CN102949458A - Traditional Chinese medicine composition for treating or preventing lithangiuria, and applications thereof - Google Patents
Traditional Chinese medicine composition for treating or preventing lithangiuria, and applications thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating or preventing lithangiuria. The traditional Chinese medicine composition for treating or preventing lithangiuria comprises the following ingredients in parts by weight: 20-60 parts of earwigs, 20-60 parts of taraxacum officinale, 20-60 parts of folium mori, and 20-60 parts of bidens poilsa. The invention further discloses an extract, traditional Chinese medicine preparation prepared by adopting the traditional Chinese medicine composition, and applications thereof. Proven clinically, the medicine has obvious characteristics of being fast in urinary calculus removal, not easy to relapse and capable of resolving tetany and relieving pain, and can fast relive renal colic after being orally administrated.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition that can be used as lithangiuria medicine or lithangiuria prophylactic agent and uses thereof.
Background technology
Along with the change with dietary habit of improving constantly of living standards of the people, the sickness rate of China's urinary system calculus is in obvious propradation.Calculus often stays in kidney, ureter, bladder and causes renal calculus, ureteral calculus, vesical calculus, and is wherein common with renal calculus.Renal calculus mostly occurred in the middle prime of life, and the male is more than the Ms.Clinical manifestation is varied, and renal calculus may long-term existence and asymptomatic, particularly larger calculus.Less calculus range of activity is large, when microlith enters UPJ or ureter, causes the wriggling that ureter is violent, discharges to impel calculus, so angor and hematuria occur.40%～50% patient is the history of pain of gapped outbreak.Pain often is positioned at waist and abdominal part, and majority is paroxysmal, also can be constant pain.Renal colic is serious lancinating pain, often suddenly outbreak, and pain often is radiated to hypogastric region, groin or burst inboard.When renal colic is serious, pale complexion, whole body is in a cold sweat, thready pulse and speed, even blood pressure drops are collapse, simultaneously with feel sick, vomiting, abdominal distention constipation.During the angor outbreak, hypourocrinia after angor is alleviated, can have the polyuria phenomenon.Hematuria is another cardinal symptom of renal calculus.During pain, often occur together gross hematuria or microscopic hematuria, in the majority with the latter, hematuria can increase the weight of after the physical exertion.The common complication of renal calculus is to block and infection, and many cases are sought medical advice because of the urinary tract infection symptom.Obstruction then can cause hydronephrosis, epigastrium or waist lump occur.
The treatment of renal calculus is mainly take open surgery and medicine dissolution therapy as main.The open surgery wound is large, complication is many, and sometimes has a strong impact on renal function because recurrence of hepatolithiasis need go Repeated Operation; Though had in recent years extracorporeal shock-wave lithotomy and some non-open operations to get the application of the minimally-invasive treatment such as stone, and made the patient of a lot of former need operative treatments exempt the misery of performing the operation.Although extracorporeal shock-wave lithotomies etc. have brought Gospel to patient, reduced wound, the still need partner treatment of medicine of the calculus behind its rubble and prevention recurrence of hepatolithiasis process, however this Western medicine medicine on the one hand is less, and often take symptomatic treatment as main, prognosis is relatively poor.
Therefore, the practitioner begins to consider to use the Chinese medicine compound calculus, to obtain better prognosis therapeutic effect.
DIWUGONG, formal name used at school: Lysimachia christinae Hance all has distribution in each province, the south of the River.Summer, Qiu Erji gather.Remove impurity, dry, cutting is given birth to and is used.Have heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling, the effect of dampness removing jaundice eliminating also has calculus, and is antibacterial, and antiinflammatory action all has inhibitory action to humoral immunization, cellular immunization.
Bidens, formal name used at school Bidens pilosaLinn is Compositae annual herb plant.Be born in wasteland, roadside, hillside and the field of 50～3100 meters of height above sea level, originate in the subtropical and tropical zones (East China, Central China, south China, each provinces and regions, southwest of comprising China) in Asia and America, be China's medical herbs commonly used among the people, can be at summer, fall flowering Sheng phase harvesting aerial parts, choose the roguing grass, using fresh herb or dry is with all herbal medicine.The water decoction that bidens and clerodendron trichotomum are mixed or ethanol preserved material PARA FORMALDEHYDE PRILLS(91,95) and albumen arthritis all have obvious antiinflammation.Single bidens or clerodendron trichotomum are then without obviously antiinflammation.
The West Herba Taraxaci, formal name used at school: Taraxacum officinale, Compositae Dandelion plant, herb heat-clearing and toxic substances removing, diuresis, eliminating carbuncle eliminating stagnation.
Folium Mori, formal name used at school Folium Mori, Folium Mori are dried leaves of moraceae plants Mulberry, have another name called a Mulberry, Jing Sang, Fructus Mori tree, yellow wood etc., national most area has production more, has the effects such as blood pressure lowering, blood fat, antiinflammatory.Being rich in rare element organic selenium, germanium, is natural powerful antioxidant, can remove interior free yl, makes the toxin and the refuse that are accumulated in the human body oxidized, increases the oxygen content in the blood, enhances metabolism and microcirculation.
Summary of the invention
The object of the invention is to overcome defective of the prior art, provide a kind of and be used for the treatment of or prevent Chinese medicine composition of lithangiuria and uses thereof.
The present invention at first provides a kind of Chinese medicine composition that is used for the treatment of or prevents lithangiuria, comprises the component of following weight portion:
20～60 parts of DIWUGONG, 20～60 parts of bidens, 20～60 parts of Western Herba Taraxacis, 20～60 parts on Folium Mori.
Preferably, described Chinese medicine composition comprises the component of following weight portion: 30～40 parts of DIWUGONG, 30～40 parts of bidens, 30～40 parts of Western Herba Taraxacis, 30～40 parts on Folium Mori.
Further, the invention also discloses a kind of Chinese medicine extract that is used for the treatment of or prevents lithangiuria, for making take above-mentioned Chinese medicine composition as the raw material effective component extracting.
Among the present invention, the prescription of crude drug is the most key, after knowing the crude drug prescription, those skilled in the art can adopt the Effective Component of Chinese Medicine extracting method of various routines to extract its effective ingredient, such as the decoction of routine, decoction and alcohol sedimentation technique, ethanol extract from water precipitation, salting out method etc., because the said extracted method all can obtain the main pharmacodynamics composition in the aforementioned Chinese medicine formula.
Wherein, decoction and alcohol sedimentation technique is: first take water as solvent extraction medical material effective ingredient, remove the method for impurity in the extracting solution with the ethanol precipitation of variable concentrations again.Generally containing amount of alcohol, to reach 50%～60%(w/v be g/100ml) time, can remove the impurity such as starch, reach more than 75% when containing the alcohol amount, except the minority invalid components such as tannin, water colo(u)r, all precipitable removals of all the other most of impurity.
Ethanol extract from water precipitation is: with the ethanol extraction medicinal ingredient of suitable concentration, water is removed the method for impurity in the extracting solution more first.
Can be again behind the described Chinese medicine composition effective component extracting concentrated through the step of routine, purification or the dry Chinese medicine extract that obtains.Wherein concentrated method includes but not limited to: atmospheric evaporation, reduction vaporization, thin film evaporation, multiple-effect evaporation, the method of purification includes but not limited to: the purification of saltouing, the macroporous resin adsorption purification, the ethanol deposition and purification, ion-exchange resin purification, the flocculation sediment purification, membrane separation purification, the polycaprolactam purification, silica gel adsorption chromatography purification etc., dry method includes but not limited to: oven drying method, the drum-type seasoning, the belt drying method, the hygroscopic desiccation method, fluid-bed drying, spray drying method, hypobaric drying method, freeze-drying, infrared drying, micro-wave drying method etc.
Better, adopt decocting method to prepare Chinese medicine extract: get by weight DIWUGONG, Western Herba Taraxaci, Folium Mori, bidens, decocting after oven dry is pulverized, decocting liquid leaves standstill, and filters, and is concentrated, gets Chinese medicine extract.
Particularly, described Chinese medicine extract adopts following mode to make: get by weight ratio DIWUGONG, Western Herba Taraxaci, Folium Mori and bidens, oven dry is pulverized, and mixes, and then adds above-mentioned DIWUGONG, bidens, the water of the West Herba Taraxaci and 8～40 times of amounts of Folium Mori gross weight soaks 60～120min, then decocts to extract 60～120min, decocting liquid leaves standstill, and is for subsequent use after filtering; Medicinal residues add the water of 8～40 times of amounts again, decoct to extract 60～120min, and decocting liquid leaves standstill, and filter, and are concentrated with the filtrate merging first time, get Chinese medicine extract.
Chinese medicine composition of the present invention or Chinese medicine extract can be used for preparing the medicine of prevention or treatment lithangiuria.
In the embodiment that recommends, described lithangiuria is ureteral calculus or renal calculus.
In the embodiment that recommends, described lithangiuria is calcium oxalate stone, calcium phosphate stone or struvite calculus.
The present invention also further provides a kind of Chinese medicine preparation, comprises aforementioned Chinese medicine extract and one or more pharmaceutic adjuvants for the treatment of effective dose.
Described pharmaceutic adjuvant is for mouldability, effectiveness, stability, safety, raising activity or the biological effectiveness that solves preparation, in the situation that the preparation relevant issues such as the oral acceptable mouthfeel of generation or abnormal smells from the patient add the medicinal material except principal agent in the prescription.
In the embodiment that recommends, described pharmaceutic adjuvant includes but not limited to filler, disintegrating agent, binding agent, wetting agent, lubricant, and described filler is starch, dextrin, lactose, sucrose, Icing Sugar, microcrystalline Cellulose, glucose, meglumine, glucosamine, mannitol, calcium sulfate or calcium bisulfate; Disintegrating agent is hyprolose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose or crosslinked hydroxypropyl methylcellulose; Binding agent is hydroxypropyl methylcellulose sodium or polyvidone; Wetting agent is water or ethanol; Lubricant is magnesium stearate or Pulvis Talci.
When selecting pharmaceutic adjuvant, should select compatible with Chinese medicine extract of the present invention, can be with its blend the adjuvant of the effect of decrease Chinese medicine extract under normal conditions not.
Medicine of the present invention or preparation can be oral formulations.
In the embodiment that recommends, described oral formulations is tablet, pill, sublimed preparation, powder, granule, powder, capsule, buccal tablet or effervescent tablet.Above-mentioned preparation can be prepared by conventional method.
The medicine for preparing or preparation can carry out administration by conventional route.When using medicine, be that fusion rotein of the present invention or its antibody with safe and effective amount is applied to object.In addition, medicine of the present invention or preparation also can use with the other treatment agent.
Unless specialize, the implication of employed all technology and scientific terminology is identical with the common implication of understanding of the technical field of the invention those skilled in the art here.Equally, all publication, patent application, patent and other reference materials are all introduced the present invention as a reference referred in this.
The present invention uses medicine of the present invention to kidney of rats calculus pathological model, finding that Chinese medicine extract of the present invention has alleviates the nephridial tissue edema that causes because of calculus, slows down damage and the pathological changes of kidney, increases voided volume, reduce the formation of calculus in the nephridial tissue, and then prevent and treat the effect of renal calculus.Acute toxicity test shows, medicine of the present invention does not have obvious toxicity phenomenon.This pharmaceutical composition of application attestation has fast, the difficult recurrence of calculus clinically, but also has the distinguishing feature of relieving spasm to stop pain, oral rear rapid recovery renal colic.
The specific embodiment
Embodiment 1
Get DIWUGONG 20g, Western Herba Taraxaci 20g, Folium Mori 20g, bidens 20g, oven dry is pulverized, and mixes, and then adds the water of above-mentioned DIWUGONG and 16 times of amounts of bidens gross weight, soaks 60min, then decocts and extracts 120min, and decocting liquid leaves standstill, and is for subsequent use after filtering; Medicinal residues add the water of 16 times of amounts again, decoct to extract 60min, and decocting liquid leaves standstill, and filter, and are concentrated with the filtrate merging first time, get 6.2g treatment active ingredient.
Embodiment 2
Get DIWUGONG 20g, bidens 60g, Western Herba Taraxaci 60g, Folium Mori 20g, oven dry is pulverized, and mixes, and then adds the water of above-mentioned DIWUGONG and 20 times of amounts of bidens gross weight, soaks 120min, then decocts and extracts 120min, and decocting liquid leaves standstill, and is for subsequent use after filtering; Medicinal residues add the water of 20 times of amounts again, decoct to extract 120min, and decocting liquid leaves standstill, and filter, and are concentrated with the filtrate merging first time, get 12.6g treatment active ingredient.
Embodiment 3
Get DIWUGONG 60g, bidens 20g, Western Herba Taraxaci 30g, Folium Mori 60g, oven dry is pulverized, and mixes, and then adds the water of above-mentioned DIWUGONG and 40 times of amounts of bidens gross weight, soaks 120min, then decocts and extracts 120min, and decocting liquid leaves standstill, and is for subsequent use after filtering; Medicinal residues add the water of 40 times of amounts again, decoct to extract 120min, and decocting liquid leaves standstill, and filter, and are concentrated with the filtrate merging first time, get 12.5g treatment active ingredient.
Embodiment 4
Get DIWUGONG 30g, bidens 40g, Western Herba Taraxaci 30g, Folium Mori 30g, oven dry is pulverized, and mixes, and then adds the water of above-mentioned DIWUGONG and 40 times of amounts of bidens gross weight, soaks 120min, then decocts and extracts 120min, and decocting liquid leaves standstill, and is for subsequent use after filtering; Medicinal residues add the water of 40 times of amounts again, decoct to extract 120min, and decocting liquid leaves standstill, and filter, and are concentrated with the filtrate merging first time, get 11.6g treatment active ingredient.
Embodiment 5
Get DIWUGONG 40g, bidens 30g, Western Herba Taraxaci 40g, Folium Mori 40g, oven dry is pulverized, and mixes, and then adds the water of above-mentioned DIWUGONG and 24 times of amounts of bidens gross weight, soaks 100min, then decocts and extracts 100min, and decocting liquid leaves standstill, and is for subsequent use after filtering; Medicinal residues add the water of 24 times of amounts again, decoct to extract 100min, and decocting liquid leaves standstill, and filter, and are concentrated with the filtrate merging first time, get 11.8g treatment active ingredient.
Experimental animal pharmacodynamics provided by the invention, clinical practice result and acute toxicity test concrete grammar step are as follows:
Test example 1: medicine of the present invention is to the control test of renal calculus rat model
Method: adopt ethylene glycol to add ammonium chloride method and induce the kidney of rats stone model, give simultaneously medicine and carry out the intervention treatment, observe medicine to the calculus degree of kidney of rats stone model, serum BUN, the impact of Cr content and 24 hours voided volume.
1 test material
Animal: the SD rat, the cleaning level, body weight 180～200g, male, health, Shanghai Slac Experimental Animal Co., Ltd..
The treatment active ingredient (trial drug) that obtains among medicine: the embodiment 5, PAISHI KELI contains 11g crude drug/g, Jisheng Pharmaceutical Factory, Nanchang, Jiangxi system.
Reagent: creatinine reagent box, blood urea nitrogen test kit, it is made that bio-engineering research is built up in Nanjing.
Instrument: SpectraMAX M2 microplate reader (Molecular Device company), electronic balance (Mettler Toledo Inc.), operating microscope, thermostat water bath.
2 test methods
2.1 modeling and index detect
60 of rats, adaptability are divided into 6 groups after raising for 1 week at random, 10 every group, are respectively Normal group, model control group, positive drug (PAISHI KELI) matched group and the large, medium and small dosage group of trial drug.Except Normal group gavage every day gives the distilled water 10ml/kg, (all add the tap water of 1% ammonium chloride as drinking water with containing 1% ethylene glycol every day in all the other 5 groups of rat modelings, drink to change into drinking separately after a week and contain 1% ethylene glycol), large to positive drug control group and trial drug simultaneously, in, small dose group is by positive drug control group (6g crude drug/kg), the heavy dose of group of trial drug (the 6g crude drug/kg), middle dosage group (the 4g crude drug/kg), small dose group (the dosage gastric infusion of 2g crude drug/kg), the model control group gavage gives distilled water, each treated animal administration capacity is 10ml/kg, continuously modeling and 4 weeks of gastric infusion.Test and carry out 14d, the rat tail blood sampling, the centrifuging and taking upper serum is used for biochemical measurement: diacetyl-oxime colorimetry is surveyed serum urea nitrogen (BUN) level, is removed protein method survey creatinine (Crea) level.Test is carried out 28d and is collected respectively on an empty stomach urine of each rat 24h with metabolic cage, measures the 24h voided volume.Get the both sides kidney after rat is put to death and weigh, calculate the organ coefficient of kidney.Every rat is got right kidney, and 10% formalin is fixed, and is used for the nephridial tissue pathological examination.
2.2 nephridial tissue histopathologic examination
Criterion is as follows:
0 grade: without crystallization;
1 grade: the renal cortex intercrystalline;
2 grades: the renal medulla intercrystalline;
3 grades: the renal papillae intercrystalline;
4 grades: the renal pelvis intercrystalline.
Be designated as respectively 1,2,3,4,5 minutes.Each administration group result of the test and model control group are organized a t inspection statistics and are processed.
3 results
3.1 trial drug is on the impact of calculus rat blood serum blood urea nitrogen, creatinine.
The results are shown in Table 1.
Compare with Normal group, renal calculus model group rat blood serum blood urea nitrogen, creatinine significantly increase (P＜0.001); Compare with model control group, trial drug heavy dose of group rat blood serum blood urea nitrogen and creatinine level obviously reduce (P＜0.05～0.001), and middle dosage group rat blood serum urea nitrogen content also obviously reduces (P＜0.05).
Table l trial drug is on the impact of large mouse with renal calculs serum urea nitrogen, creatinine
Compare * P＜0.05, * * P＜0.0l, * * * P＜0.001 with model
3.2 trial drug is on the impact of calculus rat kidney weight, 24h voided volume, renal calculus degree
The results are shown in Table 2.
Compare with model control group, heavy dose of group Kidney coefficients significantly reduces, and the 24h voided volume significantly increases (p＜0.05～0.001).Heavy dose of group, middle dosage group renal calculus degree obviously alleviate (p＜0.001).
Table 2 trial drug is on the impact of calculus rat kidney coefficient, 24h voided volume, renal calculus degree
Compare * P＜0.05, * * P＜0.01, * * * P＜0.001 with model
3.3 trial drug is learned impact to the calculus renal tissues of rats
Microscopic observation is as seen: normal rats kidney surface color is even, and the boundary of cortex medullary substance is clear, in the tangent plane without calcium oxalate crystal; Model control group rat kidney surface irregularity has obvious calcification speckle, forms some bulk granule dress calculus in the renal pelvis; The crystallization of the large, medium and small dosage group of trial drug nephridial tissue then mainly is scattered single kitchen range and local number special mess distribution; The visible crystallization of positive controls is in renal cortex, medullary substance, nipple and being dispersed in property of renal pelvis place or the assembly of many kitchen ranges property.
3.4 ordinary circumstance is observed
Normal rats hair color gloss, honey stomach, the drinking-water appropriateness, body weight increases very fast, and stool is graininess, and the twenty-four-hour urine amount is normal, and the urine color is yellowish.Modeling is respectively organized rat and lassitude occurred, bradykinesia, and hair is owed gloss, and diet reduces, and activity is few, and hematuria symptom, loose stool appear in indivedual rats.The urine amount then appears in treatment group to be increased, spiritual diet activity normal, and the mental status of rat in the trial drug group wherein, active situation, diet and voided volume all are better than the PAISHI KELI group.
Conclusion
1. trial drug has the effect that prevents and treats the kidney of rats calculus, its mechanism of action may alleviate with it damage of renal cells and promote its reparation, strengthen nephridial tissue organelle Stability Analysis of Structures, reduce inflammatory cell infiltration, strengthen pelviureteral wriggling, accelerate urine excretion, enhancing urine mobilization force etc. are relevant.
2. trial drug is basic identical to preventive and therapeutic effect and the PAISHI KELI of kidney of rats stone model, but its whole curative effect is better than PAISHI KELI, and pointing out this medicine is the active drug of preventing and treating renal calculus.
Test example 2: medicine of the present invention is to the therapeutic test of renal calculus rat model
Method: adopt ethylene glycol to add ammonium chloride method and induce the kidney of rats stone model, give medicine behind the modeling 14d and treat, the viewing test medicine is to the calculus degree of kidney of rats stone model, the impact of 24 hours voided volume.
1 test material
Animal: the SD rat, the cleaning level, body weight 180～200g, male, health, Shanghai Slac Experimental Animal Co., Ltd..
The treatment active ingredient (trial drug) that obtains among medicine: the embodiment 4, PAISHI KELI contains 11g crude drug/kg, Jisheng Pharmaceutical Factory, Nanchang, Jiangxi system.
Instrument: SpectraMAX M2 microplate reader (Molecular Device company), electronic balance (prunus mume (sieb.) sieb.et zucc. Teller one holder benefit company), operating microscope, thermostat water bath.
2 test methods
2.1 modeling and index detect
36 of rats, adaptability are divided into 6 groups after raising for 1 week at random, 6 every group, are respectively Normal group, model control group, positive drug (PAISHI KELI) matched group, the large, medium and small dosage group of trial drug.5 groups of rat modelings (all add the tap water of 1% amine-oxides as drinking water with containing 1% ethylene glycol every day), stop modeling behind the modeling 14d, Normal group gavage every day gives distilled water 10ml/kg, simultaneously to positive drug control group and the large, medium and small dosage group of trial drug by positive drug control group (6g crude drug/kg), the heavy dose of group of trial drug (6g crude drug/kg), middle dosage group (4g crude drug/kg), small dose group (the dosage gastric infusion of 2g crude drug/kg), the model control group gavage gives distilled water, and each treated animal administration capacity is 10ml/kg.Continuous gastric infusion 7d.8d is carried out in test, collects respectively on an empty stomach urine of each rat 24h with metabolic cage, measures the 24h voided volume.Get the both sides kidney after rat is put to death and weigh, calculate the organ coefficient of kidney.Every rat is got right kidney, and 10% formalin is fixed, and is used for the nephridial tissue pathological examination.
2.2 nephridial tissue histopathologic examination
Criterion is as follows:
0 grade: without crystallization;
1 grade: the renal cortex intercrystalline;
2 grades: the renal medulla intercrystalline;
3 grades: the renal papillae intercrystalline;
4 grades: the renal pelvis intercrystalline.
Be designated as respectively 1,2,3,4,5 minutes.Each administration group result of the test and model control group are organized a t inspection statistics and are processed.
3 results
3.1 trial drug is on the impact of calculus rat kidney coefficient, 24h voided volume, renal calculus degree.
The results are shown in Table 3.
Compare with model control group, heavy dose of group Kidney coefficients significantly reduces (P＜0.05～0.01), and heavy dose of group, middle dosage group renal calculus degree obviously alleviate (P＜0.001).Urine calcium ion and twenty-four-hour urine amount are without significant change.
Table 3 trial drug is on the impact of calculus rat kidney coefficient, 24h voided volume, renal calculus degree
Compare * P＜0.05, * * P＜0.01, * * * P＜0.001 with model
3.2 trial drug is learned impact to the calculus renal tissues of rats
Microscopic observation is as seen: normal rats kidney surface color is even, and the boundary of cortex medullary substance is clear, in the tangent plane without calcium oxalate crystal; Model control group rat kidney surface irregularity has obvious calcification speckle, and nephridial tissue changes and mainly forms the crystallization of many kitchen ranges property at renal medulla cone collecting tubule and renal papillae place; The crystallization of the large, medium and small dosage group of trial drug nephridial tissue then mainly is scattered single kitchen range and local number special mess distribution; The visible crystallization of positive control elder sister is in renal cortex, medullary substance, nipple and being dispersed in property of renal pelvis place or the assembly of many kitchen ranges property.
3.3 ordinary circumstance is observed
Normal rats hair color gloss, honey stomach, the drinking-water appropriateness, body weight increases very fast, and stool is graininess, and the twenty-four-hour urine amount is normal, and the urine color is yellowish.Modeling is respectively organized rat and lassitude occurred, bradykinesia, and hair is owed gloss, and diet reduces, and activity is few, loose stool.Treatment group is spiritual diet activity normal then.
Conclusion
1 trial drug can reduce the formation of calculus in the nephridial tissue, and the kidney of rats calculus is had obvious therapeutic action.
2 these medicines are basic identical to therapeutical effect and the PAISHI KELI of kidney of rats stone model.
Test example 3: the acute toxicity tests report
The amounts of reactants of test determination is: the maximum dosage-feeding test
Maximum dosage-feeding test refers in single or the 24h the maximum dosage that repeatedly (2～3 times) administration is adopted.The maximum dosage-feeding test refers to give experimental animal with the maximal dose that allows under the condition of rational administration concentration and rational administration capacity, observes the reaction that animal occurs.
1 test method
1.1 tested material
Tested material is DIWUGONG, bidens, Western Herba Taraxaci, the mixing water of the Folium Mori liquid of boiling medicine.
Extracting method: DIWUGONG 100g, bidens 100g, Western Herba Taraxaci 100g, Folium Mori 100g adds water 4000ml(1:20 after the mixing) and carry out the decocting extraction, to filter, filtrate is standby deposits; Medicinal residues add consubstantiality hydrops the same terms and extract 1 time, filter, and merge and vacuum concentration with the 1st extracting solution, get dry thing 26g.
Reagent preparation: adopt dissolved in distilled water, be made into the drug solution that maximum meltage is 1.73g/ml.
Being converted into the crude drug dosage is: 266.67g crude drug/kg body weight.
1.2 experimental animal
Adopt healthy adult KM mice, male and female half and half.Average weight 25g.The initial body weight of animal is no more than average weight ± 20%.
1.3 test grouping
This test arranges 2 groups, and 10 every group, male and female half and half are divided into blank group, administration group at random.
Blank group: 3 distilled water solutions of gavage in the 24h.
3 tested drug solutions of gavage in administration group: the 24h.
1.4 route of administration
Take the method for gastric infusion.
1.5 administration capacity
Gastric infusion, the each gavage amount of mice is 20ml/kg.
1.6 observe the time limit
Be 14 days observing time.
1.7 observation index
Comprise the weight of animals variation, diet, outward appearance, behavior, secretions, Excreta, death condition and toxic reaction (symptom of toxic reaction, the order of severity, zero-time, persistent period, whether reversible) etc.Dying and dead animal are in time dissected, and other animals are dissected after the observation period finishes, the change of observation animal organ's volume, color, quality.
2 interpretations of result
2.1 respectively organize mice all without dead.
2.2 diet: it is all normal that each organizes the mice diet situation.
2.3 outward appearance: each organizes mice hair color and glossiness no significant difference, without perpendicular hair, depilation phenomenon, without edema or erythema, points out tested medicine that renal function is had no significant effect, and skin is not produced inflammation, allergic phenomena.
2.4 breathe: each organize mice all without pant, the cyanosis phenomenon, point out tested medicine that respiratory center, cardio-pulmonary function are had no significant effect.
2.5 behavior: it is normal that each organizes the mice behavior, atremia, clonicity tic, tonic convulsion, dusk fault tic, and acerous bow anti-sheet is without irascible behavior.Point out tested medicine that central nervous system, breathing, neuromuscular, autonomic nerve are had no significant effect.
2.6 the pain sensation: each organizes the equal analgesia forfeiture of mice phenomenon.
2.7 vomiting: each organizes mice all without vomiting or retch phenomenon.
2.8 secretions: it is all normal that each organizes mice, without the moist phenomenon of mouthful peritricha.
2.9 Excreta: administration occurred voiding excreta moist glutinous greasy the same day, and stool colour is brown, without polyuria, red urine, urinary incontinence phenomenon.After this drain normal.
2.10 dissect:
Liver: the liver color and luster has no significant change, without obviously enlargement and form change.
Kidney: kidney is without the edema phenomenon, without obviously changing.
Heart: without obviously changing.
Lungs: without obviously changing.
Spleen: without obviously ripple change.
Conclusion: tested medicine does not produce obvious toxicity phenomenon to the KM mice in this maximum dosage-feeding test.
Test example 4: clinical treatment result
Complete documentation treatment renal calculus patient 62 people (calculus of urethra 23 people wherein, two renal calculus 24 people, single renal calculus 15 people are arranged at present.These patients have B ultrasonic/x-ray to take the photograph sheet as the contrast before and after the treatment).
Everyone takes this medical herbs (DIWUGONG, bidens, the weight proportion of Western Herba Taraxaci and Folium Mori are 1:1:1:1) and pulverizes the powder (60g/ bag) of making, and wrap every day one, and decocting is repeatedly worked as tea-drinking, two courses for the treatment of Monday, shares for two courses for the treatment of.
The result: renal calculus effective percentage first course for the treatment of accounts for 80%(and contains two renal calculuss), second the course for the treatment of effective percentage be more than 90%.Calculus of urethra effective percentage first course for the treatment of is 95%.
In addition, this decoct also has the distinguishing feature of relieving spasm to stop pain, can alleviate renal colic in oral rear 5～10 minutes.
Model case:
White X, man, 70 years old.Suffered from right renal calculus 3 years, ultrasound diagnosis finding " right side renal calculus (big or small approximately 5mm*4mm), companion's sinus renalis slightly separates " takes 2 weeks of this medicine, and calculus excretes.Again check B ultrasonic, show no obvious abnormalities.
Woods X, man, 48 years old.Suffer from 2 weeks of ureteral calculus, hurt like hell, ultrasound diagnosis finding " left ureter basin section calculus, big or small approximately 4mm*6mm ", pain disappearance half an hour behind oral the medicine, calculus per urethram excretes after the week, again checks B ultrasonic, recovers normal.
In sum, the present invention studies show that by lot of experiments, the Chinese herbal medicine formula that is comprised of DIWUGONG and bidens has and alleviates the nephridial tissue edema that causes because of calculus, slow down damage and the pathological changes of kidney, increase voided volume, reduce the formation of calculus in the nephridial tissue, and then can prevent or treat renal calculus.In the maximum dosage-feeding test, the KM mice is not produced obvious toxicity phenomenon.Clinical practice proves that this decoct has fast, the difficult recurrence of calculus, but also has the distinguishing feature of relieving spasm to stop pain, oral rear rapid recovery renal colic.
Above Chinese herbal medicine formula is evident in efficacy, and safety range is large, and technique is simple, and integrated cost is low, is a kind of medicine that can be used for preventing and mooring the renal calculus for the treatment of.
Above-described embodiment is the better embodiment of the present invention; but embodiments of the present invention are not restricted to the described embodiments; other any do not deviate from change, the modification done under spirit of the present invention and the principle, substitutes, combination, simplify; all should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (11)
1. Chinese medicine composition that is used for the treatment of or prevents lithangiuria comprises the component of following weight portion:
20～60 parts of DIWUGONG, 20～60 parts of bidens, 20～60 parts of Western Herba Taraxacis, 20～60 parts on Folium Mori.
2. be used for the treatment of as claimed in claim 1 or prevent the Chinese medicine composition of lithangiuria, it is characterized in that, described Chinese medicine composition comprises the component of following weight portion: 30～40 parts of DIWUGONG, 30～40 parts of bidens, 30～40 parts of the West Herba Taraxacis, 30～40 parts on Folium Mori.
3. Chinese medicine extract that is used for the treatment of or prevents lithangiuria is for making take claim 1 or 2 described Chinese medicine compositions as the raw material effective component extracting.
4. Chinese medicine extract as claimed in claim 3 is characterized in that, the method for described effective component extracting is selected from: decoction, decoction and alcohol sedimentation technique, ethanol extract from water precipitation or salting out method.
5. such as the preparation method of Chinese medicine extract as described in claim 3 or 4, comprise the following steps: to get by weight DIWUGONG, Western Herba Taraxaci, Folium Mori, bidens, decocting after oven dry is pulverized, decocting liquid leaves standstill, and filters, and is concentrated, gets Chinese medicine extract.
6. the purposes of Chinese medicine composition or claim 3 or 4 described Chinese medicine extract as claimed in claim 1 or 2 is the medicine for the preparation of prevention or treatment lithangiuria.
7. purposes as claimed in claim 6 is characterized in that, described lithangiuria is ureteral calculus or renal calculus.
8. purposes as claimed in claim 7 is characterized in that, described lithangiuria is calcium oxalate stone, calcium phosphate stone or struvite calculus.
9. a Chinese medicine preparation that is used for the treatment of or prevents lithangiuria comprises claim 3 or 4 described Chinese medicine extract and one or more pharmaceutic adjuvants for the treatment of effective dose.
10. Chinese medicine preparation as claimed in claim 9 is characterized in that, described Chinese medicine preparation is oral formulations.
11. Chinese medicine preparation as claimed in claim 10 is characterized in that, described oral formulations is tablet, pill, sublimed preparation, powder, granule, powder, capsule, buccal tablet or effervescent tablet.
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| CN1583156A (en) * | 2004-06-16 | 2005-02-23 | 叶关坤 | Chinese herbal medicines for various stones and their preparation |
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Non-Patent Citations (3)
| Title |
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| 何悠然著: "《小资辞典》", 30 April 2006, 中国纺织出版社 * |
| 汤迎爽等: "鬼针草的化学成分与药理作用研究进展", 《中医药导报》 * |
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