CN104208427A - Pharmaceutical preparation for treating nephritic syndrome and preparation method thereof - Google Patents
Pharmaceutical preparation for treating nephritic syndrome and preparation method thereof Download PDFInfo
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Abstract
The invention provides a pharmaceutical preparation for treating nephritic syndrome. The pharmaceutical preparation comprises the following crude drugs: herba ecliptae, medlar, aleppo avens, gynostemma pentaphyllum, radix codonopsis, rhizoma polygonati, cortex moutan, epimedium herbs, radix rehmanniae preparata, gorgon fruits, semen euryales, assorted Chinese herbal tea, myrrh, herba taxilli, Chinese yam, morinda officinalis, dogwoods, cortex acanthopanacis, radix adenophorae, rabdosia amethystoides, herba ephedrae, fructus broussonetiae, tuckahoe and liquorice. When the pharmaceutical preparation is used for treating nephritic syndrome, the side effect of a hormone can be reduced, and the rebound phenomenon caused after the hormone is used can be relieved; in addition, the pharmaceutical preparation can also be used for shortening the medication time of the hormone, improving the sensibility of the nephritic syndrome hormone, preventing infection, reducing the relapse frequency and increasing the cure rate of nephritic syndrome patients.
Description
Technical field
The present invention relates to Chinese medicine technical field, particularly relate to a kind of pharmaceutical preparation being used for the treatment of nephrotic syndrome and preparation method thereof.
Background technology
Nephrotic syndrome (nephrotic syndrome, NS) be called for short kidney to combine, be the one group of clinical syndrome that is feature with High-grade Proteinuria, hypoproteinemia, edema, hyperlipemia and other metabolism disorders, High-grade Proteinuria and hypoproteinemia are then the principal characters of nephrotic syndrome.The main purpose of Therapy of Nephrotic Syndrome is relief of symptoms, prevents and treats complication and renal function protecting.
Doctor trained in Western medicine thinks that primary disease is that the basement membrane permeability caused by many reasons increases, causes a large amount of plasma albumin lose from urine and cause.Treatment on, doctor trained in Western medicine based on symptomatic treatment, blood pressure lowering, blood fat reducing, anticoagulant, diuresis etc.The Drug therapys such as modern medicine conventional Hormone, cell toxicity medicament and ciclosporin, obtain certain curative effect, but often cause untoward reaction, and short term effect better but be difficult to consolidate; Also can subtract in process at treatments period and Hormone Withdrawal simultaneously and inevitably occur toxic and side effects, long-term dependence and rebound phenomenon, cause patient outcomes poor, Relapse rate, be even difficult to adhere to whole-course treatment.
Chinese medicine thinks that primary disease belongs to the category such as " edema ", " asthenia ", " kidney water ", fall ill slow or anxious, its sick position is at kidney, relate to the internal organs such as spleen, lung, three Jiao, characteristic of disease is deficiency in origin and excess in superficiality, and treatment by Chinese herbs nephrotic syndrome can reduce side effects of pharmaceutical drugs to a certain extent, enhancing human body immunity function, relative to western medicine, there is significant advantage.
The present invention is exactly based on theory of Chinese medical science, proposes a kind of pharmaceutical preparation being used for the treatment of nephrotic syndrome, adopts this pharmaceutical preparation treatment nephrotic syndrome can reduce the side effect of Corticosteroids, alleviates the rebound phenomenon after Corticosteroids; And the administration time of hormone can be reduced, improve the sensitivity of Nephrotic Syndrome with Steroid, prevention infection, reduce recurrence, improve the cure rate of Patients With Nephrotic Symdrome.
Summary of the invention
Technical problem to be solved by this invention is, proposes a kind of pharmaceutical preparation being used for the treatment of nephrotic syndrome, adopts this pharmaceutical preparation treatment nephrotic syndrome can reduce the side effect of Corticosteroids, alleviates the rebound phenomenon after Corticosteroids; And the administration time of hormone can be reduced, improve the sensitivity of Nephrotic Syndrome with Steroid, prevention infection, reduce recurrence, improve the cure rate of Patients With Nephrotic Symdrome.
In order to solve the problems of the technologies described above, the invention provides a kind of pharmaceutical preparation being used for the treatment of nephrotic syndrome, it comprises following crude drug: Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Cortex Moutan, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, assorted Chinese medicine tea, Myrrha, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis, Radix Adenophorae, Herba Rabdosiae glaucocalycis, Herba Ephedrae, Fructus Broussonetiae, Poria and Radix Glycyrrhizae.
Wherein, in described pharmaceutical preparation, the weight portion of each crude drug is respectively Herba Ecliptae 40 weight portion ~ 50 weight portion, Fructus Lycii 45 weight portion ~ 55 weight portion, Radix seu Herba Gei aleppici 45 weight portion ~ 55 weight portion, Herb Gynostemmae Pentaphylli 25 weight portion ~ 35 weight portion, Radix Codonopsis 75 weight portion ~ 85 weight portion, Rhizoma Polygonati 40 weight portion ~ 50 weight portion, Cortex Moutan 25 weight portion ~ 35 weight portion, Herba Epimedii 30 weight portion ~ 40 weight portion, Radix Rehmanniae Preparata 35 weight portion ~ 45 weight portion, Semen Euryales 40 weight portion ~ 50 weight portion, assorted Chinese medicine tea 25 weight portion ~ 35 weight portion, Myrrha 30 weight portion ~ 40 weight portion, Herba Taxilli 35 weight portion ~ 45 weight portion, Rhizoma Dioscoreae 40 weight portion ~ 50 weight portion, Radix Morindae Officinalis 30 weight portion ~ 40 weight portion, Fructus Corni 35 weight portion ~ 45 weight portion, Cortex Acanthopancis 20 weight portion ~ 30 weight portion, Radix Adenophorae 30 weight portion ~ 40 weight portion, Herba Rabdosiae glaucocalycis 25 weight portion ~ 35 weight portion, Herba Ephedrae 30 weight portion ~ 40 weight portion, Fructus Broussonetiae 25 weight portion ~ 35 weight portion, Poria 35 weight portion ~ 45 weight portion and Radix Glycyrrhizae 20 weight portion ~ 30 weight portion.
Wherein, in described pharmaceutical preparation, the weight portion of each crude drug is respectively Herba Ecliptae 43 weight portion ~ 47 weight portion, Fructus Lycii 48 weight portion ~ 52 weight portion, Radix seu Herba Gei aleppici 48 weight portion ~ 52 weight portion, Herb Gynostemmae Pentaphylli 28 weight portion ~ 32 weight portion, Radix Codonopsis 78 weight portion ~ 82 weight portion, Rhizoma Polygonati 43 weight portion ~ 47 weight portion, Cortex Moutan 28 weight portion ~ 32 weight portion, Herba Epimedii 33 weight portion ~ 37 weight portion, Radix Rehmanniae Preparata 38 weight portion ~ 42 weight portion, Semen Euryales 43 weight portion ~ 47 weight portion, assorted Chinese medicine tea 28 weight portion ~ 32 weight portion, Myrrha 33 weight portion ~ 37 weight portion, Herba Taxilli 38 weight portion ~ 42 weight portion, Rhizoma Dioscoreae 43 weight portion ~ 47 weight portion, Radix Morindae Officinalis 33 weight portion ~ 37 weight portion, Fructus Corni 38 weight portion ~ 42 weight portion, Cortex Acanthopancis 23 weight portion ~ 27 weight portion, Radix Adenophorae 33 weight portion ~ 37 weight portion, Herba Rabdosiae glaucocalycis 28 weight portion ~ 32 weight portion, Herba Ephedrae 33 weight portion ~ 37 weight portion, Fructus Broussonetiae 28 weight portion ~ 32 weight portion, Poria 38 weight portion ~ 42 weight portion and Radix Glycyrrhizae 23 weight portion ~ 27 weight portion.
Wherein, in described pharmaceutical preparation, the weight portion of each crude drug is respectively Herba Ecliptae 45 weight portion, Fructus Lycii 50 weight portion, Radix seu Herba Gei aleppici 50 weight portion, Herb Gynostemmae Pentaphylli 30 weight portion, Radix Codonopsis 80 weight portion, Rhizoma Polygonati 45 weight portion, Cortex Moutan 30 weight portion, Herba Epimedii 35 weight portion, Radix Rehmanniae Preparata 40 weight portion, Semen Euryales 45 weight portion, assorted Chinese medicine tea 30 weight portion, Myrrha 35 weight portion, Herba Taxilli 40 weight portion, Rhizoma Dioscoreae 45 weight portion, Radix Morindae Officinalis 35 weight portion, Fructus Corni 40 weight portion, Cortex Acanthopancis 25 weight portion, Radix Adenophorae 35 weight portion, Herba Rabdosiae glaucocalycis 30 weight portion, Herba Ephedrae 35 weight portion, Fructus Broussonetiae 30 weight portion, Poria 40 weight portion and Radix Glycyrrhizae 25 weight portion.
Wherein, the dosage form of described pharmaceutical preparation is granule and capsule.
Present invention also offers the preparation method of said medicine preparation, when the dosage form of prepared pharmaceutical preparation is capsule, be specially:
The first step, by Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis and Radix Adenophorae are pulverized respectively, cross 20 mesh sieves, send in mixer by weight and be uniformly mixed, obtain mixture, mixture is loaded in percolator, every 100g mixture adds ethanol 500g ~ 700g that determining alcohol is 70% ~ 80%, soak 20 hours ~ 30 hours under the condition of 25 DEG C ~ 35 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 2 ~ 4mL per minute, collect drip, obtain the percolate of 700mL ~ 1L, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder,
Second step, pulverizes respectively by each for remainder crude drug component, crosses 20 mesh sieves, send in mixer by weight and be uniformly mixed, put into boiler subsequently, add water, soak 5 ~ 8 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, the quality of the water added is 3 ~ 5 times of mixture quality, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder;
3rd step, by the first powder and the mixing of the second powder, the mixture obtained is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add the alcohol granulation that determining alcohol is 25%, the quality of the ethanol added is equivalent to 0.1 ~ 0.2 times of the mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01 ~ 0.02 times of the mixture quality of mix products and starch, mix homogeneously, loads in capsule for medicine, obtains capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, when the dosage form of described Chinese medicine composition is granule, be specially:
The first step, by Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis and Radix Adenophorae are pulverized respectively, cross 20 mesh sieves, send in mixer by weight and be uniformly mixed, obtain mixture, mixture is loaded in percolator, every 100g mixture adds ethanol 500g ~ 700g that determining alcohol is 70% ~ 80%, soak 20 hours ~ 30 hours under the condition of 25 DEG C ~ 35 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 2 ~ 4mL per minute, collect drip, obtain the percolate of 700mL ~ 1L, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder,
Second step, pulverizes respectively by each for remainder crude drug component, crosses 20 mesh sieves, send in mixer by weight and be uniformly mixed, put into boiler subsequently, add water, soak 5 ~ 8 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, the quality of the water added is 3 ~ 5 times of mixture quality, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder;
3rd step, by the first powder and the second powder Homogeneous phase mixing, obtains mixture; again pulverize, add dextrin, aspartame subsequently, be placed in wet granulator; be dry mixed 3 ~ 8 minutes, adding determining alcohol is 50% ~ 60% ethanol, granulates 2 ~ 5 minutes; dry; obtained described granule, splitting splendid attire, relative to the mixture of 100 weight portions; the addition of described dextrin is 100 weight portion ~ 120 weight portions, and the addition of described aspartame is 1 weight portion ~ 3 weight portion.
Beneficial effect of the present invention:
The pharmaceutical preparation being used for the treatment of nephrotic syndrome provided by the invention can reduce the side effect of Corticosteroids, alleviates the rebound phenomenon after Corticosteroids; And the administration time of hormone can be reduced, improve the sensitivity of Nephrotic Syndrome with Steroid, prevention infection, reduce recurrence, improve the cure rate of Patients With Nephrotic Symdrome.
Detailed description of the invention
Chinese medicine is thought, nephrotic syndrome is parenchymal lesion of the kidney, and its mechanism is relevant with disturbances of blood coagulation with immunity, and nephrotic syndrome belongs to the card of vital QI being weakened and pathogen being violent in Chinese medicine, take deficiency of spleen and stomach as this, and wind, cold, wet, the stasis of blood are mark.Research finds, spleen invigorating and warming and recuperating the kidney-YANG Chinese medicine can regulate immune status, have synergism with adrenocortical hormone and immune formulation.Drug for invigorating blood circulation and eliminating stasis is improved microcirculation, reduces blood viscosity, reduces platelet aggregation, increases the effects such as renal blood flow, can alleviate the hypercoagulability of hormone therapy, be conducive to the removing of immune complex and the reparation of pathological tissues.
In addition, nephrotic syndrome person has edema more, and Chinese medicine thinks that edema is the event of crystal's defeated cloth imbalance, and spleen, kidney are the main organs in the defeated cloth process of crystal, if the dysfunction of the spleen, then and retention of water-damp in the body; As deficiency of kidney-QI, then folding is unfavorable, can occur urine exception and edema, and Chinese medicine thinks diseases caused by retention of the body fluid and blood, pathogen usually intruding into collateral in protracted disease, the card of visible stagnation of blood stasis.
Main and the lung of the pathogenesis of this disease, spleen, kidney three are dirty in close relations, are key link especially with deficiency of spleen-YANG and kidneyYANG.(General Treatise on the Cause and Symptoms of Diseases) cloud: " water patient, all empty therefore also, suffer from a deficiency of the kidney and can not declare water flowing gas by spleen kidney, insufficiency of the spleen can not controlling the water circulation, therefore aqueous vapor brims over, seepage flow skin, all over stream extremity, so the whole body is swollen also." as can be seen here, the dirty functional disorder of spleen kidney two is this pathogenetic immanent cause, and end-stage disease then kidney qi virtual loss is particularly outstanding.
Therefore, treatment effects a permanent cure with warming YANG activating QI, invigorating spleen for diuresis eliminating dampness by diuresis is principle.
The invention provides a kind of pharmaceutical preparation being used for the treatment of nephrotic syndrome, it comprises following crude drug: Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Cortex Moutan, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, assorted Chinese medicine tea, Myrrha, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis, Radix Adenophorae, Herba Rabdosiae glaucocalycis, Herba Ephedrae, Fructus Broussonetiae, Poria and Radix Glycyrrhizae.
Further, described pharmaceutical preparation is only made up of above-mentioned raw materials medicine.
The pharmacology of each crude drug is as follows:
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.
Fructus Lycii: latin name lyciifructus, sweet in the mouth, property are flat, 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, be mainly used in Liver and kidney two void, the soreness of the waist and knees of asthenia of essence and blood, dizziness and tinnitus, seminal emission tinnitus, unconsciously sweat and tire; 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.
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.
Herb Gynostemmae Pentaphylli: another name Herba Gynostemmatis, Pentapanax, gynostemma pentaphyllum makino, Herba Gynostemmatis, Herb Gynostemmae Pentaphylli, Radix Rhodiolae, the sweet bitter edible plant are climing, southern Radix Ginseng, and cold in nature, bitter in the mouth, returns lung, spleen, kidney channel, have QI invigorating, calm the nerves, effect of blood pressure lowering, and for deficiency of vital energy and physically weak, weak breath is weak; Vexed insomnia; Hypertension, Light-headedness; Viral hepatitis; Digestive tract tumor; The cards such as chronic bronchitis, find through modern medicine study, Herb Gynostemmae Pentaphylli principle active component is polysaccharide, flavonoid, saponins and microelement kind, and its effect mainly promotes body fat class substance metabolism, nutrition human body cell, has good detoxicating, relieving inflammation effect simultaneously.
Radix Codonopsis: latin name Codonopsis Radix, sweet in the mouth, property is put down, enter lung, spleen channel, there is QI invigorating strengthening the spleen, effect of nourishing blood to promote the production of body fluid, cure mainly the fatigue and weakness of deficiency of both the splenic and pulmonary QI or QI and blood deficiency, breathe hard, the cards such as cough spontaneous perspiration, spleen reinforcing nourishing the stomach is longer than by Radix Codonopsis, adjusts regulating the function of middle-JIAO, has the effect of nourishing blood concurrently, its property put down, spleen invigorating fortune and not dry; Flavour is cloudy and do not wet, and can improve the immune state of body, improves resistance against diseases, and facilitating digestion absorbs, and improves metabolism, promotes that intestinal is to the absorption of nutrient substance.
Rhizoma Polygonati: sweet in the mouth, property is put down, and enters lung, spleen, kidney channel, has enriching qi and yin, spleen invigorating lung moistening, effect of enriching kidney essence, for 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 card such as deficiency of kidney essence, impotence and seminal emission, dizziness and tinnitus, blurred vision dim eyesight.
Cortex Moutan: cold in nature, bitter in the mouth, cool, enter the heart, liver, kidney, lung meridian, there is effect of clearing away heat and cooling blood, promoting blood circulation to remove blood stasis, for the epidemic febrile disease pathogenic heat attacking blood system in febrile diseases, send out speckle, tell nosebleed, the calentura later stage, hot Fu Yin divided heating, deficiency of YIN osteopyrexia and fever, amenorrhea due to stagnation of blood, dysmenorrhea, carbuncle sore tumefacting virus, falls and flutters the pain of injury, the cards such as beriberoid pyretic arthralgia.
Herba Epimedii: acrid in the mouth, sweet, warm in nature, enters liver, kidney channel, has kidney-replenishing, bone and muscle strengthening, the effect of wind-damp dispelling, cold extremities with aversion to cold soft for impotence due to deficiency of the kidney, seminal emission premature ejaculation, waist knee joint flaccidity; The cards such as arthralgia due to cold-dampnes or spasm of the limbs numbness.
Radix Rehmanniae Preparata: sweet in the mouth, slightly warm in nature, enters liver, kidney channel, has YIN nourishing of enriching blood, and beneficial essence fills out effect of marrow, cures mainly blood deficiency and yellow complexion; Dizzy, cardiopalmus, insomnia, menoxenia, collapses 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; Seminal emission sexual impotence; Infertility; Menoxenia; Metrostaxis; Early whitening of beard and hair; Quench one's thirst; Constipation; To suffer from a deficiency of the kidney the cards such as dyspnea with rapid and short breath.
Semen Euryales: sweet in the mouth, puckery, property is put down.Return spleen, kidney channel.Have supplementing the kidney to control the nocturnal, spleen reinforcing antidiarrheal, the function of damp eliminating leukorrhagia stopping, cures mainly emission, diarrhea due to hypofunction of the spleen, and insufficiency of the spleen nebulousurine is with inferior card.
Assorted Chinese medicine tea: bitter in the mouth, pungent, cold nature, has blood stasis dispelling regulating menstruation, and effect of removing obstruction in the collateral to relieve pain cures mainly the cards such as menoxenia, puerperal abdonimal pain, treating swelling and pain by traumatic injury, hemiplegia.
Myrrha: bitter in the mouth, pungent, property is put down, and enters liver, spleen, the heart, kidney channel, has effect of promoting blood circulation and stopping pain, detumescence and promoting granulation, cure mainly the cards such as breast abdomen stasis of blood pain, dysmenorrhea, amenorrhea, lump in the abdomen, traumatic injury, carbuncle skin infection, acute appendicitis, conjunctival congestion and swelling pain.
Herba Taxilli: bitter in the mouth, sweet, property is put down, and enters liver, kidney channel, have the effect of invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit, for the soreness of waist pain caused by deficiency of the liver and kindey, muscles and bones flaccidity is soft, the foot and knee being feeble, deficiency of the liver and kindey, essence and blood void is lost, the frequent fetal movement of liability to abortion, the cards such as waist abdomen pain.
Rhizoma Dioscoreae (nontoxic): latin name dioscoreae rhizoma, sweet in the mouth, property are flat, and enter lung, spleen, stomach warp, have spleen reinforcing nourishing the stomach, lung benefiting reinforces the kidney, and the effect of YIN nourishing and the production of body fluid promoting, cures mainly weakness of the spleen and stomach, the lack of appetite poor appetite of dysfunction of the spleen in transportation, the cards such as the vexed diarrhoea of gastral cavity.
Radix Morindae Officinalis: latin name Morindae Officinalis Radix, acrid in the mouth, sweet, slightly warm in nature, enter liver, kidney channel, there is effect of kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, for impotence due to deficiency of the kidney, seminal emission premature ejaculation, few abdomen cold type of pain, cold womb is infertile, the cards such as the muscles and bones flaccidity caused by deficiency of the liver and kindey is soft, chills and pain of the waist and kness.
Fructus Corni (nontoxic): latin name corni fructus, sour in the mouth, puckery, slightly warm in nature, returns liver, kidney channel, has liver and kidney tonifying, effect of essence astringing and desertion stemming.For vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating is collapsed.Interior-heat such as to be quenched one's thirst at the card.
Cortex Acanthopancis: the root bark for studies on plants of Acanthopanax Miq. in Araliaceae acanthopanax gracilistylus and Acanthopanax sessiliflorus(Rupr.et Maxim.) Seem.: acrid in the mouth, hardship, warm in nature, return liver, kidney, there is wind-damp dispelling; Invigorating the liver and kidney; Bone and muscle strengthening; To invigorate blood circulation effect of arteries and veins, cure mainly anemofrigid-damp arthralgia; Lumbocrural pain; Muscles and bones flaccidity is soft; Children's's walking retardation in children; Body void is frail; Traumatic injury; Fracture; Edema; Foot gas; Uncontrolled urination such as to be itched at the card.
Radix Adenophorae: sweet in the mouth, micro-hardship, cold nature, enter lung, stomach warp, there is nourishing the lung to arrest cough, the effect of nourishing the stomach to promote the production of body fluid, be mainly used in lung-dryness syndrome due to deficiency of YIN, dry cough few expectorant, chronic cough expectorant blood, the cards such as the few tongue of deficiency of stomach-Yin, mouthfeel parched throat, constipation, red tongue, cellular immunization and non-specific immunity can be improved, suppress humoral immunization, there is the function of immunity moderation balance.
Herba Rabdosiae glaucocalycis: bitter in the mouth, pungent, gas is fragrant, and cool in nature, GUIXIN, liver, spleen channel, have clearing away heat-damp and promoting diuresis, and effect of promoting blood circulation and detoxication, cures mainly jaundice due to damp-heat, stranguria, edema, laryngopharynx swelling and pain, arthralgia, amenorrhea, acute mastitis, hemorrhoid, traumatic injury, the cards such as venom.
Herba Ephedrae: acrid in the mouth, micro-hardship, warm in nature, enter lung, urinary bladder channel, have and send out cold inducing sweat, depressed lung-energy dispersing, the effect of inducing diuresis to remove edema, is mainly used in the exterior excess syndromes such as the fever without perspiration of affection of exogenous wind-cold; Rheumatic arthralgia pain; Pathogenic cold attacking the lung or accumulation of heat in the lung to cough with asthma QI rising in reverse order, edema, the cards such as dysuria.
Fructus Broussonetiae: sweet in the mouth, cold in nature, return liver, kidney channel, there is the kidney invigorating liver heat removing, effect of improving eyesight diuresis, cure mainly deficiency of the liver and kindey, soreness of the waist and knees, asthenia hectic fever due to YIN-deficiency, have a dizzy spell, the card such as edema distension.
Poria: sweet in the mouth, light, property is put down, and enters spleen, lung, bladder, heart channel, has the effect of eliminating dampness and diuresis, spleen invigorating mind calming, be mainly used in the edema of retention of water-damp, dysuria; The pyretic stranguria of damp-heat accumulation, the card such as anorexia and loose stool, phlegm retention stagnation, epilepsy of stagnation of dampness due to deficiency of the spleen.
Radix Glycyrrhizae: latin name Glycyrrhizae Radix et Rhizoma, sweet in the mouth, property put down, enter 12 warps, have heat-clearing and toxic substances removing, be in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in the abdominal distension and anorexia of weakness of the spleen and stomach, weak; Can alleviate contracture pain in abdomen, relax the strong and toxicity of some drugs, alleviating medicine stimulates to the toxic and side effects of body or to gastrointestinal, can play QI invigorating neutralization by adding Radix Glycyrrhizae, is in harmonious proportion the work of each component.
Wherein, in described pharmaceutical preparation, the weight portion of each crude drug is respectively Herba Ecliptae 40 weight portion ~ 50 weight portion, Fructus Lycii 45 weight portion ~ 55 weight portion, Radix seu Herba Gei aleppici 45 weight portion ~ 55 weight portion, Herb Gynostemmae Pentaphylli 25 weight portion ~ 35 weight portion, Radix Codonopsis 75 weight portion ~ 85 weight portion, Rhizoma Polygonati 40 weight portion ~ 50 weight portion, Cortex Moutan 25 weight portion ~ 35 weight portion, Herba Epimedii 30 weight portion ~ 40 weight portion, Radix Rehmanniae Preparata 35 weight portion ~ 45 weight portion, Semen Euryales 40 weight portion ~ 50 weight portion, assorted Chinese medicine tea 25 weight portion ~ 35 weight portion, Myrrha 30 weight portion ~ 40 weight portion, Herba Taxilli 35 weight portion ~ 45 weight portion, Rhizoma Dioscoreae 40 weight portion ~ 50 weight portion, Radix Morindae Officinalis 30 weight portion ~ 40 weight portion, Fructus Corni 35 weight portion ~ 45 weight portion, Cortex Acanthopancis 20 weight portion ~ 30 weight portion, Radix Adenophorae 30 weight portion ~ 40 weight portion, Herba Rabdosiae glaucocalycis 25 weight portion ~ 35 weight portion, Herba Ephedrae 30 weight portion ~ 40 weight portion, Fructus Broussonetiae 25 weight portion ~ 35 weight portion, Poria 35 weight portion ~ 45 weight portion and Radix Glycyrrhizae 20 weight portion ~ 30 weight portion.
Further, in described pharmaceutical preparation, the weight portion of each crude drug is respectively Herba Ecliptae 43 weight portion ~ 47 weight portion, Fructus Lycii 48 weight portion ~ 52 weight portion, Radix seu Herba Gei aleppici 48 weight portion ~ 52 weight portion, Herb Gynostemmae Pentaphylli 28 weight portion ~ 32 weight portion, Radix Codonopsis 78 weight portion ~ 82 weight portion, Rhizoma Polygonati 43 weight portion ~ 47 weight portion, Cortex Moutan 28 weight portion ~ 32 weight portion, Herba Epimedii 33 weight portion ~ 37 weight portion, Radix Rehmanniae Preparata 38 weight portion ~ 42 weight portion, Semen Euryales 43 weight portion ~ 47 weight portion, assorted Chinese medicine tea 28 weight portion ~ 32 weight portion, Myrrha 33 weight portion ~ 37 weight portion, Herba Taxilli 38 weight portion ~ 42 weight portion, Rhizoma Dioscoreae 43 weight portion ~ 47 weight portion, Radix Morindae Officinalis 33 weight portion ~ 37 weight portion, Fructus Corni 38 weight portion ~ 42 weight portion, Cortex Acanthopancis 23 weight portion ~ 27 weight portion, Radix Adenophorae 33 weight portion ~ 37 weight portion, Herba Rabdosiae glaucocalycis 28 weight portion ~ 32 weight portion, Herba Ephedrae 33 weight portion ~ 37 weight portion, Fructus Broussonetiae 28 weight portion ~ 32 weight portion, Poria 38 weight portion ~ 42 weight portion and Radix Glycyrrhizae 23 weight portion ~ 27 weight portion.
Most preferably, in described pharmaceutical preparation, the weight portion of each crude drug is respectively Herba Ecliptae 45 weight portion, Fructus Lycii 50 weight portion, Radix seu Herba Gei aleppici 50 weight portion, Herb Gynostemmae Pentaphylli 30 weight portion, Radix Codonopsis 80 weight portion, Rhizoma Polygonati 45 weight portion, Cortex Moutan 30 weight portion, Herba Epimedii 35 weight portion, Radix Rehmanniae Preparata 40 weight portion, Semen Euryales 45 weight portion, assorted Chinese medicine tea 30 weight portion, Myrrha 35 weight portion, Herba Taxilli 40 weight portion, Rhizoma Dioscoreae 45 weight portion, Radix Morindae Officinalis 35 weight portion, Fructus Corni 40 weight portion, Cortex Acanthopancis 25 weight portion, Radix Adenophorae 35 weight portion, Herba Rabdosiae glaucocalycis 30 weight portion, Herba Ephedrae 35 weight portion, Fructus Broussonetiae 30 weight portion, Poria 40 weight portion and Radix Glycyrrhizae 25 weight portion.
The dosage form of described pharmaceutical preparation is can be various regular dosage form, is preferably granule and capsule, the customary preparation methods of each dosage form can be adopted to prepare.
Present invention also offers the preparation method of said medicine preparation, when the dosage form of prepared pharmaceutical preparation is capsule, be specially:
The first step, by Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis and Radix Adenophorae are pulverized respectively, cross 20 mesh sieves, send in mixer by weight and be uniformly mixed, obtain mixture, mixture is loaded in percolator, every 100g mixture adds ethanol 500g ~ 700g that determining alcohol is 70% ~ 80%, soak 20 hours ~ 30 hours under the condition of 25 DEG C ~ 35 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 2 ~ 4mL per minute, collect drip, obtain the percolate of 700mL ~ 1L, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder,
Second step, pulverizes respectively by each for remainder crude drug component, crosses 20 mesh sieves, send in mixer by weight and be uniformly mixed, put into boiler subsequently, add water, soak 5 ~ 8 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, the quality of the water added is 3 ~ 5 times of mixture quality, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder;
3rd step, by the first powder and the mixing of the second powder, the mixture obtained is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add the alcohol granulation that determining alcohol is 25%, the quality of the ethanol added is equivalent to 0.1 ~ 0.2 times of the mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01 ~ 0.02 times of the mixture quality of mix products and starch, mix homogeneously, loads in capsule for medicine, obtains capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, when the dosage form of described Chinese medicine composition is granule, be specially:
The first step, by Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis and Radix Adenophorae are pulverized respectively, cross 20 mesh sieves, send in mixer by weight and be uniformly mixed, obtain mixture, mixture is loaded in percolator, every 100g mixture adds ethanol 500g ~ 700g that determining alcohol is 70% ~ 80%, soak 20 hours ~ 30 hours under the condition of 25 DEG C ~ 35 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 2 ~ 4mL per minute, collect drip, obtain the percolate of 700mL ~ 1L, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder,
Second step, pulverizes respectively by each for remainder crude drug component, crosses 20 mesh sieves, send in mixer by weight and be uniformly mixed, put into boiler subsequently, add water, soak 5 ~ 8 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, the quality of the water added is 3 ~ 5 times of mixture quality, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder;
3rd step, by the first powder and the second powder Homogeneous phase mixing, obtains mixture; again pulverize, add dextrin, aspartame subsequently, be placed in wet granulator; be dry mixed 3 ~ 8 minutes, adding determining alcohol is 50% ~ 60% ethanol, granulates 2 ~ 5 minutes; dry; obtained described granule, splitting splendid attire, relative to the mixture of 100 weight portions; the addition of described dextrin is 100 weight portion ~ 120 weight portions, and the addition of described aspartame is 1 weight portion ~ 3 weight portion.
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.
The preparation of embodiment 1 granule 1
By Herba Ecliptae 45g, Fructus Lycii 50g, Radix seu Herba Gei aleppici 50g, Herb Gynostemmae Pentaphylli 30g, Radix Codonopsis 80g, Rhizoma Polygonati 45g, Herba Epimedii 35g, Radix Rehmanniae Preparata 40g, Semen Euryales 45g, Herba Taxilli 40g, Rhizoma Dioscoreae 45g, Radix Morindae Officinalis 35g, Fructus Corni 40g, Cortex Acanthopancis 25g, Radix Adenophorae 35g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, obtain mixture, loaded by mixture in percolator, every 100g mixture adds the ethanol 600g that determining alcohol is 80%, soak 20 hours under the condition of 25 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 3mL per minute, collects drip, obtains the percolate of 800mL, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder, by Cortex Moutan 30g, assorted Chinese medicine tea 30g, Myrrha 35g, Herba Rabdosiae glaucocalycis 30g, Herba Ephedrae 35g, Fructus Broussonetiae 30g, Poria 40g and Radix Glycyrrhizae 25g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, put into boiler subsequently, add the water of 1kg, soak 6 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder, by the first powder and the second powder Homogeneous phase mixing, obtain mixture, again pulverize, get 300g mixture, add 300g dextrin subsequently, 6g aspartame, is placed in wet granulator, is dry mixed 5 minutes, and adding determining alcohol is 60% ethanol, granulates 3 minutes, dry, obtained described granule 1, splitting splendid attire.
The preparation of embodiment 2 granule 2
By Herba Ecliptae 43g, Fructus Lycii 48g, Radix seu Herba Gei aleppici 48g, Herb Gynostemmae Pentaphylli 28g, Radix Codonopsis 78g, Rhizoma Polygonati 43g, Herba Epimedii 33g, Radix Rehmanniae Preparata 38g, Semen Euryales 43g, Herba Taxilli 38g, Rhizoma Dioscoreae 43g, Radix Morindae Officinalis 33g, Fructus Corni 38g, Cortex Acanthopancis 23g, Radix Adenophorae 33g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, obtain mixture, loaded by mixture in percolator, every 100g mixture adds the ethanol 600g that determining alcohol is 80%, soak 20 hours under the condition of 25 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 3mL per minute, collects drip, obtains the percolate of 800mL, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder, by Cortex Moutan 30g, assorted Chinese medicine tea 30g, Myrrha 33g, Herba Rabdosiae glaucocalycis 28g, Herba Ephedrae 33g, Fructus Broussonetiae 28g, Poria 38g and Radix Glycyrrhizae 23g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, put into boiler subsequently, add the water of 1kg, soak 6 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder, by the first powder and the second powder Homogeneous phase mixing, obtain mixture, again pulverize, get 300g mixture, add 300g dextrin subsequently, 6g aspartame, is placed in wet granulator, is dry mixed 5 minutes, and adding determining alcohol is 60% ethanol, granulates 3 minutes, dry, obtained described granule 2, splitting splendid attire.
The preparation of embodiment 3 granule 3
By Herba Ecliptae 47g, Fructus Lycii 52g, Radix seu Herba Gei aleppici 52g, Herb Gynostemmae Pentaphylli 32g, Radix Codonopsis 82g, Rhizoma Polygonati 47g, Herba Epimedii 37g, Radix Rehmanniae Preparata 42g, Semen Euryales 47g, Herba Taxilli 42g, Rhizoma Dioscoreae 47g, Radix Morindae Officinalis 37g, Fructus Corni 42g, Cortex Acanthopancis 27g, Radix Adenophorae 37g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, obtain mixture, loaded by mixture in percolator, every 100g mixture adds the ethanol 600g that determining alcohol is 80%, soak 20 hours under the condition of 25 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 3mL per minute, collects drip, obtains the percolate of 800mL, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder, by Cortex Moutan 32g, assorted Chinese medicine tea 32g, Myrrha 37g, Herba Rabdosiae glaucocalycis 32g, Herba Ephedrae 37g, Fructus Broussonetiae 32g, Poria 42g and Radix Glycyrrhizae 27g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, put into boiler subsequently, add the water of 1kg, soak 6 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder, by the first powder and the second powder Homogeneous phase mixing, obtain mixture, again pulverize, get 300g mixture, add 300g dextrin subsequently, 6g aspartame, is placed in wet granulator, is dry mixed 5 minutes, and adding determining alcohol is 60% ethanol, granulates 3 minutes, dry, obtained described granule 3, splitting splendid attire.
The preparation of embodiment 4 capsule
By Herba Ecliptae 45g, Fructus Lycii 50g, Radix seu Herba Gei aleppici 50g, Herb Gynostemmae Pentaphylli 30g, Radix Codonopsis 80g, Rhizoma Polygonati 45g, Herba Epimedii 35g, Radix Rehmanniae Preparata 40g, Semen Euryales 45g, Herba Taxilli 40g, Rhizoma Dioscoreae 45g, Radix Morindae Officinalis 35g, Fructus Corni 40g, Cortex Acanthopancis 25g, Radix Adenophorae 35g pulverizes respectively, crosses 20 mesh sieves, sends in mixer and is uniformly mixed, obtain mixture, loaded by mixture in percolator, every 100g mixture adds the ethanol 600g that determining alcohol is 80%, soak 20 hours under the condition of 25 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 3mL per minute, collects drip, obtains the percolate of 800mL, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder, by Cortex Moutan 30g, assorted Chinese medicine tea 30g, Myrrha 35g, Herba Rabdosiae glaucocalycis 30g, Herba Ephedrae 35g, Fructus Broussonetiae 30g, Poria 40g and Radix Glycyrrhizae 25g pulverizes respectively, cross 20 mesh sieves, send in mixer and be uniformly mixed, put into boiler subsequently, add the water of 1kg, soak 6 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, distillate concentrating under reduced pressure, obtain dry mastic, be ground into the second dried powder, by the first powder and the second powder Homogeneous phase mixing, the mixture obtained is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, adds the alcohol granulation that determining alcohol is 25%, and the quality of the ethanol added is equivalent to 0.1 times of the mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01 times of the mixture quality of mix products and starch, mix homogeneously, load in capsule for medicine, obtain capsule.
Embodiment 5 toxicity test
Acute toxicity test
Animal: Kunming mouse, body weight 21 ~ 24g, male and female half and half.
LD
50calculate: adopt improvement karber's method, mice is divided into 5 groups at random, often organize 10, male and female half and half, granule 1 adding distil water embodiment 1 prepared dissolves, and is made into Cmax, by the administration of mice maximum permission capacity, institute is followed successively by 18,14.4 to dosage by crude drug amount, 11.5,9.2,7.4 (g/kg), in animal fasting (can't help water) after 18 hours, administration at twice in one day (interval half an hour), each 0.5ml, observes animal dead situation.
Maximum tolerated dose measures (MTD value): get mice 20, each 10 of male and female.Granule adding distil water is dissolved, is made into maximum concentration, by the maximum tolerated dose of animal, feed device and can twitch to inject to fill with and be as the criterion.In animal fasting (can't help water) after 18 hours, administration at twice in a day (interval half an hour), each 0.5ml (every ml is containing crude drug 0.72g), total dose is 36g crude drug/kgd, Continuous Observation 7 days after administration.
Result of the test
At LD
50in calculating when giving mice with maximum acceptable concentration and maximum permission capacity (36g/Kgd), have no dead mouse, namely do not measure LD
50, ask maximum tolerated dose only, in 7 day observation period, its appetite of animal, activity, hair color, the mental status etc. are all normal, grow normal, there are no death, show that acute toxicity is minimum, MTD > 36g/Kgd.
Aggregate toxicity is tested
Granule adding distil water embodiment 1 prepared dissolves, to mice by 7.69,19.18 and 43.21g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine preparation of the present invention to rat all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and each internal organs of rat are all without obviously changing.Illustrate Chinese medicine preparation of the present invention take granules of rats long-term prescription orally after toxicity little, do not have after drug withdrawal yet difference reaction, application safety.
Embodiment 6 clinical data
Physical data
160 routine nephrotic syndromes are is in hospital or outpatient service tracking patient, is divided into integrated Chinese and western therapy treatment group and simple western medicine therapy matched group at random.Treatment group 80 example, man 49 example, female 31 example; 32 ~ 60 years old age, average (36 ± 2.8) year; The course of disease 6 ~ 12 months, average (6.5 ± 1.5) individual month; Wherein 24h urine protein quantitation 4.5 ~ 14g, average (7.2 ± 1.3) g; Plasma albumin 16 ~ 29g, average (22.0 ± 2.2) g/L.Matched group 80 example, man 46 example, female 34 example; 23 ~ 63 years old age, average (35 ± 3.5) year; The course of disease 5.5 ~ 11 months, average (6.0 ± 2.2) individual month; Wherein 24h urine protein quantitation 4.0 ~ 13.8g, average (6.5 ± 1.3) g; Plasma albumin 15 ~ 28g, average (22.3 ± 2.1) g/L, all gets rid of the Secondary cases nephropathy such as lupus nephritis, diabetic nephropathy, henoch Schonlein purpura nephritis.
Diagnostic criteria
1) High-grade Proteinuria: every day > 3.5g/24h; 2) hypoproteinemia, serum albumin≤30g/L; 3) obvious edema; 4) hyperlipemia.Wherein 1) 2) item is indispensable, and invalid or rely on to glucocorticoid treatment, or recurs 3 times in 1 year, recurrence more than 2 times in half a year.
Method
Matched group: standard hormone therapy.First beginning prednisone 1mg/kg every day, plays decoction being taken at a draught morning 8 weeks, the principle that Corticosteroids is followed " use early suitable, head amount should be sufficient, removes and subtract and slowly, should hold time and should grow ".Start Tapered slowly after 8 weeks, 10% of commercial weight of successively decreasing weekly, reduce to the 0.5mg/kg of every day, change decoction being taken at a draught next day that 2d measuring into, maintain 3 ~ 6 months.Tapered slowly is to maintenance dose 0.2mg/kg every day (total amount 10mg/d) again, the decoction being taken at a draught next day of still, continues 12 ~ 18 months.
Test group: take granule prepared by the embodiment of the present invention 1, every day 3 times, each 50g, is dissolved in water, oral, continues 12 ~ 18 months.
Criterion of therapeutical effect
The indexs such as periodic detection routine blood test, routine urinalysis, 24h urine protein quantitation, hepatic and renal function and blood fat, a situation arises for toxic and side effects when observing medication 4,8,12 weeks.Complete incidence graph: the sings and symptomses such as edema disappear, measures urine protein negative more than 3 times, urine protein quantitation < 0.2g/24h, and serum albumin levels is normal or close normal, normal renal function; Partial rcsponse: the sings and symptomses such as edema disappear substantially, measure urine protein quantitation < 2.0g/24 for more than 3 times, serum albumin levels improves, and renal function improves; Invalid: urine protein >=3.5g/24h, serum albumin, blood fat and renal function are not improved; Multiple: to alleviate in latter 3 months and occur that nephrotic syndrome shows.
Statistical procedures
Adopt SPSS 11.0 systems soft ware process data, measurement data represents with (x ± s), compares employing one factor analysis of variance between group, and enumeration data adopts χ
2inspection, P < 0.05 has statistical significance for difference.
Result
After two groups of treatments, urine protein quantitation, plasma albumin, the change of T-CHOL index are compared, and the results are shown in Table 1.
After table 1 liang group treatment, urine protein quantitation, plasma albumin, the change of T-CHOL index are compared
Table 1 can be found out, to 12 weeks from the 8th week, 2 groups of patients urine protein after treatment is obviously reduced to turns out cloudy, and it is normal that plasma albumin raises basic recovery, cholesterolemia reduces, and comparatively before treatment, comparing difference has statistical significance (P < 0.05).
Two groups of general curative effects compare, and the results are shown in Table 2.
A table 2 liang group general curative effect compares
| Group | Number of cases | Complete incidence graph | Partial rcsponse | Invalid | Multiple | Total effective rate/% |
| Treatment group | 80 | 61 | 10 | 6 | 3 | 88.75 |
| Matched group | 80 | 53 | 13 | 9 | 5 | 82.5 |
Two groups of untoward reaction are compared, and the results are shown in Table 3.
A table 3 liang group untoward reaction is compared
| Untoward reaction | Treatment group | Matched group |
| Tachycardia | 9(11.25％) | 37(46.25％) |
| Leukocyte reduces | 0(0.0％) | 15(18.75％) |
| Transaminase raises | 0(0.0％) | 9(11.25％) |
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 (7)
1. one kind is used for the treatment of the pharmaceutical preparation of nephrotic syndrome, it is characterized in that: comprise following crude drug, Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Cortex Moutan, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, assorted Chinese medicine tea, Myrrha, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis, Radix Adenophorae, Herba Rabdosiae glaucocalycis, Herba Ephedrae, Fructus Broussonetiae, Poria and Radix Glycyrrhizae.
2. pharmaceutical preparation as claimed in claim 1, is characterized in that: the weight portion of each crude drug is respectively Herba Ecliptae 40 weight portion ~ 50 weight portion, Fructus Lycii 45 weight portion ~ 55 weight portion, Radix seu Herba Gei aleppici 45 weight portion ~ 55 weight portion, Herb Gynostemmae Pentaphylli 25 weight portion ~ 35 weight portion, Radix Codonopsis 75 weight portion ~ 85 weight portion, Rhizoma Polygonati 40 weight portion ~ 50 weight portion, Cortex Moutan 25 weight portion ~ 35 weight portion, Herba Epimedii 30 weight portion ~ 40 weight portion, Radix Rehmanniae Preparata 35 weight portion ~ 45 weight portion, Semen Euryales 40 weight portion ~ 50 weight portion, assorted Chinese medicine tea 25 weight portion ~ 35 weight portion, Myrrha 30 weight portion ~ 40 weight portion, Herba Taxilli 35 weight portion ~ 45 weight portion, Rhizoma Dioscoreae 40 weight portion ~ 50 weight portion, Radix Morindae Officinalis 30 weight portion ~ 40 weight portion, Fructus Corni 35 weight portion ~ 45 weight portion, Cortex Acanthopancis 20 weight portion ~ 30 weight portion, Radix Adenophorae 30 weight portion ~ 40 weight portion, Herba Rabdosiae glaucocalycis 25 weight portion ~ 35 weight portion, Herba Ephedrae 30 weight portion ~ 40 weight portion, Fructus Broussonetiae 25 weight portion ~ 35 weight portion, Poria 35 weight portion ~ 45 weight portion and Radix Glycyrrhizae 20 weight portion ~ 30 weight portion.
3. pharmaceutical preparation as claimed in claim 1 or 2, is characterized in that: the weight portion of each crude drug is respectively Herba Ecliptae 43 weight portion ~ 47 weight portion, Fructus Lycii 48 weight portion ~ 52 weight portion, Radix seu Herba Gei aleppici 48 weight portion ~ 52 weight portion, Herb Gynostemmae Pentaphylli 28 weight portion ~ 32 weight portion, Radix Codonopsis 78 weight portion ~ 82 weight portion, Rhizoma Polygonati 43 weight portion ~ 47 weight portion, Cortex Moutan 28 weight portion ~ 32 weight portion, Herba Epimedii 33 weight portion ~ 37 weight portion, Radix Rehmanniae Preparata 38 weight portion ~ 42 weight portion, Semen Euryales 43 weight portion ~ 47 weight portion, assorted Chinese medicine tea 28 weight portion ~ 32 weight portion, Myrrha 33 weight portion ~ 37 weight portion, Herba Taxilli 38 weight portion ~ 42 weight portion, Rhizoma Dioscoreae 43 weight portion ~ 47 weight portion, Radix Morindae Officinalis 33 weight portion ~ 37 weight portion, Fructus Corni 38 weight portion ~ 42 weight portion, Cortex Acanthopancis 23 weight portion ~ 27 weight portion, Radix Adenophorae 33 weight portion ~ 37 weight portion, Herba Rabdosiae glaucocalycis 28 weight portion ~ 32 weight portion, Herba Ephedrae 33 weight portion ~ 37 weight portion, Fructus Broussonetiae 28 weight portion ~ 32 weight portion, Poria 38 weight portion ~ 42 weight portion and Radix Glycyrrhizae 23 weight portion ~ 27 weight portion.
4. the pharmaceutical preparation as described in claims 1 to 3, it is characterized in that: the weight portion of each crude drug is respectively Herba Ecliptae 45 weight portion, Fructus Lycii 50 weight portion, Radix seu Herba Gei aleppici 50 weight portion, Herb Gynostemmae Pentaphylli 30 weight portion, Radix Codonopsis 80 weight portion, Rhizoma Polygonati 45 weight portion, Cortex Moutan 30 weight portion, Herba Epimedii 35 weight portion, Radix Rehmanniae Preparata 40 weight portion, Semen Euryales 45 weight portion, assorted Chinese medicine tea 30 weight portion, Myrrha 35 weight portion, Herba Taxilli 40 weight portion, Rhizoma Dioscoreae 45 weight portion, Radix Morindae Officinalis 35 weight portion, Fructus Corni 40 weight portion, Cortex Acanthopancis 25 weight portion, Radix Adenophorae 35 weight portion, Herba Rabdosiae glaucocalycis 30 weight portion, Herba Ephedrae 35 weight portion, Fructus Broussonetiae 30 weight portion, Poria 40 weight portion and Radix Glycyrrhizae 25 weight portion.
5. the pharmaceutical preparation as described in Claims 1-4, is characterized in that: the dosage form of described pharmaceutical preparation is granule and capsule.
6. the preparation method of pharmaceutical preparation described in claim 1 to 5, is characterized in that: when the dosage form of prepared pharmaceutical preparation is capsule, comprise,
The first step, by Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis and Radix Adenophorae are pulverized respectively, cross 20 mesh sieves, send in mixer by weight and be uniformly mixed, obtain mixture, mixture is loaded in percolator, every 100g mixture adds ethanol 500g ~ 700g that determining alcohol is 70% ~ 80%, soak 20 hours ~ 30 hours under the condition of 25 DEG C ~ 35 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 2 ~ 4mL per minute, collect drip, obtain the percolate of 700mL ~ 1L, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder,
Second step, pulverizes respectively by each for remainder crude drug component, crosses 20 mesh sieves, send in mixer by weight and be uniformly mixed, put into boiler subsequently, add water, soak 5 ~ 8 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, the quality of the water added is 3 ~ 5 times of mixture quality, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder;
3rd step, by the first powder and the mixing of the second powder, the mixture obtained is mixed homogeneously with starch, the amount of starch that every 100g mix products adds is 100g, add the alcohol granulation that determining alcohol is 25%, the quality of the ethanol added is equivalent to 0.1 ~ 0.2 times of the mixture quality of mix products and starch, by particle drying, add magnesium stearate, the weight of magnesium stearate is equivalent to 0.01 ~ 0.02 times of the mixture quality of mix products and starch, mix homogeneously, loads in capsule for medicine, obtains capsule.
7. the preparation method of Chinese medicine composition described in claim 1 to 5, is characterized in that: when the dosage form of described Chinese medicine composition is granule, comprise,
The first step, by Herba Ecliptae, Fructus Lycii, Radix seu Herba Gei aleppici, Herb Gynostemmae Pentaphylli, Radix Codonopsis, Rhizoma Polygonati, Herba Epimedii, Radix Rehmanniae Preparata, Semen Euryales, Herba Taxilli, Rhizoma Dioscoreae, Radix Morindae Officinalis, Fructus Corni, Cortex Acanthopancis and Radix Adenophorae are pulverized respectively, cross 20 mesh sieves, send in mixer by weight and be uniformly mixed, obtain mixture, mixture is loaded in percolator, every 100g mixture adds ethanol 500g ~ 700g that determining alcohol is 70% ~ 80%, soak 20 hours ~ 30 hours under the condition of 25 DEG C ~ 35 DEG C, regulate percolator valve, Chinese liquor medicinal liquid is slowly oozed, the speed of oozing is 2 ~ 4mL per minute, collect drip, obtain the percolate of 700mL ~ 1L, concentrated, removing alcohol solvent, dry, pulverize, obtain the first dried powder,
Second step, pulverizes respectively by each for remainder crude drug component, crosses 20 mesh sieves, send in mixer by weight and be uniformly mixed, put into boiler subsequently, add water, soak 5 ~ 8 hours, carry out distillation extraction subsequently, collect distillate to distillate and carry to the greatest extent completely, obtain distillate liquid, the quality of the water added is 3 ~ 5 times of mixture quality, distillate concentrating under reduced pressure, obtains dry mastic, is ground into the second dried powder;
3rd step, by the first powder and the second powder Homogeneous phase mixing, obtains mixture; again pulverize, add dextrin, aspartame subsequently, be placed in wet granulator; be dry mixed 3 ~ 8 minutes, adding determining alcohol is 50% ~ 60% ethanol, granulates 2 ~ 5 minutes; dry; obtained described granule, splitting splendid attire, relative to the mixture of 100 weight portions; the addition of described dextrin is 100 weight portion ~ 120 weight portions, and the addition of described aspartame is 1 weight portion ~ 3 weight portion.
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Application publication date: 20141217 |