CN1197612C - Chinese medicine preparation for treating lithiasis in urinary system and urethral infection, and preparing method thereof - Google Patents
Chinese medicine preparation for treating lithiasis in urinary system and urethral infection, and preparing method thereof Download PDFInfo
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Abstract
The present invention provides a Chinese medicinal preparation for treating the disease symptoms of lithiasis in the urinary system, urethral infection, etc. The Chinese medicinal preparation comprises the main raw materials of snowbelleaf tickclover herb, plantain herb, pyrrosia leaf and corn stigma. The production method of the Chinese medicinal preparation comprises the steps that the snowbelleaf tickclover herb, the plantain herb, the pyrrosia leaf and the corn stigma are respectively cleaned, selected, washed and cut into segments (or broken); 6 to 10 times of water is added into each kilogram of medicinal materials for decoction twice; the medicinal materials are filtered, and the filter liquid is concentrated; then, the concentrated liquid is mixed with excipient to prepare tablets, capsules, pills, granules, mixture and syrup. The Chinese medicinal preparation has the advantages of clearing heat, expelling dampness, promoting diuresis, treating lithiasis, relieving inflammation and alleviating pain. The Chinese medicinal preparation is used for treating damp and heat in the bladder, heat strangury, urolithic strangury, strangury, urethral infection, urinary calculus and renal colic. The Chinese medicinal preparation can be used as an auxiliary medicine for extracorporeal ultrasonic for treating ithiasis. The Chinese medicinal preparation has the obvious effects of alleviating pain, relieving inflammation, promoting diuresis and treating lithiasis, and also has a good therapeutic effect on frequent urination, urgency of urination and painful urination caused by urethral infection.
Description
Technical field
The present invention relates to treat the Chinese medicine preparation of diseases of urinary system, particularly treat Chinese medicine preparation of diseases such as urinary system calculus and urinary tract infection and preparation method thereof.
Background technology
Diseases of urinary system is human common disease, its cardinal symptom have frequent micturition short red, urinate puckery causalgia, serious occurred heating, thirsty, abdominal pain, waist is ached, hematuria, suppurate, constipation with dry stool or completely mashed, its reason has following several, 1, renal calculus or urinary tract, vesical calculus.Owing to calculus has been blocked kidney, urinary tract, bladder and is made urinary tract not smooth, make waist or abdominal part continue dull pain or paroxysmal pain, often be radiated to hypogastric region or cloudy down, can accompany phenomenons such as hematuria, X line plain film or radiography can show the calculus shade, and B ultrasonic also can reflect existence and big or small, the position of calculus; 2, pyelonephritis, cystitis, urethritis are mainly caused by bacterial infection or local patholoic change, when the urinary system acute inflammation, the urethral orifice redness often occurs, and purulent secretion is arranged, and the urine spectroscopy has red white corpuscle or pus cell, the urine positive bacterial culture; 3, the urinary tract infection that causes of sexually transmitted disease (STD), mainly be that patient has bad sexual behaviour and causes infecting gonococcus, non-gonococcal infection, frequent micturition, urgent micturition, pudendum redness also appear in its symptom, purulent secretion is arranged, situations such as hematuria, be surgical calculus removing and external instrument concussion rubble calculus method to kidney, urinary tract, cystolithic western medicine therapy at present, operate on modus operandi expense height, patient's misery and postoperative recurrence rate height; Though it is fast that calculus method speed is impacted in instrument concussion, short treating period, the equipment manufacturing cost height is not suitable for the extensive patients in samll cities and towns or rural area.The traditional Chinese medical science then is to adopt various calculus prescriptions, and its cost is lower, and also each is variant for treating both the principal and secondary aspects of a disease, but most prescription among the people does not pass through strict pharmacodynamic experiment and toxicity test, therapeutic effect; To acute pyelonephritis, cystitis, the Therapeutic Method of the present doctor trained in Western medicine of disease that urethritis and sexually transmitted disease (STD) cause adopts antibiotic therapy mostly, the therapeutic effect of antibiotics is obvious, speed is fast, but it is not remarkable to the chronic disease therapeutic effect, the medication that has also can produce the drug-resistant effect to antibacterial too for a long time, so the traditional Chinese medical science has been studied some preparations at present, in order to treatment urinary system calculus and urinary tract infection, as SANJIN PIAN (capsule), the treating stranguria oral medicine of money, BAZHENG HEJI, JISHENG SHENQI WAN, composite shi-wei tablet etc., these Chinese medicine preparation have therapeutical effect preferably to diseases such as treatment urinary system calculus and urinary tract infection, people still continue many Chinese medicines are studied at present, to excavate more Chinese medicine, make the Chinese medicine preparation of treatment various diseases, be mankind's service.Be mankind's service.
Technology contents
The applicant is just on the basis of research tradition Chinese herbal medicine, through test for many years, prescription in conjunction with Guangxi treatment diseases of urinary system more among the people, multiple formulations is screened, found therapeutic effect good, the several drugs that has no side effect, worked out a kind of new Chinese medicine preparation, said preparation comprises Herba Desmodii Styracifolii, Herba Plantaginis, Folium Pyrrosiae, Stigma Maydis, and made granule and tested, it has clearing heat and expelling damp, anti-inflammatory analgetic, the effect of diuresis and expelling stone, can be used for treating diseases such as urinary system calculus and urinary tract infection, through clinical trial in a few years, proved that this medicine produce effects is fast, subjective symptoms and sign are obviously improved, not seeing has side effect, and is difficult for recurrence.
Chinese medicine preparation of the present invention comprises Herba Desmodii Styracifolii, Herba Plantaginis, Folium Pyrrosiae, Stigma Maydis, and the composition of its primary raw material and weight content are:
Herba Desmodii Styracifolii: 25-60%; Herba Plantaginis 15-40%; Folium Pyrrosiae 15-40%; Stigma Maydis 5-20%.
Herba Desmodii Styracifolii is the aerial parts of leguminous plant Desmodium styracifolium (Osb.) Merr., is distributed in provinces and regions such as Guangxi, Guangdong, Fujian and Hunan. its branch and leaf can be used as medicine, diseases such as treatment urinary tract infection, urinary system calculus, cholelithiasis.Modern study proves that this plant chemical ingredient studies carefully, and separating has chemical compounds such as Xia Fota glycosides, desmodimine, desmodilactone, triterpenoid, lupin ketone and lupeol, tricosane, stearic acid, arachidic acid, Semen arachidis hypogaeae alcohol ester and cupreol.Notice that differentiation has multiple Herba Lysimachiae, the leguminous plant Herba Desmodii Styracifolii has diuresis, calculus, antiinflammation, for commonly using in Guangxi, Guangdong Province; The labiate Herba Glechomae is controlled urinary tract infection, falls damage, and the jaundice due to damp-heat effect is for commonly using in Zhejiang, Jiangsu; Also have and do that Herba Lysimachiae uses Flos Inulae section plant Herba Dichodrae (having another name called the lobule Herba Lysimachiae) arranged, clearing away heat and promoting diuresis, anti-inflammatory analgetic effect are arranged.
Herba Plantaginis has another name called Herba Plantaginis, wheel dish, donkey ear dish, cash strings grass etc., is the dry herb of Plantaginaceae plant Herba Plantaginis (Plantago asiaticaI Willd) or Plantago depressa Willd (P1antago depressa Willd).Herba Plantaginis, sweet in the mouth, cold in nature is gone into liver, kidney, lung, small intestine meridian, can inducing diuresis for treating stranguria syndrome, eliminating dampness by diuresis antidiarrheal, liver heat removing tomorrow, again can the relieving cough and reducing sputum, removing pathogenic heat from blood and toxic substance from the body.The Chinese medicine document is introduced Herba Plantaginis can treat urinary tract infection.The document record that has is that principal agent can also be treated pneumonia, hematuria, gastric flu and child disease with the Herba Plantaginis.Chemical analysis results, main effective ingredient is ursolic acid, plantagin, aucubin etc. in the Herba Plantaginis.Modern pharmacological research shows, ursolic acid has stronger anti-tumor activity, it not only has resistant function to multiple carcinogenic, short cancer thing, and to multiple malignant cell for example P388 and L4210, leukaemia, A-549 human lung adenocarcinoma cell the growth of inhibition effect is arranged, it also has mutation, antioxidation and inducing cancer cell differentiation and strengthens the effect of aspects such as cellular immune function simultaneously.
Folium Pyrrosiae is a conventional Chinese medicine, and the The Chemical Constituents of Folium Pyrrosiae genus (Pyrrosia) plant is quite deep, and its chemical classification has been done exploration.Known this platymiscium contains physiologically active ingredients such as cupreol, trifolin, isomangiferin and Fumaric acid.Pyrrosia gralla Ching is that areas such as Guangxi, Yunnan, Guangdong are used for relieving stranguria by diuresis, and lung heat clearing expels the heat-evil, the medicine commonly used of clearing away heat to stop bleeding.Have antitussive, eliminate the phlegm, antibiotic, antivirus action, for the leukopenia that chemotherapy and actinotherapy cause, Folium Pyrrosiae has the effect that makes its rising.Clinically be used for the treatment of urethritis, lithangiuria, cystitis, nephritis edema, cough due to lung-heat, metrorrhagia etc.Have analgesia, heat clearing away, diuretic effect.
Stigma Maydis is zeistic style of grass and stigma.Semen Maydis has another name called corn, luxuriant reed, maize etc., and it is China's important crops, and all there is cultivation all parts of the country, and output is very high.Stigma Maydis is a kind of Chinese medicine, and its nature and flavor are sweet, flat, nontoxic, diuresis is arranged, expels the heat-evil, the effect of suppressing the hyperactive liver, function of gallbladder promoting, and it not only can be used as the single medicinal material decoction, also can use with other drug matching, is used for treating nephritis, cholelithiasis, diabetes etc.In recent years, pharmacological research shows that Stigma Maydis extract also has blood pressure lowering and antitumaous effect.Because most Stigma Maydis are dropped, to fail to make full use of, the relevant also rare report of Stigma Maydis The Chemical Constituents has bibliographical information employing gas chromatogram-mass spectrum-computer coupling separation and has identified the chemical constituent of volatile oil in the Stigma Maydis.The result shows, 42 compositions from 57 chromatographic peaks, have been identified, wherein main chemical constituent has heneicosane (6.53%), nonacosane (10.70%), hexatriacontane (4.11%), Ethyl linoleate (3.57%), bean steroid 5-alkene-3-alcohol (6.67%), cupreol (7.89%); Stigmasterol (6.82%).
The production method of Chinese medicine preparation of the present invention is as follows:
1, the production method of tablet: with Herba Desmodii Styracifolii, Herba Plantaginis, Folium Pyrrosiae, Stigma Maydis select respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree, and (add 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), get concentrated solution, make particle drying, add disintegrating agent, lubricant with excipient, tabletting, or directly pack, or sugar coating, or the bag film-coat promptly obtains product.
The described excipient of above tablet is starch and derivant thereof, dextrin, calcium hydrogen phosphate etc.; Described disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose etc.; Described lubricant is a magnesium stearate etc.; Described sugar coating material is sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Described thin film coating material is stomach dissolution type water, pure coating material etc.Wherein the weight content of excipient, disintegrating agent, lubricant, coating material consumption is respectively: 5～75%, 0.5～20%, 0.5～2.0%, 2～45%.
2, the production method of capsule: add excipient and disintegrating agent in the concentrated solution that above-mentioned production is obtained and make it dry, in incapsulating then, obtain product.
More than preparation capsule described excipient is starch and derivant thereof, calcium hydrogen phosphate, magnesium stearate, differential silica gel etc.Weight 20～80%.
3, the production method of pill: add excipient, pill in the concentrated solution that above-mentioned production is obtained.1. make concentrated pill; 2. add excipient weight 10～100%, Mel, make water-honeyed pill, big honeyed pills, concentrated pill.
4, the production method of granule: in the concentrated solution that above-mentioned production obtains, add excipient, and make granule, make it dry, obtain product.
The composition and the content that add excipient: sucrose 50～95%, lactose 50～90%, dextrin 50～70%.
5, the production method of mixture: concentrated solution that above-mentioned production is obtained and correctives, antiseptic solution mix homogeneously promptly obtain product.
The correctives and the content thereof that add: sucrose (or Mel) 10～60%, potassium sorbate preservative 0.1～1%, ethyl hydroxybenzoate 0.1～0.3%.
6, the production method of syrup: concentrated solution that above-mentioned production is obtained and sucrose, antiseptic solution mix homogeneously promptly obtain product.
The sucrose amount that adds is 60～70%, potassium sorbate preservative 0.1～1%, ethyl hydroxybenzoate 0.1～0.3%.
Outstanding substantive distinguishing features of the present invention and obvious improvement are:
Urinary tract infection is clinical common disease, and the medicine of treatment urinary tract infection has multiple, and is many in the past with the treatment of antimicrobial drugs such as sulfonamides, aminoglycosides, cephalosporins.Because being extensive use of of these medicines, its Resistant strain increases gradually, and is not satisfactory sometimes to the urinary tract infection curative effect.Chinese medicine preparation of the present invention is a Chinese patent medicine preparation, and Main Ingredients and Appearance is Herba Desmodii Styracifolii, Herba Plantaginis, Folium Pyrrosiae, Stigma Maydis, main liver, fat, kidney, bladder four warps of returning, main relieving stranguria by diuresis, clearing heat for detumescence is simultaneously because the particulate diuresis of compound recipe Herba Lysimachiae, make the urine dilution, can reduce crystal formation.For damp-heat in the urinary bladder, urinary tract infection, lithangiuria, renal colic etc. good auxiliary treatment effect is arranged.
It is 93% with ofloxacin and Chinese medicine preparation therapeutic alliance urinary tract infection total effective rate of the present invention that the document introduction is arranged, and wherein treats complexity urinary tract infection effective percentage and also reaches 87%.The curative effect of non-complex urinary tract infection is satisfactory, and 14 examples are all effective, compare with the clinical data of Europe, the single application quinolone antibiotic of the U.S. (to the total effective rate 88% of urinary tract infection 〉, curative effect is significantly improved.The ofloxacin has a broad antifungal spectrum, sterilizing power is strong, bacterial drug resistance is little, and the dampness removing of Chinese medicine preparation of the present invention is treating stranguria in addition, urine concentration is high, few side effects; Advantages such as taking convenience can be used as present treatment urinary tract infection, particularly to an other drug more satisfactory composition of medicine of very responsive complexity urinary tract infection not, simultaneously, can be used as the choice drug of non-complex urinary tract infection.
Chinese medicine preparation clearing heat and expelling damp of the present invention, diuresis and expelling stone, anti-inflammatory analgetic.Be used for damp-heat in the urinary bladder, the pyretic stranguria stranguria caused by urinary stone drenches drop puckery pain, urinary tract infection, lithangiuria and renal colic.Indication: lithangiuria, renal colic, urinary tract infection, urine urgency-frequency, dark coloured urine pain has calculus effect preferably to established lithangiuria, can assist external stone crushing: can have tangible analgesia, antiinflammatory, diuresis, calculus effect as external supersonic ripple rubble adjuvant drug.Urinary tract infection: antimicrobial antiphlogistic has curative effect preferably to frequent micturition, urgent micturition, the dysurea of urinary tract infection.
Pharmacological experiments proves that Chinese medicine preparation of the present invention has anti-inflammation, calculus, analgesia, the lithogenous effect of prevention, and its effect is better than contrast medicines such as calculus is logical, uralyt, and almost non-toxic property.Because this medicine both can stop calculus to form, but calculus is again had simultaneously analgesic activity again.
The specific embodiment
Embodiment 1, with 40 kilograms of Herba Desmodii Styracifolii, 20 kilograms of Herba Plantaginiss, 15 kilograms of Folium Pyrrosiaes, 10 kilograms of Stigma Maydis are chosen respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree and (adds 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), get concentrated solution, with 5～75% starch or starch derivatives, dextrin, calcium hydrogen phosphate is made particle drying, adds 0.5～20% sodium carboxymethyl cellulose, hydroxypropyl cellulose, lubricant 0.5～2.0% magnesium stearate, tabletting, or directly pack, or sugar coating, or the bag film-coat promptly obtains product.
Embodiment 2, with 25 kilograms of Herba Desmodii Styracifolii, 15 kilograms of Herba Plantaginiss, 15 kilograms of Folium Pyrrosiaes, 5 kilograms of Stigma Maydis are chosen respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree (add 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, and debris continues to concentrate), get concentrated solution, with 5～75% starch or starch derivatives, dextrin, calcium hydrogen phosphate is made granule, and drying adds fluidizer, encapsulated, promptly obtain product.
Embodiment 3, with 60 kilograms of Herba Desmodii Styracifolii, 40 kilograms of Herba Plantaginiss, 40 kilograms of Folium Pyrrosiaes, 20 kilograms of Stigma Maydis choose respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree and (adds 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), concentrated solution, make concentrated pill, water-honeyed pill, big honeyed pills, promptly obtain product with excipient.
Embodiment 4, with 50 kilograms of Herba Desmodii Styracifolii, 25 kilograms of Herba Plantaginiss, 18 kilograms of Folium Pyrrosiaes, 15 kilograms of Stigma Maydis choose respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree and (adds 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, and debris continues to concentrate), get concentrated solution, add sucrose 50～95%, lactose 50～90%, dextrin 50～70%, make granule, drying promptly obtains product.
Embodiment 5, with 30 kilograms of Herba Desmodii Styracifolii, 18 kilograms of Herba Plantaginiss, 35 kilograms of Folium Pyrrosiaes, 18 kilograms of Stigma Maydis are chosen respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree and (adds 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), get concentrated solution, with correctives sucrose 10～55%, potassium sorbate preservative 0.1～1%, ethyl hydroxybenzoate 0.1～0.3% mixes, and makes mixture.
Embodiment 6, with 30 kilograms of Herba Desmodii Styracifolii, 18 kilograms of Herba Plantaginiss, 35 kilograms of Folium Pyrrosiaes, 18 kilograms of Stigma Maydis are chosen respectively, wash, cutting (broken), adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree and (adds 0.5～3 times of amount precipitation of ethanol in case of necessity, supernatant reclaims ethanol, debris continues to concentrate), concentrated solution, with the sucrose amount be 60～70%, potassium sorbate preservative 0.1～1%, ethyl hydroxybenzoate 0.1～0.3% merges, and makes syrup.
The relevant toxicity test of the present invention, clinical trial, pharmacology, pharmacodynamics situation:
One, compound recipe Herba Lysimachiae granule long term toxicity test report of the present invention
1, summary
Examine requirement by Chinese medicine three classes, 9.8g/kg, the 19.6g/kg of Chinese medicine preparation of the present invention and the dosage of the total medical material/kg of 39.2g (be equivalent to the people respectively and intended 20,40,80 times of consumption in clinical day) have been carried out long term toxicity research in 3 months to rat, the result shows that three dosage groups are not seen tangible toxic reaction to the aspects such as general situation, organ coefficient, routine blood test, blood parameters and histopathology of animal.
2, test objective
Observe compound recipe Herba Lysimachiae granule rat is carried out toxic reaction and the degree thereof that long-term gastric infusion produced, to determine clinical application safety.
3, test method
3.1 group and dosage design
With reference to long term toxicity test, new Chinese medicine toxicologic study guideline, establish high, medium and low three dosage groups: 9.8,19.6,39.2 total medical material/kg/ days, be equivalent to 20,40,80 times of the total medical material/kg of the clinical day consumption 0.49g of plan respectively.Other establishes blank group (giving distilled water).
3.2 medication
3.2.1 approach
The oral administration gavage administration
3.2.2 administration capacity
20ml/kg
3.2.3 administration number of times
Every morning gastric infusion 1 time, continuous 3 months.
3.2.4 dose titration
Adjust dosage by new body weight change weekly.
4, observing time
4.1 the administration phase
3 months
4.2 convalescent period
2 weeks
5, observation index
5.1 general situation
Observe situations such as outward appearance sign, behavioral activity, appetite, defecation.Weigh weekly during the administration 1 time.
5.2 hematological indices
Last administration and 2 all backs after 24 hours are got 12,8 rats respectively for every group, through the vena ophthalmica blood sampling, carry out the inspection of following index.(fasting is 12 hours before the blood sampling)
5.2.1 erythrocyte (RBC), leukocyte (WBC), hemoglobin (Hb), platelet (PLT)
5.2.2 leukocyte differential count
Lymphocyte (Lym), granulocyte (Gran), mononuclear cell (MID)
Above hematological indices is carried out on the BC-2000 cellanalyzer.
5.2.3 blood biochemical is learned
Last administration and 2 all backs after 24 hours are got 12,8 rats respectively for every group and are taken a blood sample through vena ophthalmica, carry out the inspection of following index: (fasting is 12 hours before the blood sampling).
Total serum protein (TP), albumin (ALB), globulin (GLB), glutamate pyruvate transaminase (ALT), alkali phosphatase (ALP), glutamic oxaloacetic transaminase, GOT (AST), blood urea nitrogen (BUN), creatinine (CRE), blood glucose (GLU), T-CHOL (T-CHO), triglyceride (TG).
These parameters is carried out on Olympus AU600 biochemistry analyzer.
5.4 organ coefficient and histological examination
12 and 8 rats are got for every group in last administration and 2 all backs after 24 hours, calculate organ coefficient after taking by weighing the weight of organs such as brain, the heart, lung, liver,spleen,kidney, adrenal gland, thymus, bladder, testis, prostate+seminal vesicle, uterus, ovary, and above internal organs and stomach, intestinal are carried out histopathological examination after with 10% formaldehyde fixed.
6, result
6.1 general situation
Blank group, each dosage group of Chinese medicine preparation of the present invention show no obvious abnormalities at duration of test activity, the mental status, defecation, hair etc., also do not see reactions such as vomiting, diarrhoea, depilation, do not see animal dead.The outstanding height of each dosage group of compound recipe Herba Lysimachiae granule, middle dosage group rat body weight have certain reduction trend from the 8th all body weight gains, but do not see significant difference (P＜0.05) with the blank group.
6.2 hematological indices
The hematological indices inspection shows that blood hemoglobin (Hb) content of administration Chinese medicine preparation high dose group of the present invention after 3 months reduces (P＜0.01) than matched group, but still in normal range, drug withdrawal returns to control level after 2 weeks.Compound recipe Herba Lysimachiae each dosage group hematological indices of granule such as erythrocyte (RBC), platelet (PLT), lymphocyte (Lym), mononuclear cell (MID) etc. are all normal after 2 weeks of drug withdrawal.
6.3 blood biochemical is learned index
Blood biochemical is learned the index inspection and is shown, after the administration 3 months, serum glutamic pyruvic transminase (ALT) content of each dosage group of Chinese medicine preparation of the present invention has certain rising trend than the blank group, and wherein the ALT of middle dosage group rising is more obvious, and drug withdrawal 2 Zhou Houjun return to the matched group level; The serum creatinine (CRE) of compound recipe Herba Lysimachiae granule high dose group has certain rising trend (P＞0.05) in administration after 3 months.The serum urea nitrogen (BUN) of each dosage group of compound recipe Herba Lysimachiae granule raise in 2 weeks of drug withdrawal, and wherein the elevated levels of the serum urea nitrogen of high dose group (BUN) and blank group relatively have notable difference (P＜0.05); Serum triglycerides (TG) also has certain downward trend after 2 weeks of drug withdrawal, wherein the serum triglycerides of high dose group (TG) content and blank group compare P value＜0.05, but These parameters all is no more than normal range value.The total serum protein (TP) of each dosage group of compound recipe Herba Lysimachiae granule, albumin (ALB), globulin (GLB), glutamic oxaloacetic transaminase, GOT (AST), alkali phosphatase (ALP), blood glucose (GLU), T-CHOL (CHO) content and blank group relatively there are no significant difference.
6.4 organ coefficient
After administration 3 months and 2 weeks of drug withdrawal, the high, medium and low dosage group of compound recipe Herba Lysimachiae granule spleen coefficient has certain trend that increases, but does not have significance with blank group comparing difference; Organ coefficient and the relatively more equal no significant differences of blank group such as brain, the heart, lung, liver, kidney, adrenal gland, thymus, bladder, testis, prostate+seminal vesicle, ovary, uterus.
6.5 histological examination
After administration finished in 3 months, Chinese medicine preparation high dose group interstitial pneumonia of the present invention, bronchiolitis companion pulmonary abscess, being dispersed in property of brain kitchen range shape corpora amylacea forms each 1 example.Middle dosage group 1 routine bronchiolitis, 4 routine liver diffusivity steatosis and 3 routine being dispersed in property of brain kitchen range shape corpora amylaceas form.Blank group 1 routine interstitial pneumonia, 3 routine fattys degeneration of liver and 2 routine being dispersed in property of brain kitchen range shape corpora amylaceas form.Each dosage group and blank group relatively there are no significant difference.Other organ after one's own heart, each group of internal organs histopathologic examinations such as spleen, kidney, stomach, small intestinal, brain, adrenal gland, thymus, bladder, testis, prostate, seminal vesicle, uterus, ovary there is no abnormal change.
7, evaluation of result
The people is clinical day to intend with the Chinese medicine preparation extractum of the present invention of 20 times, 40 times, 80 times of dosage the continuous gastric infusion of rat 3 months to be equivalent to, and rat shows no obvious abnormalities none death in general situation such as duration of test activity, the mental status, feces, hair.The hematological indices inspection shows that the Hb content of successive administration compound recipe Herba Lysimachiae granule high dose group after 3 months is lower than matched group, and drug withdrawal returns to the matched group level after 2 weeks.Blood biochemical is learned the index inspection and is shown that the Serum ALT of each dosage group of compound recipe Herba Lysimachiae granule has certain rising trend, and wherein the ALT of middle dosage group rising is more obvious, and drug withdrawal 2 Zhou Houjun return to the matched group level; The change of serum C RE of each dosage group has certain rising trend in administration after 3 months, serum TG is in drug withdrawal 2 Zhou Houyou decline in various degree, but above-mentioned variation all changes in normal range.
Behind the successive administration 3 months, histological examination is seen, high, medium and low dosage group of Chinese medicine preparation of the present invention and blank group have the changes such as pneumonia, fatty degeneration of liver, the formation of being dispersed in property of brain kitchen range shape corpora amylacea except that indivedual internal organs, all the other organs there is no obvious pathologic and change, pathological changes no significant difference in four groups of indivedual internal organs is so can think that these pathological changes and medicine factor have nothing to do.
The long term toxicity test results suggest, Chinese medicine preparation of the present invention does not have obvious toxic and side effects, so think that be comparison safety by clinical plan with using the dosage and the course of treatment Chinese medicine preparation of the present invention.
Two, the Pharmacodynamic test of active extract of compound recipe Herba Lysimachiae granule of the present invention report
1, summary
Zoopery is the result show, compound recipe Herba Lysimachiae granule compound recipe Herba Lysimachiae granule has stronger antibacterial action to staphylococcus aureus, Bacillus proteus, minimum inhibitory concentration is 4.5%, bacillus pyocyaneus and escherichia coli also there is certain antibacterial action, minimum inhibitory concentration is respectively 18.0% and 9.0%, and gonococcus is not had antibiotic effect.Golden Portugal bacterium infecting mouse had significant protective effect.Can alleviate mice auricle swelling degree due to the Oleum Tiglii and the rat paw edema degree due to the carrageenin, have certain antiinflammatory action.Obviously increase rat urine amount, have tangible diuresis.The rabbit ureter that exsomatizes is shunk and has the obvious suppression effect, the ureter smooth muscle spasm that ACh is caused have a tangible spasmolysis.External lithodialysis result of the test shows that the compound recipe Herba Lysimachiae granule of high concentration has certain litholytic effect to urinary stone.That compound recipe Herba Lysimachiae granule has is antibiotic, antiinflammatory, diuresis, spasmolytic and litholytic effect.
2, experiment purpose
Function according to compound recipe Herba Lysimachiae granule cures mainly, and investigates that it is antibiotic, antiinflammatory, diuresis, spasmolytic and litholytic effect, for its clinical practice provides foundation.
3, be subjected to the reagent thing
3.1 title and clinical usage and consumption
Compound recipe Herba Lysimachiae granule, 2 bags/time, 3 times/day, oral.
3.2 dosage setting
With reference to clinical day plan consumption, rat and mice were irritated stomach 4.9g, 9.8g or the total medical material/kg of 19.6g respectively, are equivalent to 10,20 times or 40 times of clinical consumption per day.
4, the proved recipe method is selected
Cure mainly according to the antiinflammatory of compound recipe Herba Lysimachiae granule, diuresis, urinary calculus removing function, according to the requirement of relevant pharmacodynamic study in the new drug preclinical study guideline
[1], carried out following observation index:
(1) antibacterial tests
I in-vitro antibacterial experimental observation compound recipe Herba Lysimachiae granule is to the antibacterial action of gonococcus, escherichia coli, Bacillus proteus, bacillus pyocyaneus, staphylococcus aureus
Dead protective effect behind the antibacterial tests observation injected in mice staphylococcus aureus in the II body
(2) antiinflammatory test
I causes the influence of mice auricle swelling to Oleum Tiglii
II is to the influence of rat paw edema due to the carrageenin
(3) the rat diuretic test is observed the influence to rat urine amount
(4) influence to the stripped ureter smooth muscle wriggling of rabbit reaches the spasmolysis that ACh is caused the ureter smooth muscle spasm
(5) external litholytic effect
5, test key step
5.1 antibacterial tests
5.1.1 in-vitro antibacterial test
[2]
, and then mix with bacteria culture media to required drug level with distilled water diluting compound recipe Herba Lysimachiae granule extractum, the concentration of culture medium Chinese medicine (containing total medical material amount) is 36.0%, 18.0%, 9.0%, 4.5%, 2.25%.Inoculated bacteria is observed the growing state of antibacterial after 24 hours.
5.1.2 protective effect to the mouse infection staphylococcus aureus
[3]
With clinical isolating golden Portugal bacterium inoculation and Nutrient medium in vitro, in 37 ℃ of incubators, cultivated 24 hours.Is suitable concentration with the bacterium liquid of this cultivation with the normal saline dilution, gets the mice trial test earlier and finds out and cause the minimum lethal concentration of dead mouse more than 90%.Get totally 80 of mices, 18～22g is divided into 4 groups at random, every treated animal number is 20, and male and female half and half are respectively blank group, Western medicine positive controls (penicillin 400,000 u/kg, sc), compound recipe Herba Lysimachiae high and low dose group (dosage is respectively 19.6g, the total medical material/Kg of 9.8g, ig).Grouping back successive administration 3 times, each 8 hours at interval, and the mouse inoculation staphylococcus aureus is given in administration after 30 minutes the last time.Every Mus lumbar injection about 10
9The staphylococcus aureus suspension 0.5ml of/ml.Observe and infect ordinary circumstance and the mortality rate of inoculating infection animal in back 48 hours.
5.2 antiinflammatory action
5.2.1 Oleum Tiglii is caused the influence of mice auricle swelling
[4]
40 of mices evenly are applied to the auris dextra two sides with Oleum Tiglii mixing proinflammatory agent (2% Oleum Tiglii, 20% dehydrated alcohol, 5% distilled water and 73% ether) 50 μ l and cause inflammation.The mice random packet, grouping and dosage are with under the 7.1.2 item, and the Western medicine positive controls gives dexamethasone, 4mg/Kg, sc.Cause scorching each dosage treated animal administration of compound recipe Herba Lysimachiae the previous day 2 times.Each treated animal was administered once again in second day, and behind medicine half an hour cause inflammation to animal.Causing scorching back 4 hours clip mice left and right sides ears, is the card punch of 0.7cm with internal diameter, is equal to the position towards getting left and right sides ear, accurately weighs, and as the swelling degree, estimates the influence of medicine to Fructus Crotonis oiliness inflammation with left and right sides ear weight difference.
5.2.2 the influence of rat paw edema due to the on Carrageenan
[5]
40 of rats will cause inflammation under the 1% carrageenin 0.05ml injection rat right hind leg foot plantar aponeurosis.The rat random packet, grouping is with under the 7.2.1 item.Cause scorching each dosage treated animal administration of compound recipe Herba Lysimachiae the previous day 2 times.Each treated animal was administered once again in second day, and behind medicine half an hour cause inflammation to animal.Cause scorching back 6 hours and put to death animal, foot is accurately weighed about ankle is accurately wiped out, with about sufficient weight difference as the swelling degree, estimate the influence of medicine on Carrageenan inflammation.
5.3 influence (metabolic cage method) to rat urine amount
[6]
40 of rats, prohibited water 24 hours, the 2nd day each Mus pressed the normal saline lumbar injection of 2ml/100g, and gently depress abdominal part and make the bladder emptying, random packet is respectively blank group, Western medicine positive controls (furosemide then, 4mg/kg, ip), compound recipe Herba Lysimachiae high and low dose group (dosage is respectively 9.8, the total medical material/Kg of 4.9g, ig).Immediately rat is put into metabolic cage after the administration, one in every cage is collected total urine in 5 hours, respectively organizes rat 5h amount of urine.
The ureter test 5.4 rabbit is exsomatized
[7]
6 of New Zealand white rabbit are hit to cut open the belly after hindbrain causes death with rod and are cut one section ureter, place the culture dish that fills tyrode's solution, and the segment that the ureter of rinsing well is cut into about 3cm is standby.A bit of ureter is fixed in the Magnus' bath, keep the permanent oxygen of constant temperature (38 ℃ ± 0.5 ℃), after treating that ureter is stablized 10～20 minutes in body lotion, trace one section normal ureter shrinkage curve, add compound recipe Herba Lysimachiae granule extractum then, observe variable concentrations and (contain total medical material amount in the bath liquid, its influence of) compound recipe Herba Lysimachiae granule down together the stripped ureter smooth muscle of rabbit, and ask maximal percentage inhibition by following formula, the results are shown in Table 6.
After this in bath, add earlier 0.01%ACh 0.2ml and make the ureter smooth muscle spasm that exsomatizes, treat that it steadily after, add compound recipe Herba Lysimachiae granule extractum, the compound recipe Herba Lysimachiae granule of observing variable concentrations causes the spasmolysis of ureter smooth muscle spasm to ACh.If it is 100% that ACh causes the tension force of smooth muscle spasm, ask compound recipe Herba Lysimachiae granule ACh to be caused the inhibition percentage rate of convulsion.
5.5 external lithodialysis test
[8,9]
The calculus specimen is provided by Guangxi Medical University's the 3rd Affiliated Hospital's Urology Surgery.The dry urinary stone (mixed type) of shape, size, similar weight is divided into 5 groups at random, every group 10, be grouped into the normal saline matched group, compound recipe Herba Lysimachiae each dosage group and positive controls, positive control is the lithodialysis liquid of 0.04mol/L EDTA-2Na (pH8.0).Every group of calculus placed fill the ground test tube with ground stopper that 6ml is tried thing solution or lithodialysis liquid, 1 of every pipe places test tube 37 ℃ of constant temperature water baths again, and every 24h observes once, changes liquid once, observes continuously 15 days.Took out calculus on the 16th day, weigh after to be dried,, calculate the lithodialysis percentage rate according to the forward and backward weight of lithodialysis.
6, date processing
All (x ± s) expression adopts " Chinese medicine encyclopedia-medicostatistics " statistical package (second edition) of vital statistics teaching and research room of Huaxi Medical Univ to carry out t check or X 2 test to the result with mean ± standard deviation.
7, result of the test
7.1 antibacterial tests
7.1.1 in-vitro antibacterial test
The result shows, compound recipe Herba Lysimachiae granule has stronger antibacterial action to staphylococcus aureus, Bacillus proteus, minimum inhibitory concentration is 4.5%, bacillus pyocyaneus and escherichia coli also there is certain antibacterial action, minimum inhibitory concentration is respectively 18.0% and 9.0%, and gonococcus is not had antibiotic effect.
7.1.2 protective effect to the mouse infection staphylococcus aureus
The result shows; mortality rate is 90% behind the blank treated animal infection staphylococcus aureus; the mortality rate difference 15% of compound recipe Herba Lysimachiae granule high and low dose group; 20%; significantly reduce the mortality rate (P＜0.01) of golden Portugal bacterium infecting mouse, illustrate that golden Portugal bacterium infecting mouse compound recipe Herba Lysimachiae granule is had the certain protection effect.
7.2 antiinflammatory action
[5]
7.2.1 Oleum Tiglii is caused the influence of mice auricle swelling
The result shows that the compound recipe Herba Lysimachiae granule of the total medical material/Kg of 19.6g can significantly reduce Oleum Tiglii and cause mice auricle swelling degree (P＜0.05), and Fructus Crotonis oiliness inflammation is had tangible antiinflammatory action.
7.2.2 the influence of rat paw edema due to the on Carrageenan
The result shows, the compound recipe Herba Lysimachiae granule of the total medical material/Kg of 19.6g can significantly reduce rat paw edema degree (P＜0.01) due to the carrageenin, and the on Carrageenan inflammation has tangible antiinflammatory to use.
7.3 influence (metabolic cage method) to rat urine amount
The result shows that the compound recipe Herba Lysimachiae granule of the total medical material/Kg of 19.6g can significantly increase rat urine amount, has tangible diuresis.
The ureter test 7.4 rabbit is exsomatized
The result shows that compound recipe Herba Lysimachiae granule has the obvious suppression effect to the stripped ureter contraction of rabbit.1.0% compound recipe Herba Lysimachiae granule extractum is 85.67 ± 6.45% (paired t-test P＞0.01) to the inhibition percentage rate that ACh causes convulsion, shows that compound recipe Herba Lysimachiae granule causes the tangible spasmolysis of having of ureter smooth muscle spasm to ACh.
7.5 external lithodialysis test
The result shows that 28% compound recipe Herba Lysimachiae granule has certain litholytic effect.
8, test conclusion
Zoopery is the result show, compound recipe Herba Lysimachiae granule is the result show, compound recipe Herba Lysimachiae granule has stronger antibacterial action to staphylococcus aureus, Bacillus proteus, minimum inhibitory concentration is 4.5%, bacillus pyocyaneus and escherichia coli also there is certain antibacterial action, minimum inhibitory concentration is respectively 18% and 9.0%, and gonococcus is not had antibiotic effect.Golden Portugal bacterium infecting mouse had significant protective effect.Can alleviate mice auricle swelling degree due to the Oleum Tiglii and the rat paw edema degree due to the carrageenin, have certain antiinflammatory action.Obviously increase rat urine amount, have tangible diuresis.The rabbit ureter that exsomatizes is shunk and has the obvious suppression effect, the ureter smooth muscle spasm that ACh is caused have a tangible spasmolysis.External lithodialysis result of the test shows that the compound recipe Herba Lysimachiae granule of high concentration has certain litholytic effect to urinary stone.That compound recipe Herba Lysimachiae granule has is antibiotic, antiinflammatory, diuresis, spasmolytic and litholytic effect.
Three, compound recipe Herba Lysimachiae granule acute toxicity test report of the present invention
1, purpose:
Measure compound recipe Herba Lysimachiae granule maximum tolerated dose on the one, to understand its toxicity size.Method: Kunming mouse is the research system, has observed in 24 hours the acute toxic reaction that gives mice behind the compound recipe Herba Lysimachiae granule extractum for 3 times with the gastric infusion approach, and has calculated one day maximum tolerated dose.
2, result:
Observed 7 days continuously after the mice administration in 24 hours 3 times, none example of animal is dead, and spirit, activity, defecation, appetite etc. are all no abnormal.
3, conclusion:
The acute toxic reaction that gives mice behind the compound recipe Herba Lysimachiae granule extractum for 3 times has been observed in 24 hours in this experiment with the gastric infusion approach.The result shows that none example of animal is dead behind the medicine, and the animal basic condition is no abnormal, and a day maximum tolerated dose is the total medical material/Kg of 157.5g, is equivalent to 321.4 times of clinical application amount.Think that it is safe using this product in range of doses.
Four, the clinical trial of Chinese medicine preparation treatment syndrome of dampness-heat diffusing downward of the present invention:
Four provincial hospitals transferring to Guangxi according to People's Republic of China's Chinese medicine industry standard " disease of tcm diagnosis criterion of therapeutical effect ", " provisions for new drugs approval ", " tcm syndrome standard ", " clinical disease diagnosis is according to curing the improvement standard " and " new Chinese medicine clinical research guideline " Chinese medicine preparation of the present invention carry out clinical trial, and each hospital accepts patient 120-180 example for medical treatment.
The tcm diagnosis standard:
Primary symptom: frequent micturition is short red, urinates puckery causalgia; Inferior disease: heating, bitter taste, lumbago, constipation with dry stool or yellow mashed.
The Western medicine diagnose standard:
1, kidney, ureteral calculus, symptom are the visible calculus shade of lumbago, hematuria, pyelography or B ultrasonic, X skiagram.
2, vesical calculus, symptom are dysuria, frequent micturition, urgent micturition, urinary tract infection, B ultrasonic, the visible calculus shade of X skiagram.
3, acute cystitis, frequent micturition, urgent micturition, the urinary tract bacterial infection, hematuria has purulent secretion.
4, acute urethritis, dysuria, frequent micturition, urgent micturition, hematuria has purulent secretion.
Test method
Grouping is immediately adopted in grouping, and treatment group, matched group adopt the logical electuary treatment of medicine of the present invention and stranguria caused by urinary stone.
Therapeutic outcome: the total effective rate of Chinese medicine preparation of the present invention is 90%, and matched group is 82%, illustrates that medicine of the present invention obviously is better than matched group.
This clinical trial is also carried out blood, just routine examination to 300 routine patients, and the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects, points out medicine of the present invention safe and reliable.
Five, model case
Example one, insult certain, the man 48 years old, lives Guangxi hydraulic power chamber dormitory, because of left side waist and belly paroxysmal colic companion hematuria 2 days was gone to a doctor June 28 calendar year 2001.Private prosecution is the left waist and belly paroxysmal colic of the prominent sense of no obvious inducement before 2 days, occurs fever with chills subsequently, general malaise, and waist and belly pain, the urine yellow skin, frequent micturition is short red, urinates puckery causalgia, constipation with dry stool.Deny previously having other special medical histories.Check: T38.3 degree, R23 time/minute, P80 time/minute, BP135/86mmHg.Acute face dolorosa, the skin sclera does not have xanthochromia, and whole body superficial lymph knot is little.Cardiopulmonary are checked no abnormal.Abdomen is flat soft, left midfield tenderness, no rebound tenderness.Do not touch under the liver spleen rib, borborygmus is normal.Kidney district, left side obviously kowtows pain, does not touch lump.The extremity activity freely, physiological reflex exists, pathologic reflex is not drawn.Red tongue, yellow fur, wiry and frequent pulse.Laboratory examination: routine blood test: RBC5.2 * 10
12/ L, HB138g/L, WBC12 * 10
9/ L, N75%.BCr88 μ mol/L, BUN6.6mmol/L.Routine urinalysis: RBC (++), WBC (+). stool routine examination ().Electrocardiogram is normal.ALT15u/L。Plain abdominal radiograph shows: left side ureter hypomere 1.3 * 1.3cm calculus.Tcm diagnosis: stranguria caused by urinary stone (syndrome of dampness-heat diffusing downward).Western medicine diagnose: left side ureteral calculus.Give compound recipe Herba Lysimachiae granule, boiled water is taken after mixing it with water, and each 2 bags, every day 3 times, serve on for 4 weeks.Take medicine after 1 week, body temperature is reduced to normally, and left waist and belly pain alleviates to some extent, and 6-8 overseas Chinese urinates every day.Each about 100ml of urine amount, the urine color is yellow slightly, and left midfield tenderness and left kidney district kowtow pain and all alleviate to some extent.Treated for the 2nd week, left waist and belly pain obviously alleviates, orthuria, and left lumbar region tenderness and left kidney district kowtow pain and obviously alleviate.Treated for the 4th week, conscious waist and belly pain disappears, and does not have other discomforts, and defecation is normal.Check: routine blood test: RBC4.6 * 10
12/ L, HB130g/L, WBC6.8 * 10
9/ L.Routine urinalysis (one), stool routine examination ().Electrocardiogram is normal.ALT14u/L。BCr84μmol/L，BUN6.4mmol/L。Plain abdominal radiograph shows: the left side ureteral calculus disappears.Efficacy evaluation: clinical recovery.
Example two, Deng, the women 20 years old, lives Shi Kang town, Hepu of Guangxi county.Because of heating, lumbago, frequent micturition shoot 7 days was gone to a doctor July 18 calendar year 2001.Readme played no obvious inducement and heating occurs before 7 days, lumbago, and anxious frequently, the urine time showed increased that occurs subsequently urinating, 15-20 time/day, each oliguria, yellow skin is urinated puckery causalgia, constipation with dry stool when urinating.Once checked treatment in the commune hospital, town, and do not have and take a turn for the better.Check: T38.9 degree, R26 time/minute, P102 time/minute, BP116/78mmHg.Cardiopulmonary are no abnormal.Abdomen is soft, and left and right sides midriff all has tenderness, no rebound tenderness, and the liver spleen does not touch, and borborygmus is normal.Kidney district, both sides kowtows pain.Red tongue, yellow fur is thin greasy, slippery and rapid pulse.Routine blood test: HB138g/L, RBC4.8 * 10
12/ L, WBC10.8 * 10
9/ L.Routine urianlysis: Pro (++), RBC (++), WBC (++ ++).The urine thin bacterium is cultivated escherichia coli growth, clump count＞10
5/ ml.Electrocardiogram: normal.Blood ALT:32u, BCr98 μ mol/L, BUN6.4mmol/L.Tcm diagnosis: pyretic stranguria (syndrome of dampness-heat diffusing downward).Western medicine diagnose: acute pyelonephritis.Give compound recipe Herba Lysimachiae granule, boiled water is taken after mixing it with water, and each 2 bags, every day 3 times, serve on 15 days.Temperature recovery is normal after taking medicine 5 days, and the urine color changes clear, and symptoms such as frequent micturition shoot are obviously improved.Check that the both sides percussion tenderness over kidney region alleviates.Disease diseases such as after taking medicine 10 days, urine urgency-frequency, urine amount are short of, flank pain disappear, and it is soft to defecate.After taking medicine 15 days, the urine thin bacterium is cultivated: (one).Blood, urine, just routine examination, electrocardiogram ALT, BCr, BUN check all normal.Efficacy evaluation: recovery from illness in the recent period.
Claims (2)
1, a kind of Chinese medicine preparation for the treatment of urinary system calculus and urinary tract infection is characterized in that it is made by following raw materials in weight content:
Herba Desmodii Styracifolii: 25-60%; Herba Plantaginis 15-40%; Folium Pyrrosiae 15-40%; Stigma Maydis 5-20%;
Its preparation method is: above-mentioned Herba Desmodii Styracifolii, Herba Plantaginis, Folium Pyrrosiae, Stigma Maydis are chosen respectively, select, wash, shredded, adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree, gets concentrated solution, perhaps add 0.5～3 times of amount precipitation of ethanol, supernatant reclaims ethanol, and debris continues to concentrate, and gets concentrated solution, in the concentrated solution that above-mentioned production obtains, add excipient, and make granule, and make it dry, obtain product.
2, the Chinese medicine preparation of treatment urinary system calculus as claimed in claim 1 and urinary tract infection is characterized in that it is made by following raw materials in weight content:
Herba Desmodii Styracifolii: 50 kilograms; 25 kilograms of Herba Plantaginiss; 18 kilograms of Folium Pyrrosiaes; 15 kilograms of Stigma Maydis;
Its preparation method is: with above-mentioned Herba Desmodii Styracifolii, Herba Plantaginis, Folium Pyrrosiae, Stigma Maydis is chosen respectively, choosing, wash, chopping, adding 6～10 times of water gagings by the per kilogram medical material decocted 1～3 hour, emit decocting liquid, medicinal residues decoct with water 1～2 hour again, merge the secondary decocting liquid, filter, filtrate is concentrated into suitable degree, gets concentrated solution, perhaps add 0.5～3 times of amount precipitation of ethanol, supernatant reclaims ethanol, and debris continues to concentrate, and gets concentrated solution, in the concentrated solution that above-mentioned production obtains, add sucrose 50-95%, lactose 50-90%, dextrin 50-70%, make granule, make it dry, obtain product.
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| CN101019942B (en) * | 2007-03-19 | 2010-06-30 | 沈信堂 | Chinese medicine for treating urinary tract infection |
| CN100417408C (en) * | 2007-06-29 | 2008-09-10 | 广西万通制药有限公司 | Chineses medicine prepn with several treating functions and its prepn proces and application |
| CN102475777A (en) * | 2010-11-23 | 2012-05-30 | 鲜丹科 | Urolith elimination |
| CN104013681B (en) * | 2014-07-01 | 2016-05-11 | 广西浦北华之源中药饮片有限公司 | A kind of pharmaceutical composition for the treatment of kidney stone |
| CN105561037A (en) * | 2016-01-27 | 2016-05-11 | 刘新江 | Chinese patent medicine preparation for treating kidney calculi, hydronephrosis, renal cyst and nephritis |
| CN107693709A (en) * | 2016-08-08 | 2018-02-16 | 李艳青 | Formula of urethral calculus pain and preparation method thereof is alleviated in a kind of dietotherapy |
| CN114452359A (en) * | 2022-01-28 | 2022-05-10 | 北京爱宠族科技有限公司 | Traditional Chinese medicine composition for preventing and treating pet urinary calculus and preparation method thereof |
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