CN1634332A - Chinese traditional medicine composition for treating cystitis and urethritis and preparation method thereof - Google Patents

Chinese traditional medicine composition for treating cystitis and urethritis and preparation method thereof Download PDF

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Publication number
CN1634332A
CN1634332A CN 200410065179 CN200410065179A CN1634332A CN 1634332 A CN1634332 A CN 1634332A CN 200410065179 CN200410065179 CN 200410065179 CN 200410065179 A CN200410065179 A CN 200410065179A CN 1634332 A CN1634332 A CN 1634332A
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Prior art keywords
herba
urethritis
chinese medicine
medicine composition
drying
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CN100346799C (en
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吴军
时贞平
王殿广
葛滨
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NANJING B&M SCIENCE AND TECHNOLOGY DEVELOPING Co Ltd
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NANJING B&M SCIENCE AND TECHNOLOGY DEVELOPING Co Ltd
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Abstract

The invention relates to a Chinese traditional medicine composition for treating cystitis and urethritis and preparation method, wherein the composition is prepared from (by weight ratio) dandelion 800g, plantain herb 800g, purslane 800g, dyers woad leaf 800g/1000g through charging 50% ethanol, backflow extracting, filtering, reclaiming ethanol to obtain concrete with specific gravity of 1.05-1.08 mg/ml, concentrating the concrete, and drying.

Description

Chinese medicine composition of treatment cystitis, urethritis and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of Chinese medicine composition for the treatment of urinary tract infection such as acute cystitis, urethritis and chronic cystitis, urethritis acute attack stage and preparation method thereof.
Background technology
Infection diseases of urinary system comes constantly to climb to a higher point year after year, and this pressurization with personal lifestyle, operating pressure and rhythm of life is inseparable.As relevant medicine on the market: the peaceful granule of urine sense, secrete and drench granule etc. and sell equal single variety at 3-5 more than 10,000,000 year after year, but the medicine that is used for infection diseases of urinary system at present is very few, particularly Chinese medicine is few especially.
Present most of hospital ranges antibiotic to the urinary system infection medication, do not classify according to pharmacology, so be difficult to determine separately the concrete medicining condition of urinary system infection, be shown as example with hospital of attached Xinhua of Shanghai Second Emdical University nineteen ninety-five~calendar year 2001 adult outpatient service analysis of drug use: adult's outpatient service consumes the medicine amount of money by the pharmacology classified statistic, preceding 8 and account for then that the percentage ratio of medicine total amount sees table for details of amount of money rank.
The urinary system medicine Nineteen ninety-five 1996 1997 1998 1999 2000 Calendar year 2001 The CP average
Rank ??9 ??8 ??5 ??5 ??5 ??6 ??5
????CP ??1.92 ??3.39 ??5.22 ??6.38 ??6.22 ??5.79 ??6.20 ??5.02
As can be seen, the urinary system infection medication is in rising trend, and this and epidemiology prediction match, and also judges with the related doctor of hospital to match.
Chinese medicine is reasonable at the urinary system infection sales volume to be: nephritis, prostate class and urinary tract infection.
Using reasonable medicine at urinary tract infection is: secrete sense spirit, secrete Kang Beishuan, the clear granule of pyretic stranguria, urine scorching clear, open same sheet, new monarch Bi Zhi, norfloxacin, cefradine, Da Lixin, can match easypro.
Western medicine is a main treatment with the antibiotic at the treatment primary disease exactly, along with country in the order that prohibits selling of the antibiotic of on July 1st, 2004 promulgation, for the antibiotic patient of prolonged and repeated use, bring very big inconvenience undoubtedly, it is not obvious to add side effect and curative effect that prolonged and repeated use antibiotic caused, allow most of patient hold the receptor and decoct, at this moment the speciality of Chinese medicine just is presented in face of the patient naturally.The Chinese medicine Herba Portulacae has obvious effects for the treatment urinary system infection, but the curative effect of single Herba Portulacae is not ideal enough, needs to select other compatibe drugs that are fit to, and traditional Chinese medicinal preparation method is improved.
Summary of the invention
The definite curative effect that the applicant uses clinically in conjunction with Herba Portulacae, select Herba Taraxaci, Herba Plantaginis and Folium Isatidis compatibility with it, based on this four flavors Chinese medicine, carry out thorough research, simultaneously, in order to overcome the fully deficiency of effective component extracting of traditional decocting technology, developed Chinese medicine composition of the present invention, demonstrated fully the speciality that the Chinese traditional treatment infection diseases of urinary system " effects a permanent cure ", heat-clearing and toxic substances removing has been arranged, the effect of inducing diuresis for treating stranguria syndrome has certain clinical practice experience.As finally putting on market, then the market potential is huge, should be able to obtain good social benefit and economic interests.
Technical scheme of the present invention is as follows:
A kind of Chinese medicine composition for the treatment of urinary tract infection such as acute cystitis, urethritis and chronic cystitis, urethritis acute attack stage, form by the medical material of following mass ratio:
Herba Taraxaci 700~900g,
Herba Plantaginis 700~900g,
Herba Portulacae 700~900g,
Folium Isatidis 700g/1200g.
Each 5g, every day 3 times.
Described Chinese medicine composition also includes acceptable carrier and adjuvant on the pharmaceutics, and dosage form is a granule.
The application recommends following optimized proportion:
Herba Taraxaci 800g Herba Plantaginis 800g Herba Portulacae 800g Folium Isatidis 800g/1000g.
The further optimization of above scheme is to adopt the ethanol extract of above each component to form compositions, and is specifically composed as follows:
The Herba Taraxaci of above ratio, Herba Plantaginis, Herba Portulacae, Folium Isatidis add 50% ethanol, and reflux, extract, is filtered, and reclaiming ethanol to relative density is the extractum of 1.05~1.08mg/ml (60 ℃); It is 1.10~1.15mg/ml (60 ℃) that extractum is concentrated into relative density, and drying promptly constitutes this compositions.
The method for preparing above-mentioned Chinese medicine composition:
Step 1, by the prescription quality component (or enlarging quantity in proportion) get Herba Taraxaci, Herba Plantaginis, Herba Portulacae and Folium Isatidis, standby;
Step 2, above four flavors add 8-15 and doubly measure 50% ethanol, the reflux, extract, secondary, and each 1 hour, merge extractive liquid, filtered, and reclaimed ethanol to relative density and was the extractum of 1.05~1.08mg/ml (60 ℃), and is standby;
It is 1.10~1.15mg/ml (60 ℃) that step 3, extractum are concentrated into relative density, and drying is granulated with soluble starch, and drying is made the 1000g granule.
Can also increase following steps in the prioritization scheme:
Step 4, get above granule, aluminum-plastic packaged, every bag of 5g promptly.
The drying of concentrated solution can adopt methods such as drying under reduced pressure, spray drying or vacuum drying in the above preparation method.
Urinary tract infection granular preparations such as treatment acute cystitis, urethritis and the chronic cystitis that the present invention makes, urethritis acute attack stage have dissolving rapidly, special effect, the bioavailability height, good stability, dose is little, easy to carry, advantages such as taking convenience.Granule of the present invention is a natural medicine, reasonable recipe, compatibility is simplified, has heat-clearing and toxic substances removing, the effect of inducing diuresis for treating stranguria syndrome is mainly used in urinary tract infection such as treatment acute cystitis, urethritis and chronic cystitis, urethritis acute attack stage, verifies by pharmacology, this medication is imitated definite, can reach the purpose for the treatment of both the principal and secondary aspects of a disease.
In the quality standard, with thin layer method Herba Taraxaci, Herba Plantaginis, Herba Portulacae and Folium Isatidis are differentiated respectively,, selected for use different developing solvents, all obtain satisfied result according to different materials, and with this discriminating project as this product.Select for use caffeic acid in the Herba Taraxaci as quantitative target, adopt the HPLC method, carried out precision test, repeatability test, solvent stability test and application of sample recovery test respectively, method of proof is feasible, can be used as the quantitative approach of preparation.By the soft capsule that above preparation technology, moulding process and quality standard are produced, the product that becomes high in technological content, steady quality and be easy to control.
The Chinese medicine composition of urinary tract infection such as treatment acute cystitis of the present invention, urethritis and chronic cystitis, urethritis acute attack stage, checking proves through the preclinical pharmacology toxicity:
1. this Chinese medicine composition (" sense urine secrete clever granule " hereinafter is the trade name of this Chinese medicine composition), maximum dosage-feeding is the 384g/kg crude drug, intends 480 times (it is the 0.8g/kg crude drug that clinical people intends consumption) of consumption for clinical people.
2. long term toxicity test is provided with high, medium and low three dosage groups, and high dose group is 60 times of clinical dosage, and middle dosage group is that 30 times of clinical dosage, low dose group are 15 times of clinical dosage, and matched group waits capacity 0.5%CMC-Na.Test period is 1 month, gastric infusion.Observation item: diet, body weight, outward appearance sign and behavioral activity, feces character etc.Inspection item: hematological indices, blood parameters, system become celestial and histopathologic examination.4 weeks of administration as a result and drug withdrawal 2 week each rat behavior activity of back, fur are all normal.Each organizes the equal steady growth of body weight, and food ration is no significant difference also.Organ coefficient and matched group comparisons such as the administration group rat heart, liver, spleen, lung, kidney, brain, thyroid, adrenal gland, testis, prostate, uterus, ovary, except that testis slightly raise, all the other there is no notable difference.Hematology and biochemical indicator: to each administration group data add up and with matched group relatively, the result shows that each hematology and biochemical indicator show no obvious abnormalities variation.Administration 1 month and convalescent period have been carried out system's postmortem, all no abnormal variation of perusal all animals internal organs to each group rat respectively.Histological examination: each system organization 26S Proteasome Structure and Function of matched group and high dose group rat does not all have the pathological changes such as regression, necrosis, inflammatory reaction or paraplasm after the poisoning.
In 1 month long term toxicity test of rat, find that sense urine secretes clever granule rat is had the overt toxicity effect.
3. sense urine is secreted clever granule main pharmacodynamics research
Show that it is that a kind of pharmacological action is definite that sense urine is secreted clever granule, the new drug of many target spots onset sense urine being secreted on clever particulate antiinflammatory, analgesic, analgesia, diuresis, spasmolytic, the antibiotic and enhancing immunity.
3.1 antiinflammatory action
In xylol causes the experiment of mice auricle swelling, show: sense urine secrete clever granule height, in (19.2g/20ml/kg, 9.6g/20ml/kg) two dosage groups all can suppress the mice caused by dimethylbenzene xylene auricle edema, compare significance (P<0.01) with model control group, it is better than aspirin that sense urine is secreted clever granule high dose group swelling degree effect, and the effect of middle dosage and aspirin is suitable.
Show in the influence experiment of rat arthritis swelling due to the on Carrageenan: sense urine is secreted three dosage group day parts of clever granule (2.4g/4ml/kg, 4.8g/4ml/kg, 9.6g/4ml/kg) and is all obviously suppressed the joint caused swelling of carrageenin, comparing with model control group all has significant difference (P<0.05), and the effect that sense urine is secreted each dosage group of clever granule is certain dose-effect relationship, sense urine is secreted behind the suppression ratio 2h of different time after clever granule height, the administration of middle dosage group suitable with Dexamethasone group, does not have notable difference.
3.2 refrigeration function
Show in the influence experiment of rat fever 2, due to the 2, 4-dinitrophenol: the heating that sense urine is secreted clever granule high dose group rat to 2, due to the 2, 4-dinitrophenol has the utmost point notable cooling effect (P<0.01) and the length of holding time, in the 180min of experiment, also have the obvious cooling effect, and the effect of high dose group and aspirin is suitable.Sense urine secretes that the dosage group has cooling trend in the clever granule behind 60min,, between three dosage groups at one time section have dose-effect relationship, but in, low dosage cooling-down effect not significantly (P>0.05).
Show in the influence experiment of fever in rabbits due to the endotoxin: is contrast to irritate stomach to 0.9% sodium chloride, irritating stomach secretes behind the clever granule heating to rabbit due to the endotoxin for high, middle dosage sense urine to have and significantly separate thermal effect (P<0.01) the cooling length of holding time, in the 6h of experiment, all has the obvious cooling effect, and as time passes, cooling-down effect is strengthened.It is suitable with aspirin that high, middle dosage sense urine is secreted clever granule cooling-down effect, and the low dosage cooling-down effect is not remarkable.
3.3 analgesia spasmolysis
Show in the influence experiment of acetic acid induced mice pain: sense urine is secreted three dosage groups of clever granule and all can be reduced by 0.6% acetic acid normal saline induced mice writhing response number of times, with matched group remarkable analgesic activity (P<0.01) is arranged relatively, have tangible dose-effect relationship between three dosage groups.
Show in the influence experiment to hot plate method induced mice pain: sense urine is secreted three dosage groups of clever granule and all can be improved mice hot plate method pain threshold, significant analgesia role is arranged, compared significance meaning (P<0.01) with model control group, and sense urine to secrete three dosage groups of clever granule suitable in the raising pain threshold intensity of different periods and dolantin.
3.4 diuresis
Show in the influence experiment to rabbit urine amount: oral sense urine is secreted 60 minutes later utmost points of clever granule (1.2g/4ml/kg, 2.4g/4ml/kg, 4.8g/4ml/kg) increases rabbit urine amount significantly, and tangible dose dependent is arranged.It is suitable with furosemide that sense urine is secreted clever particulate height, middle dosage diuretic effect when 60min, behind the 60min particularly when 90min diuretic effect be better than furosemide, illustrate to feel urinating and secretes clever particulate diuretic effect and hold time longer than furosemide.
Show in to the influence of isolated rat smooth muscle of bladder spasmolytic experiment: sense urine is secreted clever granule (0.022g/ml, 0.066g/ml, 0.198g/ml) all has utmost point significant inhibitory effect to rat bladder smooth muscle spasm due to the acetylcholine, and the suppression ratio of three dosage groups is all obviously greater than atropine.Sense urine is secreted clever granule (0.022g/ml, 0.066g/ml, 0.198g/ml) all has utmost point significant inhibitory effect to rat bladder smooth muscle spasm due to the barium chloride.
3.5 enhancing immunity effect
Show in to the influence of mice carbon clearance experiment: what sense urine secreted that each dosage group of clever granule all can significantly improve mice cleans up index (P<0.01, P<0.05) and phagocytic index (P<0.05, P<0.01), sense urine secrete three dosage groups of clever granule clean up index and phagocytic index is all suitable with krestin, secrete the immunity that clever granule obviously increases mice so feel urinating.
3.6 antibacterial action
Sense urine is secreted in the clever particulate antibacterial action research and confirmed: 1) minimum inhibitory concentration (MIC): sense urine is secreted clever granule the MIC50 of staphylococcus aureus, staphylococcus epidermidis, escherichia coli and Bacillus proteus is respectively 40,20,20 and 5mg crude drug/ml, and MIC90 is respectively 160,160,80 and 20mg crude drug/ml.Result of the test shows that sense urine is secreted clever granule Grain-positive and Grain-negative clinical bacteria are all had certain vitro inhibition effect; 2) cause the bacteria suspension concentration determination of mice 80%~90% death: experimental strain escherichia coli and Bacillus proteus cause that the bacteria suspension concentration of mice 80%-90% death is respectively 1.0 * 109CFU/ml and 1.0 * 108CFU/ml; 3) sense urine is secreted the vivo bacteria corrosion action of clever granule to escherichia coli and Bacillus proteus clinical bacteria strain infecting mouse: sense urine is secreted clever particulate oral administration escherichia coli and the clinical pathogenic strain mice infected of Bacillus proteus is had protective effect, and the animal dead rate obviously descends; Wherein the animal dead rate of the high, medium and low dosage group of escherichia coli administration drops to 80%, 30% and 20% respectively by 90%, and the animal dead rate of the high, medium and low dosage group of Bacillus proteus administration drops to 60%, 20% and 20% respectively by 80%; Result of the test shows that sense urine secretes clever particulate oral administration escherichia coli and the microbial mouse infection of deformed rod are had certain curative effect.
Compare with similar drug, of high quality and at a reasonable price being easy to get of medicine raw material of the present invention, preclinical pharmacology studies have shown that determined curative effect, reaches the effect of " effecting a permanent cure " that the traditional Chinese medical science is referred to as.The pharmaceutical preparation of the present invention of above preparation technology, moulding process and quality standard production has efficiently, the good product of safe without toxic side effect.
The specific embodiment
The Chinese medicine composition of urinary tract infection such as embodiment 1. treatment acute cystitis of the present invention, urethritis and chronic cystitis, urethritis acute attack stage and the preparation of preparation thereof
Herba Taraxaci 800g, Herba Plantaginis 800g, Herba Portulacae 800g, Folium Isatidis 800g (each 5g, every day 3 times).
Quality component (or enlarging quantity in proportion) by prescription is got Herba Taraxaci, Herba Plantaginis, Herba Portulacae and Folium Isatidis, and is standby;
More than four flavors, add 8-15 and doubly measure 50% ethanol, the reflux, extract, secondary, each 1 hour, merge extractive liquid, filtered, and reclaimed ethanol to relative density and was the extractum of 1.05~1.08mg/ml (60 ℃), and is standby;
It is 1.10~1.15mg/ml (60 ℃) that extractum is concentrated into relative density, and drying with soluble starch, is made granule, and drying is made 1000g, and is standby;
Get above granule, aluminum-plastic packaged, every bag of 5g promptly.
Embodiment 2, and is substantially the same manner as Example 1, but each component ratio is:
Herba Taraxaci 800g, Herba Plantaginis 800g, Herba Portulacae 800g, Folium Isatidis 1000g.
Embodiment 3, and is substantially the same manner as Example 1, but each component ratio is:
Herba Taraxaci 700g, Herba Plantaginis 700g, Herba Portulacae 700g, Folium Isatidis 1000g.
Embodiment 4, and is substantially the same manner as Example 1, but each component ratio is:
Herba Taraxaci 900g, Herba Plantaginis 900g, Herba Portulacae 900g, Folium Isatidis 1000g.
Embodiment 5, and is substantially the same manner as Example 1, but each component ratio is:
Herba Taraxaci 800g, Herba Plantaginis 800g, Herba Portulacae 800g, Folium Isatidis 1200g; And do not adopt alcohol extraction, directly make granule with crude drug.

Claims (7)

1, a kind of Chinese medicine composition for the treatment of cystitis, urethritis, mass ratio is composed as follows:
Herba Taraxaci 700~900g, Herba Plantaginis 700~900g, Herba Portulacae 700~900g, Folium Isatidis 700g/1200g.
2, the Chinese medicine composition of treatment cystitis according to claim 1, urethritis is characterized in that, each component ratio is as follows:
Herba Taraxaci 800g, Herba Plantaginis 800g, Herba Portulacae 800g, Folium Isatidis 800g/1000g.
3, the Chinese medicine composition of treatment cystitis according to claim 1 and 2, urethritis, it is characterized in that, adopt the ethanol extract of above each component to form compositions, concrete composition is: each component adds 50% ethanol, reflux, extract,, filter, reclaiming ethanol is the extractum of 1.05~1.08mg/ml to relative density; It is 1.10~1.15mg/ml that extractum is concentrated into relative density, and drying constitutes this compositions.
4, the preparation method of the Chinese medicine composition of the described treatment cystitis of a kind of claim 1, urethritis may further comprise the steps:
Get Herba Taraxaci 700~900g by the quality component, Herba Plantaginis 700~900g, Herba Portulacae 700~900g, Folium Isatidis 700g/1200g, or it is standby to enlarge quantity in proportion;
More than four flavors, add 8-15 and doubly measure 50% ethanol, the reflux, extract, secondary, each 1 hour, merge extractive liquid, filtered, and reclaimed ethanol to relative density and was the extractum of 1.05~1.08 (60 ℃), and is standby;
It is 1.10~1.15 (60 ℃) that extractum is concentrated into relative density, and drying is granulated with soluble starch, and drying is made the 1000g granule.
5, according to the preparation method of the Chinese medicine composition of the described treatment cystitis of claim 4, urethritis, it is characterized in that, also be provided with following steps:
Get above granule, aluminum-plastic packaged, every bag of 5g promptly.
6, according to the preparation method of claim 4 or 5 described Chinese medicine compositions, it is characterized in that:
Described each component ratio is:
Herba Taraxaci 800g, Herba Plantaginis 800g, Herba Portulacae 800g, Folium Isatidis 800g/1000g.
7, the preparation method of Chinese medicine composition according to claim 6 is characterized in that: the drying of described concentrated solution adopts drying under reduced pressure, spray drying or vacuum drying.
CNB2004100651795A 2004-10-29 2004-10-29 Chinese traditional medicine composition for treating cystitis and urethritis and preparation method thereof Expired - Fee Related CN100346799C (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101024054B (en) * 2007-04-05 2010-05-26 周红 Oral Chinese medicine composition for treating glandular cystitis
CN101019942B (en) * 2007-03-19 2010-06-30 沈信堂 Chinese medicine for treating urinary tract infection
CN102068479B (en) * 2009-11-19 2012-09-26 上海中医药大学附属曙光医院 Chinese medicinal composition for treating chronic urinary tract infection and preparation method thereof
CN101618105B (en) * 2009-08-06 2012-11-21 陈静静 Medicated wine for treating cystitis
CN105381308A (en) * 2015-12-18 2016-03-09 仝荣 Externally-applied hemostatic-and-antiphlogistic medicine and preparing method thereof
CN116407602A (en) * 2023-03-08 2023-07-11 张承国 Traditional Chinese medicine composition for sweating and defervescing and preparation method thereof
CN116407602B (en) * 2023-03-08 2024-04-30 张承国 Traditional Chinese medicine composition for sweating and defervescing and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1194843A (en) * 1997-04-01 1998-10-07 李恩洪 Method for producing green health medicine
CN1192783C (en) * 2000-01-01 2005-03-16 同济医科大学附属同济医院 Anti-infection Chinese medicine for clearing heat and detoxicating and its preparing process
CN1180800C (en) * 2001-03-26 2004-12-22 罗玉文 Chinese medicine for curing diseases of kidney and urinary system

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101019942B (en) * 2007-03-19 2010-06-30 沈信堂 Chinese medicine for treating urinary tract infection
CN101024054B (en) * 2007-04-05 2010-05-26 周红 Oral Chinese medicine composition for treating glandular cystitis
CN101618105B (en) * 2009-08-06 2012-11-21 陈静静 Medicated wine for treating cystitis
CN102068479B (en) * 2009-11-19 2012-09-26 上海中医药大学附属曙光医院 Chinese medicinal composition for treating chronic urinary tract infection and preparation method thereof
CN105381308A (en) * 2015-12-18 2016-03-09 仝荣 Externally-applied hemostatic-and-antiphlogistic medicine and preparing method thereof
CN116407602A (en) * 2023-03-08 2023-07-11 张承国 Traditional Chinese medicine composition for sweating and defervescing and preparation method thereof
CN116407602B (en) * 2023-03-08 2024-04-30 张承国 Traditional Chinese medicine composition for sweating and defervescing and preparation method thereof

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