CN105031177A - Traditional Chinese medicine composition for treating urinary tract infection and preparation method of traditional Chinese medicine composition - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating urinary tract infection and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials: rhizoma anemarrhenae, fructus forsythiae, honeysuckle, fringed pink, frankincense, safflower carthamus, cortex phellodendri, plantain herb, talc, the root of red-rooted salvia, Chinese yam, radix paeoniae rubra, jasmine, rush and angelica sinensis. The traditional Chinese medicine composition can well reduce the index of urinary tract infection, improve the clinic symptom of a patient, and prevent further deterioration of urinary tract infection compared with pure western drug therapy, meanwhile has no toxic or side effects, and has high safety and comfort.

Description

Chinese medicine composition being used for the treatment of urinary tract infection and preparation method thereof

Technical field

The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine composition being used for the treatment of urinary tract infection and preparation method thereof.

Background technology

Urinary tract infection (urinarytractinfection, UTI, be called for short urine sense) refers to pathogen growth and breeding in urinary tract in body, invades urinary tract mucosa or tissue and the urinary tract inflammation that causes.Antibacterial is modal pathogen, and fungus, virus, parasite etc. also can cause infection.Modern medicine thinks that primary disease declines mainly due to body resistance against diseases, and the comparatively strong and urinary tract of antibacterial pathogenicity is organic to be blocked etc. caused by many reasons.

The clinical manifestation of urinary tract infection symptom is relatively more extensive, different according to infection site, can be divided into pyelonephritis, cystitis, urethritis; According to or without the exception in urinary tract function or device matter, have again complexity and non-complex urinary tract infection not; According to the different in kind of inflammation, acute and Chronic Urinary Tract Infection can be divided into again.Incidence of urinary infections accounts for 0.91% of total population, occupies the first place of kidney disease, is the second cause of disease of renal failure, and is mainly in women.

At present, for the western medicine of urinary tract infection mainly based on ofloxacin, levofloxacin magnitude broad-spectrum antibiotic, find in clinical practice, though antibiotic can make the state of an illness of urinary tract infection alleviate to some extent, but the relapse rate of primary disease cannot be reduced.Along with antibiotic general and frequent use, drug resistance flora increases gradually, and the existing downward trend year by year of its curative effect, the antibiotic used costly of usually having to, considerably increases the financial burden of patient.Human flora can be caused in addition to lack of proper care, the even side effect such as hepatic and renal function injure, these problems have caused general concern.

Motherland medical science, according to patients of urinary tract infection symptom, is belonged to " stranguria " category more, and primarily of damp-heat in lower-JIAO, accumulation of heat in the urinary bladder and being formed, Therapeutic Method is broadly divided into damp eliminating heat extraction, diuresis promoting, activating blood circulation to dissipate blood stasis etc.In medication, no matter be acute or the non-acute phase, on dialectical basis, often select some to have the Chinese medicine of antipyretic and antidote functions, all beneficial to remission, disease recovery.Chinese medicine have in treatment urinary tract infection control symptom rapidly, determined curative effect, toxic and side effects be little, can not produce the advantages such as drug resistance, is day by day subject to the attention of medical circle.Conventional Chinese patent medicine at present for urinary tract infection comprises SANJIN PIAN, NINGMITAI etc.But its flavour of a drug composition is more, and quality is wayward, and price is relatively higher, and curative effect is not remarkable.Based on this, give full play to the special advantage of Chinese medicine, the higher and control effect and mechanism more clearly modern Chinese medicine of continual exploitation a new generation better efficacy, cost performance, will have good Social benefit and economic benefit prospect.

Object of the present invention overcomes the deficiencies such as large, the existing Chinese Herbs of Western medicine side effect is not remarkable exactly, according to traditional Chinese medical science prescription and preparation principle, Chinese medicine composition is developed meticulously, the advantages such as one is pointed by force, good effect, the cycle is short, price is low, have no side effect are provided, patient can be made again to take like a shot, the pure Chinese medicinal preparation of urinary tract infection can be treated preferably.Each component collaborative onset mutually in side, and medicine is prepared simple, rapid-action, short treating period, is had good therapeutical effect to urinary tract infection.

Summary of the invention

Technical problem to be solved by this invention is to provide a kind of Chinese medicine composition being used for the treatment of urinary tract infection, and its more simple western medicine better can reduce the index of urinary tract infection, improves the clinical sign of patient, prevents urinary tract infection from worsening further.

For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine composition being used for the treatment of urinary tract infection, its raw material components comprises the Rhizoma Anemarrhenae, Fructus Forsythiae, Flos Lonicerae, Herba Dianthi, Olibanum, Flos Carthami, Cortex Phellodendri, Herba Plantaginis, Talcum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae, Radix Paeoniae Rubra, Fructus Gardeniae, Medulla Junci and Radix Angelicae Sinensis.

Wherein, in described Chinese medicine composition, the weight portion of each raw material components is respectively Rhizoma Anemarrhenae 8-12 weight portion, Fructus Forsythiae 6-10 weight portion, Flos Lonicerae 4-10 weight portion, Herba Dianthi 5-10 weight portion, Olibanum 4-9 weight portion, Flos Carthami 8-16 weight portion, Cortex Phellodendri 8-17 weight portion, Herba Plantaginis 5-11 weight portion, Talcum 4-10 weight portion, Radix Salviae Miltiorrhizae 7-14 weight portion, Rhizoma Dioscoreae 10-18 weight portion, Radix Paeoniae Rubra 8-12 weight portion, Fructus Gardeniae 12-18 weight portion, Medulla Junci 5-10 weight portion, Radix Angelicae Sinensis 6-12 weight portion.

Preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively Rhizoma Anemarrhenae 10-12 weight portion, Fructus Forsythiae 8-10 weight portion, Flos Lonicerae 7-10 weight portion, Herba Dianthi 8-10 weight portion, Olibanum 7-9 weight portion, Flos Carthami 11-16 weight portion, Cortex Phellodendri 14-17 weight portion, Herba Plantaginis 8-11 weight portion, Talcum 7-10 weight portion, Radix Salviae Miltiorrhizae 11-14 weight portion, Rhizoma Dioscoreae 14-18 weight portion, Radix Paeoniae Rubra 10-12 weight portion, Fructus Gardeniae 15-18 weight portion, Medulla Junci 7-10 weight portion, Radix Angelicae Sinensis 9-12 weight portion.

Further preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively the Rhizoma Anemarrhenae 10 weight portion, Fructus Forsythiae 8 weight portion, Flos Lonicerae 7 weight portion, Herba Dianthi 8 weight portion, Olibanum 7 weight portion, Flos Carthami 11 weight portion, Cortex Phellodendri 14 weight portion, Herba Plantaginis 8 weight portion, Talcum 7 weight portion, Radix Salviae Miltiorrhizae 11 weight portion, Rhizoma Dioscoreae 14 weight portion, Radix Paeoniae Rubra 10 weight portion, Fructus Gardeniae 15 weight portion, Medulla Junci 7 weight portion, Radix Angelicae Sinensis 9 weight portion.

Present invention also offers the preparation method of above-mentioned Chinese medicine composition, its preparation process is:

The first step: each component in described raw material components is mixed in proportion, adding relative to mixture quality 3-5 determining alcohol is doubly the ethanol of 80-90%, reflux 1-2 hour, extract, filter acquisition first extracting solution, the determining alcohol that the medicinal residues filtering acquisition add relative to medicinal residues quality 1-3 times is again the ethanol of 80-90%, reflux 35-45 minute, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;

Second step: be placed in super micron mill by the dry cream that the first step obtains and pulverize 1-2 hour, pulverizes and sieves and obtains 200-300 object micropowders;

3rd step: add relative to its quality 0.1-0.3 microcrystalline Cellulose doubly, 0.05-0.15 lactose doubly, 0.1-0.3 starch doubly in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds relative to micropowders quality 0.005-0.05 magnesium stearate doubly, granulate, tabletting, makes.

The present invention also provides the application of above-mentioned raw materials component in the Chinese medicine composition for the preparation for the treatment of urinary tract infection.

Beneficial effect of the present invention:

The invention provides a kind of Chinese medicine composition being used for the treatment of urinary tract infection, its more simple Western medicine and existing treatment by Chinese herbs better can reduce the index of urinary tract infection, improve the clinical sign of patient, prevent urinary tract infection from worsening further, have no side effect simultaneously, have safety and the comfort of height.

Detailed description of the invention

The weight portion that the present invention mentions is a proportionate relationship between each component.

The invention provides a kind of Chinese medicine composition being used for the treatment of urinary tract infection, its raw material components comprises the Rhizoma Anemarrhenae, Fructus Forsythiae, Flos Lonicerae, Herba Dianthi, Olibanum, Flos Carthami, Cortex Phellodendri, Herba Plantaginis, Talcum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae, Radix Paeoniae Rubra, Fructus Gardeniae, Medulla Junci and Radix Angelicae Sinensis.

Further preferably, described Chinese medicine composition is only made up of above-mentioned raw materials component.

Chinese medicine composition compatibility of the present invention is reasonable, and action effect is remarkable, wherein:

The Rhizoma Anemarrhenae: bitter, sweet, cold; Clearing away heat-fire is nourshing Yin and drynsessmoistening prescription; For fever caused by exogenous pathogenic factors, high hot excessive thirst, lung-heat type cough, osteopyrexia and fever, interior-heat is quenched one's thirst, dryness of the intestine constipation.

Fructus Forsythiae: bitter, is slightly cold; Heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation, dispelling wind and heat pathogens; For carbuncle, scrofula, acute mastitis, erysipelas, anemopyretic cold, epidemic febrile disease from the beginning of, warmly join the army, high hot excessive thirst, coma sends out speckle, the puckery pain of pyretic stranguria.

Flos Lonicerae: sweet, cold; Heat-clearing and toxic substances removing, dispelling wind and heat pathogens; For carbuncle furuncle, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, epidemic febrile disease is generated heat.

Herba Dianthi: bitter, cold; Inducing diuresis for treating stranguria syndrome, promoting blood circulation to restore menstrual flow; For pyretic stranguria, stranguria with blood, stranguria caused by urinary stone, urinary obstruction, drenches the puckery pain of drop, amenorrhea stasis blocking.

Olibanum: pungent, bitter, temperature; To invigorate blood circulation analgesic therapy, detumescence and promoting granulation; For obstruction of qi in the chest and cardialgia, gastralgia, dysmenorrhea amenorrhea, postpartum stagnation, lump in the abdomen is suffered from abdominal pain, rheumatic arthralgia, the contracture of muscle arteries and veins, traumatic injury, carbuncle skin infection.

Flos Carthami: pungent, temperature; Promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain; For amenorrhea, dysmenorrhea, lochia, note of the ancient Chinese abdominal mass mass in the abdomen, obstruction of qi in the chest and cardialgia, the stagnant stomachache of the stasis of blood, costa sternales twinge, injury from falling down, skin infection swells and ache.

Cortex Phellodendri: bitter, cold; Heat clearing and damp drying, pathogenic fire purging removes steams, detoxification sore treatment; For damp-heat dysentery, jaundice dark coloured urine, leukorrhagia pudendal pruritus, the puckery pain of pyretic stranguria, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema eczema.

Herba Plantaginis: sweet, cold; Clearing away heat and promoting diuresis is treating stranguria, eliminates the phlegm, removing heat from blood, removing toxic substances; For the puckery pain of pyretic stranguria, edema oliguria, diarrhea due to summer heat and dampness, phlegm-heat cough, too fat to move sore.

Talcum: sweet, light, cold; Inducing diuresis for treating stranguria syndrome, clearing away summer-heat, external damp eliminating sore; For pyretic stranguria, stranguria caused by urinary stone, urinates hot puckery pain, heat-damp in summer excessive thirst, damp and hot watery diarrhea.

Radix Salviae Miltiorrhizae: bitter, is slightly cold; Blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, clear away heart-fire relieving restlessness, removing heat from blood eliminating carbuncle; For obstruction of qi in the chest and cardialgia, gastral cavity abdomen hypochondriac pain, lump in the abdomen, pyretic arthralgia pain, dysphoria and insomnia, menoxenia, dysmenorrhea amenorrhea, skin infection swells and ache.

Rhizoma Dioscoreae: sweet, flat; Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.For insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, and deficiency-heat is quenched one's thirst.

Radix Paeoniae Rubra: bitter, is slightly cold; Clearing away heat and cooling blood, eliminating stasis to stop pain; Enter nutrient blood for heat, noxious dampness sends out speckle, hypochondriac pain due to stagnation of liverQI, amenorrhea dysmenorrhea, and lump in the abdomen is suffered from abdominal pain, carbuncle skin infection.

Fructus Gardeniae: bitter, cold; Pathogenic fire purging relieving restlessness, clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body; Vexed for calentura, jaundice due to damp-heat, the puckery pain of stranguria, conjunctival congestion and swelling pain, pathogenic fire,toxin and furuncles.

Medulla Junci: sweet, light, is slightly cold; Clearing away heart-fire, diuresis; For vexed insomnia, the puckery pain of oliguria.

Radix Angelicae Sinensis: sweet, acrid, warm.Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation; For blood deficiency and yellow complexion, asthenia cold abdominalgia, rheumatic arthralgia, ulcer sores, dryness of the intestine constipation.

In described Chinese medicine composition, the weight portion of each raw material components is respectively Rhizoma Anemarrhenae 8-12 weight portion, Fructus Forsythiae 6-10 weight portion, Flos Lonicerae 4-10 weight portion, Herba Dianthi 5-10 weight portion, Olibanum 4-9 weight portion, Flos Carthami 8-16 weight portion, Cortex Phellodendri 8-17 weight portion, Herba Plantaginis 5-11 weight portion, Talcum 4-10 weight portion, Radix Salviae Miltiorrhizae 7-14 weight portion, Rhizoma Dioscoreae 10-18 weight portion, Radix Paeoniae Rubra 8-12 weight portion, Fructus Gardeniae 12-18 weight portion, Medulla Junci 5-10 weight portion, Radix Angelicae Sinensis 6-12 weight portion.

Preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively Rhizoma Anemarrhenae 10-12 weight portion, Fructus Forsythiae 8-10 weight portion, Flos Lonicerae 7-10 weight portion, Herba Dianthi 8-10 weight portion, Olibanum 7-9 weight portion, Flos Carthami 11-16 weight portion, Cortex Phellodendri 14-17 weight portion, Herba Plantaginis 8-11 weight portion, Talcum 7-10 weight portion, Radix Salviae Miltiorrhizae 11-14 weight portion, Rhizoma Dioscoreae 14-18 weight portion, Radix Paeoniae Rubra 10-12 weight portion, Fructus Gardeniae 15-18 weight portion, Medulla Junci 7-10 weight portion, Radix Angelicae Sinensis 9-12 weight portion.

Further preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively the Rhizoma Anemarrhenae 10 weight portion, Fructus Forsythiae 8 weight portion, Flos Lonicerae 7 weight portion, Herba Dianthi 8 weight portion, Olibanum 7 weight portion, Flos Carthami 11 weight portion, Cortex Phellodendri 14 weight portion, Herba Plantaginis 8 weight portion, Talcum 7 weight portion, Radix Salviae Miltiorrhizae 11 weight portion, Rhizoma Dioscoreae 14 weight portion, Radix Paeoniae Rubra 10 weight portion, Fructus Gardeniae 15 weight portion, Medulla Junci 7 weight portion, Radix Angelicae Sinensis 9 weight portion.

The Chinese medicine composition for the treatment of urinary tract infection provided by the invention can be prepared into various peroral dosage form according to regular dosage form preparation method.

Present invention also offers the preparation method of above-mentioned Chinese medicine composition, comprising:

The first step: each component in described raw material components is mixed in proportion, adding relative to mixture quality 3-5 determining alcohol is doubly the ethanol of 80-90%, reflux 1-2 hour, extract, filter acquisition first extracting solution, the determining alcohol that the medicinal residues filtering acquisition add relative to medicinal residues quality 1-3 times is again the ethanol of 80-90%, reflux 35-45 minute, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;

Second step: be placed in super micron mill by the dry cream that the first step obtains and pulverize 1-2 hour, pulverizes and sieves and obtains 200-300 object micropowders;

3rd step: add relative to its quality 0.1-0.3 microcrystalline Cellulose doubly, 0.05-0.15 lactose doubly, 0.1-0.3 starch doubly in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds relative to micropowders quality 0.005-0.05 magnesium stearate doubly, granulate, tabletting, makes.

The present invention also provides the application of above-mentioned raw materials component in the Chinese medicine composition for the preparation for the treatment of urinary tract infection.

Embodiment

Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.

Embodiment 1

Get the Rhizoma Anemarrhenae 8 weight portion, Fructus Forsythiae 6 weight portion, Flos Lonicerae 4 weight portion, Herba Dianthi 5 weight portion, Olibanum 4 weight portion, Flos Carthami 8 weight portion, Cortex Phellodendri 8 weight portion, Herba Plantaginis 5 weight portion, Talcum 4 weight portion, Radix Salviae Miltiorrhizae 7 weight portion, Rhizoma Dioscoreae 10 weight portion, Radix Paeoniae Rubra 8 weight portion, Fructus Gardeniae 12 weight portion, Medulla Junci 5 weight portion, Radix Angelicae Sinensis 6 weight portion, is mixed in proportion; Adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 80%, reflux 1 hour, extracts, and filters acquisition first extracting solution, it is the ethanol of 80% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 1 times again, reflux 35 minutes, extracts, and filters acquisition second extracting solution, first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract; The dry cream obtained is placed in super micron mill and pulverizes 1 hour, pulverize and sieve and obtain 200-300 object micropowders; Add relative to the microcrystalline Cellulose of its quality 0.1 times, the lactose of 0.05 times, the starch of 0.1 times in the micropowders obtained, sieve, mix homogeneously, granulate, dry, add the magnesium stearate relative to micropowders quality 0.005 times, granulate, tabletting, makes.

Usage and consumption: every day, (medicine) being taken before meal was with three times.

Taboo: (1) avoids eating anything raw or cold food; (2) diet raw meat thing; (3) internal and external haemorrhage disease, ulcerate disease tool avoid clothes first; (4) female menstrual period, the pregnancy period is not used.

Embodiment 2

Get the Rhizoma Anemarrhenae 12 weight portion, Fructus Forsythiae 10 weight portion, Flos Lonicerae 10 weight portion, Herba Dianthi 10 weight portion, Olibanum 9 weight portion, Flos Carthami 16 weight portion, Cortex Phellodendri 17 weight portion, Herba Plantaginis 11 weight portion, Talcum 10 weight portion, Radix Salviae Miltiorrhizae 14 weight portion, Rhizoma Dioscoreae 18 weight portion, Radix Paeoniae Rubra 12 weight portion, Fructus Gardeniae 18 weight portion, Medulla Junci 10 weight portion, Radix Angelicae Sinensis 12 weight portion, is mixed in proportion; Adding relative to the determining alcohol of mixture quality 5 times is the ethanol of 90%, reflux 2 hours, extracts, and filters acquisition first extracting solution, it is the ethanol of 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 3 times again, reflux 45 minutes, extracts, and filters acquisition second extracting solution, first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract; The dry cream obtained is placed in super micron mill and pulverizes 2 hours, pulverize and sieve and obtain 200-300 object micropowders; Add relative to the microcrystalline Cellulose of its quality 0.3 times, the lactose of 0.15 times, the starch of 0.3 times in the micropowders obtained, sieve, mix homogeneously, granulate, dry, add the magnesium stearate relative to micropowders quality 0.05 times, granulate, tabletting, makes.

Usage and consumption, avoid same embodiment 1.

Embodiment 3

Get the Rhizoma Anemarrhenae 10 weight portion, Fructus Forsythiae 8 weight portion, Flos Lonicerae 7 weight portion, Herba Dianthi 8 weight portion, Olibanum 7 weight portion, Flos Carthami 11 weight portion, Cortex Phellodendri 14 weight portion, Herba Plantaginis 8 weight portion, Talcum 7 weight portion, Radix Salviae Miltiorrhizae 11 weight portion, Rhizoma Dioscoreae 14 weight portion, Radix Paeoniae Rubra 10 weight portion, Fructus Gardeniae 15 weight portion, Medulla Junci 7 weight portion, Radix Angelicae Sinensis 9 weight portion, is mixed in proportion; Adding relative to the determining alcohol of mixture quality 4 times is the ethanol of 85%, reflux 1.5 hours, extracts, and filters acquisition first extracting solution, it is the ethanol of 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 times again, reflux 40 minutes, extracts, and filters acquisition second extracting solution, first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract; The dry cream obtained is placed in super micron mill and pulverizes 1.5 hours, pulverize and sieve and obtain 200-300 object micropowders; Add relative to the microcrystalline Cellulose of its quality 0.2 times, the lactose of 0.1 times, the starch of 0.2 times in the micropowders obtained, sieve, mix homogeneously, granulate, dry, add the magnesium stearate relative to micropowders quality 0.03 times, granulate, tabletting, makes.

Usage and consumption, avoid same embodiment 1.

Embodiment 4 toxicity is verified

1, acute toxicity test

Get Kunming mouse 20, body weight 19-22g, ♀ ♂ half and half.With the Chinese medicine composition of the embodiment of the present invention 3 for object, give mouse stomach administration, observe 1 week with 200 of clinical consumption per day times, the activity of record test mice, behavior and death condition, put to death after 1 week and perform an autopsy on sb..

Test proves: without remarkable toxic reaction after gavage, also without dead in one week.

2, long term toxicity test

Get SD rat 60, ♀ ♂ half and half, be divided into experimental group and matched group at random.With the Chinese medicine composition of the embodiment of the present invention 3 for object, long term administration in 6 months, dosage is 10 times of clinical dosage, carries out long term toxicity test.Matched group gives normal saline.

3 months time, each group is cutd open and kills 10 animals, checks indices comprehensively.Cut open the half of killing remaining animal when 6 months, do every detection, second half drug withdrawal, continue observation and within 2 weeks, remake body weight, food ration, routine urinalysis, routine blood test, blood biochemical, the every detection of organ coefficient.

Test proves, gives rat oral gavage 3 months continuously, and result ordinary circumstance is good, and body weight increases, and the indices such as food ration, routine urinalysis, routine blood test, blood biochemical are all normal; Histological examination shows, the internal organs such as the present invention is dirty to rat heart, liver, lungs, gland, kidney, adrenal gland, thymus, ovary, testis are without any Histological Effects.

Embodiment 5 urinary tract infection rat model

1, experiment material

1.1, laboratory animal: SD rat, SPF level, female, body weight 240 ± 10g, is provided by Shanghai Univ. of Traditional Chinese Medicine's Experimental Animal Center, and raises in this animal center.

1.2, medicine

Chinese medicine: the Chinese medicine preparation of embodiment 3

Control drug: levofloxacin

1.3, strain: commercialization available escherichia coli reference culture ATCC25922.After normal saline dilution, desired concn bacterial suspension is made for subsequent use before experiment.

2, experiment grouping: adopt random digits table to be divided into 4 groups at random, i.e. normal group, model group, Chinese drug-treated group and matched group, often organize 8.

3, method

2% pentobarbital sodium 40mg/kg body weight after rat taboo water 18h, intraperitoneal injection of anesthesia.On supine fixing operation platform, skin of abdomen is sterilized, paving aseptic operation towel.Median incision of lower abdomen, is about 2cm, and successively open abdomen enters abdominal cavity.On the left of the posterior abdominal wall identification of left side after ureter, with No. 4 suture silks from ureter both sides, stage casing respectively to threading a needle outside posterior wall of abdomen and drawing stitching thread, penis is closed with bulldog clamp folder, except Normal group external TB pin slowly injects bacterium liquid 0.5ml to intravesical, Normal group injection normal saline.Then the stitching thread two ends outside stomach wall are strained, with suitable elasticity " ligation " ureter.Layer-by-layer suture incision of abdominal wall, recover drinking-water and for food.Post operation 24h, removes Unilateral Ureteral Obstruction line outside stomach wall, ureter is reopened.

Chinese drug-treated group drug level is 2.117g/ml (being crude drug amount), matched group levofloxacin concentration is 0.0027g/ml, and within second day, start each group of gastric infusion 1 times/day, continuous 7 days, gavage volume was 1.5ml/100g.Post operation the 7th day, leaves and takes urine after administration, detects routine urinalysis.Abdominal aortic blood puts to death animal.Put to death the front bulldog clamp of animal and clamp external orifice of urethra, prevent urine from flowing out, directly extract bladder urine under cutting abdominal part taking-up left and right kidney, sterile working after putting to death animal open and treat antibacterial culturing.

4, observation index

4.1, left and right kidney ratio: the two kidney size of kidney gross examination of skeletal muscle perusal and surface, and weigh, measuring and calculating left and right kidney ratio.

4.2, antibacterial culturing is urinated: directly extract bladder urine under sterile working and make bacteriology checking.Get 1 microlitre urine to cultivate 2 days in SBA flat board, be negative without bacterial growth, have bacterial growth record bacterial number.

4.3, routine urinalysis: centrifugal midstream urine sediment leukocyte > 10/hp is positive.

5, the process of data

Continuous data all represents with meansigma methods scholar standard deviation (± S), data application SPSS13.0 statistical package carries out Treatment Analysis, measurement data variance analysis, ranked data rank test, enumeration data chi-square criterion, with p < 0.05 for significant difference, p < 0.01 is that difference is extremely remarkable.

6, result

As shown in table 1: urine colony counting Chinese drug-treated group is obviously less than model group.

Table 1 Chinese medicine preparation of the present invention is on the impact (n=8, ± s) of urinary tract infection rat model

Group	Urine bacterial population (log10)	Right kidney/left kidney	Routine urinalysis positive rate
				Normally	0±0**	1.05±0.04	0/8
Model	2.79±1.12	1.24±0.38	4/8
				Chinese medicine	0.53±0.17*	1.15±0.12	0/8
Contrast	1.14±0.57	1.21±0.33	2/8

Note: compare * * P < 0.01 with model group; * P < 0.05

Embodiment 6 clinical experiment

1, clinical data: select hospital outpatient to make a definite diagnosis the routine clinical observation of patients of urinary tract infection 400, patient is divided into two groups at random, treatment group 200 example, 7 years old-50 years old age, 37 years old mean age, the course of disease 2 months-2 years, average 1 year.Matched group 200 example, 8 years old-53 years old age, 41 years old mean age, the course of disease 1 month-1.5 years, average 10 months.The course of disease, the degrees of symptoms of two groups of cases are basically identical, without significant difference, have comparability.

2, medicament selection:

Chinese drug-treated group takes the Chinese medicine preparation of the embodiment of the present invention 3, oral, every day 3 times, each 1 time of morning, noon and afternoon, each 3; Within 7 days, be 1 course for the treatment of, the lighter 1-2 course for the treatment of, severe one 3-4 the course for the treatment of, or follow the doctor's advice and to increase by amount.

Matched group takes levofloxacin, oral, acute simplex lower urinary tract infection, a 0.1g, 2 times on the one, the 5-7 day course for the treatment of; Complexity urinary tract infection a: 0.2g, 2 times on the one, or a 0.1g, 3 times on the one, the 10-14 day course for the treatment of.

3, efficacy determination:

Criterion of therapeutical effect reference " new Chinese medicine guideline of clinical investigations (trying) " (Ministry of Health of the People's Republic of China new Chinese medicine guideline of clinical investigations (trying) [M]. Beijing: China Medical Science Press, 2002:95.) formulate.

(1) cure: urgent micturition dysurea, dysuria, high heat such as to be felt sick at the transference cure, and routine urianlysis 2 is subnormal, and urine bacterium is negative, and urinates bacterium 1 time in check in the 2nd, 6 weeks, is feminine gender, follows the trail of 6 months without recidivist.

(2) effective: above-mentioned symptom is alleviated to some extent, physical recovery is healthy, and routine urinalysis is normal or close to normal, urine bacterium is negative.

(3) invalid: symptom and urine examination improve not obvious, the quantitative check of urine bacterium is still positive, or urine bacterium is positive when check in the 2nd, 6 week, and is same strain.

4, adverse events

1. there is obvious hepatic and renal function injure; 2. there is serious disease in the blood system; 3. there is cardiovascular and cerebrovascular vessel thunder bolt.

5, therapeutic effect

Experimental result is in table 2.Effective percentage=(curing number+effective number)/total number of persons.

Table 2: the comparison of two groups of patient clinical curative effects after treatment

Group	Number of cases	Cure	Effective	Invalid	Cure rate %	Inefficiency %	Total effective rate %
								Chinese drug-treated group	200	147	45	8	73.5	4	96*
Matched group	200	102	33	65	51	32.5	67.5

Note: * represents and to compare with matched group, P < 0.05.

Through treating and following up a case by regular visits to, result display Chinese drug-treated group cures 147 people, and cure rate is 73.5%; Effective 45 people, invalid 8 people, inefficiency is 4.00%, total effective rate 96.00%.Compared with matched group, the total effective rate of Chinese drug-treated group is significantly better than matched group, and P < 0.05, difference has statistical significance.Illustrate that the clinical efficacy of traditional Chinese medicine composition for treating urinary tract infection is significantly better than matched group.

Obvious adverse events is there is not in two groups of patients at treatments period.There is not obvious hepatic and renal function injure, serious disease in the blood system and cardiovascular and cerebrovascular vessel thunder bolt.The treatment of Chinese medicine composition is described to patient without obvious harmful effect.

The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (6)

1. be used for the treatment of a Chinese medicine composition for urinary tract infection, it is characterized in that: raw material components comprises the Rhizoma Anemarrhenae, Fructus Forsythiae, Flos Lonicerae, Herba Dianthi, Olibanum, Flos Carthami, Cortex Phellodendri, Herba Plantaginis, Talcum, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae, Radix Paeoniae Rubra, Fructus Gardeniae, Medulla Junci and Radix Angelicae Sinensis.

2. Chinese medicine composition as claimed in claim 1, is characterized in that: the weight portion of each raw material components is respectively Rhizoma Anemarrhenae 8-12 weight portion, Fructus Forsythiae 6-10 weight portion, Flos Lonicerae 4-10 weight portion, Herba Dianthi 5-10 weight portion, Olibanum 4-9 weight portion, Flos Carthami 8-16 weight portion, Cortex Phellodendri 8-17 weight portion, Herba Plantaginis 5-11 weight portion, Talcum 4-10 weight portion, Radix Salviae Miltiorrhizae 7-14 weight portion, Rhizoma Dioscoreae 10-18 weight portion, Radix Paeoniae Rubra 8-12 weight portion, Fructus Gardeniae 12-18 weight portion, Medulla Junci 5-10 weight portion, Radix Angelicae Sinensis 6-12 weight portion.

3. Chinese medicine composition as claimed in claim 1 or 2, it is characterized in that: the weight portion of each raw material components is respectively Rhizoma Anemarrhenae 10-12 weight portion, Fructus Forsythiae 8-10 weight portion, Flos Lonicerae 7-10 weight portion, Herba Dianthi 8-10 weight portion, Olibanum 7-9 weight portion, Flos Carthami 11-16 weight portion, Cortex Phellodendri 14-17 weight portion, Herba Plantaginis 8-11 weight portion, Talcum 7-10 weight portion, Radix Salviae Miltiorrhizae 11-14 weight portion, Rhizoma Dioscoreae 14-18 weight portion, Radix Paeoniae Rubra 10-12 weight portion, Fructus Gardeniae 15-18 weight portion, Medulla Junci 7-10 weight portion, Radix Angelicae Sinensis 9-12 weight portion.

4. the Chinese medicine composition as described in claims 1 to 3, is characterized in that: the weight portion that the weight portion of each raw material components is respectively each raw material components is respectively the Rhizoma Anemarrhenae 10 weight portion, Fructus Forsythiae 8 weight portion, Flos Lonicerae 7 weight portion, Herba Dianthi 8 weight portion, Olibanum 7 weight portion, Flos Carthami 11 weight portion, Cortex Phellodendri 14 weight portion, Herba Plantaginis 8 weight portion, Talcum 7 weight portion, Radix Salviae Miltiorrhizae 11 weight portion, Rhizoma Dioscoreae 14 weight portion, Radix Paeoniae Rubra 10 weight portion, Fructus Gardeniae 15 weight portion, Medulla Junci 7 weight portion, Radix Angelicae Sinensis 9 weight portion.

5. the preparation method of Chinese medicine composition described in Claims 1-4, is characterized in that, preparation process is:

The first step: each component in described raw material components is mixed in proportion, adding relative to mixture quality 3-5 determining alcohol is doubly the ethanol of 80-90%, reflux 1-2 hour, extract, filter acquisition first extracting solution, the determining alcohol that the medicinal residues filtering acquisition add relative to medicinal residues quality 1-3 times is again the ethanol of 80-90%, reflux 35-45 minute, extract, filter acquisition second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, drying, obtains and gets dry extract;

Second step: be placed in super micron mill by the dry cream that the first step obtains and pulverize 1-2 hour, pulverizes and sieves and obtains 200-300 object micropowders;

3rd step: add relative to its quality 0.1-0.3 microcrystalline Cellulose doubly, 0.05-0.15 lactose doubly, 0.1-0.3 starch doubly in the micropowders that second step obtains, sieve, mix homogeneously, granulate, drying, adds relative to micropowders quality 0.005-0.05 magnesium stearate doubly, granulate, tabletting, makes.

6. the application of the raw material components any one of claim 1-4 in the Chinese medicine composition for the preparation for the treatment of urinary tract infection.