CN105288547A - Traditional Chinese medicine preparation used for treating liver and gallbladder damp-heat type cholecystolithiasis - Google Patents
Traditional Chinese medicine preparation used for treating liver and gallbladder damp-heat type cholecystolithiasis Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine preparation used for treating liver and gallbladder damp-heat type cholecystolithiasis. The traditional Chinese medicine preparation is prepared from lysimachia christinae hance, herba artemisiae capillariae, radix bupleuri, fried radix scutellariae, radix paeoniae alba, fructus aurantii immaturus, raw liquorice, saxifraga stolonifera, radix trichosanthis, angelica sinensis, wine-treated rhubarb, radix curcumae, rhizoma polygoni cuspidati, talc, rhizoma zingiberis, herba pteridis multifidae, radix clematid, endothelium corneum gigeriae galli, radix glehniae, dandelion, fructus forsythia, corn stigma, and mole cricket. The traditional Chinese medicine preparation is capable of relieving pain of patients effectively, reducing patient inflammatory response of patients, promoting eliminating or discharging of cholecystolithiasis in a treatment course, and reducing patient recurrence rate; no obvious toxic or side effect is caused; comprehensive curative effect is better than that of western medicines; and advantages of the traditional Chinese medicine preparation are displayed obviously.
Description
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine preparation for the treatment of liver gallbladder damp-heat type cholelithiasis.
Background technology
Cholelithiasis is one of the frequently-occurring disease of China, commonly encountered diseases, and it has a strong impact on healthy, the study and work of people.In recent years, along with improving constantly of national life level, the change of dietary structure, and the bad life habits of people, Patients with Cholelithiasis increases about 2 times over 10 years.The normal recurrent exerbation of primary disease, the treatment first-selection of current doctor trained in Western medicine is still essential therapeutic arsenals with surgical resection, cut the postoperative remnant gallstone rate of gallbladder calculus-fetching person and relapse rate higher, and the impact of gallbladder removal person postoperative multipair digestive function is larger.And non-operative treatment many Bian litholytic therapy of oral and direct perfusion, but therapeutic effect is unsatisfactory, and the course for the treatment of is long, and has certain toxic and side effects, is difficult to the object reaching long-term treatment and prevention.Along with developing rapidly of therapeutic endoscopy technology, interventional therapy for cholelithiasis opens new approach, make over and need operate or the patient of tolerate surgery can not have new Therapeutic Method, but it is subject to again technology, appointed condition, the restriction of economic dispatch factor is difficult to extensive popularization.
Traditional Chinese medical herbal treatment liver gallbladder damp-heat type cholelithiasis has certain advantage, and comprising easy, easy to operate, noinvasive, to injure untoward reaction few etc., is clinically used more and more widely.There is depressed liver-energy dispersing and function of gallbladder promoting, the object of disappear cementing stone, promoting the circulation of QI to relieve pain.Chinese medicine can improve biliary tract function of patients, keeps biliary tract unimpeded, promotes the secretion of bile, plays the continuation controlling calculus and increases, and can play the molten effect that disappears to a certain extent to calculus, is conducive to the discharge of calculus.Therefore traditional Chinese medical herbal treatment liver gallbladder damp-heat type cholelithiasis is also more and more subject to concern and the attention of people.
Chinese medicine preparation of the present invention, in conjunction with clinical experience for many years, and consults on the basis of a large amount of modern pharmacological research, through screening of medicaments, optimizes compatibility of drugs combination, simplifies the Empirical formula that dose is founded.Liver gallbladder damp-heat type Patients with Cholelithiasis is more clinically, how is correlated with body constitution, dietary factor, and not only high the and relapse rate of sickness rate also remains high, and how tiny its B ultrasonic display calculus is as silt sample.Chinese medicine preparation of the present invention is controlled with clearing away heat and eliminating dampness, spleen invigorating function of gallbladder promoting, clinically obtains satisfactory effect.
Summary of the invention
Technical problem to be solved by this invention is to provide the Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis, in conjunction with patients with clinical manifestations, according to traditional Chinese medical science comprehensive analysis of the data gained by the four methods of diagnosis gather information, found invention formulation, find in clinical studies, the present invention can effective reduction of patient pain condition, can reduce patient's inflammatory reaction, can promote abatement or the discharge of cholelithiasis within the course for the treatment of, reduce the relapse rate of patient, without obvious toxic-side effects, comprehensive therapeutic effect is better than Western medicine, fully shows advantage of the present invention.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis, its crude drug comprises: Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Bupleuri, Radix Scutellariae (parched), the Radix Paeoniae Alba, Fructus Aurantii Immaturus, Radix Glycyrrhizae, Herba Saxifragae, Radix Trichosanthis, Radix Angelicae Sinensis, Radix et Rhizoma Rhei (stir-fried with wine), Radix Curcumae, Rhizoma Polygoni Cuspidati, Talcum, Rhizoma Zingiberis, Herba Pteridis Multifidae, Radix Clematidis, Endothelium Corneum Gigeriae Galli, Radix Glehniae, Herba Taraxaci, Fructus Forsythiae, Stigma Maydis and Gryllotalpa.
In described Chinese medicine preparation, the weight portion of each crude drug is respectively Herba Lysimachiae 20 ~ 30 parts, Herba Artemisiae Scopariae 10 ~ 15 parts, Radix Bupleuri 10 ~ 20 parts, Radix Scutellariae (parched) 10 ~ 15 parts, the Radix Paeoniae Alba 20 ~ 25 parts, Fructus Aurantii Immaturus 10 ~ 15 parts, Radix Glycyrrhizae 10 ~ 15 parts, Herba Saxifragae 10 ~ 15 parts, Radix Trichosanthis 15 ~ 25 parts, Radix Angelicae Sinensis 10 ~ 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 10 ~ 15 parts, Radix Curcumae 10 ~ 20 parts, Rhizoma Polygoni Cuspidati 10 ~ 15 parts, 15 ~ 30 parts, Talcum, Rhizoma Zingiberis 10 ~ 15 parts, Herba Pteridis Multifidae 10 ~ 15 parts, Radix Clematidis 15 ~ 20 parts, Endothelium Corneum Gigeriae Galli 10 ~ 15 parts, Radix Glehniae 10 ~ 15 parts, Herba Taraxaci 10 ~ 15 parts, Fructus Forsythiae 20 ~ 30 parts, Stigma Maydis 10 ~ 15 parts, Gryllotalpa 10 ~ 15 parts.
Further preferably, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Herba Lysimachiae 25 ~ 30 parts, Herba Artemisiae Scopariae 10 ~ 15 parts, Radix Bupleuri 10 ~ 15 parts, Radix Scutellariae (parched) 10 ~ 15 parts, the Radix Paeoniae Alba 20 ~ 25 parts, Fructus Aurantii Immaturus 10 ~ 15 parts, Radix Glycyrrhizae 10 ~ 15 parts, Herba Saxifragae 10 ~ 15 parts, Radix Trichosanthis 15 ~ 20 parts, Radix Angelicae Sinensis 10 ~ 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 10 ~ 15 parts, Radix Curcumae 15 ~ 20 parts, Rhizoma Polygoni Cuspidati 10 ~ 15 parts, 15 ~ 20 parts, Talcum, Rhizoma Zingiberis 10 ~ 15 parts, Herba Pteridis Multifidae 10 ~ 15 parts, Radix Clematidis 15 ~ 20 parts, Endothelium Corneum Gigeriae Galli 10 ~ 15 parts, Radix Glehniae 10 ~ 15 parts, Herba Taraxaci 10 ~ 15 parts, Fructus Forsythiae 25 ~ 30 parts, Stigma Maydis 10 ~ 15 parts, Gryllotalpa 10 ~ 15 parts.
Most preferably, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Herba Lysimachiae 25 parts, Herba Artemisiae Scopariae 15 parts, Radix Bupleuri 15 parts, Radix Scutellariae (parched) 15 parts, the Radix Paeoniae Alba 25 parts, Fructus Aurantii Immaturus 10 parts, Radix Glycyrrhizae 15 parts, Herba Saxifragae 10 parts, Radix Trichosanthis 15 parts, Radix Angelicae Sinensis 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 15 parts, Radix Curcumae 20 parts, Rhizoma Polygoni Cuspidati 15 parts, 15 parts, Talcum, Rhizoma Zingiberis 15 parts, Herba Pteridis Multifidae 15 parts, Radix Clematidis 20 parts, Endothelium Corneum Gigeriae Galli 15 parts, Radix Glehniae 15 parts, Herba Taraxaci 15 parts, Fructus Forsythiae 30 parts, Stigma Maydis 15 parts, Gryllotalpa 10 parts.
Wherein, described medicine is endo-medicine.
Wherein, the dosage form of described medicine is prepared into decoction agent.
Present invention also offers the application of above-mentioned Chinese medicine in the various drug form of Chinese medicine for the preparation for the treatment of liver gallbladder damp-heat type cholelithiasis.
Present invention also offers said medicine and be prepared into the preparation method decocting agent, be specially:
Each crude drug is put into medicine pot by above-mentioned weight portion, add and soak 10 ~ 30 minutes relative to the drinking water of each crude drug quality sum 8 ~ 10 times, decoct 30 ~ 50 minutes, decoction liquor is filtered, filtering residue adds the drinking water relative to each crude drug quality sum 6 ~ 8 times again, decoct 20 ~ 40 minutes, decoction liquor is filtered, filtering residue adds the drinking water relative to each crude drug quality sum 4 ~ 6 times again, decoct after 10 ~ 20 minutes, decoction liquor is filtered, and three times decoction liquor merges, and is concentrated into 1g/ml ~ 2g/ml.
Beneficial effect of the present invention:
Technical problem to be solved by this invention is to provide the Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis, in conjunction with patients with clinical manifestations, according to traditional Chinese medical science comprehensive analysis of the data gained by the four methods of diagnosis gather information, found invention formulation, find in clinical studies, the present invention can effective reduction of patient pain condition, patient's inflammatory reaction can be reduced, abatement or the discharge of cholelithiasis can be promoted within the course for the treatment of, reduce the relapse rate of patient, without obvious toxic-side effects, comprehensive therapeutic effect is better than Western medicine and Chinese medicine positive control drug, fully shows advantage of the present invention.
Detailed description of the invention
The invention provides a kind of Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis, its crude drug comprises: Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Bupleuri, Radix Scutellariae (parched), the Radix Paeoniae Alba, Fructus Aurantii Immaturus, Radix Glycyrrhizae, Herba Saxifragae, Radix Trichosanthis, Radix Angelicae Sinensis, Radix et Rhizoma Rhei (stir-fried with wine), Radix Curcumae, Rhizoma Polygoni Cuspidati, Talcum, Rhizoma Zingiberis, Herba Pteridis Multifidae, Radix Clematidis, Endothelium Corneum Gigeriae Galli, Radix Glehniae, Herba Taraxaci, Fructus Forsythiae, Stigma Maydis and Gryllotalpa.
Further preferably, described Chinese medicine preparation is only prepared from by above-mentioned raw materials medicine.
In described Chinese medicine preparation, the weight portion of each crude drug is respectively Herba Lysimachiae 20 ~ 30 parts, Herba Artemisiae Scopariae 10 ~ 15 parts, Radix Bupleuri 10 ~ 20 parts, Radix Scutellariae (parched) 10 ~ 15 parts, the Radix Paeoniae Alba 20 ~ 25 parts, Fructus Aurantii Immaturus 10 ~ 15 parts, Radix Glycyrrhizae 10 ~ 15 parts, Herba Saxifragae 10 ~ 15 parts, Radix Trichosanthis 15 ~ 25 parts, Radix Angelicae Sinensis 10 ~ 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 10 ~ 15 parts, Radix Curcumae 10 ~ 20 parts, Rhizoma Polygoni Cuspidati 10 ~ 15 parts, 15 ~ 30 parts, Talcum, Rhizoma Zingiberis 10 ~ 15 parts, Herba Pteridis Multifidae 10 ~ 15 parts, Radix Clematidis 15 ~ 20 parts, Endothelium Corneum Gigeriae Galli 10 ~ 15 parts, Radix Glehniae 10 ~ 15 parts, Herba Taraxaci 10 ~ 15 parts, Fructus Forsythiae 20 ~ 30 parts, Stigma Maydis 10 ~ 15 parts, Gryllotalpa 10 ~ 15 parts.
Further preferably, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Herba Lysimachiae 25 ~ 30 parts, Herba Artemisiae Scopariae 10 ~ 15 parts, Radix Bupleuri 10 ~ 15 parts, Radix Scutellariae (parched) 10 ~ 15 parts, the Radix Paeoniae Alba 20 ~ 25 parts, Fructus Aurantii Immaturus 10 ~ 15 parts, Radix Glycyrrhizae 10 ~ 15 parts, Herba Saxifragae 10 ~ 15 parts, Radix Trichosanthis 15 ~ 20 parts, Radix Angelicae Sinensis 10 ~ 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 10 ~ 15 parts, Radix Curcumae 15 ~ 20 parts, Rhizoma Polygoni Cuspidati 10 ~ 15 parts, 15 ~ 20 parts, Talcum, Rhizoma Zingiberis 10 ~ 15 parts, Herba Pteridis Multifidae 10 ~ 15 parts, Radix Clematidis 15 ~ 20 parts, Endothelium Corneum Gigeriae Galli 10 ~ 15 parts, Radix Glehniae 10 ~ 15 parts, Herba Taraxaci 10 ~ 15 parts, Fructus Forsythiae 25 ~ 30 parts, Stigma Maydis 10 ~ 15 parts, Gryllotalpa 10 ~ 15 parts.
Most preferably, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Herba Lysimachiae 25 parts, Herba Artemisiae Scopariae 15 parts, Radix Bupleuri 15 parts, Radix Scutellariae (parched) 15 parts, the Radix Paeoniae Alba 25 parts, Fructus Aurantii Immaturus 10 parts, Radix Glycyrrhizae 15 parts, Herba Saxifragae 10 parts, Radix Trichosanthis 15 parts, Radix Angelicae Sinensis 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 15 parts, Radix Curcumae 20 parts, Rhizoma Polygoni Cuspidati 15 parts, 15 parts, Talcum, Rhizoma Zingiberis 15 parts, Herba Pteridis Multifidae 15 parts, Radix Clematidis 20 parts, Endothelium Corneum Gigeriae Galli 15 parts, Radix Glehniae 15 parts, Herba Taraxaci 15 parts, Fructus Forsythiae 30 parts, Stigma Maydis 15 parts, Gryllotalpa 10 parts.
Liver gallbladder damp-heat type cholelithiasis, its disease located in liver gallbladder, Chinese medicine is thought, the gallbladder being attached to the liver, and with liver phase the exterior and the interior, built-in bile, comes from liver and be hidden in gallbladder.The catharsis of liver not only can harmonizing the functional activities of vital QI, helps QI of the spleen and stomach to be elevated, and relevant with the secretion of bile.The liver failing to maintain the normal flow of QI, gallbladder loses logical falling and cholestasis, and with the passing of time damp-heat accumulation, decoct, become sandstone.Treatment is based on " dredging ", " clearly ", " leading to ", " profit ".Effect of Herba Lysimachiae is heat-clearing and toxic substances removing, dampness removing jaundice eliminating, and modern pharmacological research proves, Herba Lysimachiae has cholagogic and lithagogue, diuresis and expelling stone and antiinflammatory action, and Herba Lysimachiae has significant inhibitory action to the vascular permeability increase that histamine causes; The easy bile duct occlusion of Patients with Cholelithiasis, cause bile excretion not smooth, ferritic is again dampness-heat in the liver and gallbladder pattern of syndrome, easy cholestasis jaundice, therefore add Herba Artemisiae Scopariae, the effect played treatment and block, Herba Artemisiae Scopariae has the effect of clearing away damp-heat, jaundice eliminating subcutaneous ulcer, Papillary is monarch drug, to play the merit of heat-clearing and dampness-resolving altogether.Endothelium Corneum Gigeriae Galli, Radix Curcumae, Radix Clematidis, Herba Pteridis Multifidae, Herba Saxifragae clearing away heat-fire, dampness removing calculus, Radix Bupleuri, Radix Scutellariae (parched) depressed liver-energy dispersing and function of gallbladder promoting, Radix Paeoniae Alba nourishing blood to suppress the hyperactive liver, slow middle pain relieving; Radix Angelicae Sinensis promoting blood circulation to remove blood stasis, promoting the circulation of QI pain relieving, Fructus Aurantii Immaturus regulating the flow of QI to ease the stomach, the stagnant relieving distension of row, be ministerial drug altogether, strengthen the merit of the depressed liver-energy dispersing and QI regulating of monarch drug, and harmonizing the functional activities of vital QI, promote that calculus is discharged.Rhizoma Polygoni Cuspidati, Herba Taraxaci heat-clearing and toxic substances removing, jaundice eliminating subcutaneous ulcer, function of gallbladder promoting, Talcum, Fructus Forsythiae heat-clearing and toxic substances removing, help Herba Artemisiae Scopariae eliminating damp-heat, Radix Glycyrrhizae heat-clearing and toxic substances removing, relieving spasm to stop pain, has the merit of coordinating the actions of various ingredients in a prescription concurrently, because of dampness-heat in the liver and gallbladder, easy impairment of body fluid, thus add Radix Trichosanthis, Radix Glehniae is promoted the production of body fluid, and is adjuvant drug altogether; We add Gryllotalpa, clearing away heat-fire, sharp liver and gall damp and hot in urine, Radix et Rhizoma Rhei (stir-fried with wine), and slow its rushes down lower stagnant power, coordinate prodrug, slowly cholelithiasis are dissolved eliminating in bile duct, both can calculus, and can not cause again the blocking of bile duct, generation spasm pain, makes medicine.All medicines share, and play the merit of clearing heat secreting bile, circulation of qi promoting calculus altogether.
Each crude drug pharmacology is as follows:
Herba Lysimachiae: sweet in the mouth, slightly stringy pulse, cold nature, enters liver, gallbladder, kidney, urinary bladder channel, has 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; Sore carbuncle; Venom; The cards such as traumatic injury.
Herba Artemisiae Scopariae: bitter in the mouth, pungent, cold nature, enters spleen, stomach, liver, gallbladder meridian, has clearing away damp-heat, the effect of jaundice eliminating subcutaneous ulcer, and for jaundice, no matter damp and hot YANG jaundice or cold-damp YIN jaundice all can be applied, and also can be applicable to the cards such as oliguria with reddish urine caused by fever disease in summer or hygropyrexia.
Radix Bupleuri: latin name bupleuriradix, for the dry root of umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii., bitter in the mouth, cold nature, return Liver Channel, gallbladder meridian, have evacuate bring down a fever, effect of yang invigorating soothing liver-QI, for cold, fever, alternate attack of chill and fever, malaria, stagnation of QI due to depression of the liver, sternal rib pain, proctoptosis, the cards such as uterus comes off, menoxenia.
Radix Scutellariae (parched): bitter in the mouth, cold in nature, enter the heart, lung, stomach, gallbladder, large intestine channel, have heat clearing and damp drying, eliminating fire and detoxication, antiabortive, the effect of hemostasis, is mainly used in damp and hot caused diarrhoea, dysentery, jaundice, pyretic stranguria; Cough due to lung-heat, thirsty pharyngalgia, also can be used for excessive fetal movement due to heat in pregnancy, and pyretic toxicity pathogenic fire invades the swollen card of carbuncle sore poison of excessive skin.
The Radix Paeoniae Alba: bitter in the mouth, acid, cool in nature, enter liver, spleen channel, have nourishing blood to suppress the hyperactive liver, pain relieving in slow, yin fluid astringing receives the effect of antiperspirant, cures mainly the breast abdomen pain over the hypochondriac region, and dysentery is suffered from abdominal pain, and spontaneous sweating, fever due to yin deficiency, menoxenia, metrorrhagia, is with inferior card.
Fructus Aurantii Immaturus: bitter in the mouth, pungent, cold nature, enters spleen, stomach warp, has dispelling the stagnated QI removing food stagnancy, expectorant except the effect of painful abdominal mass, be mainly used in stagnant in stop, the YangmingFushi syndrome of distension and fullness in the abdomen, constipation.
Radix Glycyrrhizae: latin name GlycyrrhizaeRadixetRhizoma, sweet in the mouth, property put down, enter 12 warps, have heat-clearing and toxic substances removing, be in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in the abdominal distension and anorexia of weakness of the spleen and stomach, weak; Can alleviate contracture pain in abdomen, relax the strong and toxicity of some drugs, alleviating medicine stimulates to the toxic and side effects of body or to gastrointestinal, can play QI invigorating neutralization by adding Radix Glycyrrhizae, is in harmonious proportion the effect of each component.
Herba Saxifragae: latin name Saxifragastolonifera, micro-bitter, acrid, cold; Expelling wind and clearing away heat, removing pathogenic heat from blood and toxic substance from the body, cures mainly and controls rubella, eczema, otitis media, erysipelas, cough haematemesis, lung abscess, metrorrhagia, haemorrhoids.
Radix Trichosanthis: latin name TrichosanthisRadix, sweet in the mouth, micro-hardship, cold nature, enters lung, stomach warp, has clearing away heat and promoting production of body fluid, effect of detumescence and apocenosis, for calentura excessive thirst, lung-heat type cough, the cards such as interior-heat is quenched one's thirst, sore swollen toxin.
Radix Angelicae Sinensis: latin name AngelicaeSinensisRadix, sweet in the mouth, pungent, warm in nature, enter liver, the heart, spleen channel, having enriches blood invigorates blood circulation, menstruction regulating and pain relieving, effect of loosening bowel to relieve constipation, cures mainly having a dizzy spell of deficiency of heart-blood, fatigue and weakness, shortness of breath and palpitation, the sea of blood is hollow, the menoxenia of the cold and deficiency of CHONG and REN meridians or congestion retardance, dysmenorrhoea, produce or stomachache, and other blood stasis are had a pain and the card such as the constipation of deficiency of YIN insufficiency of blood dryness of the intestine.
Radix et Rhizoma Rhei (stir-fried with wine): latin name RheiRadixetRhizoma, bitter in the mouth, cold in nature, return stomach warp; Large intestine channel; Liver Channel; Spleen channel, have attack stagnant; Clearing away damp-heat; Pathogenic fire purging; Removing heat from blood; Blood stasis dispelling; Effect of removing toxic substances, cures mainly excess-heat constipation; The accumulation of heat feeling of stuffiness in chest; Damp-heat dysentery; Jaundice; Gonorrhea; Edema abdominal distention; Dysuria; Conjunctival congestion; Laryngopharynx swelling and pain; Aphtha of the mouth and tongue; Gastropyretic vomiting; Spit blood; Spitting of blood; Epistaxis; Have blood in stool; Hematuria; Blood-retention; Amenorrhea; The stagnant stomachache of the stasis of blood in puerperal; Lump in the abdomen; Traumatic injury; Pyretic toxicity carbuncle and ulcer; Erysipelas; The cards such as scald.
Radix Curcumae: acrid in the mouth, hardship, cold in nature, return liver, the heart, lung meridian, there is regulating qi to disperse stagnation, heart fire-clearing upset-relieving, effect of promoting the function of the gallbladder to alleviate jaundice, cure mainly amenorrhea dysmenorrhea, chest and abdomen swelling and pain, twinge, calentura coma, the cards such as epilepsy is gone mad, jaundice dark coloured urine.
Rhizoma Polygoni Cuspidati: mildly bitter flavor, cold nature, returns liver, gallbladder, lung meridian, has the effect of expelling wind and removing dampness, dissipating blood stasis analgesic therapy, preventing phlegm from forming and stopping coughing, for arthralgia, and jaundice due to damp-heat, amenorrhea ， WEIJIA, cough with copious phlegm, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus.
Talcum: sweet in the mouth, light, cold in nature, returns bladder, lung, stomach warp, has inducing diuresis for treating stranguria syndrome, clearing away summer-heat, effect of damp eliminating sore.For pyretic stranguria, stranguria caused by urinary stone, urinates hot puckery pain, heat-damp in summer excessive thirst, damp and hot watery diarrhea; External treatment eczema, eczema, the cards such as miliaria.
Rhizoma Zingiberis: acrid in the mouth, hot in nature, return spleen, stomach, the heart, lung meridian; Have warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, dampness expectorant, effect of warming the lung to resolve fluid-retention, and for coldness and pain in the epigastrium, vomiting, has loose bowels, the cards such as YANG-depletion is fainted inverse, and cold fluid-retention is breathed with cough, arthralgia due to cold-dampnes.
Herba Pteridis Multifidae: latin name HerbaPteridisMultifidae, light, micro-hardship, cold, return large intestine, the heart, Liver Channel; Clearing away heat-damp and promoting diuresis; Cooling blood for hemostasis; Subduing swelling and detoxicating, cure mainly dysentery, have loose bowels, stranguria with turbid discharge, leukorrhagia, jaundice, furuncle swelling toxin, sore throat tonsillitis, lymphoid tuberculosis, parotitis, mastitis, high fever tic, snake bite and insect sting, haematemesis, epistaxis, hematuria, have blood in stool, traumatic hemorrhage.
Radix Clematidis: latin name clematidisradixetrhizoma is acrid in the mouth, salty, warm in nature, slightly poisonous, enter urinary bladder channel, there is expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, expectorant water, effect of the loose hypochondriac lump, cures mainly gout insensitive impediment, rheumatic arthralgia, numb limbs and tense tendons, chills and pain of the waist and kness, the contracture of muscle arteries and veins, joint stuffiness, beriberi, malaria, lump in the abdomen, tetanus, tonsillitis, all a fishbone or other bone caught in the throat pharynxs.
Endothelium Corneum Gigeriae Galli: sweet in the mouth, cold in nature, return spleen, stomach, small intestinal, urinary bladder channel, have promoting digestion and invigorating the stomach, effect of arresting seminal emission, cure mainly food stagnation distension, vomiting regurgitation, dysentery, infantile malnutrition, quenches one's thirst, incontinence of urine, sore throat tonsillitis, the cards such as ulcerative gingivitis aphtha.
Radix Glehniae: cold nature, sweet in the mouth, micro-hardship, have nourishing YIN and clearing away lung-heat, effect of reinforcing stomach reg fluid, cures mainly the cards such as lung-heat type cough, chronic cough expectorant blood, calentura Tianjin wound be thirsty.
Herba Taraxaci: sweet in the mouth, hardship, cold in nature, enter liver, stomach warp, there is the effect of heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation, liver heat removing and eyesight improving, inducing diuresis for treating stranguria syndrome, be mainly used in the treatment of sore swollen toxin, especially remarkable to acute mastitis effect, also can be used for the cards such as the conjunctival congestion and swelling pain of flaming up of liver-fire.
Fructus Forsythiae: bitter in the mouth, cold nature, enters the heart, liver, gallbladder, small intestine meridian, has heat-clearing and toxic substances removing, effect of dispersing swelling and dissipating binds, for carbuncle, scrofula, acute mastitis, erysipelas, anemopyretic cold, epidemic febrile disease from the beginning of, warmly to join the army, high hot excessive thirst, the cards such as coma sends out speckle, pyretic stranguria urine retention.
Stigma Maydis: latin name CornStigmaStigmaMaydisYumixu, sweet in the mouth, light, property is put down, and returns bladder, liver, gallbladder meridian, has inducing diuresis to remove edema; Effect of liver heat removing function of gallbladder promoting, main edema, dribbling urination, jaundice, cholecystitis, cholelithiasis, hypertension, diabetes, galactostasis.
Gryllotalpa: latin name Gryllotalpa, nature and flavor are salty, cold.Enter stomach, urinary bladder channel.The relieving constipation of function diuretic.Can be used for treatment edema, stranguria caused by urinary stone, dysuria, scrofula, too fat to move malignant boil etc.
Medicine provided by the invention is oral medicine, can add customary adjuvant composition as required and be prepared into common formulations, as oral liquid, granule, pill, decoction agent, tablet, tablet etc., preferably be prepared into decoction agent.
Present invention also offers said medicine and be prepared into the preparation method decocting agent, be specially:
Each crude drug is put into medicine pot by above-mentioned weight portion, add and soak 10 ~ 30 minutes relative to the drinking water of each crude drug quality sum 8 ~ 10 times, decoct 30 ~ 50 minutes, decoction liquor is filtered, filtering residue adds the drinking water relative to each crude drug quality sum 6 ~ 8 times again, decoct 20 ~ 40 minutes, decoction liquor is filtered, filtering residue adds the drinking water relative to each crude drug quality sum 4 ~ 6 times again, decoct after 10 ~ 20 minutes, decoction liquor is filtered, and three times decoction liquor merges, and is concentrated into 1g/ml ~ 2g/ml.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1 decocts agent 1
By Herba Lysimachiae 25g, Herba Artemisiae Scopariae 15g, Radix Bupleuri 15g, Radix Scutellariae (parched) 15g, Radix Paeoniae Alba 25g, Fructus Aurantii Immaturus 10g, Radix Glycyrrhizae 15g, Herba Saxifragae 10g, Radix Trichosanthis 15g, Radix Angelicae Sinensis 15g, Radix et Rhizoma Rhei (stir-fried with wine) 15g, Radix Curcumae 20g, Rhizoma Polygoni Cuspidati 15g, Talcum 15g, Rhizoma Zingiberis 15g, Herba Pteridis Multifidae 15g, Radix Clematidis 20g, Endothelium Corneum Gigeriae Galli 15g, Radix Glehniae 15g, Herba Taraxaci 15g, Fructus Forsythiae 30g, Stigma Maydis 15g, Gryllotalpa 10g puts into medicine pot, the drinking water adding 3.5kg soaks 30 minutes, decoct 50 minutes, decoction liquor is filtered, filtering residue adds the drinking water of 2.5kg again, decoct 40 minutes, decoction liquor is filtered, filtering residue adds the drinking water of 1.8kg again, decoct after 20 minutes, decoction liquor is filtered, three times decoction liquor merges, be concentrated into 1g/ml.
Embodiment 2 decocts agent 2
By Herba Lysimachiae 25g, Herba Artemisiae Scopariae 10g, Radix Bupleuri 10g, Radix Scutellariae (parched) 10g, Radix Paeoniae Alba 20g, Fructus Aurantii Immaturus 10g, Radix Glycyrrhizae 10g, Herba Saxifragae 10g, Radix Trichosanthis 15g, Radix Angelicae Sinensis 10g, Radix et Rhizoma Rhei (stir-fried with wine) 10g, Radix Curcumae 15g, Rhizoma Polygoni Cuspidati 10g, Talcum 15g, Rhizoma Zingiberis 10g, Herba Pteridis Multifidae 10g, Radix Clematidis 15g, Endothelium Corneum Gigeriae Galli 10g, Radix Glehniae 10g, Herba Taraxaci 10g, Fructus Forsythiae 25g, Stigma Maydis 10g, Gryllotalpa 10g puts into medicine pot, the drinking water adding 3kg soaks 30 minutes, decoct 50 minutes, decoction liquor is filtered, filtering residue adds the drinking water of 2kg again, decoct 40 minutes, decoction liquor is filtered, filtering residue adds the drinking water of 1.5kg again, decoct after 20 minutes, decoction liquor is filtered, three times decoction liquor merges, be concentrated into 1g/ml.
Embodiment 3 decocts agent 3
By Herba Lysimachiae 30g, Herba Artemisiae Scopariae 15g, Radix Bupleuri 15g, Radix Scutellariae (parched) 15g, Radix Paeoniae Alba 25g, Fructus Aurantii Immaturus 15g, Radix Glycyrrhizae 15g, Herba Saxifragae 15g, Radix Trichosanthis 20g, Radix Angelicae Sinensis 15g, Radix et Rhizoma Rhei (stir-fried with wine) 15g, Radix Curcumae 20g, Rhizoma Polygoni Cuspidati 15g, Talcum 20g, Rhizoma Zingiberis 15g, Herba Pteridis Multifidae 15g, Radix Clematidis 20g, Endothelium Corneum Gigeriae Galli 15g, Radix Glehniae 15g, Herba Taraxaci 15g, Fructus Forsythiae 30g, Stigma Maydis 15g, Gryllotalpa 15g puts into medicine pot, the drinking water adding 4kg soaks 30 minutes, decoct 50 minutes, decoction liquor is filtered, filtering residue adds the drinking water of 3kg again, decoct 40 minutes, decoction liquor is filtered, filtering residue adds the drinking water of 2kg again, decoct after 20 minutes, decoction liquor is filtered, three times decoction liquor merges, be concentrated into 1g/ml.
Embodiment 4 pharmacology acute toxicity test
1 experiment material
1.1 laboratory animal
SPF level, C57BL/2 mice, 30,20 ~ 24g, male and female half and half, by Si Beifu laboratory animal, Technology Co., Ltd. provides, animal quality certification SCXK (capital) 2013-0204.
1.2 test medicine
1.2.1 the decocting for Chinese herbal medicine agent of the embodiment of the present invention 1 preparation: decoct to crude drug content 1.0g/ml, 2.0g/ml, 4 DEG C save backup;
1.2.2 blank group: gavage distilled water, all the other conditions are with medicine group of the present invention.
2 experimental techniques
Get SPF level, C57BL/2 mice 30, male and female half and half, under cleaning grade experimental situation, adaptability is raised one week.Being divided into 3 groups at random by body weight, is matched group 10 respectively, high dose group 10, low dose group 10, male and female half and half, sub-cage rearing.
Before experiment, the fasting of each group mice can't help water 8h, matched group gavage distilled water 0.2ml/20g body weight, 3 times/day, high dose, low dose group, decoction agent 1, the 0.2ml/20g body weight of the gavage embodiment of the present invention 1 preparation respectively, 3 times/day, crude drug concentration is 60g/kg/d, 30g/kg/d dosing interval 4h.
3 results
3.1 general states are observed
During gavage, by to observed and recordeds such as the autonomic activities before and after mouse stomach, diet, drinking-water, by to Mouse Weight surveying record, and to the observed and recorded that mice two just drains, high dose group, low dose group compare with matched group, no difference of science of statistics, P>0.05, administration interval, reacts without delayed toxicity, does not show other extremely.
3.2 internal organs are observed
During administration, each group mice is without death, and experimentally plan, after the administration is complete, disconnected neck puts to death each group of mice, dissects and detects each internal organs.
After dissection, the arrangement of perusal Organs of Mice is normal, without adhesion, without hydrops, organizes organ surface smooth, and chromaticness is normal, and Non Apparent Abnormality changes.
Weigh the internal organs such as liver, the heart, spleen, lung, two kidneys, calculate organ index, each group is carried out statistical analysis, no significant difference, and statistics is meaningless, P>0.05.
4 conclusions
High dose group mouse stomach maximum tolerated dose is 60g/kg/d, and low dose group mouse stomach maximum tolerated dose is 30g/kg/d, and the day crude drug intake of the adult of its correspondence is respectively 18.0g/kg, 9.0g/kg, is equivalent to 120 times of its intake, 60 times.It is generally acknowledged that maximum tolerated dose is equivalent to the clinical daily dosage 100 times of people and above and animal without death, when occurring without overt toxicity response situation, this medicine is safe, this experimental verification, 120 times of animal gavage people dosage, without obvious toxicity, are reacted without delayed toxicity, therefore indirect proof, decoction liquor clinical practice safety of the present invention, without obvious toxic-side effects.
Embodiment 5 rat chronic toxicity test of the present invention
1 experiment material
1.1 laboratory animal
SPF level, C57BL/2 mice, 30,20 ~ 24g, male and female half and half, by Si Beifu laboratory animal, Technology Co., Ltd. provides, animal quality certification SCXK (capital) 2013-0204.
1.2 test medicine
1.2.1 the decocting for Chinese herbal medicine agent of the embodiment of the present invention 1 preparation: decoct to crude drug content 0.5g/ml, 1.0g/ml, 1.5g/ml, 4 DEG C save backup;
1.2.2 blank group: gavage distilled water, all the other conditions are with medicine group of the present invention.
2 experimental techniques
2.1 grouping
SPF level, C57BL/2 mice, 52,20 ~ 24g, male and female half and half, according to body weight, are divided into matched group, invention formulation high dose group, middle dosage group, low dose group by table of random number, often organize 13, each group of corresponding crude drug dosage is 14.5g/kg/d, 9.0g/kg/d, 4.5g/kg/d.
2.2 medication
The each dosage group of invention formulation, by 0.2ml/20g gavage, 3 times/day; Matched group gavage distilled water, by 0.2ml/20g gavage, 3 times/day.According to clinical treatment cholelithiasis course for the treatment of, zoopery successive administration 10 weeks, drug withdrawal is observed 2 weeks.
After observation period terminates, disconnected neck puts to death each group of mice, dissects and detects each internal organs.
3 experimental results
According to clinical treatment cholelithiasis course for the treatment of, designing animal is tested, and by the gastric infusion of 10 weeks, the drug withdrawal of 2 weeks was observed, the physical signs such as body weight, diet, drinking-water, autonomic activities of each group of mice is normal, each internal organs are detected in dissection, and arrangement is normal, without adhesion, without hydrops, organize organ surface smooth, chromaticness is normal, and Non Apparent Abnormality changes.Weigh the internal organs such as liver, the heart, spleen, lung, two kidneys, calculate organ index, each group is carried out statistical analysis, no significant difference, and statistics is meaningless, P>0.05.
This experimental design rat chronic toxicity test, high, medium and low Three doses, corresponding 60kg is grown up 90 times, 60 times, 30 times of clinical administration dosage, by observing, having no invention formulation and producing Delayed onset toxic reaction and cumulative toxicity reaction.Result of the test can illustrate invention formulation prolonged application, to mice without obvious toxic-side effects, verifies further, invention formulation clinical adult's plan dosage and be in safety range the course for the treatment of.
The clinical research of embodiment 6 invention formulation treatment liver gallbladder damp-heat type cholelithiasis
1 clinical data
1.1 physical data
In July ,-2015 in January, 2015 is included in this clinical research, the clinical diagnosis of going to a doctor at surgery is Patients with Cholelithiasis 60 example of liver gallbladder damp-heat type, and patient screening standard is according to " new Chinese medicine treatment chronic bile duct infects, the guideline of clinical investigations of cholelithiasis " in Ministry of Public Health " new Chinese medicine guideline of clinical investigations " version in 2002 and " practical internal medicine " the 12nd edition formulation.After screening, in selected patient, male 28 example, women 32 example, is divided into two groups at random, is treatment group 30 example respectively, male 15 example, women 15 example, 44.33 ± 10.55 years old age; Matched group 30 example, male 13 example, women 17 example, at 45.21 ± 9.6 years old age, medical history is all at 7 ~ 180 months, and two groups at age (P>0.05), sex composition (X
2=0.0871, P>0.05), the course of disease (X
2=0.8889, P>0.05), the upper no difference of science of statistics of severity Scaling (μ=0.1979, P>0.05), there is comparability.
1.2 diagnostic criteria
1.2.1 tcm diagnosis standard: standard is according to " guideline of clinical investigations of the infection of new Chinese medicine treatment chronic bile duct, cholelithiasis " and " practical internal medicine " the 12nd edition formulation in Ministry of Public Health " new Chinese medicine guideline of clinical investigations " version in 2002.
Syndrome of dampness-heat of liver and gallbladder:
Right Upper abdominal pain, pain draw the shoulder back of the body, greasy increasing the weight of of taking food; Nausea and vomiting, bitter taste, yellow urine, or companion's constipation with dry stool.Upper right abdominal pressure pain.Body of the tongue is light red or red, yellow and greasy fur, wiry and frequent pulse or stringy and rolling pulse.
Primary symptom: right Upper abdominal pain, upper right abdominal pressure pain.
Secondary disease: pain draws the shoulder back of the body, greasy increasing the weight of of taking food; Nausea and vomiting, bitter taste, yellow urine, or companion's constipation with dry stool.Body of the tongue is light red or red, yellow and greasy fur, wiry and frequent pulse or stringy and rolling pulse.
Above-mentioned primary symptom, pulse condition are indispensable, and secondary disease possesses 2, namely diagnosable.
1.2.2 Western medicine diagnose standard:
1. chronic cholecystitis cholelithiasis
A. upper right abdomen dull pain or sense of discomfort is continued, or omoplate district pain.
B. the indigestion symptoms such as nauseating, belch, pantothenic acid, abdominal distention and scorching hot are had, the postemphasis of feed greasy food.
C. the course of disease is long, the feature of the course of disease through there being acute and slow outbreak to replace.
D. there are mild tenderness or percussion pain in gallbladder area.
The super visible gallbladder wall of E.B is crude to be thickened, and gallbladder reduces or is out of shape, with cholelithiasis.
F. the visible gallbladder of cholecystography reduces or is out of shape, and gallbladder contraction function is bad, or gallbladder development is thin, visible cholelithiasis.
All one of to possess in E, F two, adds the binomial person in A ~ D item, namely diagnosable.
2. extrahepatic biliary stone
A. under xiphoid-process and right upper quadrant rest pain, paroxysmal is aggravated, companion's nausea and vomiting.
B. shiver with cold or jaundice.
C. under xiphoid-process and the dark tenderness of upper right abdomen, gallbladder district percussion pain.
D.B is super, CT, ERCP check and find calculus.
3. calculus of intrahepatic duct
A. the vexed distending pain of hepatic region persistence, in periodical attack.
B. hepatomegaly, tenderness, percussion tenderness over hepatic region.
C. jaundice.
When D. merging extrahepatic biliary stone, show as the clinical manifestation of extrahepatic biliary stone.
E.B is super, CT, ERCP check and find calculus.
4. biliary postoperative syndrome
A. gallbladder, bile duct or Stomach duodenum history of operation is had.
B. to suffer from abdominal pain the even disease such as jaundice.
C.B is super, CT, scope, cholangiography, ERCP or PTC etc. check prompting cholelithiasis.
Severity extent grade scale
Slight: syndrome total score 0 ~ 13 point
Moderate: syndrome total score 14 ~ 26 points
Severe: syndrome total score 27 ~ 39 points
1.2 test case standards
1.2.1 include case standard in
1. Western medicine diagnose standard, TCM syndrome diagnostic criteria person is met.
2. tcm syndrome total score person between 8 ~ 32 points.
3. 18 ~ 65 years old age, men and women.
4. patient or family members' informed consent accept this clinical trial person.
Allly meet above every inpatient or outpatient all can include clinical trial case in.
1.2.2 Excluded cases standard (comprising inadaptation or rejecting standard)
1. acute simplex cholecystitis, acute suppuration cholecystitis, acute gangrenous cholecystitis, acute obstructive suppurative cholangitis, the concurrent diffuse peritonitis person of perforation of gallbladder is turned out to be on inspection.
2. tcm syndrome total score <8 divides, or the >32 person of dividing.
3. merge intentionally, the serious disease such as cerebrovascular, lung, kidney and hemopoietic system, dysgenic Other diseases can be there is after medication, as used the Other diseases of hormone therapy
4. the age is below 18 one full year of life or more than 65 one full year of life, gestation or women breast-feeding their children, allergic constitution and those who are allergic to this drug.
5. gestation or women breast-feeding their children.
6. following experiments room Indexes Abnormality: 1. renal dysfunction, albuminuria >+, have a person at least in erythrocyturia >+(urine Hb not as judge index).2. ALT exceedes the normal position upper limit more than one times.3. the arrhythmia of clinical meaning is had.
7. allergic constitution person (referring to that oneself knows that composition is irritated to two or more medicines or food allergy or this test medication).
8. allly do not meet inclusive criteria, not by regulation medication, cannot judge that curative effect and data are not congruent and affect the treatment or safety judgement person;
9. apply the patient that other similar drugs treats this disease simultaneously.
2 Therapeutic Method
2.1 treatment group
Take Chinese medicine preparation decocting for Chinese herbal medicine of the present invention agent, 100ml/ time, 2 times/day, sooner or later decoction being taken warmly, Continuous Observation 4 weeks.
2.2 matched group
DANKANG JIAONANG, 4 tablets/time, 3 times/day, warm water takes, Continuous Observation 4 weeks.
2.3 safety observations
General data: heart rate, breathing, blood pressure.
Demographic characteristics: height, body weight, nationality, age etc.
Blood, urine, feces routine, electrocardiogram, liver function (ALT, AST, r-GT) is made, renal function (BUN, Cr), courage type-B ultrasonic, Electrocardioscopy before and after medication.
At treatments period, light diet, avoid the foods such as pungent, greasy, raw food is hard, excessively sweet, over-salty, avoid fish shrimp crab etc. easily to cause irritated food as far as possible, note warming, prevent flu.
2.4 evaluation criterion
2.4.1 curative effect of disease evaluation criteria
1.. clinical recovery: symptom, somatic feature score reduce >95%, and image analysis is normal.
2.. effective: symptom, somatic feature score reduce >70%, and image analysis meets effective standard.
3.. effectively: symptom, somatic feature score reduce >30%, and image analysis reaches effective standard.
4.. invalid: symptom, somatic feature score reduce <30%, image analysis is all without improvement.
2.4.2 iconography curative effect determinate standard
1. chronic inflammatory disease
A. fully recover: the wall thickness of gallbladder or bile duct wall, crude, entrant sound three recover normal.
B. effective: above more than 2 or 2 are improved.
C. effective: above more than 1 or 1 is improved.
D. invalid: above 3 all without improvement.
2. calculus disappears molten (volume change)
A. fully recover: image analysis confirms that cholelithiasis disappears completely.
B. effective: image analysis prompting cholelithiasis volume-diminished (diameter >0.5cm, or calculus decreased number >1/3.
C. effective: image analysis prompting cholelithiasis has the molten change that disappears, calculus volume-diminished (diameter) >0.2cm, or calculus decreased number <1/3.
D. invalid: image analysis prompting cholelithiasis changes, even calculus increases increase without the dissolubility that disappears.
2.5 compliances judge
1.. actual dosage × 100% of compliance %=/answer dosage
2.. compliance is normal: 80 ~ 120%
3.. compliance is abnormal: <80%
2.6 safety evaluatio
1 grade: safety, without any untoward reaction.
2 grades: safer, if any untoward reaction, not needing to do any process can continue administration.
3 grades: have safety issue, there is moderate untoward reaction, after processing, can administration be continued.
4 grades: because untoward reaction stops test.
2.7 statistical method
(1) measurement data adopts t inspection, and enumeration data adopts X2 inspection, and ranked data adopt Ridit to analyze.
(2) report adopts form to represent to have self-evidence.Statistical test all adopts two-sided test, and P<0.05 person will be considered to statistical significance.
3 results
Cardinal symptom integration data before and after 3.1 treatments
3.1.1 abdominal pain
Compare before treatment group treatment with in group after treatment, μ=3.895, P<0.05;
Compare before treatment of control group with in group after treatment, μ=3.696, P<0.05;
Compare between treatment group with group before and after treatment of control group, μ=0.425, P>0.05.
3.1.2 abdominal tenderness
Compare before treatment group treatment with in group after treatment, μ=2.75, P<0.05;
Compare before treatment of control group with in group after treatment, μ=2.742, P<0.05;
Compare between treatment group with group before and after treatment of control group, μ=0.4166, P>0.05.
3.1.3 diet causes pain to increase the weight of situation
Compare before treatment group treatment with in group after treatment, μ=2.359, P<0.05;
Compare before treatment of control group with in group after treatment, μ=2.542, P<0.05;
Compare between treatment group with group before and after treatment of control group, μ=0.365, P>0.05.
3.2 calculus melt situation and compare, in table 1
Table 1 calculus melts situation and compares (example)
| Group | Number of cases | Cure | Effective | Effectively | Invalid | Effective percentage (%) |
| Matched group | 30 | 4 | 10 | 11 | 5 | 83.3 |
| Treatment group | 30 | 9 | 9 | 10 | 2 | 93.3 |
Treatment group effective percentage is 93.33%, and matched group effective percentage is 83.33%.Two groups of total effectses, through statistical analysis (Ridit analysis), have significant difference (P<0.05).Treatment group with matched group curative effect without significant difference, P>0.05, but treatment group is better than matched group.
3.3 total effectses compare, in table 2
Table 2 total effective rate compares
| Group | Number of cases | Cure | Effective | Effectively | Invalid | Effective percentage (%) |
| Matched group | 30 | 2 | 6 | 13 | 9 | 70.0 |
| Treatment group | 30 | 7 | 11 | 9 | 3 | 90.0 |
Treatment group effective percentage 90.0% is that matched group effective percentage is 70.0%.Two groups of total effectses, through statistical analysis (Ridit analysis), have significant difference (P>0.05).Treatment group with matched group curative effect without significant difference, P>0.05, but treatment group is better than matched group.
3.4 safety observations results
Blood, urine, feces routine, electrocardiogram, liver function (ALT, AST, r-GT) before and after two groups of treatments, renal function (BUN, Cr) checks all without exception, and do not find untoward reaction in therapeutic process, toleration is better.
4 conclusions
Current pharmacological research shows that Chinese medicine can improve biliary tract function of patients, promotes the secretion of bile, increases the output of bile, keep biliary tract unimpeded, can play and prevent the continuation of calculus from increasing, and the molten effect that disappears to a certain extent is play to calculus, thus be conducive to the discharge of calculus.The traditional Chinese medical science thinks blood stored in the liver, main catharsis, sickly often causes stagnation in liver meridian for a long time, and catharsis is unfavorable and occur resembling of various stasis blocking, the pent-up of liver and gall QI and blood and heat-transformation, the dysfunction of the spleen of holding concurrently again and domination of damp pathogen, and damp and hot friendship is steamed and sent out is jaundice.This time research is as prescription foundation, Selection drug, with clearing away heat-damp and promoting diuresis, and circulation of qi promoting calculus.Research shows that invention formulation has good therapeutic effect for liver gallbladder damp-heat type cholelithiasis.Compared with Chinese patent medicine " DANKANG JIAONANG ", although no difference of science of statistics, to the clinical observation of patient, play effect and be better than Chinese medicine matched group.This research confirms, invention formulation has good clinical efficacy, should better serve more Patients with Cholelithiasis, removes its slight illness.
Embodiment 7 animal experiment study
1 material
1.1 animals select male Wistar rat 50, cleaning grade, weight 260 ± 20g, and by Si Beifu laboratory animal, Technology Co., Ltd. provides, animal quality certification SCXK (capital) 2013-4123.
1.2 reagent
Decocting for Chinese herbal medicine agent 1 prepared by the embodiment of the present invention 1: decoct to crude drug content 1.0g/ml, 2.0g/ml4.0g/ml, 4 DEG C save backup;
DANNING PIAN (specification: 100 * 0.36g) lot number 20120618, is produced by Hehuang Pharmaceutical Co., Ltd., Shanghai;
2 methods
2.1 modelings and administration
Get Wistar rat 50, be divided into 5 groups at random, be i.e. 0.9% sodium chloride group, DANNING PIAN group (0.54g/kg); Invention formulation low dose group (5g/kg), middle dosage group (10g/kg), high dose group (20g/kg), often organize 10.Bian after 3 days, tests front 12h fasting with gastric infusion.During experiment, rat, with after 10% chloral hydrate 4ml/kg intraperitoneal injection of anesthesia, lies on the back and is fixed on animal surgery plate, in epigastrium center 3cm otch, open abdominal cavity, find white clear toughness bile duct at descendant duodenum, the bile duct first isolating vater's papilla end is about 2cm, then inserts diameter 0.7mm sealed venous detaining needle to liver direction, sealed venous detaining needle is determined in ligation face, extract nook closing member, in visible needle tubing, have faint yellow bile to flow out, collect bile with 1.0ml centrifuge tube.After operated rats model stability 20min, start to collect bile, every 1 hr collections once, is collected 4 hours altogether, and is recorded bile flow.
2.2 observation index and mensuration
2.2.1 choleresis
Each group respectively at 0 ~ lh, l ~ 2h, totally 4 time periods collect bile for 2 ~ 3h, 3 ~ 4h, with the whole bile of syringe sucking-off, metered volume.
2.2.2 biochemical of bile measures
Chemical oxidization method is adopted to measure total bilirubin (TB) in bile; Enzymic colorimetric is adopted to measure T-CHOL (TC) content; Bian enzyme parameters measures TOTAL BILE ACID TBA (TBA) content.
2.3 statistical procedures
Bian SPSS17.0 software carries out data statistics, and the data of Amount of Bile, TBA, TB, TC are used
express, compare between group and process with one factor analysis of variance.
3 results
3.1 bladder normalizing decoctions are on the impact of rat bile flow
The each dosage group of invention formulation is at the bile flow of each time period all higher than 0.9% sodium chloride group, and show that invention formulation significantly can increase rat bile flow (P<0.01), high dose group difference is the most remarkable; DANNING PIAN group obviously increases rat bile flow <0.01), effect is lower than invention formulation high dose group.See the following form.
Rat bile flow after table 3 administration 1h
| Group | Number of cases | Dosage g/kg | Bile flow ml |
| Sodium chloride group | 10 | Equal-volume | 0.92±0.21 |
| DANNING PIAN group | 10 | 0.54 | 1.55±0.22 ** |
| Low dose group | 10 | 5 | 1.43±0.27 ** |
| Middle dosage group | 10 | 10 | 1.40±0.16 * |
| High dose group | 10 | 20 | 1.66±0.18 ** |
Note: compare with sodium chloride group,
*p<0.05,
*p<0.01
Rat bile flow after table 4 administration 2h
| Group | Number of cases | Dosage g/kg | Bile flow ml |
| Sodium chloride group | 10 | Equal-volume | 0.93±0.22 |
| DANNING PIAN group | 10 | 0.54 | 1.61±0.28 ** |
| Low dose group | 10 | 5 | 1.53±0.33 ** |
| Middle dosage group | 10 | 10 | 1.36±0.16 ** |
| High dose group | 10 | 20 | 1.74±0.32 ** |
Note: compare with sodium chloride group,
*p<0.05,
*p<0.01
Rat bile flow after table 5 administration 3h
| Group | Number of cases | Dosage g/kg | Bile flow ml |
| Sodium chloride group | 10 | Equal-volume | 0.95±0.19 |
| DANNING PIAN group | 10 | 0.54 | 1.56±0.33 ** |
| Low dose group | 10 | 5 | 1.54±0.24 ** |
| Middle dosage group | 10 | 10 | 1.34±0.15 ** |
| High dose group | 10 | 20 | 1.81±0.24 ** |
Note: compare with sodium chloride group,
*p<0.05,
*p<0.01
Rat bile flow after table 6 administration 4h
| Group | Number of cases | Dosage g/kg | Bile flow ml |
| Sodium chloride group | 10 | Equal-volume | 0.91±0.18 |
| DANNING PIAN group | 10 | 0.54 | 1.51±0.28 ** |
| Low dose group | 10 | 5 | 1.52±0.27 ** |
| Middle dosage group | 10 | 10 | 1.31±0.14 ** |
| High dose group | 10 | 20 | 1.64±0.25 ** |
Note: compare with sodium chloride group,
*p<0.05,
*p<0.01
3.2 bladder normalizing decoctions are on the impact of rat bile composition
Compare with 0.9% sodium chloride solution blank group, the concentration of the bile acid in the basic, normal, high each dosage group bile of invention formulation all has increasing in various degree, the concentration of bilirubin and cholesterol all has reduction in various degree, wherein remarkable with the difference of high dose group.Show that invention formulation can not only increase the content of bile acid in bile, cholesterol and bilirubinic content can also be reduced, see the following form.
Table 7 is on the impact of rat bile composition TBA
| Group | Number of cases | TBA(μmol/L) |
| Sodium chloride group | 10 | 219.974±9.675 |
| DANNING PIAN group | 10 | 266.525±31.324 * |
| Low dose group | 10 | 262.472±29.871 * |
| Middle dosage group | 10 | 263.157±29.587 * |
| High dose group | 10 | 261.248±29.634 |
Note: compare with sodium chloride group,
*p<0.05
Table 8 is on the impact of rat bile composition CHO
| Group | Number of cases | CHO(mmol/L) |
| Sodium chloride group | 10 | 0.517±0.185 |
| DANNING PIAN group | 10 | 0.275±0.721 ** |
| Low dose group | 10 | 0.315±0.091 ** |
| Middle dosage group | 10 | 0.268±0.074 ** |
| High dose group | 10 | 0.213±0.071 ** |
Note: compare with sodium chloride group,
*p<0.01
Table 9 is on the impact of rat bile composition TB
| Group | Number of cases | TB(μmol/L) |
| Sodium chloride group | 10 | 156.478±82.487 |
| DANNING PIAN group | 10 | 65.497±20.768 ** |
| Low dose group | 10 | 72.436±16.354 ** |
| Middle dosage group | 10 | 71.842±13.687 ** |
| High dose group | 10 | 49.624±16.892 ** |
Note: compare with sodium chloride group,
*p<0.01
4 conclusions
This experiment, by the chemical composition of observing bile flow and detect in bile, judges drug effectiveness, studies the choleretic effect of invention formulation, demonstrate its good function of gallbladder promoting effect.
Experimental result shows, and invention formulation has stronger choleretic effect, namely can increase bile flow, also can affect bile component simultaneously.Collect bile from common bile duct and can reflect the secretion of bile and the change of excretion.Bile secretion and discharge number relevant with liver function, this experimental result display invention formulation can promote the secretion of bile, points out it to have choleretic effect.From the Analysis of test results of bile component, this research also finds, invention formulation can promote the secretion of bile acid, reduces bile cholesterol and bilirubinic content, infers that this medicine can reach by its choleretic effect the effect preventing and treating cholelithiasis.
The mechanism of comprehensive its function of gallbladder promoting of analysis, may have following two reasons: the first, and invention formulation directly can affect synthesis and the secretion of liver bilirubin and cholesterol, to reduce the content of bile mesobilirubin and cholesterol; The second, invention formulation obviously increases the content of bile acid in bile, may be relevant to the conversion of bile acid with promotion hepatic cholesterol.
To sum up analyze, invention formulation has obvious choleretic effect to Wistar rat, and can obviously increase Determination of Bile Acids in bile, reduces cholesterol and bilirubinic content, infers that this medicine may have the effect preventing and treating cholelithiasis thus.
All above-mentioned this intellectual properties of primary enforcement, not setting 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 is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (8)
1. be used for the treatment of a Chinese medicine preparation for liver gallbladder damp-heat type cholelithiasis, it is characterized in that: crude drug comprises Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Bupleuri, Radix Scutellariae (parched), the Radix Paeoniae Alba, Fructus Aurantii Immaturus, Radix Glycyrrhizae, Herba Saxifragae, Radix Trichosanthis, Radix Angelicae Sinensis, Radix et Rhizoma Rhei (stir-fried with wine), Radix Curcumae, Rhizoma Polygoni Cuspidati, Talcum, Rhizoma Zingiberis, Herba Pteridis Multifidae, Radix Clematidis, Endothelium Corneum Gigeriae Galli, Radix Glehniae, Herba Taraxaci, Fructus Forsythiae, Stigma Maydis and Gryllotalpa.
2. be used for the treatment of the Chinese medicine preparation of liver gallbladder damp-heat type cholelithiasis as claimed in claim 1, it is characterized in that: the weight portion of each crude drug is respectively Herba Lysimachiae 20 ~ 30 parts, Herba Artemisiae Scopariae 10 ~ 15 parts, Radix Bupleuri 10 ~ 20 parts, Radix Scutellariae (parched) 10 ~ 15 parts, the Radix Paeoniae Alba 20 ~ 25 parts, Fructus Aurantii Immaturus 10 ~ 15 parts, Radix Glycyrrhizae 10 ~ 15 parts, Herba Saxifragae 10 ~ 15 parts, Radix Trichosanthis 15 ~ 25 parts, Radix Angelicae Sinensis 10 ~ 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 10 ~ 15 parts, Radix Curcumae 10 ~ 20 parts, Rhizoma Polygoni Cuspidati 10 ~ 15 parts, 15 ~ 30 parts, Talcum, Rhizoma Zingiberis 10 ~ 15 parts, Herba Pteridis Multifidae 10 ~ 15 parts, Radix Clematidis 15 ~ 20 parts, Endothelium Corneum Gigeriae Galli 10 ~ 15 parts, Radix Glehniae 10 ~ 15 parts, Herba Taraxaci 10 ~ 15 parts, Fructus Forsythiae 20 ~ 30 parts, Stigma Maydis 10 ~ 15 parts, Gryllotalpa 10 ~ 15 parts.
3. be used for the treatment of the Chinese medicine preparation of liver gallbladder damp-heat type cholelithiasis as claimed in claim 1 or 2, it is characterized in that: the weight portion of each crude drug is respectively Herba Lysimachiae 25 ~ 30 parts, Herba Artemisiae Scopariae 10 ~ 15 parts, Radix Bupleuri 10 ~ 15 parts, Radix Scutellariae (parched) 10 ~ 15 parts, the Radix Paeoniae Alba 20 ~ 25 parts, Fructus Aurantii Immaturus 10 ~ 15 parts, Radix Glycyrrhizae 10 ~ 15 parts, Herba Saxifragae 10 ~ 15 parts, Radix Trichosanthis 15 ~ 20 parts, Radix Angelicae Sinensis 10 ~ 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 10 ~ 15 parts, Radix Curcumae 15 ~ 20 parts, Rhizoma Polygoni Cuspidati 10 ~ 15 parts, 15 ~ 20 parts, Talcum, Rhizoma Zingiberis 10 ~ 15 parts, Herba Pteridis Multifidae 10 ~ 15 parts, Radix Clematidis 15 ~ 20 parts, Endothelium Corneum Gigeriae Galli 10 ~ 15 parts, Radix Glehniae 10 ~ 15 parts, Herba Taraxaci 10 ~ 15 parts, Fructus Forsythiae 25 ~ 30 parts, Stigma Maydis 10 ~ 15 parts, Gryllotalpa 10 ~ 15 parts.
4. the Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis as described in claims 1 to 3, is characterized in that: the weight portion of each crude drug is respectively Herba Lysimachiae 25 parts, Herba Artemisiae Scopariae 15 parts, Radix Bupleuri 15 parts, Radix Scutellariae (parched) 15 parts, the Radix Paeoniae Alba 25 parts, Fructus Aurantii Immaturus 10 parts, Radix Glycyrrhizae 15 parts, Herba Saxifragae 10 parts, Radix Trichosanthis 15 parts, Radix Angelicae Sinensis 15 parts, Radix et Rhizoma Rhei (stir-fried with wine) 15 parts, Radix Curcumae 20 parts, Rhizoma Polygoni Cuspidati 15 parts, 15 parts, Talcum, Rhizoma Zingiberis 15 parts, Herba Pteridis Multifidae 15 parts, Radix Clematidis 20 parts, Endothelium Corneum Gigeriae Galli 15 parts, Radix Glehniae 15 parts, Herba Taraxaci 15 parts, Fructus Forsythiae 30 parts, Stigma Maydis 15 parts, Gryllotalpa 10 parts.
5. the Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis as described in claims 1 to 3, is characterized in that: described Chinese medicine preparation is endo-medicine.
6. the Chinese medicine preparation being used for the treatment of liver gallbladder damp-heat type cholelithiasis as described in Claims 1-4, is characterized in that: the dosage form of described medicine is prepared into decoction agent.
7. the application of Chinese medicine preparation described in claim 1 to 5 in the various drug form of Chinese medicine for the preparation for the treatment of liver gallbladder damp-heat type cholelithiasis.
8. the preparation method of Chinese medicine preparation described in claim 1 to 5, is characterized in that: when being prepared into decoction agent, be specially:
Each crude drug is put into medicine pot by above-mentioned weight portion, add and soak 10 ~ 30 minutes relative to the drinking water of each crude drug quality sum 8 ~ 10 times, decoct 30 ~ 50 minutes, decoction liquor is filtered, filtering residue adds the drinking water relative to each crude drug quality sum 6 ~ 8 times again, decoct 20 ~ 40 minutes, decoction liquor is filtered, filtering residue adds the drinking water relative to each crude drug quality sum 4 ~ 6 times again, decoct after 10 ~ 20 minutes, decoction liquor is filtered, and three times decoction liquor merges, and is concentrated into 1g/ml ~ 2g/ml.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102370950A (en) * | 2011-11-17 | 2012-03-14 | 中国中医科学院中医临床基础医学研究所 | Chinese medicinal compound preparation for treating gall-stone and preparation method thereof |
| CN104189759A (en) * | 2014-09-03 | 2014-12-10 | 商西丹 | Traditional Chinese medicine composition for treating cholelithiasis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102370950A (en) * | 2011-11-17 | 2012-03-14 | 中国中医科学院中医临床基础医学研究所 | Chinese medicinal compound preparation for treating gall-stone and preparation method thereof |
| CN104189759A (en) * | 2014-09-03 | 2014-12-10 | 商西丹 | Traditional Chinese medicine composition for treating cholelithiasis |
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Application publication date: 20160203 |