CN102091263B

CN102091263B - Application of Chinese medicine composition in preparation of medicament for treating overhigh level of urine cell factor or receptor thereof and Escherichia coli infection

Info

Publication number: CN102091263B
Application number: CN2009103111039A
Authority: CN
Inventors: 邹节明
Original assignee: Guilin Sanjin Pharmaceuticals Co Ltd
Current assignee: Guilin Sanjin Pharmaceuticals Co Ltd
Priority date: 2009-12-09
Filing date: 2009-12-09
Publication date: 2012-11-14
Anticipated expiration: 2029-12-09
Also published as: CN102091263A

Abstract

The invention relates to application of a Chinese medicine composition in preparation of a medicament for treating the overhigh level of a urine cell factor or a receptor thereof and Escherichia coli infection. The cell factor or receptor thereof is sIL-2R, IL-6 and IL-8. The Chinese medicine composition is prepared from the following raw materials in percentage by weight: 14-20 percent of cherokee rose root, 6-10 percent of chinaroot greenbrier, 7-10 percent of akebia trifoliata koidz, 3.0-6.5 percent of Japanese climbing fern and 3.2-6.8 percent of centella. The Chinese medicine composition has obvious curative effect on urinary tract infection with overhigh level of urinary sIL-2R, urinary IL-6 and urinary IL-8 and urinary tract infection and lower respiratory tract infection with Escherichia coli as a main pathogenic bacterium.

Description

A kind of Chinese medicine composition preparation treatment urine thin intracellular cytokine or its acceptor levels is too high and the medicine of infection due to Escherichia coli on application

Technical field

The invention belongs to field of medicaments, be specifically related to a kind of Chinese medicine composition preparation treatment urine thin intracellular cytokine or its acceptor levels is too high and the medicine of infection due to Escherichia coli on application.

Background technology

There are some researches show that various cytokines or its receptor prevent to play an important role in the pathogenic microorganism invasion and attack at body, have also caused tissue injury simultaneously.SIL-2R, IL-6, IL-8 are common three kinds of cytokines and cytokine receptor.SIL-2R is a serum soluble interleukin-2 receptor; It is the composition of IL-2Ra chain (IL-2Ra); IL-2R all can be expressed in mononuclear cell and some B cell line surfaces that activated T cell, LPS and IFN γ stimulate; Most scholars think that the IL-2R molecule of cell surface produces through protease hydrolysis, and the release of sIL-2R is the characteristic indication of above-mentioned cell activation.Its expression regulation is significant in the function performance of IL-2/IL-2R system; Can be used as a kind of effectively new body endolymph cell-stimulating index; The state of an illness of the variation of its level in serum and other body fluid and clinical multiple disease, the course of disease, prognosis etc. are closely related, can be used as the efficiency index that the diagnosis, monitoring, prognosis of clinical relevant disease are judged.

IL-6 is mainly derived from macrophage, mesangial cell and endotheliocyte, is the mesangial cell autocrine growth factor, and its topmost BA is participated in immunologic injury exactly.It can be produced by many lymphocytes and non-lymphocyte; Cause that like T cell, B cell, one-tenth IL-6 the immunity of organism adjusting is disorderly; Cause the pernicious of mesangial cell self to regulate; Thereby the aggravation immunologic injury, IL-6 has participated in the pathology damage process of chronic pyelonephritis, with the destruction of renal tissue and the delay difficulty of inflammation substantial connection is arranged more.

IL-8 (neutrophilic chemotactic factor) is the factor of finding in the later stage eighties that can induce multiple leukocyte chemotaxis motion; Be active the strongest a kind of in the chemotactic factor; It participates in the generating process of multiple inflammation disease, the important medium of inflammatory reaction when being bacterial infection.

Urinary system infection disease such as chronic pyelonephritis, chronic lower urinary tract infection, prostatitis, renal glomerular disease etc.; The patient is significantly higher than ordinary person with urine sIL-2R, urine IL-6, urine IL-8 level; Renal glomerular disease belongs to autoimmune disease; Its generation mainly is to cause that by the cellular immune function disorder glomerule electrostatic screen is impaired; And immune complex causes to occur nonspecific inflammation and blood coagulation phenomenon in the glomerule at GBM activating complement and blood clotting mechanism, thereby causes that glomerular mesangium changes and basement membrane molecule barrier is impaired.Common renal glomerular disease has lupus nephritis, henoch Schonlein purpura nephritis, diabetic nephropathy, chronic nephritis, radical type nephritis etc.Along with deepening continuously of pair cell factor research; Find that cytokine and above-mentioned renal glomerular disease pathogeny are in close relations; Many bibliographical informations the effect in the renal glomerular disease pathogeny of proinflammatory cytokine, chemoattracting cytoking and anti-inflammatory cytokines, wherein the effect of sIL-2R, IL-6, IL-8 is particularly evident.

Escherichia coli (Escherichia coli) is a strain representative in the enterobacteriaceae Escherichia, is commonly called as escherichia coli.It is one of normal flora member in the humans and animals intestinal, can cause that under certain condition intestinal infects outward.According to virulence factor with pathogenetic different; Can the pathogenicity escherichia coli relevant with Animal diseases be divided into five types: enterotoxigenic escherichia coli (ETEC); Produce type shiga toxin escherichia coli (SLTEC); Enteropathogenic E.Coli (EPEC), deteriorated blood property escherichia coli (SEPEC) and urethra Escherichia coli (UPEC).

Urinary system infection is one of comparatively common clinically infectious disease; Its sickness rate is in recent years by the trend that rises; Urinary system infection is mainly caused by gram negative bacilli; Wherein see to infect due to the escherichia coli again, like chronic pyelonephritis, chronic urinary tract infection, prostatitis and some renal glomerular diseases down more.Research shows that escherichia coli is the main pathogenic bacterium of above-mentioned disease.In addition, escherichia coli also causes the patient of hypoimmunity easily and causes lower respiratory infection.Common lower respiratory infection property disease has acute tracheitis, chronic tracheitis, pneumonia and Nosocomial Pneumonia.Escherichia coli like the pharyngeal field planting of suction inlet is the important pathogenesis of escherichia coli lower respiratory infection.In addition, escherichia coli is second common pathogen that causes the acquired gram-negative bacteria pneumonia of community, accounts for the 12%-45% of negative bacillus.

The appurtenance of tens of long filament shapes in the escherichia coli superficial growth, is flagellum.It has the antibacterial of promotion motor function, is " the function organ " of antibacterial.In urinary system infection; Usually cause that at first lower urinary tract infects; If treat untimely and factor such as body's immunity reduction, escherichia coli can up infection also cause urinary system infection, and the motor capacity of flagellum is one of major reason of up infection.

The applicant has applied for that the patent No. is 03124080.1, and it is that January 25, publication number in 2006 are CN1238039C that name is called " a kind of pharmaceutical composition of treating diseases of urinary system and preparation method thereof, purposes " Granted publication day.This disclosure of the Invention a kind of Chinese medicine composition of treating diseases of urinary system and preparation method thereof, purposes.Is this Chinese medicine composition specifically made up of following crude drug: Radix Rosae Laevigatae 14? 0, Rhizoma Smilacis Chinensis 6～10, YANGKAIKOU 7～10, Herba lygodii 3.0～6.5, Herba Centellae 3.2～6.8.Preferred Radix Rosae Laevigatae 15, Rhizoma Smilacis Chinensis 10, YANGKAIKOU 9, Herba lygodii 5, Herba Centellae 6.This medicine is above-mentioned raw material of Chinese medicine to be utilized modern pharmaceutical production technologies such as decocting in water, drying process capsule or granule, oral liquid, tablet.Disease that this medicine is treated is the damp heat downward flowing type disease, like pyretic stranguria, oliguria with reddish urine, the puckery pain of pouring drop, reaches the urgent, chronic nephropyeltis, acute episode of chronic pyelonephritis, acute cystitis, the urinary tract infection that belong to the syndrome of dampness-heat diffusing downward of suffering from a deficiency of the kidney.Also can be used for treating prostatitis.This medicine has the obvious suppression effect to common urinary system infection antibacterial in addition.The medicine of this medicine is called " SANJIN PIAN ", and since the listing, because its determined curative effect, advantage such as the crowd that is suitable for is wide is firmly got the user and trusted.

In recent years; The applicant has carried out broad research to other effects of above-mentioned composition; Through clinical and experimental study in recent years, the applicant finds that above-mentioned Chinese medicine composition infectd significant effect in treatment with the too high disease of urine sIL-2R, urine IL-6, urine IL-8 level and by what escherichia coli caused.And up to the present, also do not find any report that can effectively reduce sIL-2R, urine IL-6, urine IL-8 level about above-mentioned composition.Though the report of above-mentioned composition treatment with the relevant disease of sIL-2R, urine IL-6, the rising of urine IL-8 level arranged; But this treatment is the result; And unspecified be that effect through which or several links or target spot obtains medical treatment disease, also do not see how above-mentioned composition produces report antibacterial, bactericidal action to escherichia coli.

The applicant is through concentrating on studies; Finding that said compositions also has and significantly reduce urine sIL-2R, urine IL-6, urine IL-8 level and inhibition, kill the effect of escherichia coli, is the medicine of the infection of main pathogenic bacterium thereby can be applicable to prepare treatment with the too high disease of urine sIL-2R, urine IL-6, urine IL-8 level and with escherichia coli.

Summary of the invention

The object of the present invention is to provide a kind of Chinese medicine composition preparation treatment urine thin intracellular cytokine or its acceptor levels is too high and the medicine of infection due to Escherichia coli on application.

To achieve these goals, the present invention takes following technical scheme:

A kind of Chinese medicine composition preparation treatment urine thin intracellular cytokine or its acceptor levels is too high and the medicine of infection due to Escherichia coli on application; Described cytokine or its receptor are sIL-2R, IL-6, IL-8; Described Chinese medicine composition is processed by following materials of weight proportions: Radix Rosae Laevigatae 14～20, Rhizoma Smilacis Chinensis 6～10, YANGKAIKOU 7～10; Herba lygodii 3.0～6.5, Herba Centellae 3.2～6.8; Preferably, Radix Rosae Laevigatae 15, Rhizoma Smilacis Chinensis 10, YANGKAIKOU 9, Herba lygodii 5, Herba Centellae 6.

Chinese medicine composition of the present invention reduces the application on the medicine of urinating sIL-2R, urine IL-6, urine IL-8 level in preparation.

The application of Chinese medicine composition of the present invention on the medicine of preparation treatment too high urinary system infection with urine sIL-2R, urine IL-6, urine IL-8 level.

Chinese medicine composition of the present invention is treated with urine sIL-2R, urine IL-6, is urinated the application on the too high chronic pyelonephritis of IL-8 level, chronic lower urinary tract infection, prostatitis, acute nephritis, chronic nephritis, lupus nephritis, the diabetic nephropathy drugs in preparation.

Chinese medicine composition of the present invention has the application on the medicine of antibacterial, bactericidal action to escherichia coli in preparation.

Chinese medicine composition of the present invention is the application on the medicines of urinary system infection of main pathogenic bacterium with escherichia coli in preparation treatment.

Chinese medicine composition of the present invention is the application on the chronic pyelonephritis of main pathogenic bacterium, chronic lower urinary tract infection, the prostatitic medicine with escherichia coli in the preparation treatment.

The application of Chinese medicine composition of the present invention on the medicine for preparing on the lower respiratory infection that treatment is main pathogenic bacterium with escherichia coli.

Chinese medicine composition of the present invention is the application on the medicines of pneumonia, acute bronchitis, chronic bronchitis of main pathogenic bacterium with escherichia coli in preparation treatment.

Among the present invention, the dosage form of said medicine is a said dosage form on any pharmaceutics, preferred powder, capsule, tablet, concentrated pill, granule, oral liquid, syrup, drop pill, paster or injection, most preferably tablet.

The method for preparing of said medicine can have been applied for the patent No. for being 03124080.1 referring to the applicant, and it is that January 25, publication number in 2006 are the patent of invention of CN1238039C that name is called " a kind of pharmaceutical composition of treating diseases of urinary system and preparation method thereof, purposes " Granted publication day.

SIL-2R is a serum soluble interleukin-2 receptor; It is the composition of IL-2Ra chain (IL-2Ra); IL-2R all can be expressed in mononuclear cell and some B cell line surfaces that activated T cell, LPS and IFN γ stimulate; Most scholars think that the IL-2R molecule of cell surface produces through protease hydrolysis, and the release of sIL-2R is the characteristic indication of above-mentioned cell activation.Its expression regulation is significant in the function performance of IL-2/IL-2R system; Can be used as a kind of effectively new body endolymph cell-stimulating index; The state of an illness of the variation of its level in serum and other body fluid and clinical multiple disease, the course of disease, prognosis etc. are closely related, can be used as the efficiency index that the diagnosis, monitoring, prognosis of clinical relevant disease are judged.

Urinary system infection disease such as chronic pyelonephritis, chronic lower urinary tract infection, prostatitis, acute nephritis, chronic nephritis, lupus nephritis, diabetic nephropathy etc.; The patient is significantly higher than ordinary person with urine sIL-2R, urine IL-6, urine IL-8 level; Seek a kind of medicine that can effectively reduce urine sIL-2R, urine IL-6, urine IL-8 level; Can on molecular level, treat, can effectively solve the bottleneck of existing therapeutic scheme, have very considerable clinical value to the cause of disease.

Urinary system infection is one of comparatively common clinically infectious disease; Its sickness rate is in recent years by the trend that rises; Urinary system infection is mainly caused by gram negative bacilli; Wherein see to infect due to the escherichia coli again, like chronic pyelonephritis, chronic urinary tract infection, prostatitis and some renal glomerular diseases down more.Research shows that escherichia coli is the main pathogenic bacterium of above-mentioned disease.In addition, escherichia coli is a kind of gram negative bacilli that can ferment, and is the normal host virus system bacterium of human intestine.It can suppress other pathogenic entero becterias (like shigella) and saprophytic bacteria, can participate in the synthetic of vitamin B and K, can produce colicin, but when Abwehrkraft des Koepers decline or outer tissue of intrusion intestinal or organ, can cause acute inflammation or secondary infection.Escherichia coli is a conditioned pathogen, especially is prone to cause the patient of hypoimmunity and causes lower respiratory infection.Common lower respiratory infection property disease has acute tracheitis, chronic tracheitis, pneumonia and Nosocomial Pneumonia.Escherichia coli like the pharyngeal field planting of suction inlet is the important pathogenesis of escherichia coli lower respiratory infection.In addition, escherichia coli is second common pathogen that causes the acquired gram-negative bacteria pneumonia of community, accounts for the 12%-45% of negative bacillus.

Therefore the remarkable inhibiting medicine of seeking escherichia coli is the especially application on treatment urinary system infection and lower respiratory infection of infection of main pathogenic bacterium to treatment with escherichia coli, has great clinical meaning.

Description of drawings

The escherichia coli structure chart that Fig. 1 cultivates for the patient's midstream urine of not taking medicine under the Electronic Speculum;

Fig. 2 is the structure chart of the escherichia coli that patient's midstream urine is cultivated under the SANJIN PIAN effect under the Electronic Speculum.

The specific embodiment

Below in conjunction with embodiment the present invention is further described, following each embodiment only is used to the present invention is described and is not limitation of the present invention.

Embodiment 1

Get raw material: Radix Rosae Laevigatae 800g Rhizoma Smilacis Chinensis 400g YANGKAIKOU 390g Herba lygodii 250g Herba Centellae 260g

Secondary is extracted in the raw material decocte with water, and 3 hours for the first time, 2 hours for the second time, the filtrating of extraction was put in the vacuum concentration pot, is condensed into thick paste (d=1.15～1.30/70 ℃～80 ℃).With the thick paste conventional drying, dried cream powder water content≤5% that obtains.Get dried cream powder; It is an amount of to add Pulvis Talci, dried starch etc., adopts conventional method to granulate, and adds adjuvant (silicon dioxide, magnesium stearate and microcrystalline Cellulose etc. are an amount of) mix homogeneously after processing granule; Sieve; Moisture content is controlled between 3.0%～10.0%, tabletting, and large stretch of every is equivalent to crude drug 3.5g; Every of small pieces are equivalent to crude drug 2.1g, and coating gets finished product.Name of product is " SANJIN PIAN ".

Embodiment 2

Get raw material: Fructus Rosae Laevigatae grass 750g Rhizoma Smilacis Chinensis 460g YANGKAIKOU 440g Herba lygodii 260g Herba Centellae 280g

Secondary is extracted in the raw material decocte with water, and 3 hours for the first time, 2 hours for the second time, the filtrating of extraction was condensed into thick paste (d=1.15～1.25/70 ℃～80 ℃).It is an amount of to get Pulvis Talci, starch etc., adds thick paste, and combination drying is processed granule.The granule that obtains adds that adjuvant (silicon dioxide, magnesium stearate and microcrystalline Cellulose etc.) is an amount of, and mix homogeneously sieves, and moisture content is controlled between 3.0%～10.0%, tabletting subsequently, and coating gets finished product.Name of product is " SANJIN PIAN ".

Embodiment 3

Get raw material: Radix Rosae Laevigatae 680g Rhizoma Smilacis Chinensis 360g YANGKAIKOU 320g Herba lygodii 200g Herba Centellae 200g

Secondary is extracted in the raw material decocte with water, and 3 hours for the first time, 2 hours for the second time, the filtrating of extraction was put in the vacuum concentration pot, is condensed into thick paste (d=1.15～1.30/70 ℃～80 ℃).With the thick paste conventional drying, dried cream powder water content≤5% that obtains.Get dried cream powder; It is an amount of to add Pulvis Talci, dried starch etc., adopts conventional method to granulate, and adds adjuvant (silicon dioxide, magnesium stearate and microcrystalline Cellulose etc. are an amount of) mix homogeneously after processing granule; Sieve; Moisture content is controlled between 3.0%～10.0%, processes capsule through conventional technology, every suitable crude drug 3.5g.Name of product is " SANJIN JIAONANG ".

Following the applicant will be that application on the medicines of infection of main pathogenic bacterium describes in the preparation treatment disease too high with urine sIL-2R, urine IL-6, urine IL-8 level and with escherichia coli to this Chinese medicine composition through concrete pharmacodynamics test

Test Example 1 SANJIN PIAN is to chronic lower urinary tract infection and chronic pyelonephritis patient's pharmacodynamics clinical trial

One, testing program master-plan

The method of clinical research is adopted at random, contrasts in this test.Selected disease is chronic urinary system infection, and chronic pyelonephritis, chronic lower urinary tract infection are divided into test group and matched group at random in 1: 1 ratio.Use SANJIN PIAN and antibiotic respectively for two groups, be for 12 weeks the course of treatment.The result obtains two groups complete case test group and matched group and is 30 examples, totally 120 examples.

Two, the selection of subjects with withdraw from

(1) diagnostic criteria

With reference to the academic meeting of 1985 second boundaries whole nation nephropathy, in conjunction with clinical.Chinese medical discrimination standard: according to 2002 " new Chinese medicine clinical research guideline ".

1. chronic urinary tract infection acute attack diagnostic criteria is with reference to the academic meeting of 1985 second boundaries whole nation nephropathy, in conjunction with clinical.

1. routine urinalysis sediment leukocyte count＞5/HFP

2. regular CCMS (require urine rest in the bladder more than 4-6 hour) bacteria quantified is cultivated clump count>=10 ⁵/ ml

3. outbreak repeatedly comprises recurrence type, hair style again

1. possessing one in 2. gets final product

2. acute episode of chronic pyelonephritis diagnostic criteria is with reference to the academic meeting of 1985 second boundaries whole nation nephropathy, in conjunction with clinical.

1. routine urinalysis sediment leukocyte count＞5/HFP

3. the urinary tract infection medical history is more than 1 year, and through the antibacterial therapy poor effect, repeatedly mostly the equal positive of urine thin bacterium quantitative culture or frequent recurrence person are chronic pyelonephritis.

4. behind the treatment transference cure, still have renal tubular function (urine concentrating power etc.) to go down, can get rid of person due to the other reasons, be chronic pyelonephritis.

5. X line radiography or BUS (two kidney) confirm to have the distortion of renal pelvis renal calices, and the irregular even person of dwindling of kidney shadow is a chronic pyelonephritis.

6. urinating β 2-m raises

Below 1. possessing one in 2. 3.-6. can all meet one and get final product

3. Syndrome in TCM belongs to stranguria caused by overstrain, asthenia of both the spleen and kidney, damp invasion of lower energizer

Spiritlessness and weakness, the lazy speech of breathing hard, soreness of waist and knee, thick fur or yellow greasy, dry mouth with bitter taste, urine yellow skin are red, urethra scorching hot, frequent micturition, lack of appetite are indigestion and loss of appetite, distention and pain in the lower abdomen, wrist distention and fullness in the abdomen, loose stool, nocturia, mouthful in sticky, indentations at the margin of the tongue, deep-thready pulse

(2) tried case selection

1, include the case standard in:

1. meet the diagnostic criteria of chronic lower urinary tract infection acute attack or acute episode of chronic pyelonephritis;

2. the age is at 18-65 between one full year of life;

3. this medicine treatment of voluntary accepting, and signature Informed Consent Form.

2, get rid of the case standard

1. merge serious primary disease such as the heart, brain, liver and hemopoietic system, the psychotic;

2. gestation or prepare the gravid woman, women breast-feeding their children;

3. allergic constitution maybe maybe be to trial drug composition allergy sufferers;

4. participating in the patient of other drug clinical trial.

(3) experimenter drops by the wayside experimental condition

1, the case standard that comes off

[the researcher decision is withdrawed from]

(1) anaphylaxis or serious adverse events occur, judge according to the doctor to stop the experimenter;

(2) in the process of the test, patient's secondary infection, or other diseases takes place, affect the treatment and safety judgement person;

(3) experimenter's compliance poor (test compliance＜80%), or change dressings automatically midway or add the Chinese and western drugs person who bans use of with this programme;

[experimenter withdraws from voluntarily]

(4) which kind of reason no matter, the patient is unwilling maybe can not proceed clinical trial, proposes to withdraw from test requirements document and end the experimenter to physician;

(5) though the experimenter clearly proposes to withdraw from test, no longer accept medication and detection and lose visit person.

2, the come off processing of case

For dropping by the wayside the test case or losing and visit the case that comes off, researcher should actively be taken measures, and accomplishes last the detection as far as possible, in order to its curative effect and safety are analyzed.All cases that come off all should be filled in the reason that conclusion (of pressure testing) table and case come off in CRF.Have 6 kinds generally speaking, (sb.'s illness took a turn for the worse or develop complications) adverse events (comprising adverse drug reaction and anaphylaxis) promptly takes place, lacks curative effect, run counter to testing program (comprising that compliance is poor), lose visit (comprising that the patient withdraws from test voluntarily), by bidding person's termination and other.

(4) reject the case standard

1, after case is selected in, finds not meet the standard of including in or meets to get rid of case standard person;

2, case selected after medication person not;

3, case promptly comes off automatically to lose after selected and visits, and does not have the keeper that makes a house call after any treatment.

Three, testing program

(1) title and the specification of test medicament

1, investigational agent: SANJIN PIAN (Sanjin Pharmaceutical Co., Ltd., Guilin's production), specification: 0.44g/ sheet.Lot number: 0701003 medicine inspection certificate number: 0701003

2, contrast medicine: select corresponding antibiotic or experience medication for use according to susceptibility.

SANJIN PIAN is provided by bidding person Sanjin Pharmaceutical Co., Ltd., Guilin.

(2) instructions of taking and the course of treatment

Investigational agent: SANJIN PIAN, oral.Each 3, every day 3 times.

Contrast medicine: select corresponding antibiotic or experience medication for use according to susceptibility.

The course of treatment: 12 weeks.

(3) drug combination regulation

Duration of test must not be taken the treating stranguria Chinese patent medicine of other clearing away heat-damp and promoting diuresis and the prepared slices of Chinese crude drugs.

Four, the observation of adverse events

(1) the safety background information relevant with test drug

SANJIN PIAN has heat-clearing and toxic substances removing, and dampness removing is treating stranguria, and the effect of kidney tonifying cures mainly urinary system infection.

Acute toxicity test shows that SANJIN PIAN gives the maximum tolerated dose of mice greater than 324g crude drug/kg body weight, for 463 times of clinical consumption, does not see untoward reaction.

Long term toxicity test shows; Obeyed for three gold medal preparation crude drug 26 weeks of dried cream powder for respectively the rat continuous irrigation by the dosage of crude drug 70.0g/kg, 35.0g/kg, 17.5g/kg (be equivalent to clinical consumption 100,50,25 times); 70.0g/kg the serum AST content of group increases 20.7% (it can recover as for the close level of matched group after 4 weeks of drug withdrawal) than matched group, other tangible toxic reactions do not appear in each administration group; But the whole blood RBC number of 70.0g/kg group slightly increases (drug withdrawal still has this phenomenon after 4 weeks) than matched group, and 70.0g/kg organizes and the serum Glu content of 35.0g/kg group slightly reduces (it can recover as for the close level of matched group after 4 weeks of drug withdrawal) than matched group; Drug withdrawal observed for 4 weeks, and toxic reaction does not all appear significantly delaying in each administration group.

(2) adverse events definition

The experimenter occurs during clinical research observation and can influence healthy any syndrome, symptom, syndrome or disease of experimenter appearance or deterioration have been contained.This term has also comprised that find in laboratory or other diagnostic procedures and clinical relevant situation, like needs diagnosis and treatment measure outside the plan, or causes from test, withdrawing from.

Adverse events possibly be new disease; The deterioration of therapeutic state Sx; Or the deterioration of accompanying diseases; The effect of control drug; Irrelevant with the participation test; The combination of one or more factors.So the occasion Huan Zhe-recorded

The term does not imply a causal relationship with the study drug.

Serious adverse events: under any dosage of trial drug, or at viewing duration whenever, one of following adverse events of appearance: cause death; At once threat to life needs hospitalization or prolongs the hospital stays; Cause permanent or serious deformity; Cause cancer; Cause congenital malformation; There is the important medical meaning (to refer to those not threat to life or cause the dead incident that maybe need be in hospital immediately; But possibly endanger the experimenter and maybe need take measures to prevent above-mentioned defined a kind of consequence), need Medical Treatment to prevent nonvolatil damage or infringement.

The degree of adverse events and processing:

Slightly: have symptom to occur, but the ability well tolerated does not need anti symptom treatment and drug withdrawal.

Moderate: symptom influences orthobiosis, and patient is difficult to stand, and needs drug withdrawal or anti symptom treatment.

Severe: serious symptom, crisis patient life causes death or disables, and needs drug withdrawal immediately or emergent management.

(3) the dependency evaluation of adverse events and medicine

1, adverse events evaluation criterion (comprising symptom, sign, test index)

(1) time of adverse events appearance and administration time coincide.

(2) adverse events is relevant with the known untoward reaction of this medicine.

(3) adverse events can not use other reason to explain.

(4) adverse events disappears after drug withdrawal.

(5) adverse events reproduces after administration.

2, untoward reaction is judged: see table 2.

(1) certainly: meet above-mentioned the 1st, 2,3,4,5 standard simultaneously.

(2) probably: meet above-mentioned the 1st, 2,3,4 standard simultaneously.

(3) possibility: meet above-mentioned the 1st, 2 standard simultaneously.

(4) suspicious: as to meet above-mentioned the 1st standard.

(5) impossible: in above-mentioned 5 standards, one does not meet yet.

(4) untoward reaction and adverse events record

1, researcher should be explained to the experimenter, requires the change of illness state after the experimenter reacts medication strictly according to the facts.The doctor will avoid leading question.

2, in observe the curative effect, keep a close eye on and observe adverse events or unexpected toxic and side effects (comprising symptom, sign, lab testing), analyze reason, make judgement, and tracing study and record.

3, the adverse events that duration of test is occurred should be recorded in CRF with its symptom, degree, time of occurrence, persistent period, treatment measures, pass through etc., estimates the dependency of itself and trial drug, and by the researcher itemized record, signs and date.

4,, should follow up a case by regular visits to Sx and corresponding physico-chemical examination recovery 1 week of normal back to untoward reaction person occurring in the test.

(5) report of untoward reaction and adverse events

When 1, finding adverse events, observe the doctor and can whether end to observe, should carry out follow up survey case because of the untoward reaction drug withdrawal according to state of an illness decision, itemized record handle through and the result.

2, in test as serious adverse events occurring, the unit that bears clinical research must take immediate steps, protection experimenter safety, and in 24 hours, report Drug Administration, bidding person and Ethics Committee.Researcher will be signed in report and date.Bidding person will guarantee to satisfy the report program of all provisions of laws and regulations.

Five, the assessment of clinical trial

(1) observation index and observation time point

1, demography data: 1. age, 2. height, 3. body weight, 4. blood pressure etc.

2, health giving quality index

[leading indicator]

Urine sIL-2R (human IL-2,22120844), urine IL-6 (human IL-6,25060605), urine IL-8 (human IL-8,17070804), article river, Shanghai Bioisystech Co., Ltd (before and after the treatment)

Urine sense recurrent number (observing at any time)

[less important index]

(1) tcm syndrome integration (observing for the 0th, 4,8,12 weeks)

(2) routine urinalysis (observing for the 0th, 4,8,12 weeks)

3, safety indexes observation

The untoward reaction symptom that (1) possibly occur

(2) general health check-up project: (observing for the 0th, 4,8,12 weeks) such as body weight, body temperature, resting heart rate, breathing, blood pressures

(3) routine blood test, electrocardiogram and liver function (ALT, AST), renal function (BUN, Scr)

Answering the close observation occurrence of adverse reaction, is main safety evaluatio index with adverse reaction rate.

4, observe the uncommon bacterium flagellar morphology of the big whip intestinal dust in SANJIN PIAN effect front and back under the Electronic Speculum

(2) safety indexes and evaluation criterion

1, safety evaluatio index

Untoward reaction symptom, the adverse reaction rate that (1) possibly occur;

(2) general health check-up project is like temperature pulse respiration, blood pressure etc.;

(3) routine blood test, electrocardiogram and liver function (ALT, AST), renal function (BUN and Cr), before and after test, respectively carry out 1 inspection.Unusual after normal the treatment before treating, or obviously do not increase the weight of the person after the unusual treatment before treating, answer close observation check in time to recover normal until index, should give corresponding treatment in case of necessity.Answering the close observation occurrence of adverse reaction, is main safety evaluatio index with adverse reaction rate.

2, safety evaluatio standard

One-level: safety, there is not any untoward reaction; The safety indexes inspection is no abnormal.

Secondary: compare safety, mild adverse effects is arranged, need not do any processing and can continue administration; The safety indexes inspection is no abnormal.

Three grades: safety issue is arranged, moderate untoward reaction is arranged, or safety indexes inspection has mile abnormality, can continue administration after processing.

Level Four: because of test is ended in untoward reaction, or the safety indexes inspection is obviously unusual.

Six, statistical analysis

Measurement data using non-parametric test, measurement data to x Shen said that differences between groups using independent samples t-test, group differences using paired samples t-test.The total data data all adopts SPSS 11.5 softwares to analyze.

Seven, result of the test

1. tcm symptom integration

Syndrome in TCM belongs to stranguria caused by overstrain, asthenia of both the spleen and kidney, damp invasion of lower energizer

Primary symptom: spiritlessness and weakness, the lazy speech of breathing hard, soreness of waist and knee, thick fur or yellow greasy, dry mouth with bitter taste, urine yellow skin are red.Urine is anxious frequently short puckery, the urethra scorching hot twinge, and the urine yellow skin is red, the cramp and pain in the lower abdomen distending pain, or cold and heat are arranged, and bitter taste, vomiting and nausea, or lumbago tenderness, or constipation is arranged, yellow and greasy fur, slippery and rapid pulse.

Inferior disease: urethra scorching hot, frequent micturition, lack of appetite are indigestion and loss of appetite, distention and pain in the lower abdomen, wrist distention and fullness in the abdomen, loose stool, nocturia, mouthful in sticky, indentations at the margin of the tongue, deep-thready pulse: the tcm symptom primary symptom by light (2 minutes), in (4 minutes), heavy (6 minutes) score, inferior disease by light (1 minute), in (2 minutes), heavy (3 minutes) score.

Obviously be superior to matched group (P＜0.05) 1.1 the tcm symptom integration of chronic lower urinary tract infection 60 routine chronic lower urinary tract infection patient treatment groups improves situation, see table 1.

The tcm symptom integration differential relatively before and after table 1:60 chronic lower urinary tract infection patient treatment group of example and the treatment of control group

* through the t check, the difference between the difference before and after treatment group and the treatment of control group has statistical significance (P＜0.05)

1.2 the tcm symptom integration of chronic pyelonephritis 60 routine chronic pyelonephritis patient treatment groups obviously is superior to matched group (P＜0.05), sees table 2.

The tcm symptom integration differential relatively before and after table 2:60 example chronic pyelonephritis patient treatment group and the treatment of control group

2 send out number of times again

Through Mann-Whitney U check, 60 routine chronic lower urinary tract infection patient treatment group urine senses are sent out number of times again and are starkly lower than matched group (P＜0.05), and 60 routine chronic pyelonephritis patient treatment group urine senses are sent out number of times again and are starkly lower than matched group (P＜0.05) (seeing table 3).

Table 3: chronic urinary system infection patient treatment 12 all two groups send out number of times relatively (people) again

3. to urinating the regulating action (seeing table 4,5) of sIL-2R, urine IL-6, urine IL-8

3.1 zero difference (P＞0.05) between the reduction of chronic lower urinary tract infection 60 routine chronic lower urinary tract infection acute attack patient 12 week treatment back treatment group urine sIL-2R, urine IL-8 and the matched group, the reduction of treatment group urine IL-6 is superior to matched group (P＜0.05).

Table 4:60 chronic lower urinary tract infection patient treatment group of example and matched group urine sIL-2R, urine IL-6, urine IL-8 are relatively

3.2 chronic pyelonephritis 60 routine acute episode of chronic pyelonephritis patient treatment groups all are superior to matched group (P＜0.05) through the reduction of 12 weeks treatment urine SIL-2R, IL-6, IL-8.

Table 5: treatment group and matched group 60 routine chronic pyelonephritis patients urinate sIL-2R,, urine IL-6, urine IL-8 relatively

* the difference between the difference before and after t check treatment group and the treatment of control group has statistical significance (P＜0.05)

4. midstream urine is cultivated situation

Midstream urine is cultivated the flora kind before and after the treatment, sees table 6.

Table 6: flora kind before and after the chronic upper and lower urinary tract infection treatment

Eight, brief summary

1, the improvement of 60 routine chronic lower urinary tract infection acute attack patient treatment group tcm symptom integrations is superior to matched group (P＜0.05), the urine sense is sent out number of times again and also reduced (P＜0.05) than matched group; The reduction similar with matched group (P＞0.05) of urine sIL-2R, urine Il-8 after the treatment of 12 weeks, the improvement of urine IL-6 is than matched group obvious (P＜0.05).

2, the improvement that number of times is sent out in traditional Chinese medical science symptom integral, urine sense again of 60 routine acute episode of chronic pyelonephritis patient treatment groups all is superior to matched group (P＜0.05).The improvement of treatment group urine SIL-2R, IL-6, IL-8 also is superior to matched group (P＜0.05) after the treatment of 12 weeks

Nine, adverse events

All patients all detect safety indexes such as routine blood test, hepatic and renal function, electrocardiogram in the treatment front and back, see table 7.

Table 7: situation before and after routine blood test, the hepatic and renal function treatment

This test only finds that in the antibiotic group of chronic pyelonephritis a routine liver decreases, and ALT, AST have slight rising, and liver function recovery is normal after the hepatoprotective treatment, does not withdraw from test.

Test Example 2 SANJIN PIANs are to the pharmacodynamics clinical trial of prostatitis patient

The clinical trial case selection

Test group, matched group 1 and 2 are included experimenter's 50 examples respectively in, are the male, are divided into experimental group of the present invention and matched group at random.Experimental group 50 examples, 38 years old mean age.Matched group 50 examples, 40 years old mean age.Through statistics, two groups of aspect comparing difference not statistically significants (P＞0.05) such as age have comparability.

Wherein, medical history 1 year with interior 25,1 year to 3 years 48, more than 3 years 27.

Diagnostic criteria:

Primary symptom: urine is frequently many, red puckery pain.

Urethral orifice is suppurated or urinary obstruction perineum and lower abdomen pain when serious.

Send out the age well 35-50 year male.

Have above symptom and be prostatitis.

The clinical development standard:

Be almost recovered: eliminate the pain that the patient causes because of urinary obstruction.

Produce effects: it is normal thoroughly to have eliminated urgent micturition, dysurea, recovery.

Effectively: controlled frequent micturition, urine retention until not recurring for a long time.

Invalid: with compare each side before the medication and do not have improvement.

Medication

Test group: QIANLIEKANG (Kang Enbei Zhejiang Pharmaceutical Co), oral, a 3-4 sheet, 3 times on the one.Be 6 weeks the course of treatment.

Matched group: SANJIN PIAN (Sanjin Pharmaceutical Co., Ltd., Guilin's production), oral, 3/inferior, 3 times/day, be 6 weeks the course of treatment.

Four, result

N

Be almost recovered

Produce effects

Effectively

Invalid

Effectively total

Experimental group

50

24(48％)

17(34％)

5(10％)

4(8％)

46(92％)

Matched group

50

22(44％)

13(26％)

9(18％)

6(12％)

44(88％)

Interpretation of result

SANJIN PIAN is mainly used in pyretic stranguria or stranguria caused by overstrain of the syndrome of dampness-heat diffusing downward of suffering from a deficiency of the kidney etc.Bladder is the mansion of body fluid, and damp-heat accumulation is in the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, the bladder of making a bet, the damp and hot resistance in kidney and bladder; Cause kidney and functioning of bladder not normal, then water channel, dysuria, puckery pain when rushing down, dark coloured urine; Urine is muddy, frequent micturition, and drenching drop smooth (is that frequent micturition, urgent micturition, short urination are few; The urinary tract infection symptom of dysurea), very then obstructed the and lower abdomen of the difficulty in urination is anxious full, or with waist ache, fever with aversion to cold; If prolonged illness thermal burn kidney yin, essence in kidney is impaired, more increases the weight of the not normal and state of an illness of functioning of bladder.Pathogenic heat remaining in the interior, visible dryness of the mouth and throat, yellow fur rapid pulse; If injury of blood collaterals by heat, visible hematuria, with the passing of time hot wetting phase is fried in shallow oil, visible gravel stone.Reuse Radix Rosae Laevigatae in the side, sweet in the mouth, puckery, property is flat, heat-clearing and toxic substances removing, kidney tonifying reducing urination, promoting blood circulation and hemostasis are principal agent; It is acid flat to be aided with the Rhizoma Smilacis Scobinicaulis sweet in the mouth, and heat-clearing and toxic substances removing, dampness removing is treating stranguria; Herba Centellae bitter in the mouth suffering is cold in nature, and heat-clearing and toxic substances removing, dampness removing is treating stranguria, eliminating stasis to stop pain, cooling blood for hemostasis (area, Guangdong and Guangxi Provinces is usually used in diseases such as pyretic stranguria, stone sand, stranguria with blood, jaundice due to damp-heat).More than three medicines share, play heat-clearing and toxic substances removing altogether, dampness removing is treating stranguria, blood circulation promoting and blood stasis dispelling, analgesic hemostatic, the merit of kidney tonifying.The Herba lygodii bitter in the mouth is cold in nature, and heat-clearing and toxic substances removing, promoting diuresis to eliminate damp pathogen, fossil is treating stranguria, is usually used in diseases such as urinary tract infection and lithangiuria; The YANGKAIKOU sweet,sour and puckery taste, slightly warm in nature, convergence detoxifcation, removing stasis to stop bleeding, two medicines are adjuvant drug altogether.More than five medicines share, play heat-clearing and toxic substances removing altogether, dampness removing is treating stranguria, blood circulation promoting and blood stasis dispelling, analgesic hemostatic, the merit of fossil kidney tonifying.

There are some researches show that various cytokines or its receptor (especially chronic urinary system infection patient) prevent to play an important role in the pathogenic microorganism invasion and attack at body, have also caused tissue injury simultaneously.IL-2R all can be expressed in mononuclear cell and some B cell line surfaces that activated T cell, LPS and IFN γ stimulate; Most scholars think that sIL-2R is that the IL-2R molecule of cell surface produces through protease hydrolysis, and the release of sIL-2R is the characteristic indication of above-mentioned cell activation.Chronic pyelonephritis patient is then because challenge shows the sIL-2R rising.IL-8 (neutrophilic chemotactic factor) is the factor of finding in the later stage eighties that can induce multiple leukocyte chemotaxis motion; Be active the strongest a kind of in the chemotactic factor; It participates in the generating process of multiple inflammation disease, the important medium of inflammatory reaction when being bacterial infection; IL-6 is mainly derived from macrophage, mesangial cell and endotheliocyte, is the mesangial cell autocrine growth factor, and its topmost BA is participated in immunologic injury exactly.IL-6 causes that the immunity of organism adjusting is disorderly, causes the pernicious of mesangial cell self to regulate, thus the aggravation immunologic injury, and IL-6 has participated in the pathology damage process of chronic pyelonephritis, with the destruction of renal tissue and the delay difficulty of inflammation substantial connection is arranged more.

In a word; Various interleukin (IL-2, IL-6 and IL-8) are as the important member in the complicated cytokine network of body when chronic kidney bacterial infection; Promotion has also been regulated propagation and the differentiation such as various kinds of cell in immune system, the inflammatory reaction, possibly be that chronic inflammation of urinary system pathological changes continues one of major reason of making progress.

This result of the test shows that SANJIN PIAN all has the significant curative effect of improving tcm symptom for the patient of chronic lower urinary tract infection and acute episode of chronic pyelonephritis.In addition, the SANJIN PIAN group is obvious than the antibiotic group for the level that the chronic pyelonephritis patient reduces urine sIL-2R, urine IL-8, urine IL-6.

Prostatitis is the adult male commonly encountered diseases, frequently-occurring disease, and along with patient's oneself factor variable interval outbreak, the primary disease cause of disease is complicated, and symptom is various, and is obstinate difficult, treats comparatively thorny.The main at present medicines such as doctor trained in Western medicine antibiotics, estrogen, QIANLIEKANG that adopt; Or take the method for laser irradiation, local injection, operation; Doctor trained in Western medicine antibiotic life-time service can make the people produce antibody; Simultaneously, the common defects of medicines such as Western medicine antibiotics, estrogen, QIANLIEKANG is that its medicine can not be penetrated into capsula prostatica, is difficult to reach therapeutic purposes.Adopt Therapeutic Method such as laser irradiation, local injection, operation, treatment costs an arm and a leg, and cures the symptoms, not the disease easy relapse.Test Example 2 SANJIN PIANs show that to prostatitis patient clinical experimental study result SANJIN PIAN also can significantly reduce the urine sIL-2R of prostatitis patient, the level of urinating IL-8, urine IL-6.Thereby acquisition excellent curative.

Urinary system infection disease such as chronic pyelonephritis, chronic lower urinary tract infection, prostatitis, renal glomerular disease etc.; The patient is significantly higher than ordinary person with urine sIL-2R, urine IL-6, urine IL-8 level; Because SANJIN PIAN can significantly reduce the level that the patient urinates sIL-2R, urine IL-8, urine IL-6, therefore all has the good curing effect with multiple urinary system infection diseases such as the too high chronic pyelonephritis of the level of urine sIL-2R, urine IL-8, urine IL-6, chronic lower urinary tract infection, prostatitis, acute nephritis, chronic nephritis, lupus nephritis, diabetic nephropathyes for above-mentioned.In addition, adopt other dosage forms of SANJIN PIAN,, replace the SANJIN PIAN tablet that present embodiment adopts, also can reach similar effects like capsule, granule, drop pill.

Test Example 3 SANJIN PIANs are to the inhibitory action of escherichia coli flagellum

Test material and method

Test material

Test the 1 patient preceding midstream urine of taking medicine

Method

(1), get test 1 patient take medicine before the escherichia coli cultivated of midstream urine make negative staining, observe its structure under the Electronic Speculum;

(2), be affixed on planar surface (same sample), 37 with the tweezers of incineration with the filter paper that contains SANJIN PIAN? After 12 hours, get around the filter paper flora and make negative staining, observe its structure under the Electronic Speculum.

The result

1, observe the escherichia coli that patient's midstream urine is cultivated under the Electronic Speculum, its configuration is intact, and flagellar morphology is normal, the complete (see figure 1) of micro-tubular structure;

2, observe SANJIN PIAN under the Electronic Speculum and soak the escherichia coli shrinkage, most of escherichia coli flagellums come off, the unintelligible (see figure 2) of micro-tubular structure in the flagellum that part does not come off.

Test Example 4 SANJIN PIANs are to escherichia coli being the pharmacodynamics clinical trial of the lower respiratory infection of main pathogenic bacterium

1, testing data

Test group, matched group 1 and 2 are included experimenter's 200 examples respectively in, are divided into experimental group of the present invention and matched group at random.Experimental group 100 examples, wherein male 52 examples, women 48 examples, 46 years old mean age.Acute bronchitis 46 examples, chronic bronchitis 54 examples, matched group 100 examples, male 47 examples, women 53 examples, 48 years old mean age, acute bronchitis 51 examples, chronic bronchitis 49 examples.Through statistics, two groups at aspect comparing difference not statistically significants (P＞0.05) such as sex, ages, has comparability.

(1) case is selected:

Diagnostic criteria with reference to acute bronchitis or chronic bronchitis in " new Chinese medicine clinical research guideline " is formulated.

Include standard in: meet acute bronchitis or acute episode of chronic bronchitis, the age 18? 0 year old, all as including case in.

Exclusion standard: the chronic cough person of panting that factors such as tuberculosis, tumor, fungus, irritant gas allergy cause; The concurrent severe cardiac of acute/chronic bronchitis functional defect person; Merge serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic; Age is at under-18s or more than 70 years old; Gestation or women breast-feeding their children; To these article allergy sufferers.

(2) Therapeutic Method:

Matched group: adopt the conventional Comprehensive Treatment of doctor trained in Western medicine: 1. control infection; Give empirical therapeutic scheme earlier; Levofloxacin 0.2g or ceftriaxone sodium injection (production of Beijing Yuekang Pharmaceutical Group Co., Ltd.) 39 adds normal saline 100ml intravenous drip (skin test); The two share serious symptom person, every day 2 times, treats to adjust medication again after the repayment of antibacterial culturing and drug sensitivity tests; 2. apophlegmatisant is selected mucosolvan (Tianjin Medicine Research Academy Pharmaceutical Co., Ltd's production) for use, and each 30mg is every day 3 times, oral; 8. the person that do not pant gives the anti-asthmatic aminophylline, each 100mg is every day 4 times, oral; 4. the hyperpyrexia person cooling of suiting the medicine to the illness is handled.Treating 7 days is 1 course of treatment, continuous use observe the curative effect after 2 courses of treatment.

Drug group of the present invention: on the treatment of control group basis, give determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, add medicine SANJIN PIAN of the present invention (Sanjin Pharmaceutical Co., Ltd., Guilin's production), 3/inferior, 3 times/day, be 4 weeks the course of treatment.

(3) criterion of therapeutical effect

With reference to the criterion of therapeutical effect of acute bronchitis in " new Chinese medicine clinical research guideline " or chronic bronchitis, clinic control: cough, expectoration, pant and the pulmonary rale complete obiteration, followed up a case by regular visits to for two weeks and do not have recurrence;

Produce effects: cough, pant and pulmonary rale disappears basically;

Take a turn for the better: cough, expectoration, pant and pulmonary rale improves;

Invalid: cough, expectoration, asthma and pulmonary rale no change or increase the weight of.

(4) statistical procedures

2. result

2.1 two groups of acute bronchitis clinical efficacies

Through statistics, two groups of curative effects compare, and drug group therapeutic effect of the present invention is significantly higher than matched group (P＜0.05), and two groups of total effective rates compare, and medicine total effective rate of the present invention is significantly higher than matched group (P＜0.05), and the result sees table 1.

Table 1 liang group acute bronchitis clinical efficacy comparison (example, %)

N

Clinic control

Produce effects

Take a turn for the better

Invalid

Effectively total

Experimental group

46

?28(61％)

11(24％)

3(6.5％)

4(8.5％)

42(91.5％)

Matched group

51

?29(56.9％)

7(13.7％)

6(11.8％)

9(17.6％)

42(82.4％)

Through statistics, two groups of curative effect comparison drug group of the present invention matched groups (P＜0.05) that are higher than evident in efficacy, two groups of total effective rates compare, and medicine total effective rate of the present invention is significantly higher than matched group (P＜0.05), and the result sees table 2.

Table 2 liang group chronic bronchitis clinical efficacy

N

Clinic control

Produce effects

Take a turn for the better

Invalid

Effectively total

Experimental group

54

33(61.1％)

12(22.2％)

?6(11.8％)

3(5.9％)

51(94.1％)

Matched group

49

23(46.9％)

11(22.5％)

?7(14.3％)

8(16.3％)

41(83.7％)

(6) untoward reaction

We take one course of treatment of the described Chinese medicine health-care compositions of the embodiment of the invention 1 through test group 100 routine experimenters in the test, are the generation of finding to have any untoward reaction, prove that said composition is respond well to above symptom treatment.Matched group 1 does not also find to have any untoward reaction with matched group 2.

(7) brief summary

This is tested on the basis of doctor trained in Western medicine conventional therapy again, adds medicine of the present invention, and clinical efficacy significantly is superior to adopting merely the doctor trained in Western medicine conventional therapy, proves that fully medicine of the present invention can effectively treat acute and chronic bronchitis.

Interpretation of result

Urinary system infection is one of comparatively common clinically infectious disease; Its sickness rate is in recent years by the trend that rises; Urinary system infection is mainly caused by gram negative bacilli; Wherein see to infect due to the escherichia coli again, like chronic pyelonephritis, chronic urinary tract infection, prostatitis and some renal glomerular diseases down, like lupus nephritis, henoch Schonlein purpura nephritis, diabetic nephropathy, chronic nephritis, radical type nephritis etc. more.Research shows that escherichia coli is the main pathogenic bacterium of above-mentioned disease.In addition, escherichia coli is a kind of gram negative bacilli that can ferment, and is the normal host virus system bacterium of human intestine.It can suppress other pathogenic entero becterias (like shigella) and saprophytic bacteria, can participate in the synthetic of vitamin B and K, can produce colicin, but when Abwehrkraft des Koepers decline or outer tissue of intrusion intestinal or organ, can cause acute inflammation or secondary infection.Escherichia coli is a conditioned pathogen, especially is prone to cause the patient of hypoimmunity and causes lower respiratory infection.Common lower respiratory infection property disease has acute tracheitis, chronic tracheitis, pneumonia and Nosocomial Pneumonia.Escherichia coli like the pharyngeal field planting of suction inlet is the important pathogenesis of escherichia coli lower respiratory infection.In addition, escherichia coli is second common pathogen that causes the acquired gram-negative bacteria pneumonia of community, accounts for the 12%-45% of negative bacillus.

The appurtenance of tens of long filament shapes in the escherichia coli superficial growth, is flagellum.It has the function of promoting the sport of bacteria, as bacteria Lin Shuo? Bei Bai.In urinary system infection; Usually cause that at first lower urinary tract infects; If treat untimely and factor such as body's immunity reduction, escherichia coli can up infection also cause urinary system infection, and the motor capacity of flagellum is one of major reason of up infection.

The result of test 3 shows; SANJIN PIAN has significant inhibitory effect to the escherichia coli in chronic pyelonephritis, the chronic urinary tract infection patient midstream urine down; To example 2 the same test of doing experiment of isolating escherichia coli from lower respiratory infection patient oral secretion, obtain same conclusions in addition, promptly also can observe the escherichia coli shrinkage after SANJIN PIAN soaks under the Electronic Speculum; Most of escherichia coli flagellums come off, and micro-tubular structure is unintelligible in the flagellum that part does not come off.Be SANJIN PIAN to escherichia coli be the lower respiratory infection of main pathogenic bacterium and per urethram the urinary system infection disease that causes of Escherichia coli (UPEC) all have certain therapeutic effect.

The result of test 4 shows; SANJIN PIAN has good clinical drug effect to acute and chronic bronchitis; In addition, as the common lower respiratory infection disease of another kind, Nosocomial Pneumonia also is to be main pathogenic bacterium with escherichia coli; Clinical research shows that SANJIN PIAN also has good auxiliary curative effect to the escherichia coli Nosocomial Pneumonia.

In addition, adopt other dosage forms of SANJIN PIAN,, replace the SANJIN PIAN tablet that present embodiment adopts, also can reach similar effects like capsule, granule, drop pill.

Claims

1. a Chinese medicine composition is the application on the medicines of lower respiratory infection disease of main pathogenic bacterium with escherichia coli in the preparation treatment; It is characterized in that: described Chinese medicine composition is processed by following materials of weight proportions: Radix Rosae Laevigatae 14～20; Rhizoma Smilacis Chinensis 6～10; YANGKAIKOU 7～10, Herba lygodii 3.0～6.5, Herba Centellae 3.2～6.8.

2. application as claimed in claim 1 is characterized in that: described Chinese medicine composition is processed by following materials of weight proportions: Radix Rosae Laevigatae 15, Rhizoma Smilacis Chinensis 10, YANGKAIKOU 9, Herba lygodii 5, Herba Centellae 6.

3. according to claim 1 or claim 2 application is characterized in that the dosage form of said medicine is a said dosage form on any pharmaceutics.

4. application as claimed in claim 3 is characterized in that, the dosage form of said medicine is powder, capsule, tablet, concentrated pill, granule, oral liquid, syrup, drop pill, paster or injection.

5. application as claimed in claim 4 is characterized in that, the dosage form of said medicine is tablet, capsule, granule or drop pill.

6. application as claimed in claim 5 is characterized in that, the dosage form of said medicine is a tablet.