CN102188498B - Traditional Chinese medicine composition for treating pediatric high fever and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating pediatric high fever and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating pediatric high fever and a preparation method thereof. The traditional Chinese medicine composition for treating pediatric high fever is mainly prepared from radix pseudostellariae, radix tetrastigme, lepidogrammitis drymoglossoides ching, polygonum cuspidatum leaves and the like. The preparation method comprises the following steps: weighing the radix pseudostellariae, radix tetrastigme, lepidogrammitis drymoglossoides ching, polygonum cuspidatum leaves in percentage by weight, adding water for decocting and concentrating, adding alcohol for precipitation, recovering alcohol, concentrating into extractum, drying, sieving, pelletizing and making proper preparation. The invention has the characteristics that the traditional Chinese medicine composition for treating pediatric high fever is purely natural and has obvious effects on tonifying spleen and lung, dispelling the wind and reducing spitting, clearing away heat and toxic material, especially on various pediatric high fevers; due to adoption of oral administration, the use is convenient, the mouthfeeling is good and the composition is well accepted by a patient; and during clinical use, the composition has good curative effect, short period, low price and no toxic and side effects, thus being satisfactory medicament for pediatric high fever.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and namely treat Chinese medicine composition of infantile hyperpyrexia and preparation method thereof.
Background technology
Infantile hyperpyrexia is one of the most common pediatric disease.Children's's physiological and pathological feature is that internal organs are tender and lovely, and shape gas does not fill, adding cold warm can not self-regulated, the breast food can not from joint, in case nurse inappropriately, then easily be hindered by pathogenic factor, so, easily morbidity on the pathology, lung is easily got involved, the spleen tending to insufficiency usually, because the spleen lung is the dirty of mothers and sons, female sick son or illness of child viscera affecting mother one of passing influences each other at pathology, and often the lung spleen is with sick.Children's is the body of " pure sun ", YANG often being in excess, in case ill, the easy heat being transformed from excessive YANG of pathogenic factor, easily sensible heat is prosperous, so clinical children's's calentura (card) is maximum.
From the infantile hyperpyrexia etiology and pathogenesis, because of children's's physiology and pathology and adult different, so infantile hyperpyrexia often has following characteristics: 1. easily hold expectorant under the arm: children's's the bottom of heart is especially tender, and exopathogen is violated lung, easily causes impaired depurative descending of lung QI, lose in compress in water Tianjin, be detained in lung, poly-form expectorant, so after the fever of children, easily doublely hold phlegm syndrome under the arm and cough aggravation, wheezing sound in the throat etc. occur.2. easily hold under the arm stagnant: children's's the spleen tending to insufficiency usually, stomach little and a little less than, tolerant few, so after the being invaded by exogenous pathogen, often cause taste to be received and transport imbalance, water paddy instead stagnates, making heating the stagnate card and distension and fullness in the abdomen occurs of being accompanied by dyspepsia of easily holding concurrently, anorexia, even make spleen and stomach function not normal and vomit, have loose bowels etc.3. easily hold under the arm frightened: children's's conscience is had a surplus, being invaded by exogenous pathogen, and facilitation transconversion into heat fire, wind symptom is disturbed the heart, makes heating easily hold under the arm frightened and agitation occurs and cry and scream, and is frightened cautious, even faints from fear.4. easy impairment of YIN impairment of body fluid liquid: children's is because " undeveloped infantile YIN ", so easy cloudy impairment of YANG is high: again because " YANG often being in excess ", it is the heat-transformation fire-transformation that sun is had a surplus, intimately all can impairment of YIN, so the card of children's's common impairment of YIN impairment of body fluid liquid in heat syndrome and the puckery dryness in the nasal cavity of order occurs, the xerostomia parched lips, dry pharynx and the pain, thirsty, the few expectorant of dry cough, the few Tianjin of the red no fur of tongue light, constipation due to dry stool, the red .5. that waits of short urination easily holds under the arm wet: damp being a kind of YIN pathogen, deep viscous, after all taste.Because the spleen and stomach in children characteristics determine the easiest disease of children's and " wet ".Moistly be stained with greasyly, easily check mechanism of qi, retention of damp leading to blockage of QI, the stagnation of QI is added with heavily wet resistance, deadlocked being difficult to resolve, damp is difficult for speed and goes.So easily doublely during fever of children hold damp syndrome under the arm and limbs to occur sleepy, oppression sensation over the epigastrium and anorexia, the abdominal distention vomiting and nausea, the loose stool is not well, difficulty in urination, greasy fur on tongue or thick greasy etc.Arise now and then, the course of disease is longer, and touching difficulty more.
The common medicine of existing commercially available treatment fever of children has " that quick granule of child ammonia phenol ", " XIAOER QINGRE JIEDU KOUFUYE ", " infantile common cold electuary " etc., its weak point is: the one, use inconvenience, compliance is poor, children's refuses clothes and cries and screams, often because of not enough the affecting the treatment of food dose: the 2nd, there is not preferably the etiology and pathogenesis for children's's physiological and pathological feature and infantile hyperpyrexia, there are not well dispersing lung-QI and dissipating phlegm, appetizing activating the spleen, resolving depression intestinal stasis relieving, QI flow promoting, whole adjustment etc., the medication effect is relatively poor.So the exploitation of Chinese medicine composition of the present invention is exactly in order to satisfy the demand of children's's particular patient's.Minimizing improves clinical efficacy and designs the infringement of children's's health.
Summary of the invention
Purpose of the present invention is intended to infantile hyperpyrexia is played fine therapeutical effect, and has the advantages such as good effect, the cycle is short, price is low, have no side effect, and is a kind of Chinese medicine composition that the patient takes like a shot.Chinese medicine composition of the present invention mainly is comprised of Radix Pseudostellariae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Drymoglossum Herba Drymoglossi, Folium Polygoni Cuspidati etc.The Radix Pseudostellariae function is mended strengthening spleen and lung, supplementing QI for promoting the production of body fluid.Cure mainly the cough due to deficiency of the lung, insufficiency of the spleen lack of appetite, cardiopalmus, palpitation with a distress feeling, edema is quenched one's thirst, and spirit is tired.Be monarch drug in the side; Radix Apioris Fortunei (Radix Lespedezae Buergeri) is flat, mildly bitter flavor, energy heat-clearing and toxic substances removing, dispelling pathogenic wind and eliminating phlegm, promoting blood circulation and stopping pain.Being mainly used in treating children with high fever induced convulsions has specially good effect, is ministerial drug in the side; Drymoglossum Herba Drymoglossi is sweet, bitter, cold.The function that dispelling pathogenic wind and eliminating phlegm, heat-clearing and toxic substances removing, cooling blood and dissolving stasis are arranged.Cure mainly lymphadenitis, pulmonary tuberculosis, rheumatic ostalgia, infantile hyperpyrexia, interior traumatic hemorrhage, traumatic injury, external curing pyogenic infections from tumour or sore.Folium Polygoni Cuspidati is bitter, and property is flat, the function wind-damp dispelling; Relieving heat toxin cures mainly Fengshi Guanjie pain, venom, dermatitis rhus.The two cooperates the function that all can strengthen heat-clearing and toxic substances removing, and four medicines cooperate and amount to the merit of mending strengthening spleen and lung, dispelling pathogenic wind and eliminating phlegm, heat-clearing and toxic substances removing.
The present invention is understanding and the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs principle according to the high heat of traditional Chinese medicine on children ', according to traditional Chinese medical science prescription and preparation principle Chinese medicine composition is developed meticulously, realizes by following technical scheme:
The consumption of drug component of the present invention is groped to sum up to draw through the inventor in a large number, and each amounts of components has preferably curative effect in following ranges, and medicine of the present invention contains
331～999 parts of 331～999 parts of Radix Apioris Fortunei (Radix Lespedezae Buergeri)s of Radix Pseudostellariae
220～496 parts of 331～999 parts of Folium Polygoni Cuspidatis of Drymoglossum Herba Drymoglossi
Preferable range is:
498～998 parts of 331～999 parts of Radix Apioris Fortunei (Radix Lespedezae Buergeri)s of Radix Pseudostellariae
250～350 parts of 331～666 parts of Folium Polygoni Cuspidatis of Drymoglossum Herba Drymoglossi
Optimum weight part is:
666 parts of 333 parts of Radix Apioris Fortunei (Radix Lespedezae Buergeri)s of Radix Pseudostellariae
282 parts of 333 parts of Folium Polygoni Cuspidatis of Drymoglossum Herba Drymoglossi
Technical problem to be solved by this invention is to realize by following technical scheme.Be characterized in the medicine made take Radix Pseudostellariae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Drymoglossum Herba Drymoglossi, Folium Polygoni Cuspidati etc. as raw material.The Chinese medicine composition of this treatment infantile hyperpyrexia, it is characterized in that it by following main materials be component form or by the water extract of following main materials as active component with pharmaceutically acceptable additives form or be comprised of as active component and pharmaceutically acceptable additives the alcohol extract of following main materials.The present invention has the merit of mending strengthening spleen and lung, dispelling pathogenic wind and eliminating phlegm, heat-clearing and toxic substances removing by scientific combination, meticulously development, also has the effect of strengthening vital QI to eliminate pathogenic factors concurrently, and is particularly remarkable to all kinds of infantile hyperpyrexia effects.
Medicine of the present invention can adopt the Chinese medicine preparation conventional method to be prepared into any pharmaceutically useful conventional formulation.After for example these crude drug can being crushed into powder, mix homogeneously is made powder and is taken after mixing it with water; Also can be with these medicines together decocting, then the condensed water decocting liquid is made oral liquid; But in order to make each crude drug of this medicine better bring into play drug effect, preferably crude drug Radix Pseudostellariae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Drymoglossum Herba Drymoglossi, Folium Polygoni Cuspidati are carried out special distillation extraction, but this can not limit protection scope of the present invention.
Described pharmaceutically receptible additives are following one or more: such as glycerol, gelatin, Polyethylene Glycol, propylene glycol, dextrin, ethanol, dried starch, citric acid, sodium bicarbonate, ethyl hydroxybenzoate, tartaric acid, lecithin, sodium lauryl sulphate etc.
Its dosage form is said dosage form on any pharmaceutics, such as syrup, granule, capsule, tablet etc.; Described capsule is common capsule, effervescent capsule or other various suitable capsules; Described tablet is common tablet, effervescent tablet, dispersible tablet or other various suitable tablets.With suitable coating material coating or do not carry out coating.
2. effectively stable for safety of medicine of the present invention is described better, the inventor is as follows with effect experiment and clinical effect interpretation of result:
2.1 laboratory animal: white mice, body weight 18～22g; Rat, body weight 150～200g; Rabbit, body weight 18.6～21.3kg is available from Zhejiang medical courses in general institute Experimental Animal Center.
2.2 main agents
Acetic acid (analytical pure), 2,4-DNP (analytical pure), 10% egg white solution, dexamethasone injection, picric acid (labelling is used), reagent is available from Hangzhou chemical company.
2.3. experiment equipment: platform scale, thermometer, syringe, rabbit fixed mount, mouse cage, thermostat water bath, stopwatch, beaker etc.
2.4. experimental technique:
2.4.1 the present invention is to the refrigeration function of fever in rabbit
Adopt 2,4-DNP 2% aqueous solution to produce the fever in rabbits pathological model.Get 2 of healthy rabbits, the labelling of weighing, fixing.Survey respectively the anus temperature 2 times, with average as normal body temperature.From first, second two rabbit back subcutaneous injection 2,4-DNPs 2% aqueous solution 30mg/kg, treat that fervescence surpasses 1 ℃ and (needs 30～40min) approximately, respectively in the following manner administration: first rabbit (heating rabbit): intraperitoneal injection of saline 0.15ml/kg; Second rabbit (heating rabbit): lumbar injection medicinal liquid 0.15ml/kg.After the administration 30,60,90,120min tests respectively the anus temperature.The results are shown in Table 1.
The refrigeration function experimental result of table 1 pair rabbit/℃
As can be seen from Table 1 administration group fervescence is lower than 1.4 ℃ of normal saline matched groups, illustrates that this medicine is obvious to the fever in rabbit refrigeration function.
2.4.2 medicine of the present invention is to the inhibitory action of rat paw edema
50 of experimental technique and animal grouping female sd inbred rats are divided into 5 groups at random, and the rat foot causes inflammation with carrageenin; Medicine of the present invention low (0.3g/kg), in (0.6g/kg), high dose (1.2g/kg) group, compare (1.4/kg) with cortisone acetate, normal saline matched group (with the capacity normal saline).Gastric infusion, successive administration 7 days, once a day.The results are shown in Table 2.
Table 2 pharmaceutical composition of the present invention is to the inhibitory action of rat paw edema
Annotate: * * compares P＜0.01 with model control group with the control drug group
As can be seen from Table 2, Chinese drug-treated group and normal saline group relatively have obvious antiinflammatory action, but its effect is lower than Dexamethasone group.The result shows that medicine high dose of the present invention has obvious inhibitory action to rat paw edema, though in, low dose group has the trend that alleviates rat paw edema, no significant difference (table 2).
2.4.3 medicine of the present invention is tested the antitussive of mice:
30 of Kunming mouses, male and female dual-purpose, body weight 18～20g divide 3 groups at random. and 10 every group, gavage gives drug solution of the present invention respectively, high dose 20g/kg, low dose group matched group 10g/kg; The capacity water such as matched group, once a day, continuous three days.After the last administration 30 minutes, by only Mus being put into glass bell jar, put into long 10cm from bell jar is suitable for reading, wide 1.5cm is the filter paper bar still, and the above drips 0.5ml ammonia, airtight, the cough latent period of mice is whenever changed a Mus behind the observation suction ammonia, changes a filter paper bar, whenever all drip 0.5ml ammonia, experimental result sees Table 3.
Table 3 medicine of the present invention is to the antitussive action of mice
With matched group than * P＜0.05 * * P＜0.01
T check between group: high low dose group antitussive effect all has significant, P＜0.01 and P＜0.05.2.4.4 medicine of the present invention is to the experiment of eliminating the phlegm of mice: 30 of Kunming mouses, body weight 18～20g divide 3 groups at random.Every group 10, gavage gives the solution of asthma capsule respectively, high dose 20g/kg. low dose group matched group 10g/kg; The capacity water such as matched group, once a day, continuous three days, after the last administration 30 minutes, every Mus lumbar injection 0.5% phenol red 0.5ml was after half an hour.Take off cervical vertebra and put to death mice, face upward the position and be fixed on the operation plate, cut off neck center skin, separate trachea, under larynx injection needle is inserted trachea, ligation is fixed, and draws 5% carbonate ammonia natrium solution 0.5ml. flushing respiratory tract three times with syringe.Amount to flushing three times, totally nine times.Each flushing liquor is put into test tube, with 751 ultraviolet spectrophotometer colorimetrics.Experimental result sees Table 4.
Table 4: medicine of the present invention is to the phlegm-dispelling functions of mice
With matched group than * P＜0.05 * * P＜0.01
T check between group, high low dose group is eliminated the phlegm all has significant (P＜0.01 and P＜0.05)
2.4.5 medicine of the present invention is to antiviral effect in vitro
(1) each trial drug is measured through the CPE method the maximal non-toxic concentration of Vero cell, and all less than 0.04mg/ml (1: 100), in formal drug test, then the medicine of employing＜0.04mg/ml carries out the extracorporeal antivirus effect test,
(2) each trial drug causes the cytopathic inhibitory action of Vero to HSV-I virus, and RSV virus is caused the cytopathic inhibitory action of Hep-2.Result of the test is as shown in table 5.
The different trial drug antiviral effect in vitros that form of table 5 the present invention
Annotate: "-" clothing shows that cell is without pathological changes: " 1+ " about 25% cell generation pathological changes, " 2+ " about 50% cell generation pathological changes, " 3+ " about 75% cell generation pathological changes, " 4+ " about 100% cell generation pathological changes.
2.4.6 the test of infected by influenza induced mice pneumonia protective effect.
Get 100 of healthy mices, be divided at random virazole positive drug matched group, the high and low dose group of trial drug of the present invention, and model control group and Normal group, 20 every group, male and female half and half.Get 10 times of LD
5O measures (10TCLD
5O) collunarium infecting mouse pulmonary, Normal group sucks normal saline, 30ul/ only, infected rear 2 hours, and gave respectively every mice trial drug 20 of the present invention, 40mg/kg, virazole 20mg/kg, im, model control group, Normal group then all give the 0.5ml normal saline, administration every day 3 times, successive administration 5 days.Begin Continuous Observation 15 days from administration, record death toll and death time behind the mouse infection influenza virus every day, calculate as follows dead protective rate and extending life rate with the dead sum of every treated animal in 15 days:
Dead protective rate (%).(model group mortality rate-experimental group mortality rate);
Extending life rate (%): (experimental group on average life number of days-model group on average life number of days)/(model group is life number of days on average) * 100%,
It is as shown in the table for result of the test, gives the trial drug of the present invention of high and low dose after the mouse infection virus, all can reduce mortality of animals, prolongs average life number of days, and along with drug dose increases, effect increases; And the model control group animal obviously became thin afterwards at 4 days, dyspnea, and beginning is dead.Compare with model control group, the high and low dose of medicine of the present invention can significantly reduce mortality of animals (P＜0.05), and is better than virazole.
Table 6 trial drug is to the protective effect of Mouse Virus Pneumonia
Compare * P＜0.05 with model group
Experiment conclusion: by above experiment, proved invention medicine has obvious heat clearing away, antiinflammatory, cough-relieving and phlegm-dispelling functions to mice.And to extracorporeal antivirus effect with to the protection of Mouse Virus Pneumonia remarkable effect is arranged.
2.4.5 clinical verification:
With Zhejiang Province's First Hospital clinical verification, its criterion: the three days clinical symptoms partial rcsponses of taking medicine are produce effects, and the three days clinical symptoms of taking medicine substantially disappearance person are recovery from illness.By to 500 routine administration clinical observations, in the our medicine treatment 2 days, body temperature is down to normal person fully and is accounted for 86.2%, and the disease cure rate is 47.8%, and in the our medicine treatment 3 days, the disease total effective rate is 97.6%.Evident in efficacy, without any untoward reaction.
The present invention is by long-term research and practice, reasonable recipe, technique is advanced, gives full play to the speciality that Chinese Herbs is good, have no side effect, be a kind of good and cheap, consumption is little, instant effect, curative effect are high, the gratifying clear infantile hyperpyrexia medication that is easy to carry and uses.
The specific embodiment
Embodiment 1:
Take by weighing by weight percentage Radix Pseudostellariae 200 gram, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 300 grams, Drymoglossum Herba Drymoglossi 150 grams, Folium Polygoni Cuspidati 150 grams, decoct with water, concentrate, add ethanol precipitation, Recycled ethanol, be condensed into the extractum shape, drying, sieve, granulate, make suitable preparation.
Embodiment 2
Tablet takes by weighing Radix Pseudostellariae 300 grams, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 500 grams, Drymoglossum Herba Drymoglossi 250 grams, Folium Polygoni Cuspidati 150 grams by weight percentage, gets extractum with example 1 legal system, is ground into fine powder, with the appropriate amount of auxiliary materials mixing, granulate, and drying, tabletting, and get final product.
Embodiment 3:
Capsule takes by weighing Radix Pseudostellariae 250 grams, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 500 grams, Drymoglossum Herba Drymoglossi 250 grams, Folium Polygoni Cuspidati 250 grams by weight, gets extractum with example 1 legal system and makes fine powder and appropriate amount of auxiliary materials mixing, and the encapsulating capsule is packed and be get final product.
Characteristics of the present invention are that it is All Pure Nature pharmaceutical preparation, have the merit of mending strengthening spleen and lung, dispelling pathogenic wind and eliminating phlegm, heat-clearing and toxic substances removing, and are particularly remarkable to all kinds of infantile hyperpyrexia effects; Adopt peroral dosage form, easy to use, mouthfeel is good, and the patient easily accepts; In clinical use good effect, the cycle is short, price is low, have no side effect, and is a kind of gratifying clear infantile hyperpyrexia medication.
Claims (4)
1. Chinese medicine composition for the treatment of infantile hyperpyrexia, it is characterized in that: it is comprised of as active component and pharmaceutically acceptable additives water extract or the alcohol extract of following raw materials according, and the weight portion of each raw material is: 331～999 parts of Radix Pseudostellariaes, 331～999 parts of Radix Apioris Fortunei (Radix Lespedezae Buergeri)s, 331～999 parts of Drymoglossum Herba Drymoglossis, 220～496 parts of Folium Polygoni Cuspidatis.
2. a kind of Chinese medicine composition for the treatment of infantile hyperpyrexia according to claim 1, it is characterized in that: the weight portion of described each raw material is: 333 parts of Radix Pseudostellariaes, 666 parts of Radix Apioris Fortunei (Radix Lespedezae Buergeri)s, 333 parts of Drymoglossum Herba Drymoglossis, 288 parts of Folium Polygoni Cuspidatis.
3. Chinese medicine composition according to claim 1 is characterized in that: the described additives of pharmaceutically accepting are following one or more: glycerol, gelatin, Polyethylene Glycol, propylene glycol, dextrin, dried starch, ethylparaben, tartaric acid, citric acid, sodium bicarbonate, lecithin, sodium lauryl sulphate.
4. Chinese medicine composition according to claim 1, it is characterized in that: its dosage form is granule, capsule or tablet.
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