CN104689010A - Chinese traditional medicine preparation for treatment of kidney deficiency and preparation technology thereof - Google Patents
Chinese traditional medicine preparation for treatment of kidney deficiency and preparation technology thereof Download PDFInfo
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Abstract
The invention discloses a Chinese traditional medicine preparation for the treatment of kidney deficiency, and belongs to the technical field of Chinese traditional medicine. The Chinese traditional medicine preparation comprises prepared rehmannia rootss, pulp of cornus, yam, eucommia ulmoides, achyranthes bidentata, poria cocos, peach seeds, immature bitter orange, medicine terminalia fruits, cornu cervi, corydalis yanhusuo, red peony rootss, citrus, seaweed, rhizoma alismatis, mantis egg-case, semen cuscutae, astragalus membranaceus and agilawood. The traditional medicine preparation is produced in volume according to the proportion and the technology provided by the invention. According to the Chinese traditional medicine preparation, the effect on the treatment of kidney deficiency is obvious, compared with the prior art, the Chinese traditional medicine preparation has the advantages that the effect achievement is fast, both manifestation and roots cause of the disease are treated, the recuperation and the treatment are combined, the technology is simple and convenient, the preparation effect is stable, volume production is facilitated and the like.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to the Chinese medicine preparation that a kind for the treatment of is suffered from a deficiency of the kidney.
Technical background
Suffer from a deficiency of the kidney and refer to that kidney vital essence negative and positive are not enough.The kind of suffering from a deficiency of the kidney has a lot, and wherein modal is deficiency of the kidney yin, insufficiency of kidney-YANG.The symptom of suffering from a deficiency of the kidney: the symptom of insufficiency of kidney-YANG is the soreness of waist, cold extremities, fear of cold, even also have edema, be the symptom of " trembling with fear ", sexual function is bad also can cause insufficiency of kidney-YANG; The symptom of deficiency of the kidney yin is " heat ", mainly contains the soreness of waist, scorching, night sweat, sweating due to debility, dizziness, tinnitus etc.Modern science proves, when people suffers from a deficiency of the kidney, and no matter deficiency of the kidney yin or insufficiency of kidney-YANG, capital causes the reduction of the immunocompetence of people, has more evidence to show, suffer from a deficiency of the kidney occur time, the immunocompetence of kidney reduces, and the microcirculqtory system of kidney also can be blocked, and kidney network presents obstructed.So should combination be prevented and treated for the treatment of suffering from a deficiency of the kidney.
The traditional Chinese medical science thinks that the concept of suffering from a deficiency of the kidney is wide in range, and major component is five cards, was both related, and also had any different between five cards.Understand the concrete manifestation of suffering from a deficiency of the kidney, to treating very large benefit of suffering from a deficiency of the kidney.Differential diagnosis in tcm treatment is suffered from a deficiency of the kidney and is mainly divided into following five types:
1, syndrome of deficiency of kidney-YANG
Main manifestations has " trembling with fear " concurrently and resembles for suffering from a deficiency of the kidney, and as soreness of the waist and knees cold type of pain, aversion to cold and cold limbs, pale complexion, hyposexuality, watery diarrhea with indigested food or Diarrhoea, pale tongue is fat or have indentation, and tongue is white, deep-slow pulse etc.Warming and recuperating the kidney-YANG is worked as in treatment.
2, syndrome of deficiency of kidney yin
Main manifestations resembles for suffering from a deficiency of the kidney and having " heat " concurrently, as soreness of the waist and knees, has a dizzy spell, tinnitus or deafness, xerostomia pharyngalgia, and two flaccidity of the lower limbs are weak, night sweat, and man's male sexuality can be lifted, but premature ejaculation or seminal emission, woman's infrequent menstruation or metrorrhagia, red tongue with a little fluid, deep-thready pulse etc.Nourishing kidney yin is worked as in treatment.
3, kidney essense deficiency syndrome
Main manifestations is the hypofunctions such as growth, growth and reproduction, and as slow in development in children, mentally disabled, between twenty and fifty senilism, sexual hypofunction, forgetful, even spirit is dull-witted, infertility, light red tongue, deficient pulse etc., treats and works as kidney tonifying, essence replenishing.
4, syndrome of deficiency of kidney-QI
Main manifestations be kidney lose close Tibetans, astringent or styptic treatment for spontaneous sweating, change the function such as water, as soreness of the waist and knees, the clear frequency of urine, nocturia increases, the enuresis or urinate out of control, and man's spermatorrhea premature ejaculation, woman's profuse leukorrhea is rare clearly, or habitual abortion is miscarried, pale tongue, weak pulse etc.Treatment is when tonifying Qi of the kidney.
5, failure of the kidney in receiving QI card
Main manifestations is that kidney loses improving inspiration by invigorating kidney-QI function and cough with asthma, and as chronic cough and asthma is not healed for a long time, dynamic then more very, gas must not continue, expectorant is thin in vain, soreness of the waist and knees, and urine Chang Yin coughs even incontinence, or dribble of urine, and limbs are not warm, pale tongue with thin fur, faint and thready pulse or sink weak.Improving inspiration by invigorating the kidney is worked as in treatment.
Summary of the invention
The technical problem to be solved in the present invention has two, and one is that a kind for the treatment of of invention is suffered from a deficiency of the kidney the Chinese prescription of Be very effective, and another is that this prescription is made the finished product Chinese medicine preparation that can produce in batches under the prerequisite ensureing curative effect.
In order to solve above-mentioned two technical problems, the technical scheme of inventor is, just focus on it when medicine prescription under development and make condition required for preparation, in conjunction with Chinese medicine pharmacology opinion and inventor's experience of taking up a job as a doctor for many years, again in conjunction with the process characteristic of modern pharmaceutical technology, and by the inspection of clinical practice with repeatedly adjust, finally forming a brand-new Chinese prescription and a set of preparation technology matched with it, the Chinese medicine preparation made thus is very remarkable to the therapeutic effect of suffering from a deficiency of the kidney.
The Chinese medicine preparation that a kind for the treatment of of the present invention is suffered from a deficiency of the kidney is made up of the raw material of following weight portion: Radix Rehmanniae Preparata 12-28 part, Fructus Corni 16-28 part, Rhizoma Dioscoreae 11-25 part, Cortex Eucommiae 9-21 part, Radix Achyranthis Bidentatae 10-22 part, Poria 8-20 part, Semen Persicae 7-17 part, Fructus Aurantii Immaturus 7-15 part, Fructus Chebulae 9-21 part, Cornu Cervi Pantotrichum 10-22 part, Rhizoma Corydalis 13-27 part, Radix Paeoniae Rubra 7-15 part, Pericarpium Citri Reticulatae 8-18 part, Sargassum 7-17 part, Rhizoma Alismatis 9-21 part, Ootheca Mantidis 8-20 part, Semen Cuscutae 20-36 part, Radix Astragali 8-18 part, Lignum Aquilariae Resinatum 5-9 part.
The Chinese medicine preparation that a kind for the treatment of of the present invention is suffered from a deficiency of the kidney is preferably following 3 proportioning raw materials and makes:
Proportioning 1, Radix Rehmanniae Preparata 20 parts, Fructus Corni 22 parts, Rhizoma Dioscoreae 18 parts, the Cortex Eucommiae 15 parts, Radix Achyranthis Bidentatae 16 parts, 14 parts, Poria, 12 parts, Semen Persicae, Fructus Aurantii Immaturus 11 parts, Fructus Chebulae 15 parts, 16 parts, Cornu Cervi Pantotrichum, Rhizoma Corydalis 20 parts, Radix Paeoniae Rubra 11 parts, Pericarpium Citri Reticulatae 13 parts, Sargassum 12 parts, Rhizoma Alismatis 15 parts, Ootheca Mantidis 14 parts, Semen Cuscutae 28 parts, the Radix Astragali 13 parts, Lignum Aquilariae Resinatum 7 parts.
Proportioning 2, Radix Rehmanniae Preparata 22 parts, Fructus Corni 23 parts, Rhizoma Dioscoreae 19 parts, the Cortex Eucommiae 14 parts, Radix Achyranthis Bidentatae 15 parts, 13 parts, Poria, 13 parts, Semen Persicae, Fructus Aurantii Immaturus 12 parts, Fructus Chebulae 16 parts, 18 parts, Cornu Cervi Pantotrichum, Rhizoma Corydalis 21 parts, Radix Paeoniae Rubra 13 parts, Pericarpium Citri Reticulatae 11 parts, Sargassum 14 parts, Rhizoma Alismatis 13 parts, Ootheca Mantidis 16 parts, Semen Cuscutae 26 parts, the Radix Astragali 14 parts, Lignum Aquilariae Resinatum 6 parts.
Proportioning 3, Radix Rehmanniae Preparata 21 parts, Fructus Corni 24 parts, Rhizoma Dioscoreae 17 parts, the Cortex Eucommiae 16 parts, Radix Achyranthis Bidentatae 14 parts, 16 parts, Poria, 14 parts, Semen Persicae, Fructus Aurantii Immaturus 10 parts, Fructus Chebulae 14 parts, 17 parts, Cornu Cervi Pantotrichum, Rhizoma Corydalis 22 parts, Radix Paeoniae Rubra 13 parts, Pericarpium Citri Reticulatae 14 parts, Sargassum 14 parts, Rhizoma Alismatis 13 parts, Ootheca Mantidis 13 parts, Semen Cuscutae 30 parts, the Radix Astragali 15 parts, Lignum Aquilariae Resinatum 8 parts.
The preparation method of the Chinese medicine preparation that a kind for the treatment of of the present invention is suffered from a deficiency of the kidney comprises following processing step:
(1) accurately ingredients is taken by Chinese prescription of the present invention;
(2) get the alcohol-pickled 12-24 hour of Ootheca Mantidis, Radix Achyranthis Bidentatae 45-65%, drain, pulverize, parch, grinding, cross 80-120 mesh sieve and obtain fine powder a, for subsequent use;
(3) get Fructus Corni, Cornu Cervi Pantotrichum, the Cortex Eucommiae, Rhizoma Corydalis, Fructus Chebulae, Radix Astragali pulverizing, parch, grinding, crosses 80-120 mesh sieve, obtains fine powder b, for subsequent use;
(4) get Fructus Aurantii Immaturus, Semen Persicae parched with bran system, pulverize grinding, cross 80-120 mesh sieve, obtain fine powder c, for subsequent use;
(5) get Radix Rehmanniae Preparata, Lignum Aquilariae Resinatum pulverizes grinding, cross 80-120 mesh sieve, obtain fine powder d, for subsequent use;
(6) get Rhizoma Dioscoreae, Poria, Radix Paeoniae Rubra, Pericarpium Citri Reticulatae, Sargassum, Rhizoma Alismatis, Semen Cuscutae add 7-12 distilled water doubly, soak 12-24 hour, backflow decoction 3 times, each 1-4 hour, filter, mix 3 filtrates, when being evaporated to 60 DEG C, relative density of surveying is 1.25-1.30, then vacuum drying obtains dry extract, dry extract is pulverized, grinding, cross 80-120 mesh sieve, obtain fine powder e, for subsequent use;
(7) by fine powder a, b, c, d, e mix homogeneously, effective ingredient fine powder is;
(8) add suitable adjuvant, utilize modern general Chinese medicine preparation technology effective ingredient fine powder to be made the finished dosage forms of modern clinic needs, the dosage forms such as such as tablet, capsule, granule, powder, tincture, syrup, pill.
The character Characteristic of the Chinese crude drug in Chinese prescription of the present invention:
Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae.Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.
Fructus Corni: this product is the drying and ripening sarcocarp of Cornaceae plant Fructus Corni.Sour in the mouth, puckery, slightly warm in nature; Return liver, kidney channel; Liver and kidney tonifying, essence astringing and desertion stemming.
Rhizoma Dioscoreae: this product is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae.Sweet in the mouth, property is put down; Return spleen, lung, kidney channel; Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.
The Cortex Eucommiae: this product is the dry bark of the Eucommiaceae plant Cortex Eucommiae.Sweet in the mouth, warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, antiabortive.
Radix Achyranthis Bidentatae: this product is the dry root of amaranthaceous plant Radix Achyranthis Bidentatae.Bitter in the mouth, acid, property is put down; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, eliminating blood stasis and inducing menstruation, conducting blood to flow downwards.
Poria: this product is the dry sclerotia of On Polyporaceae Poria.Sweet in the mouth, light, property is put down; GUIXIN, spleen, kidney channel; Eliminating dampness and diuresis, invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming.
Semen Persicae: this product is the dry mature seed of rosaceous plant Fructus Persicae or Prunus davidiana.Bitter in the mouth, sweet, property is put down; GUIXIN, liver, large intestine channel; Blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation.
Fructus Aurantii Immaturus: this product is the dry young fruit of rutaceae Citrus aurantium Linn. and variety or Fructus Citri sinensis.Bitter in the mouth, pungent, sour, warm in nature; Return spleen, stomach warp; Dispelling the stagnated QI removing food stagnancy, loose painful abdominal mass of reducing phlegm.
Fructus Chebulae: this product is the dry mature fruit of Combretum Racemosum plant Fructus Chebulae or Terminalia chebula Retz. var. tomentella Kurt..Bitter in the mouth, acid, puckery, property is put down; Return lung, large intestine channel; Astringing intestine to stop diarrhea is astringed the lung, pathogenic fire reducing sore-throat relieving.
Cornu Cervi Pantotrichum: this product is the young horn of the unossified close raw fine hair of the stag of animal in deer family Cervus nippon Temminck or Cervus elaphus linnaeus.Sweet in the mouth, salty, warm in nature; Return kidney, Liver Channel; Invigorating kidney-YANG, benefiting essence-blood, bone and muscle strengthening, adjusts punching to appoint, holder sore.
Rhizoma Corydalis: this product is the dry tuber of papaveraceae plant corydalis.Acrid in the mouth, hardship, warm in nature; Return liver, spleen channel; Invigorate blood circulation, promoting the circulation of QI, pain relieving.
Radix Paeoniae Rubra: this product is the dry root of ranunculaceae plant Radix Paeoniae or river Radix Paeoniae Rubra.Bitter in the mouth, cold nature; Return Liver Channel; Clearing away heat and cooling blood, eliminating stasis to stop pain.
Pericarpium Citri Reticulatae: be the mature peel of rutaceae orange and variety thereof.Bitter in the mouth, pungent, warm in nature; Return lung, spleen channel; Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.
Sargassum: this product is the dry frond of Sargassaceae plant Sargassum or Sargassum fusiforme (Harv.) Setch.Bitter in the mouth, salty, cold in nature; Return liver, stomach, kidney channel; Hard masses softening and resolving, expectorant, diuretic.
Rhizoma Alismatis: this product is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis.Sweet in the mouth, cold in nature; Return kidney, urinary bladder channel; Diuresis, clearing away damp-heat.
Ootheca Mantidis: this product is the dry ootheca of Mantidae insecticide Chinese mantid, maculated mantis or hierodula patellifera.Sweet in the mouth, salty, property is put down; Return liver, kidney channel; Supplementing the kidney to control the nocturnal, reducing urination is only turbid.
Semen Cuscutae: this product is the dry mature seed of convolvulus cuscuta plant.Sweet in the mouth, warm in nature; Return liver,kidney,spleen warp; Nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.
The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.
Lignum Aquilariae Resinatum: this product is the timber that Isolated From Thymelaeaceae Species Lignum Aquilariae Resinatum contains resin.Acrid in the mouth, hardship, slightly warm in nature; Return spleen, stomach, kidney channel; Promoting the circulation of QI to relieve pain, warming middle-JIAO to arrest vomiting, helping inspiration to relieve asthma.
The side of Chinese prescription of the present invention separates:
This Chinese prescription is with Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Corydalis, Semen Cuscutae, Rhizoma Dioscoreae, Radix Achyranthis Bidentatae for monarch drug, nourishing YIN and supplementing blood, liver and kidney tonifying, promoting the circulation of QI of invigorating blood circulation, the kidney invigorating arresting seminal emission; With Cornu Cervi Pantotrichum, the Cortex Eucommiae, Ootheca Mantidis, Poria, Rhizoma Alismatis, Fructus Chebulae for ministerial drug, Yang strengthening and life essence tonifying, reducing urination only turbid, eliminating dampness and diuresis, astringing intestine to stop diarrhea are astringed the lung; With Semen Persicae, Fructus Aurantii Immaturus, Radix Paeoniae Rubra, Lignum Aquilariae Resinatum for adjuvant drug, blood circulation promoting and blood stasis dispelling, dispelling the stagnated QI removing food stagnancy, clearing away heat and cooling blood, promoting the circulation of QI to relieve pain; With Pericarpium Citri Reticulatae, the Radix Astragali, Sargassum for making medicine, regulating qi-flowing for strengthening spleen, expelling pus and promoting granulation, hard masses softening and resolving; The all medicine collocation of monarch, synergism, complement each other jointly reach nourishing YIN and supplementing blood, Yang strengthening and life essence tonifying, the effect such as promoting the circulation of QI of invigorating blood circulation, the kidney invigorating arresting seminal emission, eliminating dampness and diuresis, clearing away heat and cooling blood, all have very significant therapeutic effect to suffering from a deficiency of the kidney of symptom such as deficiency of the kidney yin, insufficiency of kidney-YANG, kidney-jing deficiency, deficiency of kidney-QI, failure of the kidney in receiving QI.
Compared with prior art, Chinese medicine preparation of the present invention has instant effect, treating both the principal and secondary aspects of a disease, medical treatment combination, simple process, preparation efficacy stability, is convenient to the technical advantages such as batch production.
Detailed description of the invention
Embodiment 1
By any proportioning (C), optimal proportion (D, E, F) in the edge proportioning (A, B) of Chinese prescription scope of the present invention, scope, and optimum production process parameter produces capsule, and the proportioning of raw material is as shown in table 1:
Table 1 proportioning raw materials table
(1) accurately ingredients is taken respectively by proportioning shown in table 1;
(2) get Ootheca Mantidis, Radix Achyranthis Bidentatae with alcohol-pickled 20 hours of 55%, drain, pulverize, parch, grinding, cross 100 mesh sieves and obtain fine powder a, for subsequent use;
(3) get Fructus Corni, Cornu Cervi Pantotrichum, the Cortex Eucommiae, Rhizoma Corydalis, Fructus Chebulae, Radix Astragali pulverizing, parch, grinding, crosses 100 mesh sieves, obtains fine powder b, for subsequent use;
(4) get Fructus Aurantii Immaturus, Semen Persicae parched with bran system, pulverize grinding, cross 100 mesh sieves, obtain fine powder c, for subsequent use;
(5) get Radix Rehmanniae Preparata, Lignum Aquilariae Resinatum pulverizes grinding, cross 80-120 mesh sieve, obtain fine powder d, for subsequent use;
(6) get Rhizoma Dioscoreae, Poria, Radix Paeoniae Rubra, Pericarpium Citri Reticulatae, Sargassum, Rhizoma Alismatis, Semen Cuscutae add the distilled water of 10 times, soak 18 hours, backflow decoction 3 times, each 2 hours, filter, mix 3 filtrates, when being evaporated to 60 DEG C, relative density of surveying is 1.25-1.30, then vacuum drying obtains dry extract, dry extract is pulverized, grinding, cross 100 mesh sieves, obtain fine powder e, for subsequent use;
(7) by fine powder a, b, c, d, e mix homogeneously, effective ingredient fine powder is;
(8) add suitable adjuvant, utilize modern general Chinese medicine preparation technology that effective ingredient fine powder is made capsule, specification is: amount to 0.96g crude drug/capsules.
Embodiment 2
The toxicity test of Chinese medicine preparation of the present invention
(1) acute toxicity test
1, tested medicine: the capsule of numbering A-F in the embodiment of the present invention 1, abolish capsule shells, adding distil water is modulated into magma, for subsequent use.
2, experimental animal: regular grade NIH mice, body weight 19g ± 4g, male and female half and half, female mice is all without pregnant.
3, to mouse stomach Chinese medicine capsules of the present invention, when given low reaches 548.6g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
4, result of the test shows: the maximum dosage-feeding of mouse stomach capsule of the present invention is 548.6g crude drug/kg/d(LD
50> 548.6g crude drug/kg).Chinese medicine clinical application every day total amount of the present invention is 0.16g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach capsule of the present invention is 3428.8 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
(2) long term toxicity test
1, test objective: the toxic reaction of viewing test animal after long-term edible Chinese medicine preparation of the present invention, assesses the basic security of Chinese medicine preparation of the present invention.
2, test material:
(1) animal: select adult healthy SD rat 210, original body mass 212 ± 13g, male and female half and half, female rats is all without pregnant.
(2) medicine: the capsule of numbering A-F in the embodiment of the present invention 1, abolish capsule shells, adding distil water is modulated into magma, for subsequent use.Per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount, and dosage is 3.2g crude drug/kg/d.
3, test method
(1) 210 SD rats are divided into 7 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1200-1400g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (22 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.
(2) medication
With the magma of the made capsule modulation of embodiment 1, respectively to wherein 6 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by same method gavage normal saline.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.
(3) test item and the time
General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.
Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).
Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na
+), blood potassium (K
+), blood calcium (Ca
+) and β
2-microglobulin.
Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β
2-MG(renal tubular function obstacle sensitive indicator).
System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.
4, result of the test
The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine capsules of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this capsule for patient.
Embodiment 3
The kidney invigorating experiment of Chinese medicine preparation of the present invention
1, experiment material
(1) Experimental agents
The capsule of D is numbered in the embodiment of the present invention 1; Testosterone Propionate injection, the accurate word H41023555 of traditional Chinese medicines, Cologne, Henan pharmaceutcal corporation, Ltd; Spring medicine, Xuzhou Huai-Hai pharmaceutical factory of En Hua Pharmaceutical group; Estradiol benzoate, the accurate word H20053392 of traditional Chinese medicines, Zhejiang Province XianJu Pharmacy stock Co., Ltd.
(2) laboratory animal
SPF level rat, is provided by Shanghai Laboratory Animal Research Institute, and animal sub-cage rearing, freely drinks water, ambient temperature (22 ± 2) DEG C.
2, experimental technique and result
(1) modeling is tested: body weight was at the male rat of 110 ± 9g, and getting concentration is 12.5% urethane, every rat skin lower injection 0.6ml, light anaesthesia from newborn 1 month to get 40, and back of the body position is fixed, and uses iodine disinfection skin of scrotum, plucks bilateral testes.Postoperative intramuscular injection penicillin sodium 20,000 U/kg is in case infect, and modeling obtains suffering from a deficiency of the kidney the male rat of model for 3 days.
(2) experiment grouping: 40 rats, after 3 days, are divided into 4 groups by modeling at random, often organizes 10.Be respectively:
Castration model group: every day gives isometric normal saline gavage;
Testosterone Propionate group: 2mg/kg subcutaneous injection every day (5 times of clinical application amount);
Capsule small dose group: 0.8g/kg gavage every day (5 times of clinical application amount);
The heavy dose of group of capsule: 2.4g/kg gavage every day (15 times of clinical application amount).
Separately get with batch non-castrated rats 10 only as Normal group.Each experimental group successive administration is after 4 weeks, take off cervical vertebra respectively with 24h after last administration put to death and dissect each group of rat, get the internal organs such as preputial glands, seminal vesicle, prostate and levator ani, and take the quality of preputial glands, seminal vesicle and prostate, levator ani immediately, calculate organ coefficient.
(3) experimental result: the specific experiment result that the large and small dosage group of normal group, model group, androlin group and capsule affects genitals's internal organs of rat model of suffering from a deficiency of the kidney, as shown in table 2.
Table 2 capsule of the present invention on the impact of rat reproductive organs internal organs of suffering from a deficiency of the kidney (
, n=10)
Note: compared with normal group, * * P < 0.01; With model group ratio,
△p < 0.05,
△ △p < 0.01.
3, experiment conclusion
The experimental result of table 2 shows, the capsule that the embodiment of the present invention 1 is produced has the preputial glands, seminal vesicle and the genitals such as prostate and the levator ani organ coefficient that significantly improve rat of suffering from a deficiency of the kidney, and shows good dose-effect relationship; In addition heavy dose of group of the embodiment of the present invention 1 capsule demonstrates effect more better than androlin, shows that Chinese medicine preparation of the present invention has significant substantial effect for suffering from a deficiency of the kidney.
Embodiment 4
The clinical trial of Chinese medicine preparation of the present invention
1, clinical physical data
The experimenter of this clinical trial provides by certain institute of traditional Chinese medicine of province Urology Department, amount to 212 people, age 26-61 year, wherein female 92 people, man 120 people, are made a definite diagnosis one or more in symptoms such as suffering from deficiency of the kidney yin, insufficiency of kidney-YANG, kidney-jing deficiency, deficiency of kidney-QI, failure of the kidney in receiving QI by hospital all.Patient is divided into 4 groups, is respectively matched group, test 1, test 2, tests 3 groups, make these 4 groups in age, sex, the course of disease, coincident with severity degree of condition, have comparability on statistical significance.
2, medication is tested
Contrast medicine: JINGUI SHENQI WAN, the accurate word Z11020054 of traditional Chinese medicines, Beijing Tongrentang Technology Development Co.ltd. Pharmaceutical Factory;
By the capsule being numbered D, E, F that optimal proportion is produced in the embodiment of the present invention 1, specification is: amount to 0.96g crude drug/capsules.
3, Therapeutic Method
The oral JINGUI SHENQI WAN of matched group, every day 2 times, each 20; Test 1, test 2, test 3 groups of oral capsules being numbered D, E, F respectively, every day 2 times, each 5; Within 4 weeks, be a course for the treatment of, treat 3 courses for the treatment of continuously.
4, therapeutic evaluation
Cure: all symptoms of suffering from a deficiency of the kidney disappear completely, and make a definite diagnosis through doctor and fully recover;
Effective: most of transference cure of suffering from a deficiency of the kidney or be clearly better;
Effective: the partial symptoms of suffering from a deficiency of the kidney makes moderate progress;
Invalid: the symptom of suffering from a deficiency of the kidney is without any improvement, even more serious.
5, result of the test statistics and analysis
Test data statistical analysis is as shown in table 3:
Table 3 test data statistical analysis table
6, conclusion (of pressure testing)
As can be seen from table 3 test data statistical analysis table, the average cure rate of invention formulation reaches 59.1%, and higher than matched group 2.8 times, average total effective rate reaches 95.6%, higher than matched group 22 percentage points.Therefore, compared with prior art, Chinese medicine preparation of the present invention has very significant technical advantage, in treatment is suffered from a deficiency of the kidney, obtain breakthrough progress.
Claims (7)
1. a treatment Chinese medicine preparation of suffering from a deficiency of the kidney, is characterized in that being made up of the raw material of following weight portion: Radix Rehmanniae Preparata 12-28 part, Fructus Corni 16-28 part, Rhizoma Dioscoreae 11-25 part, Cortex Eucommiae 9-21 part, Radix Achyranthis Bidentatae 10-22 part, Poria 8-20 part, Semen Persicae 7-17 part, Fructus Aurantii Immaturus 7-15 part, Fructus Chebulae 9-21 part, Cornu Cervi Pantotrichum 10-22 part, Rhizoma Corydalis 13-27 part, Radix Paeoniae Rubra 7-15 part, Pericarpium Citri Reticulatae 8-18 part, Sargassum 7-17 part, Rhizoma Alismatis 9-21 part, Ootheca Mantidis 8-20 part, Semen Cuscutae 20-36 part, Radix Astragali 8-18 part, Lignum Aquilariae Resinatum 5-9 part.
2. treat the Chinese medicine preparation of suffering from a deficiency of the kidney as claimed in claim 1, it is characterized in that being made up of the raw material of following weight portion: Radix Rehmanniae Preparata 20 parts, Fructus Corni 22 parts, Rhizoma Dioscoreae 18 parts, the Cortex Eucommiae 15 parts, Radix Achyranthis Bidentatae 16 parts, 14 parts, Poria, 12 parts, Semen Persicae, Fructus Aurantii Immaturus 11 parts, Fructus Chebulae 15 parts, 16 parts, Cornu Cervi Pantotrichum, Rhizoma Corydalis 20 parts, Radix Paeoniae Rubra 11 parts, Pericarpium Citri Reticulatae 13 parts, Sargassum 12 parts, Rhizoma Alismatis 15 parts, Ootheca Mantidis 14 parts, Semen Cuscutae 28 parts, the Radix Astragali 13 parts, Lignum Aquilariae Resinatum 7 parts.
3. treat the Chinese medicine preparation of suffering from a deficiency of the kidney as claimed in claim 1, it is characterized in that being made up of the raw material of following weight portion: Radix Rehmanniae Preparata 22 parts, Fructus Corni 23 parts, Rhizoma Dioscoreae 19 parts, the Cortex Eucommiae 14 parts, Radix Achyranthis Bidentatae 15 parts, 13 parts, Poria, 13 parts, Semen Persicae, Fructus Aurantii Immaturus 12 parts, Fructus Chebulae 16 parts, 18 parts, Cornu Cervi Pantotrichum, Rhizoma Corydalis 21 parts, Radix Paeoniae Rubra 13 parts, Pericarpium Citri Reticulatae 11 parts, Sargassum 14 parts, Rhizoma Alismatis 13 parts, Ootheca Mantidis 16 parts, Semen Cuscutae 26 parts, the Radix Astragali 14 parts, Lignum Aquilariae Resinatum 6 parts.
4. treat the Chinese medicine preparation of suffering from a deficiency of the kidney as claimed in claim 1, it is characterized in that being made up of the raw material of following weight portion: Radix Rehmanniae Preparata 21 parts, Fructus Corni 24 parts, Rhizoma Dioscoreae 17 parts, the Cortex Eucommiae 16 parts, Radix Achyranthis Bidentatae 14 parts, 16 parts, Poria, 14 parts, Semen Persicae, Fructus Aurantii Immaturus 10 parts, Fructus Chebulae 14 parts, 17 parts, Cornu Cervi Pantotrichum, Rhizoma Corydalis 22 parts, Radix Paeoniae Rubra 13 parts, Pericarpium Citri Reticulatae 14 parts, Sargassum 14 parts, Rhizoma Alismatis 13 parts, Ootheca Mantidis 13 parts, Semen Cuscutae 30 parts, the Radix Astragali 15 parts, Lignum Aquilariae Resinatum 8 parts.
5. prepare as arbitrary in claim 1-4 as described in treat the method for Chinese medicine preparation of suffering from a deficiency of the kidney, it is characterized in that comprising following processing step:
(1) accurately ingredients is taken by Chinese prescription of the present invention;
(2) get the alcohol-pickled 12-24 hour of Ootheca Mantidis, Radix Achyranthis Bidentatae 45-65%, drain, pulverize, parch, grinding, cross 80-120 mesh sieve and obtain fine powder a, for subsequent use;
(3) get Fructus Corni, Cornu Cervi Pantotrichum, the Cortex Eucommiae, Rhizoma Corydalis, Fructus Chebulae, Radix Astragali pulverizing, parch, grinding, crosses 80-120 mesh sieve, obtains fine powder b, for subsequent use;
(4) get Fructus Aurantii Immaturus, Semen Persicae parched with bran system, pulverize grinding, cross 80-120 mesh sieve, obtain fine powder c, for subsequent use;
(5) get Radix Rehmanniae Preparata, Lignum Aquilariae Resinatum pulverizes grinding, cross 80-120 mesh sieve, obtain fine powder d, for subsequent use;
(6) get Rhizoma Dioscoreae, Poria, Radix Paeoniae Rubra, Pericarpium Citri Reticulatae, Sargassum, Rhizoma Alismatis, Semen Cuscutae add 7-12 distilled water doubly, soak 12-24 hour, backflow decoction 3 times, each 1-4 hour, filter, mix 3 filtrates, when being evaporated to 60 DEG C, relative density of surveying is 1.25-1.30, then vacuum drying obtains dry extract, dry extract is pulverized, grinding, cross 80-120 mesh sieve, obtain fine powder e, for subsequent use;
(7) by fine powder a, b, c, d, e mix homogeneously, effective ingredient fine powder is;
(8) add suitable adjuvant, utilize modern general Chinese medicine preparation technology effective ingredient fine powder to be made the finished dosage forms of modern clinic needs.
6. treat the Chinese medicine preparation of suffering from a deficiency of the kidney as described in as arbitrary in claim 1-4, it is characterized in that: the dosage form of described Chinese medicine preparation is tablet, capsule, granule, powder, tincture, syrup and pill.
7. treat the Chinese medicine preparation of suffering from a deficiency of the kidney as described in as arbitrary in claim 1-4, it is characterized in that: described Chinese medicine preparation is used for the treatment of deficiency of the kidney yin, insufficiency of kidney-YANG, kidney-jing deficiency, deficiency of kidney-QI, failure of the kidney in receiving QI are suffering from a deficiency of the kidney of reveal any symptoms.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105169316A (en) * | 2015-09-11 | 2015-12-23 | 付彩虹 | Regimen for treating kidney deficiency |
| CN109157620A (en) * | 2018-11-08 | 2019-01-08 | 扬州市中医院 | A kind of kidney-nourishing mixture sharp clearly and preparation method thereof |
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| CN101129705A (en) * | 2007-08-24 | 2008-02-27 | 夏玉玲 | Medicine for treating deficiency of the kidney |
| CN103656195A (en) * | 2013-12-06 | 2014-03-26 | 山东中大药业有限公司 | Traditional Chinese medicine composition for treatment of kidney deficiency and preparation method thereof |
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2015
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|---|---|---|---|---|
| CN101129705A (en) * | 2007-08-24 | 2008-02-27 | 夏玉玲 | Medicine for treating deficiency of the kidney |
| CN103656195A (en) * | 2013-12-06 | 2014-03-26 | 山东中大药业有限公司 | Traditional Chinese medicine composition for treatment of kidney deficiency and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105169316A (en) * | 2015-09-11 | 2015-12-23 | 付彩虹 | Regimen for treating kidney deficiency |
| CN109157620A (en) * | 2018-11-08 | 2019-01-08 | 扬州市中医院 | A kind of kidney-nourishing mixture sharp clearly and preparation method thereof |
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