CN1853697A - Use of konjak and its extract in preparation of medicine for treating acute and chronic bronchitis - Google Patents
Use of konjak and its extract in preparation of medicine for treating acute and chronic bronchitis Download PDFInfo
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- CN1853697A CN1853697A CNA2005100207991A CN200510020799A CN1853697A CN 1853697 A CN1853697 A CN 1853697A CN A2005100207991 A CNA2005100207991 A CN A2005100207991A CN 200510020799 A CN200510020799 A CN 200510020799A CN 1853697 A CN1853697 A CN 1853697A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/882—Acoraceae (Calamus family), e.g. sweetflag or Acorus calamus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
An application of the Amorphophallus rivieri durieu and its extract in preparing the medicines for treating acute and chronic bronchitis is disclosed. A composite medicine containing Amorphophallus rivieri durieu and schisandra fruit and its preparing process and usage are also disclosed.
Description
Technical field
The present invention relates to a kind of new purposes of medicine, specifically, is the purposes of Rhizoma amorphophalli in the medicine of preparation treatment chronic bronchitis.
Background technology
Chronic bronchitis is mainly in winter-spring season, belongs to frequently-occurring disease, commonly encountered diseases, easily suffers from this disease with the crowd more than 40 years old.1998.National statistics data, chronic bronchitis are 9.7% in the rural area, city 12.4%, and about 18%, 2003 year of average middle-aged and elderly people more than 11.05%, 40 years old, the city accounts for 8.2%, and the rural area accounts for middle-aged and elderly people below 7.75%, 40 years old about 15%.The Western medicine of treatment chronic bronchitis adopts symptomatic treatment to this disease at present, lacks overall idea, is difficult for recovery from illness.And there are following problem in the Chinese patent medicine of commercially available treatment chronic bronchitis, the bonded medicine in Chinese and Western: 1, cough-relieving, relieving asthma, phlegm-dispelling functions need take for a long time, if drug withdrawal, the very fast recurrence of the state of an illness; 2, this type of medicine contains the Pericarpium Papaveris of anesthetic action mostly, and " Pericarpium Papaveris is poisonous, and easy addiction can not informal dress, and the child prohibits clothes " arranged under 2000 editions items of Chinese Pharmacopoeia; The Chinese and Western bound drug of the treatment chronic bronchitis that 3, has contains medicines such as horse Lay acid chlorphenamine and hydrochloric acid Ke Lunluo, has the drowsiness side effect of Denging, easily causes and uses inconvenience; 4, the Chinese patent medicine of some treatment chronic bronchial has certain side effect, can only take stopgap measures, and can not effect a permanent cure.
Rhizoma amorphophalli, head are stated from the Song dynasty " Kaibao Bencao ", Yuan Ming Rhizoma amorphophalli.This book claims it: " acrid in the mouth, cold, poisonous." modern " Sichuan Chinese medicinal herbal " then say it: " warm in nature, pungent." have transforming phlegm and dispersing accumulations, detoxicating and resolving stagnation of pathogens, the clots absorbing pain relieving is main effect.Its external is mainly used in skin ulcer and swells and ache bitterly, diseases such as erysipelas, insect-bite, tinea pedis, mumps; It is for oral administration, then has better with the expelling phlegm for arresting cough effect.Say that as " book on Chinese herbal medicine converge with speech " it " controls consumptive disease ", actual in expelling phlegm for arresting cough." medical center usurp will " says it: " go lung cold, control phlegmatic cough ".It is similar with the Rhizoma Pinelliae, Rhizoma Arisaematis for Sichuan meaning among the people, for a long time in order to the treatment productive cough, and phlegm dyspnea, curative effect is rather good.The property of medicine of Rhizoma amorphophalli, or say cold in naturely, or say warm in naturely, in fact, its property is gentle.Say that it is cold in nature, can cure mainly the card of sun such as sore, carbuncle and painful swelling heat, promptly get the justice of " treating heat syndrome with cold-natured drugs " and " medicine of trembling with fear of treatment heat ".Say that it is warm in nature, the product of giving birth to have zest to human body skin, tongue, throat, can cause local scorching hot, red and swollen, the pain of itching.The two prerequisite differs, real not contradiction.Rhizoma amorphophalli is as food, and is long-term edible, there is no the untoward reaction of the cold and heat property of medicine, so should be gentle product.As for toxicity, being that the living product of finger are living uses local.If, can subtract its poison, or become nontoxic food through decocting.Point out as " China's book on Chinese herbal medicine ": " fried in shallow oil for a long time 2～3 hours, and can reduce toxicity." supplementary Amplifications of the Compendium of Materia Medica record: " (this product) gone into sand basin mill and made rubber cement, and pan boiling becomes cream, treats cold then condensing as the cake piece, and one to cut open again be four, add water and boil into cream again, cream becomes, and boil again, return and boil according to preceding, be that edible order is full, one taro is boiled, and here ten people's that can make up the number abdomen is so claim Rhizoma amorphophalli." at present, still do not have Rhizoma amorphophalli and treat acute and chronic bronchitic relevant report, also still there is not rapid-action, evident in efficacy, safe Chinese patent drugs for treatment chronic bronchitis.
Summary of the invention
Technical scheme of the present invention has provided a kind of new purposes of medical material, specifically, be the purposes of Rhizoma amorphophalli in the medicine of preparation treatment chronic bronchitis, another technical scheme of the present invention has provided and has contained pharmaceutical composition of Rhizoma amorphophalli and its production and use in the raw material.
The invention provides Rhizoma amorphophalli and extract thereof (the Amorphophallus rivieri Durieu) purposes in the acute and chronic bronchitic medicine of preparation treatment.
Wherein, described Rhizoma amorphophalli extract is Rhizoma amorphophalli ethanol extraction or extractive with organic solvent.Described organic solvent is ether, methanol, ethyl acetate, petroleum ether, normal hexane.
Described Rhizoma amorphophalli ethanol extraction is 25%～95% ethanol extraction.
The present invention also provides a kind of pharmaceutical composition, and it is to be active component or raw material by Rhizoma amorphophalli and extract thereof, adds the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, described raw material also contains Fructus Schisandrae Chinensis, and its weight proportion is:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 1～10: 9～0.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 5～8: 5～2.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 6: 2.
Wherein, described medicament is capsule, granule, tablet, pill, oral liquid.
Wherein, every capsules contains schisandrin and must not be less than 1.8mg in the described capsule.
The present invention also provides this preparation of drug combination method, and it comprises the steps:
A, take by weighing each materials of weight proportions medicine:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 1～10: 9～0;
B, Rhizoma amorphophalli 25%～95% ethanol extraction get extract;
C, get Fructus Schisandrae Chinensis, pulverize, add 25%～95% ethanol, hot reflux is extracted, Fructus Schisandrae Chinensis extrat;
D, the extract that b, c step are prepared mix, concentrate, and add the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, the described ethanol extraction method of step b is an alcohol percolation method, and concentration of alcohol is 60%, and percolation speed is 1ml/minkg; The described office of step c determining alcohol is 70%.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation treatment acute bronchitis, chronic bronchitis, emphysema, pulmonary heart disease and reveal any symptoms thereof.
The main clinic symptoms of pulmonary heart disease is long-term cough, coughs up phlegm and dyspnea in various degree, particularly movable back or in sombre season symptom more obvious.In the compensatory phase of cardio-pulmonary function, patient can not have symptom when quiet, in case movable a little, just occur breathing hard, rapid breathing, cardiopalmus, precordialgia, symptom such as weak, uncomfortable in chest.
Fructus Schisandrae Chinensis in the raw material prescription of the present invention, have QI invigorating, nourishing kidney, relieving asthma, cough-relieving, eliminate the phlegm, promote the production of body fluid, multiple functions such as arresting sweating, arresting seminal emission, antidiarrheal, be successive dynasties treatment cough with asthma, especially insufficiency of lung-QI and deficiency of both the lung and kidney and cough with asthma is arranged, the important drugs of all cards of coughing up phlegm.In the Shennong's Herbal of Han dynasty, just write down it: " impairment caused by overstrain is won thin, tonifying for the deficiency reinforcing YIN-essence, beneficial man's essence for main QI invigorating, cough with dyspnea." Sun Simiao is thought; " the informal dress Fructus Schisandrae Chinensis is with the gas of lung benefiting gold, in the last source of then growing, in next the kidney invigorating." Wang Haogu says that it " controls dry the coughing of breathing with cough "." Bencao Jingshu " thought: " acid can be received, and is just going into the lung tonifying the lung, so QI invigorating also for Fructus Schisandrae Chinensis master QI invigorating person, all gas of lung master.Its main cough with dyspnea person, the deficiency of vital energy then goes up heap soil or fertilizer over and around the roots and does not return unit, and sour flavor having the property of astringing is taken the photograph gas and is returned unit, and then cough with dyspnea is from removing." " book on Chinese herbal medicine converge with speech " think: " spirit is not enough for all deficiency of vital energy dyspnea with rapid respiration, cough with dyspnea strain ... control it with Fructus Schisandrae Chinensis, its acid of salty usefulness is held back and is promoted the production of body fluid, and protects reinforcing premodial qi and does not have spermatorrhea also.Though " be advisable with the deficiency syndrome cough with asthma, the deficiency in origin and excess in superficiality person is also quite commonly used.Claim as Chen Jiamo " book on Chinese herbal medicine covers bamboo fish trap ": " cough due to wind and cold, the southern five tastes are strange, deficient impairment caused by overstrain, Chinese is the most wonderful." Wang's machine " herbal ditch of stagnant water warp " title: " five tastes are controlled to breathe heavily and are coughed, and must divide north and south.Born fluid quenches the thirst, lung moistening, and the kidney invigorating, chronic cough should be used northern person, and wind and cold should be used southern person at lung." Zhang Zhi's acute hearing " it is former that book on Chinese herbal medicine is asked " title: " and Fructus Schisandrae Chinensis is the cough key medicine, all cough due to wind and cold, and cough due to summer-heat affection, the cough due to dryness, epersalgia cough, kidney water void is coughed, and kidney fire void is coughed the chronic cough dyspnea with rapid and short breath ... all use it.The suspicious diseases caused by exogenous pathogenic factor of the sage of the past are usefulness early, and probably its getter is too rapid, does not know Zhong Jing typhoid fever cough with asthma, and the little Green Dragon is also used it ... ".
Fructus Schisandrae Chinensis is in drug regimen raw material prescription of the present invention, and last tonifying the lung gas can lose empty and main gas at lung qi, main row water, and main Xuan Fasu falls, and function mistake departments such as main fur cause loses heart, weak, is easy to being invaded by exogenous pathogen, expectorant is easy to store lung and all diseases of abnormal rising of lung-QI; Again with its cough-relieving, the merit of relievining asthma, eliminating the phlegm, the effective disease of mark urgency such as relieving cough, asthma and abundant expectoration is pretended and is monarch drug.Rhizoma amorphophalli adopts the preparation of this product production technology, and boil on the nape opposite the mouth, tongue, throat etc. are located non-stimulated, safety.
Raw material Rhizoma amorphophalli, Fructus Schisandrae Chinensis compatibility are used, and compatibility is precise and appropriate, has embodied and has set upright with eliminating evil and living, the method for treatment of giving consideration to both the incidental and fundamental, for the cough with asthma card of deficiency in origin and excess in superficiality, rather verification, its QI invigorating is astringed the lung and is not hindered heresy, eliminating evil reducing phlegm, relieving cough and asthma and do not consume impairment of QI Tianjin, so but defence obey for a long time.Has invigorating the lung and the kidney, cough-relieving, relieving asthma, the expectorant effect, chronic bronchitis is belonged to insufficiency of lung-QI or deficiency of both the lung and kidney, and the patient who cough is arranged, pant, cough up phlegm, can not only obviously alleviate symptoms such as it is coughed, breathes heavily, expectorant to control its mark, more the void that can help the lung kidney is with Zhi Qiben, and is reliable to the chronic bronchitis curative effect.
Rhizoma amorphophalli of the present invention uses separately or uses with the other medicines compatibility, and clinical efficacy is definite, and safe, and stability is strong, and is controlled, for the acute and chronic bronchitis of clinical treatment provides a kind of new selection.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Description of drawings
The extraction process flow process of Fig. 1 Rhizoma amorphophalli of the present invention
The specific embodiment
The preparation of embodiment 1 medicine capsule of the present invention
Raw material: Fructus Schisandrae Chinensis 667g, Rhizoma amorphophalli 2000g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and is an amount of
Preparation: Fructus Schisandrae Chinensis powder is broken into coarse powder, adds 70% alcohol reflux 2 times; Rhizoma amorphophalli powder is broken into coarse powder, adds 60% ethanol percolation, percolation speed is 1ml/minkg, collects percolate.Merge Fructus Schisandrae Chinensis reflux extracting liquid and Rhizoma amorphophalli percolate, decompression recycling ethanol, and concentrating under reduced pressure becomes clear paste, adds appropriate amount of auxiliary materials, and spray drying, dry granulation incapsulates promptly.
The preparation of embodiment 2 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 667g, Rhizoma amorphophalli 2000g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and is an amount of
Preparation: Fructus Schisandrae Chinensis powder is broken into coarse powder, adds 25% alcohol reflux 2 times; Rhizoma amorphophalli powder is broken into coarse powder, adds 60% ethanol percolation, percolation speed is 10ml/minkg, collects percolate.Merge Fructus Schisandrae Chinensis reflux extracting liquid and Rhizoma amorphophalli percolate, decompression recycling ethanol, and concentrating under reduced pressure becomes clear paste, adds appropriate amount of auxiliary materials, and spray drying, dry granulation incapsulates promptly.
The preparation of embodiment 3 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 667g, Rhizoma amorphophalli 2000g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and is an amount of
Preparation: Fructus Schisandrae Chinensis powder is broken into coarse powder, adds 95% alcohol reflux 2 times; Rhizoma amorphophalli powder is broken into coarse powder, adds 95% ethanol percolation, percolation speed is 0.5ml/minkg, collects percolate.Merge Fructus Schisandrae Chinensis reflux extracting liquid and Rhizoma amorphophalli percolate, decompression recycling ethanol, and concentrating under reduced pressure becomes clear paste, adds appropriate amount of auxiliary materials, and spray drying, dry granulation incapsulates promptly.
The preparation of embodiment 4 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 667g, Rhizoma amorphophalli 2000g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and is an amount of
Preparation: Fructus Schisandrae Chinensis powder is broken into coarse powder, adds 80% alcohol reflux 2 times; Rhizoma amorphophalli powder is broken into coarse powder, adds 80% ethanol percolation, percolation speed is 8ml/minkg, collects percolate.Merge Fructus Schisandrae Chinensis reflux extracting liquid and Rhizoma amorphophalli percolate, decompression recycling ethanol, and concentrating under reduced pressure becomes clear paste, adds appropriate amount of auxiliary materials, and spray drying, dry granulation incapsulates promptly.
The preparation of embodiment 5 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 1150g, Rhizoma amorphophalli 1150g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 1.
The preparation of embodiment 6 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 800g, Rhizoma amorphophalli 1600g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 2.
The preparation of embodiment 7 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 560g, Rhizoma amorphophalli 2240g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 1.
The preparation of embodiment 8 medicinal tablets of the present invention
Raw material: Fructus Schisandrae Chinensis 480g, Rhizoma amorphophalli 2400g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and is an amount of, and preparation method is with embodiment 3, granulates, tabletting, promptly.
The preparation of embodiment 9 medicinal granules of the present invention
Raw material: Fructus Schisandrae Chinensis 420g, Rhizoma amorphophalli 2520g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and is an amount of, and preparation method is granulated with embodiment 1, granulate, promptly.
The preparation of embodiment 10 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 330g, Rhizoma amorphophalli 2310g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 2.
The preparation of embodiment 11 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 330g, Rhizoma amorphophalli 2640g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 1.
The preparation of embodiment 12 medicine capsules of the present invention
Raw material: Fructus Schisandrae Chinensis 300g, Rhizoma amorphophalli 2700g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 3.
The preparation of embodiment 13 medicine capsules of the present invention
Raw material: Rhizoma amorphophalli 3300g, adjuvant: micropowder silica gel, starch, dextrin, microcrystalline Cellulose, lactose is a kind of or its mixing, and an amount of, preparation method is with embodiment 1.
The quality control of embodiment 14 medicines of the present invention
Qualitative identification:
(1) get this product content 1g, add chloroform 30ml, supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets schisandrin and deoxyschizandrin reference substance, adds methanol and makes the solution that every 1ml contains 1mg respectively, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw above-mentioned three kinds of each 2ul of solution, put respectively in same be on the silica GF254 lamellae of adhesive with the sodium carboxymethyl cellulose, with toluene-ethyl acetate (3: 2) is developing solvent, launch, take out, dry, put under the ultraviolet light (254nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, put the speckle of same color.
(2) get this product content 2g, add chloroform 30ml, supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Rhizoma amorphophalli control medicinal material 12g, adds 70% ethanol 100ml, reflux 4 hours, filter, filtrate recycling ethanol also is concentrated into driedly, and residue adds dilute hydrochloric acid 15ml makes dissolving, filters, filtrate is regulated pH value to 9-10 with the 1mol/L sodium hydroxide solution, add chloroform 15ml extraction, divide and get chloroform solution, evaporate to dryness, residue adds methanol 1ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw above-mentioned two kinds of each 10ul of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with benzene-hydrogen imitative (4: 1) is developing solvent, put in the chromatography cylinder of ammonia saturated with vapor, launch, take out, dry, place under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Quantitative assay: measure according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2000).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-water (volume ratio 65: 35) is a mobile phase; The detection wavelength is 250nm.Number of theoretical plate calculates by the schisandrin peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the schisandrin reference substance, adds methanol and make the solution that every 1ml contains 0.1mg, promptly.
The content under this product content uniformity is got in the preparation of need testing solution, and porphyrize is got about 0.8g, and accurate the title decides, and puts in the 50ml measuring bottle, add methanol 45ml, supersound process 40 minutes is taken out, and is placed to room temperature, adds methanol and is diluted to scale, shake up, centrifugal, get supernatant, promptly.
Accurate respectively reference substance solution and each 10ul of need testing solution of drawing of algoscopy injects chromatograph of liquid, calculates, promptly.
Every of capsule of the present invention contains schisandrin (C
24H
32O
7) meter, must not be less than 1.80mg.
Below prove beneficial effect of the present invention by pharmacodynamics, toxicological test.
Test example 1 Rhizoma amorphophalli effect experiment
Animal: Cavia porcellus, 60, body weight 180～220g, Sichuan Academy of Medical Sciences's Experimental Animal Center provides, and the dispensing complete feed.The quality certification number: real moving pipe matter: the 99-12 in river
Mice, 60, body weight 18～22g, Sichuan Academy of Medical Sciences's Experimental Animal Center provides, and the dispensing complete feed.The quality certification number: the real moving pipe matter in river: 24101102
Test sample preparation: get Rhizoma amorphophalli medical material 3kg, be ground into coarse powder,, collect 6 times of amount percolates with the speed percolation of 1ml/kgmin behind the immersion 24h, reclaim petroleum ether, concentrate, get sample A behind the standardize solution with the percolator of packing into after petroleum ether (60～90 ℃) moistening; Medicinal residues add ethyl acetate and continue percolation, collect 6 times of amount percolates, reclaim ethyl acetate liquid, concentrate, and get sample B behind the standardize solution; Medicinal residues add ethanol percolation, collect 6 times of amount percolates, reclaim ethanol, concentrate, and get sample C behind the standardize solution; Get sample D after the medicinal residues drying.(see figure 1)
Experimental technique:
(1) Rhizoma amorphophalli A, B, C, D sample draw the influence of the antitussive effect of coughing Cavia porcellus to citric acid
Get body weight 180～220g Cavia porcellus, male and female half and half, be divided into blank group, Rhizoma amorphophalli A sample group (the former medicine of 2g/kg), B sample group (the former medicine of 2g/kg), C sample group (the former medicine of 2g/kg), D sample group (6 groups of codeine positive controls of the former medicine of 2g/kg), 10 every group at random by body weight.Each group is all with 1ml/100g body weight volume gastric infusion every day, and the blank group gives the equivalent normal saline, successive administration 7 days, and the codeine group only is administered once the 7th day the time.After the last administration 1 hour, draw with 17.5% aqueous solution of citric acid and to cough, Cavia porcellus is put into bell glass, sprayed into 17.5% aqueous solution of citric acid 5 seconds, the cough number of times in the record Cavia porcellus 5 minutes with ultrasound atomizer.The results are shown in Table 12-1.
Table 12-1 Rhizoma amorphophalli draws the antitussive action of coughing Cavia porcellus to citric acid
| Group | Number of animals (only) | Dosage | Incubation period | The number of times of coughing in 5 minutes |
| Normal control group codeine group Rhizoma amorphophalli A Rhizoma amorphophalli B Rhizoma amorphophalli C Rhizoma amorphophalli D | 10 10 10 10 10 10 | The former medicine of-30mg/kg 2g/former medicine of the kg 2g/former medicine of kg 2g/former medicine/kg of kg 2g | 16.57±10.25 158.2±34.07 ** 55.4±14.26 52.4±12.24 76.5±17.23 37.2±10.98 | 27.4±6.75 8.32±3.26 ** 18.4±3.92 21.7±5.76 15.7±6.62 ** 24.1±6.43 |
Annotate: compare with normal group,
*P＜0.05,
*P＜0.01
The result shows: the codeine group obviously reduces the cough number of times, with matched group significant difference is arranged relatively; Rhizoma amorphophalli C group also can reduce the cough number of times, but is weaker than the codeine group.Rhizoma amorphophalli A, B group has the trend that reduces the cough number of times, but compares there was no significant difference with matched group.Rhizoma amorphophalli D group does not have obvious influence to the cough number of times.
(2) Rhizoma amorphophalli A, B, C, D sample are to the influence of mice phlegm-dispelling functions
Get body weight 18～22g mice, male and female half and half, be divided into blank group, Rhizoma amorphophalli A sample group (the former medicine of 2g/kg), B sample group (the former medicine of 2g/kg), C sample group (the former medicine of 2g/kg), D sample group (the former medicine of 2g/kg), 6 groups of ammonium chloride positive controls, 10 every group at random by body weight.Each group is all with 1ml/100g body weight volume gastric infusion every day, and the blank group gives the equivalent normal saline, successive administration 7 days.After the last administration 30 minutes, every mouse peritoneal was injected 0.5% phenol red solution 0.5ml, after 30 minutes, took off cervical vertebra and put to death mice, used 5%NaHCO
3Solution lavation mice trachea and bronchus 3 times, each 0.5ml collects the about 1.5ml of irrigating solution, measures absorption value at 520nm wavelength place with 721 type spectrophotometers, the results are shown in Table 12-2.
The influence phenol red of table 12-2 Rhizoma amorphophalli to the mice excretion
| Group | Number of animals (only) | Dosage | Absorption value |
| Normal control group ammonium chloride group Rhizoma amorphophalli A Rhizoma amorphophalli B Rhizoma amorphophalli C Rhizoma amorphophalli D | 10 10 10 10 10 10 | The former medicine of-30mg/kg 2g/former medicine of the kg 2g/former medicine of kg 2g/former medicine/kg of kg 2g | 0.72±0.31 1.76±0.52 ** 1.01±0.42 1.12±0.38 1.52±0.59 ** 0.84±0.35 |
Annotate: compare with normal group,
*P＜0.05,
*P＜0.01
The result shows: the ammonium chloride group can make mouse breathing road phenol red output obviously increase, and with matched group utmost point significant difference is arranged relatively; Rhizoma amorphophalli C dosage group can increase mouse breathing road phenol red output, but is weaker than the ammonium chloride group, with matched group utmost point significant difference is arranged more also.Rhizoma amorphophalli A, B dosage group also can make the phenol red output increase in mouse breathing road, but compare there was no significant difference with matched group.Rhizoma amorphophalli D dosage group does not have influence to mouse breathing road phenol red output.
The opposed polarity solvent extract of Rhizoma amorphophalli is carried out pharmacodynamic experiment, and the result shows: the konjac meal ethanol extraction has obvious pharmacological action, and medicinal residues do not have obvious pharmacological action, considers that therefore this medicinal alcohol extracts.
Test example 2 Rhizoma amorphophallis treatment chronic bronchitis observation of curative effect
After Rhizoma amorphophalli was carried with 95% ethanol, hot reflux was extracted again, incapsulate, so that take, and 30 routine observation of curative effect.Wherein:
Man's 12 examples account for 40%; Woman's 18 examples account for 60%; 26 examples more than 50 years old account for 87%; The right side of fifty 4 examples account for 13%;
After the treatment in March, observe 3 years recovery from illness 23 examples, account for 77%; Produce effects 5 examples account for 17%; Effective 1 example accounts for 3%; An invalid example accounts for 3%.Total effective rate is 97%, invalid 3%.
Model case:
1, the national man of woods took medicine so far 14 years in 59 years old, had been emphysema when taking medicine, and after taking, the state of an illness is not recurrence always, and is 73 years old now, healthy.
2, Xia Di man took medicine so far 13 years in 56 years old, had been 30 years medical histories when taking medicine, recurrence so far after taking medicine, 68 years old now.
3, the green mill woman of Liu took medicine so far 15 years in 56 years old, not recurrence so far after the healing, 71 years old now.
Prove that by above-mentioned pharmacodynamics test Rhizoma amorphophalli uses separately has antitussive, phlegm-dispelling functions, cough, abundant expectoration only are bronchitic clinical symptoms, prove that by clinical trial Rhizoma amorphophalli can be treated chronic bronchitis, the cure rate height, and relapse rate is low, safety, effective.
Test example 3 is the pharmacodynamics test of the pharmaceutical composition that forms of feedstock production with Rhizoma amorphophalli, Fructus Schisandrae Chinensis
Below be to be the pharmacodynamics test of the pharmaceutical composition (pressing embodiment 1 described preparation) that forms of feedstock production with Rhizoma amorphophalli, Fructus Schisandrae Chinensis.
1. medicine of the present invention has the good curing effect to the scorching model of rat chronic bronchitis due to the lipopolysaccharide, compare with model group, each dosage group of medicine of the present invention can reduce the neutrophilic granulocyte number that raises, the shared constituent ratio of pulmonary alveolar macrophage is raise to some extent, wherein, heavy dose of group relatively has significant difference (P＜0.05) with model group.Compare with the normal control group, the neutrophilic granulocyte number of each dosage group of medicine of the present invention and the shared constituent ratio of pulmonary alveolar macrophage all do not return to normally.2. each dosage group of medicine of the present invention can obviously reduce ammonia and draw the cough number of times of coughing mice, compares with matched group, and significant difference (P＜0.01) is arranged; The big or middle dosage group of medicine of the present invention can obviously reduce citric acid and draw the cough number of times (P＜0.01, P＜0.05) of coughing Cavia porcellus, shows that it has stronger antitussive action.3. the large, medium and small dosage group of medicine of the present invention all can increase mouse breathing road phenol red output, with matched group significant difference (P＜0.01, P＜0.05) is arranged relatively.The large, medium and small dosage group of chronic bronchitis health also can make rat expectoration amount increase, and compares with matched group, has significant difference (P＜0.05, P＜0.01) to show that it has expectorant effect preferably.4. the large, medium and small dosage group of medicine of the present invention can prolong due to the histamine drawing of Cavia porcellus asthma reaction breathes heavily incubation period, with matched group relatively, significant difference (P＜0.05, P＜0.01) is arranged, show that it has certain antiasthmatic effect.The large, medium and small dosage group of 5 medicines of the present invention can significantly suppress the made mice ear reaction of dimethylbenzene, compares with matched group, and significant difference (P＜0.01) is arranged; The large, medium and small dosage group of medicine of the present invention also can suppress mice granuloma induced by implantation of cotton pellets weight, compares with matched group, and significant difference (P＜0.05, P＜0.01) is arranged, and shows that it has antiinflammatory action preferably.6. the big or middle dosage group of medicine of the present invention can increase thymus index, compares with matched group, and significant difference (P＜0.01) is arranged.Small dose group also can increase thymus index, compares with matched group, and significant difference (P＜0.05) is arranged.The heavy dose of group of medicine of the present invention can increase thymus index, compares with matched group, and significant difference (P＜0.05) is arranged.The big or middle dosage group of medicine of the present invention can promote the generation of mice hemolytic antibody, compares with matched group, and significant difference (P＜0.05) is arranged.Show that it can improve the mouse immune organ weight, promote the generation of mice hemolytic antibody, body's immunological function is had certain potentiation.
Experiment showed, that medicine of the present invention has the effect and the antitussive of treatment chronic bronchitis, ends expectorant, the effect of relievining asthma, have certain antiinflammatory simultaneously, regulate immunity function.
The secondary experiment of test example 4 medicine poison of the present invention
The acute toxicity test in mice result
Medicine acute toxicity test of the present invention shows that the maximum dosage-feeding of mouse stomach medicine of the present invention is 182.4 gram crude drug in whole/kilograms, and being about is grown up drafted 456 times of clinical dosage on the 1st, and the result shows that chronic bronchitis health acute toxicity is little.
The long term toxicity test result
1, rat long term toxicity test
Medicine 26 all rat long term toxicity test results of the present invention show, irritate stomach continuous 26 weeks and give rat medicine 45.6 gram former medicine/kilograms of the present invention, 22.8 gram former medicine/kilograms, 11.4 gram former medicine/kilograms (114 times, 57 times, 28.5 times of suitable clinical dosage respectively).The result: no abnormality seens such as (1) medicine of the present invention respectively organizes rat outward appearance, behavior, ingest, administration group weight gain value and matched group be there was no significant difference (P＞0.05) relatively.(2) medicine of the present invention is respectively organized hemogram index no abnormality seens such as rat WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, through comparing there was no significant difference (P＞0.05) with matched group.(3) medicine of the present invention is respectively organized ALB, CREAT, TPROT, ALP, TC, GLU, ASAT, ALAT, BUN, BIL, TBIL, the GGT blood parameters no abnormality seen of rat, through comparing there was no significant difference (P＞0.05) with matched group.(4) medicine of the present invention is respectively organized rat and carry out careful system's obduction, the equal Non Apparent Abnormality of macroscopy is found.Main organs is weighed, measure organ coefficient, medicine of the present invention is as a result respectively organized Rats Organs and Tissues coefficient no significant difference.Compare there was no significant difference (P＞0.05) with matched group.(5) result of tissue pathology checking reflection: 24 kinds of internal organs such as liver, kidney, the heart, spleen, lung, trachea, brain, thymus, thyroid, parathyroid gland, adrenal gland, stomach, bone marrow of sternum, ileum, colon, duodenum, optic nerve, spinal cord, lymph node, uterus, ovary or testis, epididymis, prostate are not seen tissue pathologies change and drug toxicity reaction.Conclusion: this experimental result shows that medicine of the present invention continuous 26 all oral administration gavages do not have the overt toxicity effect; The pathological anatomy and the histopathologic examination of 24 kinds of internal organs such as its rat outward appearance, body weight gain, hemogram, blood biochemical and liver, kidney, the heart, spleen, lung, trachea, brain, thymus, thyroid, parathyroid gland, adrenal gland, stomach, bone marrow of sternum, ileum, colon, duodenum, optic nerve, spinal cord, lymph node, uterus, ovary or testis, epididymis, prostate there is no drug toxicity reaction.
2, dog long term toxicity test result
24 5 monthly age Beagle dogs are divided into 4 groups, are respectively medicine of the present invention (content) 4.0g/kg, 2.0g/kg, 1.0g/kg and matched group, every day oral administration, continuous 180 days, observed result was as follows:
There was the sialorrhea reaction at the initial stage after medicine of the present invention (content) heavy dose of (4.0g/kg) was given the dog oral medicine, adapted to after 1 week, no longer occurred, and the full distance test animal has stool soft, and urine is with the medicine color.Body weight gain is slow than other three groups, and the dog outward appearance is normal, and is by hair gloss, active.In (2.0g/kg), little (1.0g/kg) dosage group no abnormality seen.
Preceding 2 times of administration, administration 45 days, 90 days, 135 days, 180 days, and drug withdrawal observed 30 days, blood biochemical is learned and is detected, and rarely seen administration is the big or middle dosage group dog ALP trend that raises gradually after 45 days; Heavy dose of group and matched group comparing difference remarkable (P＜0.05) all do not have obvious influence to other index.
Preceding 2 times of administration, administration 45 days, 90 days, 135 days, 180 days, and conventional 10 the inspection no abnormality seens of dog urine were observed in drug withdrawal 30 days; The peripheral hemogram data fluctuateed in normal range; Wide and amplitude does not all have obvious influence to ripples such as ECG P, QRS, T, and the rhythm of the heart is hole.P ripple, QRS ripple are consistent with main ripple direction, and Electrocardiographic waveform plot is Non Apparent Abnormality also.Administration 180 days, and drug withdrawal observed 30 days, dog bone marrow smear no abnormality seen cell, myelosis is active.
Administration 180 days, system's each treated animal that becomes celestial, each internal organs all do not have the visible pathological changes of naked eyes and unusual, big or middle dosage group liver weight and coefficient smaller dose and matched group height, and 30 days no abnormality seens are observed in drug withdrawal.
24 dog hearts of histopathological examination, liver, lung, spleen, kidney, brain, cerebellum, hypophysis, spinal cord (neck, breast, waist), optic nerve, eyeball (retina), sciatic nerve, submaxillary gland (salivary gland), thyroid, thymus, pancreas, adrenal gland, lymph node (mesentery), testis (epididymis), prostate, ovary, uterus, mammary gland, esophagus, trachea, stomach, duodenum, ileum, colon, gallbladder, bladder, aortic tissue, each dog is respectively organized does not all have the form textural anomaly.
To sum up show: 180 days overviews 4.0 of medicine of the present invention (content) administration, that 2.0g/kg can cause dog is just soft; urine band medicine color; liver zymetology (ALP) index and liver coefficient have rising trend, drug withdrawal are observed and recovered normal in 30 days, and the following dosage of 1.0g/kg is safe to animal.The above results prompting medicine of the present invention (content) has bigger safety.
The result shows that drug toxicity of the present invention is little, and clinical using dosage is safe and reliable.
By above-mentioned pharmacodynamics test, clinical trial explanation, medicine Rhizoma amorphophalli of the present invention uses separately, the treatment chronic bronchitis, drug effect is definite, and the clinical recurrence rate is low, use or use with other medicines compatibility (as Fructus Schisandrae Chinensis), reach the effect of Synergistic, and safe, stability is strong, controlled, for the acute and chronic bronchitis of clinical treatment provides a kind of new selection.
Claims (12)
1, Rhizoma amorphophalli Amorphophallus rivieri Durieu and extract thereof the purposes in the acute and chronic bronchitic medicine of preparation treatment.
2, purposes according to claim 1 is characterized in that: described Rhizoma amorphophalli extract is Rhizoma amorphophalli ethanol extraction or extractive with organic solvent.
3, purposes according to claim 2 is characterized in that: described Rhizoma amorphophalli ethanol extraction is 25%～95% ethanol extraction.
4, a kind of pharmaceutical composition, it is to be active component or raw material by the described Rhizoma amorphophalli of claim 1-3 or its extract, adds the medicament that acceptable accessories or complementary composition are prepared from.
5, pharmaceutical composition according to claim 4 is characterized in that: described raw material also contains Fructus Schisandrae Chinensis, and its weight proportion is: Rhizoma amorphophalli: Fructus Schisandrae Chinensis 1～10: 9～0.
6, pharmaceutical composition according to claim 4 is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 5～8: 5～2.
7, pharmaceutical composition according to claim 6 is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 6: 2.
8, according to claim 6 or 7 described pharmaceutical compositions, it is characterized in that: described medicament is capsule, granule, tablet, pill, oral liquid.
9, pharmaceutical composition according to claim 8 is characterized in that; Every capsules contains schisandrin and must not be less than 1.8mg in the described capsule.
10, a kind of method for preparing each described pharmaceutical composition of claim 5-9, it comprises the steps:
A, take by weighing each materials of weight proportions medicine:
Rhizoma amorphophalli: Fructus Schisandrae Chinensis 1～10: 9～0;
B, Rhizoma amorphophalli 60%～95% ethanol extraction get extract;
C, get Fructus Schisandrae Chinensis, pulverize, add 25%～95% ethanol, reflux, extract,, Fructus Schisandrae Chinensis extrat;
D, the extract that b, c step are prepared mix, concentrate, and add the medicament that acceptable accessories or complementary composition are prepared from.
11, preparation of drug combination method according to claim 10 is characterized in that: the described ethanol extraction method of step b is an alcohol percolation method, and concentration of alcohol is 60%, and percolation speed is 1ml/minkg, and the described concentration of alcohol of step c is 70%.
12, the purposes of the described pharmaceutical composition of claim 4 in the medicine of preparation treatment acute bronchitis, chronic bronchitis, emphysema, pulmonary heart disease and reveal any symptoms thereof.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100207991A CN100536883C (en) | 2005-04-27 | 2005-04-27 | Use of konjak and its extract in preparation of medicine for treating acute and chronic bronchitis |
| KR1020077027668A KR101452394B1 (en) | 2005-04-27 | 2006-04-25 | Use of amorphophallus rivieri durieu and extract thereof in the manufacture of a medicament for treating acute, chronic bronchitis |
| JP2008508055A JP5265347B2 (en) | 2005-04-27 | 2006-04-25 | Use of konjac and its extract in formulating pharmaceuticals for the treatment of acute and chronic bronchitis |
| PCT/CN2006/000786 WO2006114054A1 (en) | 2005-04-27 | 2006-04-25 | Use of amorphophallus rivieri durieu and extract thereof in the manufacture of a medicament for treating acute, chronic bronchitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100207991A CN100536883C (en) | 2005-04-27 | 2005-04-27 | Use of konjak and its extract in preparation of medicine for treating acute and chronic bronchitis |
Publications (2)
| Publication Number | Publication Date |
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| CN1853697A true CN1853697A (en) | 2006-11-01 |
| CN100536883C CN100536883C (en) | 2009-09-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100207991A Expired - Fee Related CN100536883C (en) | 2005-04-27 | 2005-04-27 | Use of konjak and its extract in preparation of medicine for treating acute and chronic bronchitis |
Country Status (4)
| Country | Link |
|---|---|
| JP (1) | JP5265347B2 (en) |
| KR (1) | KR101452394B1 (en) |
| CN (1) | CN100536883C (en) |
| WO (1) | WO2006114054A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104096380A (en) * | 2013-04-15 | 2014-10-15 | 天津天士力现代中药资源有限公司 | Method for efficiently extracting effective compositions of traditional Chinese medicines through percolation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR102202122B1 (en) * | 2018-04-30 | 2021-01-13 | 주식회사 종근당 | Composition for anti-tussive activity or discharge of phlegm activity comprising extract of Atractylodes Rhizome White and Schizandra Fruit |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1033565A (en) * | 1987-12-22 | 1989-07-05 | 中国科学院成都生物研究所 | A kind of processing technique of refined powder of marvellous taro |
| CN1197676A (en) * | 1997-04-27 | 1998-11-04 | 李向东 | Dressing made of konjak and its preparation |
| KR19980083461A (en) * | 1997-05-15 | 1998-12-05 | 박원훈 | Use of a substance having an antagonistic activity against platelet activator receptor binding and a pharmaceutical composition containing the same |
| JP4180258B2 (en) * | 2001-08-06 | 2008-11-12 | 西川ゴム工業株式会社 | IgE antibody inhibitor and food |
| JP2003081859A (en) * | 2001-09-07 | 2003-03-19 | Taisho Pharmaceut Co Ltd | Therapeutic agent for allergic rhinitis |
| JP2004043359A (en) * | 2002-07-11 | 2004-02-12 | Unitika Ltd | Immunoglobulin e antibody production inhibitor and pollinosis preventing/treating agent |
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2005
- 2005-04-27 CN CNB2005100207991A patent/CN100536883C/en not_active Expired - Fee Related
-
2006
- 2006-04-25 WO PCT/CN2006/000786 patent/WO2006114054A1/en active Application Filing
- 2006-04-25 JP JP2008508055A patent/JP5265347B2/en not_active Expired - Fee Related
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104096380A (en) * | 2013-04-15 | 2014-10-15 | 天津天士力现代中药资源有限公司 | Method for efficiently extracting effective compositions of traditional Chinese medicines through percolation |
| CN104096380B (en) * | 2013-04-15 | 2017-07-14 | 天津天士力现代中药资源有限公司 | A kind of method of efficient seepage pressure effects effective component of chinese medicine |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2006114054A1 (en) | 2006-11-02 |
| JP5265347B2 (en) | 2013-08-14 |
| CN100536883C (en) | 2009-09-09 |
| KR101452394B1 (en) | 2014-10-21 |
| JP2008539175A (en) | 2008-11-13 |
| KR20080005592A (en) | 2008-01-14 |
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