CN102716339B - Chinese medicinal composition for treating uremia, and preparation method and application thereof - Google Patents

Chinese medicinal composition for treating uremia, and preparation method and application thereof Download PDF

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CN102716339B
CN102716339B CN2012102240551A CN201210224055A CN102716339B CN 102716339 B CN102716339 B CN 102716339B CN 2012102240551 A CN2012102240551 A CN 2012102240551A CN 201210224055 A CN201210224055 A CN 201210224055A CN 102716339 B CN102716339 B CN 102716339B
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chinese medicine
herba
radix
medicine composition
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CN102716339A (en
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刘瑞莲
丁志勇
冯梅
厉进雪
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刘瑞莲
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Abstract

The invention provides a Chinese medicinal composition which is combined with hemodialysis to treat uremia. The Chinese medicinal composition comprises herba cissampelotis, coastal glehnia root, common bletilla pseudobulb, white paeony root, oyster, yerbadetajo herb, cortex dictamni, prepared rehmannia root, chrysanthemum, ligusticum wallichii, plantain herb, pyrrosia leaf, dwarf lilyturf root, medlar, epimedium herb, rhubarb, fineleaf schizonepeta herb, mirabilite, suberect spatholobus stem and sealwort. The Chinese medicinal composition can reduce the frequency of hemodialysis; and when combined with hemodialysis to treat uremia, the Chinese medicinal composition has the advantages of small side effect, good curative effect, low cost and high cure rate, and a patient does not develop medicine tolerance.

Description

Treat uremic Chinese medicine composition, its preparation method and application
Technical field
The present invention relates to the Chinese medicine technical field, relate in particular to a kind of Chinese medicine composition that is used for the treatment of uremia's complication of hemodialysis.
Background technology
Chronic renal insufficiency develops into the forfeiture of Uremic kidney and drains and regulatory function, cause Water-Electrolyte, acid base imbalance and nitrogen matter metabolite to be put aside in vivo, finally develop into uremia, uremia is not an independently disease, but the total clinical syndrome of the nephropathy in various late periods is that chronic renal failure enters the syndrome that series of clinical manifestations that whole end occurs during the stage forms.
The first-selected hemodialysis of modern medicine treatment uremia, its purpose one is to prolong patient's life, improves patients ' life quality; The 2nd, for renal transplantation provides favourable opportunity, but conventional hemodialysis is each 3 hours, 2~3 times weekly, dialyse frequently and bring a lot of complication to the patient, and dialysis somewhat expensive, a lot of patients can't bear, and hemodialysis can only take stopgap measures, can not effect a permanent cure, chronic renal insufficiency develops into Uremic, abnormalities of sugar/lipid metabolism, anemia to be increased the weight of, these all are that hemodialysis cann't be solved, simultaneously because the non-physiologic of dialysis can produce multiple untoward reaction in dialysis procedure or after the dialysis.
Clinical symptoms can be alleviated in Chinese medicine uremia, and the protection residual renal function delays PD, postpones the time of necessary dialysis and renal transplantation, more and more is subject to the attention of domestic and international medical circle.Uremia belongs to Chinese medicine obstruction and rejection, edema, the categories such as poison, asthenia of drowning, with the passing of time Chinese medicine think this disease delay or the exopathogen invasion and attack, the overstrain internal injury, cause function deficient, turbid damp is stopped over, and three warmers are jammed, ascending or descending movement of vital Qi is not normal, though the state of an illness is critical, syndrome is complicated, and deficiency in origin and excess in superficiality is to run through the course of disease main pathogenesis all the time.Deficiency in origin is take spleen kidney yang (gas) void as main, and mark is real take turbid damp, noxious water, blood stasis as main, and strengthening vital QI to eliminate pathogenic factors is answered in treatment.
Adopt Chinese traditional treatment uremia, not only can before uremia occurs, play the effect of checking the state of an illness, also can reduce the dialysis number of times fully even the patient has developed into the uremic stage.Different from patient's dialysis treatment is, although dialysis treatment can not damage kidney, can not fundamentally improve renal function, and adopts Chinese traditional treatment can improve to a certain extent renal function, and this is that doctor trained in Western medicine is incomparable.
But uremic patient can not rely on Chinese traditional treatment merely, but must be by the technology of modern medicine doctor trained in Western medicine.In the face of the middle and advanced stage uremic patient time, the effect that simple Chinese traditional treatment can be brought into play is just more and more limited.This time, dialysis treatment and the kidney transfer operation of doctor trained in Western medicine still were important.
Therefore the invention provides the uremic Chinese medicine composition of a kind of cooperation hemodialysis; it focuses on and effects a permanent cure; take purging FU-organs the turbid descending, invigorating spleen to remove dampness, activating blood circulation to dissipate blood stasis as the Therapeutic Principle; can start with from adjusting the internal organs negative and positive of qi and blood; improve the function of human body state; Effective Raise immunity makes remaining glomerular function be protected to greatest extent, improves symptom comprehensively.
Summary of the invention
Technical problem to be solved by this invention is, provide a kind of for cooperating the uremic Chinese medicine composition of hemodialysis, adopt this Chinese medicine composition can alleviate the number of times of hemodialysis, cooperate that hemodialysis uremia has that side effect is little, good effect, cost is low, cure rate is high, the advantage that has no drug resistance.
Ask in order to solve above-mentioned technology, the invention provides the uremic Chinese medicine composition of a kind of cooperation hemodialysis, it comprises: Herba Cissampelotis pareiae, Radix Glehniae, Pseudobulbus Bletillae (Rhizoma Bletillae), the Radix Paeoniae Alba, Concha Ostreae, Herba Ecliptae, Cortex Dictamni, Radix Rehmanniae Preparata, Flos Chrysanthemi, Rhizoma Chuanxiong, Herba Plantaginis, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii, Herba Epimedii, Radix Et Rhizoma Rhei, Herba Schizonepetae, Natrii Sulfas, Caulis Spatholobi and Rhizoma Polygonati.
Wherein, the ratio of weight and number of each component is in the described Chinese medicine composition:
Herba Cissampelotis pareiae 10~20 weight portions, Radix Glehniae 20~30 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 10~20 weight portions, the Radix Paeoniae Alba 25~35 weight portions, Concha Ostreae 10~20 weight portions, Herba Ecliptae 30~40 weight portions, Cortex Dictamni 10~20 weight portions, Radix Rehmanniae Preparata 20~30 weight portions, Flos Chrysanthemi 15~25 weight portions, Rhizoma Chuanxiong 20~30 weight portions, Herba Plantaginis 10~20 weight portions, Folium Pyrrosiae 10~20 weight portions, Radix Ophiopogonis 30~40 weight portion, Fructus Lycii 25~35 weight portions, Herba Epimedii 10~20 weight portions, Radix Et Rhizoma Rhei 60~70 weight portions, Herba Schizonepetae 10~20 weight portions, Natrii Sulfas 15~25 weight portions, Caulis Spatholobi 25~35 weight portions and Rhizoma Polygonati 30~40 weight portions.
Wherein, the weight fraction of each component compares more preferably in the described Chinese medicine composition:
Herba Cissampelotis pareiae 15~20 weight portions, Radix Glehniae 25~30 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 15~20 weight portions, the Radix Paeoniae Alba 30~35 weight portions, Concha Ostreae 15~20 weight portions, Herba Ecliptae 35~40 weight portions, Cortex Dictamni 15~20 weight portions, Radix Rehmanniae Preparata 25~30 weight portions, Flos Chrysanthemi 20~25 weight portions, Rhizoma Chuanxiong 25~30 weight portions, Herba Plantaginis 15~20 weight portions, Folium Pyrrosiae 15~20 weight portions, Radix Ophiopogonis 35~40 weight portion, Fructus Lycii 30~35 weight portions, Herba Epimedii 15~20 weight portions, Radix Et Rhizoma Rhei 65~70 weight portions, Herba Schizonepetae 15~20 weight portions, Natrii Sulfas 20~25 weight portions, Caulis Spatholobi 30~35 weight portions and Rhizoma Polygonati 35~40 weight portions.
Wherein, can also further add Herba Agrimoniae and Rhizoma Imperatae in the described Chinese medicine composition, described Herba Agrimoniae and the Rhizoma Imperatae parts by weight in described Chinese medicine composition are Herba Agrimoniae 15~25 weight portions and Rhizoma Imperatae 10~20 weight portions, more preferably Herba Agrimoniae 20~25 weight portions and Rhizoma Imperatae 15~20 weight portions.
Wherein, can also further add Rhizoma Coptidis and Caulis Bambusae In Taenia in the described Chinese medicine composition, described Rhizoma Coptidis and the Caulis Bambusae In Taenia weight fraction in described Chinese medicine composition is Rhizoma Coptidis 10~20 weight portions and Caulis Bambusae In Taenia 5~15 weight portions, more preferably Rhizoma Coptidis 15~20 weight portions and Caulis Bambusae In Taenia 10~15 weight portions.
Wherein, described composition of medicine dosage form is decoct, powder, honey refining pill, hydration pill, tablet, capsule, oral liquid, granule, colloid or syrup, more preferably syrup and capsule.
The invention provides the preparation method of above-mentioned Chinese medicine composition, it comprises:
The first step is mixed in proportion each component in the described Chinese medicine composition, is ground into 100 orders~200 purpose powder;
Second step, the determining alcohol that adds 2~4 times of the powder qualities that obtain with respect to the first step is 80~90% ethanol, reflux 1~3 hour, extract, obtain extracting solution, filter and obtain the first alcohol extract, it is 70~80% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 1~2 times of filtering residue quality again, and reflux 1~3 hour is extracted, obtain extracting solution, filter and obtain the second alcohol extract, the first filtrate and the second filtrate are mixed, concentrating under reduced pressure, desolventizing, drying obtains and gets dry extract;
The 3rd step was broken into 200 orders~400 purpose powder with described dried cream powder, added various auxiliary additives and prepared needed various dosage form.
Wherein, when the dosage form of described Chinese medicine composition is syrup, described the 3rd step is for adding the water dissolution with respect to 2~3 times of powder qualities in the powder after pulverizing, regulate pH value to 7.0 with 40% sodium hydroxide solution, add subsequently correctives sucrose, antiseptic mix homogeneously, namely get syrup, the correctives of adding, antiseptic and the content in medicine thereof: sucrose 25~70%, Pyrusussuriensis acids antiseptic such as potassium sorbate 0.1~0.3%, paraben preservative such as ethyl hydroxybenzoate 0.01~0.05%.
Wherein, when the dosage form of described Chinese medicine composition is capsule, described the 3rd step is for adding 5~7 weight portion carboxymethyl starch sodium, 5~50 weight portion starch mix homogeneously in the powder after pulverizing, 3~5 weight portion magnesium stearate, 150~200 weight portion determining alcohols are 80%~90% alcohol granulation, drying, granulate, then pack in the gelatine capsule, make capsule.
The present invention also provides above-mentioned Chinese medicine composition, and it is in the application that is used for cooperating the uremic medicine of hemodialysis of the various dosage forms of preparation.
Beneficial effect of the present invention:
Adopt this Chinese medicine composition can alleviate the number of times of hemodialysis, cooperate that hemodialysis uremia has that side effect is little, good effect, cost is low, cure rate is high, the advantage that has no drug resistance.
The specific embodiment
The invention provides the uremic Chinese medicine composition of a kind of cooperation hemodialysis, it comprises: Herba Cissampelotis pareiae, Radix Glehniae, Pseudobulbus Bletillae (Rhizoma Bletillae), the Radix Paeoniae Alba, Concha Ostreae, Herba Ecliptae, Cortex Dictamni, Radix Rehmanniae Preparata, Flos Chrysanthemi, Rhizoma Chuanxiong, Herba Plantaginis, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii, Herba Epimedii, Radix Et Rhizoma Rhei, Herba Schizonepetae, Natrii Sulfas, Caulis Spatholobi and Rhizoma Polygonati.
Herba Cissampelotis pareiae: latin name Cissampelotis Herba, sweet in the mouth, hardship, warm in nature, return liver, spleen channel, have reducing swelling and alleviating pain, the effect of hemostasia and promoting granulation cures mainly traumatic injury, and wound swells and ache, wound hemorrhage, rheumatic arthralgia, the cards such as arthralgia.
Radix Glehniae: latin name Glehniae Radix, sweet in the mouth, little hardship, cold nature enters lung, spleen channel, has nourishing YIN and clearing away lung-heat, and the effect of reinforcing stomach reg fluid cures mainly nourishing YIN and clearing away lung-heat, expelling phlegm for arresting cough.Control lung-heat type cough, chronic consumptive disease chronic cough, the moon are hindered dry pharynx, the card such as thirsty.
Pseudobulbus Bletillae (Rhizoma Bletillae): latin name Bletillac Rhizoma, bitter in the mouth, sweet, puckery, cold nature is returned lung, liver, stomach warp, has the tonifying the lung hemostasis, detumescence and promoting granulation, the effect of sore cures mainly lung and hinders hemoptysis, epistaxis, incised wound is hemorrhage, swollen ulcer drug, ulcer pain, the soup fire is burnt, the cards such as rhagadia manus et pedis.
The Radix Paeoniae Alba: latin name Paeoniae Radix Alba, bitter in the mouth, acid, cool in nature; enter liver, spleen channel, have nourishing blood to suppress the hyperactive liver, slow middle pain relieving; yin fluid astringing is received the effect of antiperspirant, cures mainly the breast abdomen pain over the hypochondriac region, dysentery stomachache; spontaneous sweating; fever due to yin deficiency, menoxenia, metrorrhagia; be with inferior card, the Radix Paeoniae Alba has good liver-protective effect.
Concha Ostreae: latin name Ostreae Concha, to distinguish the flavor of into, cold nature is returned liver, gallbladder, kidney channel, have suppressing the hyperactive liver and subsiding YANG, tranquillizing the mind by relieving convulsion, hard masses softening and resolving is restrained astringent or styptic treatment for spontaneous sweating effect, cure mainly vertigo and tinnitus, brothers' chatter, palpitation and insomnia, dysphoria, infantile convulsion is demented, scrofula goiter, breast caking, spontaneous sweating, seminal emission frequent micturition, bleeding not during menses, the acid regurgitation stomachache, the cards such as eczema skin infection, Concha Ostreae polysaccharide has blood fat reducing, anticoagulation, anti thrombotic action.
Herba Ecliptae: latin name Ecliptae Herba, sweet in the mouth, acid, cold in nature, return liver, kidney channel, play liver and kidney tonifying, the effect of cooling blood for hemostasis, cure mainly have a dizzy spell due to the hepatic and renal YIN deficiency, blurring of vision, soreness of the waist and knees; Being suitable for the deficiency of YIN has hot person, the haematemesis of accumulated heat in the stomach, and the cards 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's Shigella flexneri, bacillus pyocyaneus, obviously enhancing non-specific immunity and cellular immune function.
Cortex Dictamni: latin name Dictamni Cortex, bitter in the mouth becomes, and is cold in nature, returns spleen channel; Lung meridian; Small intestine meridian; The stomach warp; Urinary bladder channel has heat clearing and damp drying; Dispelling wind for relieving itching; The effect of detoxifcation cures mainly the rubella due to the wind heat noxious dampness; Eczema; Scabies; Jaundice; The cards such as damp and hot arthralgia pain.
Radix Rehmanniae Preparata: latin name Rehmanniae Radix Praeparata, sweet in the mouth, slightly warm in nature enters liver, kidney channel, has the YIN nourishing of enriching blood, and beneficial essence is filled out the effect of marrow, cures mainly blood deficiency and yellow complexion; Dizzy, cardiopalmus, insomnia, menoxenia is collapsed more than; Hepatic and renal YIN deficiency, night sweat, sufficient knee joint pain, soreness of the waist and knees, Hiccough and deaf, the head is dim-sighted; The seminal emission sexual impotence; Infertility; Menoxenia; Metrostaxis; Early whitening of beard and hair; Quench one's thirst; Constipation; The cards such as dyspnea with rapid and short breath of suffering from a deficiency of the kidney.
Flos Chrysanthemi: latin name Chrysanthemi Flos, acrid in the mouth, sweet, bitter, cold nature is returned lung, Liver Channel, have that dispelling wind liver heat removing, suppressing the hyperactive liver make eye bright, the effect of removing toxic substances and promoting subsidence of swelling, cure mainly affection due to external wind and heat and epidemic febrile disease from the beginning of, have a dizzy spell, blurring of vision, conjunctival congestion and swelling pain, the cards such as pyretic toxicity carbuncle.
Rhizoma Chuanxiong: latin name Chuanxiong Rhizoma, acrid in the mouth, warm in nature, enter liver, gallbladder, pericardium channel, have blood-activating and qi-promoting, the effect of wind-expelling pain-stopping cures mainly stagnation of QI and blood, headache, rheumatic arthralgia, the cards such as traumatic injury.
Herba Plantaginis: latin name Plantaginis Herba, sweet in the mouth; Light; Cold nature is returned lung meridian; Liver Channel; Kidney channel; Urinary bladder channel has clearing away heat and promoting diuresis; Eliminating dampness by diuresis antidiarrheal; The effect that makes eye bright and eliminate the phlegm cures mainly dysuria; The stranguria with turbid discharge leukorrhagia; The edema distension; The heat-damp in summer dysentery; Conjunctival congestion is hidden from view; The expectorant heat syndrome cough such as breathes heavily at the card.
Folium Pyrrosiae: latin name Pyrrosiae Folium, sweet in the mouth, hardship, cold nature is returned lung, urinary bladder channel, has relieving stranguria by diuresis, and the effect that lung heat clearing expels the heat-evil cures mainly and drenches pain, hematuria, lithangiuria, nephritis, metrorrhagia, dysentery, cough due to lung-heat, chronic tracheitis, incised wound, the cards such as carbuncle.
Radix Ophiopogonis: latin name Ophiopogonis Radix, sweet in the mouth, little hardship, cold nature, enter the heart, lung, stomach warp, have the effect that nourishing YIN and moistening the lung, preventing phlegm from forming and stopping coughing, heat clearing away nourish heart, curing mainly pathogenic dryness impairing the lung or lung-dryness syndrome due to deficiency of YIN has the dry cough expectorant of heat glutinous, the chronic cough hemoptysis, dry pharynx dryness in the nasal cavity, lung abscess, dry mouth and throat due to thermal burn stomach-Yin or the deficiency of stomach-Yin, the few tongue of red tongue, vague epigastralgia, interior-heat is quenched one's thirst, constipation due to dry stool, deficiency of heart-yin and epidemic febrile disease pathogenic heat are disturbed and the heart-nutriment and the dysphoria and insomnia that causes, crimson tongue and do and wait card.
Fructus Lycii: latin name Lycii Fructus, sweet in the mouth, property are put down, enter liver, kidney channel, have liver and kidney tonifying, nourish blood enrich blood, the effect of replenishing vital essence to improve eyesight, nourishing the lung to arrest cough, cure mainly soreness of the waist and knees, dizziness and tinnitus, seminal emission tinnitus, the unconsciously sweat and tire of Liver and kidney two void, asthenia of essence and blood; The sexual impotence of insufficiency of kidney-YANG, sterile; The cards such as the dim-sighted and deficiency of YIN chronic cough of the eyes of deficiency of YIN-essence, deficiency of liver-blood, Fructus Lycii can promote liver cell regeneration, the effect of enhancing non-specific immunity function.
Herba Epimedii: latin name Epimedii Folium, acrid in the mouth, sweet, warm in nature, enter liver, kidney channel, have kidney-replenishing, bone and muscle strengthening, the effect of wind-damp dispelling cures mainly that impotence due to deficiency of the kidney, seminal emission premature ejaculation, waist knee joint flaccidity are soft, cold extremities with aversion to cold; The cards such as arthralgia due to cold-dampnes or spasm of the limbs are numb, Herba Epimedii is traditional kidney invigorating and YANG supporting Chinese medicine, is rich in flavone compound, has gonadotropic Effect, directly suppresses bone resorption and promoting bone growing, makes organism metabolism be in bone formation greater than the positive balance state of bone resorption.
Radix Et Rhizoma Rhei: latin name Rhei Radix et Rhizoma, bitter in the mouth, cold in nature, return the 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; The effect of detoxifcation cures mainly the excess-heat constipation; The accumulation of heat feeling of stuffiness in chest; Damp-heat dysentery; Jaundice; Gonorrhea; The 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 stasis of blood stagnated and suffered from abdominal pain puerperal; Lump in the abdomen; Traumatic injury; Pyretic toxicity carbuncle and ulcer; Erysipelas; The cards such as scald.
Herba Schizonepetae: latin name Schizonepetae Herba, acrid in the mouth, slightly warm in nature enters lung, Liver Channel, and relieving the exterior syndrome by diaphoresis is arranged, and declares malicious rash, and the effect of blood hemostasis, cures mainly the fever and headache due to the affection of exogenous wind-cold wind heat, no matter has antiperspirant lossless, all can use; The headache of attacking on the wind heat is dizzy, and rash goes out not saturating; The puerperal blood faints apoplexy, the cards such as discharging fresh blood stool.
Natrii Sulfas: latin name NAtrii Sulfas, distinguish the flavor of into, hardship, cold in nature, return the stomach warp; Lung meridian; Spleen channel; Kidney channel; Small intestine meridian; Tri-jiao channel; Large intestine channel is used for the excess-heat constipation, constipation due to dry stool, and stagnant stomachache, acute appendicitis swells and ache; The external treatment acute mastitis, the cards such as swelling and pain of hemorrhoid also contain the multiple lower composition that rushes down in the Natrii Sulfas, can promote the noxious substances such as carbamide, creatinine to drain from intestinal, increase renal blood flow and glomerular filtration rate, also be improved the hypercoagulability effect, thereby nephrocyte is had protective effect.
Caulis Spatholobi: latin name Spatholobi Caulis, bitter in the mouth, sweet, warm in nature, enter liver, kidney channel, blood vessel dilating is arranged, enrich blood and invigorate blood circulation, regulating menstruation, the effect of relaxing muscles and tendons and activating QI and blood in the collateral, platelet aggregation there is obvious inhibitory action, promotes animal kidney and the total phosphorus metabolism in uterus, be mainly used in treating the menoxenia that blood deficiency has silt, limbs pain is meciless, the cards such as soreness of the waist and knees, pain.
Rhizoma Polygonati: latin name Polygonati Rhizoma, sweet in the mouth, property is flat, enter lung, spleen, kidney channel, has the yin nourishing of fostering the spirit of nobility, spleen invigorating lung moistening, the effect of enriching kidney essence, be used for the taste deficiency of qi and yin, lack of appetite is unable, lung-dryness syndrome due to deficiency of YIN, the few expectorant of dry cough, quenching one's thirst of yin asthenia generating intrinsic heat, the cards such as deficiency of kidney essence, impotence and seminal emission, dizziness and tinnitus, blurred vision dim eyesight.
The ratio of weight and number of each component is in the described Chinese medicine composition:
Herba Cissampelotis pareiae 10~20 weight portions, Radix Glehniae 20~30 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 10~20 weight portions, the Radix Paeoniae Alba 25~35 weight portions, Concha Ostreae 10~20 weight portions, Herba Ecliptae 30~40 weight portions, Cortex Dictamni 10~20 weight portions, Radix Rehmanniae Preparata 20~30 weight portions, Flos Chrysanthemi 15~25 weight portions, Rhizoma Chuanxiong 20~30 weight portions, Herba Plantaginis 10~20 weight portions, Folium Pyrrosiae 10~20 weight portions, Radix Ophiopogonis 30~40 weight portion, Fructus Lycii 25~35 weight portions, Herba Epimedii 10~20 weight portions, Radix Et Rhizoma Rhei 60~70 weight portions, Herba Schizonepetae 10~20 weight portions, Natrii Sulfas 15~25 weight portions, Caulis Spatholobi 25~35 weight portions and Rhizoma Polygonati 30~40 weight portions.
The weight fraction of each component ratio is more preferably in the described Chinese medicine composition:
Herba Cissampelotis pareiae 15~20 weight portions, Radix Glehniae 25~30 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 15~20 weight portions, the Radix Paeoniae Alba 30~35 weight portions, Concha Ostreae 15~20 weight portions, Herba Ecliptae 35~40 weight portions, Cortex Dictamni 15~20 weight portions, Radix Rehmanniae Preparata 25~30 weight portions, Flos Chrysanthemi 20~25 weight portions, Rhizoma Chuanxiong 25~30 weight portions, Herba Plantaginis 15~20 weight portions, Folium Pyrrosiae 15~20 weight portions, Radix Ophiopogonis 35~40 weight portion, Fructus Lycii 30~35 weight portions, Herba Epimedii 15~20 weight portions, Radix Et Rhizoma Rhei 65~70 weight portions, Herba Schizonepetae 15~20 weight portions, Natrii Sulfas 20~25 weight portions, Caulis Spatholobi 30~35 weight portions and Rhizoma Polygonati 35~40 weight portions.
Further, described Chinese medicine composition only is made of said components.
For the hematuria patient, can also further add Herba Agrimoniae and Rhizoma Imperatae in the described Chinese medicine composition, described Herba Agrimoniae and the Rhizoma Imperatae parts by weight in described Chinese medicine composition are Herba Agrimoniae 15~25 weight portions and Rhizoma Imperatae 10~20 weight portions, more preferably Herba Agrimoniae 20~25 weight portions and Rhizoma Imperatae 15~20 weight portions.
Herba Agrimoniae: latin name Agrimoniae Herba, bitter in the mouth, puckery, property is flat, GUIXIN, Liver Channel, have astringing to arrest bleeding, the effect of dysentery relieving parasite killing cures mainly various hemorrhage cards, for example: haematemesis, hematuria, have blood in stool, metrorrhagia, spitting of blood, epistaxis, dysentery, impairment caused by overstrain is taken off power, carbuncle, traumatic injury, the cards such as wound hemorrhage.
Rhizoma Imperatae: latin name Imperatae Rhizoma, sweet in the mouth, cold in nature enters lung, stomach, small intestine meridian, has cooling blood for hemostasis, clearing away heat and promoting production of body fluid, the effect of inducing diuresis for treating stranguria syndrome, cure mainly heat in blood and spit blood, epistaxis spitting of blood, hematuria, metrorrhagia, purpura, calentura excessive thirst, the gastric heat vomiting, dyspnea and cough due to lung-heat, the puckery pain of dribbling urination, edema, the cards such as jaundice.
For the serious patient of nausea and vomiting, can also further add Rhizoma Coptidis and Caulis Bambusae In Taenia in the described Chinese medicine composition, described Rhizoma Coptidis and the Caulis Bambusae In Taenia weight fraction in described Chinese medicine composition is Rhizoma Coptidis 10~20 weight portions and Caulis Bambusae In Taenia 5~15 weight portions, more preferably Rhizoma Coptidis 15~20 weight portions and Caulis Bambusae In Taenia 10~15 weight portions.
Rhizoma Coptidis: latin name Coptidis Rhizoma, bitter in the mouth, cold in nature, enter the heart, lung, gallbladder, stomach, large intestine channel, heat clearing and damp drying is arranged, eliminating fire and detoxication, the effect of cooling blood for improving eyesight, be usually used in treating the fire of removing pathogen in the heart warp, the dysphoria and insomnia that heart-fire is prosperous, and the high fever coma of epidemic febrile disease, the symptom such as vexed, thirsty; Also can be used for treating the symptoms such as dysentery due to damp and hot, tenesmus.
Caulis Bambusae In Taenia: latin name Bambusae Caulis In Taenias, sweet in the mouth, cold nature enters lung, stomach warp, the effect that removing heat-phlegm is arranged, relieves restlessness and prevents vomiting, being mainly used in lung meridian has heat, the cough ant phlegm of expectorant and accumulation of heat; The gallbladder fire is held expectorant under the arm, violates lung and disturbs the vexed of the heart, the palpitation with fear insomnia; Middle wind-phlegm fan, insufficiency of stomach is held the cards such as vomiting of heat under the arm.
Described composition of medicine dosage form is decoct, powder, honey refining pill, hydration pill, tablet, capsule, oral liquid, granule, colloid or syrup, more preferably syrup and capsule.
The invention provides the preparation method of above-mentioned Chinese medicine composition, it comprises:
The first step is mixed in proportion each component in the described Chinese medicine composition, is ground into 100 orders~200 purpose powder;
Second step, the determining alcohol that adds 2~4 times of the powder qualities that obtain with respect to the first step is 80~90% ethanol, reflux 1~3 hour, extract, obtain extracting solution, filter and obtain the first alcohol extract, it is 70~80% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 1~2 times of filtering residue quality again, and reflux 1~3 hour is extracted, obtain extracting solution, filter and obtain the second alcohol extract, the first filtrate and the second filtrate are mixed, concentrating under reduced pressure, desolventizing, drying obtains and gets dry extract;
The 3rd step was broken into 200 orders~400 purpose powder with described dried cream powder, added various auxiliary additives and prepared needed various dosage form.
Wherein, when the dosage form of described Chinese medicine composition is syrup, described the 3rd step is for adding the water dissolution with respect to 2~3 times of powder qualities in the powder after pulverizing, regulate pH value to 7.0 with 40% sodium hydroxide solution, add subsequently correctives sucrose, antiseptic mix homogeneously, namely get syrup, the correctives of adding, antiseptic and the content in medicine thereof: sucrose 25~70%, Pyrusussuriensis acids antiseptic such as potassium sorbate 0.1~0.3%, paraben preservative such as ethyl hydroxybenzoate 0.01~0.05%.
Wherein, when the dosage form of described Chinese medicine composition is capsule, described the 3rd step is for adding 5~7 weight portion carboxymethyl starch sodium, 5~50 weight portion starch mix homogeneously in the powder after pulverizing, 3~5 weight portion magnesium stearate, 150~200 weight portion determining alcohols are 80%~90% alcohol granulation, drying, granulate, then pack in the gelatine capsule, make capsule.
The present invention also provides above-mentioned Chinese medicine composition, and it is in the application that is used for cooperating the uremic medicine of hemodialysis of the various dosage forms of preparation.
Below adopt embodiment to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implements according to this.
The syrup 1 of embodiment 1 the present invention preparation
With Herba Cissampelotis pareiae 10g, Radix Glehniae 20g, Pseudobulbus Bletillae (Rhizoma Bletillae) 10g, Radix Paeoniae Alba 25g, Concha Ostreae 10g, Herba Ecliptae 30g, Cortex Dictamni 10g, Radix Rehmanniae Preparata 20g, Flos Chrysanthemi 15g, Rhizoma Chuanxiong 20g, Herba Plantaginis 10g, Folium Pyrrosiae 10g, Radix Ophiopogonis 30g, Fructus Lycii 25g, Herba Epimedii 10g, Radix Et Rhizoma Rhei 60g, Herba Schizonepetae 10g, Natrii Sulfas 15g, Caulis Spatholobi 25g and Rhizoma Polygonati 30g mix, be ground into 100 purpose powder, the adding determining alcohol is 90% ethanol 1200g in the powder that obtains, reflux 2 hours, extract, obtain extracting solution, filter and obtain the first alcohol extract, it is 80% ethanol 400g that the medicinal residues that filter to obtain add determining alcohol again, reflux 2 hours, extract, obtain extracting solution, filter and obtain the second alcohol extract, the first filtrate and the second filtrate are mixed, concentrating under reduced pressure, desolventizing, dry, obtain and get dry extract, described dried cream powder is broken into 300 purpose powder, the water dissolution that adds 800g in the powder after pulverizing, regulate pH value to 7.0 with 40% sodium hydroxide solution, add subsequently correctives 300g sucrose, potassium sorbate 2g mix homogeneously namely gets syrup 1.
Toxicity test
Use 60 of NIH mices, the SPF level, male and female half and half, body weight 18~22g carries out acute toxicity testing.Mice is divided into two groups at random, be matched group and administration group, fasting is 12 hours before the experiment, the Chinese medicine composition syrup 1 of embodiments of the invention 1 preparation is dissolved in the water, (concentration is 6.28g crude drug/ml, maximum concentration) gavage, the gavage volume is that 5ml/kg (is that single-dose dosage is 31.4g crude drug/kg), matched group gives the equivalent normal saline, administration in 1 day 2 times, delivery time 6 hours, Continuous Observation is 14 days after the administration, and toxic reaction and the death toll of record mice, specifically see table 1 for details.Experimental result shows: with matched group relatively, mice has no notable difference after the administration, experiment Continuous Observation 14 days, the mice overall health of patients, ingest, drinking-water, body weight gain is all normal.Mice oral administration gavage capsule LD of the present invention 50>31.4g crude drug/kg, every day, maximum dosage-feeding was 62.8g crude drug/kg/ day.Chinese medicine composition clinical application amount of the present invention is 2.1g crude drug/day/people, becomes body weight for humans in 60kg, and average dosage is 0.035g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is take 20g) oral administration gavage Chinese medicine composition of the present invention is 897 times of quantity.Therefore Chinese medicine composition acute toxicity of the present invention is low, clinical drug safety.
The syrup 2 of embodiment 2 the present invention preparation
With Herba Cissampelotis pareiae 12g, Radix Glehniae 30g, Pseudobulbus Bletillae (Rhizoma Bletillae) 10g, Radix Paeoniae Alba 35g, Concha Ostreae 18g, Herba Ecliptae 38g, Cortex Dictamni 12g, Radix Rehmanniae Preparata 29g, Flos Chrysanthemi 18g, Rhizoma Chuanxiong 30g, Herba Plantaginis 20g, Folium Pyrrosiae 10g, Radix Ophiopogonis 40g, Fructus Lycii 35g, Herba Epimedii 12g, Radix Et Rhizoma Rhei 70g, Herba Schizonepetae 15g, Natrii Sulfas 12g, Caulis Spatholobi 35g and Rhizoma Polygonati 40g mix, be ground into 100 purpose powder, the adding determining alcohol is 90% ethanol 1200g in the powder that obtains, reflux 2 hours, extract, obtain extracting solution, filter and obtain the first alcohol extract, it is 80% ethanol 400g that the medicinal residues that filter to obtain add determining alcohol again, reflux 2 hours, extract, obtain extracting solution, filter and obtain the second alcohol extract, the first filtrate and the second filtrate are mixed, concentrating under reduced pressure, desolventizing, dry, obtain and get dry extract, described dried cream powder is broken into 300 purpose powder, the water dissolution that adds 800g in the powder after pulverizing, regulate pH value to 7.0 with 40% sodium hydroxide solution, add subsequently correctives 300g sucrose, potassium sorbate 2g mix homogeneously namely gets syrup 2.
The capsule of embodiment 3 the present invention preparation
With Herba Cissampelotis pareiae 20g, Radix Glehniae 30g, Pseudobulbus Bletillae (Rhizoma Bletillae) 20g, Radix Paeoniae Alba 35g, Concha Ostreae 20g, Herba Ecliptae 40g, Cortex Dictamni 20g, Radix Rehmanniae Preparata 30g, Flos Chrysanthemi 25g, Rhizoma Chuanxiong 30g, Herba Plantaginis 20g, Folium Pyrrosiae 20g, Radix Ophiopogonis 40g, Fructus Lycii 35g, Herba Epimedii 20g, Radix Et Rhizoma Rhei 70g, Herba Schizonepetae 20g, Natrii Sulfas 25g, Caulis Spatholobi 35g and Rhizoma Polygonati 40g mix, be ground into 100 purpose powder, the adding determining alcohol is 90% ethanol 1200g in the powder that obtains, reflux 2 hours, extract, obtain extracting solution, filter and obtain the first alcohol extract, it is 80% ethanol 400g that the medicinal residues that filter to obtain add determining alcohol again, reflux 2 hours, extract, obtain extracting solution, filter and obtain the second alcohol extract, the first filtrate and the second filtrate are mixed, concentrating under reduced pressure, desolventizing, dry, obtain and get dry extract, described dried cream powder is broken into 300 purpose powder, add the 50g carboxymethyl starch sodium in the powder after pulverizing, 400g starch mix homogeneously, the 15g magnesium stearate, determining alcohol is that 90% ethanol 2000g granulates drying, granulate, then pack in the gelatine capsule, make capsule.
Embodiment 2 clinical experiments
Patient's data
187 routine cases are my institute's inpatient, male 98 examples wherein, women 89 examples; 42.8 years old mean age; Sick time 2~10 years, average 4 years; Pathogenic factor: chronic glomerulonephritis 103 examples, diabetic nephropathy 65 examples, hypertensive nephropathy 19 examples.The serum creatinine average was at (830 ± 242) μ mol/L when the patient was admitted to hospital, carbamide average (38.9 ± 11.1) mmol/L, and creatinine clearance rate average (12.1 ± 4.5) mL/min all meets the indication of hemodialysis.Above-mentioned 187 routine patients are divided into 2 groups at random, treatment group 105 examples, matched group 82 examples, the clinical data such as 2 groups of Genders, age, pathogenic factor is compared difference not statistically significant (P>0.05), has comparability.
Diagnostic criteria
Treat uremic guideline of clinical investigations according to new Chinese medicine, work out following standard: 1. endogenous creatinine clearance rate Ccr drops to below the 25mL/min; 2. serum creatinine surpasses 221 μ mol/L; 3. the patient has obvious uremia symptom and clinical chronic kidney disease medical history.
Therapeutic Method
All cases all gives: the treatment of underlying diseases; The control blood pressure; High-quality is hanged down albumen, low-phosphorous, high caloric diet; Anemia.Matched group hemodialysis 2 times weekly on the basis of above-mentioned treatment, treatment group be hemodialysis 1 time weekly, takes simultaneously the Chinese medicine composition syrup 1 that the present invention makes every day, treat 2 times, and each 1 time sooner or later, each 150ml.
Observation item
Before and after dialysis checks patient's serum creatinine, carbamide, potassium, sodium, chlorine, calcium 1 time weekly, looks into its routine blood test, urine creatine clearance rate, blood fat before the treatment.Treat after 3 months all cases is carried out routine blood test, urine creatine clearance rate, blood fat check.
Criterion of therapeutical effect
The criterion of therapeutical effect standard that academic conference was drafted with reference to national renal failure conservative treatment special topic in 1987.Produce effects: 1. sx↓ or disappearance; 2. endogenous creatinine clearance rate increases 〉=30%; 3. serum creatinine reduces 〉=30%, and is above 1. indispensable, and 2. 3. possessing 1 can judge.Effectively: 1. sx↓ or disappearance; 2. endogenous creatinine clearance rate increases 〉=20%; 3. serum creatinine reduces 〉=20%, and is above 1. indispensable, and 2. 3. possessing 1 can judge.Invalid: as 1. not meet produce effects, effective decision condition person; 2. nausea and vomiting before the dialysis can not be taken food, the limbs edema, and serum creatinine, carbamide, blood potassium significantly raise.
Statistical method
Carry out statistical analysis with SPSS 13.0 softwares, relatively use χ between the rate 2Check is checked with t between the mean.
The result
Two groups of curative effects relatively see Table 1, and as can be seen from Table 1, the Chinese medicine composition syrup of taking the embodiment of the invention 1 preparation has significant advantage at treatment uremic prescription mask.
Table 1 liang group curative effect relatively
Group The example number Produce effects Effectively Invalid Total effective rate (%)
Treatment group 105 63 41 1 99.0%
Matched group 82 42 25 15 81.7%
2 groups of blood creatinines, blood urea nitrogen, potassium content treatment front and back relatively see Table 2.
Indices relatively before and after 2 groups of treatments of table 2
Group Cr/(μmol/L) BUN/(mmol/L) K +/(μmol/L)
Matched group After the dialysis 327.97±117.65 16.20±6.50 3.70±1.60
Before the dialysis 834.56±128.96 38.10±11.80 5.00±1.80
Difference 496.59±11.31 21.90±5.30 1.30±0.20
Treatment group After the dialysis 318.05±120.63 16.10±7.50 4.00±1.50
Before the dialysis 824.10±123.30 38.90±12.10 4.90±1.60
Difference 506.06±2.97 22.80±4.60 0.90±0.10
2 groups of sodium, chlorine, calcium content treatment front and back relatively see Table 3.
Indices relatively before and after 2 groups of treatments of table 3
Group Na +/(μmol/L) Cl/(mmol/L) Ca +/(μmol/L)
Matched group After the dialysis 138.40±8.90 95.20±12.30 3.10±1.30
Before the dialysis 140.50±12.80 95.60±12.10 3.00±1.20
Difference 2.10±3.90 0.40±0.20 0.10±0.10
Treatment group After the dialysis 138.40±9.20 94.60±10.80 3.20±1.20
Before the dialysis 140.30±10.80 95.30±10.90 3.00±1.10
Difference 1.90±1.60 0.70±0.10 0.20±0.10
Review result relatively sees Table 4, can find out that the index treatment front and back comparing differences such as treatment group creatinine clearance rate, hemoglobin, blood fat have statistical significance (P<0.05) from table 4, treatment group and matched group relatively have statistical significance (P<0.05) after the treatment.
Indices relatively before and after 2 groups of checks of table 4
Figure BSA00000742648900121
Figure BSA00000742648900131
Model case 1
Lin, the woman, 51 years old, uremic patient, first visit on October 4 in 2010, hemodialysis is 1 year, 3 times weekly.Long-term inappetence, weak is accompanied serious anemia, Hb42g/l, though through dialysis and with EPO without improvement, patient's emaciated physique, the low voice timidness due to deficiency of QI, the fat tender tongue of light red tongue is few, thready and weak pulse.Card belongs to deficiency of spleen-QI and stomach-QI, takes the syrup of the embodiment of the invention 2 preparations, and every day 2 times, each 150ml receives food through treatment and promotes, and through controlling 2 wheat harvesting periods, symptom takes a favorable turn, Hb79g/L.
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 those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.

Claims (5)

1. one kind cooperates the uremic Chinese medicine composition of hemodialysis, it is characterized in that, the weight portion of each component is in the described Chinese medicine composition: Herba Cissampelotis pareiae 10~20 weight portions, Radix Glehniae 20~30 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 10~20 weight portions, the Radix Paeoniae Alba 25~35 weight portions, Concha Ostreae 10~20 weight portions, Herba Ecliptae 30~40 weight portions, Cortex Dictamni 10~20 weight portions, Radix Rehmanniae Preparata 20~30 weight portions, Flos Chrysanthemi 15~25 weight portions, Rhizoma Chuanxiong 20~30 weight portions, Herba Plantaginis 10~20 weight portions, Folium Pyrrosiae 10~20 weight portions, Radix Ophiopogonis 30~40 weight portion, Fructus Lycii 25~35 weight portions, Herba Epimedii 10~20 weight portions, Radix Et Rhizoma Rhei 60~70 weight portions, Herba Schizonepetae 10~20 weight portions, Natrii Sulfas 15~25 weight portions, Caulis Spatholobi 25~35 weight portions and Rhizoma Polygonati 30~40 weight portions.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that, the weight portion of each component is in the described Chinese medicine composition: Herba Cissampelotis pareiae 15~20 weight portions, Radix Glehniae 25~30 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 15~20 weight portions, the Radix Paeoniae Alba 30~35 weight portions, Concha Ostreae 15~20 weight portions, Herba Ecliptae 35~40 weight portions, Cortex Dictamni 15~20 weight portions, Radix Rehmanniae Preparata 25~30 weight portions, Flos Chrysanthemi 20~25 weight portions, Rhizoma Chuanxiong 25~30 weight portions, Herba Plantaginis 15~20 weight portions, Folium Pyrrosiae 15~20 weight portions, Radix Ophiopogonis 35~40 weight portion, Fructus Lycii 30~35 weight portions, Herba Epimedii 15~20 weight portions, Radix Et Rhizoma Rhei 65~70 weight portions, Herba Schizonepetae 15~20 weight portions, Natrii Sulfas 20~25 weight portions, Caulis Spatholobi 30~35 weight portions and Rhizoma Polygonati 35~40 weight portions.
3. the preparation method of claim 1 or 2 described Chinese medicine compositions is characterized in that, comprising:
The first step is mixed in proportion each component in the described Chinese medicine composition, is ground into 100 orders~200 purpose powder;
Second step, the determining alcohol that adds 2~4 times of the powder qualities that obtain with respect to the first step is 80~90% ethanol, reflux 1~3 hour, extract, obtain extracting solution, filter and obtain the first alcohol extract, it is 70~80% ethanol that the medicinal residues that filter to obtain add determining alcohol with respect to 1~2 times of filtering residue quality again, and reflux 1~3 hour is extracted, obtain extracting solution, filter and obtain the second alcohol extract, the first filtrate and the second filtrate are mixed, concentrating under reduced pressure, desolventizing, drying obtains and gets dry extract;
The 3rd step was broken into 200 orders~400 purpose powder with described dried cream powder, added various auxiliary additives and prepared needed various dosage form.
4. the preparation method of the described Chinese medicine composition of claim 3 is characterized in that:
When the dosage form of described Chinese medicine composition is syrup, described the 3rd step is for adding the water dissolution with respect to 2~3 times of powder qualities in the powder after pulverizing, regulate pH value to 7.0 with 40% sodium hydroxide solution, add subsequently correctives sucrose, antiseptic mix homogeneously, namely get syrup, the correctives of adding, antiseptic and the content in medicine thereof: sucrose 25~70%, potassium sorbate 0.1~0.3%, ethyl hydroxybenzoate 0.01~0.05%.
5. the preparation method of the described Chinese medicine composition of claim 3 is characterized in that:
When the dosage form of described Chinese medicine composition is capsule, described the 3rd step is for adding 5~7 weight portion carboxymethyl starch sodium, 5~50 weight portion starch mix homogeneously in the powder after pulverizing, 3~5 weight portion magnesium stearate, 150~200 weight portion determining alcohols are 80%~90% alcohol granulation, dry, then granulate packs in the gelatine capsule, makes capsule.
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