CN105596453A - Pharmaceutical composition for treating cough variant asthma and pharmacologic action thereof - Google Patents
Pharmaceutical composition for treating cough variant asthma and pharmacologic action thereof Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for treating cough variant asthma. The pharmaceutical composition is prepared from, by weight, 6-20 parts of radix aconiti carmichaeli, 3-12 parts of honey-fried herba ephedrae and 3-12 parts of licorice roots. The pharmaceutical composition has the effects of relieving asthma, relaxing tracheal smooth muscles and reducing the leukotriene content of lung tissue. According to long-term observation, when the pharmaceutical composition is used for treating the cough variant asthma, the cough symptom can be rapidly removed, the cure rate is high, both symptoms and root causes are treated, and the cough variant asthma does not relapse after being cured.
Description
Technical field
The present invention relates to medicine, be specifically related to a kind of pharmaceutical composition for the treatment of cough variant asthma, belong to medicine technologyField.
Technical background
Cough variant asthma (CVA) has another name called cough type asthma, concealed asthma or allergic cough, is the one of asthmaSpecific type, on bed, main manifestations is continuation or chronic cough, clinical in infecting performance, or through long period antibiotic therapyInvalid, and bronchodilator can make coughing fit alleviate. Because CVA performance is special, normal out in the cold or mistaken diagnosis is exhaled on repeatedlySuction road infects, chronic bronchitis etc., so that affect best occasion for the treatment adversely, cause conditions of patients to increase the weight of.
Cough variant asthma is not asthma, and it is that body stimulates the one causing to continue to antigenicity or nonantigenicProperty inflammatory reaction, if active treatment not can develop into asthma.
Traditional Chinese medical science understanding: the clinical symptoms of cough variant asthma are taking cough as feature. According to the different dialectical traditional Chinese medical science that belongs toThe category such as " cough ", " lung convulsion ", " lung-energy stagnation syndrome ", " card of roaring " " dyspnea ". Because cough variant asthma shows effect repeatedly, its interpretation of the cause, onset and process of an illness is normalRelate to multiple internal organs. Under the effect of external cause and internal cause, cause energy and blood of human body imbalance of yin and yang, make this disease show as this void mark moreReal, simulataneous insufficiency and excessive. Most doctors think that lung spleen kidney qi deficiency is this sick basic pathogenesis, and phlegm, void, the stasis of blood are main pathological factor.
At present the western medical treatment of cough variant asthma often adopt glucocorticoid, beta 2 receptor activator, theophylline class medicine,Leukotriene modifer, anticholinergic agent, antihistamine etc., also can drug combination, can take effect at short notice, but long-term treatment pairEffect is large, and easily recurrence after drug withdrawal. The traditional Chinese medical science focus on organic conception, emphasize to search for the primary cause of disease in treatment, treat both principal and secondary aspect of disease, face card therapy many flexiblyBecome. Be not difficult to find out from above document, all extensive use and curative effect are better in the treatment of this disease and prevention for traditional Chinese medicine, in promptingThis disease of medical treatment has prospect widely. But still exist some shortcomings: 1. the clinical study design majority of Chinese medicine preparation is owed sectionLearn, most research methods are random open check experiment, lack the test of large sample, multicenter, random-blind method, and strength of confirmation is notFoot. 2. the selection of clinical testing control group lacks placebo, and the selection of positive control drug owes science, seldom has countryThe medicine medicine in contrast of the similar disease for the treatment of of generally acknowledged effective and safe, clinical testing is difficult to science evaluation test medicine exactlyThe validity of thing. 3. the curative effect of clinical research mostly is positive findings, and bad reaction report is rare, exists the serious property delivered inclined to one sideLean on. 4. lack the report of this sick pharmacological research aspect for the treatment of by Chinese herbs.
Summary of the invention
The object of the invention is pharmaceutical composition and pharmacological action thereof for a kind of cough variant asthma is provided, it is seenEffect is fast, treats both principal and secondary aspect of disease, and after curing, patient's physique is obviously improved, and is difficult for developing into asthma.
Object of the present invention is achieved through the following technical solutions:
A pharmaceutical composition for the treatment of cough variant asthma, is characterized in that: the bulk drug by following weight portion is made: attachedSub-6-20 part, processs Chinese ephedra 3-12 part, Radix Glycyrrhizae 3-12 part.
A kind of pharmaceutical composition for the treatment of cough variant asthma of the present invention, is characterized in that: by following weightThe bulk drug of part is made: 9 parts of monkshoods, process 6 parts, Chinese ephedra, 6 parts, Radix Glycyrrhizae.
A kind of pharmaceutical composition for the treatment of cough variant asthma of the present invention, is characterized in that: method for making is to add waterDecoct twice, each more than 45 minutes, obtain pharmaceutical composition extract, make preparation with extract, and with following method surveyDetermine Radix Aconiti Lateralis Preparata alkaloid content for being not less than 50 μ g/g:
Adopt high effective liquid chromatography for measuring, system suitability, with phosphoric acid solution=18:82 of acetonitrile: 0.05%-0.2% extremely25:75 is mobile phase, and wherein the phosphoric acid solution of 0.05%-0.2% is containing 0.02%-0.06% triethylamine and the positive fourth of 0.01%-0.03% bis-Amine, detection wavelength is 222-242nm, number of theoretical plate calculates and should be not less than 6000 by benzoylmesaconine peak;
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoyl time crowFormer alkali reference substance is appropriate, accurately weighed, and adding acetonitrile, to make every 1ml molten containing the mixing of 20-70 μ g, 5-20 μ g, 5-20 μ g respectivelyLiquid, product stock solution in contrast, precision measures reference substance storing solution 0.05%-0.2% phosphoric acid solution dilution 2-10 doubly, shakes up workFor reference substance solution;
Solid-phase extraction column system suitability: precision measures reference substance stock solution 5ml, room temperature recovered under reduced pressure is to dry, and precision addsEnter 0.1mol/L hydrochloric acid 50ml and make to dissolve, precision measures 10ml, is added on solid-phase extraction column, anti-phase with mixed type cation exchangeAdsorbent is filler, 150-200mg, capacity is 4-10ml, uses successively in advance acetonitrile, the each 6ml wash-out of water, successively with water 3ml,1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, place 5 minutes, continues with acetonitrile: strong ammonia solution=The mixed solution 10ml wash-out of 90:10, collects eluent, and in decompression and solvent recovery below 40 DEG C to dry, residue precision adds secondNitrile: the mixed solution 5ml of phosphoric acid solution=20:80 of 0.1% makes to dissolve, and filters, and gets subsequent filtrate suitable as SPE column systemThe property used testing liquid;
Accurate said system employment and suitability test (E & ST) solution and the each 10-30 μ of the reference substance solution l of drawing respectively, injection liquid chromatography, surveysFixed, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, must not be less than 0.95;
The preparation of need testing solution: get inspection product, take 0.2-2g, put in tool plug conical flask, precision adds 0.1mol/L salt acid-solubleLiquid 25ml, close plug, weighed weight, ultrasonic processing 10-50 minute and jolting constantly, let cool, more weighed weight, uses 0.1mol/L saltAcid solution is supplied the weight of less loss, shakes up, and leaves heart 10-40 minute with 2000-6000 per minute, filters, and precision measures continuous filterLiquid 10ml, according to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law,Prepare need testing solution;
Determination method: accurate reference substance solution and the each 10-30 μ of the need testing solution l of drawing respectively, injection liquid chromatography, measures,.
In above each component, weight is calculated with crude drug, and in the present invention, if weight in grams, this consists ofThe taking dose of being grown up one day.
Each composition is by weight as proportioning above, in the time producing, can increase or reduce according to corresponding ratio, asLarge-scale production can with kilogram or taking ton as unit, weight can increase or reduce, but crude drug weight between each component is joinedThan constant rate, the taking dose of being grown up a day is constant.
Pharmaceutical composition of the present invention can adopt Chinese medicine preparation conventional method to be prepared into any pharmaceutically useful conventional formulation. ExampleMaking powder as these bulk drugs pulverizing mixed takes after mixing it with water; Also can, by these bulk drugs together decocting, concentrate, filter, denseContracting, dry, add auxiliary material to make tablet, capsule, granule, pill, granule, soft capsule.
The pharmaceutical composition for the treatment of cough variant asthma of the present invention, with " Mahuang Fuzi Gancuo Tang Decoction of Ephedra " in treatise on Febrile Diseases noBe with part:" Mahuang Fuzi Gancuo Tang Decoction of Ephedra " epheday intermedia is more processed Chinese ephedra by the present invention: Chinese ephedra function with cure mainly as Pulvis DiaphoreticusCold, freeing lung and relieving asthma, inducing diuresis for removing edema, for anemofrigid cold, uncomfortable in chest breathing with cough, geomantic omen edema; Process Chinese ephedra and moisten the lung and relieve the cough, do without sweatingWith, for asthma and cough;The weight proportion difference of ingredients: " Mahuang Fuzi Gancuo Tang Decoction of Ephedra " ingredients is Chinese ephedra 6g, sweetGrass 6g, monkshood 3g; Pharmaceutical composition of the present invention consists of as monkshood 9g, processs Chinese ephedra 6g, Radix Glycyrrhizae 6g;Function cures mainly difference:" Mahuang Fuzi Gancuo Tang Decoction of Ephedra " has and inducing sweat loosely cold, and effect of warming kidney and enhancing yang, cures mainly shaoyin disease, catch a cold two or three days without interior symptom-complex,Diseases caused by external factors illness that has not attacked the vital organs of the human body is not gone, and aversion to cold body pain is lossless, slight fever, the micro-person of deeptensepulse. Fever with aversion to cold, for illness that has not attacked the vital organs of the human body is not separated, so its therapy original textIn point out it is " inducing perspiration slightly ", with the Chinese ephedra sweating of inducing sweat, be main ingredient with the table heresy of faling apart to the greatest extent, with the sun in monkshood solid protection table, help fiber cropsYellow, Radix Glycyrrhizae is loose evil, is ministerial drug, gathers altogether the supporing yang effect of inducing sweat. Pharmaceutical composition of the present invention has warm kidney and activates yang, and the cough-relieving of a surname's lung is flatThe merit of breathing heavily; It is monarch drug in a prescription that we reuse monkshood, and with warming channel and expelling cold, monkshood taste is pungent, sweet, hot in nature, has recuperating depleted yang, mends fire supporing yang, looseEffect of cold dehumidifying. Shennong's Herbal is recorded monkshood " the pungent temperature of taste. Main air is cold to be coughed against perverse trend, in temperature ", monkshood both can fall apart by temperature sunCold, can control again cough breathe contrary; Processing Chinese ephedra a surname lung relieving cough and asthma is ministerial drug; Make it medicine taking Radix Glycyrrhizae as assistant, monkshood is joined Radix Glycyrrhizae, Xin GanhuaSun, and make the effect of sun of monkshood temperature spleen kidney lasting, Radix Glycyrrhizae obtains that monkshood is is invigorated the spleen and benefited qi and without stopping up stagnant anxiety, processs Chinese ephedra and join sweetGrass, relieving cough and asthma. The cough variant asthma of we's lung deficiency of the kidney void, treats both principal and secondary aspect of disease, and all medicines and use, play altogether warm kidney and activate yang, a surname's lungThe effect of cough-relieving.
For better explanation feature of the present invention and progress, below carry out drug effect by pharmacological room of medical college of Shandong UniversityLearn test and clinical effectiveness, further set forth the present invention and treat the beneficial effect of cough variant asthma. Below test be intended to intoOne step illustrates effect of the present invention, but not restriction of the present invention.
Test the antiasthmatic effect test of a granule of the present invention to cavy
Healthy guinea pig is placed in the beaker of horizontal positioned of 2000ml, the sealing of beaker mouth, and leave ultrasonic atomizer nozzle,After peace and quiet, the histamine phosphate equal-volume mixing 15s that atomization sprays into 2% acecoline and 0.1%, selects in advance. SprayingAfter stopping, observing cavy in 6 minutes and draw the incubation period of breathing heavily. The insensitive person who exceedes 120 seconds incubation period will not select. The 2nd day, willThe qualified knee mouse of preliminary election is divided into negative control group (distilled water) at random, this particle high (0.4g/kg), in (0.2g/kg), low(0.1g/kg) dosage group, positive controls (SuHuang ZhiKe capsule 0.4g/kg) group, gastric infusion, administration volume 10ml/Kg, once a day, successive administration 7d, after last administration 2h, repeats above-mentioned test, observes to draw and breathes heavily incubation period and drop to animalNumber.
Result: spraying gives after acecoline-histamine phosphate, the visible obviously SOA of cavy, this particle 0.2G/kg and 0.4g/kg obviously prolonged guinea pig asthma incubation period, relatively there were significant differences with control group, can reduce and fall simultaneouslyTo number of animals. The results are shown in Table 1.
Table 1 granule of the present invention causes the impact (x ± s, n=8) of Experimental Asthma In Guinea-pigs on acetylcholine-histamine
With negative control group comparison, * P < 0.05, * * P < 0.01
Test two, the impact test of granule of the present invention on guinea-pig isolated tracheal smooth muscle
Get cavy and be divided at random negative control group (distilled water), this particle 40mg/ml, 20mg/ml and 10mg/ml group, Su HuangzhiCough capsule 40mg/ml group and isoprel 7.5ug/ml group. When test, cavy is tapped the head lethal, cut neck center skin openSkin, separates flesh layer, gets thyroid cartilage with down to tracheorrhaphy fork place whole piece tracheae, prepares tracheae sheet according to literature method, puts into ShengHave in the bath pipe of K-HShi liquid of 15ml, logical oxygen, is connected with muscular strength transducer, adjusts load for 2g, and balance 60min, then addsHistamine (final concentration 1.67ug/ml), in the time that contraction reaches maximum, adds relative medicine 0.5ml, and after observation medicine, 3min declines highDegree, calculates contraction inhibiting rate.
Height × 100% before inhibiting rate=(height after the front height-dosing of dosing) ÷ dosing.
Result is visible, and this particle 40mg/ml and 20mg/ml group all can suppress the receipts of the GPTSM due to histamineContracting, relatively there were significant differences with negative control group. The results are shown in Table 2.
The impact (x ± s, n=6) of this particle of table 2 on GPTSM
With negative control group comparison, * * P < 0.01.
Test three, granule of the present invention generate the impact test of leukotriene (LTs) on guinea pig lung tissue
(1) sensitized animal and grouping administration: get 150 ~ 200g cavy, two hind legs are intramuscular injection 5% ovalbumin physiological saline respectivelyOnly, lumbar injection 1ml/ only, is strengthened solution 0.4ml/ simultaneously. After 4 weeks, sensitization finishes. Cavy is divided into negative control at randomGroup, this particle 0.1g/kg, 0.2g/kg and 0.4g/kg dosage group and positive controls (yellow particle 0.4g/kg revives), in causingWithin quick the 22nd day, start gastric infusion, 10ml/kg, once a day, successive administration 7d.
(2) LTs preparation: after last administration 2h, 20% urethane anesthesia, arteria carotis communis bloodletting is lethal, opens thoracic cavity, getsGo out lungs, rinse lungs extremely without color from pulmonary artery with tyrode's solution. Excision connective tissue around, with filter paper suck dry moisture and cutBroken. Take lung tissue 0.5g, put into the test tube that fills 2.5ml tyrode's solution, add 60 μ g/ml indocin 50 μ l and 0.6% white of an eggAlbumen 0.5ml, shakes up, and is placed in 37 DEG C of water-bath concussions and hatches 1h, filters to obtain LTs filtrate, is put in 4 DEG C of refrigerators, for calibratingLTs。
(3) measure: get healthy guinea pig, the execution of tapping the head, opens rapidly abdominal cavity, takes out one section of ileum, prepares ileum longitudinal muscle, willLongitudinal muscle sample is fixed in 37 DEG C of constant temperature bath pipes, and logical oxygen after balance 1h, adds 100 μ g/ml histamine 75 μ l under 0.5g tension force(final concentration is 0.5 μ g/ml) recorded longitudinal muscle and shunk height. After flushing, be changed to containing atropine (1 μ g/ml), Loratadine (0.06 μG/ml) half calcium tyrode's solution, adds the LTs filtrate of preparation after 5min, record the contraction height of longitudinal muscle, and calculate and histamineThe ratio that shrinks height is shrinkage factor.
After shrinkage factor (%)=add LTs filtrate the contraction of longitudinal muscle height ÷ add the contraction height of longitudinal muscle after histamine ×100%。
Result of the test
As a result, negative control group lung tissue LTs can cause larger contraction, this particle 0.2g/kg and 0.4g/kg treated animalThe contraction that lung tissue LTs causes reduces, and relatively there were significant differences with negative control group, shows that particle of the present invention can reduce allergyThe generation of the LTs of guinea pig lung tissue or release, thus LTs content reduced. The results are shown in Table 3.
The impact (x ± s, n=6) of this particle of table 3 on LTs in sensitized guinea pig lung tissue liquid due to ovalbumin
With control group comparison: * * P < 0.01, * P < 0.05.
Conclusion
This test discovery, this granule has the contraction of the GPTSM due to obvious inhibition histamine outward. ThisGrain 0.2g/kg and 0.4g/kg obviously prolonged guinea pig spray and give after acecoline-histamine phosphate asthma incubation period,Reduce and drop to number of animals. The contraction that this particle 0.2g/kg and 0.4g/kg treated animal lung tissue LTs cause reduces, right with feminine genderAccording to group, relatively there were significant differences. The anti-cough effect of this particle of results suggest and relax tracheal smooth muscle and minimizing lung tissue LTs'sContent is relevant.
The clinical research of four particles of test
1, physical data
All cases is from Shandong ProvinceQianfoshan Hospital outpatient, totally 90 examples. Be divided at random test group and control group. Test group45 examples (male 21 examples, female's 24 examples), age 37.4 ± 4.3, contrast 45 examples (male 22 examples, female's 23 examples), age 37.5 ± 4.8. Two groupsThe data such as Gender, age, the course of disease are learned processing by statistics, and the equal not statistically significant of difference (P > 0.05), there is comparativity.
Therapeutic scheme: test group: this groups of grains 3.5g every day, divides and takes for 2 times, sooner or later respectively once; Control group: oral relaxing notBeautiful (aminophylline sustained release tablets)+Ketotifen sheet; Treatment time is 1 month.
2, diagnostic criteria
All cases all meet respirology branch of Chinese Medical Association asthma group " the Clinics and Practices guide of cough in 2005(draft) " middle CVA diagnostic criteria: (1) chronic cough is often with significantly irritable cough at night. (2) BPTPositive. (3) bronchodilator, glucocorticoid treatment are effective. (4) get rid of the chronic cough that other reasons causes. 90 routine CVAPatient all checks positive by BPT, show as pharynx and itch, and excitant dry cough, coughs very night, time cough white rare phlegm,The cards such as the cough of feed raw food increases the weight of, and pale tongue with thin fur is white, floating and tense pulse belong to the cold type person that coughs.
3, criterion of therapeutical effect, according to tcm internal medicine disease diagnostic criteria
3.1 cure: cough and expectoration disappears, and after drug withdrawal, cough was not sent out author for clinical cure more than 1 week;
3.2 take a turn for the better: cough alleviates, and expectoration reduces; Cough outbreak again in 1 week after drug withdrawal;
3.3 is invalid: though cough alleviates, after drug withdrawal, cough shows effect
4, result
Cure rate: treatment group 41 examples, cure rate is 91.1%; Control group 13 examples, cure rate is 28.9%.
Improvement rate: treatment group 1 example, improvement rate is 2.2%; Control group 11 examples, improvement rate is 24.4%.
Inefficiency: treatment group 0 example, inefficiency is 0.0%; Control group 21 examples, inefficiency is 46.7%.
BPT negative conversion rate: treatment group 41 examples, negative conversion rate is 91.1%; Control group 9 examples, negative conversion rate is20.0%。
Result shows, this particle is evident in efficacy to cough variant asthma.
Detailed description of the invention
Following examples weight is 100 times of people recipe quantity on the one
Embodiment 1: the granule preparation of medicine of the present invention
Take by weight following bulk drugs:
Monkshood 900g processs Chinese ephedra 600g Radix Glycyrrhizae 600g
Above-mentioned raw materials medicine is prepared by following method:
By the monkshood of described weight proportion, process Chinese ephedra, Radix Glycyrrhizae boiling twice, add for the first time 12 times of amounts, decoct 2 hoursSecondary adds 10 times of amounts, decocts 2 hours, merges liquid, and liquid filters, and gets filtrate, and being concentrated into relative density is 1.10～1.15(60DEG C) time, add ethanol to make to reach 70% containing alcohol amount, precipitation, leaves standstill 24 hours, draws supernatant, reclaims ethanol, obtains precipitation solution;By precipitation solution, concentrated, dry, pulverize, powder gets dry extract; Gained dried cream powder and appropriate dextrin are fully mixed, stick with ethanolMixture is granulated, dry, granulation agent.
Get above-mentioned preparation and measure Radix Aconiti Lateralis Preparata alkaloid content:
Chromatographic condition and system suitability: chromatographic column is connected phenyl bonded silica gel as filler (Welch taking polarity etherUltimatePhenyl-Ether, 250 × 4.6mm, 5 μ are m); Acetonitrile: 0.2% phosphoric acid solution (20:80) is mobile phase, every0.1% phosphoric acid solution of 1000ml adds triethylamine 0.2ml and di-n-butylamine 0.1ml, and detection wavelength is 222nm, and number of theoretical plate is pressed benzeneThe new aconine of formyl peak is calculated as 9628.
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoylInferior aconine reference substance is appropriate, accurately weighed, and add acetonitrile and make the mixed solution that every 1ml contains respectively 20 μ g, 10 μ g, 10 μ g,Product stock solution in contrast, precision measures for reference substance storing solution 2 times of 0.05% phosphoric acid solution dilutions, shakes up that product are molten in contrastLiquid.
Solid-phase extraction column system suitability: solid-phase extraction column system suitability: precision measures reference substance and stocksLiquid 5ml, room temperature recovered under reduced pressure is to dry, and precision adds 0.1mol/L hydrochloric acid 50ml to make to dissolve, and precision measures 10ml, is added in solid phase extractionGet on post, taking the anti-phase adsorbent of mixed type cation exchange as filler, 150mg, capacity is 6ml, uses successively in advance acetonitrile, waterEach 6ml wash-out, successively with water 3ml, 1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, places 5Minute, continue with acetonitrile: the mixed solution 10ml wash-out of strong ammonia solution (90:10), collect eluent, in 40 DEG C of following recovered under reduced pressureSolvent is to dry, and residue precision adds acetonitrile: the mixed solution 5ml of 0.1% phosphoric acid solution (20:80) makes to dissolve, and filters, and gets continuousFiltrate is as solid-phase extraction column system suitability solution.
Accurate said system employment and suitability test (E & ST) solution and the each 10 μ l of reference substance solution of drawing respectively, injection liquid chromatography,Measure, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, result is all greater than0.95。
The preparation of need testing solution: get inspection product porphyrize, take 0.5g, put in tool plug conical flask, precision adds 0.1mol/LHydrochloric acid solution 25ml, close plug, weighed weight, ultrasonic processing 30 minutes jolting constantly, let cool, more weighed weight, uses 0.1mol/L hydrochloric acid solution is supplied the weight of less loss, shakes up, and centrifugal (per minute 2000 turn) 40 minutes filters, and precision measures subsequent filtrate10ml, according to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law, systemAvailable test sample solution.
Determination method: accurate reference substance solution and the each 10 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures,Obtain.
Result: 3 monoester alkaloid theoretical cam curves, separating degree, tailing factors all reach requirement, and this batch of granule is attachedSub-alkaloid is 72 μ g/g.
Embodiment 2: the capsule preparation of medicine of the present invention
Monkshood 900g processs Chinese ephedra 600g Radix Glycyrrhizae 600g
Above-mentioned raw materials medicine is prepared by following method:
By the monkshood of described weight proportion, process Chinese ephedra, Radix Glycyrrhizae boiling twice, add for the first time 12 times of amounts, decoct 2 hoursSecondary adds 10 times of amounts, decocts 2 hours, merges liquid, and liquid filters, and gets filtrate, and being concentrated into relative density is 1.10～1.15(60DEG C) time, add ethanol to make to reach 70% containing alcohol amount, precipitation, leaves standstill 24 hours, draws supernatant, reclaims ethanol, obtains precipitation solution;By precipitation solution, concentrated, dry, pulverize, powder gets dry extract; Gained dried cream powder and appropriate dextrin are fully mixed, stick with ethanolMixture is granulated, dry, makes capsule.
Get above-mentioned preparation and measure Radix Aconiti Lateralis Preparata alkaloid content:
Chromatographic condition and system suitability: chromatographic column is connected phenyl bonded silica gel as filler (Welch taking polarity etherUltimatePhenyl-Ether, 150 × 4.6mm, 10 μ are m); Acetonitrile: 0.1% phosphoric acid solution (18:82) is mobile phase, every0.1% phosphoric acid solution of 1000ml adds triethylamine 0.5ml and di-n-butylamine 0.25ml, and detection wavelength is 232nm, and number of theoretical plate is pressedBenzoylmesaconine peak is calculated as 10346.
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoylInferior aconine reference substance is appropriate, accurately weighed, and add acetonitrile and make the mixed solution that every 1ml contains respectively 70 μ g, 20 μ g, 20 μ g,Product stock solution in contrast, precision measures for reference substance storing solution 10 times of 0.1% phosphoric acid solution dilutions, shakes up that product are molten in contrastLiquid.
Solid-phase extraction column system suitability: solid-phase extraction column system suitability: precision measures reference substance and stocksLiquid 5ml, room temperature recovered under reduced pressure is to dry, and precision adds 0.1mol/L hydrochloric acid 50ml to make to dissolve, and precision measures 10ml, is added in solid phase extractionGet on post, taking the anti-phase adsorbent of mixed type cation exchange as filler, 200mg, capacity is 10ml, use successively in advance acetonitrile,The each 6ml wash-out of water, successively with water 3ml, 1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, places5 minutes, continue with acetonitrile: the mixed solution 10ml wash-out of strong ammonia solution (90:10), collect eluent, reduce pressure back below in 40 DEG CReceive solvent to dry, residue precision adds acetonitrile: the mixed solution 5ml of 0.1% phosphoric acid solution (20:80) makes to dissolve, and filters, and getsSubsequent filtrate is as solid-phase extraction column system suitability solution.
Accurate said system employment and suitability test (E & ST) solution and the each 20 μ l of reference substance solution of drawing respectively, injection liquid chromatography,Measure, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, result is all greater than0.95。
The preparation of need testing solution: get inspection product porphyrize, take 1g, put in tool plug conical flask, precision adds 0.1mol/L saltAcid solution 25ml, close plug, weighed weight, ultrasonic processing 50 minutes jolting constantly, let cool, more weighed weight, uses 0.1mol/LHydrochloric acid solution is supplied the weight of less loss, shakes up, and centrifugal (per minute 6000 turn) 10 minutes filters, and precision measures subsequent filtrate 10ml,According to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law, preparation is for examinationProduct solution.
Determination method: accurate reference substance solution and the each 20 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures,Obtain.
Result: 3 monoester alkaloid theoretical cam curves, separating degree, tailing factors all reach requirement, and this batch of capsule is attachedSub-alkaloid is 55 μ g/g.
Embodiment 3: the tablet preparation of medicine of the present invention
Take by weight following bulk drugs:
Monkshood 600g processs Chinese ephedra 300g Radix Glycyrrhizae 300g
Above-mentioned raw materials medicine is prepared by following method:
By the monkshood of described weight proportion, process Chinese ephedra, Radix Glycyrrhizae boiling twice, add water for the first time 10 times and measure, decoct 1 hour,Add water for the second time 8 times and measure, decoct 1 hour, merge liquid, liquid filters, and gets filtrate, and being concentrated into relative density is 1.10～1.15When (60 DEG C), add ethanol to make to reach 80% containing alcohol amount, precipitation, leaves standstill 32 hours, draws supernatant, reclaims ethanol, concentrated, dryDry, pulverize, make binder with ethanol and granulate, dry, be pressed into tablet.
Get above-mentioned preparation and measure Radix Aconiti Lateralis Preparata alkaloid content:
Chromatographic condition and system suitability: chromatographic column is connected phenyl bonded silica gel as filler (Welch taking polarity etherUltimatePhenyl-Ether, 250 × 4.6mm, 5 μ are m); Acetonitrile: 0.1% phosphoric acid solution (22:78) is mobile phase, every0.1% phosphoric acid solution of 1000ml adds triethylamine 0.4ml and di-n-butylamine 0.1ml, and detection wavelength is 238nm, and number of theoretical plate is pressed benzeneThe new aconine of formyl peak is calculated as 14672.
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoylInferior aconine reference substance is appropriate, accurately weighed, adds acetonitrile and makes every 1ml respectively containing the mixed solution of 20 μ g, 5 μ g, 5 μ g, doesFor reference substance stock solution, precision measures 2 times of 0.05% phosphoric acid solution dilutions for reference substance storing solution, shakes up product solution in contrast.
Solid-phase extraction column system suitability: solid-phase extraction column system suitability: precision measures reference substance and stocksLiquid 5ml, room temperature recovered under reduced pressure is to dry, and precision adds 0.1mol/L hydrochloric acid 50ml to make to dissolve, and precision measures 10ml, is added in solid phase extractionGet on post, taking the anti-phase adsorbent of mixed type cation exchange as filler, 150mg, capacity is 6ml, uses successively in advance acetonitrile, waterEach 6ml wash-out, successively with water 3ml, 1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, places 5Minute, continue with acetonitrile: the mixed solution 10ml wash-out of strong ammonia solution (90:10), collect eluent, in 40 DEG C of following recovered under reduced pressureSolvent is to dry, and residue precision adds acetonitrile: the mixed solution 5ml of 0.1% phosphoric acid solution (20:80) makes to dissolve, and filters, and gets continuousFiltrate is as solid-phase extraction column system suitability solution.
Accurate said system employment and suitability test (E & ST) solution and the each 30 μ l of reference substance solution of drawing respectively, injection liquid chromatography,Measure, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, result is all greater than0.95。
The preparation of need testing solution: get inspection product porphyrize, take 0.2g, put in tool plug conical flask, precision adds 0.1mol/LHydrochloric acid solution 25ml, close plug, weighed weight, ultrasonic processing 30 minutes jolting constantly, let cool, more weighed weight, uses 0.1mol/L hydrochloric acid solution is supplied the weight of less loss, shakes up, and centrifugal (per minute 3000 turn) 30 minutes filters, and precision measures subsequent filtrate10ml, according to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law, systemAvailable test sample solution.
Determination method: accurate reference substance solution and the each 30 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures,Obtain.
Result: 3 monoester alkaloid theoretical cam curves, separating degree, tailing factors all reach requirement, this batch of tablet monkshoodAlkaloid is 79 μ g/g.
Embodiment 4: the oral liquid preparation of medicine of the present invention
Take by weight following bulk drugs:
Monkshood 2000g processs Chinese ephedra 1200g Radix Glycyrrhizae 1200g
Above-mentioned raw materials medicine is prepared by following method: boiling twice, add water for the first time 15 times and measure, decoct 2 hours, for the second timeAdd water 8 times and measure, decoct 1 hour, merge liquid, liquid filters, and gets filtrate, and being concentrated into relative density is 1.10～1.15(60 DEG C)Time, add ethanol to make to reach 60% containing alcohol amount, precipitation, leaves standstill 36 hours, draws supernatant, adds water to 2000ml; Packing,10ml/ bottle.
Get above-mentioned preparation and measure Radix Aconiti Lateralis Preparata alkaloid content:
Chromatographic condition and system suitability: chromatographic column is connected phenyl bonded silica gel as filler (Venusil taking polarity etherXBPPolar-Phenyl, 150 × 4.6mm, 5 μ are m); Acetonitrile: 0.1% phosphoric acid solution (23:77) is mobile phase, every 1000ml's0.08% phosphoric acid solution adds triethylamine 0.3ml and di-n-butylamine 0.1ml, and detection wavelength is 241nm, and it is new that number of theoretical plate is pressed benzoylAconine peak is calculated as 8106.
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoylInferior aconine reference substance is appropriate, accurately weighed, adds acetonitrile and makes every 1ml respectively containing the mixed solution of 40 μ g, 7 μ g, 7 μ g, doesFor reference substance stock solution, precision measures 2 times of 0.08% phosphoric acid solution dilutions for reference substance storing solution, shakes up product solution in contrast.
Solid-phase extraction column system suitability: solid-phase extraction column system suitability: precision measures reference substance and stocksLiquid 5ml, room temperature recovered under reduced pressure is to dry, and precision adds 0.1mol/L hydrochloric acid 50ml to make to dissolve, and precision measures 10ml, is added in solid phase extractionGet on post, taking the anti-phase adsorbent of mixed type cation exchange as filler, 150mg, capacity is 6ml, uses successively in advance acetonitrile, waterEach 6ml wash-out, successively with water 3ml, 1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, places 5Minute, continue with acetonitrile: the mixed solution 10ml wash-out of strong ammonia solution (90:10), collect eluent, in 40 DEG C of following recovered under reduced pressureSolvent is to dry, and residue precision adds acetonitrile: the mixed solution 5ml of 0.1% phosphoric acid solution (20:80) makes to dissolve, and filters, and gets continuousFiltrate is as solid-phase extraction column system suitability solution.
Accurate said system employment and suitability test (E & ST) solution and the each 20 μ l of reference substance solution of drawing respectively, injection liquid chromatography,Measure, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, result is all greater than0.95。
The preparation of need testing solution: get inspection product porphyrize, take 1.5g, put in tool plug conical flask, precision adds 0.1mol/LHydrochloric acid solution 25ml, close plug, weighed weight, ultrasonic processing 10 minutes jolting constantly, let cool, more weighed weight, uses 0.1mol/L hydrochloric acid solution is supplied the weight of less loss, shakes up, and centrifugal (per minute 6000 turn) 10 minutes filters, and precision measures subsequent filtrate10ml, according to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law, systemAvailable test sample solution.
Determination method: accurate reference substance solution and the each 20 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures,Obtain.
Result: 3 monoester alkaloid theoretical cam curves, separating degree, tailing factors all reach requirement, this batch of oral administration solutionAgent Radix Aconiti Lateralis Preparata alkaloid content is 101 μ g/g.
Embodiment 5: the oral liquid preparation of medicine of the present invention
Take by weight following bulk drugs:
Monkshood 2000g processs Chinese ephedra 300g Radix Glycyrrhizae 900g
Above-mentioned raw materials medicine is prepared by following method: boiling twice, add water for the first time 11 times and measure, decoct 2 hours, for the second timeAdd water 8 times and measure, decoct 45 minutes, merge liquid, liquid filters, and gets filtrate, and being concentrated into relative density is 1.10～1.15(60DEG C) time, add ethanol to make to reach 70% containing alcohol amount, precipitation, leaves standstill 24 hours, draws supernatant, adds water to 2000ml; Packing,10ml/ bottle.
Get above-mentioned preparation and measure Radix Aconiti Lateralis Preparata alkaloid content:
Chromatographic condition and system suitability: chromatographic column is connected phenyl bonded silica gel as filler (Venusil taking polarity etherXBPPolar-Phenyl, 250 × 4.6mm, 10 μ are m); Acetonitrile: 0.1% phosphoric acid solution (24:76) is mobile phase, every 1000ml's0.1% phosphoric acid solution adds triethylamine 0.25ml and di-n-butylamine 0.15ml, and detection wavelength is 232nm, and it is new that number of theoretical plate is pressed benzoylAconine peak is calculated as 9467.
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoylInferior aconine reference substance is appropriate, accurately weighed, and add acetonitrile and make the mixed solution that every 1ml contains respectively 20 μ g, 10 μ g, 10 μ g,Product stock solution in contrast, precision measures for reference substance storing solution 4 times of 0.1% phosphoric acid solution dilutions, shakes up that product are molten in contrastLiquid.
Solid-phase extraction column system suitability: solid-phase extraction column system suitability: precision measures reference substance and stocksLiquid 5ml, room temperature recovered under reduced pressure is to dry, and precision adds 0.1mol/L hydrochloric acid 50ml to make to dissolve, and precision measures 10ml, is added in solid phase extractionGet on post, taking the anti-phase adsorbent of mixed type cation exchange as filler, 150mg, capacity is 6ml, uses successively in advance acetonitrile, waterEach 6ml wash-out, successively with water 3ml, 1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, places 5Minute, continue with acetonitrile: the mixed solution 10ml wash-out of strong ammonia solution (90:10), collect eluent, in 40 DEG C of following recovered under reduced pressureSolvent is to dry, and residue precision adds acetonitrile: the mixed solution 5ml of 0.1% phosphoric acid solution (20:80) makes to dissolve, and filters, and gets continuousFiltrate is as solid-phase extraction column system suitability solution.
Accurate said system employment and suitability test (E & ST) solution and the each 10 μ l of reference substance solution of drawing respectively, injection liquid chromatography,Measure, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, result is all greater than0.95。
The preparation of need testing solution: get inspection product porphyrize, take 2g, put in tool plug conical flask, precision adds 0.1mol/L saltAcid solution 25ml, close plug, weighed weight, ultrasonic processing 20 minutes jolting constantly, let cool, more weighed weight, uses 0.1mol/LHydrochloric acid solution is supplied the weight of less loss, shakes up, and centrifugal (per minute 4000 turn) 20 minutes filters, and precision measures subsequent filtrate 10ml,According to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law, preparation is for examinationProduct solution.
Determination method: accurate reference substance solution and the each 10 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures,Obtain.
Result: 3 monoester alkaloid theoretical cam curves, separating degree, tailing factors all reach requirement, this batch of oral administration solutionAgent Radix Aconiti Lateralis Preparata alkaloid content is 69 μ g/g.
Embodiment 6: the tablet preparation of medicine of the present invention
Monkshood 1500g processs Chinese ephedra 900g Radix Glycyrrhizae 600g
Above-mentioned raw materials medicine is prepared by following method:
By the monkshood of described weight proportion, process Chinese ephedra, Radix Glycyrrhizae boiling twice, add water for the first time 10 times and measure, decoct 1 hour,Add water for the second time 8 times and measure, decoct 1 hour, merge liquid, liquid filters, and gets filtrate, and being concentrated into relative density is 1.10～1.15When (60 DEG C), add ethanol to make to reach 80% containing alcohol amount, precipitation, leaves standstill 32 hours, draws supernatant, reclaims ethanol, concentrated, dryDry, pulverize, make binder with ethanol and granulate, dry, be pressed into tablet.
Get above-mentioned preparation and measure Radix Aconiti Lateralis Preparata alkaloid content:
Chromatographic condition and system suitability: chromatographic column is connected phenyl bonded silica gel as filler (Venusil taking polarity etherXBPPolar-Phenyl, 250 × 4.6mm, 5 μ are m); Acetonitrile: 0.1% phosphoric acid solution (25:75) is mobile phase, every 1000ml's0.05% phosphoric acid solution adds triethylamine 0.2ml and di-n-butylamine 0.2ml, and detection wavelength is 240nm, and it is new that number of theoretical plate is pressed benzoylAconine peak is calculated as 6719.
The preparation of reference substance solution: get benzoylmesaconine reference substance, benzoyl aconine reference substance, benzoylInferior aconine reference substance is appropriate, accurately weighed, adds acetonitrile and makes every 1ml respectively containing the mixed solution of 30 μ g, 8 μ g, 8 μ g, doesFor reference substance stock solution, precision measures 2 times of 0.1% phosphoric acid solution dilutions for reference substance storing solution, shakes up product solution in contrast.
Solid-phase extraction column system suitability: solid-phase extraction column system suitability: precision measures reference substance and stocksLiquid 5ml, room temperature recovered under reduced pressure is to dry, and precision adds 0.1mol/L hydrochloric acid 50ml to make to dissolve, and precision measures 10ml, is added in solid phase extractionGet on post, taking the anti-phase adsorbent of mixed type cation exchange as filler, 150mg, capacity is 6ml, uses successively in advance acetonitrile, waterEach 6ml wash-out, successively with water 3ml, 1.25% ammonia solution, water, methyl alcohol, the each 5ml wash-out of acetonitrile, after eluent flows to end, places 5Minute, continue with acetonitrile: the mixed solution 10ml wash-out of strong ammonia solution (90:10), collect eluent, in 40 DEG C of following recovered under reduced pressureSolvent is to dry, and residue precision adds acetonitrile: the mixed solution 5ml of 0.1% phosphoric acid solution (20:80) makes to dissolve, and filters, and gets continuousFiltrate is as solid-phase extraction column system suitability solution.
Accurate said system employment and suitability test (E & ST) solution and the each 30 μ l of reference substance solution of drawing respectively, injection liquid chromatography,Measure, the ratio of each corresponding composition peak area in computing system employment and suitability test (E & ST) solution and reference substance solution, result is all greater than0.95。
The preparation of need testing solution: get inspection product porphyrize, take 1g, put in tool plug conical flask, precision adds 0.1mol/L saltAcid solution 25ml, close plug, weighed weight, ultrasonic processing 40 minutes jolting constantly, let cool, more weighed weight, uses 0.1mol/LHydrochloric acid solution is supplied the weight of less loss, shakes up, and centrifugal (per minute 4000 turn) 30 minutes filters, and precision measures subsequent filtrate 10ml,According to the method under solid-phase extraction column system suitability item, from " being added on solid-phase extraction column ", operation in accordance with the law, preparation is for examinationProduct solution.
Determination method: accurate reference substance solution and the each 30 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures,Obtain.
Result: 3 monoester alkaloid theoretical cam curves, separating degree, tailing factors all reach requirement, this batch of tablet monkshoodAlkaloid is 125 μ g/g.
Claims (3)
1. a pharmaceutical composition for the treatment of cough variant asthma, is characterized in that: the bulk drug by following weight portion is made:Monkshood 6-20 part, processs Chinese ephedra 3-12 part, Radix Glycyrrhizae 3-12 part.
2. according to a kind of pharmaceutical composition for the treatment of cough variant asthma of claim 1, it is characterized in that: by following weightThe bulk drug of part is made: 9 parts of monkshoods, process 6 parts, Chinese ephedra, 6 parts, Radix Glycyrrhizae.
3. according to the pharmacological action of a kind of pharmaceutical composition for the treatment of cough variant asthma of claim 1, have relieving asthma, pineThe effect of relaxation tracheal smooth muscle and minimizing lung tissue leukotriene content.
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