CN101045110A - Medicine composition for treating deficiency of the kidney and its preparing method - Google Patents

Medicine composition for treating deficiency of the kidney and its preparing method Download PDF

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Publication number
CN101045110A
CN101045110A CN 200610067493 CN200610067493A CN101045110A CN 101045110 A CN101045110 A CN 101045110A CN 200610067493 CN200610067493 CN 200610067493 CN 200610067493 A CN200610067493 A CN 200610067493A CN 101045110 A CN101045110 A CN 101045110A
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herba
fructus
kidney
pharmaceutical composition
parts
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邱成飞
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RENHETANG PHARMACEUTICAL CO Ltd HEILONGJIANG
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RENHETANG PHARMACEUTICAL CO Ltd HEILONGJIANG
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Abstract

A Chinese medicine in the form of capsule for treating kidney deficiency and the diseases caused by kidney deficiency is proportionally prepared from 9 Chinese-medicinal materials including ginseng, epimedium, wolfberry fruit, pilose antler, etc. Its preparing process is also disclosed.

Description

Pharmaceutical composition that a kind of treatment is suffered from a deficiency of the kidney and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition, relate in particular to Chinese medicine composition that a kind of treatment that with the Chinese herbal medicine is feedstock production becomes suffers from a deficiency of the kidney and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Chinese medicine thinks that kidney storing essence is a congenital foundation.Kidney master growth, growth and reproduction, main bone are given birth to marrow and are led in brain, brain is the place of marrow and gods high concentration, all thinking activitiess of people are all arranged by brain, the essence that " interior warp " says " the living then marrow of kidney is discontented " kidney is the source of people's life activity, it is the base substance that constitutes human body, smart energy activating QI, gas can spermatogenesis, kidney spermatogenesis, smart hemopoietic, oligospermia are then sick, smartly then dies to the greatest extent, and the essence gas that declines is then weak, smart sufficient gas is then strong, weakness of QI also then a little less than, arrogant blood is then prosperous, qi being the governor of blood, blood being the material foundation of QI, visible essence, gas, blood are mutual dependence for existencies.Cloudy essence is that yang-energy is basic.Yang transforming qi, yin shaping up body, cloudy smart and blood homology, as the shape of depletion of YIN essence, just be not enough to carry a yang-energy, so sun is born in the life of thing; The one-tenth of thing is formed in the moon, has only cloudy smart abundance, and yang-energy is vigorous, and the two coordinated balance, and human body could be healthy.If congenital defect will lose and support the day after tomorrow, or prolonged illness consumption wound, kidney store essential substances deficiency, " water loses its source, and then the disease of the deficiency of YIN is folded out on the one hand; Fire declines it, then yang deficiency levy storied." can not go up as suffering from a deficiency of the kidney warm in the heart, fill in brain will occur cardiopalmus, uncomfortable in chest, breathe hard, insomnia and dreamful sleep, dizziness headache, forgetful.QI and bloodization is given birth to obstacle menoxenia, pachylosis will occur.Hectic fever, flushed face in the afternoon will appear in the imbalance of YIN and YANG of kidney, sore waist and aching in the waist and the back, sexual hypofunction and climacteric syndrome etc.
At present, being used for the treatment of the Chinese patent medicine of suffering from a deficiency of the kidney has a variety ofly, and being used for the treatment of suffers from a deficiency of the kidney all certain curative effect, but all in various degree exist curative effect definite inadequately, can not treating both the principal and secondary aspects of a disease etc. defective.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, the pharmaceutical composition that the treatment that provide a kind of evident in efficacy, treating both the principal and secondary aspects of a disease, has no side effect is suffered from a deficiency of the kidney.
Technical problem to be solved by this invention realizes by following technological approaches:
The pharmaceutical composition that a kind of treatment is suffered from a deficiency of the kidney, make by following bulk drugs:
Radix Ginseng 70-90 part, Herba Epimedii 85-105 part, Herba Cistanches 40-60 part, Fructus Ligustri Lucidi 145-165 part, Herba Ecliptae 240-260 part, Fructus Lycii 75-95 part, Fructus Mori 125-145 part, Cornu Cervi Pantotrichum 2-8 part, Moschus 0.2-0.8 part.
Preferably, the weight portion of each crude drug is:
80 parts of Radix Ginsengs, 95 parts of Herba Epimedii, 50 parts of Herba Cistanches, 155 parts of Fructus Ligustri Lucidi, 250 parts of Herba Ecliptaes, 85 parts of Fructus Lycii, 135 parts in Fructus Mori, 5 parts in Cornu Cervi Pantotrichum, 0.5 part in Moschus.
The compatibility foundation of pharmaceutical composition of the present invention:
Radix Ginseng sweet in the mouth, little hardship, tepor is returned spleen, kidney channel, kind strongly invigorating primordial QI, invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst, the Fructus Alpiniae Oxyphyllae of calming the nerves.Kind all diseases of the deficiency of vital energy and insomnia forgetfulness, severe palpitation, blood deficiency and yellow complexion, the sexual impotence cold womb controlled." book on Chinese herbal medicine is just " cloud: " Radix Ginseng deficiency of vital energy blood deficiency all can be mended, the deficiency of YANG QI person of exhausting, this can return in the township that has of nothing else; The cloudy blood person of collapsing that bursts, this energy barrier after breaking with.Not hot precisely because gas is strong, so the energy solid and gas; Precisely because sweet in the mouth and pure is so can enrich blood.So all void and generating heat, void and spontaneous perspiration is empty and dizzy, empty and sleepy, empty and be scared, empty and lose heart, void and spermatorrhea, empty and let out profit, void and headache, empty and suffer from abdominal pain, void and desire food is not transported, and void and sputum are stopped up and stagnated, and void and hemoptysis is spitted blood is empty and drench drop and just close, and is all must indispensable person.The desires to compare with QI and blood, and then the Radix Ginseng abnormal smells from the patient is quite light and to belong to positive person many, is the medicine of edema caused by disorder of QI." " book on Chinese herbal medicine converge with speech " " the ginseng qi-tonifying hemopoietic, the medicine that helps intensive culture god also.So vital qi is weak, the very brief deficiency of vital energy is mended it with this, and as the Rong Wei inanition, that uses can control also; The palpitation with fear palpitation with a distress feeling, forgetful in a trance, with this peaceful it; Unit is refreshing not enough, and empty win is unable, trains it with this, falls into as middle weakness of QI, and that uses can rise also.”
Cornu Cervi Pantotrichum is sweet, salty, warm in the side, goes into liver, kidney channel, the energy reinforcing the kidney and supporting YANG, and spermatogenesis benefit blood, strengthening the tendons and bones is transferred regulating the function of middle-JIAO, is apt to control insufficiency of kidney-YANG, impotence and premature ejaculation, cold womb is infertile, the soft walking retardation in children of bone, asthenia of essence and blood, Mental fatigue is become thin." Cornu Cervi Pantotrichum is reported the matter of pure sun to " Bencao Jingshu " cloud, contains the gas of hair growth promoting.The married woman then be the stagnant blood that leaks down, or blood stasis is at abdomen towards conception vessel void.Man's deficiency of the liver and kindey is then thin for winning, painful limbs, and pain along the spinal column, or frequent micturition profit are let out essence.This medicine is walked the gate of vitality, and the moon of percardium and Liver and kidney divides, and mends first kidney-Yang down, thus can lead as above all cards, and the strong will of QI invigorating is also." " herbal classic is met the source " cloud: " and the special main damaging the spleen and stomach labor of Cornu Cervi Pantotrichum is exhausted, and lumbago is won thin, and getting it, to mend fire supporing yang, spermatogenesis benefit marrow, strengthening the tendons and bones, controlling nocturnal emission with astringent drugs are taken the photograph just, following first empty people, head revolves pupil, all available it.”
Herba Cistanches is sweet, salty, warm, goes into kidney, large intestine channel, the kidney invigorating and essence nourishing, and it is infertile to be apt to control sexual impotence, chills and pain of the waist and kness, muscles and bones is unable, the dryness of the intestine constipation." book on Chinese herbal medicine converges and says " " Herba Cistanches is supported the gate of vitality, nourishing kidney gas, the medicine of replenishing vital essence and blood is also.The red first cold caused by deficiency of man and Yang Dao is heavy for a long time, women's Chong and Ren channel disorder and cloudy gas is not controlled, this is the agent of flat benefits, temperature and not hot is mended and not high, warm and not dry, slides and does not let out." " book on Chinese herbal medicine justice " cloud " kidney man is directly gone in the thick and heavy decline of Herba Cistanches, and the Wen Erneng profit does not have dry strong anxiety, can the replenishing vital QI with drugs of warm nature essence and blood and the gas that activates yang, so say beneficial vital essence.”
Herba Epimedii suffering, sweet, warm is returned liver, kidney channel.The energy reinforcing the kidney and supporting YANG, strengthening the tendons and bones, expelling wind and removing dampness is apt to control insufficiency of kidney-YANG, impotence and seminal emission, enuresis frequent micturition; Rheumatic arthralgia, atrophic debility of bones paralysis disease." book on Chinese herbal medicine is stated " cloud " excessive sheep fire, " herbal classic " medicine master impotence is hindered extremely, the exhausted sun of " solar corona " also first its treatment of speech man, the woman is exhausted cloudy, and then calling the gate of vitality, mending the kidney-Yang person is also.The lid gate of vitality be a kidney-Yang in the kidney, promptly the vigour of the person also, its what is called is YANG exhaustion the moon extremely, the vigour of basis not, how hiss in both withered.So-called physical strength profiting, strong will, and control the cold air consumptive disease, and the anxious card that waits of muscles and bones contraction, all it helps the event of vigour.Old man's dusk octogenarian, the middle age is forgetful, all Yuanyang decay and can not ascensionist also.Must know this flavor to reduce to liter, it rises owing to can fall also.”
The hot temperature of Moschus, GUIXIN, spleen channel, the kind refreshment of having one's ideas straightened out, promoting blood circulation to restore menstrual flow, energy training the mind dusk, amenorrhea." Elementary Medicine " cloud its " key of being open to the custom, on reach skin, in go into bone marrow.”
The cold of Fructus Ligustri Lucidi sweetness and bitterness, GUIXIN, kidney channel.It is dizzy to be apt to control dizziness, and early whitening of beard and hair is told the nosebleed hemoptysis, the hematuria metrorrhagia." herbal classic " speech: obey hard muscles and bones for a long time and make light of one's life by commiting suicide not old." herbal steel order "; " nourishing kidney, lung moistening, make eye bright "." Bencao Jingshu " say that its " profit and nourish " held concurrently and can bring down a fever, and specially in the kidney invigorating the lung moistening and production of body fluid promoting QI invigorating, be the key medicine of Liver and kidney kidney-YIN being deficient.
The sweet acid of Fructus Mori is cold, GUIXIN Liver and kidney warp.Energy nourishing YIN and supplementing blood, the intestine moistening of promoting the production of body fluid.Be apt to control vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, interior-heat is quenched one's thirst." the southern regions of the Yunnan Province book on Chinese herbal medicine " says it: " kidney tonifying is dirty and controlling nocturnal emission with astringent drugs is obeyed hair color for a long time and made eye bright." " Bencao Jingshu " say it: " and the elite of Mulberry is tied also, sweet cold beneficial blood and heat extraction, its for removing heat from blood enrich blood tonifying YIN medicine undoubtedly." above-mentioned all medicines are harmonious, play altogether and tonify Qi of the kidney, vigorate qi and replenish the blood, giving young employees remedial-courses in general knowledge and vocational skills negative and positive, tranquilizing by nourishing the heart, the merit of defying age.
Pharmaceutical composition of the present invention adds various conventional adjuvant required when preparing different dosage form, for example disintegrating agent, lubricant, adhesive etc. are prepared into any oral formulations commonly used with the method for Chinese medicinal of routine, can be pill, capsule, tablet, powder, granule or oral liquid etc. for example, be preferably capsule.
Preferably, a kind of method for preparing pharmaceutical composition of the present invention may further comprise the steps:
1) take by weighing each raw material by following weight portion:
Radix Ginseng 70-90 part, Herba Epimedii 85-105 part, Herba Cistanches 40-60 part, Fructus Ligustri Lucidi 145-165 part, Herba Ecliptae 240-260 part, Fructus Lycii 75-95 part, Fructus Mori 125-145 part, Cornu Cervi Pantotrichum 2-8 part, Moschus 0.2-0.8 part
2) Radix Ginseng alcohol reflux filters, and reclaims ethanol, concentrates standby;
3) decoct with water after Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae 6 flavor medicines are mixed, decoction liquor filters, merging filtrate, join step 2) in the prepared concentrated solution, continue to be condensed into extractum, drying is dusted, and is standby;
4) Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and Moschus facing-up, sieves,, add adjuvant, make finished product through preparations shaping technology with the prepared dry powder blend of step 3).
In the above-mentioned preparation method, step 2) preferably the people is participated in 70% ethanol of 5 times of weight, reflux, extract, 4 hours in; Add 6-8 times of weight decocting after preferably Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae being mixed in the step 3) and boil secondary, decocted 3-6 hour for the first time, decocted 2-4 hour for the second time;
Used all raw materials of the present invention all can be bought from market and obtain, and its specification meets medical standard.
The dizziness and tinnitus that medicine of the present invention causes for deficiency of both YIN and YANG, insomnia and dreamful sleep, shortness of breath and palpitation, aversion to cold and cold limbs, the hectic fever sweating, diseases such as soreness of the waist and knees all have significant therapeutic effect.
Usage and consumption: dosage of the present invention depends on concrete dosage form, factors such as patient's age, body weight, health status.As guidance: capsule, oral, a 1-2 grain, every content of dispersion 0.25g, one day twice, warm water delivery service.
The specific embodiment
Further describe the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit the scope of the invention.
The preparation of [embodiment 1] capsule
Take by weighing each raw material by following weight: Radix Ginseng 80g, Herba Cistanches 50g, Herba Epimedii 95g, Fructus Ligustri Lucidi 155g, Cornu Cervi Pantotrichum 5g, Herba Ecliptae 250g, Fructus Mori 135g, Moschus 0.5g, Fructus Lycii 85g;
Radix Ginseng with 70% alcohol reflux of 5 times of weight 4 hours, is filtered, reclaim ethanol, concentrated solution is standby; Add 4 times of weight decoctings after Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae 6 flavor medicines are mixed and boiled 6 hours, decoction liquor filters, merging filtrate, add in the prepared concentrated solution of above-mentioned steps, continue to be condensed into extractum, drying is dusted, and is standby; Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and Moschus facing-up, crosses 100 mesh sieves,, add starch 110g, granulate with the prepared dry powder blend of above-mentioned steps, 60 ℃ of aeration-dryings, encapsulated (every contains crude drug 0.25g), promptly.
The preparation of [embodiment 2] granule
Take by weighing each raw material by following weight: Radix Ginseng 70g, Herba Epimedii 85g, Herba Cistanches 40g, Fructus Ligustri Lucidi 145g, Herba Ecliptae 240g, Fructus Lycii 75g, Fructus Mori 125g, Cornu Cervi Pantotrichum 2g, Moschus 0.2g;
The people is participated in 70% ethanol of 5 times of weight, and reflux, extract, 4 hours filters, and reclaims ethanol, and concentrated solution is standby; Add 6 times of weight decoctings after Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae 6 flavor medicines are mixed and boil secondary, decocted 3 hours for the first time, decocted 2 hours for the second time; Decoction liquor filters, and merging filtrate adds in the prepared concentrated solution of above-mentioned steps, continues to be condensed into extractum, and drying is dusted, and is standby; Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and Moschus facing-up, crosses 100 mesh sieves,, add starch 100g, granulate with the prepared dry powder blend of above-mentioned steps, 60 ℃ of aeration-dryings, granulate, promptly.
The preparation of [embodiment 3] tablet
Take by weighing each raw material by following weight: Radix Ginseng 90, Herba Epimedii 105, Herba Cistanches 60, Fructus Ligustri Lucidi 165, Herba Ecliptae 260, Fructus Lycii 95, Fructus Mori 145, Cornu Cervi Pantotrichum 8, Moschus 0.8;
The people is participated in 70% ethanol of 5 times of weight, and reflux, extract, 4 hours filters, and reclaims ethanol, and concentrated solution is standby; Add 8 times of weight decoctings after Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae 6 flavor medicines are mixed and boil secondary, decocted 6 hours for the first time, decocted 4 hours for the second time; Decoction liquor filters, and merging filtrate adds in the prepared concentrated solution of above-mentioned steps, continues to be condensed into extractum, and drying is dusted, and is standby; Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and Moschus facing-up, crosses 100 mesh sieves,, add starch 120g, granulate, add carboxymethyl starch sodium 4 grams with the prepared dry powder blend of above-mentioned steps, tabletting behind the mixing, coating, packing gets product.
The preparation of [embodiment 4] pill
Take by weighing each raw material by following weight: Radix Ginseng 80g, Herba Cistanches 50g, Herba Epimedii 95g, Fructus Ligustri Lucidi 155g, Cornu Cervi Pantotrichum 5g, Herba Ecliptae 250g, Fructus Mori 135g, Moschus 0.5g, Fructus Lycii 85g;
The people is participated in 70% ethanol of 5 times of weight, and reflux, extract, 4 hours filters, and reclaims ethanol, and concentrated solution is standby; Add 7 times of weight decoctings after Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae 6 flavor medicines are mixed and boil secondary, decocted 5 hours for the first time, decocted 3 hours for the second time; Decoction liquor filters, and merging filtrate adds in the prepared concentrated solution of above-mentioned steps, continues to be condensed into extractum, and drying is dusted, and is standby; Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and Moschus facing-up, crosses 100 mesh sieves,, add refined honey (70-80 ℃) 250 grams and close and stick together with the prepared dry powder blend of above-mentioned steps, rubbing, pill grain, coating are promptly.
The test pharmacodynamics test of [test example 1] pharmaceutical composition of the present invention
One, test material:
(1) laboratory animal: mouse NIH, body weight 25-28g, male and female half and half; Rat Wistar body weight 130-160g, male and female half and half, the feedstuff of rat, mice is provided by Mudanjiang Medical College zoopery center.
(2) be subjected to the reagent thing:
1, the prepared capsule of medicine of the present invention: embodiment 1, three use with distilled water diluting during the equal amount of mixture experiment in batches.
2, positive control medicine: JINGUI SHENQI WAN is provided by Harbin No.3 Traditional Chinese Medicine Factory.
Two, test method and result:
(1) get 80 of the healthy mices of body weight 25-28g, female, male half and half, be divided into four groups respectively by sex and body weight, 20 every group.1, take medicine of the present invention for 2,3 groups, dosage is respectively 8.6g crude drug/kg/d, 6.4g crude drug/kg/d, and 4.2g crude drug/kg/d takes the positive control drug JINGUI SHENQI WAN for the 4th group, and dosage is 8g crude drug/kg/d, logotype 15 days.
Result of the test: 1,2,3 groups of mices obviously strengthen than 4 groups of mice sexual excitation degree, and the number of copulations of 1,2,3 group of mice increases by twice than the number of copulations of 4 groups of mices average every day.
Result of the test shows that medicine of the present invention has tangible excitation to the central nervous system, thus medicine of the present invention for regulate human body function equilibrium, QI invigorating, enrich blood, slow down aging strengthens metabolism, neurolysis, sexual hypofunction all have the treatment foundation.
(2) get 40 of body weight 100-130g healthy rats, male and female half and half, measure serum total cholesterol (TC), high density lipoprotein (HDL-C) and calculate TC/HDL-C ratio, be divided into four groups then at random, every group 10,1, take the embodiment of the invention 1 drug prepared respectively for 2,3 groups, dosage is respectively 8.6g crude drug/kg/d, 6.4g crude drug/kg/d, 4.2g crude drug/kg/d.Take the An ' gong blood pressure-reducing ball for the 4th group, 6g crude drug/kg/d, logotype 15 days, result of the test shows that medicine of the present invention has antagonism.
The animal acute toxicity test of [test example 2] pharmaceutical composition of the present invention
One, test material
(1) animal mouse NIH kind male and female half and half, and body weight 20-22g is provided by Mudanjiang Medical College's Animal Lab..
(2) be subjected to the reagent thing: the capsule that the embodiment of the invention 1 is prepared becomes suspension with distilled water diluting.
Two, test method and result:
The mice maximum tolerance determination: get 32 of healthy mices, male and female half and half were divided three groups within 24 hours, only irritated the each 0.6ml/ of gastrointestinal, and gross weight 1.8ml is equivalent to crude drug in whole 4.0g, i.e. 100g crude drug/kg/d is equivalent to 857 times of clinical 65 kilograms of people.After the mice administration routinely feedstuff do not see animal dead in 12 days and toxic reaction do not occur.Therefore prove that medicine of the present invention has no side effect, clinical practice is safe and reliable.
The long-term toxicity test for animals of [test example 3] pharmaceutical composition of the present invention
One, test material and method
(1) is subjected to the reagent thing: the capsule that the embodiment of the invention 1 is prepared.
(2) laboratory animal, healthy rat Wistar, body weight 100-130g, 140 male and female half and half, by sex and body weight random packet, four groups, 35 every group.1, take and be subjected to the reagent thing for 2,3 groups, dosage is respectively 9.6/kg/d, 6.4/kg/d, 3.2/kg/d.4 groups of distilled water, rats that contrast to the respective volume amount are all irritated the gastrointestinal administration, and every group of logotype 6 months put to death half, remaining 1/2 drug withdrawal observe 12 days all dead.
Two, test index
(1) general situation comprises body weight, diet, emotion, movable energy.
(2) hemogram checking: red blood cell count(RBC), numeration of leukocyte, platelet count, hemogram etc., quantitative hemoglobin counting.
(3) biochemical analysis, serum albumin are quantitatively, cholesterol, blood glucose be quantitative.
(4) pathological tissue inspection: get the half animal after the experimental result and weigh, sacrificed by decapitation is got blood, separate simultaneously treat others for earnest, liver, kidney, lung, brain, spleen, gastrointestinal, bladder, adrenal gland do the pathological tissue inspection.
Three, result of the test: show through the rat long term toxicity test, with the heavy dose of coloclysis of medicine of the present invention six months, to growth, the weight increase of rat, brain, liver, renal function are all had no side effect.Each histoorgan, the blood circulation of rat are not found that infringement changes, and medication group and matched group be no significant difference relatively.Illustrate that medicine of the present invention has QI invigorating, drug effect such as enrich blood, avirulence.
The clinical observation on the therapeutic effect test of [test example 4] medicine composite for curing nephrasthenia syndrome of the present invention
One, clinical data
Observe case and be the out-patient, meet the diagnostic criteria that Chinese medical discrimination is suffered from a deficiency of the kidney, and strict the grasp got rid of the case standard, amount to 400 examples, insomnia and dreamful sleep forgetter 210 examples wherein, nephrasthenia syndrome person 80 examples, menoxenia person's 40 examples, sexual hypofunction person's 229 examples, decreased cardiac function person 70 examples.Be divided into treatment group and matched group at random, wherein 300 examples are organized in treatment, male 165 examples, women 135 examples, age 30-75 year, 49.5 years old mean age, course of disease 1-5; Matched group 100 examples, male 56 examples, women 44 examples, age 32-78 year, the mean age 50, course of disease 1-5, from distribution situations such as two groups of ages, the course of disease, the state of an illness, no significant difference, P>0.05.
Two, test case standard
1, includes the case standard in
Soreness of the waist and knees, fear of cold, hyposexuality, forgetful, lassitude, insomnia, dreaminess, cardiopalmus, weak, breathe hard, dizzy, enlarged tongue is big, tongue is white, the deep pulse CHI-pulse being weak.Meet the above apologist of suffering from a deficiency of the kidney, can include the test case in.
2, get rid of the case standard
(1) gestation or women breast-feeding their children, allergic constitution reaches this medicine allergy sufferers.
(2) merge severe cardiac cerebrovascular, primary diseases such as Liver and kidney, psychotic.
(3) do not meet the case standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.
Three, observation procedure
1, medication and dosage
Treatment group: take the prepared capsule of the embodiment of the invention 1, oral administration, every day 2 times, each 2.
Matched group: take JINGUI SHENQI WAN, Harbin No.3 Traditional Chinese Medicine Factory produces, and every day, secondary was oral, each 1 ball.
2, treat the course of treatment
All the case medication 1 month was a course of treatment.
Four, observation index
1, safety observation
(1) just routine test of hematuria
(2) darling renal function inspection
Respectively check 1 time before and after the medication
2, health giving quality observation
Related symptoms, sign change
Five, curative effect determinate standard
With reference to " new Chinese medicine clinical research guideline ".
1. clinical recovery: the symptom of suffering from a deficiency of the kidney, sign disappear.
2. produce effects: the symptom of suffering from a deficiency of the kidney, sign are obviously improved.
3. effective: the symptom of suffering from a deficiency of the kidney, sign all take a favorable turn.
4. invalid: the symptom of suffering from a deficiency of the kidney, sign no change.
Six, observed result
1, general curative effect relatively sees Table 1.
Table 1 general curative effect relatively
Group Recovery from illness Produce effects Effectively Invalid Total effective rate %
The treatment group 141 118 30 11 96.3
Matched group 20 40 27 13 87
As known from Table 1, two groups of curative effects compare, and there were significant differences, P<0.05
2, cardinal symptom relatively sees Table 2 before and after the treatment group treatment.
Cardinal symptom relatively before and after the treatment of table 2 treatment group
Project Treatment precedent number The routine number in treatment back Effective percentage %
Soreness of the waist and knees 271 15 94.5
Fear of cold 97 8 91.8
Hyposexuality 229 12 94.8
Menoxenia 30 4 86.7
Lassitude 198 15 92.4
Insomnia and dreamful sleep 180 10 94.4
Cardiopalmus 78 4 94.9
Weak 212 10 95.3
Dizzy 165 10 93.9
Forgetful 20 12 94.1
As shown in Table 2, this medicine has good improvement effect to above-mentioned kidney symptom.
3, symptom relatively sees Table 3 before and after the treatment of control group.
Symptom relatively before and after table 3 treatment of control group
Project Treatment precedent number The routine number in treatment back Effective percentage %
Soreness of the waist and knees 86 12 86
Fear of cold 38 7 81.6
Hyposexuality 40 6 85
Menoxenia 10 3 70
Lassitude 63 9 85.7
Insomnia and dreamful sleep 35 7 80
Cardiopalmus 25 5 80
Weak 76 10 86.8
Dizzy 70 9 87
Forgetful 70 10 85.7
By table 3 as seen, aspect doing well,improving, the treatment group obviously is better than matched group, and there is significant difference P<0.05.
4, safety detects
Through detecting before and after the medication, blood, urine, just routine and hepatic and renal function, before and after the treatment, there was no significant difference, P>0.05, illustrate this medicine safely, have no side effect.
Observed result shows that medicine of the present invention is a treatment kidney deficiency determined curative effect, and general curative effect is better than the positive control medicine, in the clinical application process, does not find any untoward reaction, illustrates that safety of medicine of the present invention is effective, no toxicity.

Claims (9)

1, a kind of treatment pharmaceutical composition of suffering from a deficiency of the kidney, make by following bulk drugs:
Radix Ginseng 70-90 part, Herba Epimedii 85-105 part, Herba Cistanches 40-60 part, Fructus Ligustri Lucidi 145-165 part, Herba Ecliptae 240-260 part, Fructus Lycii 75-95 part, Fructus Mori 125-145 part, Cornu Cervi Pantotrichum 2-8 part and Moschus 0.2-0.8 part.
2,, it is characterized in that the weight portion of each crude drug is according to the pharmaceutical composition of claim 1:
80 parts of Radix Ginsengs, 95 parts of Herba Epimedii, 50 parts of Herba Cistanches, 155 parts of Fructus Ligustri Lucidi, 250 parts of Herba Ecliptaes, 85 parts of Fructus Lycii, 135 parts in Fructus Mori, 5 parts in Cornu Cervi Pantotrichum, 0.5 part in Moschus.
3,, it is characterized in that being prepared into any oral formulations with the method for Chinese medicinal of routine according to the pharmaceutical composition of claim 1.
4,, it is characterized in that described oral formulations is pill, capsule, tablet, powder, granule or oral liquid according to the pharmaceutical composition of claim 3.
5,, it is characterized in that described oral formulations is a capsule according to the pharmaceutical composition of claim 4.
6, a kind of method for preparing the pharmaceutical composition of claim 1, step is as follows:
1) take by weighing each raw material by following weight portion:
Radix Ginseng 70-90 part, Herba Epimedii 85-105 part, Herba Cistanches 40-60 part, Fructus Ligustri Lucidi 145-165 part, Herba Ecliptae 240-260 part, Fructus Lycii 75-95 part, Fructus Mori 125-145 part, Cornu Cervi Pantotrichum 2-8 part, Moschus 0.2-0.8 part;
2) Radix Ginseng alcohol reflux filters, and reclaims ethanol, concentrates standby;
3) decoct with water after Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae are mixed, decoction liquor filters, and filtrate joins step 2) in the prepared concentrated solution, continue to be condensed into extractum, drying is dusted, and is standby;
4) Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and Moschus facing-up, sieves,, add adjuvant, make finished product through preparations shaping technology with the prepared dry powder blend of step 3).
7, according to the method for claim 6, it is characterized in that step 2) in the people is participated in 70% ethanol of 5 times of weight, reflux, extract, 4 hours.
8, according to the method for claim 6, add 6~8 times of weight decoctings after it is characterized in that in the step 3) Radix Ginseng residue and Herba Cistanches, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Mori, Fructus Lycii and Herba Ecliptae mixed and boil secondary, decocted 3~6 hours for the first time, decocted 2~4 hours for the second time.
9, the purposes of the described arbitrary pharmaceutical composition of claim 1~5 in medicine is suffered from a deficiency of the kidney in the preparation treatment.
CN 200610067493 2006-03-29 2006-03-29 Medicine composition for treating deficiency of the kidney and its preparing method Pending CN101045110A (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102188000A (en) * 2011-06-02 2011-09-21 吉林省蚕业科学研究院 Male tussah anti-aging functional food for male and production process thereof
CN102697964A (en) * 2012-05-11 2012-10-03 贾晋科 Medicine for treating male sexual dysfunction
CN103340404A (en) * 2013-07-05 2013-10-09 滕立玲 Drink with health care effect on sexual hypoactivity, deficiency of kidney yin and diabetes
CN107320631A (en) * 2017-08-02 2017-11-07 北京胡记堂医药科技中心 A kind of anti-fatigue Chinese medicinal composition and preparation method thereof
CN114767767A (en) * 2022-03-30 2022-07-22 杨朝慧 Formula and preparation process of musk wine

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102188000A (en) * 2011-06-02 2011-09-21 吉林省蚕业科学研究院 Male tussah anti-aging functional food for male and production process thereof
CN102188000B (en) * 2011-06-02 2012-07-04 吉林省蚕业科学研究院 Male tussah anti-aging functional food for male and production process thereof
CN102697964A (en) * 2012-05-11 2012-10-03 贾晋科 Medicine for treating male sexual dysfunction
CN102697964B (en) * 2012-05-11 2014-05-28 贾晋科 Medicine for treating male sexual dysfunction
CN103340404A (en) * 2013-07-05 2013-10-09 滕立玲 Drink with health care effect on sexual hypoactivity, deficiency of kidney yin and diabetes
CN107320631A (en) * 2017-08-02 2017-11-07 北京胡记堂医药科技中心 A kind of anti-fatigue Chinese medicinal composition and preparation method thereof
CN107320631B (en) * 2017-08-02 2020-09-01 北京胡记堂医药科技中心 Anti-fatigue traditional Chinese medicine composition and preparation method thereof
CN114767767A (en) * 2022-03-30 2022-07-22 杨朝慧 Formula and preparation process of musk wine

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