CN102293883B - Chinese medicinal composition for treating child acute upper respiratory tract infection, and preparation method and application thereof - Google Patents
Chinese medicinal composition for treating child acute upper respiratory tract infection, and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicinal composition for treating child acute upper respiratory tract infection. The Chinese medicinal composition consists of the following medicines in part by weight: 10 to 90 parts of patchouli, 30 to 130 parts of indigowoad leaf, 30 to 130 parts of fermented soybean, 30 to 130 parts of officinal magnolia bark, 30 to 130 parts of pachyrhizua angulatus, 10 to 90 parts of Chinese mosla herb, 100 to 220 parts of gypsum, 5 to 50 parts of coptis chinensis, 30 to 130 parts of scutellaria baicalensis, 10 to 110 parts of talcpowder, 5 to 50 parts of liquorice, 30 to 130 parts of honeysuckle, 10 to 90 parts of processed rhizoma pinelliae, and pharmaceutical excipients. The invention also provides a preparation method for the Chinese medicinal composition for treating child acute upper respiratory tract infection. The invention has the advantages that: the Chinese medicinal composition overcomes the defects of conventional formulations such as decoction and the like; by an alcohol extraction method, fat soluble active ingredients which have clinical effects in the composition are kept; and by efficient, and dynamic circulatory extraction equipment, the active ingredients are extracted to the maximum extent, and the clinical effects are guaranteed, and the Chinese medicinal composition has a solid clinical basis and good clinical effects.
Description
Technical field
The invention belongs to Chinese medicine preparation, particularly relate to a kind of child acute upper respiratory tract infection heat-damp in summer hold concurrently Chinese medicine composition and preparation method thereof and application of cold syndrome of being used for the treatment of.
Background technology
For the hold concurrently Chinese medicine composition of cold syndrome of acute upper respiratory tract infection heat-damp in summer, for infectious diseases such as control ARTIs and influenza A H1N1, hand-foot-mouth disease, be significant.
Acute respiratory infection (acute respiratory tract infections, ARTIs) be still in so far the first place of the medical number of Pediatric Clinic, be in hospital number and disease death number, the infectious disease of China children's first place, be also that antibiotic frequency of utilization is the highest, accumulative total consumption at most, use lack of standardization and owe rational disease.World Health Organization (WHO) (WHO) announces the assessment report of 2000～2003 annual death of child causes of disease: the whole world year dead child 1,0600000, wherein 73% of 5 years old following children disease death toll owing to 6 kinds of diseases, are pneumonia (19%), diarrhoea (18%), pneumonia of newborn and pyemia (10%), premature labor (10%), malaria (8%) and perinatal asphyxia (8%) successively.All, below 5 years old in dead child, 53% child's the potential cause of the death is malnutrition.China's infantile pneumonia disease death number accounts for the whole world 7%, but due to populous, dead absolute number has accounted for West Pacific region 2/3, and 75% be infant in pneumonia death, 85% occurs in rural area and outlying district, this warns us: reduce child mortality, and control ARTIs, especially pneumonia is very crucial.
At present, the Chinese medicine patent medicine of the treatment child ARTIs having gone on the market is a lot of with veriety, but be mostly for four seasons common cold, establish, for the summertime, the active drug of flu still belongs to blank field, and this Chinese medicine composition is for selecting summertime flu (heating and/or diarrhoea) as point of penetration.
Meanwhile, breaking out of the popular and bird flu of SARS, has caused serious threat to the mankind's health and life.New, the burst infectious disease that influenza A H1N1, hand-foot-mouth disease etc. are representative of take causes serious threat to public health; Research and the diagnosis and treatment of febrile disease are more and more taken seriously.This Chinese medicine composition is for exploitation active drug, and the diseases such as respiratory tract infection that treatment betides heat-damp in summer season in summertime provide the Chinese medicine preparation of determined curative effect to have important practical significance.
Chinese medicine has unique technology means and the advantage that is different from modern medicine in viral disease control, has demonstrated effect clear and definite, that obtain international endorsement in recent years in great new, burst Prevention of Infectious Diseases work.
The investigation of WHO points out, the ineffective speed of medicine is substantially similar with the speed of discovery new drug at present; Virus is the arch-criminal of many ARTIs, and antibiotic is invalid to it; The means of prevention of modern medicine, as vaccine injection, viral allopathy, owing to being subject to, virus makes a variation fast, the generation of drug resistance is restricted effect.Chinese medicine has clear and definite advantage in treatment viral disease, and anti virus herb, except direct kill virus, inhibition virus replication, can also effectively stop viral infection, and energy two-ways regulation human immune system, by immunocyte, identifies and phagocytic virus; Some Chinese medicines have antivirus action more widely, can suppress multiple virus.In this case, the unique effect of performance Chinese medicine seems particularly important.Along with the acceleration of burst epidemic disease and virus variation, it is more and more obvious that Chinese medicine employing determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs method is intervened its advantage.
The acute upper respiratory tract infection heat-damp in summer cold syndrome of holding concurrently, summer-heat diseases caused by exogenous pathogenic factor, are under the jurisdiction of ARTIs category, and its etiology and pathogenesis is that diseases caused by exogenous pathogenic factor wind heat-damp in summer is evil, and visitor defends in lung, defends table and loses due to a surname.This type of infant clinical manifestation except heating, the most and disease of being seen in the tired strongly fragrant gastrointestinal of heat-damp in summer such as sleepy in nausea and vomiting, indigestion and loss of appetite, diarrhoea, health.
GEGEN QINLIAN TANG comes from Zhang Zhongjing < < Treatise on Febrile Diseases > >, by Radix Puerariae, and Rhizoma Coptidis, Radix Scutellariae, Radix Glycyrrhizae Preparata forms, and cures mainly exterior syndrome and does not separate, pathogenic heat enter interior syndrome, disease is seen fever of the body, and diarrhea is smelly dirty, breast gastral cavity dysphoria with smothery sensation, xerostomia is done thirsty, dyspnea and sweating, red tongue with yellow fur, rapid pulse or short.The leaves of pulse plants connects soup and comes from < < A complete work on Pediatrics, a collection and arrangement of the chief contents from ancient pediatrics, written by Chen Fuzheng > >, by just refined company, Cortex Magnoliae Officinalis(processed with ginger), Radix agastaches, Rhizoma Zingiberis Recens, Fructus Jujubae forms, and cures mainly vomiting due to heat in children more than, disease is seen flushed face and red lips, tell that time to go out less thing many, newborn sheet disappears, yellow skin, fever with irritability all over, common this card of Xia Yue.Newly add Xiangru Xin and come from < < Wenbing Tiaobian, Detailed Analysis of Epidemic Warm Diseases > >, by Herba Moslae, Flos Lonicerae, fresh haricot flower, Cortex Magnoliae Officinalis, Fructus Forsythiae forms, and cures mainly fever disease in summer from the beginning of multiple sense wind and cold, disease is seen fever with aversion to cold, lossless, vexed and red, thirsty, tongue is white, the right anti-little person in a loud left side of arteries and veins.
In recent years, the research of the traditional Chinese medical science to primary disease, is obtaining considerable progress aspect etiology and pathogenesis, diagnosis and treatment rule, medicine and zoopery.At present, the Chinese medicine patent medicine of the treatment child ARTIs having gone on the market is a lot of with veriety, but be mostly for four seasons common cold, establishes, and for the summertime, the active drug of flu still belongs to blank field.Meanwhile, breaking out of the popular and bird flu of SARS, has caused serious threat to the mankind's health and life.New, the burst infectious disease that influenza A H1N1, hand-foot-mouth disease etc. are representative of take causes serious threat to public health; Research and the diagnosis and treatment of febrile disease are more and more taken seriously.The peaceful mixture of this Chinese medicine composition summer-heat betides the diseases such as respiratory tract infection in heat-damp in summer season in summertime for providing the special Chinese medicine preparation of catching a cold for children's's summertime of determined curative effect to have important practical significance as special for treating.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition for the treatment of child acute upper respiratory tract infection and preparation method thereof and application, said composition is the Chinese medicine composition of clinical prevention and treatment child acute upper respiratory tract infection, this preparation method has overcome the drawback of the conventional dosage forms such as decoction, to improving child acute upper respiratory tract infection patient's clinical symptoms, be beneficial to reduce child's mortality rate.
For achieving the above object, the technical solution used in the present invention is to provide a kind of Chinese medicine composition that is used for the treatment of child acute upper respiratory tract infection, wherein: by following flavour of a drug, formed by weight:
Herba Pogostemonis 10-90, Folium Isatidis 30-130, Semen Sojae Preparatum 30-130, Cortex Magnoliae Officinalis 30-130, Pachyrhizua angulatus 30-130, Herba Moslae 10-90, Gypsum Fibrosum 100-220, Rhizoma Coptidis 5-50, Radix Scutellariae 30-130, Pulvis Talci 10-110, Radix Glycyrrhizae 5-50, Flos Lonicerae 30-130, Rhizoma Pinelliae Preparata 10-90, also have pharmaceutic adjuvant.
A kind of preparation method for the treatment of the Chinese medicine composition of child acute upper respiratory tract infection is provided, is used for the treatment of child acute upper respiratory tract infection.
Effect of the present invention is the drawback that this Chinese medicine composition has overcome the conventional dosage forms such as decoction, adopt the method for alcohol extraction, retained the fat-soluble effective ingredient that waits in compositions with clinical efficacy, adopt high-efficiency dynamic circulating extraction device, extract to greatest extent effective ingredient, guarantee its clinical efficacy, there is sturdy Clinical Basis and good clinical efficacy.Said composition is mainly for children's's summertime catch a cold (heating and/or diarrhoea), propose " removing gastrointestinal damp and hot " method for the treatment of, connect Tang Jixin add Xiangru Xin tripartiteization and cut out and form with GEGEN QINLIAN TANG, the leaves of pulse plants, its compatibility is reasonable, prescription is rigorous, have clearing away summer-heat and expel the heat-evil, the effect that dampness removingization is turbid, for wean hotness diseases caused by exogenous pathogenic factor, fever with chills, limb acid pharyngeal swelling, dizzy heavy, distending pain, the disease such as vomits, have loose bowels.Through rather being treated to children's's summertime cold, fever 169 routine clinical observation result, summer-heat shows, its cure-remarkable-effectiveness rate reaches 80.47%, the improvement of the symptoms such as infant heating, pharynx are red and swollen, diarrhoea, dizzy, sleepy weak, nausea and vomiting is all obviously better than contrasting medicine XIAOER JIERE WAN, determined curative effect, and safe without toxic side effect.
This Chinese medicine composition is obviously better than similar drugs to the hold concurrently preventive and therapeutic action of cold syndrome of child acute upper respiratory tract infection heat-damp in summer.
The specific embodiment
Chinese medicine composition for the treatment of child acute upper respiratory tract infection of the present invention and preparation method thereof and application are described in detail in conjunction with the embodiments.
The mechanism that preclinical pharmacodynamics of San experimentation has disclosed this Chinese medicine composition prevention and treatment child acute upper respiratory tract infection is: Chinese medicine composition extractum prevention administration, treatment administration cause to bacterial endotoxin that family exempts from heating, yeast causes rat fever obvious cooling effect; Gastric infusion, can obviously alleviate that mice caused by dimethylbenzene xylene ear is swollen, carrageenin causes rat paw edema obvious detumescence effect; Gastric infusion,, intestinal propulsion emptying to Mouse Stomach, gut hormone have good regulating action; Chinese medicine composition extractum gastric infusion can significantly be alleviated the symptoms of emesis that cisplatin causes pigeon vomiting; Chinese medicine composition extractum repeatedly gastric infusion has obvious facilitation to rat paw sweat gland secretion; This Chinese medicine composition extractum repeatedly gastric infusion also there is significance effect antiviral, the aspect such as antibacterial in vivo.
The present invention is according to traditional Chinese medical science traditional theory, dissects the child acute upper respiratory tract infection heat-damp in summer symptom of cold syndrome of holding concurrently: this type of infant clinical manifestation except heating, the most and disease of being seen in the tired strongly fragrant gastrointestinal of heat-damp in summer such as sleepy in nausea and vomiting, indigestion and loss of appetite, diarrhoea, health.The etiology and pathogenesis of confirming child acute upper respiratory tract infection is that diseases caused by exogenous pathogenic factor wind heat-damp in summer is evil, and visitor defends in lung, defends table and loses due to a surname.Accordingly according to the pathogenic feature of primary disease, establish clearing away summer-heat and expel the heat-evil, the principle for the treatment of that dampness removingization is turbid, take the GEGEN QINLIAN TANG of Zhang Zhongjing, the leaves of pulse plants of Chen Feixia connect soup and Wu Jutong newly add Xiangru Xin as square foundation, in conjunction with clinical experience addition or subtraction of changes, form this Chinese medicine composition.This product, according to the hold concurrently pathogenic characteristic of cold syndrome of current clinical common child acute upper respiratory tract infection heat-damp in summer, be take diseases caused by exogenous pathogenic factor as main, taking into account the disease of wet tired gastrointestinal.With tripartiteization, cut out, catch a cold (heating and/or diarrhoea) mainly for children's's summertime, proposition " removing gastrointestinal is damp and hot " method for the treatment of, with GEGEN QINLIAN TANG, the leaves of pulse plants, connecting Tang Jixin adds Xiangru Xin tripartiteization and cuts out and to form, its compatibility is reasonable, and prescription is rigorous, has clearing away summer-heat and expels the heat-evil, the effect that dampness removingization is turbid, for wean hotness diseases caused by exogenous pathogenic factor, fever with chills, limb acid pharyngeal swelling, dizzy heavy, distending pain, the disease such as vomit, have loose bowels.
Chinese medicine composition of the present invention is comprised of Herba Pogostemonis, Folium Isatidis, Semen Sojae Preparatum, Cortex Magnoliae Officinalis, Pachyrhizua angulatus, Herba Moslae, Gypsum Fibrosum, Rhizoma Coptidis, Radix Scutellariae, Pulvis Talci, Radix Glycyrrhizae, Flos Lonicerae, Rhizoma Pinelliae Preparata.
Herba Pogostemonis dispelling exopathogens from superficies of the body in this Chinese medicine composition, removing dampness by means of aromatics, and middle preventing or arresting vomiting, be monarch drug;
Folium Isatidis, Flos Lonicerae, Gypsum Fibrosum removing summer-heat, resolving toxin and disinhibiting the throat pain relieving, Semen Sojae Preparatum a surname expelling pathogenic factors from the exterior is evil, Herba Moslae diaphoresis, removing toxic substances removing dampness, LIUYI SAN clearing away summer-heat and eliminating dampness, principal drug assistance clearing away summer-heat expels the heat-evil, and is ministerial drug altogether;
Rhizoma Pinelliae dampness sending down the abnormal ascending QI, stomach function regulating preventing or arresting vomiting, Cortex Magnoliae Officinalis circulation of qi promoting removing dampness, the chest stuffiness relieving is except full, and Radix Puerariae both can relieving muscles diaphoresis, and antipyretic promoting the production of body fluid, can rise again the gas of sending out the clear sun of taste, and Radix Scutellariae, Rhizoma Coptidis heat clearing and damp drying, be adjuvant drug altogether;
Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, priming is returned through for making medicine.
Full side 13 tastes, though Herba Pogostemonis is monarch drug, still consider children's's feature, and consumption is smart and little; Minister, the large principal drug assistance clearing away summer-heat of adjuvant drug consumption expel the heat-evil, circulation of qi promoting removing dampness; Full side's compatibility is rigorous, and cautiously grasping pathogenesis is played altogether clearing away summer-heat and expelled the heat-evil, the merit that dampness removingization is turbid.
This Chinese medicine composition function: clearing away summer-heat expels the heat-evil, and dampness removingization is turbid.
Cure mainly: the child acute upper respiratory tract infection heat-damp in summer cold syndrome of holding concurrently.Disease is seen fever with chills, limb acid pharyngeal swelling, dizzy heavy, distending pain, the diseases such as vomiting diarrhea.
Chinese medicine composition of the present invention includes following one-tenth and is grouped into:
By following flavour of a drug, formed by weight:
Herba Pogostemonis 10-90, Folium Isatidis 30-130, Semen Sojae Preparatum 30-130, Cortex Magnoliae Officinalis 30-130, Pachyrhizua angulatus 30-130, Herba Moslae 10-90, Gypsum Fibrosum 100-220, Rhizoma Coptidis 5-50, Radix Scutellariae 30-130, Pulvis Talci 10-110, Radix Glycyrrhizae 5-50, Flos Lonicerae 30-130, Rhizoma Pinelliae Preparata 10-90, also have pharmaceutic adjuvant.
The enough Fructus Forsythiaes of described Folium Isatidis flavour of a drug energy, Radix Isatidis, Indigo Naturalis, Rhizoma Osmundae, Herba Taraxaci, Herba Violae, Flos Chrysanthemi Indici, Herba Houttuyniae, Rhizoma Belamcandae, a kind of of Radix Sophorae Tonkinensis substitute; The enough Herba Menthaes of Semen Sojae Preparatum flavour of a drug energy, Fructus Arctii, Periostracum Cicadae, Folium Mori, Flos Chrysanthemi, Fructus Viticis, Radix Bupleuri, a kind of of Rhizoma Cimicifugae substitute.
The contained adjuvant of Chinese medicine composition of the present invention can be used dextrin, starch, lactose etc., and the best is dextrin.
The preparation method of Chinese medicine composition of the present invention adopts the multi-functional extraction concentrator of dynamic circulation, and concrete operation step is as follows:
A) distillation: by above-mentioned Herba Pogostemonis, Herba Moslae, Flos Lonicerae three taste vapor distillations, collect distillate, medicinal residues, standby;
B) water extraction: medicinal residues and Folium Isatidis, Semen Sojae Preparatum, Cortex Magnoliae Officinalis, Pachyrhizua angulatus, Gypsum Fibrosum, Rhizoma Coptidis, Radix Scutellariae, Pulvis Talci, Radix Glycyrrhizae, Rhizoma Pinelliae Preparata described in claim 1 a) are put in water extraction tank, the 6-10 times of water gaging that adds by weight described Chinese medicine composition, the best is that 8 times of water gagings decoct 2 times, each 1-4, the best is 2 hours, steam pressure 0.03-0.04Mpa after boiling, collecting decoction, filters;
C) concentrated: water extraction filtrate is put in concentration tank, and being concentrated into relative density is 1.01-1.03, and the best is 1.02, the clear paste of temperature 50 C, thickening temperature 50-100 ℃;
D) precipitate with ethanol: concentrated solution is put in Alcohol-settling tank, slowly adds 95% ethanol to make it contain alcohol amount and reaches 50%-75%, and the best is 65%, after fully stirring, and standing 8-20 hour, the best is 12 hours, filters;
E) reclaim ethanol: filtrate is put in reclaim under reduced pressure tank, decompression recycling ethanol, being concentrated into relative density is 1.04-1.07, the best is 1.05-1.06, the thick paste of temperature 45 C, thickening temperature 40-100 ℃, obtains water extract.
F) preparation of mixture: in water extract, add the distillate in a) step, stir, add water to relative density and be about 1.01-1.05, stir evenly, fill, sterilizing, obtains mixture.
Embodiment 1
Herba Pogostemonis 10, Folium Isatidis 30, Semen Sojae Preparatum 30, Cortex Magnoliae Officinalis 30, Pachyrhizua angulatus 30, Herba Moslae 10, Gypsum Fibrosum 100, Rhizoma Coptidis 5, Radix Scutellariae 30, Pulvis Talci 10, Radix Glycyrrhizae 5, Flos Lonicerae 30, Rhizoma Pinelliae Preparata 10.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
Embodiment 2
Herba Pogostemonis 90, Folium Isatidis 130, Semen Sojae Preparatum 130, Cortex Magnoliae Officinalis 130, Pachyrhizua angulatus 130, Herba Moslae 90, Gypsum Fibrosum 220, Rhizoma Coptidis 50, Radix Scutellariae 130, Pulvis Talci 110, Radix Glycyrrhizae 50, Flos Lonicerae 130, Rhizoma Pinelliae Preparata 90.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
Embodiment 3
Herba Pogostemonis 50, Folium Isatidis 83.3, Semen Sojae Preparatum 83.3, Cortex Magnoliae Officinalis 83.3, Pachyrhizua angulatus 83.3, Herba Moslae 50, Gypsum Fibrosum 166.7, Rhizoma Coptidis 25, Radix Scutellariae 83.3, Pulvis Talci 58.3, Radix Glycyrrhizae 25, Flos Lonicerae 83.3, Rhizoma Pinelliae Preparata 50.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
Embodiment 4
Herba Pogostemonis 80, Folium Isatidis 110, Semen Sojae Preparatum 110, Cortex Magnoliae Officinalis 110, Pachyrhizua angulatus 110, Herba Moslae 80, Gypsum Fibrosum 200, Rhizoma Coptidis 40, Radix Scutellariae 110, Pulvis Talci 100, Radix Glycyrrhizae 40, Flos Lonicerae 110, Rhizoma Pinelliae Preparata 80.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
Embodiment 5
Herba Pogostemonis 20, Folium Isatidis 50, Semen Sojae Preparatum 50, Cortex Magnoliae Officinalis 50, Pachyrhizua angulatus 50, Herba Moslae 20, Gypsum Fibrosum 130, Rhizoma Coptidis 10, Radix Scutellariae 50, Pulvis Talci 30, Radix Glycyrrhizae 10, Flos Lonicerae 50, Rhizoma Pinelliae Preparata 20.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
Embodiment 6
Herba Pogostemonis 65, Folium Isatidis 90, Semen Sojae Preparatum 100, Cortex Magnoliae Officinalis 90, Pachyrhizua angulatus 90, Herba Moslae 65, Gypsum Fibrosum 180, Rhizoma Coptidis 30, Radix Scutellariae 100, Pulvis Talci 70, Radix Glycyrrhizae 30, Flos Lonicerae 90, Rhizoma Pinelliae Preparata 70.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
Embodiment 7
Herba Pogostemonis 35, Folium Isatidis 65, Semen Sojae Preparatum 65, Cortex Magnoliae Officinalis 65, Pachyrhizua angulatus 70, Herba Moslae 70, Gypsum Fibrosum 160, Rhizoma Coptidis 20, Radix Scutellariae 65, Pulvis Talci 50, Radix Glycyrrhizae 20, Flos Lonicerae 65, Rhizoma Pinelliae Preparata 40.By the ratio of writing out a prescription above, according to the preparation method of above-mentioned Chinese medicine composition, make mixture.
By the proportion of respectively writing out a prescription above, according in above-mentioned Chinese medicine composition preparation method a), b), c), d), e) method extract, then can be made into as follows capsule:
G) preparation of capsule:
A ') water extract is laid in vacuum drying oven, vacuum drying.Vacuum-0.06--0.09Mpa, temperature 40-100 ℃, gets dry extract;
B ') dried cream powder is broken into fine powder 80-120 order;
C ') dried cream powder is blended into appropriate dextrin, sieve, and mix homogeneously, incorporation time 10-50 minute;
D ') mixed dried cream powder 95% alcohol granulation, time 3-10 minute granulates;
E ') by d ') in made wet granular be laid in drying baker, dry, the about 2cm of laying thickness, baking temperature 50-100 ℃;
F '), by dried granule granulate, with order number, be 14 object screen cloth granulate;
G ') encapsulated, every capsules dress 0.3-0.5g;
According in above-mentioned Chinese medicine composition preparation method a), b), c), d), e) method extract, a '), b ') method vacuum drying, dried cream powder broken, c ') method mix, add appropriate suitable excipient, granulate or tabletting, can be made into granule or tablet; Or directly packing is made powder; Add that syrup is mixed, sterilizing, the canned syrup that can be made into; Adding refined honey closes a small bay in a river and can be made into honeyed pill; Extract and fine drug powder add water or sweet water pill can be made into the watered pill, water-honeyed pill; Or general reference is made concentrated pill, paste pill etc.According to above-mentioned Chinese medicine composition a), b), c), d), e) method extract, c ') method mix, add appropriate Mel to be mixed and made into soft extract.
Take embodiment 3 above as optimum implementation.
Chinese medicine composition method of quality control with most preferred embodiment 3 preparations is as follows:
A) relative density should be appendix VII A of 1.01-1.05 < < Chinese Pharmacopoeia > > version in 2010.
B) pH value should be appendix VII G of 4.0-6.0 < < Chinese Pharmacopoeia > > version in 2010.
C) total solid matters is got this product 100ml, with dry filter, filters rapidly, and precision measures subsequent filtrate 25ml, puts in the evaporating dish that is dried to constant weight, in water-bath after evaporate to dryness, in 105 ℃ dry 3 hours, put in exsiccator cooling 30 minutes, rapid accurately weighed weight, calculates, and obtains.Every 1ml should be 45-95mg containing total solid matters.
D) other should meet appendix I J of every regulation < < Chinese Pharmacopoeia > > version in 2010 relevant under mixture item.
E) limit test of microbe meets the regulation of Chinese Pharmacopoeia.
F) under room temperature is preserved, the effect duration of this Chinese medicine composition is 12 months.
The toxicity test of this Chinese medicine composition
1, acute toxicity test:
Chinese medicine composition extractum is pressed 100g/kg to mouse stomach administration, without dead, occurs, and has no movable abnormal.Be equivalent to 2 times/day of quantity, 5ml/ time, everyone calculates more than 800 times by 50kg.Chinese medicine composition extractum is pressed 60g/kg to rat oral gavage administration, without dead, occurs, and also has no movable abnormal.Be equivalent to more than 400 times of quantity.
2, long term toxicity test:
Chinese medicine composition extractum with 36,16,8g/Kg/ day is to the continuous gastric infusion of rat 3 months, hematological indices is had no significant effect; Blood parameters is also had no significant effect; Organ coefficient, histopathologic examination also do not find obvious pathological change.
Below to being illustrated with the clinical practice of above-mentioned traditional Chinese medicine composition for treating child acute upper respiratory tract infection.
By implementing the clinical trial protocol of State Food and Drug Administration's reply, Children with Upper Respiratory Infection is generated heat, pharynx is red and swollen, diarrhoea, dizzy, sleepy weak, nausea and vomiting, tcm syndrome integration, tcm syndrome single index, total effects, tcm syndrome curative effect, onset time, antiviral, the antibacterial clinical observation that waits item, in research with this Chinese medicine composition with contrast medicine and compare, the standard of curative effect evaluation according to the current international practice is evaluated it, result shows that this Chinese medicine composition is the effective and safe innerwear Chinese medicine preparation for the treatment of child acute upper respiratory tract infection.
Adopt randomized, double-blind layering counter point, clinical observation acute upper respiratory tract infection 169 examples, treatment group 90 examples wherein, each 5ml, every day 2 times, take 3 days, observe that infant heating, pharynx are red and swollen, situation of change before and after the treatment of diarrhoea, dizzy, sleepy weak, nausea and vomiting, comprehensive function and body of the tongue, tongue fur, all index of pulse condition, result shows:
1, after infant fever therapy, return to 0 minute and 1 minute person is 72 examples, account for 80%; Pharynx redness returns to 0 minute after treating and 1 minute person is 75 examples, accounts for 83.3%; After diarrhea treatment, returning to the 0-2 person of dividing is 81 examples, accounts for 90%; After dizzy treatment, return to the 0-2 person of dividing and account for 82%; After sleepy weak treatment, return to the 0-2 person of dividing and account for 78%; After nausea and vomiting treatment, return to the 0-2 person of dividing and account for 83.0%;
2, infant comprehensive function level comparison before and after treatment, after patient's comprehensive function horizontal stretcher, returning to 0-2, to divide horizontal person be 80%;
3, infant picture of the tongue, pulse condition integral contrast before and after treatment, have significance to recover after body of the tongue, tongue fur and pulse condition three card treatments;
4, infant total effects comparison after treatment, the total effective rate after treatment is 91.3%, and obvious effective rate is 82%;
The total effective rate of 5, treating after rear infant tcm syndrome curative effect is relatively treated is 96.7%, and cure-remarkable-effectiveness rate is 80%;
6, after treatment, infant treatment group and matched group total effects compare in Table 1:
Total effective rate curative effect comparison [example (%)] after table 1 liang group treatment
, in therapeutic process and after treatment, all there is not untoward reaction in 7, patient safety index there was no significant difference (P > 0.05) before and after treatment.
Above indices and matched group comparison, the indices of this Chinese medicine composition and clinical efficacy are all better than contrasting medicine, and after treatment, patient's indices and symptom improvement situation are obviously better than similar drugs.
8, the peaceful mixture treatment of summer-heat child acute upper respiratory tract infection model case one example:
Infant: the Meng, man, 1 years old half, people from Hongqiao, Tianjin, main cause " is generated heat 1 day ", and on August 9th, 2007 is admitted to hospital.
There is heating in patient, 39.5 ℃ of body temperature, give Western medicine intravenous drip before 1 day, and heat is moved back, heating again after 2 hours, and companion's limb acid pharyngeal swelling, dizzy heavy, distending pain, the disease of the tired strongly fragrant gastrointestinals of heat-damp in summer such as vomitting, have loose bowels, indigestion and loss of appetite, health is sleepy, tongue is white, and the right loud left side of arteries and veins is anti-little.Lab testing: Leukocyte Counts 4.5*109/L, body temperature: 39 ℃.
Diagnosis:
Tcm diagnosis: summer-heat diseases caused by exogenous pathogenic factor (heat-damp in summer hold concurrently cold syndrome)
Western medicine diagnose: acute upper respiratory tract infection
Treatment:
With clearing away summer-heat, expel the heat-evil, the method that dampness removingization is turbid.
Side's medicine:
Use the peaceful mixture treatment of summer-heat 3 days, temperature recovery is normal, limb acid pharyngeal swelling, and giddy is heavy, distending pain is significantly improved, the transference cure of vomitting, have loose bowels, the sleepy obvious alleviation of indigestion and loss of appetite, health, body of the tongue is light red, and tongue is white, and pulse condition is gentle.While leaving hospital, check body temperature: 36.6 ℃, infant spirit, diet, two are just normal.
Claims (4)
1. a Chinese medicine composition for the treatment of child acute upper respiratory tract infection, is characterized in that: this Chinese medicine composition has following flavour of a drug to make by weight:
Herba Pogostemonis 10-90, Folium Isatidis 30-130, Semen Sojae Preparatum 30-130, Cortex Magnoliae Officinalis 30-130, Pachyrhizua angulatus 30-130, Herba Moslae 10-90, Gypsum Fibrosum 100-220, Rhizoma Coptidis 5-50, Radix Scutellariae 30-130, Pulvis Talci 10-110, Radix Glycyrrhizae 5-50, Flos Lonicerae 30-130, Rhizoma Pinelliae Preparata 10-90, also have pharmaceutic adjuvant;
Described pharmaceutic adjuvant is one of dextrin, starch, lactose.
2. treat a preparation method for the Chinese medicine composition of child acute upper respiratory tract infection, its method comprises the following steps:
A) distillation: by Herba Pogostemonis claimed in claim 1, Herba Moslae, Flos Lonicerae three taste vapor distillations, collect distillate, medicinal residues, standby;
B) water extraction: medicinal residues and Folium Isatidis claimed in claim 1, Semen Sojae Preparatum, Cortex Magnoliae Officinalis, Pachyrhizua angulatus, Gypsum Fibrosum, Rhizoma Coptidis, Radix Scutellariae, Pulvis Talci, Radix Glycyrrhizae, Rhizoma Pinelliae Preparata in a) step are put in water extraction tank, add by weight 6-10 times of water gaging of described Chinese medicine composition to decoct 2 times, each 1-4 hour, steam pressure 0.03-0.04Mpa after boiling, collecting decoction, filters;
C) concentrated: water extraction filtrate is put in concentration tank, and being concentrated into relative density is 1.01-1.03, the clear paste of temperature 50 C, thickening temperature 50-100 ℃;
D) precipitate with ethanol: concentrated solution is put in Alcohol-settling tank, slowly adds 95% ethanol to make it contain alcohol amount and reaches 50%-75%, and after fully stirring, standing 8-20 hour, filters;
E) reclaim ethanol: filtrate is put in reclaim under reduced pressure tank, decompression recycling ethanol, being concentrated into relative density is 1.04-1.07, the thick paste of temperature 45 C, thickening temperature 40-100 ℃, obtains water extract;
F) preparation of mixture: by e) in the water extract in step, add the distillate in a) step, stir, add water to relative density and be about 1.01-1.05, stir evenly, fill, sterilizing, makes mixture.
3. the preparation method of the Chinese medicine composition for the treatment of child acute upper respiratory tract infection according to claim 2, is characterized in that: described step f), the characteristic of the mixture of preparation is:
A) relative density should be appendix VII A of 1.01-1.05 < < Chinese Pharmacopoeia > > version in 2010;
B) pH value should be appendix VII G of 4.0-6.0 < < Chinese Pharmacopoeia > > version in 2010;
C) total solid matters is got this product 100ml, with dry filter, filter rapidly, precision measures subsequent filtrate 25ml, puts in the evaporating dish that is dried to constant weight, in water-bath after evaporate to dryness, in 105 ℃ dry 3 hours, put in exsiccator cooling 30 minutes, rapid accurately weighed weight, calculate, obtain, every 1ml should be 45-95mg containing total solid matters;
D) other should meet appendix I J of every regulation < < Chinese Pharmacopoeia > > version in 2010 relevant under mixture item;
E) limit test of microbe meets the regulation of Chinese Pharmacopoeia;
F) under room temperature is preserved, the effect duration of this Chinese medicine composition is 12 months.
4. the preparation method of the Chinese medicine composition for the treatment of child acute upper respiratory tract infection according to claim 2, is characterized in that: described f), in step, extract is made to pill, powder, granule, tablet, soft extract, capsule or syrup.
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