CN104800749A - Medicine for treating diabetic nephropathy - Google Patents

Medicine for treating diabetic nephropathy Download PDF

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CN104800749A
CN104800749A CN201510172905.1A CN201510172905A CN104800749A CN 104800749 A CN104800749 A CN 104800749A CN 201510172905 A CN201510172905 A CN 201510172905A CN 104800749 A CN104800749 A CN 104800749A
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herba
radix
medicine
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刘泽涛
于莉
程绍云
范爱秀
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Qingdao Third Peoples Hospital
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Qingdao Third Peoples Hospital
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Abstract

The invention provides a medicine for treating diabetic nephropathy. The medicine comprises raw materials as follows: Chinese angelica, astragalus membranaceus, aleppo avens, motherwort herb, red paeony root, four-leaf clover, moellendorf's spidemoss herb, trifoliate acanthopanax root, bamboo orchid, cherokee rose fruit, black sesame, yerbadetajo herb, medicinal changium root, turmeric, longhairy antenoron herb, common macrocarpium fruit, white paeony root and flastem milkvetch seeds. The medicine can improve clinical symptoms of a patient suffering from diabetic nephropathy, reduce urine protein and delay deterioration of kidney functions, so that the life quality of the patient can be improved.

Description

Be used for the treatment of the medicine of diabetic nephropathy
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to one and be used for the treatment of medicine for treating diabetic nephropathy.
Background technology
Diabetic nephropathy (diabetic nephropathy DN) is the glomerular sclerosis that diabetic microvascular complication causes, and its clinical manifestation mainly contains that glomerular filtration rate increases, albuminuria, edema, nephrotic syndrome.As one of complication that diabetes (diabetes mellitus DM) are the most serious, DN can also bring out other vascular complication.Meanwhile, the End-stage renal failure (ESRD) that diabetic nephropathy causes is becoming the main cause threatening diabetics life, has had a strong impact on life in patients, has consumed a large amount of medical resource.Have now found that inherited genetic factors, protein non-enzyme glycosylation, oxidative stress strengthen, Protein kinase C (PKC) activate, abnormal hemodynamics, proinflammatory cytokine, tumor necrosis factor-alpha (TNF-α) with multiple somatomedin as the factors such as transforming growth factor-β (TGF-β), Connective Tissue Growth Factor (CTGF) are all fallen ill relevant to diabetic nephropathy.
The western medical treatment of current diabetic nephropathy, mainly through controlling glucose, blood pressure, regulating lipid metabolism, all never reaches desirable therapeutic effect, during to PD to the renal failure stage, dialysis treatment can only be taked to sustain life.
The pathogenesis of diabetic nephropathy is many-sided, and relevant with factors such as heredity, metabolism, hemodynamic responses, somatomedin, cytokine, oxidative stress and Podocytes in Renal Tissues, Desmin, as Podocytes in Renal Tissue mark, can point out Podocytes in Renal Tissue degree.Chinese medicine has the features such as multipath, Mutiple Targets, low untoward reaction, in treatment diabetic nephropathy, have advantage relative to Western medicine.
About the description of diabetic nephropathy, sporadically appear in Chinese medical book in the disease such as " edema ", " distension ", " urine oil ", " diseases due to endogenous heat of ZANG FU organs ", " obstruction and rejection ", " diabetes involving the kidney ".Bright " key to Diagnosis and Treatment " cloud: " three disappear for a long time and urine is not smelly, anti-sweet gas of doing, and roll in drowning and gush, more have floating drowning to look like leaf fat, this essence be can't help, and true strength exhausts also." this symptom is more common in the diabetic nephropathy person that has High-grade Proteinuria.Tang's " medical secrets of official " cloud: " thirsty and drinking-water can not be many, but lower limb swells, foot first slight of stature, cloudy expectorant is weak, number urinator, this be diabetes involving the kidney disease also." diabetes involving the kidney symptom described herein is similar to diabetic nephropathy Late manifestations.
Diabetes Mellitus Treated With Traditional Chinese Medicine nephropathy and carbohydrate metabolism disturbance, adjusting blood lipid metabolism with correction body main to the protective effect of kidney, improve blood circulation and microangiopathies, scavenging activated oxygen, downward correlation factor are expressed, regulate the aspects such as immunity of organism relevant.The determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs of Chinese medicine can improve the clinical symptoms of diabetic nephropathy patient better, reduces urine protein, delays renal function exacerbation, improves patients ' life quality.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of medicine being used for the treatment of diabetic nephropathy, and it can improve the clinical symptoms of diabetic nephropathy patient, reduces urine protein, delays renal function exacerbation, improves patients ' life quality.
For solving the problems of the technologies described above, the invention provides a kind of medicine being used for the treatment of diabetic nephropathy, its crude drug comprises Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Herba Leonuri, Radix Paeoniae Rubra, Herba Galii Bungei, Herba Selaginellae Moellendorfii, Radix Acanthopanacis Trifoliati, Herba Murdanniae Divergentis, Fructus Rosae Laevigatae, Semen Sesami Nigrum, Herba Ecliptae, Radix Changii, Rhizoma Curcumae Longae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati.
Wherein, in described medicine, the weight portion of each crude drug is respectively Radix Angelicae Sinensis 33 weight portion ~ 43 weight portion, the Radix Astragali 52 weight portion ~ 62 weight portion, Radix seu Herba Gei aleppici 27 weight portion ~ 37 weight portion, Herba Leonuri 30 weight portion ~ 40 weight portion, Radix Paeoniae Rubra 25 weight portion ~ 35 weight portion, Herba Galii Bungei 18 weight portion ~ 28 weight portion, Herba Selaginellae Moellendorfii 15 weight portion ~ 25 weight portion, Radix Acanthopanacis Trifoliati 15 weight portion ~ 25 weight portion, Herba Murdanniae Divergentis 13 weight portion ~ 23 weight portion, Fructus Rosae Laevigatae 10 weight portion ~ 20 weight portion, Semen Sesami Nigrum 25 weight portion ~ 35 weight portion, Herba Ecliptae 39 weight portion ~ 49 weight portion, Radix Changii 16 weight portion ~ 26 weight portion, Rhizoma Curcumae Longae 25 weight portion ~ 35 weight portion, Herba Lysimachiae 23 weight portion ~ 33 weight portion, Fructus Corni 29 weight portion ~ 39 weight portion, the Radix Paeoniae Alba 30 weight portion ~ 40 weight portion, Semen Astragali Complanati 28 weight portion ~ 38 weight portion.
Wherein, in described medicine, the weight portion of each crude drug is respectively Radix Angelicae Sinensis 36 weight portion ~ 40 weight portion, the Radix Astragali 55 weight portion ~ 59 weight portion, Radix seu Herba Gei aleppici 30 weight portion ~ 34 weight portion, Herba Leonuri 33 weight portion ~ 37 weight portion, Radix Paeoniae Rubra 28 weight portion ~ 32 weight portion, Herba Galii Bungei 21 weight portion ~ 25 weight portion, Herba Selaginellae Moellendorfii 18 weight portion ~ 22 weight portion, Radix Acanthopanacis Trifoliati 18 weight portion ~ 22 weight portion, Herba Murdanniae Divergentis 16 weight portion ~ 20 weight portion, Fructus Rosae Laevigatae 13 weight portion ~ 17 weight portion, Semen Sesami Nigrum 28 weight portion ~ 32 weight portion, Herba Ecliptae 42 weight portion ~ 46 weight portion, Radix Changii 19 weight portion ~ 23 weight portion, Rhizoma Curcumae Longae 28 weight portion ~ 32 weight portion, Herba Lysimachiae 26 weight portion ~ 30 weight portion, Fructus Corni 32 weight portion ~ 36 weight portion, the Radix Paeoniae Alba 33 weight portion ~ 37 weight portion, Semen Astragali Complanati 31 weight portion ~ 35 weight portion.
Wherein, described medicine can be prepared into Tablet and Capsula agent.
Present invention also offers the preparation method of said medicine, it comprises:
The first step, gets Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Sesami Nigrum, Herba Ecliptae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati, pulverizes respectively, mix, and obtains mixture, adopts alcohol heating reflux to extract, obtains and extract powder;
Second step, pulverizes remaining crude drug respectively, mixes, and obtains mixture, adopts water boiling and extraction, obtains and extracts powder;
3rd step, the extraction powder mixing first step and second step obtained, adds adjuvant and is prepared into various dosage form.
Wherein, the described first step is specially further, get Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Sesami Nigrum, Herba Ecliptae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati, pulverize respectively, mix, obtain mixture, adding relative to the determining alcohol of mixture material medicine weight 5 ~ 10 times amount is the alcohol reflux of 70% ~ 80%, extract three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.10 ~ 1.20, add ethanol, the concentration of ethanol is made to reach 60 ~ 90%, place, precipitation, be separated to obtain supernatant, concentrated, macroporous adsorptive resins on the concentrate that obtains of concentrate, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, recycling design, obtain and get dry extract, be ground into powder.
Wherein, described second step is specially further, is pulverized respectively by remaining crude drug, mixes, and obtains mixture, adds the water relative to mixture quality 3 ~ 5 times, soak after 30 minutes ~ 60 minutes, 30 minutes at a simmer, leach medicine juice; Filtering residue adds the water relative to mixture quality 2 ~ 4 times again, and slow fire decocts 20 ~ 25 minutes again, leaches medicine juice for twice and mixes even, removes water, obtains and get dry extract, be ground into powder.
Wherein, when the dosage form of prepared medicine is tablet, after being mixed by powder, every 100g mixed-powder adds 50g ~ 70g filler, the lubricant of 3g ~ 5g binding agent, 0.5g ~ 1.5g correctives, 0.5g ~ 1.5g, mixing, and tabletting, dries, packaging.
Wherein, described filler is preferably one or more mixing in starch, beta-schardinger dextrin-, xylitol, calcium carbonate, described binding agent is preferably one or more mixing in polyvinylpyrrolidone, methylcellulose, starch slurry, described correctives is preferably one or more mixing in sucrose, aspartame, and described lubricant is preferably one or more mixing in magnesium stearate, Pulvis Talci, micropowder silica gel.
Wherein, when prepared pharmaceutical dosage form is capsule, after powder is mixed, every 100g mixed-powder adds microcrystalline Cellulose 15 ~ 25g, crospolyvinylpyrrolidone 5 ~ 15g, cross-linking sodium carboxymethyl cellulose 5 ~ 15g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 2 ~ 4g, magnesium stearate 0.5 ~ 1.5g, granulate, incapsulates.
Beneficial effect of the present invention:
The invention provides a kind of medicine being used for the treatment of diabetic nephropathy, it can improve the clinical symptoms of diabetic nephropathy patient, reduces urine protein, delays renal function exacerbation, improves patients ' life quality.
Detailed description of the invention
The weight portion that the present invention mentions is a proportionate relationship between each composition.
The traditional Chinese medical science thinks that the diabetic nephropathy initial stage is for quenching one's thirst, and occur that deteriorated case is as edema, dizzy mid-term, the later stage goes down because prolonged illness causes whole body function and sees asthenia.Ancient Chinese medicine doctor is multiple depending on effect in its morbidity of suffering from a deficiency of the kidney, and think to examine and compose not enough and long-term surfeit delicious food savoury, state food pure wine, stimulates impairing the spleen and stomach, dysfunction of the spleen in transportation, stomach-QI being unable to descend normally, and middle burnt accumulated heat rapid digestion of food consumes Tianjin and for quenching one's thirst.Emotional stress, depressed rage impairing the liver, depression of liver-QI, Yu Huahuo of a specified duration, dryness caused by consumption of body fluid, kidney element is empty in addition, the envelope Tibetan mistake department of kidney, and deficiency of the kidney liquid is withered, hyperactivity of YANG due to deficiency of YIN and see dizzy.Again because labor is for excessively, deficiency of the kidney, the raw interior-heat of the deficiency of YIN, cloudy Tianjin is secretly consumed and is caused internal organs and lose in moistening foster, and its function day by day weakness causes deficient qi and blood, imbalance of YIN and YANG.Quench one's thirst with the passing of time, yin-damaging and Qi consuming, deficiency of YIN affecting YANG is its basic trend, and examines and compose not enough or impairment caused by overstrain too, also can develop into nephrons virtual loss.Deficiency of kidney-YIN, edema with the liver involved is lost and is supported, the hepatic and renal YIN deficiency, hyperactivity of YANG due to deficiency of YIN, and nephrons envelope Tibetan is had no right, therefore early stage common urinary micturition, and companion sees dizzy order flower: deficiency of YIN consumption gas, impairment of both QI and YIN, instability of kidney QI, precise and tinyly leaks, and sees frequent micturition turbid urine; Deficiency of YIN affecting YANG, negative and positive two are hindered, and precise and tiny leaking and water liquid are stagnated, then see frequent micturition edema; The state of an illness continues progress, and kidney body labor declines, kidney mistake department, and QI and blood is all hindered, and spleen kidney loses supports, and blood vessels are not smooth, and stop in turbid poison, all diseases come in great numbers; Final nephrons decays, and the five internal organs are impaired, and three Jiao are obstructed, abnormal ascending-descending of QI, and water is wet to spread unchecked, and transfers the obstruction and rejection of qi-movement disturbance to.
Diabetes nephropathy take deficiency of both QI and YIN as basic pathogenesis, and main diseases position is at kidney, closely related with functions such as liver, the heart, lung, spleens, the progress of this disease many by part of the body cavity above the diaphragm housing the heart and lungs intenseness of heat to part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels deficiency and coldness, by deficiency of both QI and YIN to deficiency of both YIN and YANG, finally cause accumulateing in turbid poison, develop into the whole latter stage of this disease.Geng Jia etc. (keep diabetes nephropathy etiology and pathogenesis and be summarised as " strange perseverance is weak, interior-heat stifling, impairment of body fluid consumption gas, blood magma are dense, store turbid consumption of essence ", and emphasize that deficiency of both QI and YIN is primary disease basic pathogenesis, turbid retardance of becoming silted up runs through diabetes nephropathy all the time by pasture.Deficiency of both QI and YIN is the basic pathogenesis of diabetes nephropathy, and transforms to deficiency of spleen-YANG and kidneyYANG, the hepatic and renal YIN deficiency and deficiency of both YIN and YANG, and the domination of pathogen is wet based on blood stasis, phlegm retention, water, turbid poison.Deficiency of both QI and YIN is the basic pathogenesis of diabetes nephropathy, and progress is many by part of the body cavity above the diaphragm housing the heart and lungs excess-heat, and middle burnt gastric heat, part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels deficiency and coldness, by deficiency of both QI and YIN to deficiency of both YIN and YANG, finally causes accumulateing into poison in turbid damp, develop into the whole latter stage of this disease.The TCM Syndrome Features of diabetes nephropathy is deficiency in origin and excess in superficiality, deficiency in origin based on deficiency of both QI and YIN, along with the progress of the course of disease, develop into deficiency of YIN affecting YANG gradually, the card of deficiency in both YIN and YANG, double mark excess syndrome of holding under the arm because the course of disease stage is different and individual variation and show different, but syndrome of blood stasis is for running through primary disease all the time.Method is vertical with card, therefore makes laws to the treatment of primary disease with supplementing QI and nourishing YIN, and blood circulation promoting and blood stasis dispelling is main.
The invention provides a kind of medicine being used for the treatment of diabetic nephropathy, its crude drug comprises Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Herba Leonuri, Radix Paeoniae Rubra, Herba Galii Bungei, Herba Selaginellae Moellendorfii, Radix Acanthopanacis Trifoliati, Herba Murdanniae Divergentis, Fructus Rosae Laevigatae, Semen Sesami Nigrum, Herba Ecliptae, Radix Changii, Rhizoma Curcumae Longae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati.
Fang Zhong, Chinese angelica blood supplementing is invigorated blood circulation, diabetic nephropathy patient renal function can be improved, reduce the discharge of urine protein, Radix Astragali tonification spleen soil, elevate a turnable ladder yang-energy, all protective effect is had to the electrostatic barrier of glomerular basement membrane and mechanical barrier, thus reduce the albuminuretic generation of permeability, all have renal albuminuria and alleviate and eliminating effect, Radix seu Herba Gei aleppici, Herba Galii Bungei inducing diuresis to remove edema, improve protein, fat and carbohydrate metabolism, conditioner body immunity function, improve Abnormal Blood Rheology change, alleviate oxygen Bai Youji to damage, inflammation-inhibiting because of, reduce the effects such as fiber generation, Herba Leonuri, Radix Paeoniae Rubra promoting blood flow to regulate menstruation, inducing diuresis to remove edema, energy blood vessel dilating, improve microcirculation, direct protective action is risen to blood vessel endothelium, Herba Selaginellae Moellendorfii clearing away heat-damp and promoting diuresis can improve microcirculation, suppress platelet adhesion and gathering, reduce viscosity of blood, improve renal function, Radix Acanthopanacis Trifoliati expelling wind and removing dampness, relaxing muscles and tendons to promote blood circulation, suppress the proliferation of glomerular mesangial cells of people, suppression mechanism hyperplasia, Herba Murdanniae Divergentis invigorating the lung and the kidney, regulating menstruation, hemostasis, reduce urine protein secretory volume, alleviate base film thickness, to kidney by protective effect, Fructus Rosae Laevigatae tonifying the kidney to reduce urination, eliminate albuminuria, Semen Sesami Nigrum invigorating the liver and kidney, benefiting essence-blood, Herba Ecliptae liver and kidney tonifying, cooling blood for hemostasis, Radix Et Caulis Acanthopanacis Senticosi tonifying the kidney for tranquilization, reduce renal blood flow, glomerular filtration rate, Radix Changii yin nourishing stomach function regulating, prevent and alleviate renal function exacerbation, tubulointerstitial injury, Rhizoma Curcumae Longae is by suppressing phospholipid inositol signal pathway-subunit (PKC-) and β under high sugared environment 1the displacement activation control lipid peroxidation of subunit, increase activities of antioxidant enzymes, Herba Lysimachiae Tonglin Paishi, removing toxic substances and promoting subsidence of swelling, Fructus Corni can suppress TGF-β 1expression, improve podocyte damage, the Radix Paeoniae Alba has significant protective effect to diabetes rat renal tubular-interstitial injury, significantly improve diabetes rat early nephropathy, Semen Astragali Complanati can alleviate the oxidative damage of high sugar induction, and reduce blood fat, all medicines share, play supplementing QI and nourishing YIN altogether, blood circulation invigorating efficacies.
Each crude drug pharmacology is as follows:
Radix Angelicae Sinensis: latin name Angelicae Sinensis Radix, 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, produces 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, its can improve uterus blood circulation, alleviate pelvic congestion, relieving dysmenorrhea.
The Radix Astragali: latin name astragali radix, sweet in the mouth, warm in nature, enter spleen, lung meridian, there is tonification spleen soil, elevate a turnable ladder yang-energy, strengthening superficial resistance to stop perspiration, the effects such as holder skin ulcer granulation promoting, are mainly used in the weak anorexia and loose stool that deficiency of both the splenic and pulmonary QI is caused, shortness of breath and palpitation, the visceroptosis of sinking of QI of middle-JIAO, the metrorrhagia of QI failing to control blood is had blood in stool, chronic diarrhea proctoptosis; The spontaneous sweating of exterior deficiency, the cards such as insufficiency of vital energy and blood.
Radix seu Herba Gei aleppici: latin name Gei Herba, acrid in the mouth, hardship, property is put down, and return liver, spleen, lung meridian, have analgesia, blood pressure lowering, regulating menstruation, effect of expelling wind and removing dampness, cures mainly hypertension, dizziness headache, menoxenia, lower abdominal pain, leucorrhea, infantile convulsion, lumbago, skelalgia of rheumatism; Carbuncle furuncle and phyma poison is controlled in external, the cards such as traumatic injury.
Herba Leonuri: latin name Leonuri Herba, bitter in the mouth, pungent, cold nature, enters liver, pericardium channel, has promoting blood flow to regulate menstruation, and effect of inducing diuresis to remove edema, cures mainly menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema oliguria, the cards such as acute nephritis edema.
Radix Paeoniae Rubra: bitter in the mouth, micro-hardship, returns Liver Channel, has removing fire from the liver, clearing away heat and cooling blood, effect of stasis-dispelling and pain-killing, cure mainly the conjunctival congestion and swelling pain of high liver fire, have a dizzy spell, pain in chest and hypochondrium, the fever of the body crimson tongue of the epidemic febrile disease pathogenic heat attacking blood system in febrile diseases, and macule is hemorrhage, and blood stasis amenorrhea; The haematemesis hematuria of the absurd row of burning hot flourishing forcing blood; The trip of women's heat in blood is through too much; Various pain caused by blood retardance; The cards such as the furuncle carbuncle of heat in blood poison Sheng.
Herba Galii Bungei: be the herb of Rubiaceae clivers four leaf humulus, sweet in the mouth, hardship, property is put down, and have heat-clearing and toxic substances removing, effect of inducing diuresis to remove edema, cures mainly pyretic stranguria, dysentery, hemoptysis, leucorrhea with red and white discharge, infantile malnutrition, traumatic injury, the cards such as venom.
Herba Selaginellae Moellendorfii: be the herb of Selaginaceae Rock lily plant Herba Selaginellae Involventis, there is hemostasis, heat clearing away, effect of dampness removing, cure mainly lung-heat hemoptysis, pulmonary tuberculosis hemoptysis and edema, spit blood, have blood in stool, bleeding hemorrhoids, traumatic hemorrhage, heating, infantile convulsion, jaundice due to damp-heat, has a dizzy spell, gonorrhea, edema, oral aphthae in children, nasal abscess, burn due to hot liquid or fire, the cards such as venom.
Radix Acanthopanacis Trifoliati: bitter in the mouth, pungent, cool in nature, have heat-clearing and toxic substances removing, expelling wind and removing dampness, effect of relaxing muscles and tendons to promote blood circulation, cures mainly cold, fever, pharyngalgia, headache, and cough chest pain, has loose bowels, dysentery, hypochondriac pain, jaundice, stranguria caused by urinary stone, leukorrhagia, rheumatic arthralgia, waist and leg ache, the cards such as traumatic injury.
Herba Murdanniae Divergentis: be root or the herb of Commeline communis section water leaf spp plant purple back of the body Herba Pyrolae, sweet in the mouth, micro-hardship, property is put down, and have clearing away lung-heat to relieve cough, invigorating the lung and the kidney, effect of regulating menstruation, hemostasis, cures mainly cough due to lung-heat, and the deficiency of vital energy is breathed with cough, dizziness and tinnitus, fracture, spits blood.
Fructus Rosae Laevigatae: latin name Rosae Laevigatae Fructus, sour in the mouth, sweet, property is puckery, flat, and return kidney, bladder, large intestine channel, have controlling nocturnal emission with astringent drugs reducing urination, stopping metrorrhagia and leukorrhagia, effect of relieving diarrhea with astringents, cures mainly emission and spermatorrhea, enuresis frequent micturition, bleeding not during menses, the cards such as chronic diarrhea chronic dysentery.
Semen Sesami Nigrum: sweet in the mouth, property is put down, and returns liver, kidney, large intestine channel, has invigorating the liver and kidney, benefiting essence-blood, effect that intestine moistening is dry, for dizziness and blurred vision, Hiccough and deaf, early whitening of beard and hair, post disease alopecia, the cards such as dryness of the intestine constipation.
Herba Ecliptae: sweet in the mouth, acid, cold in nature, return liver, kidney channel, play liver and kidney tonifying, the effect of cooling blood for hemostasis, for having a dizzy spell caused by the hepatic and renal YIN deficiency, blurring of vision, soreness of the waist and knees; Be suitable for the deficiency of YIN and have hot person, be used for the treatment of the haematemesis of accumulated heat in stomach, the cards such as the hemoptysis of injury of blood vessel of the lung by heat.
Radix Et Caulis Acanthopanacis Senticosi: be the root of studies on plants of Acanthopanax Miq. in Araliaceae Radix Et Caulis Acanthopanacis Senticosi, rhizome or stem and leaf, latin name Acanthopanacis Senticosi Radix et Rhizoma seu Caulis, acrid in the mouth, hardship, micro-sweet, warm in nature, enter spleen, kidney, heart channel, there is replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, effect of expelling wind and removing dampness, soft for anemofrigid-damp arthralgia, lumbocrural pain, muscles and bones flaccidity, be slow in action, the card such as body weakness with emaciation is weak, traumatic injury, fracture, edema, beriberi, uncontrolled urination are itched.
Radix Changii: sweet in the mouth, micro-hardship, cold nature, returns lung, spleen, Liver Channel, has moistening the lung and resolving phlegm, yin nourishing stomach function regulating, effect of suppressing the hyperactive liver removing toxic substances, for cough due to lung-heat, vomiting regurgitation, lack of appetite xerostomia, the cards such as conjunctival congestion is dizzy, furunculosis skin infection.
Rhizoma Curcumae Longae: latin name curcumae longae rhizoma, bitter in the mouth, pungent, warm in nature, enter Liver Channel, there is removing blood stasis circulation of qi promoting, effect of inducing menstruation to relieve menalgia, twinge for the breast side of body, amenorrhea, lump in the abdomen, rheumatism shoulder arm pain, the cards such as tumbling and swelling.
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.
Fructus Corni: latin name corni fructus, sour in the mouth, puckery, slightly warm in nature, enter liver, kidney channel, the effect having liver and kidney tonifying, arresting seminal emission, arresting sweating admittedly to take off, is mainly used in deficiency of the liver and kindey, have a dizzy spell, tinnitus, the soreness of waist, seminal emission, the enuresis; frequent micturition, and incessant sweating due to debility, the cards such as human female void, menorrhagia.
The Radix Paeoniae Alba: bitter in the mouth, acid, cold nature, enters liver, spleen channel, joint venture of nourishing blood, easing the affected liver to relieve pain, and the effect of suppressing liver-YANG is mainly used in deficiecny of liver-YIN, the headache feeling of fullness in the head of excessive rising of liver-YANG, vertigo and tinnitus, irritable; Deficiency of liver-blood, battalion defends the menoxenia of inanition, metrorrhagia and metrostaxis; The dysmenorrhea of deficiency of the liver stasis dampness; Disharmony of nutrient QI with defensive QI, the cloudy outer inducing vomiting spontaneous sweating of battalion; The gastral cavity abdomen pain over the hypochondriac region of depression of liver-QI, dysentery is suffered from abdominal pain; Deficiency and exhaustion of liver-YIN, passages through which vital energy circulates loses the cards such as the carpopedal spasm pain of supporting, there are antithrombus formation and hepatoprotective effect, inhibitory action is had to dysentery bacterium, Bacillus typhi, blood dissolubility streptococcus, Diplococcus pneumoniae, bacillus pyocyaneus, staphylococcus aureus, the Radix Paeoniae Alba and Radix Rehmanniae Preparata share, enrich blood with nourishing YIN and benefiting blood, treat blood deficiency dizziness and wait card.
Semen Astragali Complanati: sweet in the mouth, warm in nature, enter liver, kidney channel, there is tonifying the kidney to consolidate the essence, the effect of liver-benefiting eye-brightening, for lumbago due to renal deficiency, impotence and seminal emission, frequent urination and enuresis, the cards such as dizziness and tinnitus and leukorrhagia stranguria with turbid discharge, have antiinflammatory, pain relieving, analgesic effect, can improve the non-specific of body and specific immune function.
Further preferably, described medicine is only prepared from by above-mentioned raw materials medicine.
In described medicine, the weight portion of each crude drug is respectively Radix Angelicae Sinensis 33 weight portion ~ 43 weight portion, the Radix Astragali 52 weight portion ~ 62 weight portion, Radix seu Herba Gei aleppici 27 weight portion ~ 37 weight portion, Herba Leonuri 30 weight portion ~ 40 weight portion, Radix Paeoniae Rubra 25 weight portion ~ 35 weight portion, Herba Galii Bungei 18 weight portion ~ 28 weight portion, Herba Selaginellae Moellendorfii 15 weight portion ~ 25 weight portion, Radix Acanthopanacis Trifoliati 15 weight portion ~ 25 weight portion, Herba Murdanniae Divergentis 13 weight portion ~ 23 weight portion, Fructus Rosae Laevigatae 10 weight portion ~ 20 weight portion, Semen Sesami Nigrum 25 weight portion ~ 35 weight portion, Herba Ecliptae 39 weight portion ~ 49 weight portion, Radix Changii 16 weight portion ~ 26 weight portion, Rhizoma Curcumae Longae 25 weight portion ~ 35 weight portion, Herba Lysimachiae 23 weight portion ~ 33 weight portion, Fructus Corni 29 weight portion ~ 39 weight portion, the Radix Paeoniae Alba 30 weight portion ~ 40 weight portion, Semen Astragali Complanati 28 weight portion ~ 38 weight portion.
Further preferably, in described medicine, the weight portion of each crude drug is respectively Radix Angelicae Sinensis 36 weight portion ~ 40 weight portion, the Radix Astragali 55 weight portion ~ 59 weight portion, Radix seu Herba Gei aleppici 30 weight portion ~ 34 weight portion, Herba Leonuri 33 weight portion ~ 37 weight portion, Radix Paeoniae Rubra 28 weight portion ~ 32 weight portion, Herba Galii Bungei 21 weight portion ~ 25 weight portion, Herba Selaginellae Moellendorfii 18 weight portion ~ 22 weight portion, Radix Acanthopanacis Trifoliati 18 weight portion ~ 22 weight portion, Herba Murdanniae Divergentis 16 weight portion ~ 20 weight portion, Fructus Rosae Laevigatae 13 weight portion ~ 17 weight portion, Semen Sesami Nigrum 28 weight portion ~ 32 weight portion, Herba Ecliptae 42 weight portion ~ 46 weight portion, Radix Changii 19 weight portion ~ 23 weight portion, Rhizoma Curcumae Longae 28 weight portion ~ 32 weight portion, Herba Lysimachiae 26 weight portion ~ 30 weight portion, Fructus Corni 32 weight portion ~ 36 weight portion, the Radix Paeoniae Alba 33 weight portion ~ 37 weight portion, Semen Astragali Complanati 31 weight portion ~ 35 weight portion.
Most preferably, in described medicine, the weight portion of each crude drug is respectively Radix Angelicae Sinensis 38 weight portion, the Radix Astragali 57 weight portion, Radix seu Herba Gei aleppici 32 weight portion, Herba Leonuri 35 weight portion, Radix Paeoniae Rubra 30 weight portion, Herba Galii Bungei 23 weight portion, Herba Selaginellae Moellendorfii 20 weight portion, Radix Acanthopanacis Trifoliati 20 weight portion, Herba Murdanniae Divergentis 18 weight portion, Fructus Rosae Laevigatae 15 weight portion, Semen Sesami Nigrum 30 weight portion, Herba Ecliptae 44 weight portion, Radix Changii 21 weight portion, Rhizoma Curcumae Longae 30 weight portion, Herba Lysimachiae 28 weight portion, Fructus Corni 34 weight portion, the Radix Paeoniae Alba 35 weight portion, Semen Astragali Complanati 33 weight portion.
Said medicine provided by the invention can be prepared into various regular dosage form according to customary preparation methods, is preferably Tablet and Capsula agent.
Present invention also offers the preparation method of said medicine, it comprises:
The first step, get Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Sesami Nigrum, Herba Ecliptae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati, pulverize respectively, mix, obtain mixture, adding relative to the determining alcohol of mixture material medicine weight 5 ~ 10 times amount is the alcohol reflux of 70% ~ 80%, extract three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.10 ~ 1.20, add ethanol, the concentration of ethanol is made to reach 60 ~ 90%, place, precipitation, be separated to obtain supernatant, concentrated, macroporous adsorptive resins on the concentrate that obtains of concentrate, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, recycling design, obtain and get dry extract, be ground into powder,
Second step, pulverizes remaining crude drug respectively, mixes, and obtains mixture, adds the water relative to mixture quality 3 ~ 5 times, soak after 30 minutes ~ 60 minutes, 30 minutes at a simmer, leach medicine juice; Filtering residue adds the water relative to mixture quality 2 ~ 4 times again, and slow fire decocts 20 ~ 25 minutes again, leaches medicine juice for twice and mixes even, removes water, obtains and get dry extract, be ground into powder;
3rd step, the powder mixing first step and second step obtained, adds adjuvant and is prepared into various dosage form.
When the dosage form of prepared medicine is tablet, after being mixed by powder, every 100g mixed-powder adds 50g ~ 70g filler, the lubricant of 3g ~ 5g binding agent, 0.5g ~ 1.5g correctives, 0.5g ~ 1.5g, mixing, and tabletting, dries, packaging.
Wherein, described filler is preferably one or more mixing in starch, beta-schardinger dextrin-, xylitol, calcium carbonate, described binding agent is preferably one or more mixing in polyvinylpyrrolidone, methylcellulose, starch slurry, described correctives is preferably one or more mixing in sucrose, aspartame, and described lubricant is preferably one or more mixing in magnesium stearate, Pulvis Talci, micropowder silica gel.
When prepared pharmaceutical dosage form is capsule, after being mixed by powder, every 100g mixed-powder adds microcrystalline Cellulose 15 ~ 25g, crospolyvinylpyrrolidone 5 ~ 15g, cross-linking sodium carboxymethyl cellulose 5 ~ 15g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 2 ~ 4g, magnesium stearate 0.5 ~ 1.5g, granulate, incapsulates.
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 tablet 1
Get Radix Angelicae Sinensis 38g, Radix Astragali 57g, Radix seu Herba Gei aleppici 35g, Semen Sesami Nigrum 30g, Herba Ecliptae 44g, Herba Lysimachiae 28g, Fructus Corni 34g, Radix Paeoniae Alba 35g, Semen Astragali Complanati 33g, pulverizes respectively, mixes, obtain mixture, the determining alcohol adding 2.5kg is the alcohol reflux of 80%, extracts three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.15, add ethanol, make the concentration of ethanol reach 70%, place, precipitation, be separated to obtain supernatant, concentrated, obtain macroporous adsorptive resins on concentrate that concentrate obtains, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, and recycling design, obtains and get dry extract, be ground into powder, by Herba Leonuri 35g, Radix Paeoniae Rubra 30g, Herba Galii Bungei 23g, Herba Selaginellae Moellendorfii 20g, Radix Acanthopanacis Trifoliati 20g, Herba Murdanniae Divergentis 18g, Fructus Rosae Laevigatae 15g, Radix Changii 21g, Rhizoma Curcumae Longae 30g, pulverizes respectively, mixes, and obtains mixture, adds 850g water, soak after 60 minutes, 30 minutes at a simmer, leach medicine juice, filtering residue adds the water of 650g again, and slow fire decocts 25 minutes again, leaches medicine juice for twice and mixes even, remove water, obtain and get dry extract, be ground into powder, by the powder mixing obtained above, every 100g mixed-powder adds 60g filler starch, 4g polyvinyl pyrrolidone, 1g correctives sucrose, 1g magnesium stearate lubricant, mixing, tabletting, dry, packaging.
Embodiment 2 toxicity is verified
1, acute toxicity test report
Test method: with the tablet 1 of the embodiment of the present invention 1 for object, selects 20 adult white mouse to test, and gives 20 white mouse of test group large enteral dispensing, observes 7 for 150 times of clinical consumption per day.20 white mouse are all strong as a result deposits, and its activity, diet, hair, Excreta are no abnormal, have no toxic reaction.
2, chronic toxicity test report:
Get Wistar rat 60, body weight 100 ~ 200g, male and female half and half, random point 3 groups: establish 2 medicine groups, high dose group (I group) is 6g/kg/ day, low dose group (II group) is 3g/kg/ day and matched group, the tablet 1 embodiment 1 prepared is made into 40% and 20% suspension, by 1.5ml/100g gastric infusion, administration every day 1 time, successive administration 60 days, matched group is given and is waited capacity water.Claim the weight of animals 1 time weekly.Drug withdrawal next day gets tail blood examination and has a blood test by often organizing half animal and resemble, and gets carotid artery blood examination and looks into blood parameters: asparagine based transferase (AST), alanine aminotransferase (ALT), alkali phosphatase (ALP), total bilirubin (T-BIU), T-CHOL (T-CHO), blood glucose (GLU), blood urea nitrogen (BUN), flesh liver (Crea), total protein (TP), albumin (ALB).Dissect animal, gross examination of skeletal muscle is carried out to organs such as the heart, liver,spleen,kidney, lung, adrenal gland, gastrointestinal, testis, uterus, ovary, brains, and claims its weight; Get each group of the rat heart, liver, spleen, testis and uterus and do histopathologic examination.After drug withdrawal 2 weeks, each treated animal also carries out the inspection of above-mentioned project.Result shows, between administration and withdrawal time, each group of rat performance all without exception, smooth, movable, the diet of hair and defecation all normal, each group of rat hemogram index is all within normal range, and respectively organize 10 indexs such as Liver and kidney function, blood glucose, T-CHOL, total protein and albumin all within normal range, medicine group compares with matched group, there was no significant difference, the discovery without exception of each group organ.Histopathologic examination, administration group compares with matched group, has no the pathological change relevant with medicine.Drug withdrawal, after 2 weeks, is showed no exception by the inspection of observation and indices.
Embodiment 3 tablet 2
Get Radix Angelicae Sinensis 36g, Radix Astragali 55g, Radix seu Herba Gei aleppici 33g, Semen Sesami Nigrum 28g, Herba Ecliptae 42g, Herba Lysimachiae 26g, Fructus Corni 32g, Radix Paeoniae Alba 33g, Semen Astragali Complanati 31g, pulverizes respectively, mixes, obtain mixture, the determining alcohol adding 2.5kg is the alcohol reflux of 80%, extracts three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.15, add ethanol, make the concentration of ethanol reach 70%, place, precipitation, be separated to obtain supernatant, concentrated, obtain macroporous adsorptive resins on concentrate that concentrate obtains, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, and recycling design, obtains and get dry extract, be ground into powder, by Herba Leonuri 33g, Radix Paeoniae Rubra 28g, Herba Galii Bungei 21g, Herba Selaginellae Moellendorfii 18g, Radix Acanthopanacis Trifoliati 18g, Herba Murdanniae Divergentis 16g, Fructus Rosae Laevigatae 13g, Radix Changii 19g, Rhizoma Curcumae Longae 28g, pulverizes respectively, mixes, and obtains mixture, adds 850g water, soak after 60 minutes, 30 minutes at a simmer, leach medicine juice, filtering residue adds the water of 650g again, and slow fire decocts 25 minutes again, leaches medicine juice for twice and mixes even, remove water, obtain and get dry extract, be ground into powder, by the powder mixing obtained above, every 100g mixed-powder adds 60g filler starch, 4g polyvinyl pyrrolidone, 1g correctives sucrose, 1g magnesium stearate lubricant, mixing, tabletting, dry, packaging.
Embodiment 4 tablet 3
Get Radix Angelicae Sinensis 40g, Radix Astragali 59g, Radix seu Herba Gei aleppici 37g, Semen Sesami Nigrum 32g, Herba Ecliptae 46g, Herba Lysimachiae 30g, Fructus Corni 36g, Radix Paeoniae Alba 37g, Semen Astragali Complanati 35g, pulverizes respectively, mixes, obtain mixture, the determining alcohol adding 2.5kg is the alcohol reflux of 80%, extracts three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.15, add ethanol, make the concentration of ethanol reach 70%, place, precipitation, be separated to obtain supernatant, concentrated, obtain macroporous adsorptive resins on concentrate that concentrate obtains, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, and recycling design, obtains and get dry extract, be ground into powder, by Herba Leonuri 37g, Radix Paeoniae Rubra 32g, Herba Galii Bungei 25g, Herba Selaginellae Moellendorfii 22g, Radix Acanthopanacis Trifoliati 22g, Herba Murdanniae Divergentis 20g, Fructus Rosae Laevigatae 17g, Radix Changii 23g, Rhizoma Curcumae Longae 32g, pulverizes respectively, mixes, and obtains mixture, adds 850g water, soak after 60 minutes, 30 minutes at a simmer, leach medicine juice, filtering residue adds the water of 650g again, and slow fire decocts 25 minutes again, leaches medicine juice for twice and mixes even, remove water, obtain and get dry extract, be ground into powder, by the powder mixing obtained above, every 100g mixed-powder adds 60g filler starch, 4g polyvinyl pyrrolidone, 1g correctives sucrose, 1g magnesium stearate lubricant, mixing, tabletting, dry, packaging.
Embodiment 5 capsule
Get Radix Angelicae Sinensis 38g, Radix Astragali 57g, Radix seu Herba Gei aleppici 35g, Semen Sesami Nigrum 30g, Herba Ecliptae 44g, Herba Lysimachiae 28g, Fructus Corni 34g, Radix Paeoniae Alba 35g, Semen Astragali Complanati 33g, pulverizes respectively, mixes, obtain mixture, the determining alcohol adding 2.5kg is the alcohol reflux of 80%, extracts three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.15, add ethanol, make the concentration of ethanol reach 70%, place, precipitation, be separated to obtain supernatant, concentrated, obtain macroporous adsorptive resins on concentrate that concentrate obtains, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, and recycling design, obtains and get dry extract, be ground into powder, by Herba Leonuri 35g, Radix Paeoniae Rubra 30g, Herba Galii Bungei 23g, Herba Selaginellae Moellendorfii 20g, Radix Acanthopanacis Trifoliati 20g, Herba Murdanniae Divergentis 18g, Fructus Rosae Laevigatae 15g, Radix Changii 21g, Rhizoma Curcumae Longae 30g, pulverizes respectively, mixes, and obtains mixture, adds 850g water, soak after 60 minutes, 30 minutes at a simmer, leach medicine juice, filtering residue adds the water of 650g again, and slow fire decocts 25 minutes again, leaches medicine juice for twice and mixes even, remove water, obtain and get dry extract, be ground into powder, after being mixed by powder, every 100g mixed-powder adds microcrystalline Cellulose 20g, crospolyvinylpyrrolidone 10g, cross-linking sodium carboxymethyl cellulose 10g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 3g, magnesium stearate 1g, granulate, incapsulates.
Embodiment 6 clinical data
1, diagnosis and inclusive criteria
(1) diabetes diagnostic criterion meets type 2 diabetes mellitus (T2DM) diagnostic criteria that WHO formulated in 1999, that is: diabetic symptom adds random time plasma glucose levels >=11.1mmol/L; Fasting plasma glucose (FPG) level >=7.0mmol/L, in glucose tolerance test (OGTT), 2h plasma glucose levels (2hPG) >=11.1mmol/L, meets 1 in 3.
(2 diabetic nephropathyes diagnosis meet the chronic renal failure diagnostic criteria and typing that primary glomerulopathy typings in 1992 and treatment and diagnostic criteria symposium summary formulate, for compensatory stage of renal insufficiency, renal insufficiency Decompensated stage, renal failure stage.Include this observation patient in all to meet: FPG 7.80 ~ 28.0mmol/L, SCr 133 ~ 707 μm of ol/L, SBP 130 ~ 180mmHg, DBP 80 ~ 110mmHg.
2, exclusion standard
(1) chronic renal failure caused by other protopathy (chronic nephritis, hypertension, gout kidney, lupus kidney, polycystic kidney, nephrotic syndrome etc.); (2) acute plasticity renal failure; (3) tumor; (4) gestation; (5) be reluctant coordinate, dietary management and curative compliance poor; (6) irritated to this drugs or have contraindication; (7) concurrent ketoacidosis stupor.
3, physical data
In March, 2009 ~ 2013 year diagnosis and treatment in May meet diabetic nephropathy patient 180 example of diagnostic criteria, include observation in.Be divided into treatment group and matched group, often organize 90 examples, treatment group man 53 example, female 37 example; 60.5 ~ 74.1 years old age, average (67.8 ± 7.1 years old); Diabetic duration 8 ~ 23 years, average (14.5 ± 9.4) year; The diabetic nephropathy course of disease 0.4 ~ 3.1 year, average (2.2 ± 0.5) year; FPG (12.20 ± 5.86) mmol/L.In matched group 90 example, man 46 example, female 44 years old; 61.2 ~ 73.9 years old age, average (67.7 ± 7.5 years old; Diabetic duration 8 ~ 22 years, average (14.8 ± 10.1) year; The DN course of disease 0.4 ~ 3.2 year, average (2.3 ± 1.7) year; FPG (11.80 ± 5.75) mmol/L.Two groups of data baselines are balanced, have comparability.
4, Therapeutic Method
Primary Care: what all patients carried out clinical trial only accepts Primary Care in first 2 weeks, comprises (1) Tighter control, low sodium is low-phosphorous, " fewer but better " protein takes in, be advisable with 0.4 ~ 0.6g/ (kgd); (2) glucose-lowering treatment: oral gliquidone or subcutaneous injection of insulin, makes glycemic control be FPG < 7.0mmol/L, 2hPG < 10.0mmol/L; (3) water, electrolyte, acid-base balance is corrected.
GP TH: treatment group is being kept on a diet, blood sugar lowering, the upper tablet 1 adopting the embodiment of the present invention 1 to prepare in the treatment such as anti symptom treatment basis, every day 2 times, sooner or later each 1 time, every day 4, every sheet 0.5g, 10 days 1 courses for the treatment of, drug withdrawal 3 days, carries out lower 1 course for the treatment of, takes 3 months.Matched group adopts Benazepril hydrochloride contents in tablets treatment, 5mg first, and every day 1 time is oral, within according to circumstances every 2 weeks, adjusts consumption, finally with 10 ~ 20mg/d administration.
5, observation index and detection method
(1) observe the symptoms, sign (spiritlessness and weakness, inappetence, dirty abdomen feeling of fullness, the acid of lumbago knee joint, puffiness of the face and limbs etc.) improves situation, disappear with symptom, sign, SCr, CCr be in the recent period healing in normal range; Alleviate with symptom, sign or disappear, SCr decline >=30% or (with) CCr increases >=30% is effective; Alleviate to some extent with symptom, sign, 10%≤SCr decline <30% or (with) 10%≤CCr increase <30% be effective; Do not reach above-mentioned standard person for invalid.(2) desk model sphygmomanometer Measure blood pressure is adopted.C3) adopt enzyme to exempt from method (ELISA) and measure 24hUpro.(4) Japanese Olympus AU-600 automatic clinical chemistry analyzer is adopted to measure BUN, SCr, CCr, blood glucose (turbidimetry).(5) record starts replacement therapy (dialysis) time, judges that kidney is survived with this.
6, statistical method
Adopt SPSS 11.0 systems soft ware process data, measurement data is used represent, compare employing one factor analysis of variance between group, enumeration data adopts χ 2inspection, P < 0.05 has statistical significance for difference.
7, result
Two groups of comparitive study, the results are shown in Table 1.
Table 1 liang group comparitive study example (%)
Group Number of cases Recent healing Effective Effectively Invalid Effectively total
Treatment group 90 19(21.1) 52(57.8) 16(17.8) 3(3.33) 87(96.7)
Matched group 90 8(8.9) 33(36.7) 37(41.1) 12(13.3) 78(86.7)
From table 1, comparatively matched group is better to adopt drug treatment of diabetic nephropathy effect provided by the invention, and significant difference (p<0.05), especially in curative effect, medicine provided by the invention has good effect.
Before and after each group for the treatment of, 24hUpro, SCr, CCr and BUN test result compares, and the results are shown in Table 2.
Table 2 is group treatment front and back 24hUpro, SCr, CCr and BUN test and comparison respectively
Group Time 24hUpro(g) SCr(μmol/L) CCr(mL/min) BUN(mmol/L)
Treatment group Before treatment 1.91±0.39 439.61±42.90 28.77±6.53 17.02±5.29
After treatment 1.08±0.27 158.39±38.99 38.10±4.06 12.50±3.92
Matched group Before treatment 1.93±0.51 428.16±35.77 28.15±5.02 18.09±4.11
After treatment 1.53±0.30 290.35±30.93 29.07±3.69 17.01±3.99
After treatment, two groups of SCr, BUN, 24hUpro all decline, and wherein treatment group SCr, 24hUpro, matched group SCr compare with before treatment, and difference has significance (P<0.01).After treatment, two groups of SCr, CCr, 24hUpro compare, and difference has significance (P<0.01 or (P<0.05).
Before and after two groups of treatments, blood pressure (BP) and blood glucose (PG) compare, and the results are shown in Table 3.
Before and after table 3 liang group treatment, BP and PG compares
All obviously reduce after two groups of PG, BP treatments, have significance (P>0.01) with comparing difference before treatment, compare after two groups of treatments, no significant difference (P>O.O5).
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 (10)

1. be used for the treatment of a medicine for diabetic nephropathy, it is characterized in that: crude drug comprises Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Herba Leonuri, Radix Paeoniae Rubra, Herba Galii Bungei, Herba Selaginellae Moellendorfii, Radix Acanthopanacis Trifoliati, Herba Murdanniae Divergentis, Fructus Rosae Laevigatae, Semen Sesami Nigrum, Herba Ecliptae, Radix Changii, Rhizoma Curcumae Longae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati.
2. medicine as claimed in claim 1, it is characterized in that: the weight portion of each crude drug is respectively Radix Angelicae Sinensis 33 weight portion ~ 43 weight portion, the Radix Astragali 52 weight portion ~ 62 weight portion, Radix seu Herba Gei aleppici 27 weight portion ~ 37 weight portion, Herba Leonuri 30 weight portion ~ 40 weight portion, Radix Paeoniae Rubra 25 weight portion ~ 35 weight portion, Herba Galii Bungei 18 weight portion ~ 28 weight portion, Herba Selaginellae Moellendorfii 15 weight portion ~ 25 weight portion, Radix Acanthopanacis Trifoliati 15 weight portion ~ 25 weight portion, Herba Murdanniae Divergentis 13 weight portion ~ 23 weight portion, Fructus Rosae Laevigatae 10 weight portion ~ 20 weight portion, Semen Sesami Nigrum 25 weight portion ~ 35 weight portion, Herba Ecliptae 39 weight portion ~ 49 weight portion, Radix Changii 16 weight portion ~ 26 weight portion, Rhizoma Curcumae Longae 25 weight portion ~ 35 weight portion, Herba Lysimachiae 23 weight portion ~ 33 weight portion, Fructus Corni 29 weight portion ~ 39 weight portion, the Radix Paeoniae Alba 30 weight portion ~ 40 weight portion, Semen Astragali Complanati 28 weight portion ~ 38 weight portion.
3. medicine as claimed in claim 1 or 2, it is characterized in that: the weight portion of each crude drug is respectively Radix Angelicae Sinensis 36 weight portion ~ 40 weight portion, the Radix Astragali 55 weight portion ~ 59 weight portion, Radix seu Herba Gei aleppici 30 weight portion ~ 34 weight portion, Herba Leonuri 33 weight portion ~ 37 weight portion, Radix Paeoniae Rubra 28 weight portion ~ 32 weight portion, Herba Galii Bungei 21 weight portion ~ 25 weight portion, Herba Selaginellae Moellendorfii 18 weight portion ~ 22 weight portion, Radix Acanthopanacis Trifoliati 18 weight portion ~ 22 weight portion, Herba Murdanniae Divergentis 16 weight portion ~ 20 weight portion, Fructus Rosae Laevigatae 13 weight portion ~ 17 weight portion, Semen Sesami Nigrum 28 weight portion ~ 32 weight portion, Herba Ecliptae 42 weight portion ~ 46 weight portion, Radix Changii 19 weight portion ~ 23 weight portion, Rhizoma Curcumae Longae 28 weight portion ~ 32 weight portion, Herba Lysimachiae 26 weight portion ~ 30 weight portion, Fructus Corni 32 weight portion ~ 36 weight portion, the Radix Paeoniae Alba 33 weight portion ~ 37 weight portion, Semen Astragali Complanati 31 weight portion ~ 35 weight portion.
4. the medicine as described in claims 1 to 3, is characterized in that: described medicine can be prepared into Tablet and Capsula agent.
5. the preparation method of medicine described in Claims 1-4, is characterized in that, comprising:
The first step, gets Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Sesami Nigrum, Herba Ecliptae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati, pulverizes respectively, mix, and obtains mixture, adopts alcohol heating reflux to extract, obtains and extract powder;
Second step, pulverizes remaining crude drug respectively, mixes, and obtains mixture, adopts water boiling and extraction, obtains and extracts powder;
3rd step, the extraction powder mixing first step and second step obtained, adds adjuvant and is prepared into various dosage form.
6. preparation method according to claim 5, it is characterized in that: the described first step is specially further, get Radix Angelicae Sinensis, the Radix Astragali, Radix seu Herba Gei aleppici, Semen Sesami Nigrum, Herba Ecliptae, Herba Lysimachiae, Fructus Corni, the Radix Paeoniae Alba, Semen Astragali Complanati, pulverize respectively, mix, obtain mixture, adding relative to the determining alcohol of mixture material medicine weight 5 ~ 10 times amount is the alcohol reflux of 70% ~ 80%, extract three times, merge extractive liquid, obtaining relative density at 60 DEG C of concentrating under reduced pressure is the extractum of 1.10 ~ 1.20, add ethanol, the concentration of ethanol is made to reach 60 ~ 90%, place, precipitation, be separated to obtain supernatant, concentrated, macroporous adsorptive resins on the concentrate that obtains of concentrate, with the ethanol gradient elution of concentration 30% ~ 90%, collecting concentration is the ethanol elution of 60% ~ 80%, recycling design, obtain and get dry extract, be ground into powder.
7. the preparation method described in claim 5 or 6, it is characterized in that: described second step is specially further, remaining crude drug is pulverized respectively, mix, obtain mixture, add the water relative to mixture quality 3 ~ 5 times, soak after 30 minutes ~ 60 minutes, 30 minutes at a simmer, leach medicine juice; Filtering residue adds the water relative to mixture quality 2 ~ 4 times again, and slow fire decocts 20 ~ 25 minutes again, leaches medicine juice for twice and mixes even, removes water, obtains and get dry extract, be ground into powder.
8. the preparation method described in claim 5 to 7, it is characterized in that: when the dosage form of prepared medicine is tablet, after powder is mixed, every 100g mixed-powder adds 50g ~ 70g filler, the lubricant of 3g ~ 5g binding agent, 0.5g ~ 1.5g correctives, 0.5g ~ 1.5g, mixing, tabletting, dry, packaging.
9. the preparation method described in claim 5 to 8, it is characterized in that: described filler is preferably one or more mixing in starch, beta-schardinger dextrin-, xylitol, calcium carbonate, described binding agent is preferably one or more mixing in polyvinylpyrrolidone, methylcellulose, starch slurry, described correctives is preferably one or more mixing in sucrose, aspartame, and described lubricant is preferably one or more mixing in magnesium stearate, Pulvis Talci, micropowder silica gel.
10. the preparation method described in claim 5 to 9, is characterized in that: when prepared pharmaceutical dosage form is capsule, after being mixed by powder, every 100g mixed-powder adds microcrystalline Cellulose 15 ~ 25g, crospolyvinylpyrrolidone 5 ~ 15g, cross-linking sodium carboxymethyl cellulose 5 ~ 15g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 2 ~ 4g, magnesium stearate 0.5 ~ 1.5g, granulate, incapsulates.
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CN109402127A (en) * 2018-09-29 2019-03-01 复旦大学附属眼耳鼻喉科医院 One group of high affinity nucleic acid aptamers and its application specifically bound with Connective Tissue Growth Factor
CN118615391A (en) * 2024-06-27 2024-09-10 广东药科大学 A Chinese medicine composition for improving diabetes and diabetic kidney damage and its application

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