The specific embodiment
Embodiment 1:
Get Herba Salviae Plebeiae 438 gram, Herba Plantaginis 438 grams, Serissa foetida 438 grams, Herba Violae 219 grams, an amount of with sucrose, dextrin.The above-mentioned medical material that meets the pharmacopeia quality standard decocts, concentrates, extractum (assay, relative density are measured), and granulation, oven dry, granulate are packaged to granule 1000 grams.Also can make other preparations of patient's acceptable.Wherein, high effective liquid chromatography for measuring is pressed dry product and is calculated, and every gram contains homoplantaginin (C
22H
22O
11) must not be lower than 0.08mg.
Instructions of taking: boiled water is taken after mixing it with water, each 15 grams, 3 times on the one.
Said preparation has antibiotic, diuresis dual function, especially to chronic urinary tract system infected patient, it is slight to take side effect for a long time, and curative effect is reliable.
Embodiment 2:
Get Herba Salviae Plebeiae 420 gram, Herba Plantaginis 420 grams, Serissa foetida 420 grams, Herba Violae 210 grams, an amount of with sucrose, dextrin.Surplus with embodiment 1.
As follows to pharmacodynamics test of the present invention:
One, in-vitro antibacterial experiment:
The present invention is to reference culture staphylococcus aureus, micrococcus luteus, and clinical isolates strain staphylococcus aureus, bacillus pyocyaneus, staphylococcus hominis, staphylococcus epidermidis, the false monospore bacillus of Bulbus Allii Cepae, citric acid enterobacteria, Bacillus proteus have stronger bacteriostasis.
Two, antibacterial experiment in the mice body:
When dosage of the present invention is 50.4g/kg, the death of Bacillus proteus infecting mouse there is obvious protective effect.
Get 200 of 19-22g Kunming mouses, be divided into 10 groups at random, 20 every group, (1), (2) are the normal saline group, normal saline 20ml/kg; (3), (4) be the SHUANGHUANLIAN group, SHUANGHUANGLIAN FENZHENJI 3.5g/kg; (5), (6) be granule small dose group of the present invention, dosage is 12.6g/kg; (7), (8) be dosage group in the granule of the present invention, dosage is 25.2g/kg; (9), (10) be the heavy dose of group of granule of the present invention, dosage is 50.4g/kg; Each group is all used the 20ml/kg gastric infusion, every day 1 time, continuous 3 days.1h after the last administration, lumbar injection escherichia coli culture fluid (1,3,5,7,9 group) and Bacillus proteus culture fluid (2,4,6,8,10 groups), 0.5ml/ only observe 72h animal dead situation.
Evidence when dosage of the present invention is 50.4g/kg, has obvious protective effect to the death of Bacillus proteus infecting mouse.
Three, antiinflammatory action
1. mice caused by dimethylbenzene xylene auricle edema test
Get 50 of Kunming mouses, body weight 18-21g, year is divided into 5 groups at random, and 10 every group, ♀ ♂ half and half (snow litchi granule is that the present invention is called for short).
(1) the normal control group gives the equivalent normal saline;
(2) Dexamethasone group 5mg/kg;
(3) granule I group 12.6g/kg of the present invention;
(4) granule II group 25.2g/kg of the present invention;
(5) granule III group 50.4g/kg of the present invention;
Each treated animal ig administration, administration capacity 0.2ml/10g Mus is heavy, and 1 time/d, continuous 5d.1h after the last administration is applied to auricle two sides, a mice left side with 30 μ l dimethylbenzene and causes inflammation, and auris dextra is contrast, cause scorching back 45min and put to death mice, lay left and right sides auricle, weigh with the card punch of diameter 8mm,, calculate swelling and suppress percentage rate as the swelling degree with left and right sides auricle weight difference.
Evidence, the present invention can significantly reduce mice caused by dimethylbenzene xylene ease auricle swelling degree when 11.6g/kg, 34.6g/kg, 69.6g/kg.
2. mouse skin capillary permeability test
Get 50 of Kunming mouses, body weight 18-21g is divided into 5 groups at random, and 10 every group, ♀ ♂ half and half.
(1) the normal control group gives the equivalent normal saline;
(2) Dexamethasone group 5mg/kg;
(3) granule I group 12.6g/kg of the present invention;
(4) granule II group 25.2g/kg of the present invention;
(5) granule III group 50.4g/kg of the present invention;
Each treated animal ig administration, administration capacity 0.2ml/10g Mus is heavy, and 1 time/d, continuous 5d.1h after the last administration, mouse tail iv 0.5% azovan blue solution 0.2ml/10g Mus is heavy, drip dimethylbenzene 40 μ 1 in the unhairing abdominal part immediately, put to death mice behind the 15min, take off homalographic indigo plant with the card punch of diameter 12mm and dye skin, shred to put into and fill 2ml acetone: the test tube of water (7: 3) solution soaks, and places the centrifugal 5min of 3000rpm behind the 20h, get supernatant in the 590nm colorimetric, judge the mouse skin capillary permeability with light absorption value (O.D).
Evidence can reduce the mouse skin capillary permeability very significantly.
Four, analgesic activity
Clear paste of the present invention can obviously reduce mice and turn round number of times when 11.6g/kg dosage, and weak analgesic activity is arranged; When 34.6g/kg and 69.6g/kg dosage, turn round number of times and more reduce, strong analgesic activity is arranged.Three kinds of dosage all can make hot plate method mice pain threshold significantly improve.
Five, heat clearing away test
Clear paste of the present invention is when 12.6g/kg, 25.0g/kg dosage, and antler glue is caused rat fever obvious heat clearing away effect, slower during beginning.When 3.6g/kg, 7.2g/kg and 14.4g/kg dosage, TAB is caused fever in rabbits tangible heat clearing away effect, and the time started is very fast.
Six, diuresis test
Get 50 of ♂ rats, body weight 180-200g is divided into 5 groups at random, 10 every group.
(1) the normal control group gives the equivalent normal saline;
(2) aspirin group 0.1g/kg;
(3) granule I group 6.3g/kg of the present invention;
(4) granule II group 12.6g/kg of the present invention;
(5) granule III group 25.2g/kg of the present invention;
Each treated animal ig administration, administration capacity 1ml/100mg Mus is heavy, and 1 time/d, continuous 3d.Animal fasting 18h before the experiment, the water load is irritated stomach, per hour 1 time totally 2 times with 38 ℃ of normal saline 25ml/kg.Gently press the thing lower abdomen during experiment beginning and drain surplus urine.Immediately rat is put into metabolic cage after the last administration, collect each treated animal urine amount totally 3 times behind the 1h, each 60min.
Evidence when above-mentioned three dosage, can make rat have obviously or very significantly increase in the urine amounts of different periods.
As follows to the toxicology test that the present invention carries out:
One, acute toxicity test
Get 50 of Kunming mouses, body weight 19-22g is divided into 5 groups at random, and 10 every group, ♀ ♂ half and half.Give a dosage, be respectively: 52.2g/kg, 61.4g/kg, 72.3g/kg, 85.0g/kg, 100.0g/kg for every group.Behind fasting (the can't help water) 12h, each group weighs gastric infusion 1 time by above-mentioned dosage 0.4ml/10g Mus respectively before testing, and observes for 1 week behind the filling stomach, and record is tried mice activity, behavior and death condition, and the back execution of 1 week performs an autopsy on sb.
Evidence: irritate no remarkable toxic reaction behind the stomach, also do not have death in the week, and this dosage is 138 times of clinical 1 day oral dose (dose,equivalents 12.5 times).
Two, long term toxicity test
Granule low dose group of the present invention: 12.5g/kg, 10.7 times of clinical dosage, 2 times of dose,equivalent; Dosage group: 31.3g/kg in the granule of the present invention, 27 times of clinical dosage, 5 times of dose,equivalent; Granule high dose group of the present invention: 62.6g/kg, 54 times of clinical dosage, 10 times of dose,equivalent.Normal control group: give the equivalent normal saline.
3 dosage groups of granule of the present invention, isometric(al) is isoconcentration not, and give respectively by above-mentioned dosage every day, administration volume 10ml/kg body weight, 1 gastric infusion, successive administration 6 months.Each group is cutd open 10 animals extremely in the time of 3 months, checks every index comprehensively.Cut open half of killing remaining animal in the time of 6 months, do every detection, second half drug withdrawal continues to observe remaking body weight, food ration, routine urinalysis, routine blood test, blood biochemical, the every detection of organ coefficient 2 weeks.
Rat oral gavage 3 months are given in evidence continuously, and ordinary circumstance is good as a result, weight increase, and every indexs such as food ration, routine urinalysis, routine blood test, blood biochemical are all normal; Histological examination shows, internal organs such as the present invention is dirty to rat heart, liver, lungs, gland, kidney, adrenal gland, thymus, ovary, testis do not have any histology's influence.
Clinical application result of the present invention is as follows:
The present invention comprises cystitis, prostatitis, chronic pyelonephritis (symptom is seen frequent micturition, urgent micturition, dysurea, waist abdominal distention and pain etc.) to damp invasion of lower energizer or double damp-heat in lower-JIAO, pyretic stranguria oliguria with reddish urine, the puckery pain of pouring drop of suffering from a deficiency of the kidney and levying, and curative effect is particularly remarkable.Its cure rate 75%, total effective rate are 90%.Short treating period, transference cure are fast.
Kidney tonifying tonify deficiency of the present invention, invigorating blood circulation dysentery, the diarrhea of heat type that disappears urine help pathogenic bacteria and toxin excretes by urine, regulate body function, the human body immunity improving ability; Antibiotic active ingredient of the present invention is rushed down with urine row through kidney, more helps the antibacterial of urinary tract pathogenic bacteria and sterilization.Do not see obvious toxicity.
Composing prescription preparation stability experiment result of the present invention is as follows:
Influence factor's test
1. strong illumination test
Place the illuminance of Lx to shine 10 days in the sample of removing outer package, respectively the 1st, 3,5,10 day every index such as sampling and measuring content.
2. hot test
Place airtight vessel to place 10 days in the sample of removing outer package, respectively the 1st, 3,5,10 day every index such as sampling and measuring content respectively at 40 ℃, 60 ℃, 80 ℃ constant temperature ovens.
3. high wet test
Place airtight vessel to place 10 days under respectively at the condition of relative humidity 75%, 92.5% in the sample of removing outer package, respectively the 1st, 3,5,10 day every index such as sampling and measuring content at 25 ℃.
The result shows, stable in properties of the present invention.