CN101766676B - Extract of Albizia chinensis (Osbeck) Merr, preparation method, combination and purpose thereof - Google Patents
Extract of Albizia chinensis (Osbeck) Merr, preparation method, combination and purpose thereof Download PDFInfo
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Abstract
The invention relates to the application of Albizia chinensis (Osbeck) Merr in the preparation of calming hypnotic medicine, an extract of the Albizia chinensis (Osbeck) Merr, a preparation method of the extract, and a medicine combination containing the extract. The stem skin of the Albizia chinensis (Osbeck) Merr is dried, crushed, extracted, concentrated and purified, so as to obtain the extract with the calming hypnotic function. Effective components include catechin compounds. Pharmacological tests show that the extract has the characteristics of low effective dose, quick medicinal effect exerting, obvious curative effect, good safety and high reliability.
Description
Technical field
The present invention relates to the application of principal columns of a hall tree Albizia chinensis (Osbeck) Merr. in preparing sedative hypnotic drug, and principal columns of a hall tree extract, specifically, relate to a kind of by the extract with sedative-hypnotic effect extracting from principal columns of a hall tree bark, the preparation method of this extract, the pharmaceutical composition that contains this extract, and this extract and the purposes of its pharmaceutical composition as medicine, especially prepare the application of sedative hypnotic drug.
Background technology
Insomnia is one of modal disease clinically, and sickness rate is higher, and statistics shows, insomnia's prevalence is about 30～35%, and wherein the suitable severe patient of degree accounts for 10～15% in insomniac.Insomnia seriously affects people's life, work and physical and mental health.At present apply clinically more sedative hypnotic and be mainly barbiturate, benzodiazepines and Non-benzodiazepine medicine, although front two class medicine curative effects are obvious, but there is the side effect such as drug resistance, dependency and addiction in it, and then generation hypomnesis, work efficiency is low, causes vicious cycle.Therefore, people start to find new Non-benzodiazepine medicine, comprise natural product active ingredient or component are studied.
Along with social development, rhythm of life is accelerated, life stress increases, insomnia will be a problem day by day receiving publicity, Chinese herbal medicine is applied through centuries, shows that it has the feature safe, side effect is little, therefore, from Chinese herbal medicine, excavate the natural active matter with sedative-hypnotic effect, have broad application prospects.
Principal columns of a hall tree Albizia chinensis (Osbeck) Merr. is pulse family albizzia (Albizia) plant.Rapidly, branch and leaf are luxuriant in this kind of growth, fit into shade tree and cover tree (Chinese Plants will editorial board of the Chinese Plants Zhi， Chinese Academy of Sciences compiles, the 39th volume, 1988, PP67).Its medicinal part is bark according to records, and bark is containing tannin.The effect that has stopping diarrhea with astringents, convergence granulation promoting, cure mainly enteritis, diarrhoea, dysentery (national Chinese herbal medicine compilation, national Chinese herbal medicine is write group volume, second edition, volume two, 1986, PP768).Another principal columns of a hall bark on the books is containing triterpene saponin (claiming again albitocin), have shrink uterus effect (Chinese medicine voluminous dictionary, the new medical college in Jiangsu is compiled, 1998, the first volume, PP937).There is not yet up to now the report of relevant other chemical composition of principal columns of a hall bark and bioactivity research aspect.
Summary of the invention
The technical problem to be solved in the present invention is to provide the sedative hypnotic drug that a class is new, i.e. the application of principal columns of a hall tree Albiziachinensis (Osbeck) Merr. in preparing sedative hypnotic drug.
Another technical problem that the present invention will solve is to provide prepares the method for principal columns of a hall tree extract and the principal columns of a hall tree extract that this method obtains.
Another technical problem that the present invention will solve is to provide a kind of pharmaceutical composition, comprises as the principal columns of a hall of active component and sets conventional carrier in extract and pharmaceutical field.
Another technical problem that the present invention will solve is to provide the application of principal columns of a hall tree extract A lbizia chinensis (Osbeck) Merr. in preparing sedative hypnotic drug.
Solve technical problem of the present invention, the present invention takes following technical scheme:
The present invention relates to a kind of sedative hypnotic drug principal columns of a hall tree extract that can be used for preparing, its preparation method is:
(1) weigh principal columns of a hall tree crude drug and use solvent extraction, the concentrated principal columns of a hall tree extract that to obtain of extracting solution.
Preferred principal columns of a hall tree crude drug is principal columns of a hall tree peel of stem.Principal columns of a hall tree crude drug drying suitable pulverizing, raise the efficiency in order to the contact area increasing with solvent.
The extraction solvent of crude drug can make water or various organic solvent; Preferred solvent is the mixture of alcohols or water and alcohols.
Preferred alcohols comprises methanol, ethanol, isopropyl alcohol, butanols etc., ethanol most preferably,
Concentration of alcohol can be volume ratio 50-100%; Preferred concentration is volume ratio 60～95%, and most preferred concentration of alcohol is volume ratio 65-75%.
During extraction, solvent use amount is that the volume/weight ratio (unit: rise/kilogram) of solvent volume and former medicine weight is 4～14: 1, preferably 6～12: 1, be more preferably 8～10: 1.
Extraction can be carried out in static state or dynamically, preferably under dynamic condition, for example, stirs.In order to improve the efficiency of extraction, can use ultrasound wave etc.
The temperature of extracting be for example, from room temperature (20 ℃) to the scope of solvent refluxing temperature in, preferably temperature is at the temperature of solvent refluxing.
Extraction can be carried out continuously or intermittently, can repeat 1～5 time during intermittent extraction, preferably 2-4 time, elects as most 3 times;
Extraction time is 1-5 hour, is preferably 1.5-4 hour, most preferably is 2-3 hour;
After upper EOS, merging filtrate, elimination medicinal residues.Filtrate, under dynamical state, is condensed into paste at normal pressure or decompression heating, preferably concentrated under reduced pressure.
Preferably the preparation method of principal columns of a hall tree extract is as follows: weigh principal columns of a hall tree peel of stem, the 65-75% alcohol reflux that per kilogram use 6-10 rises 2-4 time, each 2-3 hour; Merge extractive liquid,, it is principal columns of a hall tree extract that extracting solution obtains extractum through concentrating under reduced pressure.
(2) in order to improve drug effect, be convenient to preparation and clothes for patients use, principal columns of a hall tree extract can further be purified and refine.Comprise abstraction purification step and/or column chromatography step.
Preferably carry out abstraction purification, abstraction purification comprises the steps:
The principal columns of a hall tree extractum that upper step extraction step obtains, in the water being suspended in, is used successively polarity organic solvent extraction from small to large, and the extract of various organic solvents is concentrated respectively to the extract that obtains each organic solvent
For example polarity organic solvent is from small to large selected from petroleum ether, ethyl acetate, n-butyl alcohol; Concentrated to be extracted thing be respectively the extract of petroleum ether, the extract of the extract of ethyl acetate, n-butyl alcohol, the extract of water.
The volume/weight ratio of the volume of water and principal columns of a hall tree extractum weight during extraction (unit liter/kilogram, or ml/g) for being 1-3: 1,1.5-2.5 preferably: 1, be most preferably 2: 1.
During extraction, the volume of organic solvent and the volume ratio of water are 0.25-3: 1, and 0.5-1.5 preferably: 1, be most preferably 1: 1.
The number of times of extraction is 1-5 time, and preferably 2-4 time, having choosing is most 3 times.
Concentrate and can use the ordinary skill in the art, for example under normal pressure or reduced pressure, heating is concentrated, and thin film evaporation is preferably concentrated under reduced pressure.
Preferred purification process comprises the steps: that the extractum that upper step is obtained is suspended in the water of 2 times (volume/weight, units ml/g), and the consumption of water and the volume/weight ratio of extractum are 1.5-2.5: 1; With petroleum ether, ethyl acetate, n-butyl alcohol, extract 2-4 time respectively; The consumption of petroleum ether, ethyl acetate, n-butyl alcohol and the volume ratio of water are 0.5-1.5: 1; Concentrating under reduced pressure evaporate to dryness, obtain respectively the extract of petroleum ether, the extract of the extract of ethyl acetate, n-butyl alcohol, the extract of water.
Pharmacological research shows that the drug effect of the extract of n-butyl alcohol is best.
(3) for improving the drug effect that increases unit dose, reduce patient's use amount, be convenient to control of product quality; Extract prepared by upper step can also further refining purification.
Being further purified of paste can be passed through column chromatography, for example all kinds of exchange columns or adsorpting column chromatography, the effective site obtaining.
Preferred adsorption column comprises positive and negative phase silica gel, aluminium oxide, cellulose, polyamide, carbon column.
Preferred exchange column comprises macroporous resin column; Preferred gel column is sephadex column.
Wherein preferably macroporous resin column and polyamide column;
What have choosing most is polyamide column.
The consumption of adsorbent is 10～200 times of example weight, preferably 30～80 times.
Eluant can be used each conventional eluant of this area, for example water, organic solvent, and composition thereof.For example, the mixture of water, alcohols, water and alcohols; Conventional organic solvent comprises petroleum ether, ether, normal hexane, cyclohexane extraction, dichloromethane, chloroform, ethyl acetate, acetone.Preferred alcohols is selected from least one in methanol, ethanol, isopropyl alcohol and butanols.
The envelope-bulk to weight ratio of the molten consumption of eluting and adsorbent (rise/kilogram) be preferred 3-20: 1; Preferred 4-10: 1; More preferably 4-7: 1
Extract can become dry powder through lyophilization or vacuum drying, also concentrated liquid Direct spraying can be dried to dry powder.Or through membrane technology refine concentrated after, then become extractum or dry powder.
Preferred purification step is that polyamide column on the extract of n-butyl alcohol is separated.Specifically comprise the steps: the extract of n-butyl alcohol water-soluble, after filtration, be added on 30～60 object polyamide columns of 10～15 times of weight, water, 25～35% ethanol, 55～65% ethanol carry out gradient elution successively, water, 25～35% ethanol, 55～65% the consumption of ethanol and the envelope-bulk to weight ratio of polyamide (rise/kilogram) be 4～7: 1; Preferably 4.8～5.6: 1; Each several part is concentrated into dry, respectively water extract, 25～35% ethanol extract, 55～65% ethanol extract.Pharmacological research shows that the drug effect of 55～65% ethanol extract is best.
Certainly, extracting solution can directly carry out column purification without extraction step, but preferably first passes through extraction step.
The principal columns of a hall tree extract the present invention relates to comprises any principal columns of a hall tree extract that said method obtains.Principal columns of a hall tree extract effective ingredient of the present invention comprises catechin compounds.Extract can become dry powder through lyophilization or vacuum drying, also concentrated liquid Direct spraying can be dried to dry powder and carry out various preparations shapings.
The present invention relates to a kind of pharmaceutical composition, comprised the principal columns of a hall tree extract and the pharmaceutically acceptable carrier that with method of the present invention, extract.
The invention still further relates to and contain as the extract of the present invention of active ingredient and the pharmaceutical composition of conventional medicine excipient or adjuvant.Conventionally the extract of the present invention that pharmaceutical composition of the present invention contains 0.1～95% weight.
The present invention also provides a kind of pharmaceutical composition, and it comprises medicine effective dose, as the principal columns of a hall tree extract and/or principal columns of a hall tree and the pharmaceutically acceptable carrier that extract as the inventive method of active component.
The pharmaceutical composition of extract of the present invention can be according to method preparation well known in the art.When this object, if needed, extract of the present invention and one or more solids or liquid medicine excipient and/or adjuvant can be combined, make the suitable administration form or the dosage form that can be used as people's medicine or veterinary drug use.
Extract of the present invention or the pharmaceutical composition that contains it can unit dosage form administrations, route of administration can be intestinal or non-intestinal, as oral, intravenous injection, intramuscular injection, subcutaneous injection, lumbar injection, nasal cavity, oral mucosa, eye, lung and respiratory tract, skin, vagina, rectum etc., preferred oral administration.
Form of administration can be liquid dosage form, solid dosage forms or semisolid dosage form.Liquid dosage form can be solution (comprising true solution and colloid solution), Emulsion (comprising o/w type, w/o type and emulsion), suspensoid, injection (comprising aqueous injection, injectable powder and transfusion), eye drop, nasal drop, lotion and liniment etc.Solid dosage forms can be tablet (comprising ordinary tablet, enteric coatel tablets, buccal tablet, dispersible tablet, chewable tablet, effervescent tablet, oral cavity disintegration tablet), capsule (comprising hard capsule, soft capsule, enteric coated capsule), granule, powder, micropill, drop pill, suppository, membrane, paster, the agent of gas (powder) mist, spray etc.; Semisolid dosage form can be ointment, gel, paste etc.
Extract of the present invention can be made ordinary preparation, also can be slow releasing preparation, controlled release preparation, targeting preparation and various particulate delivery system.
For unit form of administration is made to tablet, can be widely used various excipient well known in the art, comprise diluent, adhesive, wetting agent, disintegrating agent, lubricant, fluidizer.Diluent can be starch, dextrin, sucrose, glucose, lactose, mannitol, sorbitol, xylitol, microcrystalline Cellulose, calcium sulfate, calcium hydrogen phosphate, calcium carbonate etc.; Wetting agent can be water, ethanol, isopropyl alcohol etc.; Binding agent can be that starch slurry, dextrin, syrup, Mel, glucose solution, microcrystalline Cellulose, mucialga of arabic gummy, gelatine size, sodium carboxymethyl cellulose, methylcellulose, hydroxypropyl emthylcellulose, ethyl cellulose, acrylic resin, carbomer, polyethylene adjoin pyrrolidone, poly-second two propanol etc.; Disintegrating agent can be that dried starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, crosslinked polyethylene adjoin pyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, sodium bicarbonate and citric acid, calcium carbonate, polyoxyethylene sorbitol fatty acid ester, dodecyl sodium sulfate; Lubricant and fluidizer can be Pulvis Talci, silicon dioxide, stearate, tartaric acid, liquid paraffin, Polyethylene Glycol etc.
Tablet further can also be made to coated tablet, for example sugar coated tablet, thin membrane coated tablet, ECT, or double-layer tablet and multilayer tablet.
For pill is made in administration unit, can be widely used various carrier well known in the art.Example about carrier is, for example diluent and absorbent, as glucose, lactose, starch, cocoa butter, hydrogenated vegetable oil, polyvinylpyrrolidone, Gelucire 44/14, Kaolin, Pulvis Talci etc.; Binding agent, as arabic gum, yellow Bodhisattva's glue, gelatin, ethanol, Mel, liquid sugar, rice paste or batter etc.; Disintegrating agent, as agar powder, dry starch, alginate, dodecyl sodium sulfate, methylcellulose, ethyl cellulose etc.
For suppository is made in administration unit, can be widely used various carrier well known in the art.Example about carrier is, such as the ester of Polyethylene Glycol, lecithin, cocoa butter, higher alcohol, higher alcohol, gelatin, semi-synthetic glyceride etc.
For capsule is made in administration unit, effective ingredient extract of the present invention is mixed with above-mentioned various carriers, and the mixture obtaining is thus placed in to hard gelatine capsule or soft capsule.Also effective ingredient extract of the present invention can be made to microcapsule, be suspended in aqueous medium and form suspensoid, also can pack in hard capsule or make injection application.
For example, extract of the present invention is made to injection preparation, as solution, suspensoid solution, Emulsion, lyophilized injectable powder, this preparation can be moisture or non-water, can be containing acceptable carrier, diluent, binding agent, lubricant, antiseptic, surfactant or dispersant on a kind of and/or multiple pharmacodynamics.As diluent can be selected from the isooctadecanol of water, ethanol, Polyethylene Glycol, 1,3-PD, ethoxylation, isooctadecanol of polyoxy, Polyoxyethylene Sorbitol Fatty Acid Esters etc.In addition, in order preparing etc., to ooze injection, can in injection preparation, to add appropriate sodium chloride, glucose or glycerol, in addition, can also add conventional cosolvent, buffer agent, pH adjusting agent etc.These adjuvants are that this area is conventional.
In addition,, as needs, also can in pharmaceutical preparation, add coloring agent, antiseptic, spice, correctives, sweeting agent or other material.
For reaching medication object, strengthen therapeutic effect, medicine of the present invention or pharmaceutical composition can be with any known medication administrations.
The dosage of extract pharmaceutical composition of the present invention depends on many factors, for example to prevent or treat character and the order of severity of disease, the sex of patient or animal, age, body weight, personality and individual reaction, route of administration, administration number of times, therapeutic purposes, therefore therapeutic dose of the present invention can have large-scale variation.In general, the using dosage of Chinese materia medica composition of the present invention is well known to a person skilled in the art.Can be according to the present invention contained actual drug quantity in last preparation in extractive composition, in addition suitable adjustment, to reach the requirement of its treatment effective dose, completes prevention of the present invention or therapeutic purposes.The consumption of the appropriate dose scope extract of the present invention of the every day of extract of the present invention is 0.001～150mg/Kg body weight, is preferably 0.1～100mg/Kg body weight, and more preferably 1～60mg/Kg body weight, most preferably is 2～50mg/Kg body weight.Above-mentioned dosage can single dose form or be divided into several, for example two, three or four dosage form administrations this be limited to administration doctor's clinical experience and comprise the dosage regimen of using other treatment means.Each treats that required accumulated dose can be divided into repeatedly or by dose administration.Extract of the present invention or compositions can be taken separately, or merge and use and adjust dosage with other treatment medicine or symptomatic drugs.
The technical advantage that the present invention has is:
1. be pure natural composition, the side effect such as no dependence and addiction.
2. effective dose is low, and drug effect is fast.
3. evident in efficacy, safe and reliable.
4. medical material is easy to get, and extraction process is simple, is applicable to large-scale industrial production.
Accompanying drawing explanation
The flow chart of the Preparation Example 1 of Fig. 1, principal columns of a hall tree extract.
The specific embodiment
The experiment of the following examples and pharmaceutically active is used for further illustrating the present invention, but this and do not mean that any limitation of the invention.
The preparation method of embodiment 1 principal columns of a hall tree extract
Weigh principal columns of a hall tree peel of stem 2.5Kg, with 70% alcohol reflux of 8 times of volumes three times, each 2.5 hours; Extracting solution obtains extractum 475g (note is SJ1) through concentrating under reduced pressure, be suspended in the water of 2 times, with isopyknic petroleum ether, ethyl acetate, n-butyl alcohol, extract respectively three times, concentrating under reduced pressure evaporate to dryness, obtains respectively the extract 2.7g of petroleum ether, the extract 104.5g (note is SJ2) of the extract 26.5g of ethyl acetate, n-butyl alcohol, the extract 250g of water.Polyamide column on the extract of n-butyl alcohol is separated; The extract of n-butyl alcohol is water-soluble, after filtering, (about 95.0g) is added on 1250g 30～60 object polyamide columns, successively with the water of 6L, the ethanol of the ethanol of 6L30%, 7L 60% carries out gradient elution, each several part is concentrated into dry, obtains water extract 18.1g, 30% ethanol extract 8.7g, 60% ethanol extract 5.8g (note is SJ3).Extract the flow chart of purification and see accompanying drawing 1.
Pharmacological testing
Test example 1: the impact that principal columns of a hall bark extract is fallen asleep on the pentobarbital sodium inducing mouse of sub-threshold dose
Laboratory animal: male mice in kunming, 18～20g,
Experimentation: mice is divided into 4 groups (10/group) at random, passes through gastric infusion: control group administered physiological saline 0.1mg/kg, all the other 3 groups SJ1, SJ2 and SJ3 to embodiment 1 preparation; 30min after administration, each organizes the lumbar injection pentobarbital sodium maximum sub-threshold dose 23mg/kg that sleeps, and observes and records and in 15min, respectively organize the mice number of elements of falling asleep.Experimental result is in Table 1.
The impact that table 1 principal columns of a hall bark extract is fallen asleep on sub-threshold dose pentobarbital sodium inducing mouse
With matched group comparison,
*p < 0.05,
*p < 0.01,
* *p < 0.001.
Result shows, principal columns of a hall bark extract SJ1, SJ2, SJ3 can obviously increase the mice rate of falling asleep, and relatively have significant difference with matched group.
Test example 2: the impact of principal columns of a hall tree stem and bark extract on the mouse sleep time of pentobarbital sodium induction
Laboratory animal: male mice in kunming, 18～20g.
Experimentation: mice is divided into 4 groups (10/group) at random, passes through gastric infusion: control group administered physiological saline 0.1mg/kg, all the other 3 groups of SJ1 that purify out to embodiment 1, SJ2 and SJ3; Matched group gavage is to normal saline 0.1mg/kg, and all the other respectively organize gavage to tested material; 30min after administration, each organizes the lumbar injection pentobarbital sodium dosage 39mg/kg that above threshold sleeps, and observes and records and respectively organize mice dropping asleep latency and sleep time.
Experimental result: in Table 2.
The impact of table 2 principal columns of a hall bark extract on the mouse sleep time of pentobarbital sodium induction
Data are expressed as mean ± SD.With matched group comparison,
*p < 0.05.
Result demonstration, principal columns of a hall tree stem and bark extract SJ1, SJ2, SJ3 can significantly shorten the dropping asleep latency of pentobarbital sodium induction, and extend sleep time.
Test example 3: the impact that principal columns of a hall bark extract is fallen asleep on mice again
Laboratory animal: Kunming mouse, male, 18～20g,
Experimentation: mice is divided into 4 groups (9/group) at random, passes through gastric infusion: control group administered physiological saline 0.1mg/kg, all the other 3 groups of SJ1 that purify out to embodiment 1, Sj2 and SJ3; Each organizes dosage 39mg/kg on the Minimum Threshold of lumbar injection pentobarbital sodium induced hypnotic, mice wake up after matched group lumbar injection 0.3% propylene glycol or normal saline 0.1mg/kg immediately, all the other each groups are immediately by various dose intraperitoneal injection.Observe and record and in 15min, respectively organize mice and reenter the number of elements of sleeping.
Experimental result: in Table 3.
The impact that table 3 principal columns of a hall bark extract is fallen asleep on mice again
With matched group comparison,
*p < 0.01,
* *p < 0.005.
Result demonstration, principal columns of a hall bark extract SJ1, SJ2, SJ3 obviously increase mice and reenter the rate of sleeping, and relatively have significant difference with matched group.
Claims (2)
1. the application of principal columns of a hall tree Albizia chinensis (Osbeck) Merr extract in preparing sedative hypnotic drug, is characterized in that, the preparation method of principal columns of a hall tree extract comprises the steps:
(1) weigh principal columns of a hall tree peel of stem, the 65-75% alcohol reflux that per kilogram use 6-10 rises 2-4 time, each 2-3 hour; Merge extractive liquid,, extracting solution obtains principal columns of a hall tree extractum through concentrating under reduced pressure;
(2) principal columns of a hall tree extractum obtaining in above-mentioned steps is suspended in water, the consumption of water and the volume/weight ratio of extractum are 1.5-2.5: 1; With petroleum ether, ethyl acetate, n-butyl alcohol, extract 2-4 time respectively successively; The consumption of petroleum ether, ethyl acetate, n-butyl alcohol and the volume ratio of water are 0.5-1.5: 1; Concentrating under reduced pressure evaporate to dryness, obtains the extract of n-butyl alcohol;
(3) extract of n-butyl alcohol above-mentioned steps being obtained is water-soluble, after filtration, be added on 30～60 object polyamide columns of 10-15 times of weight, the ethanol of water, 25-35% is, the ethanol of 55-65% carries out gradient elution successively, it is 4-7 with the ratio of the quality kilogram number of polyamide that the volume of the ethanol of water, 25-35%, the ethanol of 55-65% rises number: 1, each several part is concentrated into dry, obtain respectively water elution thing, the ethanol elution thing of 25-35%, 55-65% ethanol elution thing, described principal columns of a hall tree extract is 55-65% ethanol elution thing.
2. the application of principal columns of a hall tree in preparing sedative hypnotic drug.
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