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CN100571722C - Treatment is suffered from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome and preparation method thereof - Google Patents

Treatment is suffered from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome and preparation method thereof Download PDF

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Publication number
CN100571722C
CN100571722C CNB200610067496XA CN200610067496A CN100571722C CN 100571722 C CN100571722 C CN 100571722C CN B200610067496X A CNB200610067496X A CN B200610067496XA CN 200610067496 A CN200610067496 A CN 200610067496A CN 100571722 C CN100571722 C CN 100571722C
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pharmaceutical composition
vitamin
kidney
extractum
deficiency
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CN101045085A (en
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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

The invention discloses that a kind of new treatment is suffered from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome and preparation method thereof, this pharmaceutical composition is made by following bulk drugs: Radix Ginseng 56.5-76.5 part, Herba Cistanches 47-67 part, Herba Epimedii 136-156 part, vitamin E 10-30 part, oryzanol 5-15 part, Cornu Cervi Pantotrichum 2-8 part, vitamin B 12-8 part, Moschus 0.1-1 part.Pharmaceutical composition of the present invention can be prepared into any suitable oral formulations by Chinese medicine conventional formulation method, is preferably capsule.Clinical observation on the therapeutic effect is the result show, pharmaceutical composition of the present invention is for suffering from a deficiency of the kidney and climacteric syndrome all has significant curative effect, clinical drug safety, no toxicity.

Description

Treatment is suffered from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition, relate in particular to that a kind of main treatment that with the Chinese herbal medicine is feedstock production forms is suffered from a deficiency of the kidney and the Chinese medicine composition of climacteric syndrome 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.We are just by kidney invigorating and YANG supporting, spermatogenesis benefit blood, thus reach the balance of essence, gas, blood, reach the purpose for the treatment of disease.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.Because the vital essence deficiency of kidney is a rule of treatment so treatment is worked as with the kidney tonifying, essence replenishing.Concrete method of treatment has again that strong brain is healthy and strong, the effect in vigorate qi and replenish the blood, tranquilizing by nourishing the heart, Li Yin Yiyang.
Insomnia and dreamful sleep, sexual impotence, premature ejaculation, seminal emission, dizziness and tinnitus, menoxenia, infertile, the forgetful cardiopalmus of cold womb, sexual hypofunction and climacteric syndrome etc. all can be caused by the kidney essense QI-insufficiency.
Infertile, the forgetful cardiopalmus of insomnia and dreamful sleep, dizziness and tinnitus, menoxenia, cold womb, sexual hypofunction and climacteric syndrome etc. that present doctor trained in Western medicine causes suffering from a deficiency of the kidney still lack ideal medicine, are generally anti symptom treatment.Though the Chinese patent medicine that the treatment of selling on the market is suffered from a deficiency of the kidney is a variety of, these Chinese patent medicines also have certain curative effect for suffer from a deficiency of the kidney and climacteric syndrome etc., the existence of the degree defective such as can not effect a permanent cure, curative effect is definite inadequately of taking stopgap measures not.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, provides a kind for the treatment of both the principal and secondary aspects of a disease, treatment evident in efficacy to suffer from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome.
Technical problem to be solved by this invention realizes by following technological approaches:
A kind of treatment is suffered from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome, is made by following bulk drugs:
Radix Ginseng 56.5-76.5 part, Herba Cistanches 47-67 part, Herba Epimedii 136-156 part, vitamin E 10-30 part, oryzanol 5-15 part, Cornu Cervi Pantotrichum 2-8 part, vitamin B 12-8 part, Moschus 0.1-1 part.
Preferably, the weight portion of each crude drug is: 70.5 parts of Radix Ginsengs, 57 parts of Herba Cistanches, 146 parts of Herba Epimedii, 10 parts of oryzanol, 5 parts in Cornu Cervi Pantotrichum, VITAMIN B15 part, 20 parts of vitamin Es, 0.5 part in Moschus.
The compatibility foundation of medicine of the present invention:
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 then is a weakness and emaciation, 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, the lumbago weakness and emaciation, 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.”
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 weakness with emaciation is unable, trains it with this, falls into as middle weakness of QI, and that uses can rise 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.”
Also cooperate vitamin B in the side 1, vitamin E and oryzanol.Vitamin B 1, helping and keep the normal function of nerve, heart and digestive system, vitamin E has antioxidation, and circulation around improving promotes spermatogenesis with movable, increases the ovary function, and follicle is increased, and lutein cell increases and strengthens the progesterone effect.Oryzanol has effects such as the autonomic nervous dysfunction of adjusting.Above-mentioned all medicines amount to mutually to be played the strong brain of the kidney invigorating and is healthy and strong, vigorate qi and replenish the blood, tranquilizing by nourishing the heart, the cloudy supporing yang merit of reason.
Pharmaceutical composition of the present invention has the effect of kidney invigorating and YANG supporting, spermatogenesis benefit blood, strengthening the tendons and bones, the Fructus Alpiniae Oxyphyllae of calming the nerves, (disease is seen soreness of the waist and knees to be used for the treatment of the climacteric syndrome that various syndrome of deficiency of kidney-YANG due to insufficiency of kidney-YANG, the damage of essence blood deficiency and insufficiency of kidney-YANG cause clinically, palpitation and insomnia, melancholy forgetful, nocturia etc.).
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, step is as follows:
1) take by weighing each raw material by following weight portion:
Radix Ginseng 56.5-76.5 part, Herba Cistanches 47-67 part, Herba Epimedii 136-156 part, vitamin E 10-30 part, oryzanol 5-15 part, Cornu Cervi Pantotrichum 2-8 part, vitamin B 12-8 part, Moschus 0.1-1 part;
2) with the Radix Ginseng alcohol reflux, extracting solution filters, reclaim ethanol and concentrate concentrated solution; Radix Ginseng residue water decocts, and decoction liquor filters, and filtrate is added in the above-mentioned concentrated solution, continues to be concentrated into the extractum that moisture is 20%-30wt%, and it is standby to get extractum 1;
3) get Herba Cistanches and pulverize, decoct with water, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%-30wt%, and it is standby to get extractum 2;
4) get Herba Epimedii, decoct with water, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%-30wt%, and it is standby to get extractum 3;
5) with vitamin E, oryzanol, Cornu Cervi Pantotrichum, vitamin B 1After the Moschus pulverizing, be stirred in uniformly together, get mixture; 3 kinds of prepared extractum are diluted to fluid extract, join and make soft material in the mixture, make finished product through preparations shaping technology again.
In the above-mentioned preparation method, step 2) preferably the people is participated in 5 times of weight 70% ethanol, reflux, extract, 4-6 hour in; The Radix Ginseng residue is preferably boiled 2 times the 1st decoction 3-6 hour, the 2nd decoction 2-4 hour with 4-8 times of weight decocting; Boil 3 times preferably adding 6 times of weight decoctings after the Herba Cistanches pulverizing in the step 3), decocted 2-4 hour at every turn; In the step 4) Herba Epimedii is preferably added 4 times of weight water decoctings and boil 2 times, decocted 2-4 hour at every turn.
Used all raw materials of the present invention all can be bought from market and obtain, and its specification meets medical standard.
Medicine of the present invention can promote brain albumen synthetic, the effect that brain neuron is had nutrition and regulatory function, can promote erythrocyte, hemoglobin, leukocytic new life and increase, blood sugar lowering and cholesterolemia can make cardiac function strengthen, and brain stem dopamine, norepinephrine are obviously increased, cyclase activity strengthens, promote spermatogenesis, adjust hypophysis and ovum hormonal balance, strengthen sexual function.In a word, medicine of the present invention has the effect of kidney invigorating and YANG supporting, spermatogenesis benefit blood, strengthening the tendons and bones, the Fructus Alpiniae Oxyphyllae of calming the nerves, and for the various syndrome of deficiency of kidney-YANG due to insufficiency of kidney-YANG, the damage of essence blood deficiency significant curative effect is arranged all clinically.
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: obey every day 2 times, obey the 1-2 grain at every turn, every content of dispersion 0.2g, warm water takes.
Further describe beneficial effect of 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 specific embodiment
The preparation of [embodiment 1] capsule
Take by weighing each raw material by following weight: Radix Ginseng 70.5g, Herba Epimedii 146g, Herba Cistanches 57g, oryzanol 10g, Cornu Cervi Pantotrichum 5g, vitamin B1 5g, vitamin E2 0g, Moschus 0.5g; With 4 times of weight, 70% alcohol reflux 4 hours, extracting solution filtered with Radix Ginseng, reclaim ethanol and concentrate concentrated solution; The Radix Ginseng residue boils with 6 times of weight decoctings, and decoction liquor filters, and filtrate is added in the above-mentioned concentrated solution, and continuing to be condensed into moisture is 20%~30wt% extractum, and it is standby to get extractum 1; Get Herba Cistanches and pulverize, add 6 times of weight decoctings and boil, decoction liquor filters, and it is 20%~30wt% extractum that filtrate is condensed into moisture, and it is standby to get extractum 2; Get Herba Epimedii, add 4 times of weight decoctings and boil, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%~30wt%, and it is standby to get extractum 3; With vitamin E, oryzanol, Cornu Cervi Pantotrichum, vitamin B 1After the Moschus pulverizing, be stirred in uniformly together, get mixture; 3 kinds of prepared extractum are diluted to fluid extract, join and make soft material in the mixture, add starch 9.95g, granulation, drying, granulate, dress capsule (every content of dispersion 0.2g) get finished product.
The preparation of [embodiment 2] tablet
Take by weighing each raw material by following weight: Radix Ginseng 56.5g, Herba Cistanches 47g, Herba Epimedii 136g, vitamin e1 0g, oryzanol 5g, Cornu Cervi Pantotrichum 2g, vitamin B 12g, Moschus 0.1g; The people was participated in 5 times of weight, 70% alcohol reflux 4 hours, and extracting solution filters, reclaim ethanol and concentrate concentrated solution; The Radix Ginseng residue is boiled 2 times with 4 times of weight decoctings, the 1st decoction 3 hours, the 2nd decoction 2 hours, collecting decoction filters decocting liquid, and filtrate is added in the above-mentioned concentrated solution, and continuing to be condensed into moisture is 20%~30wt% extractum, and it is standby to get extractum 1; Get and add 5 times of weight decoctings after Herba Cistanches is pulverized and boil three times, decoct 2 hours decoction liquor at every turn and filter, it is 20%~30wt% extractum that filtrate is condensed into moisture, extractum 2 is standby; Herba Epimedii is added 3 times of weight decoctings boil 2 times, decocted 2 hours at every turn, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%~30wt%, and it is standby to get extractum 3; With vitamin E, oryzanol, Cornu Cervi Pantotrichum, vitamin B 1After the Moschus pulverizing, be stirred in uniformly together, get mixture; 3 kinds of prepared extractum are diluted to fluid extract, join and make soft material in the mixture, add starch 8.95g, granulation, drying, granulate, tabletting, pack finished product.
The preparation of [embodiment 3] granule
Take by weighing each raw material by following weight: Radix Ginseng 76.5g, Herba Cistanches 67g, Herba Epimedii 156g, vitamin E 30g, oryzanol 15g, Cornu Cervi Pantotrichum 8g, vitamin B 18g, Moschus 1g; The people is participated in 5 times of weight 70% ethanol, reflux, extract, 6 hours, extracting solution filters, reclaim ethanol and concentrate concentrated solution; The Radix Ginseng residue is boiled 2 times with 8 times of weight decoctings, the 1st decoction 6 hours, the 2nd decoction 4 hours, collecting decoction filters decocting liquid, and filtrate is added in the above-mentioned concentrated solution, and continuing to be condensed into moisture is 20%~30wt% extractum, and it is standby to get extractum 1; Get and add 6 times of weight decoctings after Herba Cistanches is pulverized and boil three times, decoct 4 hours decoction liquor at every turn and filter, it is 20%~30%wt extractum that filtrate is condensed into moisture, extractum 2 is standby; Herba Epimedii is added 3 times of weight water decoctings boil 2 times, decocted 2 hours at every turn, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%~30wt%, and it is standby to get extractum 3; With vitamin E, oryzanol, Cornu Cervi Pantotrichum, vitamin B 1After the Moschus pulverizing, be stirred in uniformly together, get mixture; 3 kinds of prepared extractum are diluted to fluid extract, join and make soft material in the mixture, add starch 10.95g, granulation, drying, granulate, packing, pack finished product.
[test example 1] pharmacopathology test 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: the capsule that the embodiment of the invention 1 is prepared.
3, positive control medicine: the climacteric curing capsule is provided by the Yellow River, Shanxi Chinese medicine company limited.
Two, experimental technique and result
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 and be subjected to the reagent thing 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, the 4th group is taken the positive control pharmaceutical quantities 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 3 times 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, can treat nervous system, for regulate human body function equilibrium, QI invigorating, enrich blood, slow down aging strengthens metabolism, neurolysis, sexual hypofunction etc. are all effective.
[test example 2] medicine animal acute toxicity test of the present invention
One, experiment material:
1, laboratory animal: mouse NIH kind male and female half and half, 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 suspensoid with distilled water diluting.
Two, experimental 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.
[test example 3] animal long term toxicity test
One, experiment material
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.1,2,3 groups are subjected to the reagent thing to clothes, and dosage is respectively 9.6g crude drug/kg/d, 6.4g crude drug/kg/d, 3.2g crude drug/kg/d.4 groups contrast to clothes equal volume amounts distilled water, rat and all irritate 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, proves medicine life-time service avirulence of the present invention.
[test example 4] medicine composite for curing nephrasthenia syndrome clinical observation on the therapeutic effect test 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 133 examples, insomnia and dreamful sleep forgetter 69 examples wherein, climacteric syndrome person's 30 examples, menoxenia person's 10 examples, sexual hypofunction person's 80 examples, decreased cardiac function person 22 examples.Be divided into treatment group and matched group at random, wherein 100 examples are organized in treatment, male 55 examples, women 45 examples, age 30-75 year, 50 years old mean age, course of disease 1-5; Matched group 33 examples, male 20 examples, women 13 examples, age 31-76 year, the mean age 49, 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, adopt oral administration, every day 2 times, each 2.
Matched group: take the climacteric curing capsule, the Yellow River, Shanxi Chinese medicine company limited is produced, 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 treatment group and matched group general curative effect are relatively
Group Recovery from illness Produce effects Effectively Invalid Total effective rate %
The treatment group 47 38 10 3 97
Matched group 6 14 9 4 87.8
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 90 4 95.6
Fear of cold 33 2 93.9
Hyposexuality 76 4 94.7
Menoxenia 10 1 90
Lassitude 66 6 90.9
Insomnia and dreamful sleep 60 2 93.3
Cardiopalmus 26 1 96.2
Nocturia 72 4 94.4
Dizzy 54 3 94.4
Forgetful 67 3 95.5
As shown in Table 2, medicine of the present invention 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 29 4 86.2
Fear of cold 13 2 84.6
Hyposexuality 14 2 85.7
Menoxenia 4 1 75
Lassitude 21 3 85.7
Insomnia and dreamful sleep 12 2 83.3
Cardiopalmus 8 1 87
Nocturia 29 4 86.2
Dizzy 27 3 87
Forgetful 24 4 83.3
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.
Seven, conclusion (of pressure testing)
1, by Drug therapy kidney deficiency 100 routine clinical observations of the present invention, the result shows that medicine of the present invention is 97% to the primary disease effective percentage, and the matched group effective percentage is 87.8%, and the treatment group obviously is better than matched group (P<0.05).
2, drug administration of the present invention is convenient, curative effect is reliable, be easy to preservation, in use, does not find any untoward reaction.
[test example 5] medicine composite for curing climacteric syndrome clinical observation on the therapeutic effect test of the present invention
One, case is selected:
570 routine patients are all from the outpatient service and the inpatient of Mudanjiang City 5 tame hospitals, outpatient's 520 examples, inpatient's 50 examples, wherein 361 examples are organized in treatment, male's 195 examples, women's 166 examples, 35.1 ± 19.1 years old mean age, matched group 209 examples, male's 101 examples, women's 108 examples, 32.9 ± 19.2 years old mean age.
Two, diagnostic criteria:
Cure: the symptom complete obiteration; Produce effects: symptom disappears substantially;
Effectively: it is invalid that symptom partly disappears: symptom does not have improvement;
Three, experimental technique:
Adopt completely random controlled trial method to study, distributing odd number by table of random number is the treatment group, and even number is a matched group.
Four, Therapeutic Method:
1, treatment group: the capsule that the oral embodiment of the invention is prepared, one time 2, a twice-daily.
2, matched group: oral climacteric curing capsule (production of the Yellow River, Shanxi Chinese medicine company limited), one time 2, a twice-daily.
3, the course of treatment: 15 days is a course of treatment, can observe respectively at the 3rd day and the 7th day of treatment and fill up a form, and judge in the 15th heaven-made curative effect.
Five, efficacy analysis:
(1) date processing
All case input IBM/PC microcomputers are set up the data base with dBASEIII and are managed, and use PCMS (medical statistics program) statistical software to carry out statistical disposition then, and ranked data are analyzed with Ridit, and group data is with comparing X 2Check, two sample means are relatively checked with t.
(2) the comparability inspection sees Table 4
Table 4 liang group sex, age ratio are
Group The example number The man The woman Age
The treatment group 361 195 166 35.1±19.1
Matched group 209 101 108 32.9±19.2
X 2=1.72 P=0.19 I=1.32 P=0.1877
Two groups of sexes, age ratio are learned by statistics and are handled difference and do not have significance meaning (P>0.05)
Preceding two groups of sick the kinds relatively of table 5 treatment
Group The example number Insomnia and dreamful sleep Headache and dizzy Cardiopalmus is uncomfortable in chest
The treatment group 361 97 125 139
Matched group 209 50 57 102
X 2=6.01 P=0.0496
Comprehensive as seen above-mentioned:
The treatment group: insomnia and dreamful sleep accounts for 26.9%, and headache and dizzy accounts for 34.6%, and cardiopalmus is uncomfortable in chest to account for 38.5%.
Matched group: insomnia and dreamful sleep accounts for 23.9%, and headache and dizzy accounts for 27.3%, and cardiopalmus is uncomfortable in chest to account for 48.8%.
Two groups of comparing differences have significance meaning (P<0.05).
(3) efficacy analysis:
1, the analysis of total effects sees Table 6.
The analysis result of table 6 treatment group and matched group total effects
Figure C20061006749600141
As seen: adopt Drug therapy climacteric syndrome 361 examples of the present invention, total effective rate is 91.4%, and produce effects and clinical recovery rate are 60.9%, and matched group 209 routine total effective rates are 67.5%, and produce effects and clinical recovery rate are 28.7%.Two groups relatively, and difference has the meaning (P<0.0001) of highly significant.
(1) curative effect of Cure for insomnia dreaminess relatively.
The curative effect comparative result of table 7 Cure for insomnia dreaminess
Figure C20061006749600151
As seen: the effective percentage that adopts Drug therapy insomnia and dreamful sleep of the present invention is 90.7%, produce effects and clinical recovery rate are 60.8%, and matched group 50 routine effective percentage are 48.0%, and 18.0%, two group of comparing difference of produce effects and clinical recovery rate has highly significant meaning (P<0.0001).
(2) curative effect of treatment headache and dizzy relatively.
The curative effect comparative result of table 8 treatment headache and dizzy
Figure C20061006749600152
As seen: the effective percentage that adopts Drug therapy headache and dizzy of the present invention is 89.5%, produce effects and clinical recovery rate are 50.0%, and the effective percentage of matched group is 66.7%, and produce effects and clinical recovery rate are 38.6%, and both comparing differences have significance meaning (P<0.05).
(3) treatment cardiopalmus curative effect uncomfortable in chest compares.
Table 9 treatment cardiopalmus curative effect comparative result uncomfortable in chest
Figure C20061006749600153
As seen: adopting Drug therapy cardiopalmus of the present invention effective percentage uncomfortable in chest is 94.2%, produce effects and clinical recovery rate are 71.2%, and the effective percentage of matched group is 77.5%, and produce effects and clinical recovery rate are that 28.4%, two group of comparing difference has highly significant meaning (P<0.0001).
Observation of curative effect is the result show: medicine of the present invention has good improvement and treatment function to climacteric syndrome, and is evident in efficacy, clinical drug safety.

Claims (9)

1, a kind of treatment is suffered from a deficiency of the kidney and the pharmaceutical composition of climacteric syndrome, is made by following bulk drugs: Radix Ginseng 56.5-76.5 part, Herba Cistanches 47-67 part, Herba Epimedii 136-156 part, vitamin E 10-30 part, oryzanol 5-15 part, Cornu Cervi Pantotrichum 2-8 part, vitamin B 12-8 part, Moschus 0.1-1 part.
2, according to the pharmaceutical composition of claim 1, it is characterized in that the weight portion of each crude drug is: 70.5 parts of Radix Ginsengs, 57 parts of Herba Cistanches, 146 parts of Herba Epimedii, 10 parts of oryzanol, 5 parts in Cornu Cervi Pantotrichum, VITAMIN B15 part, 20 parts of vitamin Es, 0.5 part in Moschus.
3,, it is characterized in that being prepared into any oral formulations by Chinese medicine conventional formulation method 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) takes by weighing each raw material by following weight portion: Radix Ginseng 56.5-76.5 part, Herba Cistanches 47-67 part, Herba Epimedii 136-156 part, vitamin E 10-30 part, oryzanol 5-15 part, Cornu Cervi Pantotrichum 2-8 part, vitamin B 12-8 part, Moschus 0.1-1 part;
2) with the Radix Ginseng alcohol reflux, extracting solution filters, reclaim ethanol and concentrate concentrated solution; Radix Ginseng residue water decocts, and decoction liquor filters, and filtrate is joined in the above-mentioned concentrated solution, continues to be concentrated into the extractum that moisture is 20%-30wt%, and it is standby to get extractum 1;
3) get Herba Cistanches and pulverize, decoct with water, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%~30wt%, and it is standby to get extractum 2;
4) get Herba Epimedii, decoct with water, decoction liquor filters, and filtrate is concentrated into the extractum that moisture is 20%-30%wt, and it is standby to get extractum 3;
5) with vitamin E, oryzanol, Cornu Cervi Pantotrichum, vitamin B 1After the Moschus pulverizing, be stirred in uniformly together, get mixture; 3 kinds of prepared extractum are diluted to fluid extract, join and make soft material in the mixture, make finished product through preparations shaping technology again.
7, according to the method for claim 6, it is characterized in that step 2) in the people is participated in 5 times of weight 70% ethanol, reflux, extract, 4-6 hour; The Radix Ginseng residue is boiled 2 times the 1st decoction 3-6 hour, the 2nd decoction 2-4 hour with 4-8 times of weight decocting; Boil 3 times adding 6 times of weight decoctings after the Herba Cistanches pulverizing in the step 3), decocted 2-4 hour at every turn; In the step 4) Herba Epimedii is added 4 times of weight decoctings and boil 2 times, decocted 2-4 hour at every turn.
8, 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.
9, the purposes of the described arbitrary pharmaceutical composition of claim 1-5 in preparation treatment climacteric syndrome medicine.
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Title
国家药品监督管理局国家中成药标准汇编中成药地方标准上升国家标准部分外科妇科分册. 国家药品监督管理局,134-137. 2002
国家药品监督管理局国家中成药标准汇编中成药地方标准上升国家标准部分外科妇科分册. 国家药品监督管理局,134-137. 2002 *
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