CN102526209B - Traditional Chinese medicine solid preparation (dosage form) - Google Patents
Traditional Chinese medicine solid preparation (dosage form) Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine solid preparation used for preventing hand-foot-mouth diseases and exopathic diseases and treating mild symptoms, wherein drug substances of the traditional Chinese medicine solid preparation adopt the recipe as follows: 250 to 350 parts of honeysuckle, 250 to 350 parts of, forsythia,, 160 to 240 parts of ageratum, 70 to 130 parts of artemisia leaves, 70 to 130 parts of menthol, 160 to 240 parts of puccoon, and 70 to 130 parts of raw glycyrrhiza .
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of solid preparation and method for making thereof that is used for the treatment of the Chinese medicine composition of hand-foot-mouth disease and diseases caused by exogenous pathogenic factor class disease, belong to medical technical field.
Background technology
Theory of Chinese medical science think the main syndrome of exogenous disease have evil defend at lung, damp pathogen obstructing the spleen, intestinal be damp and hot, evil in few sun and lung-heat syndrome, gallbladder-heat card, syndrome of heat in the stomach, internal organs excess syndrome, bladder heat syndrome etc.The common trait of these syndromes be have seasonality, morbidity is anxious, the course of disease short, all outer is because exopathogen is attacked in table, the exopathogen people and exopathogen is reluctant to leave and is caused the syndrome of corresponding function due to not normal.Mainly comprise flu, fever caused by exogenous pathogens, wet resistance, dysentery, malaria etc.
Hand-foot-mouth disease is a kind of common communicate illness that causes with enterovirus, is mainly in children's, mainly shows as congested herpes or pimple, ruddy pain on every side, and be mainly in hands, foot, oral cavity and gain the name, spread speed is fast, and spread scope is wide.The minority infant can cause complication such as myocarditis, pulmonary edema, aseptic meningitis, if indivedual serious symptom infant PD is fast, can cause death.
Hand-foot-mouth disease in the world a plurality of countries and regions break out with popular.Sickness rate in China significantly raises in recent years, and presents seasonal popularly and distribute trend the whole year, and severe cases and death report is arranged, and has brought tremendous loss and influence for family and society.China is defined as the Class C infectious disease of statutory report management in May, 2008 with it.
Hand-foot-mouth disease is global infectious disease, and all there is this sick popular report in most of area, the world.Nineteen fifty-seven, New Zealand's reported first should disease.Isolated Coxsackie virus in 1958, nineteen fifty-nine proposes the hand-foot-mouth disease name.The pathogen of the hand-foot-mouth disease of early discovery is mainly Cox A16 type, and EV71 was confirmed first in the U.S. in 1969.After this EV71 infects with Cox A16 and infects alternately appearance, becomes the main pathogens of hand-foot-mouth disease.
For the treatment of hand-foot-mouth disease, doctor trained in Western medicine is mainly based on the Supporting Therapy of suiting the medicine to the illness, reinforcement nursing and close observation change of illness state; Do not see the name of disease that hand-foot-mouth disease is arranged in the Traditional Chinese medical theory as yet, primary disease be generate heat, herpes appears in the hand-foot-mouth disease position or erythra is that feature is named, be heat-clearing and toxic substances removing, removing dampness expelling pathogenic factors from the exterior to the plain edition Therapeutic Principle on the traditional Chinese medical science, so heat clearing away, detoxifcation, removing dampness are its main treatment means.Hand-foot-mouth disease does not still have specificity therapeutic method at present, based on supporting treatment, but most patient's spontaneous recovery.Yet dead example can appear in small number of patients prognosis weak effect, mainly be because late complication is serious, rescues untimely causing.
According to tradition and modern Chinese medicine theory, the sick position of hand-foot-mouth disease is dirty at lung, spleen, the heart three, and its sick basic characteristics be real, heat, wet.Diseases caused by exogenous pathogenic factor seasonal pathogen epidemic disease poison is invaded human body, defends table and is held back, and lung qi is inappropriate, so see heating, cough, watery nasal discharge.Plain body retention of damp-heat in the interior, heart channel fire are contained, and interior diplomacy are striven, and steam in dispute on the fire of heart channel, and damp-heat in the spleen and stomach is fumigated in extremity, then sends out to be herpes.Damp and hot holding accumulate long-pending taste, and poor appetite and nausea and vomiting etc. then appear in the fortuneization imbalance.Hand-foot-mouth disease belongs to categories such as the traditional Chinese medical science " epidemic febrile disease ", " hygropyrexia ", " epidemic disease ", is the case of a physically strong patient running a high fever, heat symptom-complex, and Therapeutic Method has expelling wind and clearing away heat, clearing heart fire, clearing away summer-heat and eliminating dampness, nourishing YIN to lower pathogenic fire etc.
Prevent and treat hand-foot-mouth disease clinically and diseases caused by exogenous pathogenic factor class disease adopts antiviral, cooling and symptomatic treatment more, also will use hormone individually, its therapeutic effect has certain limitation, the scope of application is little, can not remove the damp and hot and Detoxication in the body, cure the symptoms, not the disease, easily outbreak repeatedly, treat not thorough, behind the Western medicine life-time service, easy damaged liver and kidney, even produce some serious adverse effects, and treatment slowly makes clinical drug safety have hidden danger.
Summary of the invention
Technical problem to be solved by this invention is in order to overcome the deficiency on the existing treatment technology, provide a kind of and prevent solid preparation of Chinese medicine with light disease treatment and preparation method thereof for hand-foot-mouth disease and diseases caused by exogenous pathogenic factor class disease, solid preparation of Chinese medicine of the present invention not only therapeutic effect is good, and preparation technology is simple, and is cheap.
One of purpose of the present invention provides a kind of Chinese medicine composition that is mainly used in hand-foot-mouth disease and the sick prevention of diseases caused by exogenous pathogenic factor class and light disease treatment.
One of purpose of the present invention provides a kind of solid preparation and method for making thereof that is mainly used in the Chinese medicine composition of hand-foot-mouth disease and the sick prevention of diseases caused by exogenous pathogenic factor class and light disease treatment.
One of purpose of the present invention, the method that provides the sick prevention of a kind of hand-foot-mouth disease and diseases caused by exogenous pathogenic factor class and light disease to treat.
Flos Lonicerae, is the perennial half evergreen winding bejuco of Caprifoliaceae at famous Radix Ophiopogonis.The medical material Flos Lonicerae is Caprifoliaceae woodbine Radix Ophiopogonis and congener dry flower or the first flower of opening of band.Flos Lonicerae is described as the good medicine of heat-clearing and toxic substances removing from ancient times.The sweet cold fragrance of its property, clearing away heat with drugs sweet in flavor and cold in nature and not injuring one's stomach, fragrance reaches thoroughly and can get rid of evils.Flos Lonicerae can dispelling wind-heat, and also kind removing summer-heat blood poison is used for various febrile diseases, and as fever of the body, dermexanthesis, send out diseases such as speckle, pyretic toxicity carbuncle sore, laryngopharynx swelling and pain, all effect is remarkable.
Fructus Forsythiae is the Chinese medicine of heat-clearing and toxic substances removing, cures mainly calentura from the beginning of, anemopyretic cold, and heating is vexed, laryngopharynx swelling and pain, acute nephritis etc.
Herba Pogostemonis is the Labiatae herbaceos perennial, can dispelling summer-heat from superficies of the body, and removing dampness to restore normal function of the stomach.Be used for the summertime flu, the cold and heat headache, breast gastral cavity painful abdominal mass is vexed, and vomiting is had loose bowels, vomiting during pregnancy, nasal sinusitis, hands, tinea pedis.
Folium Artemisiae Argyi, for the leaf of feverfew Chinese mugwort can dispersing cold for relieving pain, warming the meridian for stopping bleeding.Be used for few abdomen cold type of pain, coldness and unbalance in meridians, cold womb is infertile, spits blood, epistaxis, the metrorrhagia warp is many, gestation hemorrhage; The external treatment skin pruritus, decortication.Vinegar Chinese mugwort charcoal warming the meridian for stopping bleeding.It is hemorrhage to be used for deficiency and coldness.
Herba Menthae, popular name are " lunar caustic grass ", for labiate " Herba Menthae " namely belongs to other dry herbs together.It is hot cold sweating and heat resolving medicine, controls influenza, headache, conjunctival congestion, fever of the body, throat, dental bed disease such as swell and ache.But external training the mind dysmenorrhoea, skin pruritus, erythra and eczema etc.
Radix Arnebiae (Radix Lithospermi), the root for comfrey Radix Arnebiae (Radix Lithospermi), the false Radix Arnebiae (Radix Lithospermi) in Xinjiang-Tibet or Yunnan Radix Arnebiae (Radix Lithospermi) is used for removing heat from blood, invigorates blood circulation the detoxifcation rash.Be used for that the heat in blood poison is contained, purple black, the measles without adequate eruption of macule, skin infection, eczema, burn due to hot liquid or fire.Clearing away heat and cooling blood is used for measles, calentura skin eruption, eczema, hematuria, stranguria with blood, dysentery, skin infection, erysipelas, burn, constipation with heat retention.
Radix Glycyrrhizae is the pulse family herbaceos perennial.Can invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Theory of Chinese medical science think the main syndrome of exogenous disease have evil defend at lung, damp pathogen obstructing the spleen, intestinal be damp and hot, evil in few sun and lung-heat syndrome, gallbladder-heat card, syndrome of heat in the stomach, internal organs excess syndrome, bladder heat syndrome etc.The common trait of these syndromes be have seasonality, morbidity is anxious, the course of disease short, all outer is because exopathogen is attacked in table, the exopathogen people and exopathogen is reluctant to leave and is caused the syndrome of corresponding function due to not normal.Mainly comprise flu, fever caused by exogenous pathogens, wet resistance, dysentery, malaria etc.
Exogenous disease is that exopathogen is hindered, so the treatment main points of exogenous disease at first are to dispel exopathogen timely and effectively.Different with the syndrome feature with exopathogen character, and adopt dispelling wind, cold expelling, heat clearing away, removing dampness respectively, drive away summer heat, method for the treatment of such as purging FU-organs, preventing the attack (or recurrence) of malaria.The function that its less important conditioning is not normal.The conditioning viscera function not only helps lend some impetus to the function of imbalance and recovers early, also helps to dispel exopathogen.
The technical scheme that the present invention solves is as follows:
A kind of Chinese medicine composition is mainly made by the following crude drug based on the weight portion meter: Flos Lonicerae 250-350 part, Fructus Forsythiae 250-350 part, Herba Pogostemonis 160-240 part, Folium Artemisiae Argyi 70-130 part, Herba Menthae 70-130 part, Radix Arnebiae (Radix Lithospermi) 160-240 part, Radix Glycyrrhizae 70-130 part; Preferably, described Chinese medicine composition is solid preparation of Chinese medicine.
As optimized technical scheme of the present invention, a kind of Chinese medicine composition is mainly made by the following crude drug based on the weight portion meter: Flos Lonicerae 280-320 part, Fructus Forsythiae 280-320 part, Herba Pogostemonis 185-215 part, Folium Artemisiae Argyi 90-110 part, Herba Menthae 90-110 part, Radix Arnebiae (Radix Lithospermi) 185-215 part, Radix Glycyrrhizae 90-110 part; Preferably, described Chinese medicine composition is solid preparation of Chinese medicine.
As optimized technical scheme of the present invention, a kind of Chinese medicine composition is mainly made by the following crude drug based on the weight portion meter: 300 parts of Flos Loniceraes, 300 parts of Fructus Forsythiaes, 200 parts of Herba Pogostemoniss, 100 parts of Folium Artemisiae Argyis, 100 parts of Herba Menthaes, 200 parts of Radix Arnebiae (Radix Lithospermi)s, 100 parts of Radix Glycyrrhizae; Preferably, described Chinese medicine composition is solid preparation of Chinese medicine.
One of purpose of the present invention provides a kind of method for preparing solid preparation of Chinese medicine: may further comprise the steps:
(1) component takes by weighing seven in prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, collects volatile oil simultaneously, and is standby;
(2) decocting liquid merges, filters concentrated filtrate;
(3) add ethanol, leave standstill, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) with the volatile oil of step (1) and the dried cream powder of step (3), add the acceptable mixed with excipients of pharmacy in the mode of accepting on the medicine and make solid preparation of Chinese medicine.
Preparation method described above preferably wherein adds for the first time water 10-12 in the step (1) and doubly measures and soaked 30-60 minute, decocts and distills 1.5 hours; For the second time, adding 8-10 for the third time respectively doubly measures and respectively decocts and distilled 1 hour.
Preparation method described above, preferably wherein in the step (2) filtrate be concentrated into relative density and be about 1.10～1.12 (60 ℃).
Preparation method described above preferably wherein adds ethanol in the step (3), makes to contain the alcohol amount and reach between the 60%-65%.
Preparation method described above preferably wherein left standstill 24-48 hour behind the middle adding of step (3) ethanol.
As one of preferred embodiment of the invention, with the volatile oil of step (1) and the dried cream powder of step (3), add the acceptable excipient of pharmacy in the mode of accepting on the medicine and make solid preparation of Chinese medicine of the present invention.
Above-mentioned solid preparation of Chinese medicine comprises pill, tablet, capsule, granule and dispersible tablet etc.
The used excipient of above-mentioned solid preparation comprises filler, disintegrating agent, sweeting agent, solubilizing agent, wetting agent, binding agent, lubricant etc.
Wherein, filler is selected from one or more in starch, lactose, amylum pregelatinisatum, sorbitol, microcrystalline Cellulose, the dextrin, is preferably starch and mannitol.
Wherein, disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, the dried starch, preferred low-substituted hydroxypropyl cellulose and polyvinylpolypyrrolidone.
Wherein, sweeting agent is selected from a kind of in sucrose, stevioside, aspartame, the saccharin sodium, is preferably stevioside.
Wherein, solubilizing agent is selected from a kind of in polyethylene glycol 6000, Tween 80, polysorbas20, sorbester p17 and the span 20, preferred Tween 80.
Wherein, binding agent is selected from a kind of in 30 POVIDONE K 30 BP/USP 30, starch slurry, hypromellose, sodium carboxymethyl cellulose, ethyl cellulose, arabic gum, the xanthan gum, is preferably 30 POVIDONE K 30 BP/USP 30.
Wherein, lubricant is selected from one or more in magnesium stearate, zinc stearate, sodium laurylsulfate, Pulvis Talci, micropowder silica gel, Macrogol 4000, the stearic acid, is preferably Macrogol 4000.
Wherein, wetting agent is selected from 30% alcoholic solution.
One of purpose of the present invention provides a kind of following indication for the treatment of: hand-foot-mouth disease, flu, fever caused by exogenous pathogens, cold and heat headache, breast gastral cavity painful abdominal mass are vexed, the method for laryngopharynx swelling and pain, wet resistance, dysentery, malaria etc.
One of purpose of the present invention provides a kind of obvious method that suppresses staphylococcus aureus, Hemolytic streptococcus, dysentery, typhoid fever, meningococcus, Diplococcus pneumoniae, green pus and influenza virus etc.
Hand-foot-mouth disease is cardinal symptom with pimple or the herpes at positions such as heating and hands, foot, oral cavity, and infectiousness is strong, and morbidity has certain seasonality, meets the characteristics of epidemic febrile disease " epidemic disease with rashes ".The traditional Chinese medical science is to eruption and to send out the understanding of speckle disease with a long history, to being recited as the earliest of rash " element is asked. the most pure virginity will be discussed greatly ": " few sun department day, visitor win then red heat rash send out outward ", this place speech red heat rash namely is flourishing and outer the erythema of fire-toxin.Macule is mentioned in the same breath, see the Sui Dynasty Chao Yuanfang (550-630 A.D.) " General Treatise on the Cause and Symptoms of Diseases. the typhoid fever macule is waited ": " poison both looses and table is empty, and pyretic toxicity is taken advantage of a weak point in opponent's defence for skin, so send out speckle skin ulcer urticaria as the brocade literary composition, weight person, aditus laryngis, health all become skin ulcer also ".Ye Tianshi thinks " macule all is resembling of exposing of pathogen ", but " should see should not see many ", advocates " anxious letting out skin rashes completely for will ".And there is certain difference in the Qing Dynasty to the pathogenesis method for the treatment of of speckle and rash, and Lu Zixian says: " speckle is positive bright pyretic toxicity, and rash is lunar wind heat ", Wu Kunan says: " speckle is sent out by the bright gastric heat of sun; rash is given birth to because lung is subjected to pathogenic wind-warm ", so " speckle should clearing stomach expels the heat-evil, cooling blood and dissolving purpura, and rash answers lung qi dispersing to reach heresy, clearing away heat in YIN system for letting the eruptions out ".Epidemic disease with rashes sees the surplus Shi Yu of the Qing Dynasty " A View of Epidemic Febrile Diseases with Rashes " as name of disease head, and Yu Shi thinks " epidemic disease with rashes person, 4 o'clock just epidemic miasma not.Husband's epidemic miasma is invisible poison, insufficiency of stomach person sense and be subjected to it ", " big person be speckle, and little person is rash " thinks that speckle and rash do not have substantive difference, only is big or small different.And epidemic disease with rashes can the branch wind heat hinder on dialectical network, simultaneous occurrence of syndromes of both QI and WEI systems, heresy hold back pleurodiaphragmatic in terspace, sun bright red-hot, gas battalion (blood) two is burnt, bleeding due to blood-heat, poison fall into pericardium, healthy energy sudden collapse, surplus heresy not to the greatest extent etc., control with dispelling wind and ventilating the lung rash, removing summer-heat the exterior and the interior respectively, dredge that profit reaches thoroughly, clearing stomach detoxifcation removing heat from blood, clearing away heat from both QI and YING systems, removing heat from the heart to restore the consciousness detoxifcation, supplementing QI to prevent collapse recuperating depleted YANG, invigorating the spleen and regulating the stomach yin nourishing etc., says in " Wenbing Tiaobian, Detailed Analysis of Epidemic Warm Diseases " " lunar pathogenic wind-warm ... but heat not aversion to cold and person yearningly, pungent and cool prescription with moderate action Lonicerae and Forsythiae Powder master it ".Chinese medical discrimination thinks that hand-foot-mouth disease belongs to " epidemic febrile disease " category, and epidemic disease caused by damp-heat pathogen poisons mouth and nose and going into are sent out in brothers, last smoked oropharynx, the skin of passing through inside is sent out and is herpes, and see heating, asthenia, feel sick, symptom such as constipation; Or evil poison caves in, and it is soft high heat, shake, limbs flaccidity to occur, very then breathes heavily, takes off, threat to life.Infant is the body of the young sun of young the moon, experience the epidemic disease poison after, change of illness state is rapid, suitable early finds early treatment, anti-cancerating.
Flos Lonicerae wind and heat dispersing of the present invention, the rash of inducing sweat; Fructus Forsythiae dispelling wind and heat pathogens, heat-clearing and toxic substances removing, mass dissipating and swelling eliminating; Herba Pogostemonis removing dampness by means of aromatics, the rash of inducing sweat, stomach function regulating preventing or arresting vomiting; Radix Arnebiae (Radix Lithospermi) removing heat from blood and promoting blood circulation, detoxifcation rash; The Herba Menthae dispelling wind and heat pathogens, declare malicious rash, clearing throat; Folium Artemisiae Argyi removing dampness to relieve itching, dispelling cold by warming the meridian; Radix Glycyrrhizae heat-clearing and toxic substances removing, relieving spasm to stop pain, the mediation property of medicine.Modern pharmacological research confirm Flos Lonicerae can be antibiotic, analgesic, the antiendotoxin of antiviral, antiinflammatory, promotion phagocytic activity of leukocytes; Fructus Forsythiae can antiinflammatory, antibiotic, antiviral, analgesic, analgesia, antiendotoxin; Herba Pogostemonis energy antifungal, antibacterium, antiviral, sweating and heat resolving analgesia, preventing or arresting vomiting antidiarrheal; Radix Arnebiae (Radix Lithospermi) can be antibiotic, antiviral, antiinflammatory, slightly analgesic; Herba Menthae can be antibiotic, antiviral, sweating and heat resolving, anti-inflammatory analgesic; Folium Artemisiae Argyi can be antibiotic, antiviral, antiallergic, enhancing immunity; Radix Glycyrrhizae can be antibiotic, antiviral, antiinflammatory, antiallergic action, adjusting immunity of organism.Effects such as antiviral, antiinflammatory, antipyretic-antalgic, adjusting immunity are played by full side, to the cause of disease and all treatments targetedly of symptom of hand-foot-mouth disease infant.In preliminary examination in early stage process, find the most energy of infant partner treatment, and do not see toxicity, can safe and effectively be applied to clinical.
Benefit of the present invention:
Of the present invention is to be that major ingredient is made with pure Chinese herbal medicine, no hormone, and toxic and side effects is little, and treating both the principal and the secondary aspects of a disease at the same time is evident in efficacy, and clinical effectiveness is remarkable, and no drug dependence does not have phenomenon repeatedly after the healing.
The specific embodiment
Following examples are to further specify of the present invention, but never limit the scope of the present invention.Further elaborate the present invention below with reference to embodiment, but it will be appreciated by those skilled in the art that the present invention is not limited to the preparation method of these embodiment and use.And those skilled in the art can be equal to replacement, combination, improvement or modification to the present invention according to description of the invention, but these all will comprise within the scope of the invention.
Embodiment 1 tablet
The crude drug prescription is formed:
Flos Lonicerae 250g, Fructus Forsythiae 350g, Herba Pogostemonis 160g, Folium Artemisiae Argyi 130g, Herba Menthae 70g, Radix Arnebiae (Radix Lithospermi) 240g, Radix Glycyrrhizae 130g.
In batches: 1000
Preparation method:
(1) component takes by weighing seven in above-mentioned prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, adds water 15L for the first time and soaks 60 minutes, decocts and distills 1.5 hours; For the second time, adding 13L water for the third time respectively respectively decocts and distilled 1 hour; Collect volatile oil simultaneously, standby;
(2) decocting liquid merges, filters, and filtrate is concentrated into relative density and is about 1.12 (60 ℃), gets the 960ml concentrated solution;
(3) add 1740ml ethanol in above-mentioned concentrated solution, left standstill 24 hours, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) add an amount of starch to above-mentioned dried cream powder and mix, cross 80 mesh sieve mix homogeneously, add the volatile oil in the step (1) then, add an amount of 30% alcoholic solution and prepare soft material and cross 24 mesh sieves and granulate drying;
(5) with dried granule and an amount of Macrogol 4000 mix homogeneously, cross 20 mesh sieve granulate, tabletting makes Chinese medicinal tablet.
Embodiment 2 pills
The crude drug prescription is formed:
Flos Lonicerae 250g, Fructus Forsythiae 350g, Herba Pogostemonis 160g, Folium Artemisiae Argyi 130g, Herba Menthae 70g, Radix Arnebiae (Radix Lithospermi) 240g, Radix Glycyrrhizae 130g.
In batches: 1000
Preparation method:
(1) component takes by weighing seven in above-mentioned prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, adds water 15L for the first time and soaks 60 minutes, decocts and distills 1.5 hours; For the second time, adding 13L water for the third time respectively respectively decocts and distilled 1 hour; Collect volatile oil simultaneously, standby;
(2) decocting liquid merges, filters, and filtrate is concentrated into relative density and is about 1.12 (60 ℃), gets the 960ml concentrated solution;
(3) add 1740ml ethanol in above-mentioned concentrated solution, left standstill 24 hours, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) add an amount of starch to above-mentioned dried cream powder and mix, cross 80 mesh sieve mix homogeneously, add the volatile oil in the step (1) then, add an amount of 30% alcoholic solution and prepare soft material;
(5) be prepared into medicine pill with the associating pellet processing machine.
Embodiment 3 dispersible tablets
The crude drug prescription is formed:
Flos Lonicerae 350g, Fructus Forsythiae 250g, Herba Pogostemonis 240g, Folium Artemisiae Argyi 70g, Herba Menthae 130g, Radix Arnebiae (Radix Lithospermi) 160g, Radix Glycyrrhizae 70g.
In batches: 1000
Preparation method:
(1) component takes by weighing seven in above-mentioned prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, adds water 15L for the first time and soaks 60 minutes, decocts and distills 1.5 hours; For the second time, adding 13L water for the third time respectively respectively decocts and distilled 1 hour; Collect volatile oil simultaneously, standby;
(2) decocting liquid merges, filters, and filtrate is concentrated into relative density and is about 1.12 (60 ℃), gets the 960ml concentrated solution;
(3) add 1740ml ethanol in above-mentioned concentrated solution, left standstill 24 hours, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) add an amount of polyvinylpolypyrrolidone to above-mentioned dried cream powder and mix, cross 80 mesh sieve mix homogeneously, add the volatile oil in the step (1) then, add an amount of 30% alcoholic solution and prepare soft material;
(5) with dried granule and an amount of Macrogol 4000 mix homogeneously, cross 20 mesh sieve granulate, tabletting makes dispersible tablets of Chinese medicine.
Embodiment 4 capsules
The crude drug prescription is formed:
Flos Lonicerae 300g, Fructus Forsythiae 300g, Herba Pogostemonis 200g, Folium Artemisiae Argyi 100g, Herba Menthae 100g, Radix Arnebiae (Radix Lithospermi) 200g, Radix Glycyrrhizae 100g.
In batches: 1000
Preparation method:
(1) component takes by weighing seven in above-mentioned prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, adds water 15L for the first time and soaks 60 minutes, decocts and distills 1.5 hours; For the second time, adding 13L water for the third time respectively respectively decocts and distilled 1 hour; Collect volatile oil simultaneously, standby;
(2) decocting liquid merges, filters, and filtrate is concentrated into relative density and is about 1.10 (60 ℃), gets the 1020ml concentrated solution;
(3) add 1800ml ethanol in above-mentioned concentrated solution, left standstill 24 hours, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) add an amount of starch to above-mentioned dried cream powder and mix, cross 80 mesh sieve mix homogeneously, add the volatile oil in the step (1) then, add an amount of 30% alcoholic solution and prepare soft material, cross 24 mesh sieves and granulate drying;
(5) with dried granule, cross 20 mesh sieve granulate, filled capsules makes the Chinese medicinal capsule agent.
Embodiment 5Granule
Prescription is formed:
Flos Lonicerae 350g, Fructus Forsythiae 350g, Herba Pogostemonis 160g, Folium Artemisiae Argyi 700g, Herba Menthae 120g, Radix Arnebiae (Radix Lithospermi) 200g, Radix Glycyrrhizae 120g.
In batches: 1000 bags
Preparation method:
(1) component takes by weighing seven in above-mentioned prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, adds water 15L for the first time and soaks 60 minutes, decocts and distills 1.5 hours; For the second time, adding 13L water for the third time respectively respectively decocts and distilled 1 hour; Collect volatile oil simultaneously, standby;
(2) decocting liquid merges, filters, and filtrate is concentrated into relative density and is about 1.10 (60 ℃), gets the 1020ml concentrated solution;
(3) add 1800ml ethanol in above-mentioned concentrated solution, left standstill 24 hours, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) add an amount of starch to above-mentioned dried cream powder and mix, cross 80 mesh sieve mix homogeneously, add the volatile oil in the step (1) then, add an amount of 30% alcoholic solution and prepare soft material, cross 24 mesh sieves and granulate drying;
(5) with dried granule, cross 20 mesh sieve granulate, pack makes Chinese medicine granules.
Test example 1Antibacterial tests
The Kunming kind white mice that is 18-22g with 60 body weight is divided into 6 groups at random, 10 every group.Just embodiment 3,4,51 slice// bag solid preparation are dissolved in respectively in the 5ml water, and the 1-3 group is irritated stomach respectively and given the embodiment 3,4 of 0.5ml, 5 solid preparation solution, every day 1 time, continuous 4 days; The 4th group of positive matched group, subcutaneous injection penicillin sodium 20,000 u/, every day 1 time, continuous 4 days, the 5th group of negative matched group (only injecting bacterium liquid), the 6th group is the blank group.Except the 6th group, each treated animal all in 24 as a child lumbar injection staphylococcus aureus bacterium liquid 1ml/ only, every ml contains 2 * 10
9Individual bacterium, the death condition of observing and adding up each treated animal in 4 days, result such as following table:
The therapeutical effect of table 1 pair infection of staphylococcus aureus mice
Compare with negative control group
*Expression difference is extremely remarkable.
Result of the test shows that Chinese medicine composition of the present invention has significant therapeutical effect to the mice of infection of staphylococcus aureus.
Test example 2Refrigeration function to fever in rabbits due to the endotoxin
50 of rabbits are used in test, and male and female half and half give escherichia coli endotoxin auricular vein injection 250ng/kg, and the record normal body temperature is injected and surveyed each rabbit body temperature in back 60 minutes before the injection, selects temperature rising 0.8-1.2 ℃ 40, is divided into 5 groups at random.Embodiment 3,4,51 slice// bag of solid preparation are dissolved in respectively in the 5ml water, and the 1-3 group is irritated stomach respectively and is given the embodiment 3,4 of 0.5ml, 5 solid preparation solution; The 4th group only gives dipyrone 150mg/, as positive control; The 5th group of not administration is as blank.After the record administration 1,2,3 and the 6h rabbit body temperature, and calculate each rabbit body temperature and the normal body temperature temperature difference, the results are shown in following table:
The influence of fever in rabbits due to the table 2 pair endotoxin
Above result of the test shows the cooling of Chinese medicine composition of the present invention, the prophylactic treatment effect of antibiotic and resisting exogenous cold disease.
Test example 3The extracorporeal antivirus effect ability is measured
1. cell culture
The pernicious rhabdomyoma cell of people (RD-A) is so kind as to give by Hainan Center for Disease Control ﹠ Prevention, contains the DMEM culture fluid of 10% hyclone at 37 ℃, 5% CO
2And cultivate in the saturated humidity environment.
2. medicine of the present invention is to the Cytotoxic mensuration of RD-A
Cell is made into the mother solution of 6.4mg/ml with the granule of the embodiment of the invention 5 after 96 orifice plates grow up to monolayer, by six concentration dilutions (extension rate is respectively 2,4,8,16,32), every hole adds 100 μ l.In conjunction with cytopathy or CCK8 method, to observe 3-5 days, medicine is established 5 concentration and is measured, and obtains the Cmax (TD nontoxic to cell with the Reed-Muench method
0) and median toxic concentration (TD
50).Every concentration liquid at least 3 pipes, repeated trials 3 times.
3.EV71 virus virulence is measured
Select the RD cell to be used for Virus culture, add EV71 virus (Hainan Center for Disease Control ﹠ Prevention is so kind as to give) culture fluid of 11 concentration of 10 times of serial dilutions.Cultivate the back under the suitable condition and use inverted microscope observation of cell pathological changes (CPE) every day, calculate viral 50 3nfective dose (TCID with the Reed-Muench method
50), every concentration is established 4 multiple holes, and repeated trials is determined the virulence of EV71 virus.
4. medicine of the present invention is to the inhibitory action of EV71
Obtain the TCID of virus
50TD with medicine
0After, carrying out the anti-EV71 virus activity screening of medicine of the present invention at the RD cell model, suitable culture liquid and condition of culture are cultivated.After 96 orifice plate cells grew up to monolayer, every hole added 100 μ l viral infection, adsorbed after 2 hours, and inclining virus.Add medicine to be measured then, from maximal non-toxic concentration (TD
0) beginning establishes seven concentration, every group of 4 holes continuously.Virus control, cell contrast and positive drug (ribavirin, 1mg/ml stock solution) contrast are established in test.Test repeats 3 times.
5. calculate medium effective concentration (IC with the Reed-Muench method
50) and therapeutic index (TI) TI=median toxic concentration (TD
50)/medium effective concentration (IC
50), see Table 3-table 6.
Table 3 medicine of the present invention is to the toxicity of RD-A cell
Table 4 medicine of the present invention is to the toxicity test of RD-A cell
Table 5 medicine of the present invention is to the inhibitory action of EV71 virus
The result shows: medicine of the present invention is 0.05mg/ml to the inhibiting medium effective concentration of EV71 virus, and the inhibiting medium effective concentration of positive control EV71 virus is 0.0625mg/ml.
Table 6 medicine of the present invention is to the toxicity of RD-A cell with to the inhibitory action summary table of EV71 virus
| TD 0 | TD 50 | IC 50 | TI |
| 0.8 | 3.2 | 0.05 | 64 |
This result of the test shows, medicine of the present invention has the effect of tangible anti-EV71 virus external to the RD-A cell, can effectively treat hand-foot-mouth disease.
In recent years hand-foot-mouth disease multiple during, medicine of the present invention has successfully been cured many hand-foot-mouth disease patients, wherein the typical case of effect has:
The patient 1, woman, 2 years old, live Haikou City Longhua District Dao Xin village No. 32, suffer from hand-foot-mouth disease in May, 2010, and symptom shows as the low grade fever, many places, oral cavity ulcer, and with halitosis, hands, foot, hip place bear many erythema blisters, and growth is taken the tablet of the embodiment of the invention 1 rapidly immediately, took effect the same day, recovery from illness in 5 days.
The patient 2, man 4 years old lives Haikou City Meilan District Lingshan village No. 159, infects hand-foot-mouth disease in June, 2010, its symptom is very serious, trick inboard and on one's body the large-area erythema in many places fester, the oral cavity inwall is covered with ulcer, by the dispersible tablet of taking the embodiment of the invention 3, and after using Cotton Gossypii fine laundering affected part repeatedly, can take food the same day, and recovery from illness in four days there is no and produces sequela and untoward reaction.
The patient 3, the man 3 years old, lives Haikou City Longhua District Dao Xin village No. 15, suffer from hand-foot-mouth disease in May, 2009, the serious ulcer in oral cavity makes it cry incessantly, breaks to after the hand-foot-mouth disease granule of the embodiment of the invention of namely taking after mixing it with water 5 through hospital's rash, take effect at once, and can take food, after the week, trick health erythema blister is everywhere all fully recovered.
In sum, medicine of the present invention is used for treatment and the prevention of hand-foot-mouth disease, can produce obvious effect, should vigorously promote the use in the clinical application of hand-foot-mouth disease treatment and the prevention of hand-foot-mouth disease.
Claims (4)
1. one kind is prevented and treatment hand-foot-mouth disease and diseases caused by exogenous pathogenic factor class disease solid preparation of Chinese medicine, it is characterized in that being made by the following crude drug based on the weight portion meter: Flos Lonicerae 250-350 part, Fructus Forsythiae 250-350 part, Herba Pogostemonis 160-240 part, Folium Artemisiae Argyi 70-130 part, Herba Menthae 70-130 part, Radix Arnebiae (Radix Lithospermi) 160-240 part, Radix Glycyrrhizae 70-130 part, described solid preparation is selected from pill, tablet, capsule, granule and dispersible tablet.
2. solid preparation of Chinese medicine according to claim 1 is characterized in that being made by the following crude drug based on the weight portion meter: Flos Lonicerae 280-320 part, Fructus Forsythiae 280-320 part, Herba Pogostemonis 185-215 part, Folium Artemisiae Argyi 90-110 part, Herba Menthae 90-110 part, Radix Arnebiae (Radix Lithospermi) 185-215 part, Radix Glycyrrhizae 90-110 part.
3. a method for preparing the described solid preparation of Chinese medicine of claim 1 is characterized in that comprising the steps:
(1) component takes by weighing seven in prescription flavor Chinese medicine by weight, decocts with water and distillation extraction three times, collects volatile oil simultaneously, and is standby;
(2) decocting liquid merges, filters concentrated filtrate;
(3) add ethanol, leave standstill, filter, filtrate recycling ethanol concentrates, drying, and the powder that gets dry extract is standby;
(4) with the volatile oil of step (1) and the dried cream powder of step (3), add the acceptable mixed with excipients of pharmacy in the mode of accepting on the medicine and make solid preparation of Chinese medicine.
4. a kind of method for preparing solid preparation of Chinese medicine according to claim 3 is characterized in that pharmaceutically acceptable excipient is selected from filler, disintegrating agent, sweeting agent, solubilizing agent, wetting agent and lubricant.
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| CN105031095B (en) * | 2015-09-11 | 2020-10-20 | 陈泉 | Traditional Chinese medicine composition for treating hand-foot-and-mouth disease |
| CN106237232A (en) * | 2016-09-26 | 2016-12-21 | 防城港思创信息技术有限公司 | Medicament for clearing ying and relaxing bowels and detoxifying |
| CN110193061B (en) * | 2019-05-25 | 2021-09-28 | 无锡济煜山禾药业股份有限公司 | Preparation and application of traditional Chinese medicine granules for treating or preventing children influenza virus infection |
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