CN105535738A - Traditional Chinese medicine preparation for treating chronic cough and preparing method thereof - Google Patents

Traditional Chinese medicine preparation for treating chronic cough and preparing method thereof Download PDF

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Publication number
CN105535738A
CN105535738A CN201610045535.XA CN201610045535A CN105535738A CN 105535738 A CN105535738 A CN 105535738A CN 201610045535 A CN201610045535 A CN 201610045535A CN 105535738 A CN105535738 A CN 105535738A
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China
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radix
chinese medicine
cough
medicine preparation
semen
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CN201610045535.XA
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葛云洁
李靖
肖芝秀
袁莉
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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Abstract

The invention provides a traditional Chinese medicine preparation for treating a chronic cough. The traditional Chinese medicine preparation is prepared from roasted herba ephedra, apricot kernel, gypsum, raw radix glycyrrhizae, caulis bambusae in taenia, fruit of immature citron, rhizoma pinellinae praeparata, raw fructus gardeniae, radix scutellariae, radix platycodi, perillaseed, white mulberry root-bark, cortex lycii radicis, polished round-grained rice, semen lepidii, rhizoma phragmitis, ophiopogon root, thunberg fritillary bulb, poria cocos, fructus trichosanthis, radix peucedani, cynanchum glaucescens, radix stemonae, herba houttuyniae, dried tangerine or orange peel, honeysuckle flower, indigo naturalis, pummelo peel and dandelion. Under the guidance of the theory of traditional Chinese medicine, based on massive clinical observation and comprehensive analysis of syndrome pattern, clinical manifestation and treatment prognosis, the medicinal materials are combined to relieve a cough and asthma and reduce phlegm. Furthermore, animal experiment verification and traditional Chinese medicine safety evaluation prove that the traditional Chinese medicine preparation has a good chronic cough treating effect.

Description

A kind of Chinese medicine preparation being used for the treatment of chronic cough and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicine, be specially a kind of Chinese medicine preparation being used for the treatment of chronic cough and preparation method thereof, particularly relate to a kind of expectorant heat that is used for the treatment of and stop up Chinese medicine preparation of the chronic cough containing pattern of syndrome and preparation method thereof.
Background technology
Chronic cough thinks a kind of reflexive defence action at modern medicine, when human body is coughed, and can secretions in clearing pneogaster and foreign body.Such as, but meanwhile cough and also have disadvantageous one side, cough can make infection at respiratory tract internal diffusion, and violent cough can cause respiratory tract hemorrhage, even brings out spontaneous pneumothorax etc.Frequent cough can cause serious impact to the work of patient, life and social activity.Scholar is constantly had to study the pathogenesis of coughing, Treatment and diagnosis in recent years.Use the diagnostic means such as x-ray inspection, pulmonary function test, anaphylactogen inspection, branchofiberoscope, the reason causing cough can be found early, and treat for the cause of disease.
Chronic cough is as symptom, western medicine is summarized as the clinical manifestation of diseases in respiratory system it, although diagnosis can be made to most of disease, but because the abuse such as antibiotic and hormone limits the clinical efficacy of medicine, thus, in the face of the cough symptom of failing to respond to any medical treatment, often sink into without medicine can poverty-stricken.Chinese medicine as independent name of disease, has certain realistic meaning " cough "."Nei Jing" cloud " vital organs of the human body all make us coughing, and non-only lung also ", explicitly pointing out cough all has close contacting with the vital organs of the human body, and the relation of chronic cough and internal organs is close especially.This based on Overall View to the understanding of cough and treatment, the curative effect obtained clinically so far not second to the treatment of doctor trained in Western medicine.Current, to the understanding of the traditional Chinese medical science " chronic cough ", think closely related with " chronic bronchitis ", " cough variant asthma " of western medicine etc. more, and this few class disease often western medicine clinical efficacy dispatch a person by force meaning, the treatment of Chinese medicine but shows superiority especially.
Clinical report shows, chronic cough is mainly seen in the disease of chronic bronchitis, this two large class doctor trained in Western medicine of cough variant asthma, and expectorant heat stops up that to contain card be an important pattern of syndrome, this with chronic cough course of disease length, prolonged illness injures lung spleen close ties.Research and development as new Chinese medicine must coach with theory of Chinese medical science, chronic cough is as clinical frequently-occurring disease commonly encountered diseases, at present miscellaneous Chinese patent medicine Clinical practice curative effect is dissatisfied, Chinese medicine preparation of the present invention is under the guidance of theory of Chinese medical science, according to a large amount of clinical observations, to pattern of syndrome, clinical manifestation and treatment prognosis etc. are comprehensively analyzed, prescription medicine, not only there is cough-relieving, relieving asthma, to reduce phlegm effect, and verified by zoopery, and have passed Chinese native medicine security evaluation, proved invention Chinese medicine preparation has well treatment expectorant heat and stops up the chronic cough effect of containing pattern of syndrome, carry out wider clinical research and the evaluation of expected results more further, be expected to that the chronic cough containing pattern of syndrome is stopped up to national medicine treatment expectorant heat and a kind of new treatment means is provided, for certain experiment and Clinical Basis are established in research and development further.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of expectorant heat that is used for the treatment of and stops up Chinese medicine preparation of the chronic cough containing pattern of syndrome and preparation method thereof, Chinese medicine preparation of the present invention is under the guidance of theory of Chinese medical science, according to a large amount of clinical observations, to pattern of syndrome, clinical manifestation and treatment prognosis etc. are comprehensively analyzed, prescription medicine, not only there is cough-relieving, relieving asthma, to reduce phlegm effect, and verified by zoopery, and have passed Chinese native medicine security evaluation, proved invention Chinese medicine preparation has well treatment expectorant heat and stops up the chronic cough effect of containing pattern of syndrome, carrying out wider clinical research and the evaluation of expected results further, be expected to that the chronic cough containing pattern of syndrome is stopped up to national medicine treatment expectorant heat and a kind of new treatment means is provided, for certain experiment and Clinical Basis are established in research and development further.
Based on this, the invention provides a kind of Chinese medicine preparation being used for the treatment of the chronic cough of expectorant heat heap soil or fertilizer over and around the roots Sheng pattern of syndrome, its crude drug comprises Herba Ephedrae (processed), Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Rhizoma Pinelliae Preparatum, Fructus Gardeniae, Radix Scutellariae, Radix Platycodonis, Fructus Perillae, Cortex Mori, Cortex Lycii, Semen oryzae sativae, Semen Lepidii (Semen Descurainiae), Rhizoma Phragmitis, Radix Ophiopogonis, Bulbus Fritillariae Thunbergii, Poria, Fructus Trichosanthis, Radix Peucedani, Rhizoma Cynanchi Stauntonii, Radix Stemonae (processed), Herba Houttuyniae, Pericarpium Citri Reticulatae, Flos Lonicerae, Indigo Naturalis.
Also can add Exocarpium Citri Grandis and Herba Taraxaci further.
Wherein, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 25g ~ 40g, Semen Armeniacae Amarum 10g ~ 20g, Gypsum Fibrosum 20g ~ 30g, Radix Glycyrrhizae 15g ~ 25g, Caulis Bambusae In Taenia 20g ~ 40g, Fructus Aurantii Immaturus 10g ~ 25g, Rhizoma Pinelliae Preparatum 15g ~ 25g, Fructus Gardeniae 20g ~ 40g, Radix Scutellariae 25g ~ 40g, Radix Platycodonis 10g ~ 20g, Fructus Perillae 10g ~ 20g, Cortex Mori 15g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 20g, Rhizoma Phragmitis 10g ~ 20g, Radix Ophiopogonis 25g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 25g, Poria 10g ~ 20g, Fructus Trichosanthis 15g ~ 25g, Radix Peucedani 10g ~ 20g, Rhizoma Cynanchi Stauntonii 10g ~ 20g, Radix Stemonae (processed) 15g ~ 25g, Herba Houttuyniae 25g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 20g, Flos Lonicerae 30g ~ 40g and Indigo Naturalis 5g ~ 10g.
Also can add Exocarpium Citri Grandis 10g ~ 20g and Herba Taraxaci 10g ~ 20g.
In described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 25g ~ 40g, Semen Armeniacae Amarum 10g ~ 20g, Gypsum Fibrosum 20g ~ 30g, Radix Glycyrrhizae 15g ~ 25g, Caulis Bambusae In Taenia 20g ~ 40g, Fructus Aurantii Immaturus 10g ~ 25g, Rhizoma Pinelliae Preparatum 15g ~ 25g, Fructus Gardeniae 20g ~ 40g, Radix Scutellariae 25g ~ 40g, Radix Platycodonis 10g ~ 15g, Fructus Perillae 10g ~ 20g, Cortex Mori 15g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 20g, Rhizoma Phragmitis 10g ~ 20g, Radix Ophiopogonis 25g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 25g, Poria 10g ~ 20g, Fructus Trichosanthis 15g ~ 25g, Radix Peucedani 10g ~ 20g, Rhizoma Cynanchi Stauntonii 10g ~ 20g, Radix Stemonae (processed) 15g ~ 25g, Herba Houttuyniae 25g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 20g, Flos Lonicerae 15g ~ 25g, Indigo Naturalis 5g ~ 10g, Exocarpium Citri Grandis 10g ~ 20g and Herba Taraxaci 10g ~ 20g.
Wherein, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 30g ~ 35g, Semen Armeniacae Amarum 10g ~ 15g, Gypsum Fibrosum 25g ~ 30g, Radix Glycyrrhizae 15g ~ 20g, Caulis Bambusae In Taenia 25g ~ 30g, Fructus Aurantii Immaturus 15g ~ 20g, Rhizoma Pinelliae Preparatum 15g ~ 20g, Fructus Gardeniae 25g ~ 30g, Radix Scutellariae 30g ~ 35g, Radix Platycodonis 15g ~ 20g, Fructus Perillae 10g ~ 15g, Cortex Mori 20g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 15g, Rhizoma Phragmitis 10g ~ 15g, Radix Ophiopogonis 30g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 20g, Poria 15g ~ 20g, Fructus Trichosanthis 15g ~ 20g, Radix Peucedani 10g ~ 15g, Rhizoma Cynanchi Stauntonii 15g ~ 20g, Radix Stemonae (processed) 15g ~ 20g, Herba Houttuyniae 30g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 15g, Flos Lonicerae 35g ~ 40g and Indigo Naturalis 5g ~ 10g.
Wherein, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 30g, Semen Armeniacae Amarum 15g, Gypsum Fibrosum 25g, Radix Glycyrrhizae 20g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Rhizoma Pinelliae Preparatum 20g, Fructus Gardeniae 30g, Radix Scutellariae 30g, Radix Platycodonis 15g, Fructus Perillae 15g, Cortex Mori 20g, Cortex Lycii 20g, Semen oryzae sativae 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 20g, Poria 15g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 20g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 15g, Flos Lonicerae 35g and Indigo Naturalis 10g.
In described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 30g, Semen Armeniacae Amarum 15g, Gypsum Fibrosum 25g, Radix Glycyrrhizae 20g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Rhizoma Pinelliae Preparatum 20g, Fructus Gardeniae 30g, Radix Scutellariae 30g, Radix Platycodonis 15g, Fructus Perillae 15g, Cortex Mori 20g, Cortex Lycii 20g, Semen oryzae sativae 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 20g, Poria 15g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 20g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 15g, Flos Lonicerae 20g, Indigo Naturalis 10g, Exocarpium Citri Grandis 15g and Herba Taraxaci 15g.
Wherein, described Chinese medicine preparation is in traditional Chinese medicine extraction component, add the oral formulations that the acceptable adjuvant of pharmacy is prepared from.
Wherein, described oral formulations comprises decoct, tablet, capsule, granule, oral liquid, powder, powder.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, it comprises:
The first step, take Herba Ephedrae (processed) by weight, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Radix Scutellariae, Cortex Mori, Semen oryzae sativae, Radix Ophiopogonis, Bulbus Fritillariae Thunbergii, Fructus Trichosanthis, Radix Peucedani, Herba Houttuyniae, Pericarpium Citri Reticulatae and Indigo Naturalis, clean respectively, pulverize, mix, the determining alcohol adding mixture quality 5 ~ 10 times amount is soak 1 ~ 2 hour in the ethanol of 70% ~ 80%, heating extraction 2 times, each 1 ~ 2 hour, merge extractive liquid, 100 orders filter, be the ultrafiltration post ultrafiltration of 5000 ~ 10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 60 DEG C 1.30 ~ 1.36 extractum, stand for standby use,
Second step, take remaining crude drug by weight, clean respectively, pulverize, mix, the determining alcohol adding this step mixture quality 6 ~ 8 times amount is the ethanol water heating and refluxing extraction 1 ~ 3 time of 50% ~ 70%, the time of each extraction is 0.5 ~ 2 hour, collect extracting solution, filter, when concentrating filtrate to 60 DEG C, relative density is the concentrated solution of 1.02 ~ 1.18, upper macroporous adsorptive resins, the quality of macroporous adsorbent resin is 10 ~ 15 times of this step crude drug quality sum, with the aqueous solution of alcohol eluting that determining alcohol is 40 ~ 70%, collect eluent, when concentrating under reduced pressure relative density is 60 DEG C 1.30 ~ 1.36 extractum,
3rd step, the extractum mixing first step and second step obtained, gets 200g extractum, then adds adjuvant and make the dosage form being applicable to using clinically.
Wherein, when being prepared into oral liquid, the 3rd step is specially, and the first extractum and the second extractum is mixed, get 200g extractum, add the cane sugar powder relative to mixing extractum quality 2 ~ 4 times, mix homogeneously, is prepared into granules of sugar, drying, makes 1000 altogether, splitting splendid attire, every bag of 10g.
Useful technique effect
The Chinese medicine preparation being used for the treatment of the chronic cough of expectorant heat heap soil or fertilizer over and around the roots Sheng pattern of syndrome provided by the invention, drug safety, has no side effect, and has the chronic cough effect of well treatment expectorant heat heap soil or fertilizer over and around the roots Sheng pattern of syndrome.
Detailed description of the invention
The invention provides a kind of Chinese medicine preparation being used for the treatment of the chronic cough of expectorant heat heap soil or fertilizer over and around the roots Sheng pattern of syndrome, its crude drug comprises Herba Ephedrae (processed), Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Rhizoma Pinelliae Preparatum, Fructus Gardeniae, Radix Scutellariae, Radix Platycodonis, Fructus Perillae, Cortex Mori, Cortex Lycii, Semen oryzae sativae, Semen Lepidii (Semen Descurainiae), Rhizoma Phragmitis, Radix Ophiopogonis, Bulbus Fritillariae Thunbergii, Poria, Fructus Trichosanthis, Radix Peucedani, Rhizoma Cynanchi Stauntonii, Radix Stemonae (processed), Herba Houttuyniae, Pericarpium Citri Reticulatae, Flos Lonicerae and Indigo Naturalis.
Phlegm-heat cough, for heresy violate air flue, impaired depurative descending of lung QI and cause phlegm-heat accumulated in the lung card.Clinical manifestation is cough, expectorant Huang is thick, cough up tell not well, the turbid tears of nasal obstruction stream, pharyngalgia celostomia, red tongue, yellow and thin fur or greasy, the symptoms such as slippery and rapid pulse.Modern medicine is diagnosed as more, and " chronic bronchitis, or " cough variant asthma ", have suffer from cold infection or contact history more, 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 expectorant goes out; Or expectorant transconversion into heat fire, bright lung is hindered network therefore is seen expectorant blood pharyngalgia; Or expectorant heat is stopped up and contained, disorder of QI movement, therefore uncomfortable in chest, xerostomia and hardship be heat very impairment of body fluid, and existing yellow fur, slippery and rapid pulse, this is hot the resembling of expectorant.Therefore the respectful lung of heat clearing away, eliminating phlegm cough-relieving is worked as during treatment.Chinese medicine preparation of the present invention is for the etiology and pathogenesis of primary disease, prescription combination drug, use Gypsum Fibrosum, Fructus Gardeniae, Radix Scutellariae, Cortex Mori, Cortex Lycii, Rhizoma Phragmitis, Herba Houttuyniae, Flos Lonicerae, Semen oryzae sativae, Indigo Naturalis lung heat clearing pathogenic fire purging, the consolidating YIN of heat clearing away simultaneously, pathogenic heat one is gone, then state of an illness speed subtracts, and all medicines share, and is monarch drug group; For patient's cough, dyspnea with rapid and short breath symptom, Chinese medicine preparation of the present invention uses Herba Ephedrae (processed), Semen Armeniacae Amarum, Radix Platycodonis, Fructus Perillae, Semen Lepidii (Semen Descurainiae), Pericarpium Citri Reticulatae, Radix Peucedani, Rhizoma Cynanchi Stauntonii, Radix Stemonae (processed) depressed lung-energy dispersing, its epheday intermedia is processed and is retained the merit of depressed lung-energy dispersing by the power can delaying its diaphoresis, Semen Lepidii (Semen Descurainiae) has the use of eliminating pathogen from the lung for relieving asthma, Radix Peucedani, Rhizoma Cynanchi Stauntonii, Radix Stemonae (processed) all have good cough-relieving effect, all medicines share, and are ministerial drug group; Stop up for its expectorant heat the pathogenesis contained, eliminating the phlegm is also important business, therefore adds the medicines such as Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Rhizoma Pinelliae Preparatum, Fructus Perillae, Bulbus Fritillariae Thunbergii, Poria, Fructus Trichosanthis, Radix Stemonae (processed), Radix Peucedani, Rhizoma Cynanchi Stauntonii, coordinate monarch drug group clear heat and eliminate phlegm, expectorant heat is not fought mutually, then expectoration is breathed heavily and all removed, and is adjuvant drug; YIN damaged by pathogenic heat, disease treatment makes to protect cloudy liquid when Gu, therefore adds the medicines such as Semen oryzae sativae, Rhizoma Phragmitis, Radix Ophiopogonis with foster lung yin, up in lung with Radix Platycodonis medicine carrying, therefore for making medicine.Full side share, and plays removing heat-phlegm altogether, lung qi dispersing cough-relieving effect, rapid patients in remission, and for patient's prognosis 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 crude drug is respectively Herba Ephedrae (processed) 25g ~ 40g, Semen Armeniacae Amarum 10g ~ 20g, Gypsum Fibrosum 20g ~ 30g, Radix Glycyrrhizae 15g ~ 25g, Caulis Bambusae In Taenia 20g ~ 40g, Fructus Aurantii Immaturus 10g ~ 25g, Rhizoma Pinelliae Preparatum 15g ~ 25g, Fructus Gardeniae 20g ~ 40g, Radix Scutellariae 25g ~ 40g, Radix Platycodonis 10g ~ 20g, Fructus Perillae 10g ~ 20g, Cortex Mori 15g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 20g, Rhizoma Phragmitis 10g ~ 20g, Radix Ophiopogonis 25g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 25g, Poria 10g ~ 20g, Fructus Trichosanthis 15g ~ 25g, Radix Peucedani 10g ~ 20g, Rhizoma Cynanchi Stauntonii 10g ~ 20g, Radix Stemonae (processed) 15g ~ 25g, Herba Houttuyniae 25g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 20g, Flos Lonicerae 30g ~ 40g and Indigo Naturalis 5g ~ 10g.
Further preferably, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 30g ~ 35g, Semen Armeniacae Amarum 10g ~ 15g, Gypsum Fibrosum 25g ~ 30g, Radix Glycyrrhizae 15g ~ 20g, Caulis Bambusae In Taenia 25g ~ 30g, Fructus Aurantii Immaturus 15g ~ 20g, Rhizoma Pinelliae Preparatum 15g ~ 20g, Fructus Gardeniae 25g ~ 30g, Radix Scutellariae 30g ~ 35g, Radix Platycodonis 15g ~ 20g, Fructus Perillae 10g ~ 15g, Cortex Mori 20g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 15g, Rhizoma Phragmitis 10g ~ 15g, Radix Ophiopogonis 30g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 20g, Poria 15g ~ 20g, Fructus Trichosanthis 15g ~ 20g, Radix Peucedani 10g ~ 15g, Rhizoma Cynanchi Stauntonii 15g ~ 20g, Radix Stemonae (processed) 15g ~ 20g, Herba Houttuyniae 30g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 15g, Flos Lonicerae 35g ~ 40g and Indigo Naturalis 5g ~ 10g.
Further preferably, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 25g ~ 40g, Semen Armeniacae Amarum 10g ~ 20g, Gypsum Fibrosum 20g ~ 30g, Radix Glycyrrhizae 15g ~ 25g, Caulis Bambusae In Taenia 20g ~ 40g, Fructus Aurantii Immaturus 10g ~ 25g, Rhizoma Pinelliae Preparatum 15g ~ 25g, Fructus Gardeniae 20g ~ 40g, Radix Scutellariae 25g ~ 40g, Radix Platycodonis 10g ~ 15g, Fructus Perillae 10g ~ 20g, Cortex Mori 15g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 20g, Rhizoma Phragmitis 10g ~ 20g, Radix Ophiopogonis 25g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 25g, Poria 10g ~ 20g, Fructus Trichosanthis 15g ~ 25g, Radix Peucedani 10g ~ 20g, Rhizoma Cynanchi Stauntonii 10g ~ 20g, Radix Stemonae (processed) 15g ~ 25g, Herba Houttuyniae 25g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 20g, Flos Lonicerae 15g ~ 25g, Indigo Naturalis 5g ~ 10g, Exocarpium Citri Grandis 10g ~ 20g and Herba Taraxaci 10g ~ 20g.
Most preferably, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 30g, Semen Armeniacae Amarum 15g, Gypsum Fibrosum 25g, Radix Glycyrrhizae 20g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Rhizoma Pinelliae Preparatum 20g, Fructus Gardeniae 30g, Radix Scutellariae 30g, Radix Platycodonis 15g, Fructus Perillae 15g, Cortex Mori 20g, Cortex Lycii 20g, Semen oryzae sativae 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 20g, Poria 15g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 20g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 15g, Flos Lonicerae 35g and Indigo Naturalis 10g.
Most preferably, in described Chinese medicine preparation, the weight of each crude drug is respectively Herba Ephedrae (processed) 30g, Semen Armeniacae Amarum 15g, Gypsum Fibrosum 25g, Radix Glycyrrhizae 20g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Rhizoma Pinelliae Preparatum 20g, Fructus Gardeniae 30g, Radix Scutellariae 30g, Radix Platycodonis 15g, Fructus Perillae 15g, Cortex Mori 20g, Cortex Lycii 20g, Semen oryzae sativae 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 20g, Poria 15g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 20g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 15g, Flos Lonicerae 20g, Indigo Naturalis 10g, Exocarpium Citri Grandis 15g and Herba Taraxaci 15g.
Described Chinese medicine preparation is in traditional Chinese medicine extraction component, add the oral formulations that the acceptable adjuvant of pharmacy is prepared from, and described oral formulations comprises decoct, tablet, capsule, granule, oral liquid, powder, powder.
Each crude drug pharmacology is as follows:
Herba Ephedrae (processed): acrid in the mouth, micro-hardship, warm in nature, enter lung, urinary bladder channel, have and send out cold inducing sweat, depressed lung-energy dispersing, the effect of inducing diuresis to remove edema, is mainly used in the exterior excess syndromes such as the fever without perspiration of affection of exogenous wind-cold; Rheumatic arthralgia pain; Pathogenic cold attacking the lung or accumulation of heat in the lung to cough with asthma QI rising in reverse order, edema, the cards such as dysuria.
Semen Armeniacae Amarum: bitter in the mouth, warm in nature, enter lung, large intestine channel, there is expelling phlegm for arresting cough, relieving asthma, effect of intestine moistening.Cure mainly exogenous cough, dyspnea with fullness of the chest, sore throat, the cards such as dryness of the intestine constipation.
Gypsum Fibrosum: acrid in the mouth, sweet, property Great Cold, enter lung, stomach warp, there is clearing away heat-fire, to quench the thirst the effect of relieving restlessness, the all thin and matter weight of its abnormal smells from the patient, the excess-heat of energy removing summer-heat stomach of foot Yang Ming, filling the air for the treatment of pathogen invading YANG MING is high hot, profuse sweating, thirsty, vexed, the symptoms such as arteries and veins flood, for the key medicine of the bright stomach warp of sun, to epidemic encephalitis, encephalitis b, high heat caused by pneumonia etc. has good antipyretic effect, and have relieving convulsion effect concurrently, also can be used for the burning pain in the epigastrium that the high Sheng of stomach-fire is caused, headache, aphtha of the mouth and tongue and heat-damp in summer dysphoria with smothery sensation, lung-heat cough with asthma, restlessness and thirst, damp and hot obstruction of meridian, the cards such as the pyretic arthralgia of arthralgia.
Radix Glycyrrhizae: sweet in the mouth, property put down, enter 12 warps, have heat-clearing and toxic substances removing, be in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in the abdominal distension and anorexia of weakness of the spleen and stomach, weak; Can alleviate contracture pain in abdomen, relax the strong and toxicity of some drugs, alleviating medicine stimulates to the toxic and side effects of body or to gastrointestinal, can play QI invigorating neutralization by adding Radix Glycyrrhizae, is in harmonious proportion the effect of each component.
Caulis Bambusae In Taenia: cold nature, sweet in the mouth, attaches to the lung and stomach meridians, and has removing heat-phlegm, the effect relieved restlessness and prevented vomiting, and holds the card such as expectorant, dysphoria with smothery sensation vomiting, palpitation with fear insomnia, middle wind-phlegm fan, aphasia with stiff tongue, gastropyretic vomiting, pregnancy reactions, frequent fetal movement under the arm for phlegm-heat cough, gallbladder fire.
Fructus Aurantii Immaturus: bitter in the mouth, pungent, cold nature, enters spleen, stomach warp, has dispelling the stagnated QI removing food stagnancy, expectorant except the effect of painful abdominal mass, be mainly used in stagnant in stop, the YangmingFushi syndrome of distension and fullness in the abdomen, constipation.
Rhizoma Pinelliae Preparatum: acrid in the mouth, warm in nature, returns spleen, stomach, lung meridian, has effect of drying dampness to eliminate phlegm, cures mainly abundant expectoration cough, dizziness due to wind-phlegm, the cards such as syncope due to accumulation of phlegm headache.
Fructus Gardeniae: latin name gardeniaefructus, bitter in the mouth, cold in nature, GUIXIN, lung, three Jiao, have the effect of relieving restlessness pathogenic fire purging, dispersing the stagnated live-QI to relieve the stagnation of QI, clearing away heat-damp and promoting diuresis, cooling blood for hemostasis, cure mainly the vexed uneasiness of epidemic febrile disease heat stagnation breast gastral cavity, bother not peaceful, stagnation of liver-QI is not relaxed or Liver Channel has having a dizzy spell of heat, pain in chest and hypochondrium, conjunctival congestion dry pharynx, jaundice due to damp-heat, the cards such as the abdominal distention of qi depression to blood stasis.
Radix Scutellariae: bitter in the mouth, cold in nature, GUIXIN, lung, stomach, gallbladder, large intestine channel, have heat clearing and damp drying, and eliminating fire and detoxication is antiabortive, the effect of hemostasis, is mainly used in damp and hot caused diarrhoea, dysentery, jaundice, pyretic stranguria; Cough due to lung-heat, thirsty pharyngalgia, also can be used for excessive fetal movement due to heat in pregnancy, and pyretic toxicity pathogenic fire invades the swollen card of carbuncle sore poison of excessive skin.
Radix Platycodonis: bitter in the mouth, pungent, slightly warm in nature, enters lung meridian, has expelling phlegm for arresting cough, and has lung qi dispersing, evacuation of pus effect, cures mainly: cough with copious phlegm, laryngopharynx swelling and pain, lung abscess vomiting pus, fullness in the chest and hypochondriac pain, dysentery stomachache, aphtha of the mouth and tongue, conjunctival congestion and swelling pain, uroschesis.
Fructus Perillae: acrid in the mouth, warm in nature, return lung, large intestine channel, there is sending down the abnormal ascending QI expectorant, relieving cough and asthma, effect of loosening bowel to relieve constipation.QI rising in reverse order is stopped up, cough and asthma, the cards such as dryness of the intestine constipation for expectorant.
Cortex Mori: latin name moricortex, sweet in the mouth, cold in nature, enter lung meridian, there is eliminating pathogen from the lung for relieving asthma, the effect of inducing diuresis to remove edema, for one of the common drug of eliminating the pathogens from the lung row water, be mainly used in the strongly fragrant lung of pathogenic heat, dyspnea with rapid respiration and cough that QI rising in reverse order is not fallen, excessive phlegm, yellow skin, stops in phlegm retention, the distension cough with dyspnea that breast sun is not declared, Lung Qi obstraction, steam do not walk to edema dyspnea with fullness of the chest, dysuria, function of gallbladder promoting, promote the production of body fluid, the cards such as eliminating stagnation.
Cortex Lycii: latin name LyciiCortex, cold in nature, sweet in the mouth, have removing heat from blood except steaming, effect of lung heat clearing pathogenic fire reducing, cures mainly the cards such as deficiency of YIN hectic fever, hectic fever due to YIN-deficiency night sweat, cough due to lung-heat, spitting of blood, epistaxis.
Semen oryzae sativae: sweet in the mouth, property is put down, and enters spleen; Stomach; Lung meridian, has warming middle-JIAO for easing the stomach, effect of QI invigorating stopping leak.Cure mainly irritated thirsty, the cards such as bloody dysentery heat is hot-tempered, Sunstroke heating.
Semen Lepidii (Semen Descurainiae): acrid in the mouth, bitter, cold in nature, return lung meridian, heart channel, Liver Channel, stomach warp, urinary bladder channel, there is eliminating the pathogens from the lung sending down the abnormal ascending QI, eliminating phlegm and relieving asthma, inducing diuresis to remove edema, let out the effect by heresy, cure mainly the dyspnea and cough with excessive sputum that sputum stops up lung, lung abscess, edema, breast abdomen hydrops, dysuria, chronic pulmonary heart disease, the cards such as breathing heavily of heart failure is swollen, scrofula tuberculosis.
Rhizoma Phragmitis: sweet in the mouth, cold in nature, attach to the lung and stomach meridians, there is lung heat clearing gastric heat, diuresis, dissipating depression of QI clearing away phlegm, effect of YIN nourishing and the production of body fluid promoting, cure mainly the dysphoria with smothery sensation that epidemic febrile disease joins the army point thirsty, dryness of the tongue Tianjin is few, and the rash of measles goes out not saturating, and pathogenic heat violates the cough and expectoration of lung, the cough vomiting pus of lung abscess, the damp and hot card such as vomiting singultus blocked in stomach.
Radix Ophiopogonis: sweet in the mouth, micro-hardship, cold nature, enter the heart, lung, stomach warp, the effect having nourishing YIN and moistening the lung, preventing phlegm from forming and stopping coughing, heat clearing away to nourish heart, is mainly used in treating the few expectorant of dry cough of lung-dryness syndrome due to deficiency of YIN, consumptive lung disease, sticky expectorant and sputum mixed with blood are told in coughing of lung abscess, its kind nourishing stomach-YIN, promotes the production of body fluid and moisturizes, and is particularly useful for the symptoms such as the dryness of the mouth and throat of consumption of body fluid caused by febrile disease, vexed uneasiness.
Bulbus Fritillariae Thunbergii: bitter in the mouth, cold in nature, enter lung, heart channel, have removing heat-phlegm, effect of powder detoxifcation, cures mainly cough due to pathogenic wind-heat, lung abscess sore throat, scrofula, the cards such as sore swollen toxin.
Poria: sweet in the mouth, light, property is put down, and enters spleen, lung, bladder, heart channel, has the effect of eliminating dampness and diuresis, spleen invigorating mind calming, be mainly used in the edema of retention of water-damp, dysuria; The pyretic stranguria of damp-heat accumulation, the card such as anorexia and loose stool, phlegm retention stagnation, epilepsy of stagnation of dampness due to deficiency of the spleen.
Fructus Trichosanthis: sweet in the mouth, micro-hardship, cold in nature, enter lung, stomach, large intestine channel, have removing heat-phlegm, relieving stuffiness of the chest by dispersing aggregation of pathogens, effect of loosening bowel to relieve constipation, for cough due to lung-heat, the turbid Huang of expectorant is thick, obstruction of qi in the chest and cardialgia, blocked-up chest feeling of fullness, acute mastitis, lung abscess, the cards such as acute appendicitis swells and ache, constipation.
Radix Peucedani: latin name PeucedaniRadix, bitter in the mouth, pungent, cold nature, enters lung meridian, has dispelling wind-heat, and the effect of lowering the adverse-rising QI and dispelling phlegm, is mainly used in wind-heat cough, and the card such as the caused cough with asthma of expectorant heat choke, lung qi poetry anthology, chest and diaphragm be unfavorable.
Rhizoma Cynanchi Stauntonii: acrid in the mouth, hardship, slightly warm in nature, returns lung meridian, there is lowering the adverse-rising QI to resolve phlegm, the effect of cough-relieving, this product slightly warm in nature and not dry strong, be longer than and eliminate the phlegm, fall lung qi with flat cough with asthma, no matter belong to cold and belong to heat, Exogenous and internal injuries, chronic cough of newly coughing all available it, " detailed outline ": Rhizoma Cynanchi Stauntonii, is longer than sending down the abnormal ascending QI, and lung qi heap soil or fertilizer over and around the roots has expectorant in fact, and person should it.If empty and long choking person is unavailable.Zhang Zhongjing is controlled and is coughed and deep pulse person, also uses it in Herba Euphorbiae Helioscopiae soup.
Radix Stemonae (processed): sweet in the mouth, hardship, slightly warm in nature, returns lung meridian, has effect of nourishing the lung to keep the adverse QI downward, cough-relieving parasite killing, coughs for new chronic cough, pulmonary tuberculosis cough, pertussis, head louse, body louse, enterobiasis, the cards such as pudendum Pruritus.
Herba Houttuyniae: latin name houttuyniaeherba, acrid in the mouth, cold nature, enters lung, urinary bladder channel, has heat-clearing and toxic substances removing, removing pus and relieving carbuncle, effect of inducing diuresis for treating stranguria syndrome, and for lung abscess vomiting pus, expectorant heat syndrome cough is breathed heavily, toxic-heat and blood stasis, damp-heat gonorrhoea, pyretic toxicity carbuncle sore, and snakeworm wants first-class card.
Pericarpium Citri Reticulatae: warm in nature, acrid in the mouth, hardship; Return spleen, lung meridian, for diseases such as distension and fullness of the chest and abdomen.The pungent loose logical temperature of Pericarpium Citri tangerinae, fragrant odour, is longer than and regulates the flow of vital energy, spleen lung can be entered, therefore can go loose sluggishness of lung-QI, again can promoting the circulation of QI to alleviate the stagnation in middle-JIAO, gather around stagnant, chest and diaphragm feeling of fullness and the disease such as stagnation of QI in spleen and stomach, distension and fullness in the abdomen for lung qi, for retention of dampness in middle-JIAO, gastral cavity abdomen painful abdominal mass is swollen, have loose bowels in loose stool, and the disease such as abundant expectoration cough.
Flos Lonicerae: latin name loniceraejaponicaeflos, sweet in the mouth, cold in nature, enter the heart, lung, stomach, large intestine channel, have the effect of heat-clearing and toxic substances removing, holding concurrently can eliminating pathogenic heat from blood to cure dysentery.Be mainly used in affection due to external wind and heat, epidemic febrile disease pyretic toxicity is comparatively contained, or when epidemic febrile disease is still not descending at the part of the body cavity above the diaphragm housing the heart and lungs from the beginning of pathogenic heat; Pyretic toxicity dysentery, stool hematochezia; Fever disease in summer is demonstrate,proved; The carbuncle sore that pyretic toxicity gathers is from the beginning of the, inflammation heat person of swelling and ache etc., Flos Lonicerae has good antipyretic effect, energy antiinflammatory, what control inflammation oozes out and inflammatory hyperplasia, leukocytic phagocytic function can be promoted, there is stronger bacteriostasis to multiple pyococcus and pathogenic entero becteria, comprise staphylococcus, Hemolytic streptococcus, meningococcus, dysentery bacterium, Bacillus typhi, escherichia coli, bacillus pyocyaneus, tubercule bacillus etc.
Indigo Naturalis: salty in the mouth, cold in nature, enter Liver Channel, there is effect of heat-clearing and toxic substances removing, cooling blood for hemostasis, purging liver-fire, send out the cards such as all cards of pyretic toxicity such as speckle, haematemesis, laryngopharynx swelling and pain, herpes eczema, liver-fire invading the lung, cough chest pain, sputum mixed with blood, high hot infantile convulsion, convulsion with spasms for epidemic febrile disease.
Exocarpium Citri Grandis: cold expelling, dampness, promoting the circulation of QI, expectorant.Get sick from drinking too much wine for cough due to wind and cold, itching of the throat abundant expectoration, food stagnation, jailbird is vexed.Preventing phlegm from forming and stopping coughing, cough due to wind and cold, the primary effect of Exocarpium Citri Rubrum, no matter tremble with fear and cough or dry cough, take Exocarpium Citri Rubrum all can take effect, cough is divided into heat syndrome cough and trembles with fear coughs two kinds: heat syndrome cough is the recurrent cough caused by lung-heat, such as excessive edible food of getting angry, as food such as frying, Broiled Dishes, show as that throat is dryly itched, the few expectorant of dry cough or expectorant yellow skin matter sticky; Trembling with fear and cough, how causing by catching cold, show as itching throat and cough frequently, sputum is thin in cystose.Chronic cough, tracheitis, asthma middle-aged and elderly people all the year round chronic cough or asthma take Exocarpium Citri Rubrum for first-selected.Food stagnation is got sick from drinking too much wine, change general regulating the flow of vital energy, the good merchantable brand of the personage that smokes and drink, tobacco and wine to lung stomach liver and throat damage maximum, live in city automobile and industrial waste gas is in the majority, permanent suction excessively easily causes habitual respiratory tract infection inflammation afterwards simultaneously.Informal dress Exocarpium Citri Grandis just can alleviate ethanol and waste gas to the infringement of these human organs.Vomiting singultus, eating accumulation, the personages such as frequent dinner party dinner party answer informal dress Exocarpium Citri Grandis, and Exocarpium Citri Grandis is to the stagnant good effects that has that disappears of the intestines and stomach, and one after each meal can make alleviating in stomach and digest pressure.
Herba Taraxaci, heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation.Enter spleen, stomach, kidney three warp.Upper respiratory tract infection, eye conjunctivitis, mumps, hyperglycemia, acute mastitis swells and ache, gastritis, dysentery, hepatitis, cholecystitis, acute appendicitis, urinary system infection, pelvic inflammatory disease, carbuncle furuncle furuncle, pharyngitis, controls acute mastitis, lymphadenitis, scrofula, furuncle carbuncle toxin, acute conjunctivitis, cold, fever, acute tonsillitis, acute bronchitis, urinary tract infection.Containing multiple health-nutrition compositions such as taraxol, taraxacin, choline, organic acid, inulin in Herba Taraxaci plant, there are the effects such as diuresis, cathartic, jaundice eliminating subcutaneous ulcer, function of gallbladder promoting.Herba Taraxaci containing protein, fat, carbohydrate, trace element and vitamin etc., has abundant nutritive value simultaneously.The carotene wherein contained and C and mineral, to the effect that dyspepsia, constipation are all improved.Leaf is also improved eczema in addition, the effect of dermatitis of releiving, and root then has antiinflammation, and flower decocts into medicine juice can remove freckle.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, it comprises:
The first step, take Herba Ephedrae (processed) by weight, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Radix Scutellariae, Cortex Mori, Semen oryzae sativae, Radix Ophiopogonis, Bulbus Fritillariae Thunbergii, Fructus Trichosanthis, Radix Peucedani, Herba Houttuyniae, Pericarpium Citri Reticulatae and Indigo Naturalis, clean respectively, pulverize, mix, the determining alcohol adding mixture quality 5 ~ 10 times amount is soak 1 ~ 2 hour in the ethanol of 70% ~ 80%, heating extraction 2 times, each 1 ~ 2 hour, merge extractive liquid, 100 orders filter, be the ultrafiltration post ultrafiltration of 5000 ~ 10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 60 DEG C 1.30 ~ 1.36 extractum, stand for standby use,
Second step, take remaining crude drug by weight, clean respectively, pulverize, mix, the determining alcohol adding this step mixture quality 6 ~ 8 times amount is the ethanol water heating and refluxing extraction 1 ~ 3 time of 50% ~ 70%, the time of each extraction is 0.5 ~ 2 hour, collect extracting solution, filter, when concentrating filtrate to 60 DEG C, relative density is the concentrated solution of 1.02 ~ 1.18, upper macroporous adsorptive resins, the quality of macroporous adsorbent resin is 10 ~ 15 times of this step crude drug quality sum, with the aqueous solution of alcohol eluting that determining alcohol is 40 ~ 70%, collect eluent, when concentrating under reduced pressure relative density is 60 DEG C 1.30 ~ 1.36 extractum,
3rd step, the extractum mixing first step and second step obtained, gets 200g extractum, then adds adjuvant and make the dosage form being applicable to using clinically.
When being prepared into oral liquid, the 3rd step is specially, and the first extractum and the second extractum is mixed, gets 200g extractum, add the cane sugar powder relative to mixing extractum quality 2 ~ 4 times, mix homogeneously, is prepared into granules of sugar, dry, make 1000 altogether, splitting splendid attire, every bag of 10g.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1 oral liquid 1
Take Herba Ephedrae (processed) 30g, Radix Glycyrrhizae 20g, Rhizoma Pinelliae Preparatum 20g, Radix Scutellariae 30g, Cortex Mori 20g, Semen oryzae sativae 20g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 20g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 15g and Indigo Naturalis 10g, cleans respectively, pulverize, mix, the determining alcohol adding mixed 2.2kg is soak 2 hours in the ethanol of 80%, heating extraction 2 times, each 2 hours, merge extractive liquid, 100 orders filter, then are the ultrafiltration post ultrafiltration of 10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 60 DEG C 1.36 extractum, stand for standby use, takes Semen Armeniacae Amarum 15g, Gypsum Fibrosum 25g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Fructus Gardeniae 30g, Radix Platycodonis 15g, Fructus Perillae 15g, Cortex Lycii 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Poria 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 20g, Flos Lonicerae 35g, cleans respectively, pulverize, mix, the determining alcohol adding 2kg is the ethanol water heating and refluxing extraction 3 times of 70%, the time of each extraction is 1 hour, collect extracting solution, filter, when concentrating filtrate to 60 DEG C, relative density is the concentrated solution of 1.18, upper macroporous adsorptive resins, the quality of macroporous adsorbent resin is 3kg, is the aqueous solution of alcohol eluting of 60% with determining alcohol, collects eluent, when concentrating under reduced pressure relative density is 60 DEG C 1.35 extractum, first extractum and the second extractum are mixed, gets 200g extractum, add the cane sugar powder of 600g, mix homogeneously, be prepared into granules of sugar, dry, make 1000 altogether, splitting splendid attire, every bag of 10g.
Embodiment 2 oral liquid 2
Take Herba Ephedrae (processed) 30g, Radix Glycyrrhizae 15g, Rhizoma Pinelliae Preparatum 15g, Radix Scutellariae 30g, Cortex Mori 20g, Semen oryzae sativae 20g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 15g, Fructus Trichosanthis 15g, Radix Peucedani 10g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 10g and Indigo Naturalis 5g, cleans respectively, pulverize, mix, the determining alcohol adding mixed 2kg is soak 2 hours in the ethanol of 80%, heating extraction 2 times, each 2 hours, merge extractive liquid, 100 orders filter, then are the ultrafiltration post ultrafiltration of 10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 60 DEG C 1.36 extractum, stand for standby use, takes Semen Armeniacae Amarum 10g, Gypsum Fibrosum 25g, Caulis Bambusae In Taenia 25g, Fructus Aurantii Immaturus 15g, Fructus Gardeniae 25g, Radix Platycodonis 15g, Fructus Perillae 10g, Cortex Lycii 15g, Semen Lepidii (Semen Descurainiae) 10g, Rhizoma Phragmitis 10g, Poria 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 15g, Flos Lonicerae 20g, Exocarpium Citri Grandis 15g and Herba Taraxaci 15g, cleans respectively, pulverize, mix, the determining alcohol adding 2kg is the ethanol water heating and refluxing extraction 3 times of 70%, the time of each extraction is 1 hour, collect extracting solution, filter, when concentrating filtrate to 60 DEG C, relative density is the concentrated solution of 1.18, upper macroporous adsorptive resins, the quality of macroporous adsorbent resin is 3kg, is the aqueous solution of alcohol eluting of 60% with determining alcohol, collects eluent, when concentrating under reduced pressure relative density is 60 DEG C 1.35 extractum, first extractum and the second extractum are mixed, gets 200g extractum, add the cane sugar powder of 600g, mix homogeneously, be prepared into granules of sugar, dry, make 1000 altogether, splitting splendid attire, every bag of 10g.
Embodiment 3 oral liquid 3
Take Herba Ephedrae (processed) 35g, Radix Glycyrrhizae 20g, Rhizoma Pinelliae Preparatum 20g, Radix Scutellariae 35g, Cortex Mori 25g, Semen oryzae sativae 25g, Radix Ophiopogonis 35g, Bulbus Fritillariae Thunbergii 20g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Herba Houttuyniae 35g, Pericarpium Citri Reticulatae 15g and Indigo Naturalis 10g, cleans respectively, pulverize, mix, the determining alcohol adding mixed 2.2kg is soak 2 hours in the ethanol of 80%, heating extraction 2 times, each 2 hours, merge extractive liquid, 100 orders filter, then are the ultrafiltration post ultrafiltration of 10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 60 DEG C 1.36 extractum, stand for standby use, takes Semen Armeniacae Amarum 15g, Gypsum Fibrosum 30g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Fructus Gardeniae 30g, Radix Platycodonis 20g, Fructus Perillae 15g, Cortex Lycii 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Poria 20g, Rhizoma Cynanchi Stauntonii 20g, Radix Stemonae (processed) 20g, Flos Lonicerae 40g, cleans respectively, pulverize, mix, the determining alcohol adding 2kg is the ethanol water heating and refluxing extraction 3 times of 70%, the time of each extraction is 1 hour, collect extracting solution, filter, when concentrating filtrate to 60 DEG C, relative density is the concentrated solution of 1.18, upper macroporous adsorptive resins, the quality of macroporous adsorbent resin is 3kg, is the aqueous solution of alcohol eluting of 60% with determining alcohol, collects eluent, when concentrating under reduced pressure relative density is 60 DEG C 1.35 extractum, first extractum and the second extractum are mixed, gets 200g extractum, add the cane sugar powder of 600g, mix homogeneously, be prepared into granules of sugar, dry, make 1000 altogether, splitting splendid attire, every bag of 10g.
Embodiment 4 drug toxicology is tested
One, acute toxicity testing
After investigation mice gave Chinese medicine oral liquid of the present invention by Cmax and maximum gavage volume per os 2 times in 24 hours, the first target organs of the acute toxic reaction that animal produces and toxic reaction, for the heavy dose of medication of Clinical Acute provides safety foundation.
Laboratory animal
Strain: Kunming mouse, grade: SPF level, sex: male and female half and half, quantity: 40, body weight 18 ~ 22g.
Experimental agents
The embodiment of the present invention 1 prepare granule: specification: l0g/ bag, clinical adult (body weight is in 60kg) daily dosage: one time 1 bag, one day 3 times.Compound method: get Chinese medicinal granule 40g of the present invention, be made into 55ml solution with drinking water, be equivalent to 0.73g/ml, for subsequent use.
Animal feeding and management
Environmental condition
Experimental animal room laboratory animal barrier system, temperature 20 ~ 26 DEG C, humidity 40 ~ 70%.
Feedstuff
Mus granule word material, the two lion laboratory animal feed technology company limited in Suzhou provides.
Drinking water
Drinking water, through sterilization treatment.
Experimental technique
Preliminary experiment
To pass through Cmax 0.73g/ml and the mice maximum administration volume 40ml/kg body weight of mouse stomach pin, gavage 2 times in 24 hours, mice is without death.Due to cannot LD be measured by the restriction of administration concentration and volume 50, therefore with 0.73g/ml during formal test, gavage 2 times in 24 hours.
Formal test
Route of administration
Gavage, administration volume 40ml/kg, administration 2 times in 24 hours.
Animal divides into groups
Get the mouse weights that quarantine is qualified, be divided into 2 groups at random by body weight, every treated animal 20, male and female half and half.
Administration
Water is can't help in each Mus fasting, after 12 hours, and administration 2 times in oral liquid 1,24 hours prepared by the embodiment of the present invention 1 that administration group gives 0.73g/ml by 40ml/kg body weight gavage, then Continuous Observation 14 days.
Observation item and index
General observation of symptoms
Observed content comprises drinking-water, feed, and outward appearance sign, general behavior are movable.
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 to the 14th day, morning every day, afternoon respectively observe once.
Observed and recorded: record toxic reaction symptom occurs, increase the weight of, alleviate and time of death.
Body weight
Mouse Weight is weighed the next day of within after administration the 2nd day, rising.
Anatomic observation
Administration the 14th day, put to death and gross anatomy animal, the main organs such as the perusal heart, liver, spleen, lung, kidney are with or without pathological changes, and ill dirty device carries out pathologic finding.
Statistical method
Statistical method is t inspection.
Experimental result
General observation of symptoms result
After the oral liquid 1 of 2 the gavage embodiment of the present invention 1 preparations in 24 hours, mice drinking-water, feed, outward appearance sign, general behavior activity are all normal, observe and have no dead mouse in 14 days.
Body weight observed result
After administration, mice is movable normal.Observe in 14 days, animal has no dead, general status is good, diet, two is just normal, and outward appearance, fur, behavior, breathing are all normal, nose, eye, oral cavity secretions without exception, except after the administration of administration group male rat, the 2nd day body weight and matched group comparing difference are very significant except (P<0.01), have no other obvious abnormal response.
Anatomic observation result
Observation terminates rear execution mice, the no abnormality seens such as each main organs color and luster such as the gross anatomy perusal heart, liver, spleen, lung, kidney, shape, size.
Maximum dosage-feeding calculates
The maximum dosage-feeding of Chinese medicine oral liquid mouse stomach of the present invention administration is 58.4g/kg, this dosage is 30g conversion in clinical adult (body weight is by 60kg) daily dosage, be equivalent to 116.8 times of clinical adult's consumption, modern pharmacology is thought, zoopery administration is more than 100 times of human body dosage, and react without obvious toxic-side effects and without delayed toxicity, can think that this medicine is without obvious toxic-side effects, therefore by Chinese medicine preparation acute toxicity testing research of the present invention, its dosage is 116.8 times of human body dosage, can think that it has good safety.
Two long term toxicity test researchs of the present invention
Investigate in mice 30, continuous 2 administrations every day, after giving oral liquid 1 prepared by the embodiment of the present invention 1 by 0.7 times of Cmax and 0.49 times of per os, the first target organs of the chronic toxicity that animal produces and toxic reaction, for clinical long-term prescription provides safety foundation.
Laboratory animal:
With anxious toxicity test.
Experimental agents
The embodiment of the present invention 1 prepare granule: specification: l0g/ bag, clinical adult (body weight is in 60kg) daily dosage: one time 1 bag, one day 3 times.Compound method: get Chinese medicinal granule 40g of the present invention, be made into 55ml solution with drinking water, be equivalent to 0.365g/ml, for subsequent use.
Animal feeding and management
With anxious toxicity test.
Experimental technique
Route of administration
Gavage, administration volume 40ml/kg, daily 2 times, successive administration 30 days.
Animal divides into groups
Get the mouse weights that quarantine is qualified, be divided into 3 groups at random by body weight, every treated animal 20, male and female half and half.
Administration
Water is can't help in each Mus fasting, and administration group gives the Chinese medicine oral liquid of the present invention 1 of 0.365g/ml by 40ml/kg body weight gavage, daily 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 observation of symptoms result
After every day 2 gavage Chinese medicinal granules of the present invention, mice drinking-water, feed, outward appearance sign, general behavior activity are all normal, and Continuous Observation has no dead mouse in 30 days.
Body weight observed result
After administration, mice is movable normal.Observe in 30 days, animal has no dead, general status is good, diet, two is just normal, and outward appearance, fur, behavior, breathing are all normal, nose, eye, oral cavity secretions without exception, compare with matched group, show no obvious abnormalities reaction, no statistical difference difference (P>0.05).
Anatomic observation result
Observation terminates rear execution mice, the no abnormality seens such as each main organs color and luster such as the gross anatomy perusal heart, liver, spleen, lung, kidney, shape, size.
Maximum dosage-feeding calculates
The maximum dosage-feeding of Chinese medicine oral liquid mouse stomach of the present invention administration is 29.2g/kg, this dosage is 30g conversion in clinical adult (body weight is by 60kg) daily dosage, be equivalent to 58.4 times of clinical adult's consumption, modern pharmacology is thought, zoopery administration successive administration 30 days, animal, without obvious toxic-side effects, also without obvious cumulative toxicity, can think that it has good safety.
Embodiment 5 clinical and experimental study
Physical data
MethodsThe cases enrolled is all from Chinese medicine preparation pilot hospital of the present invention, totally 224 examples, wherein treatment group 128 example and each 96 examples of matched group, demographic data's group difference not statistically significant (P > 0.05) such as age, height, body weight, sex, nationality, occupation when entering to organize to two groups of experimenters, baseline has balanced comparability
Diagnostic criteria
Western medicine diagnose standard
Formulate with reference to national chronic bronchitis clinical speciality meeting revised standard:
(1) cough, expectoration or companion pant, annual morbidity 3 months, continuous 2 years or more persons
(2) fall ill less than 3 months every year, and have clear and definite objective determination also diagnosable according to (as x-ray, determination of respiratory function etc.) person.
TCM syndrome diagnostic criteria
Syndrome of phlegm-heat obstructing lung CM syndrome differentiation criterion is formulated with reference to " new Chinese medicine guideline of clinical investigations " 2002 (trial version)
Primary symptom: cough, expectoration is not well; Secondary disease: expectorant yellow thickness, thirst and liking drink or see heating;
Tongue pulse condition: red tongue, yellow fur, slippery and rapid pulse
Possess cough, cough up phlegm or accompany and pant, to add in disease last time any 2, in conjunction with tongue arteries and veins and diagnosable
Inclusive criteria
Meet acute episode of chronic bronchitis phase Western medicine diagnose standard and traditional Chinese medical science syndrome of phlegm-heat obstructing lung CM syndrome differentiation criterion; 18 ~ 65 years old age; These course of disease≤3 day of showing effect. symptom score >=8 point, leukocyte≤11.0 × 109/L, the patient of neutrophilic granulocyte ratio≤80% can include in
Exclusion standard
(1) turn out to be chronic cough that the factors such as pulmonary tuberculosis, fungus, tumor, pneumosilicosis, irritative gas be irritated cause on inspection to pant patient
(2) body temperature > 38.5 DEG C;
(3) the severe primary disease such as heart disease, hypertension and other 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
Therapeutic Method
Selected patients is divided into treatment group and matched group at random, and treatment group takes the embodiment of the present invention 1 Chinese medicinal granule 1,10g, and 2 times on the one, boiled water is taken after mixing it with water;
Matched group takes 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 produces, the accurate word of traditional Chinese medicines: Z10970027) 4g, and 2 times on the one, boiled water is taken after mixing it with water;
10 days courses for the treatment of, observe 3 courses for the treatment of altogether.
Observation index
It is curative effect index that Syndrome in TCM marquis integration improves situation
Curative effect determinate standard
Demonstrate,prove marquis's curative effect determinate standard with reference to " new Chinese medicine guideline of clinical investigations " to formulate
Efficacy determination value=(before (before treatment the rear total mark of total mark-treatment)/treatment total mark) × l00%
Tcm syndrome efficacy assessment standard
(1) clinic control: clinical symptoms, sign disappear or substantially disappear, syndrome integral reduces >=95%;
(2) effective: clinical symptoms, sign are obviously improved, syndrome integral reduces >=70%;
(3) effective: clinical symptoms, sign all take a favorable turn, syndrome integral reduces >=30%;
(4) invalid: clinical symptoms, sign are not improved, syndrome integral reduces less than 30%
Statistical procedures
Adopt SPSS15.0 software to carry out statistical analysis, all statistical test all adopt T to check, and P<0.05 is considered to checked difference 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 Effective percentage %
Matched group 94 15 45 23 11 88.30
Treatment group 128 38 58 24 8 93.75
Note: between cure rate two groups, comparing difference has statistical significance (P<0.05)
Table 2 pant curative effect multicenter analyze (FAS)
Group N Recovery from illness Effective Effectively Invalid Effective percentage %
Matched group 94 16 45 28 14 85.11
Treatment group 128 42 61 19 6 95.31
Note: between cure rate two groups, 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 Effective percentage %
Matched group 94 19 52 19 4 95.74
Treatment group 128 55 57 14 2 98.44
Note: between cure rate two groups, comparing difference has statistical significance (P<0.05)
Table 4 tcm syndrome efficacy analysis (FAS)
Group N Recovery from illness Effective Effectively Invalid Effective percentage %
Matched group 94 14 37 31 11 88.30
Treatment group 128 50 60 13 5 96.09
Note: between cure rate, obvious effective rate two groups, comparing difference has statistical significance (P<0.05)
3 discuss
Syndrome of phlegm-heat obstructing lung is common urgency card fever caused by exogenous pathogenic factors, the four seasons all can occur, especially multiple with winter and spring, and main manifestations cough, expectoration, expectorant Huang are measured many, red tongue, yellow and thin fur or yellow greasyly wait actute infection symptom, the factors such as this disease and antibacterial, viral infection and autoimmune are relevant, according to differentiation of tcm viewpoint, the main method for the treatment of of treatment syndrome of phlegm-heat obstructing lung is removing heat-phlegm, therapeutic method to keep the adverse QI flowing downwards cough-relieving, control from basic overall conditioning, effect is rather good.Treatment syndrome of phlegm-heat obstructing lung clinical with heat clearing away, eliminate the phlegm, cough-relieving, relieving asthma for method for the treatment of, Chinese medicine preparation of the present invention is made up of pure natural medical, there is effect of reducing heat and dispersing lung-QI, preventing phlegm from forming and stopping coughing, its Chinese medicinal components contains antibacterial active ingredient, In vitro Bactericidal Experiments result shows, this product truly has antibacterial action to the common pathogenic bacteria of upper respiratory tract.Pharmacological research confirms: this medicine can dilute sputum, promotes the motion of respiratory mucosa epithelial cell cilium, makes expectorant be easy to expectoration; Can cough latent period be extended, reduce cough number of times; There are stronger antiinflammatory, antibacterial, reduction airway hyperreactivity effect; Strengthen immunoloregulation function in addition.Syndrome of phlegm-heat obstructing lung is respiratory system commonly encountered diseases, treatment and to alleviate syndrome of phlegm-heat obstructing lung symptom significant to raising quality of life of patients.Chinese medicine preparation of the present invention its to eliminating phlegm and stopping cough curative effect through clinical verification for many years and prove from test this medicine have better antibacterial, antitussive, relieving asthma, resolve phlegm effect.
This test carries 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 test shows Chinese medicine preparation of the present invention all has certain therapeutical effect to the cardinal symptom of syndrome of phlegm-heat obstructing lung.It is 93.75% to the effective percentage of cough symptom, and being 95.31% to the effective percentage of wheezing symptoms, is 98.44% to expectoration symptom effective percentage, is 96.09% to the effective percentage of traditional Chinese medical science therapeutic effect of syndrome.Chinese medicine preparation treatment syndrome of phlegm-heat obstructing lung cough-relieving curative effect of the present invention and tcm syndrome curative effect are better than the sudden and violent red cough-stopping granule group of a kind of reed mentioned in ancient books.Therefore, in syndrome of phlegm-heat obstructing lung clinical treatment, Chinese medicine preparation of the present invention has good potential applicability in clinical practice.
Embodiment 6 pharmacodynamic experiment is studied
Experiment purpose
Granule 1 prepared by the embodiment of the present invention 1 has effect of removing heat from the lung and dissipating phlegm, relieving cough and asthma, clinical in the cough caused by phlegm-heat accumulated in the lung, expectorant Huang, dyspnea with fullness of the chest person.The technical requirement about pharmacodynamic study is registered according to new Chinese medicine, in conjunction with this product prescription feature, from experimental viewpoint study Chinese medicinal granule of the present invention cough-relieving, relieving asthma, the pharmacological action such as to reduce phlegm, preliminary assessment is used as, for clinical research provides laboratory reference to the Pharmacodynamics of granule 1 of the present invention.
Material and method
Laboratory animal
KM mice, SPF level, body weight 18 ~ 22g, male and female half and half.
Cavia porcellus: regular grade, body weight 150 ~ 250g, male and female are not limit.
Experimental agents and reagent
Chinese medicine granules 1:l0g/ bag prepared by the embodiment of the present invention 1, clinical Coming-of-Age Day dosage: one time 1 bag, one day 3 times, (adult's body weight is in 60kg).
Compound codeine phosphate oral administration solution: produced by Hong Kong Australia pharmaceutical factory made in U.S.A, specification: every 5ml contains brompheniramine maleate 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 tablets: Kunming Medicine Group Stock Co., Ltd produces, specification: 0.1g/ sheet, lot number: 141010-03
Ammonia: analytical pure, Chuanjiang River, Chongqing chemical reagent factory is produced, specification: 500ml, content (NH 3) % is 25 ~ 28, lot number: 20141113
Phenol red: analytical pure, Shanghai reagent three factory belonging to Solution on Chemical Reagents in Shanghai head factory produces, specification: 25g, lot number: 141212
Citric acid: analytical pure, Tianjin Feng Chuan chemical reagent Science and Technology Ltd. (former Tianjin chemical reagent three factory) produces, 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 detector, L`V-190 Japan Shimadzu is produced
Experimental situation
Mouse species feeding environment condition
Experimental animal room laboratory animal barrier system, temperature 20 ~ 26 DEG C, humidity 40 ~ 70%.
Feedstuff
Mus granule word material, the two lion laboratory animal feed technology company limited in Suzhou provides.
Drinking-water
Drinking water meets the requirement of GB5749, through sterilization treatment.
Cavia porcellus feeding environment condition
Experimental animal room laboratory animal barrier system, temperature 20 ~ 26 DEG C, humidity 40 ~ 70%.
Experimental technique
On the impact of ammonia induced mice cough latent period and number of times
Get KM mice 64, male and female half and half, body weight 18 ~ 22g, be divided into negative control group, positive drug 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) at random, totally 4 groups, often organize 16.Chinese medicinal granule high and low dose of the present invention is equivalent to 3.12 times, 1.56 times of clinical equivalent amount respectively.Test each group of mice respectively by 20ml/kg body weight gastric infusion, the distilled water of the capacity such as negative control group gavage, every day 1 time, for three days on end, terminate rear 1h in last administration, mice is put into YLS-8A multi-functional lure to cough to draw breathe heavily instrument animal activity case, one time 1, spray into the strong aqua ammonia of about 15%, spray time is 4s, the cough latent period (from spraying into the time of ammonia to mice first time cough) of observed and recorded mice and 4min interior cough number of times.Carry out statistical procedures with t inspection, compare 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 Cavia porcellus is selected in advance, Cavia porcellus is put into YLS-8A multi-functional lure to cough to draw breathe heavily instrument animal activity case, start nebulizer 60s, the cough latent period of observing in Cavia porcellus 5min (is injected 35% citric acid to start, it is incubation period that cough required time extremely occurs) and cough number of times, the Cavia porcellus reaching more than 10 times with number of times of coughing in 5min is qualified Cavia porcellus, alternate tests.By qualified Cavia porcellus random packet, be respectively negative control group, positive controls (ig compound codeine phosphate oral administration solution 12ml/kg), Chinese medicinal granule high dose group of the present invention (7.0g/kg), low dose group (3.5g/kg), totally 4 groups, often organize 10.Chinese medicinal granule high and low dose of the present invention is equivalent to 2.58 times, 1.29 times of clinical equivalent amount respectively.Test each group of Cavia porcellus respectively by 20ml/kg body weight gastric infusion, the distilled water of the capacity such as negative control group gavage, every day 1 time, for three days on end, 1h after last administration, observes animal cough latent period and cough number of times by prescreening method.Carry out statistical procedures with t inspection, compare diversity 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 in the cattle container of instrument, spray into 0.2% histamine phosphate 20s.Observe asthmatic latent period (namely from spraying to the time occurring asthma, dyspnea and tic).Exceed 120s person, will not select.By qualified Cavia porcellus random packet, be respectively negative control group, positive controls (aminophylline 0.1g/kg), Chinese medicinal granule high dose group of the present invention (7.0g/kg), low dose group (3.5g/kg), totally 4 groups, often organize 10.Chinese medicinal granule high and low dose of the present invention is equivalent to 2.58 times, 1.29 times of clinical equivalent amount respectively.Test each group of Cavia porcellus respectively by 20ml/kg body weight gastric infusion, the distilled water of the capacity such as negative control group gavage, every day 1 time, for three days on end, 1h after last administration, measures asthmatic latent period (more than 6min person in 6min) again by prescreening method.
On the impact of mice trachea section phenol red output
Get KM mice 80, male and female half and half, body weight 22 ~ 25g, is divided into negative control group, positive drug control group (ammonium chloride 1.0g/kg), Chinese medicinal granule high dose group of the present invention (14.2g/kg), low dose group (7.1g/kg) at random, totally 4 groups, often organize 16.Chinese medicinal granule high and low dose of the present invention is equivalent to 3.12 times, 1.56 times of clinical equivalent amount respectively.Each group of mice gastric infusion respectively, the distilled water of the capacity such as negative control group gavage, every day 1 time, for three days on end, 1h after last administration, the phenol red normal saline solution 500mg/kg of lumbar injection 5%, 30min after injection, put to death animal, fixing Mus body, is separated trachea, it is put into and 2ml normal saline is housed in vitro, after vibration 30min, add 1mol/LNaOH0.2mL, with spectrophotometer colorimetric under wavelength 546nm condition, according to phenol red standard curve, calculate phenol red output, carry out statistical procedures with t inspection, compare the significance degree of group difference.
Statistical procedures
Adopt SPSS15.0 software to carry out statistical analysis, experimental data adopts represent, all statistical test all adopt T to check, and P<0.05 is considered to checked difference statistical significance.
Experimental result
On the impact of ammonia induced mice cough latent period and number of times
Compare with negative control group, Chinese medicinal granule high dose group of the present invention can extend the mouse cough incubation period (P<0.01) that ammonia causes, Chinese medicinal granule high dose group of the present invention all can reduce the number of times (P<0.01) of cough, compare with negative control group, Chinese medicinal granule low dose group of the present invention can extend the mouse cough incubation period (P<0.05) that ammonia causes, Chinese medicinal granule low dose group of the present invention all can reduce the number of times (P<0.05) of cough, dose-effect relationship is had to the antitussive action of the mouse cough that ammonia causes.And positive control drug compound codeine phosphate oral administration solution obviously can extend the mouse cough incubation period that ammonia causes and the number of times (P<0.01) reducing cough.
Table 5 Chinese medicinal granule of the present invention is on the impact of ammonia induced mice cough latent period and number of times
Group Dosage N Cough latent period (s) Cough number of times
Negative control group Equal-volume solvent 16 36.3±36.9 9.6±3.4
Positive controls 15ml/kg 16 102.4±79.6 ** 4.9±4.1 *
High dose group 14.2ml/kg 16 119.2±81.8 ** 3.2±3.1 **
Low dose group 7.1ml/kg 16 92.3±87.5 * 5.3±4.9 *
Note: compared with negative control group, *p<0.05, *p<0.01.
The acid of structure rafter is caused to the impact of guinea pig cough's incubation period and cough number of times
Compare with negative control group, Chinese medicinal granule high and low dose group of the present invention all significantly can reduce the number of times (P<0.05) of guinea pig cough caused by citric acid, and to a certain degree extends cough latent period.And positive control drug compound codeine phosphate oral administration solution obviously can reduce the number of times (P<0.01) of cough.The results are shown in Table 6.
Table 6 Chinese medicinal granule of the present invention is on the impact of guinea pig cough's incubation period caused by 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: compared with negative control group, *p<0.05, *p<0.01.
Histamine phosphate is caused to the impact of Experimental Asthma In Guinea-pigs
Compare with negative control group, Chinese medicinal granule high dose group of the present invention and positive control drug aminophylline significantly all can extend Experimental Asthma In Guinea-pigs incubation period (P<0.01) caused by histamine phosphate.And Cavia porcellus heavy breathing end incubation period (P<0.05) caused by low dose group energy significant prolongation histamine phosphate.The results are shown in Table 7.
Table 7 Chinese medicinal granule of the present invention is on the impact of Experimental Asthma In Guinea-pigs asthmatic latent period caused by 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: compared with negative control group, *p<0.05, *p<0.01.
4. on the impact of mice trachea section phenol red output
Compare with negative control group, Chinese medicinal granule high and low dose group of the present invention all significantly can strengthen the phenol red effect of trachea excretion (P<0.05).And positive control drug ammonium chloride can strengthen the phenol red effect of trachea excretion (P<0.05).The results are shown in Table 8.
Table 8 Chinese medicinal granule of the present invention is on the impact of mice trachea section phenols contents
Group Dosage N Trachea phenols contents (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: compared with negative control group, *p<0.05.
Conclusion
Chinese medicine preparation of the present invention studies confirmation by experiment, the cough caused for different excitaton source all has good mitigation, experiment for PSP effect also confirms to have good effect, its effect of overall merit, can be good at cough-relieving for during Chinese medicine preparation Clinical practice of the present invention, relievings asthma, expectoration mechanism of action provides experimental basis.
All above-mentioned this intellectual properties of primary enforcement, not setting restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (6)

1. treat the Chinese medicine preparation of chronic cough for one kind, it is characterized in that: the weight of crude drug is respectively Herba Ephedrae (processed) 25g ~ 40g, Semen Armeniacae Amarum 10g ~ 20g, Gypsum Fibrosum 20g ~ 30g, Radix Glycyrrhizae 15g ~ 25g, Caulis Bambusae In Taenia 20g ~ 40g, Fructus Aurantii Immaturus 10g ~ 25g, Rhizoma Pinelliae Preparatum 15g ~ 25g, Fructus Gardeniae 20g ~ 40g, Radix Scutellariae 25g ~ 40g, Radix Platycodonis 10g ~ 20g, Fructus Perillae 10g ~ 20g, Cortex Mori 15g ~ 25g, Cortex Lycii 15g ~ 20g, Semen oryzae sativae 20g ~ 25g, Semen Lepidii (Semen Descurainiae) 10g ~ 20g, Rhizoma Phragmitis 10g ~ 20g, Radix Ophiopogonis 25g ~ 35g, Bulbus Fritillariae Thunbergii 15g ~ 25g, Poria 10g ~ 20g, Fructus Trichosanthis 15g ~ 25g, Radix Peucedani 10g ~ 20g, Rhizoma Cynanchi Stauntonii 10g ~ 20g, Radix Stemonae (processed) 15g ~ 25g, Herba Houttuyniae 25g ~ 35g, Pericarpium Citri Reticulatae 10g ~ 20g, Flos Lonicerae 30g ~ 40g and Indigo Naturalis 5g ~ 10g.
2. Chinese medicine preparation as claimed in claim 1, is characterized in that: also can add Exocarpium Citri Grandis 10g ~ 20g and Herba Taraxaci 10g ~ 20g in crude drug.
3. Chinese medicine preparation as described in claim 1 to 2, is characterized in that: the weight of each crude drug is respectively Herba Ephedrae (processed) 30g, Semen Armeniacae Amarum 15g, Gypsum Fibrosum 25g, Radix Glycyrrhizae 20g, Caulis Bambusae In Taenia 30g, Fructus Aurantii Immaturus 20g, Rhizoma Pinelliae Preparatum 20g, Fructus Gardeniae 30g, Radix Scutellariae 30g, Radix Platycodonis 15g, Fructus Perillae 15g, Cortex Mori 20g, Cortex Lycii 20g, Semen oryzae sativae 20g, Semen Lepidii (Semen Descurainiae) 15g, Rhizoma Phragmitis 15g, Radix Ophiopogonis 30g, Bulbus Fritillariae Thunbergii 20g, Poria 15g, Fructus Trichosanthis 20g, Radix Peucedani 15g, Rhizoma Cynanchi Stauntonii 15g, Radix Stemonae (processed) 20g, Herba Houttuyniae 30g, Pericarpium Citri Reticulatae 15g, Flos Lonicerae 35g and Indigo Naturalis 10g.
4. Chinese medicine preparation as described in claims 1 to 3, is characterized in that: described Chinese medicine preparation is in traditional Chinese medicine extraction component, add the oral formulations that the acceptable adjuvant of pharmacy is prepared from.
5. Chinese medicine preparation as described in Claims 1-4, is characterized in that: described oral formulations comprises decoct, tablet, capsule, granule, oral liquid, powder, powder.
6. the preparation method of Chinese medicine preparation described in claim 1 to 5, is characterized in that, concrete steps are as follows:
The first step, take Herba Ephedrae (processed), Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Radix Scutellariae, Cortex Mori, Semen oryzae sativae, Radix Ophiopogonis, Bulbus Fritillariae Thunbergii, Fructus Trichosanthis, Radix Peucedani, Herba Houttuyniae, Pericarpium Citri Reticulatae and Indigo Naturalis, clean respectively, pulverize, mix, the determining alcohol adding mixture quality 5 ~ 10 times amount is soak 1 ~ 2 hour in the ethanol of 70% ~ 80%, heating extraction 2 times, each 1 ~ 2 hour, merge extractive liquid, 100 orders filter, be the ultrafiltration post ultrafiltration of 5000 ~ 10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 60 DEG C 1.30 ~ 1.36 extractum, stand for standby use;
Second step, take remaining crude drug by weight, clean respectively, pulverize, mix, the determining alcohol adding this step mixture quality 6 ~ 8 times amount is the ethanol water heating and refluxing extraction 1 ~ 3 time of 50% ~ 70%, the time of each extraction is 0.5 ~ 2 hour, collect extracting solution, filter, when concentrating filtrate to 60 DEG C, relative density is the concentrated solution of 1.02 ~ 1.18, upper macroporous adsorptive resins, the quality of macroporous adsorbent resin is 10 ~ 15 times of this step crude drug quality sum, with the aqueous solution of alcohol eluting that determining alcohol is 40 ~ 70%, collect eluent, when concentrating under reduced pressure relative density is 60 DEG C 1.30 ~ 1.36 extractum,
3rd step, the extractum mixing first step and second step obtained, gets 200g extractum, then adds adjuvant and make the dosage form being applicable to using clinically.
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CN105998374A (en) * 2016-08-11 2016-10-12 华梅 Traditional Chinese medicine composition for treating infantile cough asthma and preparation method thereof
CN105998984A (en) * 2016-08-01 2016-10-12 毛德西 Traditional Chinese medicine for treating children with lung heat type cough and asthma
CN107456535A (en) * 2017-07-25 2017-12-12 黄煜阶 A kind of cough relief traditional Chinese medicine decoction and preparation method thereof
CN108014264A (en) * 2017-12-29 2018-05-11 缪荣明 It is a kind of to be used to treat oral traditional Chinese medicine preparation of silicosis and preparation method thereof

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CN105998984A (en) * 2016-08-01 2016-10-12 毛德西 Traditional Chinese medicine for treating children with lung heat type cough and asthma
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CN107456535A (en) * 2017-07-25 2017-12-12 黄煜阶 A kind of cough relief traditional Chinese medicine decoction and preparation method thereof
CN108014264A (en) * 2017-12-29 2018-05-11 缪荣明 It is a kind of to be used to treat oral traditional Chinese medicine preparation of silicosis and preparation method thereof

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Application publication date: 20160504