CN102552767A - Traditional Chinese medicine for treating kidney stone, preparation method and administration mode - Google Patents

Traditional Chinese medicine for treating kidney stone, preparation method and administration mode Download PDF

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CN102552767A
CN102552767A CN2012100624932A CN201210062493A CN102552767A CN 102552767 A CN102552767 A CN 102552767A CN 2012100624932 A CN2012100624932 A CN 2012100624932A CN 201210062493 A CN201210062493 A CN 201210062493A CN 102552767 A CN102552767 A CN 102552767A
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CN102552767B (en
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刘霞
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Rugao Binjiang Urban Construction Investment Co Ltd
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Abstract

The invention provides a traditional Chinese medicine for treating kidney stone. The traditional Chinese medicine comprises myrrh, rhizoma sparganii, folium callicarpae formosanae, radix salviae miltiorrhizae, fructus psoraleae, radix linderae, herba glechomae, herba lysimachiae, cinnamon, flos caryophylli, black sesame, herba ecliptae, radix astragali, rhizoma atractylodis, semen plantaginis, flos lonicerae and lasiosphaera seu calvatia. The traditional Chinese medicine provided by the invention has obvious curative effect, low price, no toxic or side effect, high cure rate and no drug resistance; the traditional Chinese medicine has a perfect effect for the patient, of which small stones are not discharged in short term, or for the patient with stones smaller than 1cm and having sound renal function without obvious infection; and for big stones, the traditional Chinese medicine also has a good curative effect with the help of extracorporeal shock wave lithotripsy.

Description

Chinese medicine, method for preparing and the administering mode of treatment renal calculus
Technical field
The present invention relates to technical field of Chinese medicines, relate in particular to a kind of Chinese medicine that is used to treat renal calculus.
Background technology
Renal calculus is claimed nephrolithiasis again, belongs to a kind of of urinary system calculus, is positioned at renal pelvis, renal calices, is one of modal disease of urinary tract, and the traditional Chinese medical science belongs to " stranguria ", " stranguria caused by urinary stone " " hematuria ", " lumbago " etc.In recent years its sickness rate rises gradually, and pain in various degree can appear in renal calculus patient, suffers from the patient of renal calculus for a long time, and its body parent receives great wound, and therefore the treatment to renal calculus has positive meaning.
Renal calculus patient is a Combination renal calculus mostly, contains two or more composition.The calculus type can be divided into calcium oxalate stone, calcium phosphate stone, calcium urate calculus, urate calculus, magnesium ammonium phosphate calculus, cystine stone.Calcium oxalate stone is the most common, accounts for more than 80% of renal calculus.
Renal calculus is mainly caused by diet, the material of the relevant composition of calculus that can form because of Excessive Intake in the diet.Oxalic acid accumulates when too much, is one of factor that causes renal calculus, like foods such as Herba Spinaciae, beans, Fructus Vitis viniferae, cocoa, Folium Camelliae sinensis, Fructus Citri tangerinae, Fructus Lycopersici esculenti, Rhizoma Solani tuber osi, Fructus Pruni salicinae, bamboo sprout oxalic acid content food with high just.After Excessive Intake pluck seafood, Semen arachidis hypogaeae, fresh kidney beans, Herba Spinaciae etc. contain the food than polypurine, finally can form uric acid, uric acid can impel the deposition of urine oxalate, in case purine metabolism is not normal, abundant purine can impel the formation urinary stone.The fat picked-up is too much, sugar increases, and protein is excessive also to be to cause calcium oxalate to accumulate the main cause that forms urinary stone in vivo.
Clinical manifestation can be different because of the individual, be decided by calculus the cause of disease, composition, size, number, mobility, have or not to block and infect and the degree of excess of the kidney matter pathological lesion.But the lighter's non-evident sympton, anuria, renal failure, toxic shock and death can appear in severe patient.Renal calculus can show as the waist dull pain; Hematuria can appear after the strenuous exercise, severe patient even renal colic occurs, and kidney district mouth pain is obvious; Pain when outbreak patient pale complexion, whole body cold sweat, pulse be faint even blood pressure drops fast, often with feel sick, gastrointestinal symptoms such as vomiting and abdominal distention.When pain and hematuria outbreak, the visible grains of sand or microlith are discharged with urine.Calculus has during through urethra urine stream to stop up and infects twinge in the urethra, and calculus is discharged back urine stream and recovered unobstructed immediately, feels easily comfortable immediately.Renal calculus patient is concurrent infection usually, symptoms such as fear of cold, heating, lumbago, frequent micturition, urgent micturition, dysurea even pyuria can occur during acute attack.Renal failure possibly appear in severe patient, urinary tract obturation etc.
The Western medicine medicine of treatment renal calculus is less at present, though had extracorporeal shock-wave lithotomy and some non-open operations to get minimally-invasive treatment such as stone in recent years, says from traditional Chinese medical science angle; This treatment can only take stopgap measures, and is difficult to reach the purpose of effecting a permanent cure, and certain adaptability is arranged; Kidney there is certain damage,, has reduced wound though Therapeutic Method such as extracorporeal shock-wave lithotomy can bring patient certain Gospel; But rubble still is difficult to well excrete, and the time possibility of recurrence is arranged, in addition; The method of extracorporeal shock-wave lithotomy is relatively poor to the therapeutic effect of the little calculus of size, even invalid.
Based on this; The invention provides a kind of Chinese medicine of novel treatment renal calculus, have obvious, cheap, the characteristics such as have no side effect of curative effect, especially microlith is not discharged in a short time; Or calculus is below 1cm and renal function is good and not have obvious the infected's effect excellent; Remedied operation, external stone crushing to microlith and muddy stone weak effect or invalid defective,, better curative effect has been arranged also under the help of extracorporeal shock-wave lithotomy for the bulk calculus.
Summary of the invention
Technical problem to be solved by this invention is; Overcome the existing deficiency that adopts extracorporeal shock-wave lithotomy and some non-open operations; Utilize the traditional theory of Chinese medical science of China; A kind of Chinese medicine of treating renal calculus is provided, and its curative effect is obvious, cheap, have no side effect, cure rate is high, have no drug resistance, microlith is discharged in a short time, or calculus is below 1cm and renal function is good and not have obvious the infected's effect excellent; For the bulk calculus, better curative effect is arranged also under the help of extracorporeal shock-wave lithotomy.
Ask in order to solve above-mentioned technology; The invention provides a kind of Chinese medicine that is used to treat renal calculus, it comprises: Myrrha, triangular, Folium Callicarpae Formosanae, Radix Salviae Miltiorrhizae, Fructus Psoraleae, the Radix Linderae, Herba Glechomae, Herba Lysimachiae, Cortex Cinnamomi, Flos Caryophylli, Semen Sesami Nigrum, Herba Ecliptae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Semen Plantaginis, Flos Lonicerae and Lasiosphaera Seu Calvatia.
Wherein, the ratio of weight and number of each component in the said Chinese medicine be that 25~35 weight portion Myrrhas, 18~24 weight portions are triangular, 28~36 weight portion Folium Callicarpae Formosanaes, 21~27 weight portion Radix Salviae Miltiorrhizaes, 45~55 weight portion Fructus Psoraleaes, 14~18 weight portion Radixs Linderae, 35~40 weight portion Herba Glechomaes, 45~55 weight portion Herba Lysimachiaes, 16~20 weight portion Cortex Cinnamomis, 20~24 weight portion Flos Caryophyllis, 50~60 weight portion Semen Sesami Nigrums, 60~70 weight portion Herba Ecliptaes, 35~45 weight portion Radixs Astragali, 27~33 weight portion Rhizoma Atractylodis Macrocephalaes, 37~43 weight portion Semen Plantaginiss, 10~16 weight portion Flos Loniceraes and 8~12 weight portion Lasiosphaera Seu Calvatia.
Wherein, the ratio of weight and number of each component in the said Chinese medicine be that 30~35 weight portion Myrrhas, 22~24 weight portions are triangular, 32~36 weight portion Folium Callicarpae Formosanaes, 24~27 weight portion Radix Salviae Miltiorrhizaes, 50~55 weight portion Fructus Psoraleaes, 16~18 weight portion Radixs Linderae, 38~40 weight portion Herba Glechomaes, 50~55 weight portion Herba Lysimachiaes, 18~20 weight portion Cortex Cinnamomis, 22~24 weight portion Flos Caryophyllis, 55~60 weight portion Semen Sesami Nigrums, 66~70 weight portion Herba Ecliptaes, 40~45 weight portion Radixs Astragali, 30~33 weight portion Rhizoma Atractylodis Macrocephalaes, 40~43 weight portion Semen Plantaginiss, 13~16 weight portion Flos Loniceraes and 10~12 weight portion Lasiosphaera Seu Calvatia.
Wherein, the ratio of weight and number of each component in the said Chinese medicine be that 32 weight portion Myrrhas, 23 weight portions are triangular, 34 weight portion Folium Callicarpae Formosanaes, 26 weight portion Radix Salviae Miltiorrhizaes, 53 weight portion Fructus Psoraleaes, the 17 weight portion Radixs Linderae, 40 weight portion Herba Glechomaes, 52 weight portion Herba Lysimachiaes, 18 weight portion Cortex Cinnamomis, 24 weight portion Flos Caryophyllis, 60 weight portion Semen Sesami Nigrums, 68 weight portion Herba Ecliptaes, the 43 weight portion Radixs Astragali, the 32 weight portion Rhizoma Atractylodis Macrocephalaes, 43 weight portion Semen Plantaginiss, 13 weight portion Flos Loniceraes and 10 weight portion Lasiosphaera Seu Calvatia.
Wherein, the said dosage form that is used to treat the Chinese medicine of renal calculus can be decoct, injection, tablet.
For solving the problems of the technologies described above, the present invention also provides above-mentioned preparation method of Chinese medicine:
When the dosage form of said Chinese medicine was decoct, it comprised,
100~200 purpose powder are pulverized and be screened into to the first step with said component proportional mixing;
Second step obtained powder with the first step and adds in the cold water and soaked 3 hours~5 hours, and with slow fire boiling, decocting time is 2 hours~3 hours, and decoction liquor is filtered, and obtains first filtrating, and the quality that institute adds water is 2~4 times of powder quality of first step acquisition;
In the 3rd step, the filtering residue that second step filter was obtained adds in the cold water once more, with slow fire boiling 1 hour~2 hours, filters and obtains second filtrating, identical in the quality of the water that is added and second step;
The 4th step merged filtrating twice, obtained said decoct.
For solving the problems of the technologies described above, the present invention also provides above-mentioned preparation method of Chinese medicine:
When the dosage form of said Chinese medicine was tablet, it comprised,
The first step with said component proportional mixing, is ground into 100~200 purpose powder, adds in the cold water to soak 3 hours~5 hours; With slow fire boiling 2 hours~3 hours, the quality of the cold water that is added was 2~4 times of the mixture quality that obtains of the first step, and decoction liquor is filtered; Filtering residue is put into cold water once more, and with slow fire boiling 1 hour~2 hours, the quality of the cold water that is added was 1~2 times of the mixture quality that obtains of the first step; Merge filtrate, concentrating under reduced pressure obtains the condensed water extract;
Second step made concentration of alcohol reach concentration 70~85% with adding ethanol in the spissated water extract of first step acquisition, left standstill, and filtered, and the filtrating that obtains is concentrated recovery section ethanol, refiltered the acquisition filtering liquid medicine;
The 3rd step, second step was handled medicinal liquid that the back obtains through Semi-polarity macroporous adsorbent resin or low polar macroporous adsorption resin, first water or concentration are lower than 20% ethanol and are eluted to eluent as eluent and are colourless; It is 1~1.5 times of the mixture quality that obtains of the first step that employed water or concentration are lower than 20% alcoholic acid quality, and reuse concentration is 90%~95% ethanol elution, collects ethanol elution; Employed concentration is that 90%~95% alcoholic acid quality is 3~5 times of the mixture quality that obtains of the first step, and the pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 6.5~7.5, places; Filter, concentrate and reclaim ethanol, the acquisition ethanol content is 10%~15% solution; Through polyamide resin column, first water is eluted to eluent and is closely colourless, and the quality of employed water is 1~1.5 times of the mixture quality that obtains of the first step; The reuse determining alcohol is 80%~95% ethanol elution, collects ethanol elution, employed concentration be 80%~95% alcoholic acid quality be 1~1.5 times of the mixture quality that obtains of the first step; Reclaim ethanol; Concentrate, drying under reduced pressure obtains and gets dry extract;
The 4th step with the dried cream of above-mentioned acquisition, added excipient and granulates, and drying adds disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or the bag film-coat promptly obtains product.
Wherein, said excipient is starch and derivant, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hypromellose and pharmaceutic adjuvant with water swelling; Described lubricant is the pharmaceutic adjuvant of Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication; Described sugar coating material is sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Described thin film coating material is that water, the alcohol of stomach dissolution type dissolves coating material.Wherein excipient, disintegrating agent, lubricant, sugar coating, the weight content of bag film-coat material in medicine are respectively: 5~70%, 1~30%, 0.1~10%, 35~90%, 1.5~5%.
For solving the problems of the technologies described above, the present invention also provides above-mentioned preparation method of Chinese medicine:
When the dosage form of said Chinese medicine was injection, it comprised,
The first step with said component proportional mixing, is ground into 100~200 purpose powder, adds in the cold water to soak 3 hours~5 hours; With slow fire boiling 2 hours~3 hours, the quality of the cold water that is added was 2~4 times of the mixture quality that obtains of the first step, and decoction liquor is filtered; Filtering residue is put into cold water once more, and with slow fire boiling 1 hour~2 hours, the quality of the cold water that is added was 1~2 times of the mixture quality that obtains of the first step; Merge filtrate, concentrating under reduced pressure obtains the condensed water extract;
Second step made concentration of alcohol reach concentration 70~85% with adding ethanol in the spissated water extract of first step acquisition, left standstill, and filtered, and the filtrating that obtains is concentrated recovery section ethanol, refiltered the acquisition filtering liquid medicine;
The 3rd step, second step was handled medicinal liquid that the back obtains through Semi-polarity macroporous adsorbent resin or low polar macroporous adsorption resin, first water or concentration are lower than 20% ethanol and are eluted to eluent as eluent and are colourless; It is 1~1.5 times of the mixture quality that obtains of the first step that employed water or concentration are lower than 20% alcoholic acid quality, and reuse concentration is 90%~95% ethanol elution, collects ethanol elution; Employed concentration is that 90%~95% alcoholic acid quality is 3~5 times of the mixture quality that obtains of the first step, and the pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 6.5~7.5, places; Filter, concentrate and reclaim ethanol, the acquisition ethanol content is 10%~15% solution; Through polyamide resin column, first water is eluted to eluent and is closely colourless, and the quality of employed water is 1~1.5 times of the mixture quality that obtains of the first step; The reuse determining alcohol is 80%~95% ethanol elution, collects ethanol elution, employed consistency be 80%~95% alcoholic acid quality be 1~1.5 times of the mixture quality that obtains of the first step; Reclaim ethanol; Concentrate, drying under reduced pressure obtains and gets dry extract;
The 4th step is with the dried cream of the 3rd step acquisition, behind 5~10 times of waters for injection of adding with respect to dried cream quality; With 0.5mol/L sodium hydroxide adjust pH to 6.0~7.0, press 0.2g/100ml and add active carbon, adding 10% ethanol to crude drug concentration again is 1.15g/100ml~1.25g/100ml; Stirred 10 minutes, the microporous filter membrane with 0.45 μ m, 0.22 μ m filters respectively, promptly obtains injection; The injection that obtains is propped up the branch cillin bottle of packing into by 10ml/, add a cover butyl rubber plug and aluminium lid, 115 ℃ of pressure sterilizings 30 minutes; Label check.
For solving the problems of the technologies described above, the present invention also provides the administering mode of above-mentioned Chinese medicine: oral or injection.
Beneficial effect of the present invention:
Chinese medicine curative effect of the present invention is obvious, cheap, have no side effect, cure rate is high, have no drug resistance, microlith is discharged in a short time; Or calculus is below 1cm and renal function is good and not have obvious the infected's effect excellent; For the bulk calculus, better curative effect is arranged also under the help of extracorporeal shock-wave lithotomy.
The specific embodiment
Doctor trained in Western medicine thinks that the pathogenic factors of renal calculus is very complicated; Clear and definite influence factor comprises heredity, sex, age, metabolism, infection, dietary structure, moisture absorption; Even relevant with socioeconomic status, also the someone think with the working environment air in dust concentration relevant.Motherland's medical science has a deep understanding to the pathology of urolithiasis.Think " a little less than kidney qi, the pathogenic heat crescendo " (Huatuo's Zhongzang classic)." suffer from a deficiency of the kidney and bladder is warm " (source of disease), " it is moving that essence exhausts fire " endogenous causes of ill such as (units of medical association) is taken advantage of by heat so that suffer from a deficiency of the kidney, and then causes that gasification is not normal, and is vehement with the stasis of blood damp and hot friendship of QI and blood that stagnates again, with the passing of time ties to gather to form sandstone.In " medical science stream purport ", have " stranguria caused by urinary stone is that the bladder accumulation of heat forms, especially like the soup bottle for a long time in fire, the white alkali of bear building-up and can not go " record." control wet not diuresis, Fei Qizhi also.”
It is to cause that residue is difficult to discharge in the urine owing to suffer from a deficiency of the kidney that renal calculus forms; Generate crystal, receive its damp and hot with the passing of time Cheng Shi that decocts, or cause stagnation of QI blood stasis because of insufficiency of kidney-YANG and damp-heat accumulation, irritability stasis, damage cause the stasis of blood etc.; Stasis of blood heat-transformation of a specified duration; Heat is annotated bladder, and the gasification function of kidney and bladder is not normal in addition, and heat decocts crystal Cheng Shi in the urine for a long time.
The etiology and pathogenesis that forms renal calculus is an internal organs QI and blood functional disorder, and stagnation of damp-heat is in kidney and bladder, and physiological function is impaired, and the gasification of water liquid is drained disorderly, remains in water and urine in kidney and the bladder, and deposition concentrates and turns to lump, and rust joint changes from small to big becomes calculus.Certainly can't get rid of patient residence of living in and water quality situation, diet and living habit, every day amount of drinking water few, urine concentration is high and calculus forms substantial connection.The method of treatment renal calculus is the Pumex of surging, and current stone is capable, washes away the discharge calculus.
Therefore; The present invention is with the principle of " eliminating stagnation softening the hard mass, row stagnate and dredge profit, removing summer-heat is hot and suffocating " combination " freeing lung-Qi and eliminating damp, the suitable spleen of the kidney warming, blood circulation promoting and blood stasis dispelling " as the treatment primary disease; Be main wherein with " the kidney warming should spleen, blood circulation promoting and blood stasis dispelling ", with " determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs " as treatment primary disease practical basis clinically.In whole therapeutic process, all following the principle of " is usefulness to lead to ".
Based on this principle, Chinese medicine of the present invention comprises following component: Myrrha, triangular, Folium Callicarpae Formosanae, Radix Salviae Miltiorrhizae, Fructus Psoraleae, the Radix Linderae, Herba Glechomae, Herba Lysimachiae, Cortex Cinnamomi, Flos Caryophylli, Semen Sesami Nigrum, Herba Ecliptae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Semen Plantaginis, Flos Lonicerae and Lasiosphaera Seu Calvatia.
Myrrha promoting blood circulation to remove blood stasis, detumescence and promoting granulation in the side, Folium Callicarpae Formosanae cooling blood for hemostasis, dissipating blood stasis for subsidence of swelling, triangular, Folium Callicarpae Formosanae removing stasis to stop bleeding; The Fructus Psoraleae warming the kidney to activate YANG, Radix Linderae warming kidney for dispelling cold, the Herba Glechomae dampness removing is treating stranguria; Herba Lysimachiae Tonglin Paishi, removing toxic substances and promoting subsidence of swelling, Cortex Cinnamomi, Flos Caryophylli dispersing cold for relieving pain, warming the meridian and promoting blood circulation, Semen Sesami Nigrum, Herba Ecliptae liver and kidney tonifying; The Radix Astragali, Rhizoma Dioscoreae air making-up and spleen enlivening, YIN nourishing and the production of body fluid promoting, Semen Plantaginis relieving stranguria by diuresis, Flos Lonicerae, Lasiosphaera Seu Calvatia heat-clearing and toxic substances removing; All medicines share, play altogether " eliminating stagnation softening the hard mass, row stagnate dredge sharp, removing summer-heat is hot and suffocating, freeing lung-Qi and eliminating damp, the suitable spleen of the kidney warming, blood circulation promoting and blood stasis dispelling " merit.
Each component pharmacology is following in the side:
Myrrha: bitter in the mouth, suffering, property is flat, goes into liver, spleen, the heart, kidney channel; Has diffusing blood blood stasis removing; The effect of subduing swelling and relieving pain is used to control cards such as traumatic injury, incised wound, muscles and bones, all pains of trusted subordinate, lump in the abdomen, amenorrhea, ulcer sore pain, anal fistula, diseases of the eye, and " Bencao Jingshu ": the Myrrha bitter in the mouth is flat nontoxic.Right putting down should be made suffering, and gas should be slightly cold.All malignant boil anal fistula all forms because of the heat in blood stasis of blood stagnates, and receives Jin Ren and flogging trauma to make skin ulcer outward, and also all flesh and blood receives disease.Flesh and blood is hindered then the stasis of blood and is generated heat and have a pain, and this medicine hardship can be let out, hot can loosing, the ability of trembling with fear heat extraction.Water belongs to cloudy, and blood also belongs to the moon, with class from, so can go into blood system, dissipating blood stasis blood, control all skin ulcers of heat in blood and soldier right under blood disorder also.The Liver Channel heat in blood, then order is also pain, skin nebula, the heat in blood of the Liver Channel that looses, then the order disease is removed.
Triangular: bitter in the mouth, suffering, property is flat, goes into liver, spleen channel, has the removing blood stasis circulation of qi promoting, and removing food stagnancy analgesic effect is used for the blood stasis amenorrhea, dysmenorrhea, the stasis of blood stagnated and suffered from abdominal pain lump in the abdomen mass in the abdomen in the abdomen, stagnation of QI due to dyspepsia, cards such as abdominal distention puerperal.
Folium Callicarpae Formosanae: property is flat; Distinguish the flavor of little suffering, hardship have hemostasis and anti-inflammation, the effect of dissipating blood stasis for subsidence of swelling; Be used for that gastric and duodenal ulcers is hemorrhage, traumatic hemorrhage, epistaxis, gingiva bleeding gingival hemorrhage, sprain swell and ache, card such as suppurative skin ulcer, burn, influenza; Folium Callicarpae Formosanae is because of having the merit of removing stasis to stop bleeding, analgesic therapy, and the speciality of the stasis of blood is not stayed in hemostasis, so skin lesion, the hematuria that causes behind the rubble played decisive role." Chinese medicine sea " the record Folium Callicarpae Formosanae beginning is stated from supplement to the Herbal, for Verenaceae Callicarpa plant callicarpa pedunculata and Callicarpa dichotoma, is used as medicine with stem, leaf and root.Nature and flavor are bitter, puckery, cool, return liver, spleen two warps, and effect cures mainly, and hemostasis with astringents is astringing to arrest bleeding good medicine.Folium Callicarpae Formosanae is widely used in treatment spitting of blood, hematemesis, epistaxis, hematuria, has blood in stool, external haemorrhage card in metrostaxis and the wound hemorrhage etc.Modern pharmacological research shows that the Folium Callicarpae Formosanae injection can make platelet increase to human body, and contract time, hemase elementary time of bleeding time, blood shortens; To frog mesentery performance vasoconstriction; The Folium Callicarpae Formosanae drips of solution on the rabbit intestinal wall, can be caused the strong spasm contraction of intestinal tube, and serous coat is bleached by pink, to the rabbit bleeding time, can make it to shorten; Folium Callicarpae Formosanae all has anastalsis to liver, trauma of spleen and gunshot wound.
Radix Salviae Miltiorrhizae: bitter in the mouth, cold nature is gone into the heart, Liver Channel, has promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, the removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, the effect of nourishing blood to tranquillize the mind is used for menoxenia, the amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, cards such as angina pectoris, " book on Chinese herbal medicine is looked for the truth ": Radix Salviae Miltiorrhizae, book carry can go into percardium removing blood stasis with potent drugs one language, to the greatest extent the Radix Salviae Miltiorrhizae effect.Opinion is so arranged, and it is can tissue regeneration promoting antiabortive, and the regulating menstruation relieving restlessness is reposed and decided will, and all migratory arthralgia, metrorrhagia and leukorrhagia, lump in the abdomen, conjunctival congestion, colic, skin ulcer scabies disease such as swell and ache, and is always all gone by its stasis of blood, removes invariably to see disease, non-very can be antiabortive with tissue regeneration promoting, repose and decide will also.
Fructus Psoraleae: acrid in the mouth, hardship, warm in nature, go into kidney, spleen channel, kidney invigorating and YANG supporting is arranged, warming spleen and stopping diarrha effect is mainly used in decline of the fire from the gate of life, the chills and pain of the waist and kness of below element deficiency and cold, frequent urination and enuresis, sexual impotence lingering diarrhea; It is cold that insufficiency of kidney-YANG, spleen soil lose using warming therapy stomachache limb, has loose bowels just before dawn, and Fructus Psoraleae also has the antidiarrheal effect.
The Radix Linderae: acrid in the mouth, warm in nature, go into lung, spleen, kidney, urinary bladder channel, promoting the circulation of QI to relieve pain are arranged; The effect of warming kidney for dispelling cold, it is vexed to be used for fullness in the chest and hypochondrium, abdominal distention, headache; Colic of cold type pain due to the QI stagnated by cold, abdominal pain during menstruation and puerperal abdonimal pain, following first deficiency and coldness, the frequent micturition of failure in functioning of QI; Card such as the enuresis or dysuria, the Radix Linderae can accelerate blood circulate, and makes local vascular dilation.
Herba Glechomae: Herba Glechomae acrid in the mouth, little hardship, cold nature is gone into liver, kidney, urinary bladder channel, and it is treating stranguria to have a dampness removing, heat-clearing and toxic substances removing; The effect of dissipating blood stasis for subsidence of swelling is used for pyretic stranguria, stranguria caused by urinary stone, jaundice due to damp-heat; The skin infection carbuncle, rheumatism pyretic arthralgia, traumatic injury, cards such as pain caused by ecchymoma; Herba Glechomae has remarkable diuresis, and the effect of dissolving calculus is arranged, and can make urine become acidity, and make the litholysis that is present under the alkali condition.
Herba Lysimachiae: sweet in the mouth, slightly stringy pulse, cold nature is gone into liver, gallbladder, kidney, urinary bladder channel, has the effect of clearing away heat-damp and promoting diuresis, Tonglin Paishi, removing toxic substances and promoting subsidence of swelling, cures mainly liver and gall and urinary system calculus; Pyretic stranguria; Oedema due to nephritis; Jaundice due to damp-heat; The sore carbuncle; Venom; Cards such as traumatic injury, Herba Lysimachiae have cholagogic and lithagogue and diuresis and expelling stone effect, can cause that ureter epimere cavity pressure increases, and ureteral peristalsis strengthens, and the urine amount increases, and ureteral calculus is had extruding and percussion, impel ureteral calculus to discharge.
Cortex Cinnamomi: acrid in the mouth, sweet, extremely hot in nature is returned kidney, spleen, the heart, Liver Channel, and it is fiery supporing yang to have benefit, let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow, warming the spleen and stomach, removing accumulated cold, the effect of promoting blood circulation.Control decline of the fire from the gate of life, the cold extremities faint pulse, the YANG-depletion collapse, stomachache is had loose bowels, the colic of cold type renal mass, chills and pain of the waist and kness, the amenorrhea lump in the abdomen, carbuncle of yin nature, multiple abscess, and empty sun is more floating, cards such as heat in the upper and cold in the lower.
Flos Caryophylli: sweet in the mouth, suffering, extremely hot in nature, have warming the stomach, the effect of the kidney warming is used for cards such as cold syndrome of the stomach pain with distension, singultus, vomiting and diarrhoea, arthralgia pain, colic, halitosis, toothache.
Semen Sesami Nigrum: sweet in the mouth, property is flat, returns liver, kidney, large intestine channel, has invigorating the liver and kidney, benefiting essence-blood, the effect that intestine moistening is dry is used for dizziness and blurred vision, Hiccough and deaf, early whitening of beard and hair, post disease alopecia, cards such as dryness of the intestine constipation.
Herba Ecliptae: sweet in the mouth, acid, cold in nature, return liver, kidney channel, play liver and kidney tonifying, the effect of cooling blood for hemostasis is used for having a dizzy spell due to the hepatic and renal YIN deficiency, blurring of vision, soreness of the waist and knees; Be suitable for the deficiency of YIN hot person is arranged; Be used for treating the haematemesis of the long-pending heat of stomach; Symptoms such as the hemoptysis of injury of blood vessel of the lung by heat, Herba Ecliptae has inhibitory action to staphylococcus aureus, Bacillus typhi, Song Shi dysentery bacterium, bacillus pyocyaneus, obviously enhancing non-specific immunity and cellular immune function.
The Radix Astragali: sweet in the mouth, warm in nature, go into spleen, lung meridian, tonification spleen soil is arranged; Elevate a turnable ladder yang-energy, strengthening superficial resistance to stop perspiration, effects such as holder skin ulcer granulation promoting are mainly used in the weak anorexia and loose stool due to the deficiency of both the splenic and pulmonary QI, shortness of breath and palpitation; The visceroptosis of sinking of QI of middle-JIAO, the metrorrhagia of QI failing to control blood is had blood in stool, the chronic diarrhea proctoptosis; The spontaneous sweating of exterior deficiency, cards such as insufficiency of vital energy and blood, the Radix Astragali strengthen the heart contraction ability, can improve the blood circulation of whole body, can coronary artery dilator, kidney blood vessel and Rhizoma Bistortae peripheral vessel, make cutaneous circulation vigorous; Can improve the nonspecific immunity power of body, the effect that protects the liver with blood sugar lowering is arranged, staphylococcus, blood dissolubility streptococcus, Diplococcus pneumoniae, dysentery bacterium etc. are had inhibitory action.
The Rhizoma Atractylodis Macrocephalae: bitter, sweet, warm in nature, go into spleen, stomach warp, have invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive effect.Be used for deficiency of spleen-QI and stomach-QI, fortuneization is unable, dysuria due to the anorexia and loose stool, the soft Mental fatigue of limb, spleen insufficiency, retention of water-damp in the body, and edema, distention and fullness in the chest and hypochondrium, deficiency of spleen-QI and stomach-QI, cards such as frequent fetal movement, the Rhizoma Atractylodis Macrocephalae can improve body's immunological function, leukocyte increasing quantity.
Semen Plantaginis: sweet in the mouth, cold in nature, go into kidney, urinary bladder channel, have relieving stranguria by diuresis; Liver heat removing and eyesight improving, the effect of removing heat from the lung and dissipating phlegm is used for dysuria, drenches the puckery pain of drop; Have loose bowels, the wind heat Akamu swells and ache, cards such as the many tears of photophobia; Semen Plantaginis has diuresis, has the strong sedimentary effect of inhibition kidney calcium oxalate crystal, can prevent the formation of renal calculus.
Flos Lonicerae: sweet in the mouth, cold in nature, go into the heart, lung, stomach, large intestine channel, the effect of heat-clearing and toxic substances removing is arranged, holding concurrently can eliminating pathogenic heat from blood to cure dysentery.Be mainly used in affection due to external wind and heat, epidemic febrile disease pyretic toxicity and contain, or epidemic febrile disease is from the beginning of pathogenic heat still at the part of the body cavity above the diaphragm housing the heart and lungs and when not descending; Pyretic toxicity dysentery, stool hematochezia; The fever disease in summer card; The carbuncle sore that pyretic toxicity gathers is from the beginning of the 、 inflammation heat person of swelling and ache etc., and Flos Lonicerae has antipyretic effect preferably, can antiinflammatory, and what control inflammation oozes out and inflammatory hyperplasia, can promote leukocytic phagocytic function, and multiple pyococcus and pathogenic entero becteria are had stronger bacteriostasis.
Lasiosphaera Seu Calvatia: acrid in the mouth, property are put down, and go into lung meridian, have moistening lung and nourishing throat, and detoxifcation hemostatic effect is used for laryngopharynx swelling and pain, lung-heat cough with asthma, pharyngitis, hoarseness, hemorrhage, chilblain, cards such as decubital ulcer.
Further preferred, the said Chinese medicine that is used to treat renal calculus only is made up of said components.
The said Chinese medicine that is used for treating renal calculus, the ratio of weight and number of various components can be preferably: 25~35 weight portion Myrrhas, 18~24 weight portions are triangular, 28~36 weight portion Folium Callicarpae Formosanaes, 21~27 weight portion Radix Salviae Miltiorrhizaes, 45~55 weight portion Fructus Psoraleaes, 14~18 weight portion Radixs Linderae, 35~40 weight portion Herba Glechomaes, 45~55 weight portion Herba Lysimachiaes, 16~20 weight portion Cortex Cinnamomis, 20~24 weight portion Flos Caryophyllis, 50~60 weight portion Semen Sesami Nigrums, 60~70 weight portion Herba Ecliptaes, 35~45 weight portion Radixs Astragali, 27~33 weight portion Rhizoma Atractylodis Macrocephalaes, 37~43 weight portion Semen Plantaginiss, 10~16 weight portion Flos Loniceraes and 8~12 weight portion Lasiosphaera Seu Calvatia.
The said Chinese medicine that is used for treating renal calculus, the ratio of weight and number of various components also can further be preferably: 30~35 weight portion Myrrhas, 22~24 weight portions are triangular, 32~36 weight portion Folium Callicarpae Formosanaes, 24~27 weight portion Radix Salviae Miltiorrhizaes, 50~55 weight portion Fructus Psoraleaes, 16~18 weight portion Radixs Linderae, 38~40 weight portion Herba Glechomaes, 50~55 weight portion Herba Lysimachiaes, 18~20 weight portion Cortex Cinnamomis, 22~24 weight portion Flos Caryophyllis, 55~60 weight portion Semen Sesami Nigrums, 66~70 weight portion Herba Ecliptaes, 40~45 weight portion Radixs Astragali, 30~33 weight portion Rhizoma Atractylodis Macrocephalaes, 40~43 weight portion Semen Plantaginiss, 13~16 weight portion Flos Loniceraes and 10~12 weight portion Lasiosphaera Seu Calvatia.
The said Chinese medicine that is used for treating renal calculus, the ratio of weight and number of various components also can further be preferably: 32 weight portion Myrrhas, 23 weight portions are triangular, 34 weight portion Folium Callicarpae Formosanaes, 26 weight portion Radix Salviae Miltiorrhizaes, 53 weight portion Fructus Psoraleaes, the 17 weight portion Radixs Linderae, 40 weight portion Herba Glechomaes, 52 weight portion Herba Lysimachiaes, 18 weight portion Cortex Cinnamomis, 24 weight portion Flos Caryophyllis, 60 weight portion Semen Sesami Nigrums, 68 weight portion Herba Ecliptaes, the 43 weight portion Radixs Astragali, the 32 weight portion Rhizoma Atractylodis Macrocephalaes, 43 weight portion Semen Plantaginiss, 13 weight portion Flos Loniceraes and 10 weight portion Lasiosphaera Seu Calvatia.
The said dosage form that is used to treat the Chinese medicine of renal calculus can be preferably decoct, injection, tablet for various common dosage forms, and administering mode is preferably oral or injection.
When the dosage form of Chinese medicine of the present invention was decoct, its preparation method may further comprise the steps:
100~200 purpose powder are pulverized and be screened into to the first step with said component proportional mixing;
Second step obtained powder with the first step and adds in the cold water and soaked 3 hours~5 hours, and with slow fire boiling, decocting time is 2 hours~3 hours, and decoction liquor is filtered, and obtains first filtrating, and the quality that institute adds water is 2~4 times of powder quality of first step acquisition;
In the 3rd step, the filtering residue that second step filter was obtained adds in the cold water once more, with slow fire boiling 1 hour~2 hours, filters and obtains second filtrating, identical in the quality of the water that is added and second step;
The 4th step merged filtrating twice, obtained said decoct.
When the dosage form of Chinese medicine of the present invention was injection, its preparation method may further comprise the steps:
The first step with said component proportional mixing, is ground into 100~200 purpose powder, adds in the cold water to soak 3 hours~5 hours; With slow fire boiling 2 hours~3 hours, the quality of the cold water that is added was 2~4 times of the mixture quality that obtains of the first step, and decoction liquor is filtered; Filtering residue is put into cold water once more, and with slow fire boiling 1 hour~2 hours, the quality of the cold water that is added was 1~2 times of the mixture quality that obtains of the first step; Merge filtrate, concentrating under reduced pressure obtains the condensed water extract;
Second step made concentration of alcohol reach concentration 70~85% with adding ethanol in the spissated water extract of first step acquisition, left standstill, and filtered, and the filtrating that obtains is concentrated recovery section ethanol, refiltered the acquisition filtering liquid medicine;
The 3rd step, second step was handled medicinal liquid that the back obtains through Semi-polarity macroporous adsorbent resin or low polar macroporous adsorption resin, first water or concentration are lower than 20% ethanol and are eluted to eluent as eluent and are colourless; It is 1~1.5 times of the mixture quality that obtains of the first step that employed water or concentration are lower than 20% alcoholic acid quality, and reuse concentration is 90%~95% ethanol elution, collects ethanol elution; Employed concentration is that 90%~95% alcoholic acid quality is 3~5 times of the mixture quality that obtains of the first step, and the pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 6.5~7.5, places; Filter, concentrate and reclaim ethanol, the acquisition ethanol content is 10%~15% solution; Through polyamide resin column, first water is eluted to eluent and is closely colourless, and the quality of employed water is 1~1.5 times of the mixture quality that obtains of the first step; The reuse determining alcohol is 80%~95% ethanol elution, collects ethanol elution, employed consistency be 80%~95% alcoholic acid quality be 1~1.5 times of the mixture quality that obtains of the first step; Reclaim ethanol; Concentrate, drying under reduced pressure obtains and gets dry extract;
The 4th step is with the dried cream of the 3rd step acquisition, behind 5~10 times of waters for injection of adding with respect to dried cream quality; With 0.5mol/L sodium hydroxide adjust pH to 6.0~7.0, press 0.2g/100ml and add active carbon, adding 10% ethanol to crude drug concentration again is 1.15g/100ml~1.25g/100ml; Stirred 10 minutes, the microporous filter membrane with 0.45 μ m, 0.22 μ m filters respectively, promptly obtains injection; The injection that obtains is propped up the branch cillin bottle of packing into by 10ml/, add a cover butyl rubber plug and aluminium lid, 115 ℃ of pressure sterilizings 30 minutes; Label check.
When the dosage form of Chinese medicine of the present invention was sheet, its preparation method may further comprise the steps:
The first step with said component proportional mixing, is ground into 100~200 purpose powder, adds in the cold water to soak 3 hours~5 hours; With slow fire boiling 2 hours~3 hours, the quality of the cold water that is added was 2~4 times of the mixture quality that obtains of the first step, and decoction liquor is filtered; Filtering residue is put into cold water once more, and with slow fire boiling 1 hour~2 hours, the quality of the cold water that is added was 1~2 times of the mixture quality that obtains of the first step; Merge filtrate, concentrating under reduced pressure obtains the condensed water extract;
Second step made concentration of alcohol reach concentration 70~85% with adding ethanol in the spissated water extract of first step acquisition, left standstill, and filtered, and the filtrating that obtains is concentrated recovery section ethanol, refiltered the acquisition filtering liquid medicine;
The 3rd step, second step was handled medicinal liquid that the back obtains through Semi-polarity macroporous adsorbent resin or low polar macroporous adsorption resin, first water or concentration are lower than 20% ethanol and are eluted to eluent as eluent and are colourless; It is 1~1.5 times of the mixture quality that obtains of the first step that employed water or concentration are lower than 20% alcoholic acid quality, and reuse concentration is 90%~95% ethanol elution, collects ethanol elution; Employed concentration is that 90%~95% alcoholic acid quality is 3~5 times of the mixture quality that obtains of the first step, and the pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 6.5~7.5, places; Filter, concentrate and reclaim ethanol, the acquisition ethanol content is 10%~15% solution; Through polyamide resin column, first water is eluted to eluent and is closely colourless, and the quality of employed water is 1~1.5 times of the mixture quality that obtains of the first step; The reuse determining alcohol is 80%~95% ethanol elution, collects ethanol elution, employed concentration be 80%~95% alcoholic acid quality be 1~1.5 times of the mixture quality that obtains of the first step; Reclaim ethanol; Concentrate, drying under reduced pressure obtains and gets dry extract;
The 4th step with the dried cream of above-mentioned acquisition, added excipient and granulates, and drying adds disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or the bag film-coat promptly obtains product.
Wherein, excipient is starch and derivant, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hypromellose and pharmaceutic adjuvant with water swelling; Described lubricant is the pharmaceutic adjuvant of Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication; Described sugar coating material is sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Described thin film coating material is that water, the alcohol of stomach dissolution type dissolves coating material.Wherein excipient, disintegrating agent, lubricant, sugar coating, the weight content of bag film-coat material in medicine are respectively: 5~70%, 1~30%, 0.1~10%, 35~90%, 1.5~5%.
Said macroporous adsorbent resin model can be D101, AB-8, X-5, HPD100.
Below adopt embodiment to specify embodiment of the present invention, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can make much of and implement according to this.
The toxicity test of embodiment 1 Chinese medicine of the present invention
1, test medication:
35g Myrrha, 24g is triangular, 36g Folium Callicarpae Formosanae, 27g Radix Salviae Miltiorrhizae, 55g Fructus Psoraleae, the 18g Radix Linderae, 40g Herba Glechomae, 55g Herba Lysimachiae, 20g Cortex Cinnamomi, 24g Flos Caryophylli, 60g Semen Sesami Nigrum, 70g Herba Ecliptae, the 45g Radix Astragali, the 33g Rhizoma Atractylodis Macrocephalae, 43g Semen Plantaginis, 16g Flos Lonicerae and 12g Lasiosphaera Seu Calvatia mix, and are ground into 200 purpose powder, add in the 1800g cold water and soak 4 hours, with slow fire boiling 3 hours; Decoction liquor is filtered, and filtering residue is put into 700g cold water once more, with slow fire boiling 2 hours, merges filtrate; Concentrating under reduced pressure obtains the condensed water extract, makes concentration of alcohol reach concentration 70% with adding ethanol in the spissated water extract that obtains, and leaves standstill; Filter, the filtrating that obtains is concentrated recovery section ethanol, refilter, obtain filtering liquid medicine; With the macroporous adsorbent resin of the medicinal liquid that obtains through the D101 model, be eluted to eluent with 700g water as eluent earlier and be colourless, reuse 2000g concentration is 95% ethanol elution, collects ethanol elution; The pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 7, places, and filters, and concentrates to reclaim ethanol; The acquisition ethanol content is 15% solution, through polyamide resin column, is closely colourless with 700g water elution to eluent earlier, and reuse 1000g determining alcohol is 95% ethanol elution; Collect ethanol elution, reclaim ethanol, concentrate; Drying under reduced pressure obtains and gets dry extract, and adds 50g starch subsequently and granulates; Drying adds 10g sodium carboxymethyl cellulose, 8g Polyethylene Glycol again, and tabletting obtains the tablet product.
2, acute toxicity test process:
Get 60 of ICR mices (Beijing Vital River Experimental Animals Technology Co., Ltd. provides), body weight is smashed the Chinese medicinal tablet of the present invention that obtains to pieces powdered at 25~30 grams, and companion's water is irritated the stomach mice, to the median lethal dose(LD 50) (LD of administration 50) carried out test determination, but do not measure LD 50, therefore carried out mtd test.Result: with Cmax (60%); Maximum dosage-feeding (120ml/kg divides in one day to give for four times) 100g/kg irritates stomach, is equivalent to crude drug amount 60g/kg; 300 times (pressing 75kg) of the daily dosage of clinical plan are equivalent to be grown up; None death of mice in seven days is put to death each internal organs of mice anatomic observation and is not found toxic reaction, and administration group and control group mice do not have any difference.
2, long term toxication process:
Application Wistar rat (Beijing Vital River Experimental Animals Technology Co., Ltd. provides) will be tested medicine and will be set at high, medium and low three dosage, be respectively tablet 8g/kg, 4g/kg, 2g/kg.Press human dosage 0.1g/kg/ sky-backing and calculate, be 80 times, 40 times and 20 times of human effective dose; Other establishes a matched group, and gastric infusion 90 days, 180 days and the drug withdrawal of part animal were observed the influence to rat each item physiology, biochemical indicator after 10 days continuously.Experimental result shows: gave the rat continuous oral 180 days with various dose, food-intake and the body weight gain of rat all do not had influence.Hepatic and renal function is not all found the overt toxicity effect.Routine blood test, blood are biochemical, urine is biochemical and bone marrow sheet etc. all do not seen obvious influence, between each group with matched group no significant difference relatively.
The tablet of embodiment 2 Chinese medicine preparations of the present invention
32g Myrrha, 23g is triangular, 34g Folium Callicarpae Formosanae, 26g Radix Salviae Miltiorrhizae, 53g Fructus Psoraleae, the 17g Radix Linderae, 40g Herba Glechomae, 52g Herba Lysimachiae, 18g Cortex Cinnamomi, 24g Flos Caryophylli, 60g Semen Sesami Nigrum, 68g Herba Ecliptae, the 43g Radix Astragali, the 32g Rhizoma Atractylodis Macrocephalae, 43g Semen Plantaginis, 13g Flos Lonicerae and 10g Lasiosphaera Seu Calvatia mix, and are ground into 200 purpose powder, add in the 1800g cold water and soak 4 hours, with slow fire boiling 3 hours; Decoction liquor is filtered, and filtering residue is put into 700g cold water once more, with slow fire boiling 2 hours, merges filtrate; Concentrating under reduced pressure obtains the condensed water extract, makes concentration of alcohol reach concentration 70% with adding ethanol in the spissated water extract that obtains, and leaves standstill; Filter, the filtrating that obtains is concentrated recovery section ethanol, refilter, obtain filtering liquid medicine; With the macroporous adsorbent resin of the medicinal liquid that obtains through the D101 model, be eluted to eluent with 700g water as eluent earlier and be colourless, reuse 2000g concentration is 95% ethanol elution, collects ethanol elution; The pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 7, places, and filters, and concentrates to reclaim ethanol; The acquisition ethanol content is 15% solution, through polyamide resin column, is closely colourless with 700g water elution to eluent earlier, and reuse 1000g determining alcohol is 95% ethanol elution; Collect ethanol elution, reclaim ethanol, concentrate; Drying under reduced pressure obtains and gets dry extract, and adds 50g starch subsequently and granulates; Drying adds 10g sodium carboxymethyl cellulose, 8g Polyethylene Glycol again, and tabletting obtains the tablet product.
The injection of embodiment 3 Chinese medicine preparations of the present invention
34g Myrrha, 23g is triangular, 35g Folium Callicarpae Formosanae, 26g Radix Salviae Miltiorrhizae, 53g Fructus Psoraleae, the 18g Radix Linderae, 39g Herba Glechomae, 55g Herba Lysimachiae, 19g Cortex Cinnamomi, 24g Flos Caryophylli, 58g Semen Sesami Nigrum, 68g Herba Ecliptae, the 44g Radix Astragali, the 33g Rhizoma Atractylodis Macrocephalae, 43g Semen Plantaginis, 15g Flos Lonicerae and 12g Lasiosphaera Seu Calvatia mix, and are ground into 200 purpose powder, add in the 1800g cold water and soak 4 hours, with slow fire boiling 3 hours; Decoction liquor is filtered, and filtering residue is put into 700g cold water once more, with slow fire boiling 2 hours, merges filtrate; Concentrating under reduced pressure obtains the condensed water extract, makes concentration of alcohol reach concentration 70% with adding ethanol in the spissated water extract that obtains, and leaves standstill; Filter, the filtrating that obtains is concentrated recovery section ethanol, refilter, obtain filtering liquid medicine; With the macroporous adsorbent resin of the medicinal liquid that obtains through the D101 model, be eluted to eluent with 700g water as eluent earlier and be colourless, reuse 2000g concentration is 95% ethanol elution, collects ethanol elution; The pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 7, places, and filters, and concentrates to reclaim ethanol; The acquisition ethanol content is 15% solution, through polyamide resin column, is closely colourless with 700g water elution to eluent earlier, and reuse 1000g determining alcohol is 95% ethanol elution; Collect ethanol elution, reclaim ethanol, concentrate drying under reduced pressure; Obtain and get dry extract, with the dried cream that obtains, add 7000g water for injection after, with 0.5mol/L sodium hydroxide adjust pH to 7.0; Press 0.2g/100ml and add active carbon, adding 10% ethanol to crude drug concentration again is 1.20g/100ml, stirs 10 minutes, and the microporous filter membrane with 0.45 μ m, 0.22 μ m filters respectively; Promptly obtain injection, the injection that obtains is propped up the branch cillin bottle of packing into by 10ml/, add a cover butyl rubber plug and aluminium lid; 115 ℃ of pressure sterilizings 30 minutes are labelled, check.
The decoct of embodiment 4 Chinese medicine preparations of the present invention
34g Myrrha, 23g is triangular, 35g Folium Callicarpae Formosanae, 26g Radix Salviae Miltiorrhizae, 53g Fructus Psoraleae, the 18g Radix Linderae, 39g Herba Glechomae, 55g Herba Lysimachiae, 19g Cortex Cinnamomi, 24g Flos Caryophylli, 58g Semen Sesami Nigrum, 68g Herba Ecliptae, the 44g Radix Astragali, the 33g Rhizoma Atractylodis Macrocephalae, 43g Semen Plantaginis, 15g Flos Lonicerae and 12g Lasiosphaera Seu Calvatia mix, and pulverize and be screened into 200 purpose powder, will obtain powder and add in the 1800g cold water immersion 5 hours; With slow fire boiling, decocting time is 3 hours, and decoction liquor is filtered; Obtain first filtrating; Add once more in the 1800g cold water filtering the filtering residue that obtains,, filter and obtain second filtrating with slow fire boiling 2 hours; Merge filtrating twice, obtain said decoct.
Embodiment 5 zooperies
1 experiment material
1.1 experimental animal
90 of male SD rats, body weight 180~220g, regular grade is available from Anhui Province medical university Experimental Animal Center.
1.2 trial drug
Become stone liquid: by containing ethylene glycol 12.5g+ ammonium chloride 10g preparation in every liter of liquid;
The tablet of the embodiment of the invention 2 preparations;
Ethylene glycol is available from the good girl of Wuxi City chemical plant;
Ammonium chloride is available from Quzhou, Zhejiang hugeization reagent company limited;
Potassium citrate is available from Shanghai chemical reagent purchasing and supply station.。
1.3 test apparatus
Centrifuge, ordinary optical microscope, refiner, ultraviolet spectrophotometer.
1.4 animal divides into groups and pharmaceutical intervention
90 rats are divided into 3 groups at random, i.e. positive controls (model group), Chinese drug-treated group of the present invention (experimental group), curative effect comparision group (potassium citrate group), 30 every group, adaptability was raised 3 days.
All animals become stone liquid 10ml (freely absorbing)+water 30ml (freely absorbing) every day.The A group gives normal saline, and every animal 2ml every day irritates stomach; B group gives the tablet of the embodiment of the invention 2 preparations, every animal 0.6g/ days; C group gives potassium citrate, every animal 0.5g/ days.More than each medicine all be configured to 2ml liquid and irritate stomach.Dosage proportionately people's consumption calculates, and sees table 1.
Table 1 animals administer amount computer chart
Dosage (g) Chinese medicine of the present invention Monopotassium citrate
Adult 60kg 30.0 25.0
SD rat 200g * coefficient (k=6.25) 0.6 0.5
1.5 observation index and method
After raising for 4 weeks, get BIAO and BEN the same period.
(1) access urine, smear is observed the urine Calcium Oxalate, and every smear is got 5 high power fields, the assessment of averaging.Criterion: (-): do not see calcium oxalate crystal in the high power field; (<+): 0~10/HP; (+): 10~20/HP; (++): 20~30/HP; (+++):>30/HP.
(2) with 10% chloral hydrate 1ml lumbar injection, promptly cut open the belly after the anesthetized rat success and get two kidneys, the fixing conventional section statining in back of all left side kidneys, ordinary optical microscope is observed the kidney calcium oxalate crystal down and is formed situation.Criterion: (-): do not see calcium oxalate crystal in the high power field; (+): renal cortex and medullary substance intercrystalline are main, about 0~40/HP; (++): renal papillae and renal pelvis intercrystalline are main, pact>40/HP.
(3) right kidney calcium oxalate crystal quantity in average each high power field of counting.Method: get conventional section statining after right kidney 1/3 fixation of tissue, ordinary optical microscope is observed down, 5 high power fields countings of every sections observation calcium oxalate crystal quantity, meansigma methods.(4) after right kidney 2/3 tissue is weighed, add and prepare tissue homogenate with interior cut Potter-Elvehjem Tissue Grinders after 1mol/LHCl10ml soaks 4h, the centrifugal 20min of 3000r/min gets supernatant and surveys oxalic acid content with the chromotropic acid colorimetry.
1.6 statistical method
Adopt SPSS 11.5 statistical packages,, adopt mean t-check relatively for right calcium oxalate crystal quantity and oxalic acid content index; Judge left kidney calcium oxalate crystal situation for urine examination and semiquantitative method, adopt the Mann-Whitney U check of non parametric tests (rank test); For the comparison of gallstone formation rate, adopt pearson Chi-square check.
1.7 result
1.7.1 animals survived situation
Raise in the administration process, animal does not all occur dead, so so obtain 90 rats that have of experimental data.
1.7.2 the urine Calcium Oxalate detects
Calcium oxalate crystal is prone to observe under ordinary optical microscope, shows as the luminous octahedron of colourless square flicker, has 2 diagonal to intersect each other, presents rhombus sometimes, and idol is cheese or dumbbell shape.Testing result is seen table 2.
Table 2 is respectively organized semiquantitative method urine Calcium Oxalate detection case (only)
Figure BSA00000682248200161
Visible by table 2, B group (Chinese drug-treated group of the present invention) Calcium Oxalate is drained apparently higher than A group (positive controls) and C group.
1.7.3 left kidney calcium oxalate crystal detects
After the nephridial tissue section HE dyeing, calcium oxalate crystal shows as: light blue crystal, and irregular, refractivity is strong, and testing result is seen table 3.
Table 3 is respectively organized semiquantitative method left side kidney calcium oxalate crystal detection case (only)
Figure BSA00000682248200171
Visible by table 3, B organizes left kidney calcium oxalate crystal and obviously is less than A group and C group.
1.7.4 calcium oxalate crystal and kidney oxalic acid content are measured
The result sees table 4, and is visible by table 4, and B organizes right kidney calcium oxalate crystal quantity and obviously is less than A group and C group.
Table 4 count testing situation right renal calcium oxalate crystals and chromotropic acid colorimetric determination of oxalic acid in the right kidney (
Figure BSA00000682248200172
mmol / L)
Group n The kidney calcium oxalate crystal (/HP) Right kidney oxalic acid content (mmol/L)
The A group 30 43.1±30.7 0.81±0.25
The B group 30 10.0±9.6 0.41±0.12
The C group 30 12.8±10.7 0.75±0.23
Clinical data
This group case is all through ultrasound diagnosis, and IVU is diagnosed as the kidney calculi symptom patient, and 100 routine cases are divided into two groups according to patient's symptom, tongue, pulse condition, and with waist dull pain, spiritlessness and weakness, pale tongue, thready and weak pulse are that 60 examples are organized in treatment; With the waist angina abdominis, oliguria with reddish urine, yellow and greasy fur, stringy and rolling pulse are matched group 40 examples.
Two groups of ordinary circumstances are relatively seen table 5
Table 5 liang group ordinary circumstance comparative example (%)
Figure BSA00000682248200181
Two groups of clinical symptoms and sign are relatively seen table 6
Table 6 liang group clinical symptoms and sign are relatively
Figure BSA00000682248200182
Therapeutic Method
Calculus is directly taken the Chinese herbs decoction lithagogue treatment of the embodiment of the invention 2 less than 1cm person in two groups, if calculus all cooperates extracoporeal shock wave lithotripsy rubble to back below the 1cm to use the Chinese herbs decoction calculus greater than 1cm person.
Divide into groups
Treatment group: with the Chinese herbs decoction treatment of the embodiment of the invention 4;
Decoction method: 1 dose of every day, divide clothes 2 times;
Matched group: with traditional clearing away heat-damp and promoting diuresis calculus decoction treatment, square medicine is formed: Spora Lygodii 30g, Herba Lysimachiae 30g, Radix Bupleuri 10g, Medulla Tetrapanacis 10g, Herba Dianthi 10g, Semen Plantaginis 10g, Folium Pyrrosiae 10g, Talcum 10g, Radix Glycyrrhizae 10g, succinum 3g (taking after mixing it with water), Semen Abutili 10g;
Decoction method: with the treatment group.
Observation of curative effect
Two groups is a course of treatment with 10 doses all, the 1 week check B ultrasonic of having a rest after having obeyed 10 doses.
Other
Two groups general all without other Chinese and western drugs in therapeutic process, if there are special circumstances to deal with on the merits of each case.
The treatment standard
Cure: calculus is discharged or is disappeared through the ultrasound diagnosis calculus, and symptom and sign all disappear.Effectively: the part calculus is discharged or is dwindled, moves down through the ultrasound diagnosis calculus, and symptom and sign obviously alleviate.Invalid: calculus is not seen discharge, does not have change through ultrasound diagnosis calculus situation, and symptom and sign do not have obvious improvement.
Therapeutic outcome
Two groups all through the 1 week check B ultrasonic of having a rest after the course of treatment, observation therapeutic effect.
Two groups of curative effect situation are relatively seen table 7
Table 7 liang group treatment situation comparative example (%)
Group n Cure Effectively Invalid Total effective rate
The treatment group 60 45 12 3 95%
Matched group 20 24 6 10 75%
Table 7 is visible, and treatment group cure rate is 75%, total effective rate 95%, and matched group cure rate 60%, total effective rate 75% is through relatively can draw treatment group curative effect is superior to matched group (P<0.001).
Two groups of clinical symptoms in treatment back and sign are relatively seen table 8.
Table 8 treatment back two groups of clinical symptoms comparative examples (%)
Figure BSA00000682248200191
Model case 1
Zhang, the man, 35 years old, on November 31st, 2009 went to a doctor.The right waist and belly pain of patient is 4 little, the time, through B ultrasonic, the right renal calculus of diagnosis after the urine examination, calculus 0.6cm * 0.5cm size, intramuscular injection atropine, pethidine relieving spasm to stop pain, but pain does not stop yet fully.Look into: right kidney district kowtows pain, right ureter epimere tenderness, and picture of the tongue is normal, deep and stringy pulse.Chinese medical discrimination stagnates for the mechanism of qi stasis of blood, and passages through which vital energy circulates is obstructed, takes the tablet in the embodiment of the invention 2, and the specification of tablet is the 0.3g/ sheet, and each 3, every day 3 times.The patient only obeys pain on the 2nd and promptly ends, and checks B ultrasonic after 10 days continue clothes and does not see calculus sign.Following up a case by regular visits to the half a year state of an illness does not have repeatedly.
Model case 2
Chen, the man, 26 years old, first visit in June, 2009, patient left side renal calculus 2 years was once carried out the external ripple rubble 3 times of shaking in the court, take traditional Chinese medicine and uralyt invalid half a year.Disease is seen left waist paroxysmal colic, and frequent micturition is dripping not smooth, yellowish urine, and constipation, there is petechia on the red tongue limit, yellow fur, wiry and frequent pulse, have a medical check-up: left kidney district kowtows pain (+).The urinary system ultrasound diagnosis: left renal calculus 1.2cm * 1.0cm, left ureter epimere expansion companion is hydrops in a small amount.Card belongs to blood-stasis internal-depression, and damp-heat accumulation is taken the Chinese herbs decoction in the embodiment of the invention 4, serve on 10 doses, discharges size like 1 in Semen Glycines calculus.
This intellectual property of primary enforcement that all are above-mentioned is not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any professional and technical personnel of being familiar with possibly utilize the technology contents of above-mentioned announcement to change or be modified as the equivalent embodiment of equivalent variations.But everyly do not break away from technical scheme content of the present invention, to any simple modification, equivalent variations and remodeling that above embodiment did, still belong to the protection domain of technical scheme of the present invention according to technical spirit of the present invention.

Claims (10)

1. Chinese medicine that is used to treat renal calculus; It is characterized in that, comprising: Myrrha, triangular, Folium Callicarpae Formosanae, Radix Salviae Miltiorrhizae, Fructus Psoraleae, the Radix Linderae, Herba Glechomae, Herba Lysimachiae, Cortex Cinnamomi, Flos Caryophylli, Semen Sesami Nigrum, Herba Ecliptae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Semen Plantaginis, Flos Lonicerae and Lasiosphaera Seu Calvatia.
2. Chinese medicine as claimed in claim 1 is characterized in that: the ratio of weight and number of each component in the said Chinese medicine is that 25~35 weight portion Myrrhas, 18~24 weight portions are triangular, 28~36 weight portion Folium Callicarpae Formosanaes, 21~27 weight portion Radix Salviae Miltiorrhizaes, 45~55 weight portion Fructus Psoraleaes, 14~18 weight portion Radixs Linderae, 35~40 weight portion Herba Glechomaes, 45~55 weight portion Herba Lysimachiaes, 16~20 weight portion Cortex Cinnamomis, 20~24 weight portion Flos Caryophyllis, 50~60 weight portion Semen Sesami Nigrums, 60~70 weight portion Herba Ecliptaes, 35~45 weight portion Radixs Astragali, 27~33 weight portion Rhizoma Atractylodis Macrocephalaes, 37~43 weight portion Semen Plantaginiss, 10~16 weight portion Flos Loniceraes and 8~12 weight portion Lasiosphaera Seu Calvatia.
3. according to claim 1 or claim 2 Chinese medicine is characterized in that: the ratio of weight and number of each component in the said Chinese medicine is that 30~35 weight portion Myrrhas, 22~24 weight portions are triangular, 32~36 weight portion Folium Callicarpae Formosanaes, 24~27 weight portion Radix Salviae Miltiorrhizaes, 50~55 weight portion Fructus Psoraleaes, 16~18 weight portion Radixs Linderae, 38~40 weight portion Herba Glechomaes, 50~55 weight portion Herba Lysimachiaes, 18~20 weight portion Cortex Cinnamomis, 22~24 weight portion Flos Caryophyllis, 55~60 weight portion Semen Sesami Nigrums, 66~70 weight portion Herba Ecliptaes, 40~45 weight portion Radixs Astragali, 30~33 weight portion Rhizoma Atractylodis Macrocephalaes, 40~43 weight portion Semen Plantaginiss, 13~16 weight portion Flos Loniceraes and 10~12 weight portion Lasiosphaera Seu Calvatia.
4. like the described Chinese medicine of claim 1 to 3, it is characterized in that: the ratio of weight and number of each component in the said Chinese medicine is that 32 weight portion Myrrhas, 23 weight portions are triangular, 34 weight portion Folium Callicarpae Formosanaes, 26 weight portion Radix Salviae Miltiorrhizaes, 53 weight portion Fructus Psoraleaes, the 17 weight portion Radixs Linderae, 40 weight portion Herba Glechomaes, 52 weight portion Herba Lysimachiaes, 18 weight portion Cortex Cinnamomis, 24 weight portion Flos Caryophyllis, 60 weight portion Semen Sesami Nigrums, 68 weight portion Herba Ecliptaes, the 43 weight portion Radixs Astragali, the 32 weight portion Rhizoma Atractylodis Macrocephalaes, 43 weight portion Semen Plantaginiss, 13 weight portion Flos Loniceraes and 10 weight portion Lasiosphaera Seu Calvatia.
5. like the described Chinese medicine of claim 1 to 4, it is characterized in that: the said dosage form that is used to treat the Chinese medicine of renal calculus can be decoct, injection, tablet.
6. adopt the described preparation method of Chinese medicine of claim 1 to 5, it is characterized in that: when the dosage form of said Chinese medicine was decoct, it comprised,
100~200 purpose powder are pulverized and be screened into to the first step with said component proportional mixing;
Second step obtained powder with the first step and adds in the cold water and soaked 3 hours~5 hours, and with slow fire boiling, decocting time is 2 hours~3 hours, and decoction liquor is filtered, and obtains first filtrating, and the quality that institute adds water is 2~4 times of powder quality of first step acquisition;
In the 3rd step, the filtering residue that second step filter was obtained adds in the cold water once more, with slow fire boiling 1 hour~2 hours, filters and obtains second filtrating, identical in the quality of the water that is added and second step;
The 4th step merged filtrating twice, obtained said decoct.
7. adopt the described preparation method of Chinese medicine of claim 1 to 5, it is characterized in that: when the dosage form of said Chinese medicine was tablet, it comprised,
The first step with said component proportional mixing, is ground into 100~200 purpose powder, adds in the cold water to soak 3 hours~5 hours; With slow fire boiling 2 hours~3 hours, the quality of the cold water that is added was 2~4 times of the mixture quality that obtains of the first step, and decoction liquor is filtered; Filtering residue is put into cold water once more, and with slow fire boiling 1 hour~2 hours, the quality of the cold water that is added was 1~2 times of the mixture quality that obtains of the first step; Merge filtrate, concentrating under reduced pressure obtains the condensed water extract;
Second step made concentration of alcohol reach concentration 70~85% with adding ethanol in the spissated water extract of first step acquisition, left standstill, and filtered, and the filtrating that obtains is concentrated recovery section ethanol, refiltered the acquisition filtering liquid medicine;
The 3rd step, second step was handled medicinal liquid that the back obtains through Semi-polarity macroporous adsorbent resin or low polar macroporous adsorption resin, first water or concentration are lower than 20% ethanol and are eluted to eluent as eluent and are colourless; It is 1~1.5 times of the mixture quality that obtains of the first step that employed water or concentration are lower than 20% alcoholic acid quality, and reuse concentration is 90%~95% ethanol elution, collects ethanol elution; Employed concentration is that 90%~95% alcoholic acid quality is 3~5 times of the mixture quality that obtains of the first step, and the pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 6.5~7.5, places; Filter, concentrate and reclaim ethanol, the acquisition ethanol content is 10%~15% solution; Through polyamide resin column, first water is eluted to eluent and is closely colourless, and the quality of employed water is 1~1.5 times of the mixture quality that obtains of the first step; The reuse determining alcohol is 80%~95% ethanol elution, collects ethanol elution, employed concentration be 80%~95% alcoholic acid quality be 1~1.5 times of the mixture quality that obtains of the first step; Reclaim ethanol; Concentrate, drying under reduced pressure obtains and gets dry extract;
The 4th step with the dried cream of above-mentioned acquisition, added excipient and granulates, and drying adds disintegrating agent, lubricant, tabletting, or directly pack, or sugar coating, or the bag film-coat promptly obtains product.
8. the said preparation method of Chinese medicine of claim 7, it is characterized in that: said excipient is starch and derivant, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hypromellose and pharmaceutic adjuvant with water swelling; Described lubricant is the pharmaceutic adjuvant of Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication; Described sugar coating material is sucrose, Pulvis Talci, gelatin, pigment, river wax etc.; Described thin film coating material is that water, the alcohol of stomach dissolution type dissolves coating material.Wherein excipient, disintegrating agent, lubricant, sugar coating, the weight content of bag film-coat material in medicine are respectively: 5~70%, 1~30%, 0.1~10%, 35~90%, 1.5~5%.
9. the said preparation method of Chinese medicine of claim 1 to 5 is characterized in that:
When the dosage form of said Chinese medicine was injection, it comprised,
The first step with said component proportional mixing, is ground into 100~200 purpose powder, adds in the cold water to soak 3 hours~5 hours; With slow fire boiling 2 hours~3 hours, the quality of the cold water that is added was 2~4 times of the mixture quality that obtains of the first step, and decoction liquor is filtered; Filtering residue is put into cold water once more, and with slow fire boiling 1 hour~2 hours, the quality of the cold water that is added was 1~2 times of the mixture quality that obtains of the first step; Merge filtrate, concentrating under reduced pressure obtains the condensed water extract;
Second step made concentration of alcohol reach concentration 70~85% with adding ethanol in the spissated water extract of first step acquisition, left standstill, and filtered, and the filtrating that obtains is concentrated recovery section ethanol, refiltered the acquisition filtering liquid medicine;
The 3rd step, second step was handled medicinal liquid that the back obtains through Semi-polarity macroporous adsorbent resin or low polar macroporous adsorption resin, first water or concentration are lower than 20% ethanol and are eluted to eluent as eluent and are colourless; It is 1~1.5 times of the mixture quality that obtains of the first step that employed water or concentration are lower than 20% alcoholic acid quality, and reuse concentration is 90%~95% ethanol elution, collects ethanol elution; Employed concentration is that 90%~95% alcoholic acid quality is 3~5 times of the mixture quality that obtains of the first step, and the pH value that uses 0.5mol/L sodium hydroxide aqueous slkali to regulate ethanol elution is 6.5~7.5, places; Filter, concentrate and reclaim ethanol, the acquisition ethanol content is 10%~15% solution; Through polyamide resin column, first water is eluted to eluent and is closely colourless, and the quality of employed water is 1~1.5 times of the mixture quality that obtains of the first step; The reuse determining alcohol is 80%~95% ethanol elution, collects ethanol elution, employed consistency be 80%~95% alcoholic acid quality be 1~1.5 times of the mixture quality that obtains of the first step; Reclaim ethanol; Concentrate, drying under reduced pressure obtains and gets dry extract;
The 4th step is with the dried cream of the 3rd step acquisition, behind 5~10 times of waters for injection of adding with respect to dried cream quality; With 0.5mol/L sodium hydroxide adjust pH to 6.0~7.0, press 0.2g/100ml and add active carbon, adding 10% ethanol to crude drug concentration again is 1.15g/100ml~1.25g/100ml; Stirred 10 minutes, the microporous filter membrane with 0.45 μ m, 0.22 μ m filters respectively, promptly obtains injection; The injection that obtains is propped up the branch cillin bottle of packing into by 10ml/, add a cover butyl rubber plug and aluminium lid, 115 ℃ of pressure sterilizings 30 minutes; Label check.
10. the administering mode of the said Chinese medicine of claim 1 to 5 is characterized in that: said administering mode is oral or injection.
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CN103251684A (en) * 2013-06-09 2013-08-21 李伟丽 Medicine composition for treating kidney stone and preparation method of drug composition
CN103272082A (en) * 2013-05-01 2013-09-04 韩明镜 Preparation method of traditional Chinese medicine decoction for treating pulmonary hypertension

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CN103272082A (en) * 2013-05-01 2013-09-04 韩明镜 Preparation method of traditional Chinese medicine decoction for treating pulmonary hypertension
CN103251684A (en) * 2013-06-09 2013-08-21 李伟丽 Medicine composition for treating kidney stone and preparation method of drug composition
CN103251684B (en) * 2013-06-09 2014-09-03 李伟丽 Medicine composition for treating kidney stone and preparation method of drug composition

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