CN105596929A - Preparing method for traditional Chinese medicine preparation for treating phlegm-heat excessive accumulation type chronic cough - Google Patents

Preparing method for traditional Chinese medicine preparation for treating phlegm-heat excessive accumulation type chronic cough Download PDF

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CN105596929A
CN105596929A CN201610046139.9A CN201610046139A CN105596929A CN 105596929 A CN105596929 A CN 105596929A CN 201610046139 A CN201610046139 A CN 201610046139A CN 105596929 A CN105596929 A CN 105596929A
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root
cough
phlegm
chinese medicine
tuber
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葛云洁
李靖
肖芝秀
袁莉
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Abstract

The invention provides a preparing method for a traditional Chinese medicine preparation for treating a phlegm-heat excessive accumulation type chronic cough. The traditional Chinese medicine preparation is prepared from roasted ephedra herb, almond kernels, gypsum, raw licorice roots, bamboo shavings, fruits of immature citron, processed pinellia tuber, fructus gardeniae, radix scutellariae, radix platycodi, perillaseed, the root bark of white mulberry, cortex lycii radicis, polished round-grained rice, pepperweed seeds, rhizoma phragmitis, dwarf lilyturf roots, fritillary bulb, poria cocos, snakegourd fruits, radix peucedani, willowleaf swallowwort rhizomes, prepared radix stemonae, heartleaf houttuynia herb, tangerine peel, honeysuckle flowers and indigo naturalis. According to the traditional Chinese medicine preparation, under the guidance of the traditional Chinese medicine theory, medicine compounding and applying are carried out based on comprehensive analysis on symptom types, clinical manifestation, treatment prognosis and the like according to a large amount of clinical observation, and the effects of relieving the cough and asthma and reducing phlegm are achieved; in addition, through verification of animal experiments and traditional Chinese medicine safety evaluation, it is proved that the traditional Chinese preparation has a very good effect on treating the phlegm-heat excessive accumulation type chronic cough.

Description

Be used for the treatment of the preparation method that phlegm heat is stopped up the Chinese medicine preparation of the chronic cough of containing card type
Technical field
The present invention relates to traditional Chinese medicine technical field, relate in particular to a kind of phlegm heat that is used for the treatment of and stop up the slow of Sheng card typeThe preparation method of the Chinese medicine preparation of property cough.
Background technology
Chronic cough is thought a kind of reflexive defence action at modern medicine, in the time that human body is coughed, and canWith the secretion in clearing pneogaster and foreign matter. But meanwhile cough also has disadvantageous one side, for example, coughCough can make to infect and spread in respiratory tract, violent cough can cause hemorrhage from respiratory tract, even brings out spontaneousProperty pneumothorax etc. Frequent cough can cause serious impact to patient's work, life and social activities. CloselyOver year, constantly there is scholar to study pathogenesis, diagnosis and the treatment of cough. The inspection of utilization x-ray,The diagnostic means such as pulmonary function test, anaphylactogen inspection, branchofiberoscope, can find early to cause and coughThe reason of coughing, and treat for the cause of disease.
Chronic cough is as symptom, and western medicine is summarized as the clinical manifestation of diseases in respiratory system it,Although can make diagnosis to most of disease, because the abuse such as antibiotic and hormone has limited medicineClinical efficacy, thereby in the face of the cough symptom of failing to respond to any medical treatment, that often sinks into can to use without medicine is poverty-stricken. InMedical science as independent name of disease, has certain realistic meaning " cough ". "Nei Jing" cloud " the five internal organs sixInternal organs all makes us coughing, and non-only lung is also ", explicitly pointing out cough all has close contacting with the vital organs of the human body, and slowProperty cough is close especially with the relation of internal organs. This understanding and the treatment to cough based on Overall View, so farThe curative effect obtaining clinically not second to the treatment of doctor trained in Western medicine. Current, to recognizing of the traditional Chinese medical science " chronic cough "Know, think closely related with " propping up slowly ", " cough variant asthma " etc. of western medicine, and these are several moreClass disease often western medicine clinical efficacy dispatches a person by force to anticipate, and the treatment of traditional Chinese medicine but shows superiority especially.
Clinical report shows, chronic cough is mainly seen in slow, this two large class doctor trained in Western medicine of cough variant asthmaDisease, phlegm heat stops up that to contain card be an important card type, this injures lung with chronic cough course of disease length, prolonged illnessSpleen has close ties. Research and development as new Chinese medicine must coach with theory of traditional Chinese medical science, chronic cough conductClinical frequently-occurring disease common disease, the clinical use curative effect of miscellaneous Chinese patent drug is dissatisfied at present, the present inventionChinese medicine preparation under the guidance of theory of traditional Chinese medical science, according to a large amount of clinical observations, verification type, clinical manifestation andTreatment prognosis etc. is comprehensively analyzed, and prescription medicine not only has cough-relieving, an effect of relievining asthma, reduce phlegm, andAnd verify by zoopery, and passed through Chinese native medicine security evaluation, proved invention Chinese medicine preparation toolThere is good treatment phlegm heat to stop up the chronic cough effect of containing card type, more further carry out wider clinicalThe evaluation of research and expected results, being expected to provides the chronic cough of national medicine treatment phlegm heat heap soil or fertilizer over and around the roots Sheng card typeNew treatment means, for further researching and developing and establish certain experiment and Clinical Basis.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of phlegm heat that is used for the treatment of and stops up chronic the coughing of containing card typeThe preparation method of the Chinese medicine preparation of coughing, Chinese medicine preparation of the present invention is under the guidance of theory of traditional Chinese medical science, according in a large numberClinical observation, verification type, clinical manifestation and treatment prognosis etc. comprehensively analyzed, prescription medicine, noOnly there is cough-relieving, the effect of relievining asthma, reduce phlegm, and verify by zoopery, and passed through Chinese medicine peaceFull property evaluation, proved invention Chinese medicine preparation has good treatment phlegm heat and stops up the chronic cough effect of containing card typeReally, more further carry out wider clinical research and the evaluation of expected results, be expected to national medicineThe chronic cough that treatment phlegm heat is stopped up Sheng card type provides a kind of new treatment means, for further research and development are establishedFixed certain experiment and Clinical Basis.
Based on this, the invention provides a kind of Chinese medicine system that phlegm heat is stopped up the chronic cough of containing card type that is used for the treatment ofAgent, its bulk drug comprise process Chinese ephedra, almond, gypsum, raw Radix Glycyrrhizae, caulis bambusae in taenian, the dried immature fruit of citron orange, rhizoma pinellinae praeparata,Raw cape jasmine, the root of large-flowered skullcap, balloonflower root, perillaseed, the root bark of white mulberry, the root bark of Chinese wolf-berry, polished rice, lepidium seed, reed rhizome, Mai MenWinter, fritillaria thunbergii, Poria cocos, Snakegourd Fruit, the root of purple-flowered peucedanum, Cynanchum glaucescens, process the tuber of stemona, cordate houttuynia, dried orange peel, honeysuckle,Indigo naturalis.
Wherein, in described Chinese medicine preparation, the weight of each bulk drug is respectively and processs Chinese ephedra 25g~40g, almond10g~20g, gypsum 20g~30g, raw Radix Glycyrrhizae 15g~25g, caulis bambusae in taenian 20g~40g, dried immature fruit of citron orange 10g~25g, rhizoma pinellinae praeparata 15g~25g, raw cape jasmine 20g~40g, root of large-flowered skullcap 25g~40g, balloonflower root 10g~20g,Perillaseed 10g~20g, root bark of white mulberry 15g~25g, root bark of Chinese wolf-berry 15g~20g, polished rice 20g~25g, Roripa montanaSub-10g~20g, reed rhizome 10g~20g, tuber of dwarf lilyturf 25g~35g, fritillaria thunbergii 15g~25g, Poria cocos 10g~20g, Snakegourd Fruit 15g~25g, root of purple-flowered peucedanum 10g~20g, Cynanchum glaucescens 10g~20g, process tuber of stemona 15g~25g, fishRaw meat grass 25g~35g, dried orange peel 10g~20g, honeysuckle 15g~25g and indigo naturalis 5g~10g.
Further also can add Exocarpium Citri Grandis 10g~20g.
Wherein, in described Chinese medicine preparation, the weight of each bulk drug is respectively and processs Chinese ephedra 30g~35g, almond10g~15g, gypsum 25g~30g, raw Radix Glycyrrhizae 15g~20g, caulis bambusae in taenian 25g~30g, dried immature fruit of citron orange 15g~20g, rhizoma pinellinae praeparata 15g~20g, raw cape jasmine 25g~30g, root of large-flowered skullcap 30g~35g, balloonflower root 15g~20g,Perillaseed 10g~15g, root bark of white mulberry 20g~25g, root bark of Chinese wolf-berry 15g~20g, polished rice 20g~25g, Roripa montanaSub-10g~15g, reed rhizome 10g~15g, tuber of dwarf lilyturf 30g~35g, fritillaria thunbergii 15g~20g, Poria cocos 15g~20g, Snakegourd Fruit 15g~20g, root of purple-flowered peucedanum 10g~15g, Cynanchum glaucescens 15g~20g, process tuber of stemona 15g~20g, fishRaw meat grass 30g~35g, dried orange peel 10g~15g, honeysuckle 35g~40g and indigo naturalis 5g~10g.
Wherein, in described Chinese medicine preparation, the weight of each bulk drug is respectively and processs Chinese ephedra 30g, almond 15g, lifeGypsum 25g, raw Radix Glycyrrhizae 20g, caulis bambusae in taenian 30g, dried immature fruit of citron orange 20g, rhizoma pinellinae praeparata 20g, raw cape jasmine 30g, the root of large-flowered skullcap30g, balloonflower root 15g, perillaseed 15g, root bark of white mulberry 20g, root bark of Chinese wolf-berry 20g, polished rice 20g, lepidium seed 15g,Reed rhizome 15g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 20g, Poria cocos 15g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g, Cynanchum glaucescens15g, process tuber of stemona 20g, cordate houttuynia 30g, dried orange peel 15g, honeysuckle 35g and indigo naturalis 10g.
Wherein, in described Chinese medicine preparation, the weight of each bulk drug is respectively and processs Chinese ephedra 30g, almond 15g, lifeGypsum 25g, raw Radix Glycyrrhizae 20g, caulis bambusae in taenian 30g, dried immature fruit of citron orange 20g, rhizoma pinellinae praeparata 20g, raw cape jasmine 30g, the root of large-flowered skullcap30g, balloonflower root 15g, perillaseed 15g, root bark of white mulberry 20g, root bark of Chinese wolf-berry 20g, polished rice 20g, lepidium seed 15g,Reed rhizome 15g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 20g, Poria cocos 15g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g, Cynanchum glaucescens15g, process tuber of stemona 20g, cordate houttuynia 30g, dried orange peel 15g, honeysuckle 25g, Exocarpium Citri Grandis 15g and indigo naturalis10g。
Wherein, described Chinese medicine preparation for adding the acceptable auxiliary material preparation of pharmacy in traditional Chinese medicine extraction compositionThe oral formulations becoming.
Wherein, described oral formulations comprise decoction, tablet, capsule, granule, oral liquid, powder,Pulvis.
The present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and it comprises:
The first step, take by weight process Chinese ephedra, raw Radix Glycyrrhizae, rhizoma pinellinae praeparata, the root of large-flowered skullcap, the root bark of white mulberry, polished rice,The tuber of dwarf lilyturf, fritillaria thunbergii, Snakegourd Fruit, the root of purple-flowered peucedanum, cordate houttuynia, dried orange peel and indigo naturalis, clean respectively, pulverize, mixedBe combined, in the ethanol that the determining alcohol that adds 5~10 times of amounts of mixture quality is 70%~80%, soak 1~2 hours, heating was extracted 2 times, and each 1~2 hour, merge extract, 100 orders filter, then through cuttingThe ultrafiltration post ultrafiltration that stream molecular weight is 5000~10000, when ultrafiltrate reduced pressure concentration relative density is 60 DEG C1.30~1.36 medicinal extract, stand for standby use;
Second step, takes remaining bulk drug by weight, cleans respectively, pulverizes, and mixes, and addsThe ethanol water heating and refluxing extraction that the determining alcohol of 6~8 times of amounts of this step mixture quality is 50%~70%1~3 time, each time of extracting is 0.5~2 hour, collects extract, filters, by filtrate decompressionThe concentrate that while being concentrated into 60 DEG C, relative density is 1.02~1.18, upper large pore resin absorption column, macroporeThe quality of polymeric adsorbent is 10~15 times of this step bulk drug quality sum, is 40~70% with determining alcoholAqueous solution of alcohol wash-out, collects eluent, when reduced pressure concentration relative density is 60 DEG C 1.30~1.36Medicinal extract,
The 3rd step, mixes the medicinal extract of the first step and second step acquisition, gets 200g medicinal extract, then adds auxiliary materialMake and be applicable to the formulation of use clinically.
Wherein, in the time being prepared into oral liquid, the 3rd step is specially, and the first medicinal extract and the second medicinal extract are mixedTogether, get 200g medicinal extract, add with respect to the cane sugar powder that mixes 2~4 times of medicinal extract quality, mix allEven, be prepared into granules of sugar, dry, make altogether 1000, splitting splendid attire, every bag of 10g.
Useful technique effect
The Chinese medicine preparation of the chronic cough that is used for the treatment of phlegm heat heap soil or fertilizer over and around the roots Sheng card type provided by the invention, drug safety,Have no side effect, there is good treatment phlegm heat and stop up the chronic cough effect of containing card type.
Detailed description of the invention
The Chinese medicine preparation that the invention provides a kind of chronic cough that is used for the treatment of phlegm heat heap soil or fertilizer over and around the roots Sheng card type, it is formerMaterial cartridge bag draw together process Chinese ephedra, almond, gypsum, raw Radix Glycyrrhizae, caulis bambusae in taenian, the dried immature fruit of citron orange, rhizoma pinellinae praeparata, raw cape jasmine,The root of large-flowered skullcap, balloonflower root, perillaseed, the root bark of white mulberry, the root bark of Chinese wolf-berry, polished rice, lepidium seed, reed rhizome, the tuber of dwarf lilyturf, Zhejiang shellfishMother, Poria cocos, Snakegourd Fruit, the root of purple-flowered peucedanum, Cynanchum glaucescens, process the tuber of stemona, cordate houttuynia, dried orange peel, honeysuckle and indigo naturalis.
Phlegm-heat cough, for heresy is violated air flue, lung loses Xuan Suer and causes phlegm-heat accumulated in the lung card. Clinical manifestation for cough,Phlegm Huang is thick, cough up tell not well, the turbid tears of nasal obstruction stream, pharyngalgia celostomia, red tongue body, the thin Huang of tongue or greasy, slippery and rapid pulseEtc. symptom. Modern medicine be diagnosed as more " chronic bronchitis, or " cough variant asthma ", manySuffer from cold and infect or contact history, auscultation of lung audible and dry, moist rales. Phlegm-heat accumulated in the lung, impairment of dispersing and descending function of the lung,Therefore the yellow difficulty of cough phlegm goes out; Or phlegm thermalization fire, therefore hindering network, bright lung sees phlegm blood pharyngalgia; Or phlegm heat is stopped up Sheng, mechanism of qiUnfavorable, thus uncomfortable in chest, dry and bitterly very hinder Tianjin for heat, and show tongue Huang, and slippery and rapid pulse, this is resembling of phlegm heat.Therefore while treatment, work as the respectful lung of heat-clearing, open-minded phlegm and relieving cough. Chinese medicine preparation of the present invention is for this sick etiology and pathogenesis,Prescription combination drug, uses gypsum, raw cape jasmine, the root of large-flowered skullcap, the root bark of white mulberry, the root bark of Chinese wolf-berry, reed rhizome, fish raw meatGrass, honeysuckle, polished rice, indigo naturalis clearing lung-heat purging intense heat, the consolidating the yin of heat-clearing simultaneously, heat evil one is gone, and state of an illness speed subtracts,All medicines share, and are monarch drug in a prescription group; For patient's cough, syndrome characterized by dyspnea symptom, Chinese medicine preparation of the present invention uses processs fiber cropsHuang, almond, balloonflower root, perillaseed, lepidium seed, dried orange peel, the root of purple-flowered peucedanum, Cynanchum glaucescens, process the tuber of stemona and freeing lung and relieving asthma, itsEpheday intermedia is processed with delaying the power of its sweating and is retained the merit of freeinging lung and relieving asthma, and lepidium seed has the use of removing heat from lung and relieving asthma,The root of purple-flowered peucedanum, Cynanchum glaucescens, process the tuber of stemona and all have good cough-relieving effect, all medicines share, and are ministerial drug group; For itPhlegm heat is stopped up the interpretation of the cause, onset and process of an illness of containing, and eliminating the phlegm is also important business, therefore adds caulis bambusae in taenian, the dried immature fruit of citron orange, rhizoma pinellinae praeparata, perillaseed, ZhejiangThe bulb of fritillary, Poria cocos, Snakegourd Fruit, process the medicines such as the tuber of stemona, the root of purple-flowered peucedanum, Cynanchum glaucescens, coordinate monarch drug in a prescription group clear heat and eliminate phlegm, phlegm heatDo not fight mutually, expectoration is breathed heavily all and is removed, and is adjutant; Pyretic damage of yin, disease treatment makes to protect cloudy liquid when turning round and look at, thereforeAdd the medicines such as polished rice, reed rhizome, the tuber of dwarf lilyturf to support lung yin, up in lung with balloonflower root medicine carrying, therefore for making medicine.Full side share, and plays altogether clearing heat and eliminating phlegm, a surname's lung cough-relieving effect, and patients in remission rapidly, and be that patient is pre-After nurse to certain intervention.
Further preferably, described Chinese medicine preparation is only prepared from by above-mentioned raw materials medicine.
In described Chinese medicine preparation the weight of each bulk drug be respectively process Chinese ephedra 25g~40g, almond 10g~20g, gypsum 20g~30g, raw Radix Glycyrrhizae 15g~25g, caulis bambusae in taenian 20g~40g, dried immature fruit of citron orange 10g~25g,Rhizoma pinellinae praeparata 15g~25g, raw cape jasmine 20g~40g, root of large-flowered skullcap 25g~40g, balloonflower root 10g~20g, perillaseed10g~20g, root bark of white mulberry 15g~25g, root bark of Chinese wolf-berry 15g~20g, polished rice 20g~25g, lepidium seed 10g~20g, reed rhizome 10g~20g, tuber of dwarf lilyturf 25g~35g, fritillaria thunbergii 15g~25g, Poria cocos 10g~20g,Snakegourd Fruit 15g~25g, root of purple-flowered peucedanum 10g~20g, Cynanchum glaucescens 10g~20g, process tuber of stemona 15g~25g, cordate houttuynia25g~35g, dried orange peel 10g~20g, honeysuckle 30g~40g and indigo naturalis 5g~10g.
Further preferably, in described Chinese medicine preparation the weight of each bulk drug be respectively process Chinese ephedra 30g~35g,Almond 10g~15g, gypsum 25g~30g, raw Radix Glycyrrhizae 15g~20g, caulis bambusae in taenian 25g~30g, the dried immature fruit of citron orange15g~20g, rhizoma pinellinae praeparata 15g~20g, raw cape jasmine 25g~30g, root of large-flowered skullcap 30g~35g, balloonflower root 15g~20g, perillaseed 10g~15g, root bark of white mulberry 20g~25g, root bark of Chinese wolf-berry 15g~20g, polished rice 20g~25g,Lepidium seed 10g~15g, reed rhizome 10g~15g, tuber of dwarf lilyturf 30g~35g, fritillaria thunbergii 15g~20g, FuSiberian cocklebur 15g~20g, Snakegourd Fruit 15g~20g, root of purple-flowered peucedanum 10g~15g, Cynanchum glaucescens 15g~20g, process tuber of stemona 15g~20g, cordate houttuynia 30g~35g, dried orange peel 10g~15g, honeysuckle 35g~40g and indigo naturalis 5g~10g.
Further preferably, in described Chinese medicine preparation the weight of each bulk drug be respectively process Chinese ephedra 30g~35g,Almond 10g~15g, gypsum 25g~30g, raw Radix Glycyrrhizae 15g~20g, caulis bambusae in taenian 25g~30g, the dried immature fruit of citron orange15g~20g, rhizoma pinellinae praeparata 15g~20g, raw cape jasmine 25g~30g, root of large-flowered skullcap 30g~35g, balloonflower root 15g~20g, perillaseed 10g~15g, root bark of white mulberry 20g~25g, root bark of Chinese wolf-berry 15g~20g, polished rice 20g~25g,Lepidium seed 10g~15g, reed rhizome 10g~15g, tuber of dwarf lilyturf 30g~35g, fritillaria thunbergii 15g~20g, FuSiberian cocklebur 15g~20g, Snakegourd Fruit 15g~20g, root of purple-flowered peucedanum 10g~15g, Cynanchum glaucescens 15g~20g, process tuber of stemona 15g~20g, cordate houttuynia 30g~35g, dried orange peel 10g~15g, honeysuckle 15g~25g, Exocarpium Citri Grandis 10g~20gWith indigo naturalis 5g~10g.
Most preferably, in described Chinese medicine preparation the weight of each bulk drug be respectively process Chinese ephedra 30g, almond 15g,Gypsum 25g, raw Radix Glycyrrhizae 20g, caulis bambusae in taenian 30g, dried immature fruit of citron orange 20g, rhizoma pinellinae praeparata 20g, raw cape jasmine 30g, HuangA kind of reed mentioned in ancient books 30g, balloonflower root 15g, perillaseed 15g, root bark of white mulberry 20g, root bark of Chinese wolf-berry 20g, polished rice 20g, lepidium seed15g, reed rhizome 15g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 20g, Poria cocos 15g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g,Cynanchum glaucescens 15g, process tuber of stemona 20g, cordate houttuynia 30g, dried orange peel 15g, honeysuckle 35g and indigo naturalis 10g.
Most preferably, in described Chinese medicine preparation the weight of each bulk drug be respectively process Chinese ephedra 30g, almond 15g,Gypsum 25g, raw Radix Glycyrrhizae 20g, caulis bambusae in taenian 30g, dried immature fruit of citron orange 20g, rhizoma pinellinae praeparata 20g, raw cape jasmine 30g, HuangA kind of reed mentioned in ancient books 30g, balloonflower root 15g, perillaseed 15g, root bark of white mulberry 20g, root bark of Chinese wolf-berry 20g, polished rice 20g, lepidium seed15g, reed rhizome 15g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 20g, Poria cocos 15g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g,Cynanchum glaucescens 15g, process tuber of stemona 20g, cordate houttuynia 30g, dried orange peel 15g, honeysuckle 20g, Exocarpium Citri Grandis 20g andIndigo naturalis 10g.
Described Chinese medicine preparation is the mouth that adds the acceptable auxiliary material of pharmacy to be prepared from traditional Chinese medicine extraction compositionFormulation, described oral formulations comprises decoction, tablet, capsule, granule, oral liquid, powder, powderAgent.
Each bulk drug pharmacology is as follows:
Process Chinese ephedra: pungent, the micro-hardship of taste, warm in nature, enter lung, urinary bladder channel, have and send out cold inducing sweat, freeing lung and relieving asthma,The effect of inducing diuresis for removing edema, is mainly used in the superficies excess syndromes such as the fever without perspiration of catching cold; Rheumatic numbness pain; ColdEvil criminal's lung or accumulation of heat in the lung are to coughing the cards such as contrary, oedema, difficult urination of breathing.
Almond: bitter, warm in nature, enter lung, large intestine channel, there is expelling phlegm and arresting coughing, relieving asthma, effect of ease constipation.Cure mainly exogenous cough, breathe heavily completely larynx numbness, the cards such as the dry constipation of intestines.
Gypsum: taste is pungent, sweet, property Great Cold, enters lung, stomach warp, has clearing heat-fire, a work of the relieving restlessness of quenching the thirstWith all thin and matter weights of, its smell, reality heat that can removing summer-heat stomach of foot Yang Ming, treatment pathogen invading YANG MING fill the air high hot,The symptoms such as profuse sweating, thirsty, vexed, arteries and veins is big vast are the key medicine of the bright stomach warp of sun, to epidemic meningitis, encephalitis, pneumoniaDeng due to high heat have good antipyretic effect, and have relieving convulsion effect concurrently, also can be used for due to the high Sheng of stomach fireBurning pain in the epigastrium, headache, aphthae and summer-heat and damp dysphoria with smothery sensation, lung heat cough breathe heavily, restlessness and thirst, damp and hot resistanceThe cards such as the hot numbness of stagnant passages through which vital energy circulates, arthralgia.
Raw Radix Glycyrrhizae: taste is sweet, property is flat, enters 12 warps, has clearing heat and detoxicatingly, is in harmonious proportion the property of medicine, expelling phlegm and arresting coughingEffect, and can invigorating the spleen and in, relieving spasm to stop pain, is mainly used in weakness of the spleen and the stomach abdominal distension and anorexia, weak; EnergyAlleviate contraction pain in abdomen, relax the strong and toxicity of some drugs, alleviate the poison pair of medicine to bodyEffect or to GI stimulation, by adding Radix Glycyrrhizae can play tonifying Qi neutralization, is in harmonious proportion the effect of each component.
Caulis bambusae in taenian: cold nature, taste is sweet, attaches to the lung and stomach meridians, and has clearing heat and eliminating phlegm, the effect relieving restlessness and preventing vomiting,Hold phlegm, dysphoria with smothery sensation vomiting, palpitation with fear insomnia, apoplexy phlegm fan, aphasia with stiff tongue, stomach under the arm for phlegm-heat cough, courage fireThe cards such as hot vomiting, pernicious vomiting, fetal irritability.
The dried immature fruit of citron orange: bitter, pungent, cold nature, enters spleen, stomach warp, has relieving stagnant Qi to disappear long-pending, and dissolving phlegm removes the effect of ruffian,Be mainly used in stagnant stopping, the Yangming fu-viscera excess card of abdominal fullness and distention, constipation.
Rhizoma pinellinae praeparata: taste is pungent, warm in nature, returns spleen, stomach, lung channel, has eliminating dampness and eliminating phlegm effect, cures mainly phlegmMany coughs, anemophlegmatic vertigo, the cards such as coma due to blocking of the respiratory system headache.
Raw cape jasmine: latin name gardeniaefructus, bitter, cold in nature, the thoughts of returning home, lung, three warmers,There is the effect of relieving restlessness purging intense heat, soothing liver-qi stagnation, clearing heat and promoting diuresis, cooling blood and hemostasis, cure mainly the strongly fragrant chest of warm heat disease heatThe vexed uneasiness of gastral cavity, rather do not bother, liver depression is not relaxed or Liver Channel has having a dizzy spell of heat, pain in chest and hypochondrium, orderRed dry throat, jaundice with damp-heat pathogen, the cards such as the abdominal distention of qi depression to blood stasis.
The root of large-flowered skullcap: bitter, cold in nature, the thoughts of returning home, lung, stomach, courage, large intestine channel, have heat-clearing and damp-drying drug, purging intense heat solutionPoison, antiabortive, the effect of hemostasis, the diarrhoea, dysentery, jaundice, the heat that are mainly used in due to damp and hot are drenched; LungHeat cough, thirsty pharyngalgia, also can be used for fetal movement with fever, and hot malicious fire-evil is invaded the swollen card of sore carbuncle poison of excessive skin.
Balloonflower root: bitter, pungent, slightly warm in nature, enters lung channel, has expelling phlegm and arresting coughing, and has a surname's lung, apocenosis to doWith, cure mainly: coughing with a lot of sputum, abscess of throat, lung carbuncle pyemesis, fullness in the chest and hypochondriac pain, dysentery stomachache, dispute lifeSore, red eye, swell pain, uroschesis.
Perillaseed: taste is pungent, warm in nature, return lung, large intestine channel, there is sending down abnormally ascending dissolving phlegm, relieving cough and asthma, ease constipation is logicalJust effect. Stop up the circulation of vital energy in the wrong direction, cough and asthma, the cards such as the dry constipation of intestines for phlegm.
The root bark of white mulberry: latin name moricortex, taste is sweet, cold in nature, enters lung channel, has removing heat from lung and relieving asthma,The effect of inducing diuresis for removing edema, for one of common drug of purging the lung of pathogenic fire row water, is mainly used in the strongly fragrant lung of heat evil, gasThe contrary dyspnea with rapid respiration and cough not falling, many phlegm, look Huang, stops in phlegm and retained fluid, and the turgor that chest sun is not declared is coughed contrary, lungGas loses a surname, steam does not walk to oedema and breathes heavily completely, difficult urination, and cholagogic, promotes the production of body fluid, the cards such as dissipating bind.
The root bark of Chinese wolf-berry: latin name LyciiCortex, cold in nature, taste is sweet, has cool blood except steaming, and fire falls in clearing lung-heatEffect, cure mainly the cards such as deficiency of Yin hectic fever, hectic fever due to yin night sweat, cough with lung heat, spitting of blood, bleeding from five sense organs or subcutaneous tissue.
Polished rice: taste is sweet, property is flat, enters spleen; Stomach; Lung channel, has warming middle-JIAO for easing the stomach, effect of beneficial gas stopping leak.Cure mainly agitation thirsty, dysentery characterized by blood in the stool heat is hot-tempered, hinders the cards such as heat heating.
Lepidium seed: taste is pungent, hardship, cold in nature, return lung channel, the heart channel of Hang-Shaoyin, Liver Channel, stomach warp, urinary bladder channel, toolThere is purging the lung of pathogenic fire sending down abnormally ascending, eliminating phlegm and relieving asthma, inducing diuresis for removing edema, lets out by evil effect, cures mainly sputum and stops up breathing heavily of lungExpectoration is many, lung carbuncle, oedema, chest abdomen ponding, difficult urination, chronic cor pulmonale, mental and physical effortsThe cards such as breathing heavily of exhaustion is swollen, scrofula tuberculosis.
Reed rhizome: taste is sweet, cold in nature, attach to the lung and stomach meridians, there is clearing lung-heat stomach energy, diuresis, opens Yu Di phlegm, supportsEffect of Yin and promoting production of body liquid, cures mainly the dysphoria with smothery sensation that warm heat disease joins the army point thirsty, and the dry Tianjin of tongue is few, and the rash of measles goes out not saturating,Heat evil is violated the cough and expectoration of lung, the cough pyemesis of lung carbuncle, damp and hot retardance in cards such as the vomiting hiccups of stomach.
The tuber of dwarf lilyturf: sweet, the micro-hardship of taste, cold nature, enters the heart, lung, stomach warp, has Yin nourishing and lung moistening, only reduces phlegmThe effect of cough, heat-clearing being nourished heart, is mainly used in treating the few phlegm of dry cough of the lung-dryness syndrome due to yin deficiency, consumptive lung disease, the coughing of lung carbuncleTell sticky phlegm and blood-stained sputum, its kind nourishing stomach-YIN, promotes the production of body fluid and moisturizes, and the mouth that is particularly useful for consumption of body fluid caused by febrile disease is dryThe symptom such as dry throat, vexed uneasiness.
Fritillaria thunbergii: bitter, cold in nature, enter lung, the heart channel of Hang-Shaoyin, there is clearing heat and eliminating phlegm, effect of powder detoxifcation,Cure mainly cough due to wind-heat evil, lung carbuncle larynx numbness, scrofula, the cards such as sore swollen toxin.
Poria cocos: taste is sweet, light, property is flat, enters spleen, lung, bladder, the heart channel of Hang-Shaoyin, has eliminating dampness and diuresis, invigorating the spleen peacefulThe effect of the heart, is mainly used in the oedema of retention of water-damp, difficult urination; The heat of damp-heat accumulation is drenched, insufficiency of the spleen wetThe cards such as tired anorexia and loose stool, phlegm and retained fluid stagnation, epilepsy.
Snakegourd Fruit: taste is sweet, micro-hardship, cold in nature, enter lung, stomach, large intestine channel, there is clearing heat and eliminating phlegm, wide chest looseKnot, the effect relaxing bowel, for cough with lung heat, the turbid Huang of phlegm is thick, chest impediment and cardialgia, accumulation of pathogens in chest ruffian is full, breastCarbuncle, lung carbuncle, the card such as acute appendicitis swells and ache, constipation.
The root of purple-flowered peucedanum: latin name PeucedaniRadix, bitter, pungent, cold nature, enters lung channel, has a surname looseWind-heat, the effect of lowering the adverse-rising QI and dispelling phlegm, is mainly used in wind-heat cough, and phlegm heat choke, lung qi poetry anthologyDue to cough and the card such as breathe heavily, chest diaphragm is unfavorable.
Cynanchum glaucescens: taste is pungent, bitter, slightly warm in nature is returned lung channel, has lowering the adverse-rising QI to resolve phlegm, the effect of cough-relieving, these productSlightly warm in nature and not dry strong, is longer than and eliminates the phlegm, and falls lung qi to breathe heavily to put down to cough, and no matter belonging to the cold heat that belongs to, Exogenous and internal injuries,Newly cough chronic cough all available it, " detailed outline ": Cynanchum glaucescens, be longer than sending down abnormally ascending, lung qi is stopped up real and is had phlegm person should it.If empty and length is choked, gas person is unavailable. Zhang Zhongjing is controlled and is coughed and deeptensepulse person, in wartwort soup, also uses it.
Process the tuber of stemona: taste is sweet, bitter, slightly warm in nature is returned lung channel, has effect of moistening lung to lower qi, cough-relieving desinsection,Cough for new chronic cough, pulmonary tuberculosis cough, pertussis, head louse, body louse, enterobiasis, private parts is disturbed the card such as itch.
Cordate houttuynia: latin name houttuyniaeherba, taste is pungent, and cold nature enters lung, urinary bladder channel,Have clearing heat and detoxicating, removing pus and relieving carbuncle, effect of inducing diuresis for treating strangurtia, for lung carbuncle pyemesis, phlegm heat is coughed and is breathed heavily, heatPoison bloody flux, damp-heat gonorrhoea, hot carbuncle carbuncle, snakeworm is wanted first-class card.
Dried orange peel: warm in nature, taste is pungent, bitter; Return spleen, lung channel, for diseases such as fullness and oppression of chest and abdomen. Orange peel is pungent looseLogical temperature, fragrant odour, is longer than and regulates the flow of vital energy, and can enter spleen lung, therefore can go loose sluggishness of lung-QI, can manage it againDuring gas is wide, gather around the diseases such as the full and taste stagnation of the circulation of vital energy of stagnant, chest diaphragm ruffian, abdominal fullness and distention for lung qi, for wetBurnt in resistance, gastral cavity abdomen ruffian is swollen, have loose bowels in loose stool, and the phlegm disease such as cough more.
Honeysuckle: latin name loniceraejaponicaeflos, taste is sweet, cold in nature, enter the heart, lung,Stomach, large intestine channel, have clearing heat and detoxicating effect, double can removing heat from the blood and relieve diarrhea. Be mainly used in affection of exogenous wind-heat, warmSick hot poison is contained, or warm disease is from the beginning of heat evil still at the part of the body cavity above the diaphragm housing the heart and lungs and when not descending; The malicious diarrhea of heat, the lower blood of stool;Heat temperature card; The sore carbuncle that hot poison gathers is from the beginning of, inflammation heat person of swelling and ache etc., and honeysuckle has good antipyretic effect,Energy anti-inflammatory, what control inflammation oozes out and inflammatory hyperplasia, can promote leukocytic phagocytic function, to multipleizationPurulence coccus and pathogenic entero becteria have stronger bacteriostasis, comprise staphylococcus, hemolytic streptococcus,Diplococcus meningitidis, shigella dysenteriae, typhoid bacillus, Escherichia coli, Pseudomonas aeruginosa, tubercle bacillus etc.
Indigo naturalis: taste is salty, cold in nature, enter Liver Channel, there is the merit of clearing heat and detoxicating, cooling blood and hemostasis, clearing liver-fireEffect, sends out the malicious all cards of heat, the liver-fire attacking lungs such as spot, haematemesis, abscess of throat, the wet sore of bleb, coughs for warm diseaseThe cards such as pectoralgia, blood-stained sputum, the frightened epilepsy of high heat, convulsion of coughing.
Exocarpium Citri Grandis: loose cold, eliminating dampness, sharp gas, dissolving phlegm. Itching for cough due to wind-cold evil, larynx, phlegm is many, dyspepsia woundWine, jailbird are vexed. Preventing phlegm from forming and stopping coughing, cough due to wind-cold evil, no matter the primary effect of Exocarpium Citri Rubrum, tremble with fear and cough or dry cough, clothesAll can take effect by Exocarpium Citri Rubrum, cough is divided into heat and coughs and tremble with fear and cough two kinds: heat is coughed, and is repeatedly coughing of being caused by lung heatCough, for example excessive edible food of getting angry, as food such as frying, Broiled Dishes, shows as that throat is dry to be itched, doCough few phlegm or phlegm look xanthin is sticky; How cold coughing, cause by catching cold, and shows as pharynx and itch and cough frequently, and sputum is thinAs foam-like. Chronic cough, tracheitis, asthma the elderly all the year round chronic cough or asthma take Exocarpium Citri Rubrum for first-selected.General regulating the flow of vital energy got sick from drinking too much wine, changed to dyspepsia, the personage's that smokes and drink good merchantable brand, and tobacco and wine are maximum to lung stomach liver and throat damage,Live in city automobile and industrial waste gas is in the majority simultaneously, suck for a long time excessive rear habitual breathing that easily causeRoad infection inflammation. Informal dress just can alleviate the infringement to these human organs of alcohol and waste gas with Exocarpium Citri Grandis. VomitTell hiccup, eating accumulation, often the personage such as dinner party dinner party answers informal dress Exocarpium Citri Grandis, and Exocarpium Citri Grandis is to stomachThe stagnant good efficacy that has that disappears, one after each meal can make alleviating in stomach and digest pressure.
The present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and it comprises:
The first step, take by weight process Chinese ephedra, raw Radix Glycyrrhizae, rhizoma pinellinae praeparata, the root of large-flowered skullcap, the root bark of white mulberry, polished rice,The tuber of dwarf lilyturf, fritillaria thunbergii, Snakegourd Fruit, the root of purple-flowered peucedanum, cordate houttuynia, dried orange peel and indigo naturalis, clean respectively, pulverize, mixedBe combined, in the ethanol that the determining alcohol that adds 5~10 times of amounts of mixture quality is 70%~80%, soak 1~2 hours, heating was extracted 2 times, and each 1~2 hour, merge extract, 100 orders filter, then through cuttingThe ultrafiltration post ultrafiltration that stream molecular weight is 5000~10000, when ultrafiltrate reduced pressure concentration relative density is 60 DEG C1.30~1.36 medicinal extract, stand for standby use;
Second step, takes remaining bulk drug by weight, cleans respectively, pulverizes, and mixes, and addsThe ethanol water heating and refluxing extraction that the determining alcohol of 6~8 times of amounts of this step mixture quality is 50%~70%1~3 time, each time of extracting is 0.5~2 hour, collects extract, filters, by filtrate decompressionThe concentrate that while being concentrated into 60 DEG C, relative density is 1.02~1.18, upper large pore resin absorption column, macroporeThe quality of polymeric adsorbent is 10~15 times of this step bulk drug quality sum, is 40~70% with determining alcoholAqueous solution of alcohol wash-out, collects eluent, when reduced pressure concentration relative density is 60 DEG C 1.30~1.36Medicinal extract,
The 3rd step, mixes the medicinal extract of the first step and second step acquisition, gets 200g medicinal extract, then adds auxiliary materialMake and be applicable to the formulation of use clinically.
In the time being prepared into oral liquid, the 3rd step is specially, the first medicinal extract and the second medicinal extract are mixed,Get 200g medicinal extract, add with respect to the cane sugar powder that mixes 2~4 times of medicinal extract quality, mix, preparationBecome granules of sugar, dry, make altogether 1000, splitting splendid attire, every bag of 10g.
Below adopt embodiment to describe embodiments of the present invention in detail, whereby how the present invention is appliedTechnological means solves technical problem, and the implementation procedure of reaching technique effect can fully understand and real according to thisExecute.
Embodiment 1 oral liquid 1
Take and process Chinese ephedra 30g, raw Radix Glycyrrhizae 20g, rhizoma pinellinae praeparata 20g, root of large-flowered skullcap 30g, root bark of white mulberry 20g, round-grained riceRice 20g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 20g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g, cordate houttuynia 30g, dried orange peel15g and indigo naturalis 10g, clean respectively, pulverize, and mixes, and adds the determining alcohol of mixed 2.2kg to beIn 80% ethanol, soak 2 hours, heating is extracted 2 times, each 2 hours, merges extract, 100 ordersFilter, then be 10000 ultrafiltration post ultrafiltration through the molecular weight that dams, ultrafiltrate reduced pressure concentration relative density is1.36 medicinal extract 60 DEG C time, stand for standby use, takes almond 15g, gypsum 25g, caulis bambusae in taenian 30g, trifoliate orangeReal 20g, raw cape jasmine 30g, balloonflower root 15g, perillaseed 15g, root bark of Chinese wolf-berry 20g, lepidium seed 15g, reed rhizome15g, Poria cocos 15g, Cynanchum glaucescens 15g, process tuber of stemona 20g, honeysuckle 35g, clean respectively, pulverize, mixTogether, the ethanol water heating and refluxing extraction that the determining alcohol that adds 2kg is 70% 3 times is carried at every turnThe time of getting is 1 hour, collects extract, filters relative density while concentrating filtrate to 60 DEG CBe 1.18 concentrate, upper large pore resin absorption column, the quality of macroporous absorbent resin is 3kg, with pure and strongDegree is 60% aqueous solution of alcohol wash-out, collects eluent, when reduced pressure concentration relative density is 60 DEG C 1.35Medicinal extract, the first medicinal extract and the second medicinal extract are mixed, get 200g medicinal extract, add the sugarcane of 600gIcing Sugar, mixes, and is prepared into granules of sugar, dry, makes altogether 1000, splitting splendid attire, every bag10g。
Embodiment 2 oral liquids 2
Take and process Chinese ephedra 30g, raw Radix Glycyrrhizae 15g, rhizoma pinellinae praeparata 15g, root of large-flowered skullcap 30g, root bark of white mulberry 20g, round-grained riceRice 20g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 15g, Snakegourd Fruit 15g, root of purple-flowered peucedanum 10g, cordate houttuynia 30g, dried orange peel10g and indigo naturalis 5g, clean respectively, pulverize, and mixes, and adding the determining alcohol of mixed 2kg is 80%Ethanol in soak 2 hours, heating is extracted 2 times, each 2 hours, merges extract, 100 orders filtersCross, then be 10000 ultrafiltration post ultrafiltration through the molecular weight that dams, ultrafiltrate reduced pressure concentration relative density is 60 DEG CTime 1.36 medicinal extract, stand for standby use, take almond 10g, gypsum 25g, caulis bambusae in taenian 25g, dried immature fruit of citron orange 15g,Raw cape jasmine 25g, balloonflower root 15g, perillaseed 10g, root bark of Chinese wolf-berry 15g, lepidium seed 10g, reed rhizome 10g, Poria cocos15g, Cynanchum glaucescens 15g, process tuber of stemona 15g, honeysuckle 20g, Exocarpium Citri Grandis 20g, clean respectively, pulverize, mixedBe combined, the ethanol water heating and refluxing extraction that the determining alcohol that adds 2kg is 70% 3 times, eachThe time of extracting is 1 hour, collects extract, filters, relatively close while concentrating filtrate to 60 DEG CDegree is 1.18 concentrate, upper large pore resin absorption column, and the quality of macroporous absorbent resin is 3kg, uses alcoholConcentration is 60% aqueous solution of alcohol wash-out, collects eluent, when reduced pressure concentration relative density is 60 DEG C 1.35Medicinal extract, the first medicinal extract and the second medicinal extract are mixed, get 200g medicinal extract, add the sugarcane of 600gIcing Sugar, mixes, and is prepared into granules of sugar, dry, makes altogether 1000, splitting splendid attire, every bag10g。
Embodiment 3 oral liquids 3
Take and process Chinese ephedra 35g, raw Radix Glycyrrhizae 20g, rhizoma pinellinae praeparata 20g, root of large-flowered skullcap 35g, root bark of white mulberry 25g, round-grained riceRice 25g, tuber of dwarf lilyturf 35g, fritillaria thunbergii 20g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g, cordate houttuynia 35g, dried orange peel15g and indigo naturalis 10g, clean respectively, pulverize, and mixes, and adds the determining alcohol of mixed 2.2kg to beIn 80% ethanol, soak 2 hours, heating is extracted 2 times, each 2 hours, merges extract, 100 ordersFilter, then be 10000 ultrafiltration post ultrafiltration through the molecular weight that dams, ultrafiltrate reduced pressure concentration relative density is1.36 medicinal extract 60 DEG C time, stand for standby use, takes almond 15g, gypsum 30g, caulis bambusae in taenian 30g, trifoliate orangeReal 20g, raw cape jasmine 30g, balloonflower root 20g, perillaseed 15g, root bark of Chinese wolf-berry 20g, lepidium seed 15g, reed rhizome15g, Poria cocos 20g, Cynanchum glaucescens 20g, process tuber of stemona 20g, honeysuckle 40g, clean respectively, pulverize, mixTogether, the ethanol water heating and refluxing extraction that the determining alcohol that adds 2kg is 70% 3 times is carried at every turnThe time of getting is 1 hour, collects extract, filters relative density while concentrating filtrate to 60 DEG CBe 1.18 concentrate, upper large pore resin absorption column, the quality of macroporous absorbent resin is 3kg, with pure and strongDegree is 60% aqueous solution of alcohol wash-out, collects eluent, when reduced pressure concentration relative density is 60 DEG C 1.35Medicinal extract, the first medicinal extract and the second medicinal extract are mixed, get 200g medicinal extract, add the sugarcane of 600gIcing Sugar, mixes, and is prepared into granules of sugar, dry, makes altogether 1000, splitting splendid attire, every bag10g。
Embodiment 4 drug toxicology tests
One, acute toxicity testing
Investigation mouse gave Chinese medicine of the present invention by Cmax and maximum gavage volume per os 2 times in 24 hoursAfter oral liquid, the main target organ of the acute toxic reaction that animal produces and toxic reaction, is clinical urgencyProperty heavy dose of medication security foundation is provided.
Animal used as test
Strain: Kunming mouse, grade: SPF level, sex: male and female half and half, quantity: 40, bodyWeigh 18~22g.
Experimental agents
Granule prepared by the embodiment of the present invention 1: specification: l0g/ bag, (body weight is with 60kg for clinical adultMeter) daily dosage: one time 1 bag, one day 3 times. Compound method: get Chinese medicinal granule 40g of the present invention, useDrinking water is made into 55ml solution, is equivalent to 0.73g/ml, for subsequent use.
Animal feeding and management
Environmental condition
Experimental animal room animal used as test barrier system, 20~26 DEG C of temperature, humidity 40~70%.
Feed
Mouse particle word material, Suzhou two lion animal used as test feed technology Co., Ltd provides.
Drinking water
Drinking water, through sterilization treatment.
Experimental technique
Preliminary experiment
With the Cmax 0.73g/ml by mouse stomach pin and the maximum administration volume of mouse 40ml/kgBody weight, gavage 2 times in 24 hours, mouse is without death. Because the restriction that is subject to administration concentration and volume cannotMeasure LD50Therefore, when formal test with 0.73g/ml, gavage 2 times in 24 hours.
Formal test
Method of administration
Gavage, administration volume 40ml/kg, administration 2 times in 24 hours.
Animal grouping
Get the qualified mouse of quarantine and weigh, be divided at random 2 groups by body weight, 20 of every treated animals, male and female are eachHalf.
Administration
Water is can't help in each mouse fasting, and after 12 hours, administration group gives 0.73g/ml by 40ml/kg body weight gavageThe oral liquid prepared of the embodiment of the present invention 11,24 hour in administration 2 times, then Continuous Observation 14My god.
Observation item and index
General Symptom Observation
Observed content comprises drinking-water, feed, outward appearance sign, general behavior activity.
Observing time: Continuous Observation 14 days after administration.
Observed frequency: test administration on the same day after 1/2,1,2,3,4,6,8h. Test the 2nd day to14 days, morning every day, each observation in afternoon were once.
Observed and recorded: record toxic reaction symptom and occur, increase the weight of, alleviate and the dead time.
Body weight
Within after administration the 2nd day, the next day of rising, weigh Mouse Weight.
Anatomic observation
Administration the 14th day, puts to death and gross anatomy animal, visually observes the heart, liver, spleen, lung, kidney etc. mainWant internal organs to have or not pathology, ill dirty device carries out pathologic finding.
Statistical method
Statistical method is t inspection.
Experimental result
General Symptom Observation result
After the oral liquid 1 that in 24 hours prepared by 2 gavage embodiment of the present invention 1, mouse drinking-water, feed,Outward appearance sign, general behavior activity are all normal, observe and within 14 days, have no dead mouse.
Body weight observed result
After administration, mouse is movable normal. Observe in 14 days, it is dead that animal has no, and general status is good, drinkFood, two just normal, and outward appearance, fur, behavior, breathing are all normal, and nose, eye, oral cavity are without extremely dividingSecretion, except the 2nd day body weight after the administration of administration group male rat and control group comparing difference have very significantOutside meaning (P < 0.01), have no other obvious abnormal response.
Anatomic observation result
Observation finishes rear execution mouse, and it is each main that gross anatomy visually observes the heart, liver, spleen, lung, kidney etc.The no abnormality seens such as internal organs color and luster, shape, size.
Maximum dosage-feeding calculates
The maximum dosage-feeding of traditional Chinese medicine oral liquid mouse stomach of the present invention administration is 58.4g/kg, and this dosage is to faceBed adult (body weight is by 60kg) daily dosage is 30g conversion, is equivalent to 116.8 of clinical adult's consumptionDoubly, modern pharmacology thinks, zoopery administration is the more than 100 times of human body dosage, and without obviouslyToxic and side effect and without delayed toxicity reaction, can think that this medicine is without obvious toxic-side effects, therefore by thisBright Chinese medicine preparation acute toxicity testing research, its dosage is 116.8 times of human body dosage, canTo think that it has good security.
Two long term toxicity test researchs of the present invention
Investigate in mouse 30, continuous 2 administrations every day, by 0.7 times of Cmax and 0.49 times of warpMouth gives after oral liquid 1 prepared by the embodiment of the present invention 1, the chronic toxicity that animal produces and poisonThe main target organ of property reaction, for clinical long-term prescription provides security foundation.
Animal used as test:
With anxious toxicity test.
Experimental agents
Granule prepared by the embodiment of the present invention 1: specification: l0g/ bag, (body weight is with 60kg for clinical adultMeter) daily dosage: one time 1 bag, one day 3 times. Compound method: get Chinese medicinal granule 40g of the present invention, useDrinking water is made into 55ml solution, is equivalent to 0.365g/ml, for subsequent use.
Animal feeding and management
With anxious toxicity test.
Experimental technique
Method of administration
Gavage, administration volume 40ml/kg, administration every day 2 times, successive administration 30 days.
Animal grouping
Get the qualified mouse of quarantine and weigh, be divided at random 3 groups by body weight, 20 of every treated animals, male and female are eachHalf.
Administration
Water is can't help in each mouse fasting, and administration group gives the present invention of 0.365g/ml by 40ml/kg body weight gavageTraditional Chinese medicine oral liquid 1, administration every day 2 times, then Continuous Observation 30 days.
Observation item and index
With anxious toxicity test.
Statistical method
Statistical method is t inspection.
Experimental result
General Symptom Observation result
After every day 2 gavage Chinese medicinal granules of the present invention, mouse drinking-water, feed, outward appearance sign, generally goFor activity is all normal, Continuous Observation has no dead mouse for 30 days.
Body weight observed result
After administration, mouse is movable normal. Observe in 30 days, it is dead that animal has no, and general status is good, drinkFood, two just normal, and outward appearance, fur, behavior, breathing are all normal, and nose, eye, oral cavity are without extremely dividingSecretion, with control group comparison, shows no obvious abnormalities reaction, difference no difference of science of statistics (P > 0.05).
Anatomic observation result
Observation finishes rear execution mouse, and it is each main that gross anatomy visually observes the heart, liver, spleen, lung, kidney etc.The no abnormality seens such as internal organs color and luster, shape, size.
Maximum dosage-feeding calculates
The maximum dosage-feeding of traditional Chinese medicine oral liquid mouse stomach of the present invention administration is 29.2g/kg, and this dosage is to faceBed adult (body weight is by 60kg) daily dosage is 30g conversion, is equivalent to 58.4 of clinical adult's consumptionDoubly, modern pharmacology is thought, zoopery administration successive administration 30 days, and animal is without obvious toxic-side effects,Also without obvious cumulative toxicity, can think that it has good security.
Embodiment 5 clinical and experimental studies
Physical data
MethodsThe cases enrolled is all from Chinese medicine preparation pilot of the present invention hospital, totally 224 examples, wherein treatment group 128Example and each 96 examples of control group, age when two groups of experimenters are entered to organize, height, body weight, sex, nationality,The demography data group difference not statistically significants (P > 0.05) such as occupation, baseline has balanced comparativity
Diagnostic criteria
Western medicine diagnose standard
Formulate with reference to national chronic bronchitis clinical speciality meeting revised standard:
(1) cough, expectoration or companion pant, and fall ill every year 3 months, continuous 2 years or above person
(2) fall ill every year less than 3 months, and have clear and definite objective determination according to (as x-ray, respiratory functionMeasuring etc.) person is also diagnosable.
TCM syndrome diagnostic criteria
The dialectical standard of syndrome of phlegm-heat obstructing lung (is tried with reference to " new Chinese medicine guideline of clinical investigations " for 2002Version) formulate
Primary symptom: cough, expectoration is not well; Inferior disease: phlegm yellow thickness, thirst and liking drink or see heating;
Tongue pulse condition: tongue is red, tongue is yellow, slippery and rapid pulse
Possess cough, cough up phlegm or accompany and pant, add in disease last time any 2, diagnosable in conjunction with tongue arteries and veins
Inclusive criteria
Meet AECB phase Western medicine diagnose standard and the dialectical mark of traditional Chinese medical science syndrome of phlegm-heat obstructing lungAccurate; 18~65 years old age; These course of disease≤3 day of showing effect. symptom scores >=and 8 points, leucocyte≤11.0 ×109/L, the patient of neutrophil leucocyte ratio≤80% can include in
Exclusion standard
(1) turning out to be on inspection the factors such as pulmonary tuberculosis, fungi, tumour, silicosis, irritative gas allergy drawsThe chronic cough patient that pants who rises
(2) 38.5 DEG C of body temperature >;
(3) the serious primary disease such as heart disease, hypertension and other is cardiovascular, liver, kidney, hemopoietic system;Merge severe cardiac pulmonary insufficiency person; Insane
(4) gestation or women breast-feeding their children;
(5) allergic constitution or to two kinds and two or more food or drug allergy person
Methods for the treatment of
To be selected in patient and be divided at random treatment group and control group, treatment group is taken the embodiment of the present invention 1 Chinese medicine1,10g of particle, 2 times on the one, boiling water is taken after mixing it with water;
Control group is taken the sudden and violent red cough-stopping granule of a kind of reed mentioned in ancient books (specification: 4g/ bag, Heilungkiang Rui Ge pharmaceutical Co. Ltd is rawProduce the accurate word of traditional Chinese medicines: Z10970027) 4g, 2 times on the one, boiling water is taken after mixing it with water;
10 days courses for the treatment of, observe altogether 3 courses for the treatment of.
Observation index
Syndrome in TCM marquis's integration improvement situation is curative effect index
Curative effect determinate standard
Formulate with reference to " new Chinese medicine guideline of clinical investigations " card marquis curative effect determinate standard
Efficacy determination value=(total mark before (the rear total mark of total mark-treatment before treatment)/treatment) × l00%
Tcm syndrome efficacy assessment standard
(1) clinic control: clinical symptoms, sign disappear or substantially disappear, and syndrome integration reduces >=95%;
(2) effective: clinical symptoms, sign are obviously improved, syndrome integration reduces >=70%;
(3) effective: clinical symptoms, sign all take a favorable turn, syndrome integration reduces >=30%;
(4) invalid: clinical symptoms, sign are not improved, syndrome integration reduces less than 30%
Statistical procedures
Adopt SPSS15.0 software to carry out statistical analysis, all statistical checks all adopt T inspection, P < 0.05Be considered to checked difference and have statistical significance.
Result
Cardinal symptom efficacy result, in table 1 to table 4.
Table 1 cough curative effect multicenter analyze (FAS)
Group N Recovery from illness Effective Effectively Invalid Efficient %
Control group 94 15 45 23 11 88.30
Treatment group 128 38 58 24 8 93.75
Note: between two groups of cure rates, comparing difference has statistical significance (P < 0.05)
Table 2 pant curative effect multicenter analyze (FAS)
Group N Recovery from illness Effective Effectively Invalid Efficient %
Control group 94 16 45 28 14 85.11
Treatment group 128 42 61 19 6 95.31
Note: between two groups of cure rates, comparing difference has statistical significance (P < 0.05)
Table 3 cough up phlegm curative effect multicenter analyze (FAS)
Group N Recovery from illness Effective Effectively Invalid Efficient %
Control group 94 19 52 19 4 95.74
Treatment group 128 55 57 14 2 98.44
Note: between two groups of cure rates, comparing difference has statistical significance (P < 0.05)
Table 4 tcm syndrome efficacy analysis (FAS)
Note: between two groups of cure rates, obvious effective rate, comparing difference has statistical significance (P < 0.05)
3 discuss
Syndrome of phlegm-heat obstructing lung is common anxious card fever caused by exogenous pathogenic factors, and the four seasons all can occur, especially multiple with winter and spring,The acute infection symptoms such as main manifestations cough, expectoration, phlegm Huang are measured many, and tongue is red, and the thin Huang of tongue or Huang are greasy, this diseaseRelevant with factors such as bacterium, virus infections and autoimmunities, according to differentiation of tcm viewpoint, controlTreating the main therapy of syndrome of phlegm-heat obstructing lung is clearing heat and eliminating phlegm, and lower gas cough-relieving is controlled from basic entirety conditioning, and effect quiteGood. Treatment syndrome of phlegm-heat obstructing lung clinical taking heat-clearing, eliminate the phlegm, cough-relieving, relieving asthma as therapy, Chinese medicine system of the present inventionAgent is made up of pure natural medical, has effect of clearing heat and freeing lung, preventing phlegm from forming and stopping coughing, and its traditional Chinese medicinal components contains anti-Bacterium effective ingredient, In vitro Bactericidal Experiments result shows, this product truly has antibacterial work to the common germ of the upper respiratory tractWith. Pharmacological research confirms: this medicine can dilute sputum, promotes the motion of respiratory mucosa epithelial cell cilium,Make phlegm be easy to expectoration; Can extend cough latent period, reduce cough number of times; Have stronger anti-inflammatory, antibacterial, fallLow airway hyperreactivity effect; Strengthen in addition immunoloregulation function. Syndrome of phlegm-heat obstructing lung is that respiratory system is commonDisease, treatment and alleviation syndrome of phlegm-heat obstructing lung symptom are significant to improving quality of life of patients. Chinese medicine of the present inventionIt has proved through clinical verification for many years and from test that to cough-relieving apophlegmatic curative effect this medicine has better resisting preparationBacterium, antibechic, relieving asthma, resolve phlegm effect.
This test is carried out clinical observation on the therapeutic effect to Chinese medicine preparation treatment syndrome of phlegm-heat obstructing lung of the present invention. Result of the testShow that Chinese medicine preparation of the present invention all has certain therapeutic action to the cardinal symptom of syndrome of phlegm-heat obstructing lung. It is to coughThe efficient of symptom is 93.75%, and the efficient of the symptom of panting is to 95.31%, effective to expectoration symptomRate is 98.44%, is 96.09% to the efficient of traditional Chinese medical science therapeutic effect of syndrome. Chinese medicine preparation treatment phlegm heat of the present inventionStop up lung card cough-relieving curative effect and tcm syndrome curative effect and be better than the sudden and violent red cough-stopping granule group of a kind of reed mentioned in ancient books. Therefore, in phlegm-heat obstructing lungIn card clinical treatment, Chinese medicine preparation of the present invention has good potential applicability in clinical practice.
Embodiment 6 pharmacodynamic experiment researchs
Experiment purpose
Granule 1 prepared by the embodiment of the present invention 1 has clearing lung and eliminating phlegm, relieving cough and asthma effect, clinicalFor cough, phlegm Huang due to phlegm-heat accumulated in the lung, breathe heavily full person. Registering relevant pharmacodynamics according to new Chinese medicine grindsThe technical requirement of studying carefully, in conjunction with this product prescription feature, studies stopping of Chinese medicinal granule of the present invention from experimental viewpointPharmacological actions such as coughing, relieving asthma, reduce phlegm, is used as tentatively and comments the Pharmacodynamics of granule 1 of the present inventionValency, for clinical research provides laboratory reference.
Material and method
Animal used as test
KM mouse, SPF level, body weight 18~22g, male and female half and half.
Cavy: regular grade, body weight 150~250g, male and female are not limit.
Experimental agents and reagent
Chinese herbal granules 1:l0g/ bag prepared by the embodiment of the present invention 1, clinical Coming-of-Age Day dosage: oneInferior 1 bag, one day 3 times, (becoming body weight for humans in 60kg).
Compound codeine phosphate oral administration solution: produced specification by Hong Kong Australia pharmaceutical factory made in U.S.A: every 5ml containsBPM 2.0mg, codeine phosphate 4.5mg, ephedrine hydrochloride 5.0mg
The cruel glycerin ether 100.0mg of guaiaci lignum. Lot number: 1105301
Ammonium chloride: Zigong, Sichuan Hong He Pharmaceutical Co produces, specification: medicinal plastic bag packaging,500 grams/bag. Lot number: 140514
Aminophylline sheet: Kunming Medicine Group Stock Co., Ltd produces, specification: 0.1g/ sheet, lot number:141010-03
Ammoniacal liquor: analyze pure, Chuanjiang River, Chongqing chemical reagent factory produce, specification: 500ml, content (NH3) % is25~28, lot number: 20141113
Phenol red: analyze purely, reagent three factories in Shanghai produce under Solution on Chemical Reagents in Shanghai head factory, specification: 25g,Lot number: 141212
Citric acid: analyze pure, Tianjin Feng Chuan chemical reagent Science and Technology Ltd. (former Tianjin chemical reagent threeFactory) produce specification: 500g, lot number: 20140928
Histamine phosphate: U.S. BIOFER produces, content > 98.0%, lot number: 20141022
Experiment key instrument
Electronic balance: BP310S, BL1500, SARTORILS produces.
YLS-8A is multi-functional to be lured to cough to draw and breathes heavily instrument: Shandong Academy of Medical Sciences's equipment station produces.
Visible uv-spectrophotometric instrument, L`V-190 Japan Shimadzu is produced
Experimental situation
Mouse animal feeding environmental condition
Experimental animal room animal used as test barrier system, 20~26 DEG C of temperature, humidity 40~70%.
Feed
Mouse particle word material, Suzhou two lion animal used as test feed technology Co., Ltd provides.
Drinking-water
Drinking water meets the requirement of GB5749, through sterilization treatment.
Cavy feeding environment condition
Experimental animal room animal used as test barrier system, 20~26 DEG C of temperature, humidity 40~70%.
Experimental technique
On the impact of ammoniacal liquor induced mice cough latent period and number of times
Get 64 of KM mouse, male and female half and half, body weight 18~22g, is divided into negative control group, the positive at randomMedicine control group (ig compound codeine phosphate oral administration solution 15ml/kg), Chinese medicinal granule high dose group of the present invention(14.2g/kg), low dose group (7.1g/kg), totally 4 groups, 16 every group. Chinese medicinal granule of the present invention is high,Low dosage is equivalent to respectively 3.12 times, 1.56 times of clinical equivalent amount. Testing each group of mouse presses respectively20ml/kg body weight gastric infusion, the distilled water of the capacity such as negative control group gavage, every day 1 time, continuously3 days, finish rear 1h in last administration, by mouse put into YLS-8A multi-functional lure cough draw breathe heavily instrument animal liveIn moving case, one time 1, spray into approximately 15% concentrated ammonia liquor, spray time is 4s, observed and recorded mouseCough number of times in cough latent period (time of coughing for the first time from spraying into ammoniacal liquor to mouse) and 4min. With tStatistical procedures is carried out in inspection, relatively difference between administration group and negative control group.
Citric acid is caused to the impact of guinea pig cough's incubation period and cough number of times
First cavy is selected in advance, by cavy put into YLS-8A multi-functional lure to cough to draw breathe heavily instrument animal activity caseIn, start atomizer 60s, observe cough latent period in cavy 5min (inject 35% citric acid and start,To occur cough required time be incubation period) and cough number of times, with the number of times of coughing in 5min reach 10 times withOn cavy be qualified cavy, alternate tests. By qualified cavy random packet, be respectively negative control group,Positive controls (ig compound codeine phosphate oral administration solution 12ml/kg), Chinese medicinal granule high dose of the present inventionGroup (7.0g/kg), low dose group (3.5g/kg), totally 4 groups, 10 every group. Chinese medicinal granule of the present inventionHigh and low dose is equivalent to respectively 2.58 times, 1.29 times of clinical equivalent amount. Test each group of cavy respectivelyPress 20ml/kg body weight gastric infusion, the distilled water of the capacity such as negative control group gavage, every day 1 time, connectsContinuous 3 days, 1h after last administration, observed animal cough latent period and cough number of times by prescreening method. With tStatistical procedures is carried out in inspection, relatively otherness between administration group and negative control group.
Histamine phosphate is caused to the impact of Experimental Asthma In Guinea-pigs
Get the healthy Baby guinea pig of body weight 150 ± 20g, put it into YLS-8A multi-functional lure to cough to draw breathe heavily instrumentCattle container in, spray into 0.2% histamine phosphate 20s. Observation is drawn and is breathed heavily incubation period and (starts to going out from sprayingThe time of existing asthma, expiratory dyspnea and tic). Exceed 120s person, will not select. By qualified cavy withMachine grouping, is respectively negative control group, positive controls (aminophylline 0.1g/kg), Chinese medicine of the present inventionGrain high dose group (7.0g/kg), low dose group (3.5g/kg), totally 4 groups, 10 every group. The present inventionChinese medicinal granule high and low dose is equivalent to respectively 2.58 times, 1.29 times of clinical equivalent amount. Test each groupCavy is pressed respectively 20ml/kg body weight gastric infusion, the distilled water of the capacity such as negative control group gavage, every day1 time, for three days on end, 1h after last administration, again measures to draw to breathe heavily incubation period by prescreening method and (exceedes 6minPerson is in 6min).
On the impact of the phenol red discharge rate of mouse tracheae section
Get 80 of KM mouse, male and female half and half, body weight 22~25g, is divided into negative control group, the positive at randomMedicine control group (ammonium chloride 1.0g/kg), Chinese medicinal granule high dose group of the present invention (14.2g/kg), low dosageGroup (7.1g/kg), totally 4 groups, 16 every group. Chinese medicinal granule high and low dose of the present invention is equivalent to respectively3.12 times, 1.56 times of clinical equivalent amount. Each group mouse gastric infusion respectively, negative control group gavageDeng the distilled water of capacity, every day 1 time, for three days on end, and 1h after last administration, lumbar injection 5% is phenol redNormal saline solution 500mg/kg, 30min after injection, puts to death animal, and fixing mouse body, separates tracheae,It is put into and 2ml physiological saline is housed in vitro, after vibration 30min, add 1mol/LNaOH0.2mL,With spectrophotometer colorimetric under wavelength 546nm condition, according to phenol red calibration curve, calculate phenol red dischargeAmount, carries out statistical procedures with t inspection, relatively the significance degree of group difference.
Statistical procedures
Adopt SPSS15.0 software to carry out statistical analysis, experimental data adoptsRepresent all statisticsInspection all adopts T inspection, and P < 0.05 is considered to checked difference statistical significance.
Experimental result
On the impact of ammoniacal liquor induced mice cough latent period and number of times
With negative control group comparison, Chinese medicinal granule high dose group of the present invention can extend the mouse that ammoniacal liquor causes and coughCough incubation period (P < 0.01), Chinese medicinal granule high dose group of the present invention all can reduce the number of times of cough(P < 0.01), with negative control group comparison, Chinese medicinal granule low dose group of the present invention can extend that ammoniacal liquor causesMouse cough incubation period (P < 0.05), Chinese medicinal granule low dose group of the present invention all can reduce the number of times of cough(P < 0.05), the antitussive action of the mouse cough that ammoniacal liquor is caused has dose-effect relationship. And positive control drug is multipleSide's codeine phosphate oral administration solution can obviously extend mouse cough incubation period and the minimizing cough that ammoniacal liquor causesNumber of times (P < 0.01).
The impact of table 5 Chinese medicinal granule of the present invention on ammoniacal liquor induced mice cough latent period and number of times
Note: compare with negative control group,*P<0.05,**P<0.01。
On structure rafter, acid causes the impact of guinea pig cough's incubation period and cough number of times
With negative control group comparison, Chinese medicinal granule high and low dose group of the present invention all can significantly reduce citric acidDue to guinea pig cough's number of times (P < 0.05), and to a certain degree extend cough latent period. And positive control drugCompound codeine phosphate oral administration solution can obviously reduce the number of times (P < 0.01) of cough. The results are shown in Table 6.
The impact of table 6 Chinese medicinal granule of the present invention on guinea pig cough's incubation period due to citric acid and number of times
Group Dosage N Cough latent period (s) Cough number of times
Negative control group Equal-volume solvent 10 115.3±36.8 14.8±6.5
Positive controls 12ml/kg 10 179.4±92.6* 4.6±3.8*
High dose group 7.0ml/kg 10 138.1±88.2* 2.9±3.9**
Low dose group 3.5ml/kg 10 112.8±81.4 5.8±3.8*
Note: compare with negative control group,*P<0.05,**P<0.01。
Histamine phosphate is caused to the impact of Experimental Asthma In Guinea-pigs
With negative control group comparison, Chinese medicinal granule high dose group of the present invention and positive control drug aminophylline can showWork all can extend Experimental Asthma In Guinea-pigs incubation period (P < 0.01) due to histamine phosphate. And low dose group energy significant prolongationDue to histamine phosphate, cavy is roared and holds incubation period (P < 0.05). The results are shown in Table 7.
Table 7 Chinese medicinal granule of the present invention draws and breathes heavily preclinical impact Experimental Asthma In Guinea-pigs due to histamine phosphate
Group Dosage N Asthma incubation period (s)
Negative control group Equal-volume solvent 10 85.2±14.2
Positive controls 0.1g/kg 10 264.4±76.8**
High dose group 7.0g/kg 10 259.5±101.5**
Low dose group 3.5g/kg 10 184.9±84.4*
Note: compare with negative control group,*P<0.05,**P<0.01。
4. the impact on the phenol red discharge rate of mouse tracheae section
With negative control group comparison, Chinese medicinal granule high and low dose group of the present invention all can significantly strengthen tracheae rowSecrete phenol red effect (P < 0.05). And positive control drug ammonium chloride can strengthen the phenol red effect of tracheae excretion(P < 0.05). The results are shown in Table 8.
The impact of table 8 Chinese medicinal granule of the present invention on the phenol red excretion amount of mouse tracheae section
Group Dosage N The phenol red excretion amount of tracheae (μ g/ml)
Negative control group Equal-volume solvent 10 1.52±1.18
Positive controls 0.1g/kg 10 3.46±1.68*
High dose group 7.0g/kg 10 3.55±1.98*
Low dose group 3.5g/kg 10 3.049±1.49*
Note: compare with negative control group,*P<0.05。
Conclusion
Chinese medicine preparation of the present invention studies confirm that by experiment, and the cough causing for different excitaton sources all hasWell mitigation, also confirms to have good effect for the experiment of phenol red excretion effect, comprehensively commentsIts effect of valency, can be good at cough-relieving during for the clinical use of Chinese medicine preparation of the present invention, relievings asthma, expectoration doesProvide experimental basis by mechanism.
All above-mentioned these intellectual properties of primary enforcement, do not set the other forms of enforcement of restriction thisPlant new product and/or new method. Those skilled in the art will utilize this important information, foregoing amendment,To realize similar implementation status. But all modifications or transformation belong to reservation based on new product of the present inventionRight.
The above, be only preferred embodiment of the present invention, is not that the present invention is made to other formRestriction, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changedOr be modified as the equivalent embodiment of equivalent variations. But every technical solution of the present invention content that do not depart from, complies withAny simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention,Still belong to the protection domain of technical solution of the present invention.

Claims (4)

1. treat the preparation method that phlegm heat is stopped up the Chinese medicine preparation of the chronic cough of containing card type, its feature existsIn, the bulk drug of described Chinese medicine preparation is respectively processs Chinese ephedra 25g~40g, almond 10g~20g, gypsum20g~30g, raw Radix Glycyrrhizae 15g~25g, caulis bambusae in taenian 20g~40g, dried immature fruit of citron orange 10g~25g, rhizoma pinellinae praeparata 15g~25g, raw cape jasmine 20g~40g, root of large-flowered skullcap 25g~40g, balloonflower root 10g~20g, perillaseed 10g~20g, mulberryWhite skin 15g~25g, root bark of Chinese wolf-berry 15g~20g, polished rice 20g~25g, lepidium seed 10g~20g, reed rhizome10g~20g, tuber of dwarf lilyturf 25g~35g, fritillaria thunbergii 15g~25g, Poria cocos 10g~20g, Snakegourd Fruit 15g~25g, root of purple-flowered peucedanum 10g~20g, Cynanchum glaucescens 10g~20g, process tuber of stemona 15g~25g, cordate houttuynia 25g~35g,Dried orange peel 10g~20g, honeysuckle 20g~25g and indigo naturalis 5g~10g, specifically comprise the steps:
The first step, take by weight process Chinese ephedra, raw Radix Glycyrrhizae, rhizoma pinellinae praeparata, the root of large-flowered skullcap, the root bark of white mulberry, polished rice,The tuber of dwarf lilyturf, fritillaria thunbergii, Snakegourd Fruit, the root of purple-flowered peucedanum, cordate houttuynia, dried orange peel and indigo naturalis, clean respectively, pulverize, mixedBe combined, in the ethanol that the determining alcohol that adds 5~10 times of amounts of mixture quality is 70%~80%, soak 1~2 hours, heating was extracted 2 times, and each 1~2 hour, merge extract, 100 orders filter, then through cuttingThe ultrafiltration post ultrafiltration that stream molecular weight is 5000~10000, when ultrafiltrate reduced pressure concentration relative density is 60 DEG C1.30~1.36 medicinal extract, stand for standby use;
Second step, takes remaining bulk drug by weight, cleans respectively, pulverizes, and mixes, and addsThe ethanol water heating and refluxing extraction that the determining alcohol of 6~8 times of amounts of this step mixture quality is 50%~70%1~3 time, each time of extracting is 0.5~2 hour, collects extract, filters, by filtrate decompressionThe concentrate that while being concentrated into 60 DEG C, relative density is 1.02~1.18, upper large pore resin absorption column, macroporeThe quality of polymeric adsorbent is 10~15 times of this step bulk drug quality sum, is 40~70% with determining alcoholAqueous solution of alcohol wash-out, collects eluent, when reduced pressure concentration relative density is 60 DEG C 1.30~1.36Medicinal extract,
The 3rd step, mixes the medicinal extract of the first step and second step acquisition, gets 200g medicinal extract, then adds auxiliary materialMake and be applicable to the formulation of use clinically.
2. preparation method as claimed in claim 1, is characterized in that: the weight of each bulk drug is respectivelyProcess Chinese ephedra 30g~35g, almond 10g~15g, gypsum 25g~30g, raw Radix Glycyrrhizae 15g~20g, bambooEat 25g~30g, dried immature fruit of citron orange 15g~20g, rhizoma pinellinae praeparata 15g~20g, raw cape jasmine 25g~30g, root of large-flowered skullcap 30g~35g, balloonflower root 15g~20g, perillaseed 10g~15g, root bark of white mulberry 20g~25g, root bark of Chinese wolf-berry 15g~20g,Polished rice 20g~25g, lepidium seed 10g~15g, reed rhizome 10g~15g, tuber of dwarf lilyturf 30g~35g, Zhejiang shellfishFemale 15g~20g, Poria cocos 15g~20g, Snakegourd Fruit 15g~20g, root of purple-flowered peucedanum 10g~15g, Cynanchum glaucescens 15g~20g, process tuber of stemona 15g~20g, cordate houttuynia 30g~35g, dried orange peel 10g~15g, honeysuckle 20g~25gWith indigo naturalis 5g~10g.
3. the preparation method as described in claim 1 to 2, is characterized in that: the weight fraction of each bulk drugNot for process Chinese ephedra 30g, almond 15g, gypsum 25g, raw Radix Glycyrrhizae 20g, caulis bambusae in taenian 30g, dried immature fruit of citron orange 20g,Rhizoma pinellinae praeparata 20g, raw cape jasmine 30g, root of large-flowered skullcap 30g, balloonflower root 15g, perillaseed 15g, root bark of white mulberry 20g, boneSkin 20g, polished rice 20g, lepidium seed 15g, reed rhizome 15g, tuber of dwarf lilyturf 30g, fritillaria thunbergii 20g, Poria cocos15g, Snakegourd Fruit 20g, root of purple-flowered peucedanum 15g, Cynanchum glaucescens 15g, process tuber of stemona 20g, cordate houttuynia 30g, dried orange peel 15g,Honeysuckle 25g and indigo naturalis 10g.
4. the preparation method described in claims 1 to 3, is characterized in that: in the time being prepared into oral liquid,The 3rd step is specially, and the first medicinal extract and the second medicinal extract are mixed, and gets 200g medicinal extract, adds relativelyIn the cane sugar powder that mixes 2~4 times of medicinal extract quality, mix, be prepared into granules of sugar, dry, altogetherMake 1000, splitting splendid attire, every bag of 10g.
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Application publication date: 20160525