychotics Mental disease or phrenoblabia are treated, wherein plant cannabinoids include cannabidiol (CBD), but the patent is not provided and individually applied With the pharmaceutical dosage of cannabidiol (CBD).
Patent CN103391775A discloses cannabidiol (CBD) with the dosage higher than 300mg/ days with leading to by sodium or calcium The standard anti-epileptic drug combination of road effect is used for the purposes for treating epilepsy, but whether said medicine dosage is suitable for depression Treatment be unknown.
Therefore, the present invention provides a kind of cannabidiol (CBD) with low dosage or its pharmaceutically acceptable salt to exist Prepare the application in the pharmaceutical preparation of prevention and/or treatment depression.
The content of the invention
The present invention provides a kind of cannabidiol (CBD) or its pharmaceutically acceptable salt to prepare prevention and/or treatment Application in depressed pharmaceutical preparation, wherein cannabidiol (CBD) in the pharmaceutical preparation containing low dosage or its pharmaceutically Acceptable salt.
Preferably, it in pharmaceutical preparation containing unit dose is 25-200mg cannabidiols that low dosage of the present invention, which is, (CBD), it is furthermore preferred that the low dosage is in pharmaceutical preparation containing unit dose to be 25-150mg cannabidiols (CBD), Most preferably, it in pharmaceutical preparation containing unit dose is 50-120mg cannabidiols (CBD) that the low dosage, which is, in this hair In bright embodiment, in the pharmaceutical preparation containing unit dose can also be 25mg, 30mg, 40mg, 50mg, 60mg, 70mg, 80mg, 90mg, 100mg, 110mg, 120mg, 130mg, 140mg, 150mg, 160mg, 170mg, 180mg, 190mg or 200mg cannabidiols (CBD).
Present invention also offers a kind of method prevented and/or treatment is depressed, the method includes daily administration medicine Dosage is 25-200mg cannabidiols (CBD), it is furthermore preferred that daily administration drug dose is 25-150mg cannabidiols (CBD), most preferably, daily administration drug dose is 50-120mg cannabidiols (CBD), in embodiments of the present invention, Daily administration drug dose can also be 25mg, 30mg, 40mg, 50mg, 60mg, 70mg, 80mg, 90mg, 100mg, 110mg, 120mg, 130mg, 140mg, 150mg, 160mg, 170mg, 180mg, 190mg or 200mg cannabidiol (CBD).
Although think that application of the cannabidiol (CBD) in treatment is depressed depends on dosage, its antidepression in existing research Inverted U may be presented between sample activity and dosage, in 30 mgkg-1Dosage in mouse forced swim test performance it is the brightest It is aobvious.The present invention has surprisingly found that, when giving mouse low dosage, passes through 5-HTP(5-HTP)A behavior and habit are got rid of in induction Obtain helpless experiment to show, mouse shows obvious antidepression sample activity, but when dosage is too low, antidepressant activity disappears. Therefore, the present invention has surprisingly found that after being converted by mouse dosage, is 25-200mg hemps when applying containing unit dose Diphenol(CBD)When, patient can significantly improve depressive symptom, be finally reached the depressed purpose for the treatment of.
Present invention also offers a kind of pharmaceutical preparation, it is 25-200mg cannabidiols that the preparation, which includes unit dose, (CBD), it is furthermore preferred that containing unit dose being 25-150mg cannabidiols (CBD) in the pharmaceutical preparation, most preferably, Containing unit dose it is 50-120mg cannabidiols (CBD), in embodiments of the present invention, institute in the pharmaceutical preparation In the pharmaceutical preparation stated containing unit dose can also be 25mg, 30mg, 40mg, 50mg, 60mg, 70mg, 80mg, 90mg, 100mg, 110mg, 120mg, 130mg, 140mg, 150mg, 160mg, 170mg, 180mg, 190mg or 200mg cannabidiol And pharmaceutically acceptable auxiliary material (CBD),.
Cannabidiol (CBD) of the present invention can be chemosynthesis product, biosynthetic products, plant extracts Or it is prepared using other modes.Preferably, cannabidiol of the present invention is plant extracts, and the plant can be with For hempCannabis sativa LStalk core, flower, leaf, the shell of root and/or seed.
When cannabidiol of the present invention is plant extracts, Extraction solvent can be low mass molecule alcohol(Such as methanol, second Alcohol, butanol or propyl alcohol);Acetic acid esters(Such as methyl acetate or ethyl acetate);Ketone(Such as acetone);Ether(Such as methyl ether or second Ether);Low-boiling aliphatic hydrocarbon either aromatic hydrocarbon or chlorinated hydrocabon.The method of extraction includes:
(1)Using the said extracted solvent or its mixture of about 3-10 times weight to hempCannabis sativa LStalk Core, flower, leaf, the shell of root and/or seed are heated to reflux, preferably at least handle about 1 it is small when, be then filtered to remove residue, then Solvent is removed, preferably removes solvent in vacuum condition, the medicinal extract of acquisition is heated about 40 minutes for about 110-135 DEG C in temperature, with After carry out chromatographic isolation, be preferred for it is chromatographic flowing phase mixture by methanol/water and acetic acid or ethanol/water and acetic acid group Into.
(2)Using about 3-10 times weight said extracted solvent or its mixture to the stalk core of hemp, flower, leaf, root and/or The shell of seed is heated to reflux, preferably at least handle about 1 it is small when, filtering, then at least extracted with the sodium hydrate aqueous solution of 1-10% Take twice, the sodium hydrate aqueous solution preferably comprises from about the ethanol of 20wt%, extract is mixed with 5% sulfuric acid solution with Make pH value about 2-4, then using low boiling point solvent(Such as low boiling point aliphatic hydrocarbon, aromatic hydrocarbon, chlorohydrocarbon, methyl acetate, ethyl acetate Or its mixture)Extraction at least twice, removes solvent, then carries out chromatographic isolation, be preferred for chromatography under cryogenic vacuum Flowing phase mixture be made of methanol/water and acetic acid or ethanol/water and acetic acid.
It will be understood by those skilled in the art that when cannabidiol of the present invention is plant extracts, described carries Take in thing and be not less than 50% in mass ratio containing cannabidiol, preferably not less than 80%, more desirably not less than 90%, most preferably not Less than 95%.
Pharmaceutically acceptable salt of the present invention can be cannabidiol (CBD) and sodium hydroxide, potassium hydroxide, Calcium hydroxide, magnesium hydroxide, aluminium hydroxide, lithium hydroxide, zinc hydroxide, barium hydroxide, ammonia, methylamine, dimethylamine, diethylamine, Picoline, monoethanolamine, diethanol amine, triethanolamine, ethylenediamine, lysine, arginine, ornithine, choline, N, N '-hexichol Methyl ethylenediamine, chloroprocanine, diethanol amine, procaine, N- benzyls phenyl ethylamine, N-METHYL-ALPHA-L-GLUCOSAMINE piperazine, three (hydroxyls Ylmethyl) formation such as-aminomethane salt.
Pharmaceutical preparation of the present invention is selected from tablet, pill, pulvis, lozenge, powder, elixir, suspension, lotion, molten Liquid, syrup, aerosol, ointment, cutaneous permeable agent, soft capsule, hard shell capsules, suppository, aseptic injectable solution and freeze-dried powder The forms such as agent.
Also contain pharmaceutically acceptable auxiliary material in pharmaceutical preparation of the present invention, it is preferred that the auxiliary material is selected from Carrier and diluent(Lactose, dextrose, sucrose, sorbierite, mannitol, starch, gum arabic, calcium phosphate, alginates, Bassora gum, gelatin, calcium silicates, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrup, methylcellulose, hydroxy benzenes It is more than one or both of carboxylic acid methyl ester and hydroxybenzoic acid propyl diester, talcum, magnesium stearate and mineral oil), lubricant, Solubilizer, wetting agent, emulsifying agent and suspending agent, preservative, sweetener or flavouring.
The application process of pharmaceutical preparation of the present invention is selected from oral, subcutaneous, intracutaneous, intramuscular, peritonaeum, intravenously, Intranasal, Epidural cavity, sublingual, intranasal, intracerebral, leaf sheath are interior, transdermal, rectum etc..
It is of the present invention depressed depressed, false including psychogenic depression, endogenous depression, hypochondriasis type depression and anxiety Dementia form is depressed, chronic depression.It is furthermore preferred that depression of the present invention is chronic depression.Preferably, it is of the present invention pre- Anti- and/or treatment is depressed to be included prevention and/or treats depressive symptom chosen from the followings:Persistent sad, anxiety or empty mood, Feeling of despair, pessimism, sense of guilt, valueless sense or helplessness, lose the hobby once enjoyed and the inclusive interest of activity or Happy, energy reduces, is tired or slow, be difficult to concentrate on, memory difficulty or be difficult to is made decision, have a sleepless night, morning early awakening or sleeps Excessively, without appetite and/or weight loss or overfeeding and weight gain, expect dead or suicides, conamen, move more, Irritability, any combinations to treating unresponsive continuation physical symptom or foregoing conditions.
Patient of the present invention is mammal, such as people, mouse, rat, cavy, dog, cat, horse, ox, pig, or non- People primate, such as monkey, chimpanzee or baboon.Preferably, the patient behaves.
Unless otherwise stated, term " unit dosage forms ", which refers to, is suitable as the single of people experimenter and other mammals The physically discrete unit of dosage, each unit include combined with the pharmaceutical carrier of needs be computed can be during treatment During produce it is desired prevention or therapeutic effect scheduled volume active material.
Unless otherwise stated, term " pharmaceutically acceptable auxiliary material " be meant that the component do not have bioactivity or its His bad active impurity, such as the component can be included in disclosed pharmaceutical preparation and give patient, but do not cause it is significant not Good biological effect produces interaction with the other compositions included in said preparation in harmful manner.
Unless otherwise stated, term " treatment " includes suppression, delay, mitigation, decrease, limitation, mitigation or regression disease Disease, obstacle, illness or state, it occurs and/or process, and/or its symptom.
Unless otherwise stated, term " prevention " includes reducing following risk:Suffer from, infect or undergo disease, obstacle, Illness or state, it occurs and/or process, and/or its symptom.
Unless otherwise stated, term "comprising" represents " opening " or " inclusive " term so that they include enumerating Key element, but also allow to include extra, unmentioned key element.
Unless otherwise stated, term " about " generally means that +/- the 5% of described value, more generally refer to the +/- of described value 4%, more generally refer to +/- the 3% of described value, more generally refer to +/- the 2% of described value, more generally refer to +/- the 1% of described value, it is more logical Often refer to +/- the 0.5% of described value.
The pharmaceutical preparation of cannabidiol (CBD) of the present invention containing low dosage or its pharmaceutically acceptable salt has There is the effect of obvious antidepression sample.Particularly contain 25-200mg cannabidiols (CBD) or its pharmaceutically acceptable salt Pharmaceutical preparation, depressive symptom can significantly be improved by being administered to patient, achieve the purpose that treatment is depressed.
Embodiment
Below in conjunction with the attached drawing in the embodiment of the present invention, the technical solution in the embodiment of the present invention is carried out clear, complete Site preparation describes, it is clear that and described embodiment is only the section Example of the present invention, rather than all.Based in the present invention Embodiment, those of ordinary skill in the art's all other embodiments obtained without making creative work, all Belong to the scope of protection of the invention.
1 capsule unit formulation of embodiment
Formulation ingredients:Cannabidiol(Purity >=80%) 200mg
Microcrystalline cellulose 90mg
Pregelatinized starch 100mg
Cross-linked carboxymethyl cellulose 7mg
Magnesium stearate 0.5mg
Preparation method:The active ingredient is sieved, and is mixed with auxiliary material, is filled this blend into hard gelatin capsule.
2 capsule unit formulation of embodiment
Formulation ingredients:Cannabidiol(Purity >=50%) 120mg
Microcrystalline cellulose 100mg
Pregelatinized starch 150mg
Cross-linked carboxymethyl cellulose 10mg
Magnesium stearate 0.2mg
Preparation method is the same as embodiment 1.
3 tablet unit dosage form of embodiment
Formulation ingredients:Cannabidiol(Plant extracts, purity >=95%)100mg
Pregelatinized starch 100mg
Microcrystalline cellulose 25mg
Polyvinylpyrrolidone 10mg
Sodium carboxymethyl starch 15mg
Magnesium stearate 1mg
Preparation method:Cannabidiol is sieved, and is formed sediment with pregelatinized starch, microcrystalline cellulose, polyvinylpyrrolidone, carboxymethyl The mixing of powder sodium is until form uniform mixture, sieving obtains mixture, and is mixed with magnesium stearate.Then by the powder type of gained Mixture is pressed into the tablet for needing shapes and sizes.
4 tablet unit dosage form of embodiment
Formulation ingredients:Cannabidiol(Plant extracts, purity >=95%)25mg
Pregelatinized starch 150mg
Microcrystalline cellulose 25mg
Polyvinylpyrrolidone 10mg
Sodium carboxymethyl starch 15mg
Magnesium stearate 1mg
Preparation method is the same as embodiment 3.
5 injection unit dosage forms of embodiment(10mL)
Formulation ingredients:Cannabidiol(Plant extracts, purity >=99%)2.5g
Appropriate hydroxypropyl-β-cyclodextrin
0.1mol/L HCl are appropriate
Appropriate sodium chloride
Water for injection adds to 1000mL
Preparation method:Water for injection about 800ml is taken, adds appropriate hydroxypropyl-β-cyclodextrin, CBD is added and is allowed to dissolve, is used It is 6.2-6.5 that 0.1mol/L HCl, which adjust pH value, adds to the full amount of water for injection, stirs evenly, and adds sodium chloride and allocates to isotonic, filter Cross, embedding is passed through 121 DEG C of sterilizing 15min of steam in ampoule.
6 injection unit dosage forms of embodiment(10mL powder-injection)
Formulation ingredients:Cannabidiol(Plant extracts, purity >=99%)5g
Mannitol 50g
0.1mol/L HCl are appropriate
Appropriate hydroxypropyl-β-cyclodextrin
Appropriate sodium chloride
Water for injection adds to 1000mL
Preparation method:Water for injection about 800ml is taken, the mannitol of recipe quantity and appropriate hydroxypropyl-β-cyclodextrin is added, adds CBD is allowed to dissolve, and stirring is lower to add appropriate 0.1mol/L HCl adjustings pH value to be 6.2-6.5, then adds to the full amount of water for injection, adds Enter sodium chloride to allocate to isotonic, filtration, is freeze-dried according to freeze drying powder injection technique, powder-injection is made.
7 Xi Ze-zong of embodiment is tested
Rat(About 200g)70, it is randomly divided into 7 groups, every group 10 are respectively normal group, model control group, 30mg/Kg CBD Group, 20mg/Kg CBD, 6mg/Kg CBD, 3mg/Kg CBD, 1.5 mg/Kg CBD groups.Rat shuttle box is consistent by 2 volumes Experimental box form, be divided into 2 equal cells with the partition plate with door opening among each experimental box, respectively for 20cm × 6.5cm × There are 1 wicket (7cm × 7cm) in 20cm, centre.Top is equipped with 1 8W tengsten lamp.Each case passes through main controller and computer phase Even, bottom portion is stainless steel grid, and the distance between grid is 1cm, is connected with electric shock device.
Rat is divided into helpless group and control group, and is separately placed one and has two compartments(Centre is equipped with passage)'s In shuttle box.Helpless group is subject to a series of foot shocks that can not avoid in shuttle box, and control group is then not affected by electric shock. Two days later, these rats have been taken back in shuttle box again, and receive conditionity escape training for three days on end.
Xi Zezong depression model induction period:Rat is put into electric shock Induction experiments case during experiment in the 1st day, per case 1 Only, the dual chamber foot shock of 60 no signal inevitabilities is continuously given, using the voltage of 40V, shocks by electricity continue 15s every time, Phase semi-randomization of having a rest (programme-control 45,60,75s), every rat are trained 1 time.Normal group animal is put into experimental box equally Time (1h), but do not give foot shock.Experiment in 2nd day is similar.
The conditioned avoidance response learning period:(after electric shock induction 48h) progress conditioned avoidance response training in 3rd day, daily 1 It is secondary.During training, rat is put into shuttle box, per 1, case, after adapting to 5min, is carried out continuously 30 cycles of operation.Each operation The time in cycle is 30s, is followed successively by 3s conditional stimulus (light) phase, 3s conditions+unconditioned stimulus (electric shock 35V) are between phase and 24s Have a rest the phase (not to any stimulation).When rat only light the conditional stimulus phase shuttle to case opposite side to exempt from electric shock when, It is denoted as avoiding reaction;Shuttle in the case that rat has light at the same time and electric shock stimulates to the opposite side of case to hide electric shock When, then it is denoted as fugue reaction.Experimental arrangement is controlled by computer, avoids number and escape number being recorded automatically by computer.The 4,5 days experimental methods did not had to carry out shuttle box adaptation as the 3rd day.Observation index (returns to escape the frequency of failure=30- Keep away number+escape number).
In 5 days after training, each group rat relative medicine is given once daily, record, which calculates, escapes the frequency of failure, and The frequency of failure, which was escaped, to the 4th, 5 day carries out statistical analysis.
Experimental result is referring to table 1, and compared with model group, 30mg/Kg CBD groups and 20mg/Kg CBD groups are considerably reduced and escaped The frequency of failure is kept away, 6mg/Kg and 3 mg/Kg CBD groups can similarly reduce the escape frequency of failure.But 1.5mg/Kg CBD Then CBD no longer shows active effect to group.
1 Xi Ze-zong experimental result of table
8 5-HTP of embodiment(5-HTP)A behavioral experiment is got rid of in induction
Rat(About 200g)7 groups are randomly divided into, every group 5, be respectively model control group, 20mg/kg Prozac groups, 30mg/Kg CBD groups, 20mg/Kg CBD groups, 6mg/Kg CBD groups, 3mg/Kg CBD groups, 1.5mg/Kg CBD groups, are injected intraperitoneally Pargyline After (100 mg/kg) 30min, gastric infusion, is injected intraperitoneally 5-HTP (10 mg/kg) after 60min again, and is immediately placed in 24cm In the open top container of × 15cm × 15cm, that observes 10-15min, 20-25min, 30-35min respectively gets rid of a number.
Experimental result is referring to table 2, the wherein basic class of antidepressant effect of 30mg/Kg CBD groups and 20mg/kg Prozac groups Seemingly, when CBD groups dosage reduces, remain able to that antidepressant activity is presented, until CBD dosages are reduced to 1.5mg/ Then CBD no longer shows active effect during Kg.
2 5-HTP of table(5-HTP)A behavioral experiment result is got rid of in induction
The cannabidiol CBD of 9 low dosage of embodiment treats patients with depression
Experimental animal dosage of the present invention and people's dosage can be according to《Pharmacological experimental methodology》(Xu Shuyun master Compile, People's Health Publisher, 2002)Record method converts, and conversion coefficient therebetween is 0.018, such as rat Dosage be 30mg/kg, the dosage for the adult that converts is 30 mg/kg × 0.2kg/ (0.018 × 70kg)=4.8mg/ kg.It is the medicine system containing 25-200mg cannabidiols to patient's daily administration drug dose after being converted according to rat experimental result Pharmaceutical preparation in agent, including embodiment 1-6.
Experimental program:Psychology and medical evaluation are carried out in the assessment before testing is added.Medical inspection includes electrocardiogram And complete haemanalysis, different cell line (red blood cell, leucocyte and blood platelet) and biochemical feelings have studied by haemanalysis Condition (glucose, creatinine, urea, cholesterol and their component, it is triglycerides, alkaline phosphatase, GOT, GPT, GGT, LDH, total Albumen etc.).
Medicining cycle:6 months.
Diagnostic criteria:With mental state it is low based on, it is and 4 at least following:
(1) hebetude, without happiness feel;
(2) decreased energy or tired sense;
(3) psychomotor activity is sluggish or intense;
(4) self-assessment is too low, feels guilty, or has feeling of guilt;
(5) associate difficult or conscious elaborative faculty to decline;
(6) occur the thought wanted to die repeatedly or have suicide, autolesionism;
(7) sleep-disorder, such as insomnia, early awakening, or hypersomnia;
(8) appetite reduces or weight substantially mitigates;
(9) sexual hypoesthesia.
Proof cycle:The 2nd week after medication, check every month afterwards.

Claims (12)

1. a kind of cannabidiol or its pharmaceutically acceptable salt answering in the pharmaceutical preparation for preparing prevention and/or treatment depression With, it is characterised in that in wherein described pharmaceutical preparation containing unit dose be 25-200mg cannabidiol or its pharmaceutically may be used The salt of receiving.
2. the application described in claim 1, it is characterised in that in the pharmaceutical preparation containing unit dose be 25-150mg it is big Numb diphenol or its pharmaceutically acceptable salt.
3. the application described in claim 2, it is characterised in that in the pharmaceutical preparation containing unit dose be 50-120mg it is big Numb diphenol or its pharmaceutically acceptable salt.
4. the application described in claim 1, it is characterised in that cannabidiol for chemosynthesis product, biosynthetic products and/or Plant extracts.
5. the application described in claim 4, it is characterised in that the cannabidiol is plant extracts, plant choosing From hempCannabis sativa LStalk core, flower, leaf, the shell of root and/or seed.
6. the application described in claim 5, it is characterised in that be not less than in mass ratio containing cannabidiol in the extract 50%, preferably not less than 80%, more desirably not less than 90%, most desirably not less than 95%.
7. the application described in claim 1, it is characterised in that the pharmaceutical preparation be selected from tablet, pill, pulvis, lozenge, dissipate Agent, elixir, suspension, lotion, solution, syrup, aerosol, ointment, cutaneous permeable agent, soft capsule, hard shell capsules, suppository, Aseptic injectable solution and freeze dried powder.
8. the application described in claim 1, it is characterised in that the depression includes psychogenic depression, endogenous depression, hypochondriasis Type depression and anxiety are depressed, pseudodementia type is depressed, chronic depression.
9. the application described in claim 1, it is characterised in that the prevention and/or treatment is depressed to include prevention and/or treatment Depressive symptom chosen from the followings:Persistent sad, anxiety or empty mood, feeling of despair, pessimism, sense of guilt, valueless sense or nothing Help sense, lose the hobby once enjoyed and interest that activity is inclusive or happy, energy reduce, are tired or slow, being difficult to collect Middle spirit, memory difficulty or be difficult to make decision, have a sleepless night, morning early awakening or sleep excessively, without appetite and/or weight loss or eat Excessive and weight gain, expect dead or suicides, conamen, move more, irritability, to the unresponsive continuation physical symptom for the treatment of Or any combinations of foregoing conditions.
10. the application described in claim 1, it is characterised in that depressed patient be selected from people, mouse, rat, cavy, dog, cat, Horse, ox, pig, or non-human primate.
A kind of 11. method prevented and/or treatment is depressed, it is characterised in that the method includes daily administration drug dose For 25-200mg cannabidiols, it is furthermore preferred that daily administration drug dose is 25-150mg cannabidiols (CBD), most preferably , daily administration drug dose is 50-120mg cannabidiols.
12. a kind of pharmaceutical preparation, it is characterised in that it is 25-200mg hemps two that the pharmaceutical preparation, which includes unit dose, Phenol, it is furthermore preferred that containing unit dose being 25-150mg cannabidiols, most preferably, the medicine in the pharmaceutical preparation Containing unit dose it is 50-120mg cannabidiols in thing preparation, and pharmaceutically acceptable auxiliary material.
CN201610893569.4A 2016-10-14 2016-10-14 Pharmaceutical preparation and its application containing cannabidiol Pending CN107951869A (en)

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CN110200953A (en) * 2019-06-15 2019-09-06 汉义生物科技(北京)有限公司 Cannboid is preparing the application in inhalation drug
CN110339304A (en) * 2019-08-23 2019-10-18 云南汉木森生物科技有限责任公司 A kind of antidepression composite essential oil containing CBD ingredient
CN110742861A (en) * 2018-07-04 2020-02-04 汉义生物科技(北京)有限公司 Cannabidiol self-emulsifying drug delivery system, solid self-emulsifying preparation and preparation method thereof
CN111574333A (en) * 2020-04-14 2020-08-25 云南古润生物科技有限责任公司 Preparation process of water-soluble cannabidiol
CN112439019A (en) * 2019-08-30 2021-03-05 黑龙江阳光工业大麻研究院 Anti-epileptic composition containing cannabidiol and preparation method of granules of anti-epileptic composition
CN113116869A (en) * 2019-12-31 2021-07-16 汉义生物科技(北京)有限公司 Composition for preventing and/or treating depression
WO2022099347A1 (en) * 2020-11-12 2022-05-19 Emyria Use of cannabidiol for the treatment of psychological distress
CN114832226A (en) * 2022-05-10 2022-08-02 中国标准化研究院 Anti-depression sleep-aiding self-soluble microneedle patch and preparation method thereof

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