CN101485757B - Chinese medicinal composition for treating children's exogenous fever and preparation method thereof - Google Patents
Chinese medicinal composition for treating children's exogenous fever and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese traditional medicine composition for treating child exteroceptive fever and a method for preparing the same. The Chinese traditional medicine composition is prepared from Chinese traditional medicines of radix scutellariae, honeysuckle, rhubarb, and the like, and has good curative effect of treating defensive Qi fever symptoms of child exteroceptive fever with the total effectiveness up to more than 91.3 percent. The oral liquid of the Chinese traditional medicine composition has remarkable defervescence effect which is stable.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, particularly Chinese medicine composition of treatment infantile fever caused by exogenous pathogens and preparation method thereof.
Background technology
Infantile fever caused by exogenous pathogens belongs to the category of modern medicine acute upper respiratory tract infection more, is a class commonly encountered diseases, the frequently-occurring disease of department of pediatrics, and sickness rate accounts for the first place of pediatric disease.Used antipyretic-antalgic class Western medicine and antibiotic therapy mostly, although determined curative effect because abuse of antibiotics produced such as serious problems such as pathogen drug resistance, medicine toxicities, is restricted its application, curative effect is affected in the past.For example penicillins can produce fatal anaphylactic shock reaction, and the streptomycin class can cause the infant permanent deafness, and sulfonamides has inhibitory action to hemopoietic system, and also there are toxic and side effects such as gastrointestinal reaction, hepatotoxicity and inhibition hematopoietic function in antipyretic analgesic.Thereby when selecting active drug, often can't guarantee its safety for the infant of fever caused by exogenous pathogens.And the upper respiratory infection overwhelming majority is due to the viral infection, still lacks effective etiological treatment medicine in the Western medicine.Therefore, development good effect, the little Chinese medicine preparation of side effect have crucial clinical meaning and using value.
The most onset of infantile fever caused by exogenous pathogens is anxious, variation is fast, and the Chinese medicine decoction is difficult to take medicine in time rapidly, has often had a strong impact on the performance of curative effect.Though have some heat clearing away class Chinese medicine novel forms to come out in recent years, kind is few, curative effect is not very good, is difficult to apply.Especially in department of pediatrics is clinical, far can not satisfy the treatment demand of high incidence like this, thereby still genus waits development field.
Radix Scutellariae nature and flavor bitter cold is gone into the heart, lung, gallbladder, large intestine channel, and merit is apt to clear part of the body cavity above the diaphragm housing the heart and lungs lung-heat, again can eliminating fire and detoxication, and heat clearing and damp drying cures mainly, and high fever excessive thirst, lung-heat cough with asthma, damp-heat dysentery, yellow cellulitis, pyretic stranguria, carbuncle are treated diseases such as skin ulcer.
Radix Et Rhizoma Rhei nature and flavor bitter cold is gone into stomach, large intestine, Liver Channel.Function is purged heat, and poison, removing mass stagnate, clots absorbing blood.Row epidemic disease due to heat pathogen when curing mainly, fever accumulation and constipation, delirium are gone mad, dysentery from the beginning of, jaundice, tell nosebleed, diseases such as carbuncle and ulcer toxic swelling.
Flos Lonicerae is sweet in flavor and cold in property, goes into lung, the stomach warp.The function heat-clearing and toxic substances removing.Cure mainly affection due to external wind and heat, or heat is gone into edema caused by disorder of QI and nutrient blood, fever and cough, laryngopharynx swelling and pain, dysentery, diseases such as carbuncle sore.
Fructus Gardeniae nature and flavor bitter cold is gone into the heart, liver, lung, stomach warp.The function clearing away heat-fire, removing pathogenic heat from blood and toxic substance from the body.Cure mainly the calentura agitation, the conjunctival congestion pharyngalgia, dysentery, jaundice, dark coloured urine drenches pain, diseases such as pathopyretic ulcer.
Because Radix Scutellariae, Flos Lonicerae, Radix Et Rhizoma Rhei, Fructus Gardeniae four medical instruments have infection pharmacology activity more widely, in addition the producible synergism of combination drug.
Summary of the invention
First purpose of the present invention is to disclose a kind of Chinese medicine composition for the treatment of infantile fever caused by exogenous pathogens.
Second purpose of the present invention is to disclose a kind of preparation method for the treatment of the Chinese medicine composition of infantile fever caused by exogenous pathogens.
The 3rd purpose of the present invention is to disclose a kind of new pharmaceutical use for the treatment of the Chinese medicine composition of infantile fever caused by exogenous pathogens.
First purpose of the present invention is achieved by the following technical solution:
The Chinese medicine composition of treatment infantile fever caused by exogenous pathogens of the present invention is made by the raw material of following weight ratio:
Radix Scutellariae 200-320 weight portion Flos Lonicerae 200-320 weight portion
Radix Et Rhizoma Rhei 200-320 weight portion Fructus Gardeniae 100-220 weight portion.
The Chinese medicine composition of treatment infantile fever caused by exogenous pathogens of the present invention, preferably make by the raw material of following weight ratio:
Radix Scutellariae 240-300 weight portion Flos Lonicerae 240-300 weight portion
Radix Et Rhizoma Rhei 240-300 weight portion Fructus Gardeniae 120-180 weight portion.
The Chinese medicine composition of treatment infantile fever caused by exogenous pathogens of the present invention, preferably make by the raw material of following weight ratio:
Radix Scutellariae 285 weight portion Flos Loniceraes 285 weight portions
Radix Et Rhizoma Rhei 285 weight portion Fructus Gardeniaes 150 weight portions.
The Chinese medicine composition of treatment infantile fever caused by exogenous pathogens of the present invention, preferably make by the raw material of following weight ratio:
Radix Scutellariae 300 weight portion Flos Loniceraes 285 weight portions
Radix Et Rhizoma Rhei 260 weight portion Fructus Gardeniaes 170 weight portions.
The Chinese medicine composition of treatment infantile fever caused by exogenous pathogens of the present invention, most preferably make by the raw material of following weight ratio:
Radix Scutellariae 285 weight portion Flos Loniceraes 285 weight portions
Radix Et Rhizoma Rhei 260 weight portion Fructus Gardeniaes 170 weight portions.
A kind of preparation method for the treatment of the Chinese medicine composition of infantile fever caused by exogenous pathogens disclosed by the invention is:
Step 1: get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 6-18 and doubly measure (weight ratio) water boil, add Radix Scutellariae, decocting 0.5-3 hour, filter, filtrate A;
Step 2: medicinal residues add 6-12 times of water and decocted 0.5-1.5 hour again, filter, and get liquor B;
Step 3: merging filtrate A, B, concentrating under reduced pressure is put the cold liquor C that gets;
Step 4: liquor C adds ethanol, makes to contain the alcohol amount and reach 60-80%, stir evenly, cold preservation 12-48 hour, filter, supernatant;
Step 5: supernatant reclaims ethanol to there not being the alcohol flavor, concentrates, and preparation process is routinely made the acceptable any conventional dosage form of pharmaceutics, comprises capsule, tablet, granule, gel, slow releasing agent, oral liquid.
Preferable methods is in the above-mentioned steps 1: Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae add 15 times of water gagings boils, and adds Radix Scutellariae, decocting 2.5 hours;
Preferable methods is in the above-mentioned steps 2: medicinal residues add 10 times of water and decocted 1 hour again, filter;
Preferable methods is in the above-mentioned steps 4: add ethanol, make to contain the alcohol amount and reach 75%.
For above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.For making above-mentioned dosage form can realize pharmacy of Chinese materia medica, need when these dosage forms of preparation, to add acceptable other adjuvant of pharmacy (adjuvant of each dosage form record among the Fan Biting " pharmacy of Chinese materia medica ", Shanghai Science Press December in 1997 the 1st edition).
The preparation method of the oral liquid of a kind of Chinese medicine composition for the treatment of infantile fever caused by exogenous pathogens disclosed by the invention is (described weight portion/parts by volume is corresponding to g/ml):
Step 1: get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 6-18 and doubly measure (weight ratio) water boil, add Radix Scutellariae, decocting 0.5-3 hour, filter, filtrate A;
Step 2: medicinal residues add 6-12 times of water and decocted 0.5-1.5 hour again, filter, and get liquor B;
Step 3: merging filtrate A, B, concentrating under reduced pressure is put the cold liquor C that gets;
Step 4: liquor C adds ethanol, makes to contain the alcohol amount and reach 60-80%, stir evenly, cold preservation 12-48 hour, filter, supernatant;
Step 5: supernatant reclaims ethanol to there not being the alcohol flavor, concentrates, and adds refined honey 80-150 weight portion, and sucrose 100-200 weight portion dissolves and stirs evenly, put coldly, thin up with sodium hydroxide adjust pH to 5.0～7.0, is adjusted total amount to 1000 parts by volume, stirs evenly, leave standstill, filter, embedding, sterilization is promptly.
Oral liquid of the present invention is defended all heat syndromes of gas to infantile fever caused by exogenous pathogens and is had good curative effect, and total effective rate reaches 91.3%.This oral liquid possesses the effect of bringing down a fever significantly, and the effect stability of bringing down a fever.
Because compositions is cold and cool medicine, cause diarrhoea easily, proportioning provided by the present invention had both realized the effect of bringing down a fever significantly, had also avoided the diarrheal generation simultaneously.
In the preparation method of the present invention, adopt decocting to boil, control contains the alcohol amount, can improve the content of main component significantly, improves the antibiotic effect of bringing down a fever, and alleviating diarrhoea is had certain effect.
In the preparation method of oral liquid of the present invention, can guarantee the stable content of baicalin in the oral liquid with sodium hydroxide adjust pH to 5.0～7.0.
Following experimental example and embodiment do further explanation to the present invention, but are not construed as limiting the invention.
Yellow Cape jasmine frondosa oral liquid described in the following experimental example is the prepared product of embodiment 1 method.
Experimental example 1 clinical experiment
Physical data
Observe 402 examples altogether.Wherein, 302 examples are organized in treatment, matched group 100 examples; Outpatient service infant 302 examples, infant 100 examples of being in hospital.
One, sex
In 402 routine infants, male's 215 examples, women's 187 examples.Two groups of infant sex compositioies relatively see Table 1.
Table 1 liang group sex composition comparison sheet
X
2Check: two groups of sex compositioies compare X
2=0.655, P＞0.05, difference does not have the significance meaning.
Two, the age
Between year, two groups of age distribution relatively see Table 2.
The table 2 liang group age (year) the distribution comparison sheet
X
2Check: X is compared in two groups of age distribution
2=5.226, P＞0.05, difference does not have the significance meaning.
Three, the course of disease
Between 1 hour～48 hours.Two groups of courses of disease relatively see Table 3.
The table 3 liang group course of disease (hour) comparison sheet
X
2Check: two groups of courses of disease compare X
2=5.146, P＞0.05, difference does not have the significance meaning.
Four, the state of an illness
Two groups of state of an illness relatively see Table 4.
Table 4 liang group state of an illness comparison sheet
X
2Check: two groups of state of an illness compare X
2=0.207, P＞0.05, difference does not have the significance meaning.
Five, body temperature
The body temperature average relatively sees Table 5 before two groups of infant treatments.
Table 5 liang group body temperature average comparison (℃) table
The U check: treat preceding body temperature average relatively for two groups, P＞0.05, difference does not have the significance meaning.
Six, syndrome analysis
Treat preceding two groups of infant syndrome analyses relatively, see Table 6.
Table 6 a liang group infant syndrome is analyzed the situation comparison sheet
Two groups relatively, and difference does not have the significance meaning.
Seven, lab testing
1. blood leukocytes sum abnormal conditions relatively see Table 7 around the preceding two groups of infants of treatment.
Table 7 liang group total white blood cells abnormal conditions relatively
Annotate: WBC sum＞10 * 10
9/ L is for increasing＜4 * 10
9/ L is for reducing.
X
2Check: △ and matched group compare, X
2=0.757, P＞0.05, difference does not have the significance meaning.
2. paper antibacterial culturing situation is wiped away in the preceding two groups of infants pharynx of treatment, sees Table 8.
Paper antibacterial culturing situation is wiped away in table 8 a liang group pharynx
X
2Check: two groups relatively, X
2=2.423, P＞0.05, difference does not have the significance meaning.
3. the preceding two groups of infant blood neutrophil alkaline phosphatase situations of treatment see Table 9.
Table 9 liang group alkali phosphatase detection case relatively sees Table 9.
X
2Check: two groups relatively, X
2=0.255, P＞0.05, difference does not have the significance meaning.
Test method
According to " new Chinese medicine treatment infantile fever caused by exogenous pathogens clinical research guideline ", cure mainly in conjunction with yellow Cape jasmine frondosa oral liquid effect, it is as follows to formulate this medicine II clinical trial phase method.
One, diagnoses dialectical standard
1. tcm diagnosis standard: infantile fever caused by exogenous pathogens (defending all heat syndromes of gas)
(1) heating, aversion to cold, nasal obstruction, watery nasal discharge, sneeze, pharyngeal swelling and ache.
All had in (2) four o'clock, and be more common in the Winter-Spring, often fall ill because of the weather cataclysm.
(3) have concurrently cough, restlessness and thirst, be hard and dry, the yellow urine amount is few, red tongue, yellow fur, full and rapid pulse.
Possess above-mentioned (1), (2) item, can be diagnosed as flu, have 2 above persons in (3) item simultaneously, then can examine to defending all heat syndromes of gas.
2. Western medicine diagnose standard: acute upper respiratory tract infection
Make diagnosis according to symptoms such as fever with chills, nasal obstruction watery nasal discharge, cough, red swelling of the pharynx, be divided into three types by its state of an illness weight.
Light-duty: generate heat T37.2 ℃～37.9 ℃, slightly aversion to cold, slight nasal obstruction, idol watery nasal discharge, sneeze are arranged, tussicula, swallow red, mouth slightly yearningly, be hard and dry, once red tongue with thin fur was white in 1～2 day, floating and rapid pulse.
Medium-sized: as T38 ℃～38.9 ℃ aversion to cold that generate heat, nasal obstruction watery nasal discharge, to be interrupted cough, thirsty, happiness drink, yellow urine, to be hard and dry 3 days once, red swelling of the pharynx, tonsil I～II ° enlargement, pain slightly, red tongue with yellow fur, the swollen number of floating pulse.
Heavy: heating is more than T39 ℃.Aversion to cold need add clothing, nasal obstruction watery nasal discharge, hacking cough, thirst and liking cold drink, vexed restlessness, yellow urine amount are few round the clock, stool is stiff as spherical, and 3～4 days once, pharyngeal hyperemia, pharyngeal cavity, soft palate are red and swollen or see herpes, ulcer, tonsil II～III ° enlargement, pain, red tongue with yellow fur, floating and rapid pulse.
Two, test case standard
1. include the case standard in
Meet this diagnosis of disease and Chinese medical discrimination standard, the age, the course of disease can be included the test case in 2 days more than 2.5 years old.
2. get rid of the case standard
(1) severe malnutrition or with the serious systemic disease patient of other cardiovascular, liver, kidney and hemopoietic system, the psychotic is to this medicine allergy sufferers.
(2) patients such as suppurative tonsillitis, bronchitis, bronchiolitis, pneumonia.
Three, group technology
Adopt the treatment of random packet, be divided into treatment group (yellow Cape jasmine frondosa oral liquid group) and matched group (QINGRE JIEDU KOUFUYE group).
Four, the medication and the course of treatment
1. medication
Treatment group: oral yellow Cape jasmine frondosa oral liquid.
Instructions about how to take medicine: 3 times 4～6 years old on the one one time 10ml of 2～3 years old one time 5ml 3 times on the one
7～10 years old one time 15ml 3 times 11 years old on the one is with last 20ml 3 times on the one
Matched group: oral QINGRE JIEDU KOUFUYE.
Instructions about how to take medicine: with the treatment group.
2. course of treatment: 72 hours.
Five, observation item and syndrome standards of grading
1. heating
Normally: T＜37.2 ℃ (axil temperature) 0 minute is slight: T37.2 ℃～37.9 ℃ 2 minutes
Moderate: T38 ℃～38.9 3 minutes severe: T 〉=39 ℃ 4 minutes
2. nasal obstruction watery nasal discharge
Normally: it is slight not have nasal obstruction watery nasal discharge 0 minute: slight nose is cold, idol had watery nasal discharge 1 minute
Moderate: nasal obstruction light night in daytime is heavy, be interrupted watery nasal discharge 2 minutes
Severe: continue nasal obstruction, frequent watery nasal discharge 3 minutes
3. cough
Normally: do not have and cough 0 fen slightly: daytime, 1 minute orthobiosis is coughed, do not influenced to idol
Moderate: be interrupted cough 2 minutes round the clock
Severe: hacking cough or apasm of coughing round the clock, influence are lived and were slept 3 fens
4. pharyngeal swelling and ache
Normally: swallowed not red not bitterly 0 minute
Slightly: swallow red not swelling and ache 2 fens
Moderate: red swelling of the pharynx, tonsil I～II ° enlargement be pain 3 minutes slightly
Severe: pharyngeal hyperemia, pharyngeal cavity, soft palate are red and swollen or saw herpes, ulcer, tonsil II～III ° enlargement, pain 4 minutes
5. aversion to cold
Normally: no aversion to cold 0 minute is slight: slightly aversion to cold, need not add clothing 1 minute
Moderate: aversion to cold, the 2 fens severe of need putting on more clothes: aversion to cold, need add quilt 3 minutes
6. thirsty
Normally: mouthful not thirsty 0 minute slight: mouthful thirsty slightly 1 minute
Moderate: thirstyly like 2 fens severe: thirst and liking cold drink 3 minutes
7. defecate
Normally: defecated normal 0 minute
Slightly: be hard and dry 1～2 day one time 1 minute
Moderate: be hard and dry 3 days one time 2 minutes
Severe: big dry stool such as spherical 3～4 days one time 3 minutes
8. irritated
Normally: do not have irritated 0 minute unusually: vexed restlessness 1 minute
9. urinate
Normally: urinate normal 0 minute unusually: few 1 minute of the yellow amount of stool
10. body of the tongue
Normally: light red 0 minute of body of the tongue is unusual: red tongue 1 minute
11. tongue fur
Normally: white and thin fur 0 minute is unusual: yellow fur 1 minute
12. pulse condition
Normally: normal pulse 0 minute is unusual: several 1 minute of floating and rapid pulse or flood
Six, statistical method
Adopt Ridit analysis, X
2Check and t check or u-test method.
Result of the test
One, efficacy assessment standard
Formulate the criterion of therapeutical effect of " new Chinese medicine clinical research guideline " infantile fever caused by exogenous pathogens with reference to Ministry of Public Health.
1. recovery from illness: took medicine 24～48 hours in, temperature recovery is normal, and (below the axil temperature drop to 37.2 ℃, no longer ging up), syndrome disappears, and unusual physical and chemical index recovers normal.
2. produce effects: took medicine 24～48 hours in, temperature recovery is normal, and main syndrome is most of to disappear, and integrated value descends 〉=2/3, and unusual physical and chemical index is near normal.
3. effective: took medicine 48～72 hours in, temperature recovery is normal, and main syndrome partly disappears, and integrated value descends 〉=1/3, and unusual physical and chemical index makes moderate progress.
4. invalid: as not meet above standard.
Two, result and analysis
1. two groups of total effectses relatively see Table 10.
Table 10 liang group total effects relatively
Ridit analyzes: 95% credibility interval of matched group R is (0.299,0.415), does not comprise and less than 0.5, illustrates that treatment group curative effect is better than matched group.
2. each observation unit's total effects relatively sees Table 11.
The curative effect of yellow Cape jasmine frondosa oral liquid relatively between each observation unit of table 11
Ridit analyzes: to add up to routine number is criterion group, and the R value of Tianjin College of Traditional Chinese Medicine one attached institute, Affiliated Hospital of Medical University Of Tianjin, Tianjin Children's hospital is respectively 0.5053,0.5514,0.4637, and the curative effect between each observation unit compares, X
2=4.0936, P＞0.05 illustrates that difference does not have the significance meaning between the yellow Cape jasmine frondosa oral liquid curative effect that three tame hospitals observe.
3. treatment group compares the curative effect of different state of an illness typings, sees Table 12.
Table 12 treatment group compares the curative effect of different state of an illness infants
Ridit analyzes: light-duty group of R95% credibility interval be (0.582,0.659), do not comprise and greater than medium-sized group of (criterion group) 0.5, and heavy to organize the R95% credibility interval be (0.349,0.475), do not comprise and less than 0.5.Illustrate that light-duty group of curative effect is better than medium-sized group, medium-sized group of curative effect is better than heavy group.
4. bring down a fever onset time relatively for two groups, see Table 13.
Table 13 a liang group is brought down a fever onset time relatively
Annotate: body temperature descended 1 ℃ of required time after the onset time of bringing down a fever referred to take medicine.
T check: ※ and matched group comparison, t=5.306, P＜0.001, treatment group onset time of bringing down a fever is significantly shorter than matched group.
5. two groups of complete fever times relatively see Table 14.
The table 14 liang complete fever time of group
Annotate: body temperature dropped to below 37.2 ℃ no longer to go up the required time after fever time referred to take medicine fully.
U-test: ※ and matched group compare, u=2.157, and P＜0.05, the treatment group is brought down a fever onset time less than matched group.
6. two groups of treatment group symptoms compare with unusual tongue arteries and veins disappearance situation, see Table 15.
Table 15 liang group treatment back syndrome analytical table
The treatment group to heating, nasal obstruction watery nasal discharge, the red and swollen pain of pharynx, thirsty, be hard and dry and the treatment disappearance rate of tongue body and tongue coating, pulse condition apparently higher than matched group.
7. two groups of treatment front and back symptoms compare with unusual tongue arteries and veins integration differential, see Table 16.
Syndrome integration differential analytical table before and after the table 16 liang group treatment
The treatment group to heating, nasal obstruction watery nasal discharge, the red and swollen pain of pharynx, thirsty, be hard and dry and the treatment of unusual tongue, tongue, pulse condition etc. before and after integration differential greater than matched group.
8. two groups of treatment back unusual recovery situations of total white blood cells compare, and see Table 17.
Table 17 liang group leukocyte disorder recovery situation relatively
X
2Check: △ and matched group compare, X
2=1.314, P＞0.05.
9. the two groups of neutrophil alkaline phosphatase abnormal restoring situations in treatment back relatively see Table 18.
Table 18 liang group treatment back neutrophil alkaline phosphatase abnormal restoring situation relatively
X
2Check: compare with matched group, it recovers natural rate of interest through X
2Check difference does not have the significance meaning, P＞0.05, and alkali phosphatase reduces close with rising person's recovery situation and matched group before the treatment.
Three, safety evaluation
Organize in 302 examples in the treatment of yellow Cape jasmine frondosa oral liquid, have 6 examples to take medicine for the first time and nausea and vomiting occurs, do not see vomiting after continuing to take medicine, do not find other untoward reaction in addition.Lab index detects, and does not also find that this medicine has harmful effect to hematuria routine, hepatic and renal function and electrocardiogram.Laboratory detects and does not find that yellow Cape jasmine frondosa oral liquid has harmful effect to the hematuria routine.
Experimental example 2 yellow Cape jasmine frondosa oral liquid extracorporeal bacteria inhibitor tests
(1) test objective:
Observe the external anti-shady effect of yellow Cape jasmine frondosa oral liquid.
(two〉be subjected to the reagent thing
Yellow Cape jasmine frondosa oral liquid, medicament teaching and research room of Beijing University of Chinese Medicine provides, lot number 950701
Gentamycin (Gm), lot number 9507083, the 600 μ g/mg that tire, Qingdao pharmaceutical factory provides.
Pipemidic acid (PPA), lot number 9486007, purity 99.6%, Shandong Xinhua Pharmaceutical Factory provides.
Solvent: gentamycin is water-soluble, and PPA dissolves with a small amount of 0.5N NaOH.
Compound method:
Control sample is mixed with desired concn with MH meat soup with a small amount of molten Liu's dissolving after the dissolving.
(3) test procedure:
1. that to be MH (DIFCO) transfer to 8.0,15 pounds of sterilizations in 30 minutes of PH with the MH culture medium to culture medium is standby.
2. test organisms:
(1) Quality Control bacterium: the golden bacterium ATCC25923 of Portugal, (calibrating of Ministry of Public Health pharmaceutical biological product provides for escherichia coli ATCC25922 and bacillus pyocyaneus ATCC27853.)
(2) reference culture: the calibrating of Ministry of Public Health pharmaceutical biological product provides.
(3) clinical separation pathogenic bacterium are differentiated rearmounted-80 ℃ of cryogenic refrigerators preservation through separating, and all are the clinical collections of nearly 1-2.Most of strains derive from this city various big hospital.
3. test method and step
Plate doubling dilution: will dissolve agar culture medium and quantitatively pour the interior and medicine mixing (streptococcus and enterococcus add 5% and go the fiber Sanguis caprae seu ovis to make blood meida) of plate that preparation contains medicine series concentration into.After waiting to solidify, will dilute bacterium liquid (10 again
6CFU/ml) will dilute bacterium liquid with multiple spot inoculation instrument is inoculated in and contains on the medicine series plate agar, cultivate the least concentration of observing the medicine bacteria growing inhibiting through 37 ℃ of 18h, be minimum inhibitory concentration (MIC), and calculate medicine MIC50 and MIC90 and other antibacterials relatively.
Note:
MIC50: suppress the minimum bacteriostatic concentration of 50% bacterial growth.
MIC90: suppress the minimum bacteriostatic concentration of 90% bacterial growth.
4. the test knot is tired:
To totally 118 strains and totally 201 strains of 3 strain Quality Controls gold Portugal bacterium of clinical separation pathogenic bacterium, the antibacterial activity result is as follows with reference to antibacterials for yellow Cape jasmine flower and 2 kinds:
Yellow as can be seen from Table 1 Cape jasmine is spent streptococcus pneumoniae, the Class B streptococcus, and enterococcal MIC50 and MIC90 all are inferior to GM and PPA at 12-48mg/ml.
Yellow Cape jasmine is spent producing enzyme gold Portugal bacterium and not producing enzyme gold Portugal bacterium, produce the enzyme form staph and do not produce the enzyme form staph and certain antibacterial activity MIC50 and MIC90 are arranged all at 0.8-6mg/ml, than streptococcus pneumoniae, group B streptococcus, enterococcus is strong, and its antibacterial activity is inferior to GM and PPA (seeing Table 1).Yellow Cape jasmine is spent escherichia coli, bacillus pyocyaneus, and 6 strain bacterium such as pneumobacillus and proteus vulgaris also have certain antibacterial activity (seeing Table 2)
The yellow Cape jasmine flower of table 1 and 2 kinds of antibacterials are to streptococcus and enterococcus and the staphylococcic antibacterial activity comparison of 54 strains
Annotate: mg/ml is that every ml contains dry extract mg in the table
The antibacterial action of yellow Cape jasmine flower of table 2 and antibacterials
Annotate: mg/ml is that every ml contains dry extract mg number in the table.
5. conclusion
Yellow Cape jasmine flower has stronger activity in the Chinese medicine antibacterial action, to the enterococcus antibacterial action a little less than, streptococcus pneumoniae and Class B streptococcus also there is certain antibacterial action, but demonstrate good antibacterial action to producing non-product enzyme gold Portugal bacterium of enzyme and form staph, this product is to the negative bacterium pneumobacillus, escherichia coli, bacillus pyocyaneus and proteus vulgaris all can be measured antibacterial activity.
Antibacterial tests in the experimental example 3 yellow Cape jasmine frondosa oral liquid mice bodies
One, experiment purpose: observe protective effect and the dose-effect relationship of yellow Cape jasmine frondosa oral liquid to the infection of staphylococcus aureus mice.
Two, animal: NIH kind mice, 12-14g, male and female half and half, quality certification 9209M23, Ministry of Public Health institute of Biological Products.
Three, infection bacteria species: staphylococcus aureus (26002), available from Nat'l Pharmaceutical ﹠ Biological Products Control Institute strain chamber.
Four, infection dosage and route of infection
1. infection dosage: 6 * 10
8/ only as infection dosage, trial test mouse death rate 85%.
2. route of infection: lumbar injection, 0.4ml/ are only.
Five, test drug:
Yellow Cape jasmine frondosa oral liquid, lot number 950701, Beijing University of Chinese Medicine's Chinese medicine provides.
Positive control drug amoxicillin dry syrup, lot number 950602, Chinese-foreign joint Dong Le pharmaceutical Co. Ltd produces.
Six, test method
(1) trial test of infection dosage
Get 100 of NIH kind mices, body weight 12-14g is divided into 5 groups at random, and 20 every group, each organizes body weight does not have significant difference (P＞0.05), and respectively bacterium liquid 0.4ml/ of group difference lumbar injection variable concentrations gradient, the bacterium amount is respectively 2 * 10
8/ only, 4 * 10
8/ only, 6 * 10
8/ only, 8 * 110
8/ only, 10 * 10
8/ only.Observe the death condition of animal in 15 days, infection dosage 6 * 10 as a result
8/ mortality rate is determined with 6 * 10 at last more than 80%
8/ only use infection dosage for test, the results are shown in Table 1.
Table 1 infection dosage result of the test
(2) yellow Cape jasmine frondosa oral liquid is to the endogenous protective effect test of infecting mouse
Get 100 of NIH kind mices, body weight 12.8 ± 0.96g, male and female half and half, be divided into 5 groups at random, comprise normal group, infect matched group, positive controls (the disposable administration of amoxycillin toximycin dry syrup 0.5g/kg), yellow Cape jasmine flower low dose group 20.0g crude drug (2.2g dry extract)/kg/d, (low dosage is equivalent to 1/2 of clinical equivalent dosage by what people and the weight of animals ratio were converted into to yellow Cape jasmine flower high dose group 40.0g crude drug (4.4g dry extract)/kg/d, high dose is its 2 times), each organizes weight ratio than there was no significant difference (P＞0.05), before the infection, yellow Cape jasmine flower medication group difference gastric infusion 1 day, 2 times on the one, each 0.2ml/ only is total to its and only irritates distilled water 0.2ml/, second day, except that normal group lumbar injection equal-volume normal saline, other only respectively organize the lumbar injection gold bacterium liquid 0.4ml/ of Portugal, and infection dosage is 6 * 10
8/ only, normal group, infect and irritate distilled water 0.2ml at once after matched group infects, the disposable filling amoxicillin of positive controls dry syrup 0.5g/kg, yellow Cape jasmine spend two dosage groups gastric infusion respectively, a twice-daily, successive administration two days, observe general behavior, death toll, the death time of animal, observed X continuously 15 days
2 (2 * 2)Method check experimental result the results are shown in Table 2.
Antibacterial tests result in the yellow Cape jasmine frondosa oral liquid of table 2 body
Table 2 is the result show, the animal dis motility rate of yellow Cape jasmine frondosa oral liquid 40g crude drug (4.4g dry extract)/kg/d dosage group is significantly higher than and infects matched group (P0.05), and has certain dose-effect relationship.
The refrigeration function of experimental example 4 yellow Cape jasmine frondosa oral liquids
Heating is the most outstanding symptom of infantile respiratory tract infection.This experiment is a model with yeast pyrogenicity rat and Typhoid Vaccine pyrogenicity rabbit, studies the refrigeration function of yellow Cape jasmine frondosa oral liquid, for the clinical treatment infantile fever caused by exogenous pathogens provides experimental basis.
(1) material
Animal: the big white family of ear of Japan exempts from, and is male, body weight 1.6-2.0 kilogram.The Wistar rat, male, body weight is the 160-220 gram.Provide by Chinese Academy of Medical Sciences's animal center, word 9209-R018 is moved in quality certification capital.
Medicine: yellow Cape jasmine frondosa oral liquid is provided by this school TCM Preparation Room, lot number 920805, and every 10ml, every ml includes crude drug 1g, and the time spent heating concentrates or is diluted to desired concn.
Aspirin is produced lot number 911115 for pharmaceutical factory of Shenyang Pharmacy College.The typhoid fever triple vaccine is produced by the Ministry of Public Health institute of biological products, lot number 921-5.Yeast is the marketable high activity dry yeast, is produced lot number 9206 by sugar refinery, Dongguan, Guangdong Province yeast subsidiary factory.
Electronic clinical thermometer is for Japan produces OMRON MC-8 type.
(2) method and result
1. to the influence of yeast pyrogenicity rat:
Get 40 of rats, be divided into five groups at random, after recording normal anus temperature, in nape portion subcutaneous injection 10% yeast suspension 10ml/kg with pyrogenicity, inject and measured the preceding pyrogenicity body temperature of administration in back 6 hours, gastric infusion then, yellow Cape jasmine spend large, medium and small dosage group to be respectively 30g/kg, 15g/kg and 5g/kg (be equivalent to respectively human body ampoule 0.4g/kg 75 times, 37.5 times and 12.5 times).It is 0.4g/kg (for 40 times of people's body and function amount 10mg/kg/ time) that the aspirin group is treated dosage, and matched group waits the capacity normal saline.Thermometric 1 time per hour after administration is surveyed 6 times altogether.The difference of body temperature and pyrogenicity body temperature after the calculating administration.Thermometer inserts the about 3cm of anus.22～24 ℃ of room temperatures.The results are shown in Table 1.
(3) conclusion
Yellow Cape jasmine frondosa oral liquid all has tangible antipyretic effect to two kinds of pyrogenicity animal models.The strongest to yeast pyrogenicity rat with the effect of heavy dose group, keep and reach more than 6 hours.Reduce with dosage, action intensity weakens to some extent, and the shortening of holding time still has remarkable antipyretic effect during 5g/kg, and holding time still reaches 4 hours.Typhoid Vaccine pyrogenicity man is exempted from that obvious antipyretic effect is also arranged, and acting duration is more than 2 hours, effect in 1 hour particularly significantly (P＜0.01) after the wherein low dose of administration.
Experimental example 5 yellow Cape jasmine frondosa oral liquid acute toxicity tests
One, test material:
1. animal: Kunming mouse, body weight 18-22 gram is provided by Chinese Academy of Medical Sciences's animal center, the quality certification number: M139290.
2. tried thing:
Yellow Cape jasmine frondosa oral liquid, TCM Preparation Room provide by this school, lot number: 920805, every ml contains crude drug 1g, and heating is concentrated into the 1.75g/ml crude drug before the test.
Contrast 1: Radix Scutellariae 315g, Flos Lonicerae 285g, Radix Et Rhizoma Rhei 300g, Fructus Gardeniae 190g; According to the method preparation of embodiment 1, every ml contains the about 1g of crude drug.
Contrast 2: Radix Scutellariae 330g, Flos Lonicerae 265g, Radix Et Rhizoma Rhei 270g, Fructus Gardeniae 180g.According to the method preparation of embodiment 1, every ml contains the about 1g of crude drug.
Two, method and result
Get 60 of above-mentioned healthy mices, divide three groups, fasting 12 hours, male and female half and half, every oral awarding of mice is tried thing 0.8ml/20g, a twice-daily, and total amount is equivalent to crude drug 140g/kg, 93.3 times of quite clinical people's consumption, at once observe after the administration, and observed continuously 7 days, the results are shown in Table:
Table: yellow Cape jasmine frondosa oral liquid acute toxicity test in mice result
| Experimental group | Number of animals (only) | Dosage g/kg | Body weight (g) X ± SD before the administration | The 7th day body weight (g) of reaction of animals administration X ± SD after the administration | The extremity activity | Hair | Diet | Drinking-water | Drain | Dead |
| Yellow Cape jasmine frondosa oral liquid | 20 | 140 | 20.2±1.5 | 26.1±2.0 | Normally | Normally | Normally | Normally | Shaping or slightly rare | Do not have |
| Contrast 1 | 20 | 140 | 20.1±1.2 | 23.2±1.8 | Movable less slightly | Normally | Less slightly | Less slightly | Rare soft shapeless | Do not have |
| Contrast 1 | 20 | 140 | 20.5±1.3 | 24.8±1.6 | Movable less slightly | Normally | Less slightly | Less slightly | Rare soft shapeless | Do not have |
Three, conclusion
By table as seen, the oral yellow Cape jasmine frondosa oral liquid 140g/kg crude drug of mice is equivalent to 93.3 times of human dosage, and all healthy survival of mice as a result and weight increase only have a small amount of animal laxativeness to occur, and can recover normal in 24 hours.And matched group 1 and matched group 2 diarrhoea are comparatively serious, and lose weight obviously.
Following embodiment all can realize the described effect of above-mentioned experimental example
The specific embodiment
Embodiment 1: oral liquid
Radix Scutellariae 285g, Flos Lonicerae 285g, Radix Et Rhizoma Rhei 260g, Fructus Gardeniae 170g
Method for making: above four flavors, Radix Scutellariae, Radix Et Rhizoma Rhei are made decoction pieces, Fructus Gardeniae is smashed.Get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 15 times of water gagings and boil, add Radix Scutellariae, decocting 2.5 hours.Filter, medicinal residues add 10 times of water and decocted 1 hour again, filter.Merge decocting liquid twice, be evaporated to about 1000ml, put cold.Add ethanol, make to contain the alcohol amount and reach 75%, stir evenly, cold preservation 24 hours filters.Filtrate recycling ethanol continues to be concentrated into relative density 1.15～1.20 (50 ℃ of heat are surveyed) to there not being the alcohol flavor.Add refined honey 100g, sucrose 150g dissolves and stirs evenly, and puts coldly, and thin up 800ml adjusts total amount to 1000ml with sodium hydroxide adjust pH to 5.0～7.0., stirs evenly.Leave standstill. filter, embedding, sterilization is promptly.
Function with cure mainly: lung heat clearing expelling pathogenic factors from the exterior, eliminating fire and detoxication.Be used for exogenous affected hyperthermia, simultaneous occurrence of syndromes of both QI and WEI systems, disease sees that heating do not move back, aversion to cold headache, laryngopharynx swelling and pain, restlessness and thirst, constipation, oliguria with reddish urine.
Usage and dosage: oral.Each 3-5ml below 3 years old, each 5-10ml of 3-6 year, each 10-20ml of 6-12 year, 3 times on the one.
Embodiment 2: tablet
Radix Scutellariae 285g Flos Lonicerae 285g Radix Et Rhizoma Rhei 285g Fructus Gardeniae 150g
Method for making: above four flavors, Radix Scutellariae, Radix Et Rhizoma Rhei are made decoction pieces, Fructus Gardeniae is smashed.Get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 15 times of water gagings and boil, add Radix Scutellariae, decocting 2.5 hours; Filter, medicinal residues add 10 times of water and decocted 1 hour again, filter.Merge decocting liquid twice, be evaporated to about 1000ml, put cold.Add ethanol, make to contain the alcohol amount and reach 75%, stir evenly, cold preservation 24 hours filters.Filtrate recycling ethanol continues to be concentrated into relative density 1.15～1.20 (50 ℃ of heat are surveyed) to there not being the alcohol flavor, makes tablet through conventional technology.
Embodiment 3: capsule
Radix Scutellariae 300g Flos Lonicerae 285g Radix Et Rhizoma Rhei 260g Fructus Gardeniae 170g
Method for making: above four flavors, Radix Scutellariae, Radix Et Rhizoma Rhei are made decoction pieces, Fructus Gardeniae is smashed.Get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 15 times of water gagings and boil, add Radix Scutellariae, decocting 2.5 hours.Filter, medicinal residues add 10 times of water and decocted 1 hour again, filter.Merge decocting liquid twice, be evaporated to about 1000ml, put cold.Add ethanol, make to contain the alcohol amount and reach 75%, stir evenly, cold preservation 24 hours filters.Filtrate recycling ethanol continues to be concentrated into relative density 1.15～1.20 (50 ℃ of heat are surveyed) to there not being the alcohol flavor, makes capsule through conventional technology.
Embodiment 4: oral liquid
Radix Scutellariae 285g, Flos Lonicerae 285g, Radix Et Rhizoma Rhei 260g, Fructus Gardeniae 170g
Method for making: above four flavors, Radix Scutellariae, Radix Et Rhizoma Rhei are made decoction pieces, Fructus Gardeniae is smashed.Get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 15 times of water gagings and boil, add Radix Scutellariae, decocting 1.5 hours.Filter, medicinal residues add 8 times of water and decocted 1.2 hours again, filter.Merge decocting liquid twice, be evaporated to about 1000ml, put cold.Add ethanol, make to contain the alcohol amount and reach 75%, stir evenly, cold preservation 24 hours filters.Filtrate recycling ethanol continues to be concentrated into relative density 1.15～1.20 (50 ℃ of heat are surveyed) to there not being the alcohol flavor.Add refined honey 100g, sucrose 150g dissolves and stirs evenly, and puts coldly, and thin up 800ml adjusts total amount to 1000ml with the sodium hydroxide adjust pH to 5.5., stirs evenly.Leave standstill. filter, embedding, sterilization is promptly.
Embodiment 5: oral liquid
Radix Scutellariae 285g, Flos Lonicerae 285g, Radix Et Rhizoma Rhei 260g, Fructus Gardeniae 170g
Method for making: above four flavors, Radix Scutellariae, Radix Et Rhizoma Rhei are made decoction pieces, Fructus Gardeniae is smashed.Get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 12 times of water gagings and boil, add Radix Scutellariae, decocting 2 hours.Filter, medicinal residues add 10 times of water and decocted 1 hour again, filter.Merge decocting liquid twice, be evaporated to about 1000ml, put cold.Add ethanol, make to contain the alcohol amount and reach 75%, stir evenly, cold preservation 24 hours filters.Filtrate recycling ethanol continues to be concentrated into relative density 1.15～1.20 (50 ℃ of heat are surveyed) to there not being the alcohol flavor.Add refined honey 100g, sucrose 150g dissolves and stirs evenly, and puts coldly, and thin up 800ml with sodium hydroxide adjust pH to 6.0, adjusts total amount to 1000ml, stirs evenly.Leave standstill. filter, embedding, sterilization is promptly.
Claims (9)
1. Chinese medicine composition for the treatment of infantile fever caused by exogenous pathogens is characterized in that being made by the crude drug of following weight ratio:
Radix Scutellariae 240-300 weight portion Flos Lonicerae 240-300 weight portion
Radix Et Rhizoma Rhei 240-300 weight portion Fructus Gardeniae 120-180 weight portion.
2. Chinese medicine composition as claimed in claim 1 is characterized in that being made by the crude drug of following weight ratio:
Radix Scutellariae 285 weight portion Flos Loniceraes 285 weight portions
Radix Et Rhizoma Rhei 285 weight portion Fructus Gardeniaes 150 weight portions.
3. Chinese medicine composition as claimed in claim 1 is characterized in that being made by the crude drug of following weight ratio:
Radix Scutellariae 300 weight portion Flos Loniceraes 285 weight portions
Radix Et Rhizoma Rhei 260 weight portion Fructus Gardeniaes 170 weight portions.
4. Chinese medicine composition as claimed in claim 1 is characterized in that being made by the crude drug of following weight ratio:
Radix Scutellariae 285 weight portion Flos Loniceraes 285 weight portions
Radix Et Rhizoma Rhei 260 weight portion Fructus Gardeniaes 170 weight portions.
5. as the preparation method of described any one Chinese medicine composition of claim 1-4, it is characterized in that this method comprises the steps:
Step 1: get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 6-18 times of water gaging by weight and boil, add Radix Scutellariae, decocting 0.5-3 hour, filter, filtrate A;
Step 2: medicinal residues add 6-12 times of water and decocted 0.5-1.5 hour again, filter, and get liquor B;
Step 3: merging filtrate A, B, concentrating under reduced pressure is put the cold liquor C that gets;
Step 4: liquor C adds ethanol, makes to contain the alcohol amount and reach 60-80%, stir evenly, cold preservation 12-48 hour, filter, supernatant;
Step 5: supernatant reclaims ethanol to there not being the alcohol flavor, concentrates, and preparation process is routinely made the acceptable any conventional dosage form of pharmaceutics.
6. the preparation method of Chinese medicine composition as claimed in claim 5, it is characterized in that Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae add 15 times of water gagings in this method step 1 boils, and adds Radix Scutellariae, decocting 2.5 hours.
7. the preparation method of Chinese medicine composition as claimed in claim 5 is characterized in that these method step 2 Chinese medicine slags add 10 times of water and decocted 1 hour again, filters.
8. the preparation method of Chinese medicine composition as claimed in claim 5 is characterized in that in this method step 4: add ethanol, make to contain the alcohol amount and reach 75%.
9. the preparation method of Chinese medicine composition as claimed in claim 5 is characterized in that the preparation method of oral liquid comprises the steps:
Step 1: get Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae and add 6-18 times of water gaging and boil, add Radix Scutellariae, decocting 0.5-3 hour, filter, filtrate A;
Step 2: medicinal residues add 6-12 times of water and decocted 0.5-1.5 hour again, filter, and get liquor B;
Step 3: merging filtrate A, B, concentrating under reduced pressure is put the cold liquor C that gets;
Step 4: liquor C adds ethanol, makes to contain the alcohol amount and reach 60-80%, stir evenly, cold preservation 12-48 hour, filter, supernatant;
Step 5: supernatant reclaims ethanol to there not being the alcohol flavor, concentrates, and adds refined honey 80-150 weight portion, and sucrose 100-200 weight portion dissolves and stirs evenly, put coldly, thin up with sodium hydroxide adjust pH to 5.0～7.0, is adjusted total amount to 1000 parts by volume, stirs evenly, leave standstill, filter, embedding, sterilization is promptly;
Described weight portion is corresponding to g; Described parts by volume is corresponding to ml.
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