CN105012437A - Traditional Chinese medicine preparation for treating urinary system inflammation and preparation method thereof - Google Patents

Traditional Chinese medicine preparation for treating urinary system inflammation and preparation method thereof Download PDF

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CN105012437A
CN105012437A CN201510524213.9A CN201510524213A CN105012437A CN 105012437 A CN105012437 A CN 105012437A CN 201510524213 A CN201510524213 A CN 201510524213A CN 105012437 A CN105012437 A CN 105012437A
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herba
chinese medicine
powder
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medicine preparation
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不公告发明人
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Qingdao You Cheng New And High Technology Co Ltd
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Abstract

The invention discloses a traditional Chinese medicine preparation for treating urinary system inflammation. The traditional Chinese medicine preparation comprises the following components: dandelion, Chinese ixeris herb, fructus kochiae, cornus officinalis, herba polygoni avicularis, tangut barberry bark, herba dianthi, semen pruni, pteris multifida, fructus foeniculi, herba swertiae mileensis, potentilla chinensis, rhizoma cimicifugae, radix echinopsis and pig gallbladder powder. The invention further discloses a preparation method of the traditional Chinese medicine preparation. With the adoption of the traditional Chinese medicine preparation for treating urinary system inflammation, provided by the invention, the advantages of low cost, good curative effect, high cure rate and no adverse drug reaction and the like are achieved, the disease can be quickly mitigated, the preparation process is simple and convenient, the toxic and side effect is little, the manufacturing is easy, the raw materials are economic, the preparation method is simple, and large-scale application to clinical practice is feasible.

Description

A kind of Chinese medicine preparation for the treatment of Urinary system inflammation and preparation method thereof
Technical field
The present invention relates to a kind of medicinal preparation, particularly relate to a kind of Chinese medicine preparation being used for the treatment of Urinary system inflammation and preparation method thereof.
Background technology
Human body urinary system comprises kidney, ureter, bladder form with urethra and relevant nervus vasculairs, and main department generates and discharges urine.Because the antibacterials such as escherichia coli invade urinary tract, just cause multiple urinary tract infection, comprise urethritis, cystitis and pyelonephritis etc., wherein urethritis and cystitis are called as lower urinary tract infection, and pyelonephritis is called as upper urinary tract infection.Male genital infection refers to that male reproductive system (urethra, prostate, epididymis, deferent duct, seminal vesicle, testis etc.) is subject to antibacterial, virus or parasitic infection and the disease caused.Male genetic infectious disease is because the invasion infection of outside antibacterial causes mostly, often causes orchitis, epididymitis, prostatitis, seminal vesiculitis, urethritis etc.The pathogen of reproductive tract infection is caused to have gonococcus, tubercule bacillus, virus, mycoplasma, chlamydia trachomatis, infusorian and other non-specific pathogenic bacterium, wherein common with the reproductive tract infection that mycoplasma and chlamydia cause.
Treat not thorough after there is urinary tract infection, antibacterial fails to kill just drug withdrawal completely, and residual pathogenic bacteria also hides there, once run into fatigue or passive protective physical fitness reduction, the residual antibacterial hidden grows breeding again again, and this is the another kind of reason of urinary system infection recurrent exerbation.Urinary system infection person suffers from congenital malformation simultaneously, blocks, calculus etc., is also the major incentive of urinary tract infection recurrent exerbation.
All inflammation occurred at human body renal pelvis, ureter, bladder, urethra, are referred to as Urinary system inflammation.Urinary system inflammation is global commonly encountered diseases, also higher at the sickness rate of China, mostly is urinary system infection, prostatosis, acute nephritic syndrome, the radical type nephritic syndrome, glomerulopathy etc.
Urinary system inflammation is treated at present usually based on doctor trained in Western medicine by China, but the measure that doctor trained in Western medicine adopts in treatment Urinary system inflammation is generally antibiotic and chemicals use in conjunction, curative effect is comparatively general, and the easy prolonged and repeated outbreak of chronic inflammatory disease, systemic administration DeGrain.Although had the open source literature utilizing treatment by Chinese herbs urethritis at present, mostly can only play the object of alleviation, can not cure completely.
Summary of the invention
In order to solve the problem, the invention provides a kind of toxic and side effects little, there is splendid curative effect and the Chinese medicine preparation that cost is low, relapse rate is low to Urinary system inflammation.
The technical solution used in the present invention is: a kind of Chinese medicine preparation for the treatment of Urinary system inflammation, and each component of described Chinese medicine preparation is Herba Taraxaci, Herba Ixeritis chinensis, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis, Cortex berberidis dasystachyae, Herba Dianthi, Semen Pruni, Herba Pteridis multifidae, Fructus Foeniculi, Herba Swertiae Mileensis, Herba Potentillae Chinensis, Rhizoma Cimicifugae.
Preferably, the ratio of weight and number of various component is, Herba Taraxaci 10-20 part, Herba Ixeritis chinensis 10-20 part, Fructus Kochiae 10-20 part, Fructus Corni 10-20 Fen, Herba Polygoni Avicularis 10-20 part, Cortex berberidis dasystachyae 10-20 part, Herba Dianthi 5-15 part, Semen Pruni 10-20 part, Herba Pteridis multifidae 10-20 part, Fructus Foeniculi 10-20 part, Herba Swertiae Mileensis 10-20 part, Herba Potentillae Chinensis 5-15 part, Rhizoma Cimicifugae 10-20 part.
Preferred, the ratio of weight and number of various component is, Herba Taraxaci 10-15 part, Herba Ixeritis chinensis 10-15 part, Fructus Kochiae 10-15 part, Fructus Corni 10-15 Fen, Herba Polygoni Avicularis 10-15 part, Cortex berberidis dasystachyae 10-15 part, Herba Dianthi 5-10 part, Semen Pruni 10-15 part, Herba Pteridis multifidae 10-15 part, Fructus Foeniculi 10-15 part, Herba Swertiae Mileensis 10-15 part, Herba Potentillae Chinensis 5-10 part, Rhizoma Cimicifugae 10-15 part.
Wherein, described Chinese medicine can also add Radix Echinopsis and Pulvis Fellis Suis, and described Radix Echinopsis and the ratio of weight and number of Pulvis Fellis Suis in described Chinese medicine are: Radix Echinopsis 10-12 part, Pulvis Fellis Suis 8-10 part.
Wherein, the dosage form of described Chinese medicine preparation is: sublimed preparation, powder, injection, plaster, syrup, oral liquid, suck agent, granule, sugar coated tablet, film coated tablet, capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, when the dosage form of described Chinese medicine is capsule, comprising:
The first step, Herba Taraxaci, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis are mixed in proportion, with being equivalent to mixture quality 3-4 normal propyl alcohol reflux, extract, doubly 3-5 time, merging filtrate, being evaporated to relative density at 60 DEG C is the mastic of 1.10-1.15, subsequently vacuum drying be ground into powder;
Second step, Herba Ixeritis chinensis, Cortex berberidis dasystachyae, Herba Dianthi, Herba Pteridis multifidae are mixed in proportion, with being equivalent to alcohol reflux 3-5 time that mixture quality 3-4 determining alcohol is doubly 60-70%, merging filtrate, concentrating under reduced pressure, drying be ground into powder, subsequently with normal propyl alcohol purification 2-4 time, merge extractive liquid, reclaim under reduced pressure normal propyl alcohol to be concentrated into relative density at 60 DEG C be the mastic of 1.10-1.15, is dryly also ground into powder;
3rd step, it is ethanol extraction 3-4 time of 80-90% by Fructus Foeniculi, Herba Swertiae Mileensis, Semen Pruni determining alcohol, merge extractive liquid, concentrating under reduced pressure also carries out drying, is ground into powder, adding the powder after pulverizing relative to its quality is the water dissolution of 3-5 times amount, and static 2-4 hour, filters, filtrate reduced in volume is mastic and dry, pulverize powdered;
4th step, is mixed in proportion remaining component, decocts with water 3 times, and each 1-2 hour, filters respectively, merging filtrate, and filtrate is condensed into mastic and dry, pulverize powdered, and the quality of the water added is 1-3 times of the mixture quality of the 4th step;
5th step, by above-mentioned powder and starch mixing, carry out pelletization treatment subsequently and drying, obtain compound particles, magnesium stearate is added again in compound particles, described magnesium stearate and described compound particles mass ratio are 0.25-100:0.5-100, obtain capsule 's content, are incapsulated in housing by described capsule 's content and namely obtain capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, when the dosage form of described Chinese medicine is injection, comprising:
The first step, Spora Lygodii, Rhizoma Alismatis, the Cortex Eucommiae, Herba Centipedae, Rhizoma Zingiberis are mixed in proportion, with being equivalent to alcohol reflux 2-4 time that mixture quality 3-5 determining alcohol is doubly 50-60%, merging filtrate, be evaporated to the mastic that relative density is 1.04-1.10 (60 DEG C), subsequently vacuum drying be ground into powder;
Second step, Endothelium Corneum Gigeriae Galli, Radix Bupleuri, Ophicalcitum, Spina Gleditsiae are mixed in proportion, with being equivalent to alcohol reflux 3-5 time that mixture quality 3-5 determining alcohol is doubly 60-70%, merging filtrate, concentrating under reduced pressure, drying be ground into powder, subsequently with normal propyl alcohol purification 2-4 time, merge extractive liquid, reclaim under reduced pressure normal propyl alcohol is also concentrated into the mastic of relative density 1.10-1.15 (60 DEG C), is dryly also ground into powder;
3rd step, by Fructus Litseae, Fructus Viticis, Semen Persicae, Herba Lysimachiae, Herba Polygoni Avicularis n-propanol extraction 2-4 time, merge extractive liquid, concentrating under reduced pressure also carries out drying, is ground into powder, adding the powder after pulverizing relative to its quality is the water dissolution of 2-4 times amount, and static 3-5 hour, filters, filtrate reduced in volume is mastic and dry, pulverize powdered;
4th step, is mixed in proportion remaining component, decocts with water 2 times, and each 1-3 hour, filters respectively, merging filtrate, and filtrate is condensed into mastic and dry, pulverize powdered, and the quality of the water added is 1-3 times of the mixture quality of the 4th step;
5th step, above-mentioned powder is mixed, being dissolved in quality is subsequently mixture 2-4 water doubly, the sodium hydroxide hydrotropy relative to powder quality 5%-10% is added under stirring, filter, to add concentration be the salt acid for adjusting pH value of 1mol/L is 5-6, filter, precipitate for subsequent use, filtrate passes through polyamide column, first wash decontamination with water, be the ethanol elution of 80-90% with determining alcohol subsequently, collect ethanol elution, precipitation determining alcohol is the ethanol extraction 2 times of 80-90%, filter, filtrate and above-mentioned eluent merge, reclaim ethanol, be evaporated to mastic and be spray dried to powder, the powder of acquisition is added relative to its quality 1-2 sodium chloride doubly and water for injection appropriate, the volume of needs is injected water to again further after dissolving, filter, embedding, sterilizing, obtain the injection needed.
Herba Taraxaci bitter in the mouth, sweet, cold in nature, return liver, stomach warp, heat-clearing and toxic substances removing, diuresis eliminating stagnation.Control acute mastitis, lymphadenitis, scrofula, furuncle carbuncle toxin, acute conjunctivitis, cold, fever, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, urinary tract infection.
Herba Ixeritis chinensis acrid in the mouth, hardship, cold nature, returns liver, stomach, large intestine channel, heat-clearing and toxic substances removing, removing heat from blood, eliminating carbuncle evacuation of pus, stasis-dispelling and pain-killing.For acute appendicitis, the high heat of lung abscess, coughs vomiting bloody pus, pyretic toxicity skin ulcer furuncle, and furuncle pain is swollen, breast abdomen pain, appendicitis, enteritis, dysentery, puerperal abdonimal pain, dysmenorrhea.
Fructus Kochiae acrid in the mouth, hardship, cold in nature, return kidney, urinary bladder channel, clearing away heat-damp and promoting diuresis, wind-expelling pain-stopping, for difficulty and pain in micturition, pudendal pruritus leukorrhagia, rubella, eczema, skin pruritus.
Pathogen cold and heat under the main heart of Fructus Corni, warming middle-JIAO, by cold-damp numbness, goes three worms, liver and kidney tonifying; Convergence is solid de-.Cure mainly and have a dizzy spell; Deafness and tinnitus; Soreness of the waist and knees; Emission and spermatorrhea; Frequent micturition; Incessant sweating due to debility; Woman uterine bleeding; Interior-heat is quenched one's thirst; Warming the liver the kidney invigorating, except a wind cutting, only menorrhagia, controls senile frequent micturition.
Herba Polygoni Avicularis bitter in the mouth, cold nature, returns urinary bladder channel, inducing diuresis for treating stranguria syndrome, and parasite killing is antipruritic.For bladder pyretic stranguria, oliguria with reddish urine, drenches the puckery pain of drop, skin eczema, pudendal pruritus leukorrhagia.
Cortex berberidis dasystachyae bitter in the mouth, cold in nature, enter lung, stomach, large intestine three warp, heat clearing and damp drying, eliminating fire and detoxication, controls hematodiarrhoea and has blood in stool, damp and hot yellow pox, and lower limb swell and ache, hectic fever night sweat, wind-fire ophthalmalgia, erosion of the oral mucosa, tongue boil, mastitis and carbuncle skin ulcer from the beginning of.
Herba Dianthi bitter in the mouth, cold in nature, have heat clearing away, diuresis, removing blood stasis stimulate the menstrual flow effect, control urinary obstruction, gonorrhea, edema, amenorrhea, carbuncle, conjunctival congestion is hidden from view, contamination sore.
Herba Pteridis multifidae heat-clearing and toxic substances removing, antiinflammatory diuresis, activating collaterals to relieve pain.Control dysentery, enteritis, hepatitis, pharyngolaryngitis, inflammation of urinary system, carbuncle furuncle swells, rheumatism, traumatic injury pain.
Semen Pruni is put down, acrid in the mouth, hardship, sweet, returns spleen, large intestine, small intestine meridian, moisturizes laxation, the therapeutic method to keep the adverse QI flowing downwards, diuretic.For intestine-dryness due to consumption of fluid, stagnation of QI due to dyspepsia, abdominal distention constipation, edema, beriberi, dysuria.Have and moisturize laxation, making the adverse QI downward and promoting urination and defecation, effect of inducing diuresis to remove edema.
Fructus Foeniculi acrid in the mouth, warm in nature, return liver,kidney,spleen, stomach warp, have effect of dispersing cold for relieving pain, regulating qi-flowing for harmonizing stomach, for colic of cold type stomachache, the testis swelling and hanging down of either of the testes, dysmenorrhea, few abdomen cold type of pain, abdominal distention, lack of appetite and vomiting.
Herba Swertiae Mileensis bitter in the mouth, sweet, cold in nature, return liver, gallbladder, urinary bladder channel, liver heat removing function of gallbladder promoting, clearing away heat-damp and promoting diuresis, cures mainly dampness-heat in the liver and gallbladder, jaundice dark coloured urine, gallbladder-distention hypochondriac pain, the puckery pain of pyretic stranguria.
Herba Potentillae Chinensis bitter in the mouth, cold in nature, return liver, large intestine channel, heat-clearing and toxic substances removing, eliminating pathogenic heat from blood to cure dysentery.For bloody dysentery stomachache, chronic dysentery is more than, bleeding hemorrhoids, carbuncle sore tumefacting virus.
Rhizoma Cimicifugae acrid in the mouth, micro-sweet, be slightly cold, return spleen, lung, stomach, large intestine channel, deliver rash, heat-clearing and toxic substances removing, elevate a turnable ladder yang-energy.For headache due to pathogenic wind-heat, toothache, aphtha, laryngopharynx swelling and pain, measles without adequate eruption, YANG toxin syndrome sends out speckle; Proctoptosis, uterine prolapse.
Radix Echinopsis bitter in the mouth, cold in nature, return stomach warp, heat-clearing and toxic substances removing, evacuation of pus is stopped blooding, eliminating carbuncle stimulating milk secretion.Swell for all carbuncle sore, acute mastitis swells and ache, galactostasis, scrofula sore.
Pulvis Fellis Suis bitter in the mouth, cold in nature, return liver, gallbladder, lung, large intestine channel, heat clearing away, moisturize, removing toxic substances, relieving cough and asthma.Yearningly dry for calentura, conjunctival congestion, sore throat, jaundice, pertussis, asthma, has loose bowels, dysentery, constipation, carbuncle pyogenic infections from tumour or sore.
Beneficial effect of the present invention:
Relative to the medicine being used for the treatment of Urinary system inflammation of the prior art, adopt the advantages such as Chinese medicinal composition preparation of the present invention has good effect for Urinary system inflammation treatment, cost is low, cure rate is high, limitation is little, have no adverse reaction, and targeting is strong, energy is mitigate the disease rapidly, and toxic and side effects is little.The present invention is easy to use, and cheap, easy to use, can create good social value and economic interests.
Detailed description of the invention
Embodiment 1:
(1) treat a Chinese medicine for Urinary system inflammation, formed by following raw material medicaments in part by weight proportioning:
Herba Taraxaci 10 parts, Herba Ixeritis chinensis 10 parts, the Fructus Kochiae 10 parts, Fructus Corni 15 Fen, Herba Polygoni Avicularis 15 parts, Cortex berberidis dasystachyae 10 parts, Herba Dianthi 5 parts, Semen Pruni 15 parts, Herba Pteridis multifidae 10 parts, Fructus Foeniculi 10 parts, Herba Swertiae Mileensis 10 parts, Herba Potentillae Chinensis 5 parts, Rhizoma Cimicifugae 10 parts.
(2) preparation method:
The first step, Herba Taraxaci, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis are mixed in proportion, with being equivalent to mixture quality 3-4 normal propyl alcohol reflux, extract, doubly 3-5 time, merging filtrate, being evaporated to relative density at 60 DEG C is the mastic of 1.10-1.15, subsequently vacuum drying be ground into powder;
Second step, Herba Ixeritis chinensis, Cortex berberidis dasystachyae, Herba Dianthi, Herba Pteridis multifidae are mixed in proportion, with being equivalent to alcohol reflux 3-5 time that mixture quality 3-4 determining alcohol is doubly 60-70%, merging filtrate, concentrating under reduced pressure, drying be ground into powder, subsequently with normal propyl alcohol purification 2-4 time, merge extractive liquid, reclaim under reduced pressure normal propyl alcohol to be concentrated into relative density at 60 DEG C be the mastic of 1.10-1.15, is dryly also ground into powder;
3rd step, it is ethanol extraction 3-4 time of 80-90% by Fructus Foeniculi, Herba Swertiae Mileensis, Semen Pruni determining alcohol, merge extractive liquid, concentrating under reduced pressure also carries out drying, is ground into powder, adding the powder after pulverizing relative to its quality is the water dissolution of 3-5 times amount, and static 2-4 hour, filters, filtrate reduced in volume is mastic and dry, pulverize powdered;
4th step, is mixed in proportion remaining component, decocts with water 3 times, and each 1-2 hour, filters respectively, merging filtrate, and filtrate is condensed into mastic and dry, pulverize powdered, and the quality of the water added is 1-3 times of the mixture quality of the 4th step;
5th step, by above-mentioned powder and starch mixing, carry out pelletization treatment subsequently and drying, obtain compound particles, magnesium stearate is added again in compound particles, described magnesium stearate and described compound particles mass ratio are 0.25-100:0.5-100, obtain capsule 's content, are incapsulated in housing by described capsule 's content and namely obtain capsule.
Embodiment 2:
(1) treat a Chinese medicine for Urinary system inflammation, formed by following raw material medicaments in part by weight proportioning:
Herba Taraxaci 10 parts, Herba Ixeritis chinensis 10 parts, the Fructus Kochiae 10 parts, Fructus Corni 15 Fen, Herba Polygoni Avicularis 15 parts, Cortex berberidis dasystachyae 10 parts, Herba Dianthi 5 parts, Semen Pruni 15 parts, Herba Pteridis multifidae 10 parts, Fructus Foeniculi 10 parts, Herba Swertiae Mileensis 10 parts, Herba Potentillae Chinensis 5 parts, Rhizoma Cimicifugae 10 parts, Radix Echinopsis 12 parts, Pulvis Fellis Suis 8 parts.。
(2) preparation method: with the preparation method of embodiment 1.
Embodiment 3:
(1) treat a Chinese medicine for Urinary system inflammation, formed by following raw material medicaments in part by weight proportioning: with embodiment 1.
(2) preparation method:
The first step, Herba Taraxaci, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis are mixed in proportion, with being equivalent to mixture quality 3-4 normal propyl alcohol reflux, extract, doubly 3-5 time, merging filtrate, being evaporated to relative density at 60 DEG C is the mastic of 1.10-1.15, subsequently vacuum drying be ground into powder;
Second step, Herba Ixeritis chinensis, Cortex berberidis dasystachyae, Herba Dianthi, Herba Pteridis multifidae are mixed in proportion, with being equivalent to alcohol reflux 3-5 time that mixture quality 3-4 determining alcohol is doubly 60-70%, merging filtrate, concentrating under reduced pressure, drying be ground into powder, subsequently with normal propyl alcohol purification 2-4 time, merge extractive liquid, reclaim under reduced pressure normal propyl alcohol to be concentrated into relative density at 60 DEG C be the mastic of 1.10-1.15, is dryly also ground into powder;
3rd step, it is ethanol extraction 3-4 time of 80-90% by Fructus Foeniculi, Herba Swertiae Mileensis, Semen Pruni determining alcohol, merge extractive liquid, concentrating under reduced pressure also carries out drying, is ground into powder, adding the powder after pulverizing relative to its quality is the water dissolution of 3-5 times amount, and static 2-4 hour, filters, filtrate reduced in volume is mastic and dry, pulverize powdered;
4th step, is mixed in proportion remaining component, decocts with water 3 times, and each 1-2 hour, filters respectively, merging filtrate, and filtrate is condensed into mastic and dry, pulverize powdered, and the quality of the water added is 1-3 times of the mixture quality of the 4th step;
5th step, above-mentioned powder is mixed, being dissolved in quality is subsequently mixture 2-4 water doubly, the sodium hydroxide hydrotropy relative to powder quality 5%-15% is added under stirring, filter, to add concentration be the salt acid for adjusting pH value of 1mol/L is 5-6, filter, precipitate for subsequent use, filtrate passes through polyamide column, first wash decontamination with water, be the ethanol elution of 80-90% with determining alcohol subsequently, collect ethanol elution, precipitation determining alcohol is the ethanol extraction 2 times of 80-90%, filter, filtrate and above-mentioned eluent merge, reclaim ethanol, be evaporated to mastic and be spray dried to powder, the powder of acquisition is added relative to its quality 1-2 sodium chloride doubly and water for injection appropriate, the volume of needs is injected water to again further after dissolving, filter, embedding, sterilizing, obtain the injection needed.
Embodiment 4:
(1) treat a Chinese medicine for Urinary system inflammation, formed by following raw material medicaments in part by weight proportioning: with embodiment 2.
(2) preparation method: with embodiment 3.
Embodiment 5:
1, acute toxicity test process:
Application ICR mice (Beijing Vital River Experimental Animals Technology Co., Ltd. provides) 60, body weight, at 25-30 gram, carries out acute toxicity testing.Mice is divided into three groups at random, i.e. matched group, administration 1 group, administration 2 groups, fasting 12 hours before experiment, then Chinese medicine capsules suspension of the present invention (be dissolved in water by capsule and the obtain suspension) gavage as embodiment 1 prepares is given, test determination is carried out to the median lethal dose(LD 50) (LD50) of administration, but has not measured LD 50, because this has been mtd test.Result: with Cmax (60%), maximum dosage-feeding (120ml/kg, in one day, part gives for four times) 100g/kg gavage, be equivalent to crude drug amount 60g/kg, be equivalent to be grown up 300 times (by 75kg) of the daily dosage of clinical plan, in seven days mice none is dead, put to death each internal organs of mice anatomic observation and do not find toxic reaction, administration group with contrast 1,2 group of mice without any difference.
2, long term toxicity test process:
Experimental agents is set as high, medium and low three dosage by application Wistar rat (Beijing Vital River Experimental Animals Technology Co., Ltd. provides), is respectively capsule 8g/kg, 4g/kg, 2g/kg of embodiment 1 formula and capsule 8g/kg, 4g/kg, 2g/kg of embodiment 2 formula.Calculating with dosage 0.1g/kg/ sky-backing by people, is 80 times of people's effective dose, 40 times and 20 times respectively; Separately establish a matched group, continuous gastric infusion 90 days, 180 days and Some Animals drug withdrawal, after 10 days, observe the impact on the every physiology of rat, biochemical indicator.Experimental result shows: by various dose to rat continuous oral 180 days, increases all without affecting the food-intake of rat and body weight.Overt toxicity effect is not all found to hepatic and renal function.Obvious impact is showed no on routine blood test, blood biochemistry, urine biochemistry and bone marrow sheet etc., between each group, compares no significant difference with matched group.
Embodiment 6:
Clinical treatment observation of the present invention is as follows:
(1) patient 200 example, wherein male 80 example, women 120 example.
(2) diagnostic criteria: with " Chinese medical disease Standardization of diagnosis and curative effect " (national Chinese medicine management board, Chinese medical disease Standardization of diagnosis and curative effect [S], Nanjing: publishing house of Nanjing University, 1994:26.) be reference, patient has frequent micturition, urgent micturition, urethra scorching hot, not to the utmost dripping or have lower abdominal pain, lumbago, fever with aversion to cold, nausea and vomiting etc.; Dialectical is damp-heat accumulation, red tongue, yellow fur or yellow greasy, the disease such as turbid urine of cardiopulmonary serious condition, tuberculosis, calculus, acute and chronic nephritis, urethral syndrome and the traditional Chinese medical science except above diagnostic criteria needs.
(3) Therapeutic Method: 1 group: adopt capsule 100g as obtained in embodiment 1 preparation method, be divided into 10 parts, every morning, (medicine) being taken before meal was a, within 30 days, was a course for the treatment of, took two courses for the treatment of continuously; 2 groups: adopt capsule 100g as obtained in embodiment 2 preparation method, be divided into 10 parts, every morning, (medicine) being taken before meal was a, within 30 days, was a course for the treatment of, took two courses for the treatment of continuously; 3 groups: adopt injection 100g as obtained in embodiment 3 preparation method, be divided into 10 parts, every morning injects portion on an empty stomach, within 30 days, is a course for the treatment of, injects two courses for the treatment of continuously; 4 groups: adopt injection 100g as obtained in embodiment 4 preparation method, be divided into 10 parts, every morning injects portion on an empty stomach, within 30 days, is a course for the treatment of, injects two courses for the treatment of continuously; Separately establish a matched group.
(4) efficacy assessment standard:
Cure: clinical symptom disappearance, laboratory examination results is negative;
Take a turn for the better: clinical symptom disappearance, but laboratory examination results is not turned out cloudy, or clinical symptoms does not disappear completely, but laboratory examination results is turned out cloudy;
Invalid: clinical symptoms is improved not obvious, and laboratory examination results is not turned out cloudy, or clinical symptoms is without improvement person.
(5) therapeutic outcome
Group Cure Take a turn for the better Invalid
Matched group 0 0 40
1 group 27 7 6
2 groups 30 7 3
3 groups 32 5 3
4 groups 37 2 1
Above-described embodiment, just in order to technical conceive of the present invention and feature are described, its objective is and is one of ordinary skilled in the art can be understood content of the present invention and implement according to this, can not limit the scope of the invention with this.The change of every equivalence done by the essence of content of the present invention or modification, all should be encompassed in protection scope of the present invention.

Claims (7)

1. treat a Chinese medicine preparation for Urinary system inflammation, it is characterized in that: each component of described Chinese medicine preparation is Herba Taraxaci, Herba Ixeritis chinensis, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis, Cortex berberidis dasystachyae, Herba Dianthi, Semen Pruni, Herba Pteridis multifidae, Fructus Foeniculi, Herba Swertiae Mileensis, Herba Potentillae Chinensis, Rhizoma Cimicifugae.。
2. Chinese medicine preparation as claimed in claim 1, is characterized in that: the ratio of weight and number of various component is Herba Taraxaci 10-20 part, Herba Ixeritis chinensis 10-20 part, Fructus Kochiae 10-20 part, Fructus Corni 10-20 Fen, Herba Polygoni Avicularis 10-20 part, Cortex berberidis dasystachyae 10-20 part, Herba Dianthi 5-15 part, Semen Pruni 10-20 part, Herba Pteridis multifidae 10-20 part, Fructus Foeniculi 10-20 part, Herba Swertiae Mileensis 10-20 part, Herba Potentillae Chinensis 5-15 part, Rhizoma Cimicifugae 10-20 part.
3. Chinese medicine preparation as claimed in claim 1, is characterized in that: the ratio of weight and number of various component is Herba Taraxaci 10-15 part, Herba Ixeritis chinensis 10-15 part, Fructus Kochiae 10-15 part, Fructus Corni 10-15 Fen, Herba Polygoni Avicularis 10-15 part, Cortex berberidis dasystachyae 10-15 part, Herba Dianthi 5-10 part, Semen Pruni 10-15 part, Herba Pteridis multifidae 10-15 part, Fructus Foeniculi 10-15 part, Herba Swertiae Mileensis 10-15 part, Herba Potentillae Chinensis 5-10 part, Rhizoma Cimicifugae 10-15 part.
4. the Chinese medicine preparation according to any one of claim 1-3, it is characterized in that, described Chinese medicine can also add Radix Echinopsis and Pulvis Fellis Suis, and described Radix Echinopsis and the ratio of weight and number of Pulvis Fellis Suis in described Chinese medicine are: Radix Echinopsis 10-12 part, Pulvis Fellis Suis 8-10 part.
5. according to any one of claim 1-4, treat the Chinese medicine preparation of Urinary system inflammation, it is characterized in that, the dosage form of described Chinese medicine preparation is: sublimed preparation, powder, injection, plaster, syrup, oral liquid, suck agent, granule, sugar coated tablet, film coated tablet, capsule.。
6. according to any one of claim 1-4, treat a preparation method for the Chinese medicine preparation of Urinary system inflammation, it is characterized in that: when the dosage form of described Chinese medicine is capsule, comprising:
The first step, Herba Taraxaci, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis are mixed in proportion, with being equivalent to mixture quality 3-4 normal propyl alcohol reflux, extract, doubly 3-5 time, merging filtrate, being evaporated to relative density at 60 DEG C is the mastic of 1.10-1.15, subsequently vacuum drying be ground into powder;
Second step, Herba Ixeritis chinensis, Cortex berberidis dasystachyae, Herba Dianthi, Herba Pteridis multifidae are mixed in proportion, with being equivalent to alcohol reflux 3-5 time that mixture quality 3-4 determining alcohol is doubly 60-70%, merging filtrate, concentrating under reduced pressure, drying be ground into powder, subsequently with normal propyl alcohol purification 2-4 time, merge extractive liquid, reclaim under reduced pressure normal propyl alcohol to be concentrated into relative density at 60 DEG C be the mastic of 1.10-1.15, is dryly also ground into powder;
3rd step, it is ethanol extraction 3-4 time of 80-90% by Fructus Foeniculi, Herba Swertiae Mileensis, Semen Pruni determining alcohol, merge extractive liquid, concentrating under reduced pressure also carries out drying, is ground into powder, adding the powder after pulverizing relative to its quality is the water dissolution of 3-5 times amount, and static 2-4 hour, filters, filtrate reduced in volume is mastic and dry, pulverize powdered;
4th step, is mixed in proportion remaining component, decocts with water 3 times, and each 1-2 hour, filters respectively, merging filtrate, and filtrate is condensed into mastic and dry, pulverize powdered, and the quality of the water added is 1-3 times of the mixture quality of the 4th step;
5th step, by above-mentioned powder and starch mixing, carry out pelletization treatment subsequently and drying, obtain compound particles, magnesium stearate is added again in compound particles, described magnesium stearate and described compound particles mass ratio are 0.25-100:0.5-100, obtain capsule 's content, are incapsulated in housing by described capsule 's content and namely obtain capsule.
7. the preparation method of the Chinese medicine preparation of Urinary system inflammation according to any one of claim 1-4, is characterized in that: when the dosage form of described Chinese medicine is injection, comprising:
The first step, Herba Taraxaci, the Fructus Kochiae, Fructus Corni, Herba Polygoni Avicularis are mixed in proportion, with being equivalent to mixture quality 3-4 normal propyl alcohol reflux, extract, doubly 3-5 time, merging filtrate, being evaporated to relative density at 60 DEG C is the mastic of 1.10-1.15, subsequently vacuum drying be ground into powder;
Second step, Herba Ixeritis chinensis, Cortex berberidis dasystachyae, Herba Dianthi, Herba Pteridis multifidae are mixed in proportion, with being equivalent to alcohol reflux 3-5 time that mixture quality 3-4 determining alcohol is doubly 60-70%, merging filtrate, concentrating under reduced pressure, drying be ground into powder, subsequently with normal propyl alcohol purification 2-4 time, merge extractive liquid, reclaim under reduced pressure normal propyl alcohol to be concentrated into relative density at 60 DEG C be the mastic of 1.10-1.15, is dryly also ground into powder;
3rd step, it is ethanol extraction 3-4 time of 80-90% by Fructus Foeniculi, Herba Swertiae Mileensis, Semen Pruni determining alcohol, merge extractive liquid, concentrating under reduced pressure also carries out drying, is ground into powder, adding the powder after pulverizing relative to its quality is the water dissolution of 3-5 times amount, and static 2-4 hour, filters, filtrate reduced in volume is mastic and dry, pulverize powdered;
4th step, is mixed in proportion remaining component, decocts with water 3 times, and each 1-2 hour, filters respectively, merging filtrate, and filtrate is condensed into mastic and dry, pulverize powdered, and the quality of the water added is 1-3 times of the mixture quality of the 4th step;
5th step, above-mentioned powder is mixed, being dissolved in quality is subsequently mixture 2-4 water doubly, the sodium hydroxide hydrotropy relative to powder quality 5%-15% is added under stirring, filter, to add concentration be the salt acid for adjusting pH value of 1mol/L is 5-6, filter, precipitate for subsequent use, filtrate passes through polyamide column, first wash decontamination with water, be the ethanol elution of 80-90% with determining alcohol subsequently, collect ethanol elution, precipitation determining alcohol is the ethanol extraction 2 times of 80-90%, filter, filtrate and above-mentioned eluent merge, reclaim ethanol, be evaporated to mastic and be spray dried to powder, the powder of acquisition is added relative to its quality 1-2 sodium chloride doubly and water for injection appropriate, the volume of needs is injected water to again further after dissolving, filter, embedding, sterilizing, obtain the injection needed.
CN201510524213.9A 2015-08-24 2015-08-24 Traditional Chinese medicine preparation for treating urinary system inflammation and preparation method thereof Pending CN105012437A (en)

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* Cited by examiner, † Cited by third party
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Application publication date: 20151104