CN103721226B - A kind ofly prevent and treat Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction and preparation method thereof - Google Patents
A kind ofly prevent and treat Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction and preparation method thereof Download PDFInfo
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Abstract
The invention discloses and a kind ofly prevent and treat Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction and preparation method thereof.Said composition medical material consists of: Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Poria, Pericarpium Citri Reticulatae, Rhizoma Pinelliae Preparatum, Rhizoma Zingiberis Recens, Folium Perillae, Rhizoma Coptidis, Haematitum, Radix Et Rhizoma Rhei, Herba Epimedii, Fructus Amomi, Radix Glycyrrhizae.The Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction provided by the invention is safe and effective, simplify symptom of digestive tract chronic kidney hypofunction (CKD3 phase) is dialectical, in method for the treatment of, invigorating the spleen and regulating the stomach is main, kidney tonifying, lets out turbid, blood stasis dispelling and carries throughout, common method for the treatment of and being innovated.
Description
Technical field
The present invention relates to pharmaceutical sanitary field, be specifically related to a kind ofly prevent and treat Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction and preparation method thereof.
Background technology
Chronic renal failure (CRF) refers to that a variety of causes causes chronic progressive external Renal lesion, cause the obvious atrophy of kidney, can not maintain basic function, clinical appearance is with metabolite retention, water, electrolyte, acid base imbalance, each system involvement of whole body is the clinical syndrome of main manifestations.Etiological has primary glomerulonephritis, chronic pyelonephritis, hypertensive renal arteriolar sclerosis, diabetic nephropathy, secondary glomerulonephritis, interstitial disease of renal tubule, hereditary Kidney Diseases and the agent of long-term taking antipyretic-antalgic and contact heavy metal etc.
Chronic renal failure is the disease causing Multisystem damage, stomach symptom is the symptom occurred the earliest, disease progression is to the CKD5 phase, kidney can not Edera Extract, Nausea and vomiting can be there is, toxin stimulating gastrointestinal mucous membrane causes inflammation and ulcer, and the peptic ulcer incidence rate of CRF patient is higher than normal person, and digestive tract hemorrhage is also very common in uremic patient.
For the treatment of chronic renal failure, the Therapeutic Method of western medicine, be mostly that the metabolic waste storage to chronic renal failure shows is stayed, soda acid and water power are thanked to the clinical syndromes such as matter is unbalance, anemia and are treated.As adsorbed the noxious substance such as creatinine, uric acid with Ai Xi Te from gastrointestinal tract, excreted by intestinal, to reduce serum creatinine, uric acid; Or mend alkali by entangling acid, to thank to matter unbalance to improve soda acid and water power to fall the methods such as potassium is replenished the calcium, diuresis; Or use the anemia such as erythropoietin, iron preparation etc.Though above remedy measures is in the improvement of These parameters or helpful, and there is no in order to do benefit in the fundamental turn for the better of renal function.
There is no the name of disease of chronic kidney hypofunction in motherland's medical science, the sage of the past is belonged to the category such as " difficulty in urination ", " obstruction and rejection ", " edema ", " the kidney-wind syndrome ", " poison of drowning ", " asthenia " according to its clinical manifestation.In recent years, Chinese medicine CRF aspect achieves great success, and its curative effect also obtain generally acknowledging of national medical circle.Large quantifier elimination shows, spleen invigorating, kidney tonifying, QI invigorating, invigorate blood circulation, dampness removing, let out the multiple methods such as turbid, toxin expelling for improving renal function, prevent and treat complication, slow down renal function progress, improve the equal tools in aspect such as life in patients and have certain effect.But because primary disease etiology and pathogenesis is intricate, how to cause reality by void, finally form the card of simulataneous insufficiency and excessive.Its side's of ruling by law by law medicine is changeful, and clinical efficacy is difficult to evaluate, and pole is unfavorable for using and exchanging.
Summary of the invention
The object of this invention is to provide a kind of Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction;
Another object of the present invention is to provide a kind of preparation method of preventing and treating the Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction.
The object of the invention is by following technical scheme realize:
The Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction of the present invention, its parts by weight of raw materials is: Radix Codonopsis 5-20 part, Rhizoma Atractylodis Macrocephalae 5-25 part, Poria 5-25 part, Pericarpium Citri Reticulatae 3-8 part, Rhizoma Pinelliae Preparatum 5-20 part, Rhizoma Zingiberis Recens 5-15 part, Folium Perillae 5-25 part, Rhizoma Coptidis 1-5 part, Haematitum 5-25 part, Radix Et Rhizoma Rhei 3-8 part, Herba Epimedii 5-15 part, Fructus Amomi 3-8 part, Radix Glycyrrhizae 3-8 part.
Preferably: Radix Codonopsis 10-15 part, Rhizoma Atractylodis Macrocephalae 10-20 part, Poria 10-20 part, Pericarpium Citri Reticulatae 4-7 part, Rhizoma Pinelliae Preparatum 10-15 part, Rhizoma Zingiberis Recens 8-12 part, Folium Perillae 10-20 part, Rhizoma Coptidis 2-4 part, Haematitum 10-20 part, Radix Et Rhizoma Rhei 4-7 part, Herba Epimedii 8-12 part, Fructus Amomi 4-7 part, Radix Glycyrrhizae 4-7 part.
More preferably: Radix Codonopsis 12 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, 15 parts, Poria, Pericarpium Citri Reticulatae 6 parts, Rhizoma Pinelliae Preparatum 12 parts, 10 parts, Rhizoma Zingiberis Recens, Folium Perillae 15 parts, Rhizoma Coptidis 3 parts, Haematitum 15 parts, Radix Et Rhizoma Rhei 6 parts, Herba Epimedii 10 parts, Fructus Amomi 6 parts, 6 parts, Radix Glycyrrhizae.
Below crude drug source of the present invention:
Radix Codonopsis is Campanulaceae Radix Codonopsis Codonopsispilosula(Franch.) Nannf., element flower Radix Codonopsis (RADIX CODONOPSIS PILOSULAE from Northwest of China) CodonopsispilosulaNannf.var.modesta(Nannf.) dry root of L.T.Shen or radix codonpsis tangshen CodonopsistangshenOliv..Sweet, flat.Return spleen, lung meridian.Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
The Rhizoma Atractylodis Macrocephalae is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae AtractylodesmacrocephalaKoidz..Bitter, sweet, temperature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.
Poria is On Polyporaceae Poria Poriacocos(Schw.) dry sclerotia of Wolf.Sweet, light, flat.GUIXIN, lung, spleen, kidney channel.Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Pericarpium Citri Reticulatae is the dry mature skin of rutaceae orange CitrusreticulataBlanco and variety thereof.Bitter, pungent, temperature.Return lung, spleen channel.Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
Rhizoma Pinelliae Preparatum is the Preparation process product of the Rhizoma Pinelliae.The Rhizoma Pinelliae is aroid Rhizoma Pinelliae Pinelliaternata(Thunb.) dry tuber of Breit..Pungent, warm.Return spleen, stomach, lung meridian.Drying dampness to eliminate phlegm.For abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, syncope due to accumulation of phlegm is had a headache.
Rhizoma Zingiberis Recens is the fresh rhizome of zingiber ZingiberofficinaleRosc..Pungent, tepor.Return lung, spleen, stomach warp.Induce sweat cold expelling, warming middle-JIAO to arrest vomiting, preventing phlegm from forming and stopping coughing.For anemofrigid cold, gastrofrigid vomiting, cold-phlegm is coughed.
Folium Perillae is labiate Folium Perillae Perillafrutescens(L.) dried leaves of Britt (or band twig).Pungent, temperature.Return lung, spleen channel.Induce sweat cold expelling, relieving QI stagnancy in the stomach.For anemofrigid cold, cough vomiting and nausea, vomiting during pregnancy, fish Eriocheir sinensis is poisoning.
Rhizoma Coptidis is the dry rhizome of ranunculaceae plant Rhizoma Coptidis CoptischinensisFranch., Coptis deltoidea C.Y.Cheng et Hsiao CoptisdeltoideaC.Y.ChengetHsiao or Coptis Teeta Wall CoptisteetaWall..Hardship, cold.GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.Heat clearing and damp drying, eliminating fire and detoxication.For damp and hot feeling of fullness, vomiting acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, hyperactivity of heart-fire, dysphoria and insomnia, heat in blood tells nosebleed, conjunctival congestion, and toothache, quenches one's thirst, carbuncle furuncle; External treatment eczema, eczema, auditory meatus is suppurated.
Haematitum is the Ore of oxide-based mineral bloodstone.Bitter sweet, flat.Enter liver, stomach, heart born of the same parents warp.Suppressing the hyperactive liver town is inverse, cooling blood for hemostasis.Control eructation vomiting, dysphagia and regurgitation, asthma, infantile convulsion, spit blood, epistaxis, hemorrhoidal hamorrhage, hemorrhoid complicated by anal fistula, bleeding not during menses.
Radix Et Rhizoma Rhei is polygonum rheum palmatum RheumpalmatumL., Rheum tanguticum RheumtanguticumMaxim.exBalf。Or Rheum officinale RheumofficinaleBaill.Dry root and rhizome.Get clean Radix Et Rhizoma Rhei block, steam method (appendix II D) according to stewed with wine or wine and stew or steam to inside and outside all in black.Hardship, cold.Return spleen, stomach, large intestine, liver, pericardium channel.Purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, eliminating blood stasis and inducing menstruation.For excess-heat constipation, stagnant stomachache, dysentery is not well, jaundice due to damp-heat, and heat in blood tells nosebleed, conjunctival congestion, pharyngeal swelling, abdominalgia with intestinal abscess, carbuncle furuncle, blood stasis amenorrhea, traumatic injury, external treatment burn due to hot liquid or fire; Upper gastrointestinal hemorrhage.Radix Et Rhizoma Rhei rushes down exerts oneself to delay, eliminating fire and detoxication.For pathogenic fire,toxin and furuncles.
Herba Epimedii is Berberidaceae plant Herba Epimedii EpimediumbrevicornumMaxim., Epimedium sagittatum Epimediumsagittatum(Sieb.etZucc.) dry aerial parts of Maxim., E. Pubescens EpimediumpubescensMaxim., Epimedium wushanense EpimediumwushanenseT.S.Ying or Herba Epimedii EpimediumkoreanumNakai.Acrid, sweet, warm.Return liver, kidney channel.Kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For impotence and seminal emission, muscles and bones flaccidity is soft, rheumatic arthralgia, numbness contracture; Climacteric hypertension.
Fructus Amomi is the dry mature fruit of zingiberaceous plant Fructus Amomi AmomumvillosumLour., green shell sand AmomumvillosumLour.var.xanthioidesT.L.WuetSenjen or SEMEN AMOMI LONGILIGULA AmomumlongiligulareT.L.Wu.Pungent, temperature.Return spleen, stomach, kidney channel.Removing dampness is whetted the appetite, warming spleen and stopping diarrha, regulates the flow of vital energy antiabortive.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass is not hungry, Deficiency and coldness of spleen and stomach, and vomiting is had loose bowels, pregnancy reactions, frequent fetal movement.
Radix Glycyrrhizae is the dry root of glycyrrhizic legume GlycyrrhizauralensisFisch., Glycyrrhiza inflata Bat. GlycyrrhizainflataBat. or Glycyrrhiza glabra L. GlycyrrhizaglabraL..Sweet, flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Another aspect of the present invention there is provided the preparation method of the active component of Chinese medicine composition of the present invention, and the method is the ethanol extraction adopting water extraction or 40-80% concentration expressed in percentage by volume.Concrete preparation method is as follows:
Scheme one: whole medical material in the side of getting, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge extractive liquid, filters, when filtrate is concentrated into 70-80 DEG C, relative density is the clear paste of 1.10-1.25, obtains described active component.
Scheme two: whole medical material in the side of getting, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge extractive liquid, filters, and when filtrate is concentrated into 70-80 DEG C, relative density is the clear paste of 1.05-1.20, add ethanol, make alcohol content be 40-70%, leave standstill 12-24 hour, filter, when filtrate is concentrated into 70-80 DEG C, relative density is the extractum of 1.10-1.25, obtains described active component.
Scheme three: whole medical material in the side of getting, with 40-80% alcohol reflux 2-3 time, each ethanol consumption be the 4-10 of medical material total amount doubly, extraction time is 1-3 hour, merge extractive liquid, filters, when filtrate is concentrated into 60-80 DEG C, relative density is the extractum of 1.10-1.25, obtains described active component.
The Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction of the present invention, with pharmaceutically acceptable carrier combination, can make various common dosage forms, as tablet, granule, capsule, syrup, mixture, oral liquid etc.
Pharmaceutically acceptable carrier of the present invention includes but not limited to following:
Diluent: starch, Icing Sugar, lactose, dextrin, microcrystalline Cellulose, inorganic salt, sugar alcohols etc.
Wetting agent and binding agent: purified water, ethanol, gelatin, Polyethylene Glycol, cellulose derivative etc.
Disintegrating agent: starch, carboxymethyl starch sodium, cellulose derivative, polyvinylpolypyrrolidone etc.
Lubricant: magnesium stearate, micropowder silica gel, Pulvis Talci, Polyethylene Glycol etc.
Cosolvent: water, ethanol, glycerol, propylene glycol, liquid Paraffin, plant wet goods.
Correctives: sucrose, simple syrup, aromatic, Mel, simple syrup, glycyrrhizic acid and stevioside etc.
Antiseptic: benzoic acid, sorbic acid, propanoic acid, methyl ester, ethyl ester, propyl ester etc.
Method 1: tablet
Get one of scheme one to scheme three gained active component, add tablet and commonly use adjuvant, production method is prepared into Tablets routinely.
Above-mentioned tablet is commonly used adjuvant and is comprised one of diluent, wetting agent, binding agent, disintegrating agent, lubricant or whole.
Method 2: granule
Get one of scheme one to scheme three gained active component, add granule and commonly use adjuvant, production method is prepared into granule of the present invention routinely.
Above-mentioned granule is commonly used adjuvant and is comprised one of diluent, wetting agent, binding agent, disintegrating agent or whole.
Method 3: capsule
Get one of scheme one to scheme three gained active component, add capsule and commonly use adjuvant, production method is prepared into capsule of the present invention routinely.
Above-mentioned capsule is commonly used adjuvant and is comprised one of diluent, wetting agent, binding agent, disintegrating agent, lubricant or whole.
Method 4: syrup
Get one of scheme one to scheme three gained active component, add syrup and commonly use adjuvant, production method is prepared into syrup of the present invention routinely.
Above-mentioned syrup is commonly used adjuvant and is comprised one of correctives, antiseptic, cosolvent or whole.
Method 5: mixture
Get one of scheme one to scheme three gained active component, add mixture and commonly use adjuvant, production method is prepared into mixture of the present invention routinely.
Above-mentioned mixture is commonly used adjuvant and is comprised one of correctives, antiseptic or whole.
Method 6: oral liquid
Get one of scheme one to scheme three gained active component, dissolve after-purification, concentrate, add oral liquid and commonly use adjuvant, production method is prepared into oral liquid of the present invention routinely.
Present invention applicant takes up a job as a doctor 30 over-carriages, to chronic kidney hypofunction early, the treatment in mid-term have accumulated abundant clinical experience, it is under differentiation of tcm theoretical direction, experience in conjunction with this disease of diagnosis and treatment for many years defines the opinion of oneself uniqueness, and sum up and effectively distinguish the method for controlling: " internal organs virtual loss, turbid damp blood-stasis internal-depression " be the main pathogenesis that this disease is fallen ill, with Pei Qiben, its heresy of dispelling is then, " to have, without symptom of digestive tract " control for just carrying out opinion, simplify early stage chronic kidney hypofunction (CKD3 phase) is dialectical, common method for the treatment of is innovated, spleen invigorating in method for the treatment of, kidney tonifying, let out turbid, blood stasis dispelling is carried throughout.To early stage chronic kidney hypofunction (CKD3 phase) treatment, it is basic to catch, and based on general character, combines with individual character, collects all elite, repeated screening, refinement, form unique countermeasure system of early stage chronic kidney hypofunction (CKD3 phase) gradually.
In side, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae invigorating the spleen and benefiting QI are with reinforcing; Poria, Fructus Amomi spleen invigorating are let out turbid; Rhizoma Pinelliae Preparatum, Rhizoma Zingiberis Recens, Folium Perillae warming YANG warm up spleen; Herba Epimedii warming and recuperating the kidney-YANG; Haematitum cooling blood for hemostasis; Radix Et Rhizoma Rhei blood stasis dispelling purges heat; Pericarpium Citri Reticulatae circulation of qi promoting is with tonify without causing stagnation; Rhizoma Coptidis antiinflammatory stops blooding, for improving with inflammation and the congested various symptoms caused.All medicine compatibilities play the effect of warming YANG and strengthening the spleen, kidney tonifying, blood stasis dispelling the turbid descending altogether, can make that spleen kidney yang is strong, turbid damp goes, blood stasis.Originally obviously can alleviate gastrointestinal symptom, make patient recover normal feed, improve nutritional status, the chronic renal failure Be very effective for the treatment of symptom of digestive tract.
A kind of Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction provided by the invention has the following advantages:
1, the Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction provided by the invention is safe and effective, control for just carrying out opinion with " having, without symptom of digestive tract ", simplify symptom of digestive tract chronic kidney hypofunction (CKD3 phase) is dialectical, spleen invigorating, kidney tonifying in method for the treatment of, let out turbid, blood stasis dispelling and carry throughout, common method for the treatment of and being innovated.
2, clinical test results display, compared with Primary Care group, symptom of digestive tract chronic renal failure (P<0.01) can effectively be alleviated and be treated to western medical treatment group, treatment group of the present invention all; Therapeutic effect of the present invention has pole significant difference (P<0.01) compared with western medical treatment group; Treatment group of the present invention and the present invention add compared with doctor trained in Western medicine group, no significant difference (P>0.05).
Clinical test results is pointed out: the present invention treats symptom of digestive tract chronic renal failure Be very effective, is far superior to existing western medicine therapy.
3, Traditional Chinese medicine composition formula of the present invention is rationally innovated, easy to be easy-to-use, is convenient to promote exchange; And production cost is low, technique is simple.
Detailed description of the invention
The present invention is further illustrated below by embodiment.It should be understood that embodiments of the invention are for illustration of the present invention instead of limitation of the present invention.Essence according to the present invention all belongs to the scope of protection of present invention to the simple modifications that the present invention carries out.
Embodiment 1 syrup
Get Radix Codonopsis 0.5kg, Rhizoma Atractylodis Macrocephalae 0.5kg, Poria 0.5kg, Pericarpium Citri Reticulatae 0.3kg, Rhizoma Pinelliae Preparatum 0.5kg, Rhizoma Zingiberis Recens 0.5kg, Folium Perillae 0.5kg, Rhizoma Coptidis 0.1kg, Haematitum 0.5kg, Radix Et Rhizoma Rhei 0.3kg, Herba Epimedii 0.5kg, Fructus Amomi 0.3kg, Radix Glycyrrhizae 0.3kg.
Whole medical material in the side of getting, extracting in water 2 times, twice amount of water is respectively 10 times, 8 times of medical material gross weight, and the extracted twice time is respectively 2 hours, 1 hour, merge extractive liquid, filters, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10.In extractum, add syrup adjuvant sucrose, sorbic acid, water stirs, obtained syrup.
Embodiment 2 tablet
Get Radix Codonopsis 2kg, Rhizoma Atractylodis Macrocephalae 2.5kg, Poria 2.5kg, Pericarpium Citri Reticulatae 0.8kg, Rhizoma Pinelliae Preparatum 2kg, Rhizoma Zingiberis Recens 1.5kg, Folium Perillae 2.5kg, Rhizoma Coptidis 0.5kg, Haematitum 2.5kg, Radix Et Rhizoma Rhei 0.8kg, Herba Epimedii 1.5kg, Fructus Amomi 0.8kg, Radix Glycyrrhizae 0.8kg.
Whole medical material in the side of getting, with 40% alcohol reflux 3 times, each ethanol consumption is respectively 10 times, 8 times, 4 times of medical material total amount, 3 hours, 2 hours, 1 hour respectively extraction time, merge extractive liquid, filters, and when filtrate concentrates 60 DEG C, relative density is the extractum of 1.25, add supplementary product starch, ethanol, Pulvis Talci, obtained tablet.
Embodiment 3 mixture
Get Radix Codonopsis 1kg, Rhizoma Atractylodis Macrocephalae 1kg, Poria 1kg, Pericarpium Citri Reticulatae 0.4kg, Rhizoma Pinelliae Preparatum 1kg, Rhizoma Zingiberis Recens 0.8kg, Folium Perillae 1kg, Rhizoma Coptidis 0.2kg, Haematitum 1kg, Radix Et Rhizoma Rhei 0.4kg, Herba Epimedii 0.8kg, Fructus Amomi 0.4kg, Radix Glycyrrhizae 0.4kg.
Whole medical material in the side of getting, extracting in water 3 times, three amount of water are equivalent to 12 times of medical material gross weight respectively, 8 times, 6 times, 3 hours respectively each extraction time, 2 hours, 1 hour, merge extractive liquid, filter, when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.20, add ethanol, alcohol content is made to be 40%, leave standstill 24 hours, filter, it is the extractum of 1.10 that filtrate is concentrated into relative density when filtrate is concentrated into 70 DEG C, add 3 times that purified water ad pond om is medical material gross weight, fill, add mixture adjuvant sucrose, ethyl ester, water, sorbic acid stirs, obtained mixture.
Embodiment 4 oral liquid
Get Radix Codonopsis 1.5kg, Rhizoma Atractylodis Macrocephalae 2kg, Poria 2kg, Pericarpium Citri Reticulatae 0.7kg, Rhizoma Pinelliae Preparatum 1.5kg, Rhizoma Zingiberis Recens 1.2kg, Folium Perillae 2kg, Rhizoma Coptidis 0.4kg, Haematitum 2kg, Radix Et Rhizoma Rhei 0.7kg, Herba Epimedii 1.2kg, Fructus Amomi 0.7kg, Radix Glycyrrhizae 0.7kg.
Whole medical material in the side of getting, extracting in water 2 times, 2 amount of water are equivalent to 10 times, 8 times of medical material gross weight respectively, 2 hours respectively each extraction time, merge extractive liquid, filters, when filtrate is concentrated into 80 DEG C, relative density is the clear paste of 1.15, adds ethanol, makes alcohol content be 50%, leave standstill 24 hours, filter, filtrate is concentrated into 2 times of medical material gross weight, add adjuvant Mel, monoglycosides, benzoic acid, after stirring evenly fine straining, subpackage, sterilizing, obtained oral liquid.
Embodiment 5 tablet
Get Radix Codonopsis 1.2kg, Rhizoma Atractylodis Macrocephalae 1.5kg, Poria 1.5kg, Pericarpium Citri Reticulatae 0.6kg, Rhizoma Pinelliae Preparatum 1.2kg, Rhizoma Zingiberis Recens 1kg, Folium Perillae 1.5kg, Rhizoma Coptidis 0.3kg, Haematitum 1.5kg, Radix Et Rhizoma Rhei 0.6kg, Herba Epimedii 1kg, Fructus Amomi 0.6kg, Radix Glycyrrhizae 0.6kg.
Whole medical material in the side of getting, with alcohol reflux 2 times, each concentration of alcohol is respectively 80%, 60%, each ethanol consumption is respectively 10 times, 8 times of medical material total amount, and extraction time is respectively 4 hours, 3 hours, merge extractive liquid, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.10, adds supplementary product starch, ethanol, Pulvis Talci, obtained tablet.
Embodiment 6 capsule
Get Radix Codonopsis 1.5kg, Rhizoma Atractylodis Macrocephalae 2.5kg, Poria 1.0kg, Pericarpium Citri Reticulatae 0.6kg, Rhizoma Pinelliae Preparatum 1kg, Rhizoma Zingiberis Recens 1kg, Folium Perillae 2.5kg, Rhizoma Coptidis 0.8kg, Haematitum 2kg, Radix Et Rhizoma Rhei 0.4kg, Herba Epimedii 1.5kg, Fructus Amomi 0.6kg, Radix Glycyrrhizae 0.4kg.
Whole medical material in the side of getting, extracting in water 3 times, three amount of water are respectively 12 times, 8 times, 6 times of medical material gross weight, three extraction times are respectively 3 hours, 2 hours, 1 hour, merge extractive liquid, filters, and when filtrate is concentrated into 70 DEG C, relative density is the clear paste of 1.25, add supplementary product starch, ethanol, dextrin, magnesium stearate, incapsulate shell, obtained capsule.
Embodiment 7 granule
Get Radix Codonopsis 1.2kg, Rhizoma Atractylodis Macrocephalae 0.5kg, Poria 2.5kg, Pericarpium Citri Reticulatae 0.4kg, Rhizoma Pinelliae Preparatum 1.2kg, Rhizoma Zingiberis Recens 0.5kg, Folium Perillae 0.5kg, Rhizoma Coptidis 0.4kg, Haematitum 2kg, Radix Et Rhizoma Rhei 0.7kg, Herba Epimedii 1.5kg, Fructus Amomi 0.3kg, Radix Glycyrrhizae 0.4kg.
Whole medical material in the side of getting, extracting in water 2 times, each amount of water is equivalent to 12 times, 10 times of medical material gross weight respectively, each extraction time is respectively 3 hours, 2 hours, merge extractive liquid, filters, it is the clear paste of 1.05 that filtrate is concentrated into relative density at 80 DEG C, add ethanol, make alcohol content be 70%, leave standstill 12 hours, filter, when filtrate is concentrated into 70 DEG C, relative density is the extractum of 1.25, adds adjuvant Icing Sugar, starch, dextrin, ethanol, obtained granule.
Embodiment 8 powder
Get Radix Codonopsis 0.8kg, Rhizoma Atractylodis Macrocephalae 1kg, Poria 1kg, Pericarpium Citri Reticulatae 0.4kg, Rhizoma Pinelliae Preparatum 2kg, Rhizoma Zingiberis Recens 0.5kg, Folium Perillae 0.5kg, Rhizoma Coptidis 0.4kg, Haematitum 1kg, Radix Et Rhizoma Rhei 0.2kg, Herba Epimedii 0.5kg, Fructus Amomi 0.3kg, Radix Glycyrrhizae 0.7kg.
Whole medical material in the side of getting, medical material cleans, pulverize, and crosses 80-100 mesh sieve, obtains powder of the present invention.
clinical trial
The curative effect of the present invention being treated to symptom of digestive tract chronic kidney hypofunction carries out clinical observation, take medicine whether Patients Before And After symptom of digestive tract disappears by contrast, symptom and sign, urine protein index whether take a turn for the better and analyze therapeutic effect of the present invention.
1 case is collected: the research approach adopting multicenter, random, single blind, parallel control, testing program is ratified through constituent parts center Ethics Committee.All in-patients or family members all need to sign Written informed consent.All data are responsible for collecting and statistics by the court's nephropathy sick section Absolute risk reduction, measurement, assessment centers data management group.
2 diagnostic criterias:
2.1 Western medicine diagnose standards: " clinical practice guideline of chronic kidney disease and dialysis " (2002 editions) instructing (NKF-K/DOQI) working group with reference to AKF one nephropathy quality of life.
The diagnostic criteria of chronic kidney disease:
2.1.1 renal damage >=3 month;
2.1.2 Chronic glomerular disease, glomerular proteinuria, companion (not accompanying) glomerule source property hematuria, there is (no) hypertension and edema;
2.1.3 and get rid of secondary glomerulonephritis;
2.1.4 this test adopts the kidney ball filtration rate (eGFR) of MDRD equation estimation
[eGFR(ml/min/1.73m
2=170 Х SCr)
-0.999Х the age)
-0.176Х BUN)
-0.170Х ALB)
0.318Х 0.762 women)] 30 1 59mL/min/1.73m
2.
2.2 Standards of Chinese Medical Syndrome Differentiations: asthenia of both the spleen and kidney, turbid damp type of blood-stasis obstructing in the interior CM syndrome differentiation criterion: with reference to versions " new Chinese medicine clinical research guide principle " in 2002 and formulate Standards of Chinese Medical Syndrome Differentiation: disease is seen: fatigue and weakness or lazy speech of breathing hard, spinal column are aching and limp, nocturia increases, limbs tired weight, nausea and vomiting, distension and fullness in the abdomen, lack of appetite is indigestion and loss of appetite, squamous and dry skin, numb limbs and tense tendons, thick fur are greasy, purplish tongue or have petechia ecchymosis, thready and hesitant pulse.
3 inclusive criterias
3.1 ages are between 18-70 year;
3.2 Chronic glomerular disease, meet early stage chronic kidney hypofunction (CKD-3 phase) and GFR30-59mL/min/1.73m2 in 3 months;
3.3 application ACEI, ARB treat two weeks eluting phases;
3.4 make blood pressure≤140/90mmHg through basic blood pressure lowering (using non-ACEI/ARB hypotensor);
3.5 Chinese medical discriminations are deficiency of spleen and stomach, turbid damp blood-stasis internal-depression;
3.6 in above-mentioned critical field digestive tract symptom;
3.7 follow Principles in Informed Consent.
4 exclusion standards and termination criteria
4.1 exclusion standards:
4.1.1 gestation or prepare gestation and women breast-feeding their children;
4.1.2 merge intentionally, brain, lung, liver, serious primary disease, diabetes or the wasting diseases such as malignant tumor, active tuberculosis such as hemopoietic system patient, chronic hepatitis B active stage and lag phase, cirrhosis patients in decompensation, or renal transplantation the latter;
4.1.3 psychosis or can not partner;
4.1.4 just other clinical trial persons are participated in;
4.1.5 knownly maybe cannot to tolerate certain drug allergy in this research
4.1.6 middle anemia, blood red egg is from (Hb) <80g/L person.
4.2 termination criteria:
4.2.1 there is serious adverse events: occur in the research phase that serum creatinine level is double, End-stage renal disease, death or great cardiocerebrovasculaevents events;
4.2.2 there is serious complication: in the research phase, occur continuous 3 hyperpotassemia (blood potassium >=6.0mmol/L), acidosis (TCO2<13mmol/L), digestive tract hemorrhage, severe arrhythmia etc. in severe infections, serious acomia 2 weeks of being corrected by internal medicine conservative treatment;
4.2.3 study in the phase and find activeness malignant tumor, Decompensated liver cirrhosis or serious blood systemic disease etc.;
4.2.4 seriously testing program medication is violated;
4.2.5 lost to follow-up or exit experimenter voluntarily.
5 case groupings: the patient meeting above-mentioned standard amounts to 400 examples, adopt random digits table to divide equally tcm syndrome differentiation and treatment group 100 example, western medical treatment group 100 example, Chinese medical discrimination+western medical treatment group 100 example, Primary Care group 100 example.
6 Therapeutic Method
6.1 Primary Care group:
6.1.1 less salt (<6g), low protein diet are 0.75/(Kgd), about 50% albumen is high bioprotein, high caloric diet;
6.1.2 fat is adjusted: hyperlipidemia patient gives atorvastatin; Be that main patient gives fenofibrate to increasing with triglyceride.Therapeutic goal value is total gallbladder solid <5.72mmol/L, triglyceride <2.26mmol/L;
6.1.3 blood pressure lowering: use non-ACEI/ARB hypotensor;
6.1.4 entangle acid: oral sodium bicarbonate 3-10g/d, divide and take for 3 times, intravenous applications sodium bicarbonate pin if desired;
6.1.5 correct electrolyte disturbance: blood potassium is greater than 5.5mmol/L, give internal medicine and guard way process; Serium inorganic phosphorus is greater than 1.49mmol/L, answers the intake of dietary restriction, gives calcium carbonate if desired, drink with food, and 3-10g, divided and took for 3 times every day; Blood calcium is less than 2.15mmol/L, and should replenish the calcium 1.5-2.0g/d, uses activated vitamin D etc. simultaneously;
6.1.6 anemia: use recombiant erythropoietin (EPO), give low dose of subcutaneous administration, (5000-7000IU/ week in 80-120IU/Kg week, divide 2-3 administration, therapeutic goal value: 100-130g/L, HCT:33-36%, maintenance dose varies with each individual, and gives the treatments such as iron supplement if desired.
6.2 tcm syndrome differentiation and treatment groups: give the embodiment of the present invention 5 tablet, 4 pieces/times, 3 times/day;
6.3 western medical treatment groups: on the basis of Primary Care, add with benazepril 10mg/ day, once a day.
6.4 Chinese medical discriminations+western medicine: Chinese traditional treatment is with 6.2, and western medical treatment is with 6.3.
Above four groups equal 4 weeks be a course for the treatment of, 3 courses for the treatment of sum up curative effect.
7 curative effect determinate standards
7.1 curative effect determinate standards:
7.1.1 clinical remission: symptom and sign disappear completely, the lasting feminine gender of urine protein or 24h urine protein quantitation <0.4g, eGFR are higher than before treatment;
7.1.2 effective: symptom and sign disappear substantially, 24h urine protein quantitation comparatively treats front decline >=50%; Or eGFR maintains before the treatment (fluctuation≤5%);
7.1.3 effective: to compare with before treatment, 24h urine protein quantitation decline 25%-50%; Or eGFR decline 5%-20%;
7.1.4 invalidly above-mentioned criterion of therapeutical effect is not reached.
7.2 traditional Chinese medical science sign curative effect determinate standards:
7.2.1 clinical remission: syndrome integral comparatively treats front decline >=95%;
7.2.2 effective: to compare with before treatment, syndrome integral declines 70% one 94%;
7.2.3 effective: to compare with before treatment, syndrome integral declines 30% ~ 69%;
7.2.4 invalid: to compare with before treatment, syndrome integral decline <29%.
Obvious effective rate (%)=(clinical remission number of cases+effective number of cases)/total number of cases × 100%, total effective rate (%)=(clinical remission number of cases+effective number of cases+effectively number of cases)/total number of cases × 100%.
8 clinical treatment outcome, in table 1:
Table 1 therapeutic outcome compares
Note: compared with Primary Care group, * P<0.01; Compared with western medical treatment group, #P<0.01.
Conclusion: table 1 result shows, and compared with Primary Care group, symptom of digestive tract chronic renal failure (P<0.01) can effectively be alleviated and be treated to western medical treatment group, treatment group of the present invention all; Therapeutic effect of the present invention has pole significant difference (P<0.01) compared with western medical treatment group; Treatment group of the present invention and the present invention add compared with doctor trained in Western medicine group, no significant difference (P>0.05).
Clinical test results is pointed out: the present invention treats symptom of digestive tract chronic renal failure Be very effective, is far superior to existing western medicine therapy.
model case
Wei, female, 49 years old, first visit on the 08th in 02 month in 2010, found during health check-up that creatinine is 413mmoL/L, urine protein (++), hemoglobin 88/L; Two kidney B ultrasonic shows: two kidney diffuse lesion, volume-diminished.Disease is seen: sticky in poor appetite abdominal distention, mouth, nausea and vomiting, darkish complexion, halitosis urine taste, two lower limb pneumonedema, and loose stool, urine is on the low side, and light red tongue is dark, and tongue is greasy in vain, deep-rolling pulse, and blood pressure is normal.Diagnosis obstruction and rejection is for there being symptom of digestive tract-deficiency of spleen and stomach, and turbid damp violates stomach, blood-stasis internal-depression.Give the embodiment of the present invention 2 tablet, each 4, every day 3 times.Do not give any western medical treatment.Nausea and vomiting obviously improves after 1 week, and after January, patient's nausea and vomiting is alleviated, appetite still can, creatinine is down to 330mmoL/L, and hemoglobin 93/L patient adheres to taking medicine, and follow up a case by regular visits to patient's creatinine fluctuation half a year at about 250mmol/L, clinical symptoms is clearly better.
Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (8)
1. prevent and treat a Chinese medicine composition for symptom of digestive tract chronic kidney hypofunction, it is characterized in that its parts by weight of raw materials is: Radix Codonopsis 5-20 part, Rhizoma Atractylodis Macrocephalae 5-25 part, Poria 5-25 part, Pericarpium Citri Reticulatae 3-8 part, Rhizoma Pinelliae Preparatum 5-20 part, Rhizoma Zingiberis Recens 5-15 part, Folium Perillae 5-25 part, Rhizoma Coptidis 1-5 part, Haematitum 5-25 part, Radix Et Rhizoma Rhei 3-8 part, Herba Epimedii 5-15 part, Fructus Amomi 3-8 part, Radix Glycyrrhizae 3-8 part.
2. prevent and treat the Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction as claimed in claim 1, it is characterized in that its parts by weight of raw materials is: Radix Codonopsis 10-15 part, Rhizoma Atractylodis Macrocephalae 10-20 part, Poria 10-20 part, Pericarpium Citri Reticulatae 4-7 part, Rhizoma Pinelliae Preparatum 10-15 part, Rhizoma Zingiberis Recens 8-12 part, Folium Perillae 10-20 part, Rhizoma Coptidis 2-4 part, Haematitum 10-20 part, Radix Et Rhizoma Rhei 4-7 part, Herba Epimedii 8-12 part, Fructus Amomi 4-7 part, Radix Glycyrrhizae 4-7 part.
3. prevent and treat the Chinese medicine composition of symptom of digestive tract chronic kidney hypofunction as claimed in claim 1, it is characterized in that its parts by weight of raw materials is: Radix Codonopsis 12 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, 15 parts, Poria, Pericarpium Citri Reticulatae 6 parts, Rhizoma Pinelliae Preparatum 12 parts, 10 parts, Rhizoma Zingiberis Recens, Folium Perillae 15 parts, Rhizoma Coptidis 3 parts, Haematitum 15 parts, Radix Et Rhizoma Rhei 6 parts, Herba Epimedii 10 parts, Fructus Amomi 6 parts, 6 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction as described in claim 1-3 any one, is characterized in that its active component adopts the ethanol extraction of water extraction or 40-80% concentration expressed in percentage by volume to be prepared from.
5. Chinese medicine composition as claimed in claim 4, it is characterized in that its active component is prepared from by the following method: whole medical material in the side of getting, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge extractive liquid, filters, when filtrate is concentrated into 70-80 DEG C, relative density is the clear paste of 1.10-1.25, obtains described active component.
6. Chinese medicine composition as claimed in claim 4, it is characterized in that its active component is prepared from by the following method: whole medical material in the side of getting, extracting in water 2-3 time, each amount of water is equivalent to the 6-12 of medical material gross weight doubly, each extraction time is 1-3 hour, merge extractive liquid, filter, when filtrate is concentrated into 70-80 DEG C, relative density is the clear paste of 1.05-1.20, adds ethanol, makes alcohol content be 40-70%, leave standstill 12-24 hour, filter, when filtrate is concentrated into 70-80 DEG C, relative density is the extractum of 1.10-1.25, obtains described active component.
7. Chinese medicine composition as claimed in claim 4, it is characterized in that its active component is prepared from by the following method: whole medical material in the side of getting, with 40-80% alcohol reflux 2-3 time, each ethanol consumption is 4-10 times of medical material total amount, extraction time is 1-3 hour, merge extractive liquid, filters, when filtrate is concentrated into 60-80 DEG C, relative density is the extractum of 1.10-1.25, obtains described active component.
8. prevent and treat a Chinese medicine composition for symptom of digestive tract chronic kidney hypofunction, in the Chinese medicine composition preventing and treating symptom of digestive tract chronic kidney hypofunction any one of claim 1-3 and pharmaceuticals industry, acceptable carrier is formulated.
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