CN1102342A - Radix sophorae flavescentis, large-flowered skullcap root and coptis root tablet - Google Patents
Radix sophorae flavescentis, large-flowered skullcap root and coptis root tablet Download PDFInfo
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Abstract
The medicinal tablet for treating heat diarrhea and heat dysentery without by-effect is made of such raw materials (Wt.%) as flavescent sophora root (22-26), coptis root (12-16), scutellaria root (12-16), white peony root (10-14), plantain seed (10-14), huneysuckle flower (12-16) and liquorice root (8-12).
Description
The present invention relates to the medicine of a kind of treatment diarrhea of heat type, hematodiarrhoea (enteritis, dysentery).
Diarrhea of heat type, hematodiarrhoea is a common clinical, frequently-occurring disease, old children irrespective of sex, all can take place throughout the year, especially be many summer and autumn, this disease very harmful, treat acute enteritis at present, the medicine of diseases such as bacillary dysentery mainly is antibiotics and sulfa drugs and Chinese medicine etc., though certain curative effect is arranged, but exist following deficiency, antibiotics class medicine can make skin allergy, stimulating intestine and stomach cause nausea the vomiting etc., sulfonamides can cause skin allergy, and contain prednisone in the XIELITING, belong to hormones, can cause osteoporosis, therefore treat diarrhea of heat type, hematodiarrhoea class disease is because the medicine that does not have to be suitable for has become a difficult problem.
Task of the present invention is: invent a kind of Chinese medicine that can treat diarrhea of heat type, hematodiarrhoea class disease effectively and have no side effect.
Task of the present invention realizes as follows: constituting each radix sophorae flavescentis, large-flowered weight percentages of components is Radix Sophorae Flavescentis 22～26%, Rhizoma Coptidis 12～16%, Radix Scutellariae 12～16%, the Radix Paeoniae Alba 10～14%, Semen Plantaginis 10～14%, Flos Lonicerae 12～16%, Radix Glycyrrhizae 8～12%.
In above-mentioned composition, also can add percentage by weight and be 4～4.5% Semen daturae fluid extract.Its preparation technology is: getting the Radix Paeoniae Alba half amount, to be ground into fine powder (80～120 order) standby.The Radix Scutellariae section decocts with water three times, is respectively 2 hours, 1 hour, 1 hour, gradation filtered, collecting decoction, filtrate are concentrated into 1/3 of inventory, add hydrochloric acid (2mol/l) and regulate pH value to 2 in the time of 80 ℃, 80 ℃ are incubated 1 hour, leave standstill 24 hours, and precipitation is washed till PHZhi $4.0 with ethanol, filter, be deposited in 60 ℃ of dryings, be ground into fine powder, stand-by.Radix Sophorae Flavescentis powder is broken into coarse powder, according to extractum percolation (" 17 pages of appendix of Chinese pharmacopoeia), with alcohol dipping 24 hours, with the speed of per minute 1-2ml percolation slowly, till the inanimate object alkali reaction, collect percolate, reclaim ethanol, and to be concentrated into relative density be 1.28～1.32(55-60 ℃ of survey) extractum, standby.
Radix Glycyrrhizae, Rhizoma Coptidis, the Radix Paeoniae Alba (half amount in addition) section, the decocting that adds ten times of amounts boiled 1 hour, filter, medicinal residues add Semen Plantaginis (decocting a drug wrapped), the decocting that adds the octuple amount boiled 1 hour, filter, medicinal residues add the water of octuple amount again, and add Flos Lonicerae decoction 1 hour, filter to merge three filtrates, be evaporated to relative density 1.10～1.15(80 ℃ mensuration), add ethanol and make and contain alcohol amount and reach 65%, left standstill 12 hours, filter, filtrate reclaims ethanol and also is concentrated into relative density 1.20～1.25(80 ℃ mensuration) extractum, standby.
Above-mentioned respectively distinguish the flavor of medicine and medicated powder merged adds an amount of Semen daturae fluid extract, mix homogeneously, granulate, dry, knit sheet, coating promptly.
The present invention be directed to diseases such as diarrhea of heat type, hematodiarrhoea, and the pathogeny of this class disease is damp and hot accumulateing in the intestines and stomach, causing the intestines and stomach transformation failure of spleen, turbid damp tenesmus to form defecation frequency increases, and makes matter thin sticky.Even part and QI and blood, and be resembling of the red white tenesmus of diarrhea, control to be rule of treatment with the heat clearing and damp drying, Radix Sophorae Flavescentis in the prescription is monarch, get its clearing up internal heat by using drugs of bitter in taste and cold in nature dampness-eliminating and dysentery-stopping, " Mingyi Bielu " says that it " removes the latent heat morbid state ", " big bright wood grass " called it and " controlled hemorrhoidal hamorrhage and rush down blood and hematodiarrhoea ", as far back as " core deposit hall through proved recipe " is end with the Radix Sophorae Flavescentis parching to brown just, and it is more than to control dysentery, " book on Chinese herbal medicine justice " title: the big hardship of Radix Sophorae Flavescentis Great Cold, the pathogenic fire reducing of bringing down a fever, swing to fry in shallow oil and wash wet fire, its effect and a kind of reed mentioned in ancient books connect, Radix Gentianae is all close, and the hardship of Radix Sophorae Flavescentis more, and it is dry outstanding strongly to prove that according to pharmacological research matrine is to dysentery bacterium, escherichia coli, Bacillus proteus etc. all have the obvious suppression effect.
Join Rhizoma Coptidis, Radix Scutellariae is a ministerial drug, the two is all the product of clearing up internal heat by using drugs of bitter in taste and cold in nature dampness, just call Rhizoma Coptidis master " spouting bleeding from anus stomachache dysentery " Radix Scutellariae " main all hot jaundice, spouting bleeding from anus is let out dysentery " as far back as Shennong's Herbal, Compendium of Material Medica is called Rhizoma Coptidis " controlling order and dysentery is key medicine " again, the Radix Scutellariae eliminating heart-fire, it is damp and hot to control spleen channel, controls the inferior the dysentery pus and blood, and the stomachache back is heavy, fever of the body, for a long time can not the person of ending, treatise on Febrile Diseases is controlled the Gegen Huangqin Huanglian Tang of diarrhea of heat type, and " element ask mechanism of qi save one's life collection " controls Radix Paeoniae Decoction of hematodiarrhoea etc., all share with this two thing, to strengthen the power of clearing up internal heat by using drugs of bitter in taste and cold in nature dampness, according to pharmacological research, Rhizoma Coptidis, Radix Scutellariae all has wider antimicrobial spectrum, to dysentery bacterium, escherichia coli, bacillus pyocyaneus etc. all have antibacterial action in various degree, responsive higher with the Shu Shi dysentery bacterium especially wherein, next Fei Shi, Song Nei Shi, its effect is parity with or superiority over sulfanilamide, and do not resemble sulfonamides, chloromycetin etc. easily have side effect.
With Flos Lonicerae, the Radix Paeoniae Alba, Semen Plantaginis are adjuvant drug, wherein Flos Lonicerae is apt to the energy heat-clearing and toxic substances removing, eliminating pathogenic heat from blood to cure dysentery, " the SHENGCAO property of medicine fully will " be called its " can eliminating carbuncle cellulitis sore, dysentery relieving disease ", " explaining abstruseness of the canon of materia medica " claims " Flos Lonicerae master distension dysentery; the eliminating carbuncle poison that looses, tonify deficiency is treated wind ... surplusly use it in all diseases, takes effect repeatedly ", the Radix Paeoniae Alba is longer than easing the affected liver to relieve pain, its " main pathogen stomachache is removed arthralgia due to stagnation of blood " of Shennong's Herbal cloud " medicine justice " Yan Qizhi " dysentery stomachache " " Bencao Jingshu " further explains: " Radix Paeoniae Alba can eliminating pathogen in the liver be separated spleen, insufficiency of the spleen then sinking of QI of middle-JIAO; form dysentery; the Radix Paeoniae Alba is yang invigorating in the spleen then, and the heresy of liver and gall dare not be violated, then dysentery oneself end ", the Semen Plantaginis clearing away heat and promoting diuresis, eliminating dampness by diuresis antidiarrheal, " the southern regions of the Yunnan Province book on Chinese herbal medicine " calls its " sealing rushes down ", and Compendium of Material Medica says that it " ends the heat-damp in summer dysentery ", " doctor pounce on usurp will " explains: " so want it; row water goes absurd heat, is that it can be grown, and separates and controls the arthralgia chiefly caused by damp pathogen five types of stranguria; and the summer-heat dysentery, tonneau urine ".
With the Radix Glycyrrhizae mediation property of medicine, and double spleen reinforcing stomach function regulating, in case all medicine bitter colds injure one's stomach, share with the Radix Paeoniae Alba, can strengthen the effect of relieving spasm to stop pain.
More than seven medicines share, play heat clearing and damp drying altogether, dampness removing antidiarrheal, the merit of easing the affected liver to relieve pain is applicable to and has loose bowels dysentery due to damp and hot.
Accompanying drawing is a process chart of the present invention.
A most preferred embodiment of the present invention, produce 1000 radix sophorae flavescentis, large-flowered, get Radix Sophorae Flavescentis 600g, Rhizoma Coptidis 350g, Radix Scutellariae 350g, Radix Paeoniae Alba 300g, Semen Plantaginis 300g, Flos Lonicerae 350g, Radix Glycyrrhizae 250g, its preparation method is: it is standby that the Radix Paeoniae Alba half amount is ground into fine powder (80-120 order), Radix Scutellariae is cut into slices, decoct with water three times, be respectively 2,1,1 hour, gradation filters, collecting decoction, filtrate is concentrated into 1/3 of inventory, adds hydrochloric acid (2mol/l) and regulate pH value to 2 in the time of 80 ℃, insulation is 1 hour in the time of 80 ℃, left standstill 24 hours, and be deposited under 60 ℃ the temperature dry, be ground into fine powder, standby.Radix Sophorae Flavescentis powder is broken into coarse powder, according to the extractum percolation, with alcohol dipping 24 hours, with the speed of per minute 1-2ml percolation slowly, till the inanimate object alkali reaction, collect percolate and reclaim ethanol, and be concentrated into relative density 1.28-1.32(55-60 ℃ of mensuration) extractum standby.
Radix Glycyrrhizae, Rhizoma Coptidis, the Radix Paeoniae Alba (half amount in addition) section, the decocting that adds ten times of amounts boils 1 hour, filtration, medicinal residues and adds Semen Plantaginiss (decocting a drug wrapped) and add doubly that the decocting of amount boils filtration in 1 hour, merge three times filtrate, be evaporated to relative density 1.10-1.15(80 ℃ mensuration) add ethanol and make and contain alcohol amount and reach 65%, left standstill 12 hours, filtration, filtrate recycling ethanol also are concentrated into relative density 1.20-1.25(80 ℃ mensuration) extractum, standby.
The extractum of the above-mentioned medicine of respectively distinguishing the flavor of and medicated powder are merged, add 7ml Semen daturae fluid extract mix homogeneously, routinely technology granulate, dry, beat sheet, coating gets final product.The effective dose of this new drug is for the each 2-4 sheet of adult, and is every day three times, oral.The physicochemical property discrimination test choosing meaning matrine relevant with radix sophorae flavescentis, large-flowered quality, berberine hydrochloride, baicalin, paeoniflorin, chlorogenic acid, glycyrrhizic acid etc. are done following discriminating:
One, discrimination test
Total seven flavor medicine material in radix sophorae flavescentis, large-flowered prescription: Radix Sophorae Flavescentis, Rhizoma Coptidis, Radix Scutellariae, the Radix Paeoniae Alba, Semen Plantaginis, Flos Lonicerae, Radix Glycyrrhizae, by the composition of above-mentioned seven flavors, selected matrine, berberine hydrochloride, baicalin, paeoniflorin, chlorogenic acid, glycyrrhizic acid etc. are done following discriminating:
1, the TLC method is differentiated Rhizoma Coptidis:
Get 5 of this product, porphyrize, it is an amount of to add ethanol, and supersound process 20 minutes filters, and filtrate is concentrated into about 5ml, as need testing solution.
Lack the flavor negative fluid and be contrast liquid (blank solution).
Get the berberine hydrochloride reference substance and make the solution of 0.2mg/ml, as positive control solution.
With above-mentioned three kinds of solution according to thin layer chromatography (" 57 pages of appendix of Chinese pharmacopoeia) check, draw need testing solution, lack flavor negative fluid and each 2 μ l of reference substance solution, put respectively on the same silica gel g thin-layer plate made from 4% sodium acetate solution, with ethyl acetate-butanone-formic acid-water (10: 7: 1: 1) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, on the corresponding position of reference substance chromatograph, show bright orange green fluorescence speckle, then there is not this fluorescence speckle in the negative fluid chromatograph.Because of Main Ingredients and Appearance in the Rhizoma Coptidis is a berberine, this law can be thought the specificity discriminating of Rhizoma Coptidis.
2; get 5 of this product; porphyrize; take by weighing 1g; with alcohol reflux 1 hour, reclaim ethanol to doing, residue adds ethanol 2ml makes dissolving; as need testing solution; other gets the baicalin reference substance, be made into the solution that every ml contains 0.1mg, in contrast product solution; draw each 5 μ l point of above-mentioned two kinds of solution on same polyamide film according to thin layer chromatography (" 57 pages of 1990 editions appendix of Chinese pharmacopoeia) check; with 36% acetic acid is developing solvent, launches, take out; dry; inspect under ultra-violet lamp (365nm); in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.Coloured picture is seen declaration material-13 Fig. 1.
3; get 5 of this product; porphyrize; take by weighing 1g; with alcohol reflux one hour; reclaim ethanol to doing; residue adds ethanol 2ml makes dissolving, and as need testing solution, other gets the matrine reference substance; be made into the solution that every ml contains 0.5mg;, draw each 10 μ l of above-mentioned two kinds of solution according to thin layer chromatography (" 57 pages of 1990 editions appendix of Chinese pharmacopoeia) check, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent; with cyclohexane-chloroform-methanol-ammonia (25: 50: 6: 2) mixed liquor lower floor was developing solvent; launch, and took out, and dried; spray is with bismuth potassium iodide solution; in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange red speckle.This product is that the specificity of Radix Sophorae Flavescentis is differentiated.
Two, the research of assay
The selected berberine of radix sophorae flavescentis, large-flowered assay at first adopts thin layer-colorimetry to carry out quantitatively as quantitative criterion, through the evidence of 6 batches of little trial products, and this method poor reproducibility, evaluated error is big, and structure is inaccurate, therefore is not used.Now thin layer colorimetry research process is described below:
The content of the berberine during the TLC-colorimetric method for determining is radix sophorae flavescentis, large-flowered
Experimental section
One, instrument is looked medicine
Ultraviolet spectrophotometer UV-260 type
Libra Beijing
Examine institute in the berberine hydrochloride
Radix sophorae flavescentis, large-flowered lab scale 0,1,2,3,4,5 batches
Ethyl acetate analytical pure Beijing
Butanone analytical pure Beijing
N-butyl alcohol analytical pure Beijing
Acetic acid 30% analytical pure Beijing
Two, method and result
Radix sophorae flavescentis, large-flowered (0-5 criticizes) 20 got in the preparation of need testing solution respectively, weighs porphyrize, take by weighing an amount of about 2g, add ethanol 50ml, supersound process 20 ', filter, filtrate for later use, residue heating washing with alcohol three times, each 10ml, merging is washed, filtrate, reclaim ethanol, be evaporated to driedly, add dissolve with ethanol and be transferred in the measuring bottle of 5ml as need testing solution.
The preparation of reference substance solution takes by weighing berberine hydrochloride 10mg, is dissolved in the 10ml measuring bottle, adds dissolve with ethanol and is diluted to scale.Standby.
Draw test sample liquid 40 μ l according to thin layer color general (" 57 pages of appendix of Chinese pharmacopoeia), reference substance liquid 10ml, ribbon is put on the silica gel g thin-layer plate made from 4% sodium acetate solution, with ethyl acetate-butanone-formic acid-water (10: 7: 1: 1) be developing solvent, launch that taking-up is dried, under ultra-violet lamp (365nm), inspect, scrape and get corresponding band speckle, eluting, colorimetric.Measure trap at 345nm wavelength place, press C
20H
18ClNO
4Absorptance (E
1cm) be 728 calculating, promptly.
Measurement result sees the following form:
Three, discuss
By above measurement result as seen, this TLC-colorimetry, poor reproducibility, error is big, and is credible poor.Its reason is as follows:
1, this method operating procedure complexity, scraper plate, eluting, the error of bringing, not belonging to systematic error can't eliminate, and therefore causes poor reproducibility.
2, silica gel adsorption is stronger, still has absorption behind the eluting, therefore causes error.
3 thus method be that soft board (not adding binding agent) operation is made troubles, be not suitable for as standard.
Animal experiment:
One, reagent: radix sophorae flavescentis, large-flowered: the each 4-8 sheets of 1,2,3 people's consumptions (0.8-1.6) in the lot number.
Two, medicine: XIELITING, the Harbin No.6 Pharmaceutical Factory produces, lot number 930408, people's consumption first 4 keep 2 (2g.1g) normal saline, by breathing out the Drug Manufacturing Room of the medical university lot number 921108 of producing.
Three, laboratory animal: Kunming mouse, the wistar rat is provided by animal housing of Harbin railway hospital.Japan rabbit grinds mice 18-22g, rat 150-180g, rabbit 1.5-1.3kg is provided by breathing out beast.
Experimental technique and result
One, to the influence of the acute abdominal cavity infection of dysentery bacterium induced mice
1, the preparation of infectious bacteria liquid
With three kinds of dysentery bacteriums (will Hayes 51259) (Song Nei Shi) standard strain (providing) (Fu Shi) by province's epidemic prevention station, provincial hospital, be inoculated in the broth medium respectively, cultivate 18h for 37 ℃, again with 5% gastric Mucin (Mianyang, Sichuan biochemical-pharmaceutical factory product lot number 930605), diluted becomes three kinds of bacterium suspensions, and dilution factor is 10
-1The suspendible bacterium liquid of preparation uses immediately.
2, abdominal cavity infection of mice and administration
Get Kunming mouse, body weight 20 ± 2g, ♂ ♀ dual-purpose, random packet, radix sophorae flavescentis, large-flowered component are three groups of (1.8g/kg, 3.6g/kg, 7.3g/kg) the positive drug group is XIELITING group 1.6g/kg, negative medicine group is with the volume normal saline, model control group is not given any material, each group of administration, test the daystart administration in advance, each organizes the gastric infusion volume is the 0.4ml/20g body weight, is administered once 2h after the administration in second day in one day, the abdominal cavity infection of beginning mice, the infection method adopts abdominal cavity bacterium liquid injection method [3], and bacterium liquid abdominal cavity injection rate is the 0.5ml/20g body weight, and administration two days is continued in the inoculation back, observe the mortality rate of animal in 72 hours, the results are shown in Table 1-3.
The radix sophorae flavescentis, large-flowered influence of table 1 to the acute abdominal cavity infection of dysentery bacterium induced mice.
Annotate: * * P＜0.01 * P＜0.05(and normal saline group ratio), down together.
The radix sophorae flavescentis, large-flowered influence of table 2 to the acute abdominal cavity infection of sonne bacillus induced mice.
The radix sophorae flavescentis, large-flowered influence of table 3 to the acute abdominal cavity infection of bacterium flexneri induced mice
By table 1-3 as can be seen, the radix sophorae flavescentis, large-flowered mouse peritoneal that three kinds of dysentery bacteriums are caused infects significant antagonism (P＜0.05 is arranged, P＜0.01) mouse peritoneal that will Hayes and Song Nei Shi bacillus is caused but when low dose of infects no significant antagonism (P＞0.05), the strongest with inhibitory action to bacterium flexneri, when 3.6g/kg and the inhibitory action of XIELITING (1.6g/kg) quite (P＞0.05).
Two, to rat acute abdominal cavity infection due to the dysentery bacterium
Method is the same, and the grouping administration is also the same, and the infectious bacteria injection rate is 4ml/100g, the results are shown in Table 4-6.
The radix sophorae flavescentis, large-flowered influence of table 4 to rat acute abdominal cavity infection due to the dysentery bacterium
The radix sophorae flavescentis, large-flowered influence of table 5 to rat acute abdominal cavity infection due to the sonne bacillus
The radix sophorae flavescentis, large-flowered influence of table 6 to rat acute abdominal cavity infection due to the bacterium flexneri
By table 4-6 as can be seen, radix sophorae flavescentis, large-flowered acute rat abdominal cavity due to three kinds of dysentery bacteriums is infected has significant antagonism (P＜0.01, P＜0.05).Action intensity and selectivity match with the inhibitory action that mouse peritoneal is infected.
Three, radix sophorae flavescentis, large-flowered to influence normal and the diarrhea mice colon movement
Get fasting 24hr(and can't help water) Kunming mouse, body weight 20 ± 2g ♂ ♀ dual-purpose, be divided into 6 groups at random, gavage each medicinal liquid that contains charcoal end (0.1g/ml) respectively, gavage volume and be 0.4ml/20g, behind the administration 90min, take off cervical vertebra and put to death mice, open the abdominal cavity, gently carry intestinal tube, separate mesentery, clip caecum to colon is extremely tied a section intestinal tube, places on the water-moistened glass plate and stretches, and measures the distance that move in colon at colon total length and charcoal end, be charcoal end advance distance in large intestine, and calculate charcoal end propelling percentage rate.
The charcoal end advances percentage rate %=(the charcoal end is advance distance (cm) in large intestine)/(colon length overall (cm)) * 100%
Experimental result sees Table 7.
By table 7 as seen, radix sophorae flavescentis, large-flowered motion to the normal mouse large intestine does not have obvious influence (P＞0.05).But the intestinal peristalsis to the diarrhea-type mice has significant antagonism (P＜0.01.But no statistical significance (P＞0.05) when low dose of, and XIELITING is no matter to normally, or diarrhea mice does not all have influence.Heavy dose of radix sophorae flavescentis, large-flowered inhibitory action to the diarrhea mice intestinal peristalsis is suitable with tannic acid Radix Sophorae Flavescentis a kind of reed mentioned in ancient books alkali capsule.
Four, radix sophorae flavescentis, large-flowered to influence normal and diarrhoea rat colon movement
Get fasting (can't help water) 24h, body weight 150-180g rat, ♂ ♀ dual-purpose, careless grouping, gavage each medicinal liquid respectively, irritate the stomach volume and be 1.5l/100g, behind the 20min, with % urethane anesthesia (1.0k/kg), on the fixing operation platform, open the abdominal cavity, take out blind intestinal segment, inject normal saline charcoal end suspension (0.3ml/100g) from terminal ileum to colon top with syringe.Timing is immediately cracked and is closed otch, puts to death behind the 2h, measures colon length charcoal end advance distance, and calculates charcoal end propelling percentage rate, the results are shown in Table 8.
Five, the influence of radix sophorae flavescentis, large-flowered xylol induced mice inflammatory capillary permeability
Get Kunming mouse, be divided into 6 groups at random, 10 every group, male and female dual-purpose, body weight 20 ± 2g.Cause inflammation and a few days ago begin gastric infusion, positive controls is a chlorphenamine, negative control group is the normal saline with volume, administration the 3rd day, after irritating stomach 2h, every Mus angular vein injection 1% according to the blue 10ml/kg of the train of thought, while at each three melted paraxylene of mice two ear places (with the whole moistenings of ear), behind the 20min, is put to death animal with No. 5 syringe needles, take off the tissue of two ear equal areas with card punch, shred, immerse in 5ml water-acetone (3: 7) solution, behind the 24h, (λ=610nm) photometry trap the results are shown in Table 9 to the centrifuging and taking supernatant with the 721-spectrophotometer.
Dosage OD value
Group number of animals P value
(g/kg) ( x±SD)
Radix sophorae flavescentis, large-flowered big by 10 7.2 0.03 ± 0.01＜0.01
" in 10 3.6 0.045 ± 0.01＜0.01
" little by 10 1.8 0.095 ± 0.02＜0.01
XIELITING 10 1.6 0.24 ± 0.05〉0.05
Chlorphenamine 10 50 (mg) 0.02 ± 0.005＜0.01
Reason saline 10 is with volume 0.24 ± 0.025
Experimental result shows, the radix sophorae flavescentis, large-flowered inhibitory action (P＜0.01) that mice inflammatory capillary permeability is had highly significant.Its inhibitory action and dosage are proportionate, and XIELITING does not have this effect.
Six, radix sophorae flavescentis, large-flowered influence to foot swelling due to the rat Ovum Gallus domesticus album
Get the Wistar rat, male and female half and half, body weight 150-180g adopts gastric infusion.Random packet, positive drug is a dexamethasone, and feminine gender is a normal saline, once a day, continuous three days, after the administration in the 3rd day, 5min, it is subcutaneous that each Mus is injected the left back sufficient sole of the foot with 10% fresh albumen 0.1ml respectively, survey a joint girth every 1h, survey altogether three times, measured value deducts and causes scorching preceding numerical value is the swelling degree, the results are shown in Table 10.
The result shows, radix sophorae flavescentis, large-flowered have significant inhibitory effect (P＜0.05) to foot swelling due to the rat Ovum Gallus domesticus album.
The radix sophorae flavescentis, large-flowered influence of table 10. to foot swelling due to the rat Ovum Gallus domesticus album
Dosage number of animals swelling degree mm
Group (x ± SD)
(g/kg) (only)
1h 2h 3h
Radix sophorae flavescentis, large-flowered big by 4.2 8 5.7 ± 0.4
*6.7 ± 0.8
*8.5 ± 1.1
*
In 2.1 8 6.1 ± 0.5
*7.2 ± 0.6
*9.3 ± 1.2
*
Little by 1.05 8 6.9 ± 0.3
*7.5 ± 0.5
*9.8 ± 1.8
*
XIELITING 1.0 8 9.2 ± 0.5 2.5 ± 0.9 15.8 ± 2.7
Dexamethasone 2mg/kg 8 4.7 ± 0.2
*7.2 ± 0.8
*9.4 ± 2.0
*
Normal saline is with volume 0 9.1 ± 0.7 12.8 ± 1.3 15.6 ± 1.8
Seven, radix sophorae flavescentis, large-flowered influence to 0.7% acetic acid induced mice pain
Get mice, body weight 20 ± 2g, random packet, positive group is rotundine 60mg/kg, negative group is with the volume normal saline, and route of administration is observed the mouse writhing reaction for irritating stomach, successive administration three days, behind the 1.5h, each Mus lumbar injection 0.7% acetic acid (0.2ml/20g body weight) picks up counting from occurring writhing response first after the administration in the 3rd day, observe 10min mouse writhing number of times, the results are shown in Table 11.
The influence of the radix sophorae flavescentis, large-flowered Dichlorodiphenyl Acetate induced mice of table 11. pain reaction
Dosage number of animals 10min turns round the body number of times
Group P value
(g/kg) (only) (x ± SD)
Radix sophorae flavescentis, large-flowered big by 7.2 10 24.52 ± 4.78〉0.05
In 3.8 10 21.31 ± 6.04〉0.05
Little by 1.8 10 26.87 ± 8.05〉0.05
XIELITING 1.6 10 20.43 ± 6.21〉0.05
Rotundine 60 (mg) 10 11.21 ± 4.21＜0.05
Normal saline is with volume 10 25.04 ± 6.18
The result shows, radix sophorae flavescentis, large-flowered do not have an analgesic activity (P＞0.05).
Eight, radix sophorae flavescentis, large-flowered influence to rabbit fever models due to the Typhoid Vaccine is got Japan rabbit, body weight 1.5-3.0kg; Male and female dual-purpose, random packet, 20 ℃ of chamber experimental results show, radix sophorae flavescentis, large-flowered do not have an analgesic activity (P＞0.05).
Eight, radix sophorae flavescentis, large-flowered influence to rabbit fever models due to the Typhoid Vaccine
Get Japan rabbit, body weight 1.5-3.0kg, male and female dual-purpose, random packet experimentizes under 20 ℃ of chambers, 8 every group, each treated animal is surveyed normal rectal temperature before the experiment, and secondary is got the body temperature eligible, get the secondary arithmetic mean of instantaneous value, irritate stomach then and give respectively to organize medicine, behind the 4h again gastric infusion once, second-dose is identical, positive drug is an antondin, feminine gender is a normal saline, after the administration for the second time, and quiet immediately notes typhoid fever, paratyphoid fever, the second triple vaccine, (1ml/kg), to 30min behind the vaccine, be administered once again, for the third time after the administration, 60min, 120min, 180min, each surveys body temperature once, and to deduct normal body temperature with body temperature measured value behind the medicine be the fervescence value, the results are shown in Table 12.
The result shows that the radix sophorae flavescentis, large-flowered fever in rabbits that Typhoid Vaccine is caused has inhibitory action (P＜0.01), and temperature lowering curve is seen Fig. 1.
Radix sophorae flavescentis, large-flowered acute toxicity testing
The radix sophorae flavescentis, large-flowered compound preparation of being made up of pure Chinese medicine has heat-clearing and toxic substances removing, and the effect of dampness-eliminating and dysentery-stopping cures mainly diseases such as dysentery, enteritis, and in order to investigate the toxicity of said preparation, we have carried out acute toxicity testing research.Now experimental result is reported as follows:
Experiment material
One, reagent: radix sophorae flavescentis, large-flowered: in the lot number 1,2,3, people's consumption, each 4-8 sheet (1.5-3g), every day three times.
Two, laboratory animal: Kunming mouse, 20 ± 2g, male and female half and half are provided by animal housing of Harbin railway hospital, Kazakhstan animal medicine portion of medical university.
Experimental technique and result
Adopt Sun Ruiyuan professor's LD
50Assay method experimentizes, but because the toxicity of this preparation is too little, and be subjected to the restriction of administration volume again, do not determine LD
50We have carried out the mensuration of medicine maximum tolerated dose for this reason, and the result is as follows:
Maximum tolerance determination:
50 of Kunming mouses (providing by breathing out animal medicine portion of medical university) are provided, male and female half and half, this experiment is with the Cmax (45%) of this preparation, the each 0.8ml/20g of the maximum volume of mouse stomach, irritate stomach every day 3 times, administration one day was observed 7 days continuously, do not see death, in experiment, the mice spiritedness is not good, the performance of diarrhoea, unpeace, but none death, this moment, dosage was the 1.08g/20g body weight/day, promptly 54g/kg/ days.
Conclusion: total dosage of radix sophorae flavescentis, large-flowered maximum tolerated dose is 54g/kg, is equivalent to 300 times of clinical application amount (0.18g/kg/ days).
Annotate: clinical consumption 9g/50kg/ days of providing by sample presentation unit (1.5-3g/ time, promptly the 4-8 sheet/time, every day three times) Rapid Dose Calculation.
Radix sophorae flavescentis, large-flowered preliminarily stabilised test
One, instrument and material
Ultraviolet spectrophotometer UV-260 type
Thermostatic drying chamber Beijing
Balance Beijing
Radix sophorae flavescentis, large-flowered self-control
Examine institute in the berberine hydrochloride
Two, method and result
This product (clinical application product plastic bag sealing) is put the normal temperature drying place investigate by quality standard, except that investigating this month once, examination in later every month was once examined three months altogether, and it the results are shown in Table.
The result is radix sophorae flavescentis, large-flowered according to said determination, and outward appearance, discriminating, hardness, disintegration, inspection bacterium, content etc. all do not change this drug stabilisation.
Radix sophorae flavescentis, large-flowered long term toxicity test
Radix sophorae flavescentis, large-flowered is the compound preparation that pure Chinese medicine is formed, and has heat-clearing and toxic substances removing, effects such as dampness-eliminating and dysentery-stopping, cure mainly diseases such as dysentery, enteritis, in order to investigate the toxic action of this medicine, we have carried out radix sophorae flavescentis, large-flowered long term toxication, now experimental result are reported as follows:
Experiment material
One, experimental drug: radix sophorae flavescentis, large-flowered, 1,2,3 normal saline in the lot number, the Drug Manufacturing Room of medical university lot number 921013.
Two, experimental rat: the Wistar rat, 6 ages in week, body weight 75-89g, male and female half and half, animal medicine portion of Harbin Medical University provides.
Three, experiment equipment: rat oral gavage device, torsion balance, biological microscope: optical instrument factory, Ningbo, 721 spectrophotometers: the highly dense Electronic Instruments Plant in Shandong, blood cell counting plate, hemometer, microtome etc.
Experiment condition
Room temperature: 18-25 ℃ lucifuge
Feeding manner: monoculture
Feedstuff: provide by animal housing of Harbin railway hospital
Time: 1993.4.5-1993.4.19
Experimental technique
Get Wistar rat (body weight 75-83g) and observe a week, reject disease Mus and unusual Mus, be divided into 4 groups at random, every group 20, male and female half and half, weigh in, each Mus venous blood collection carries out blood routine examination before the administration, and the angular vein clump is got blood and carries out the inspection of Liver and kidney merit, then respectively with 9g/kg, 4.5g/kg, 2.25g/kg, the administration of 2ml/100g body weight, matched group are 2ml/100g body weight normal saline, every day gastric infusion once, successive administration 14 days is observed the animal behavior activity after the administration, appetite, the feces situation, routine blood test was surveyed in administration in 7 days, hepatic and renal function, and the measurement body weight, carry out These parameters again after administration finishes and measure, then with sacrifice of animal, dissect and take out the heart, liver, spleen, lung, kidney, the adrenal gland, brain, stomach, small intestinal, large intestine, gonad dislikes the first five internal organs to weigh) formalin solution fixes, H.E dyeing, histopathological examination is carried out in section, the results are shown in Table 1-4 and annex.
Appetite decline appears in administration group gastric infusion in the experiment after two days, this phenomenon disappearance of back of one week, rat is only thrown feedstuff by 15g/ every day, loose stool occurs on the 3rd day after the administration, and just excrement is irregular, color is pale brown color, the activity of administration group reduces, and is rest state, other no abnormality seen, routine blood test, kidney merit, liver function no abnormality seen, postmortem and microscopy no abnormality seen before and after the administration.
Supplemental instruction about long toxic agent amount:
Because LD50 does not record the result in the anxious poison experiment, so the heavy dose that this experiment is adopted is radix sophorae flavescentis, large-flowered Cmax 45% of irritating stomach, the administration volume is the acceptable maximum long-pending 2ml/100g body weight of body of stomach of irritating of rat, the dosage of this moment is 9g/kg, the dosage that low dose of 2.25g/kg also tells on greater than rat.
The variation of the malicious experimental rat body weight of the radix sophorae flavescentis, large-flowered length of table 1
Annotate: between each group (P＞0.05)
Visible radix sophorae flavescentis, large-flowered by table 1 to rat body weight do not make significant difference (P＞0.05)
The radix sophorae flavescentis, large-flowered influence (n=10) of table 3 to long malicious experimental rat main organs weight
Learn check there was no significant difference (P＞0.05) by statistics, conclusion: radix sophorae flavescentis, large-flowered weight to long malicious experimental rat main organs (heart, liver, spleen, lung, kidney) does not have influence.
Annex: radix sophorae flavescentis, large-flowered long poison experiment 40 routine Rats Organs and Tissues pathological examination results
Check 40 of rats (male and female half and half), totally four groups.Every group 10, check after the sacrificed by decapitation, and core, liver, spleen, lung, kidney, brain, stomach, small intestinal, large intestine, adrenal gland, 11 kinds of internal organs of gonad (ovary or testis), be fixed in immediately in 10% formalin solution 24 hours, repeatedly be cut to the thick piece of tissue of 3mm then, through gradient alcohol dehydration, paraffin embedding, conventional section (beautiful AO-820 rotary microtome) 5um is thick, lignin-Yihong (H.E) dyeing, light microscopic (day-01ympusCH) observe, do the pathology histological examination, the result is as follows: see Table 1-5.
1, by visible each the treated animal 11 internal organs inspection of table 1-5, majority is not seen obvious pathological changes, and except that liver, organa parenchymatosum's skins such as heart and brain kidney have rotten sexually transmitted disease (STD) to become, and gonad, adrenal gland's functional status are normal.
2, each is organized all has part example liver to be mixed pus distension related to the liver change, but compares there was no significant difference (P＞0.05) between group, illustrates with medication to have nothing to do.
3, each group all have minority example patient light-the chronic inflammatory illness of moderate lung and renal pelvis, its illness rate does not have group difference, and all is the old pathological changes, so have nothing to do with medication.
Conclusion: the long poison experiment of radix sophorae flavescentis, large-flowered large, medium and small dosage, 11 internal organs inspections, each organ there is no the damaging pathological changes of drug toxicity.
Annotate: statistical procedures is carried out with microcomputer
List of references
(1) national clinical examination rule of operation P226
(2) practical medical test is learned P348-352
Claims (3)
1, a kind of radix sophorae flavescentis, large-flowered, the percentage by weight of its each composition is: Radix Sophorae Flavescentis 22～26%, Rhizoma Coptidis 12～16%, Radix Scutellariae 12～16%, the Radix Paeoniae Alba 10～14%, Semen Plantaginis 10～14%, Flos Lonicerae 12～16%, Radix Glycyrrhizae 8～12%.
2, as claimed in claim 1 radix sophorae flavescentis, large-flowered, it is characterized in that in the above-mentioned composition adding percentage by weight and be 4～4.5% Semen daturae fluid extract.
3, as claim 1,2 described radix sophorae flavescentis, large-flowered, it is characterized in that its processing technique is:
A, getting the Radix Paeoniae Alba half amount, to be ground into fine powder (80～120 order) standby;
B, Radix Scutellariae section decoct with water three times, are respectively 2 hours, 1 hour, 1 hour, gradation filtered, collecting decoction, filtrate are concentrated into 1/3 of inventory, add hydrochloric acid (2mol/l) and regulate pH value to 2 in the time of 80 ℃, 80 ℃ are incubated 1 hour, leave standstill 24 hours, and precipitation is washed till PHZhi $4.0 with ethanol, filter, be deposited in 60 ℃ of dryings, be ground into fine powder, stand-by;
C, Radix Sophorae Flavescentis powder are broken into coarse powder, adopt the extractum percolation, with alcohol dipping 24 hours, with the speed of per minute 1-2ml percolation slowly, till the inanimate object alkali reaction, collect percolate, reclaim ethanol, and to be concentrated into relative density be 1.28～1.32 extractum;
D, Radix Glycyrrhizae, Rhizoma Coptidis, the Radix Paeoniae Alba (half amount in addition) section, the decocting that adds ten times of amounts boiled 1 hour, filter, medicinal residues add Semen Plantaginis (decocting a drug wrapped), and the decocting that adds the octuple amount boiled 1 hour, filter, merge three filtrates, be evaporated to relative density 1.10～1.15, add ethanol and make and contain alcohol amount and reach 65%, left standstill 12 hours, filtered and recycled ethanol also is concentrated into the extractum of relative density 1.20～1.25;
E, above-mentioned medicine and the medicated powder of respectively distinguishing the flavor of is merged, can add percentage by weight and be 0.4～0.45 Semen daturae fluid extract, mix homogeneously, it is dry to granulate, and beats sheet, coating.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN94104915A CN1057210C (en) | 1994-04-29 | 1994-04-29 | Radix sophorae flavescentis, large-flowered skullcap root and coptis root tablet |
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| Application Number | Priority Date | Filing Date | Title |
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| CN94104915A CN1057210C (en) | 1994-04-29 | 1994-04-29 | Radix sophorae flavescentis, large-flowered skullcap root and coptis root tablet |
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| CN1057210C CN1057210C (en) | 2000-10-11 |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1060044C (en) * | 1997-12-23 | 2001-01-03 | 李伟 | Medicine for treating enterogastric disease |
| CN1089243C (en) * | 1997-02-20 | 2002-08-21 | 孙文基 | Medicine for promoting digestion function of stomach and intestine |
| CN104069375A (en) * | 2014-06-18 | 2014-10-01 | 合肥瑾翔医药科技有限公司 | Traditional Chinese medicine composition for treating bacillary dysentery |
| CN104585508A (en) * | 2015-01-30 | 2015-05-06 | 北京康华远景科技股份有限公司 | Feed additive for preventing and treating swine red dysentery and preparation method thereof |
| CN104678045A (en) * | 2014-12-18 | 2015-06-03 | 南方医科大学 | Method for detecting radix sophorae flavescentis-eucalyptus robusta rash-eliminating gel medicine |
| CN104997993A (en) * | 2015-07-09 | 2015-10-28 | 张鑫 | Traditional Chinese medicinal preparation for treating colon infection diarrhoea |
| CN108524608A (en) * | 2018-06-28 | 2018-09-14 | 四川齐全红动物药业有限公司 | Prevent the Chinese medicine composition and preparation method, application method of poultry diarrhea |
| CN108743724A (en) * | 2018-09-06 | 2018-11-06 | 柳舒 | A kind of Chinese medicine composition and its preparation and preparation method for antidiarrheal |
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1994
- 1994-04-29 CN CN94104915A patent/CN1057210C/en not_active Expired - Fee Related
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1089243C (en) * | 1997-02-20 | 2002-08-21 | 孙文基 | Medicine for promoting digestion function of stomach and intestine |
| CN1060044C (en) * | 1997-12-23 | 2001-01-03 | 李伟 | Medicine for treating enterogastric disease |
| CN104069375A (en) * | 2014-06-18 | 2014-10-01 | 合肥瑾翔医药科技有限公司 | Traditional Chinese medicine composition for treating bacillary dysentery |
| CN104678045A (en) * | 2014-12-18 | 2015-06-03 | 南方医科大学 | Method for detecting radix sophorae flavescentis-eucalyptus robusta rash-eliminating gel medicine |
| CN104585508A (en) * | 2015-01-30 | 2015-05-06 | 北京康华远景科技股份有限公司 | Feed additive for preventing and treating swine red dysentery and preparation method thereof |
| CN104997993A (en) * | 2015-07-09 | 2015-10-28 | 张鑫 | Traditional Chinese medicinal preparation for treating colon infection diarrhoea |
| CN108524608A (en) * | 2018-06-28 | 2018-09-14 | 四川齐全红动物药业有限公司 | Prevent the Chinese medicine composition and preparation method, application method of poultry diarrhea |
| CN108743724A (en) * | 2018-09-06 | 2018-11-06 | 柳舒 | A kind of Chinese medicine composition and its preparation and preparation method for antidiarrheal |
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| Publication number | Publication date |
|---|---|
| CN1057210C (en) | 2000-10-11 |
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