CN104758849A

CN104758849A - Medicine composition for treating climacteric osteoporosis and preparation method of medicine composition

Info

Publication number: CN104758849A
Application number: CN201510199362.2A
Authority: CN
Inventors: 马祥海
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-04-24
Filing date: 2015-04-24
Publication date: 2015-07-08

Abstract

The invention discloses a medicine composition for treating climacteric osteoporosis and a preparation method of the medicine composition. The medicine composition comprises the various bulk drugs: English walnut seeds, rhizoma homalonemae, pericarpium citri reticulatae, glossy privet fruit, eclipta, wild groundnut seeds, rhizoma cibotii, sargentgloryvine stems, rhizoma drynariae, radix morindae officinalis, herba epimedii, rhizoma curculiginis, sword bean, auriculate swallowwort roots, dutchmanspipe roots, boxwood, turmeric, polished round-grained rice, dahurian rose fruit, diaphragma juglandis, common mappianthus stems, fruit of highland barley malt, seeds of field pennycress, sieve sedge, oldham fissistigma roots, wideleaf osbeckia roots, wild water-chestnut fruit and sheathstipe greenbrier tubers and roots. The medicine composition has the beneficial effects that the medicine composition has the efficacies of tonifying qi, nourishing blood, regulating qi, strengthening a spleen, and warming and recuperating the kidney-yang, as well as the effects of building bones and muscles, tonifying a liver and a kidney, strengthening bone and alleviating pain, and has the advantages that the medicine composition takes effect rapidly, is high in efficiency, definite in treatment effect, short in treatment course and low in cost, and has no toxic or side effect.

Description

A kind of pharmaceutical composition for the treatment of postmen opausal and preparation method thereof

Technical field

The present invention relates to technical field of medicine, particularly a kind of pharmaceutical composition for the treatment of postmen opausal and preparation method thereof.

Background technology

Osteoporosis is one group of osteopathia that multiple reasons causes, and osseous tissue has normal calcification, and calcium salt and substrate are normal rates, and the metabolic osteopathy being reduced to feature with unit volume inner bone tissues amount becomes.In most osteoporosis, caused by the minimizing of osseous tissue increases mainly due to bone absorption.Fall ill how slowly indivedual very fast, with skeleton pain, be easy to fracture for feature biochemical analysis is normal.The visible cortical bone of pathological anatomy is belittled, and bone trabecula sparse atrophy osteoid layer is not thick.Osteoporosis, primary osteoporosis be reduce with bone amount, the microstructure degeneration of bone is feature, cause the fragility of bone to increase and be easy to occur a kind of systemic skeletal disease of fracture.Alcoholic osteoporosis (AOP) refers to because long-term, a large amount of Ethanol intakes causes bone amount to reduce, the microstructural damage of bone, bone fragility increases, a kind of general bone metabolism disorder disease that risk of bone fracture increases, belong to secondary osteoporosis, also being low conversion type osteoporosis, is one of clinical common Alcoholic osteopathia.

The pathogenic factor of osteoporosis: 1, the shortage of calcium; 2, calcitonin; 3, vitamin D; 4, acidic physique.Vulnerable crowd: the risk factor of male is the age, body weight Height Ratio, and long-term alcohol, smoking, gives up doing exercise.The risk factor of women is the age, body weight Height Ratio, and age of menarche, menopause time, at the first tire age, parturition number, gives up doing exercise.Advanced age is the main risk factor of elderly men hip osteoporosis, and the longer post menopausal time is the main risk factor of old women hip osteoporosis.

The symptom of osteoporosis: (1) pain: the modal disease of primary osteoporosis, common with lumbago and backache, account for the 70%-80% in pain patients.Pain spreads along spinal column to both sides, lie on the back or seat time pain relief, stretch after time upright or standing for a long time, sitting time the pain increased, pain is light in the daytime, increases the weight of, bends over, muscular movement, cough, stool increase the weight of when exerting oneself when night and early morning wake up.Osteodynia can be there is when general bone loss more than 12%.During senile osteoporosis, the atrophy of vertebral bone girder, quantity reduces, and Vertebral Compression is out of shape, flexion of vertebral column, and waist rash flesh is in order to correct flexion of vertebral column, and double to shrink, muscle fatigue is spasm even, produces pain.Recently compressed fracture of thoracic vertebra and lumber vertebra, also can produce acute pain, and the spinous process of corresponding site can have strong tenderness and percussion pain, and general 2-3 Zhou Houke alleviates gradually, and some patients can be chronic back pain.If oppress corresponding spinal nerves can produce extremity radiating pain, two lower limb sensorimotor obstacle, intercostal neuralgia, the similar angina pectoris of retrosternal pain, the similar acute abdomen of upper abdominal pain also can be there is.If compressing spinal cord, horse hair are also middle affect bladder, rectum function.(2) height shortening, hunchback: how to occur after pain; Vertebra vertebral body front portion mostly almost is spongy bone composition, and this position is the pillar of health, and loading weight is large, easy compression, vertebra is leaned forward, and the bent aggravation of the back of the body, is formed bow-backed, with age, osteoporosis increases the weight of, and bow-backed curvature strengthens, and causes knee joint contraction to be arrested significantly.Everyone has 24 joint vertebral bodys, and each vertebral height of normal person is about about 2cm, Vertebral Compression during senile osteoporosis disease, and every vertebral body shortens about 2mm, height shorten in average 3-6cm.(3) fracture: this is the most common and the most serious complication of degeneration osteoporosis.(4) respiratory function declines: thoracolumbar vertebrae compression fracture, vertebra palintrope, and chest deformity, can make vital capacity and maximal breathing capacity significantly reduce, patient often can occur uncomfortable in chest, breathe hard, the symptom such as dyspnea.

The diagnosis of osteoporosis: the common index clinically for osteoporosis is: 1. fragility fractures: the fracture occurred when referring to non-wound or microtrauma, this is the obvious embodiment that bone strength declines.Also be final result and the complication of osteoporosis.Common is wrist (distal radius), vertebral body, hip (proximal femur).There occurs fragility fractures and can be diagnosed as osteoporosis.2. based on the diagnostic criteria of bone densitometry: the diagnostic criteria of world health organisation recommendations: bone density belongs to normal (T value ﹥-1) less than a standard deviation lower than same sex, agnate normal person's peak bone mass, bone density value is for bone amount reduces (-2.5<T is worth <-1) between-1 ~-2.5, and bone density is osteoporosis (T value≤2.5) less than or equal to-2.5.Bone density reduce degree meet diagnosis of osteoporosis standard simultaneously with a place or repeatedly fracture time be serious osteoporosis.Typical X-ray photo can show that tubulose cortical bone is thinning, and pulp cavity broadens, bone trabecula decreased number, and its gap is also broadening.

The osteoporosis pathology cause of disease: the cause of disease of primary osteoporosis is not bright, may with following a kind or several factors relevant.1. endocrine function is not normal.(1) sex hormone deficiency: estrogen and (or) hypoandrogenism and out of proportion, cause: 1. protein synthesis reduces, bone matrix generates not enough; 2. function of osteoblast declines; 3. PTH increases the sensitivity of bone effect; 4. glucocorticoids on bone action intensity increases relatively; 5. intestinal calcium absorption and renal tubules calcium heavily absorb reduction, and the osteoporosis that menopause, senile and premature ovarian failure etc. cause all may be relevant therewith, and estrogen deficiency may be the main cause of postmen opausal.(2) PTH secretion increasing: the blood PTH of some primary osteoporosiies (bone high-conversion rate osteoporosis) person slightly increases, this is more obvious in the patient of senile renal hypofunction and impaired glucose tolerance; Add the reasons such as sex hormone deficiency, PTH and gonadal hormone ratio are not normal, can osteoporosis be caused.(3) calcitonin (CT) lacks: after menopause, CT level reduces, and may facilitate the generation of osteoporosis because suppressing bone resorption factor reduction.(4) other functionss of hormones: some data show, there is the diacrisis of thyroxin, glucocorticoid, growth hormone, Lifestyle factor (especially somatomedin C), gastrin in Osteoporosis, but its causal significance is not illustrated.Osteoblast (OB) and osteoclast (OC) form bone reconstructive unit.Break bone and osteogenetic process keeps balancing in health adult, this depends on OB and OC good mutual adjustment each other.Osteoclast belongs to the cell of monocyte/macrophage pedigree, plays a crucial role in maintenance bone remoulding balance and body in calcium balance.The activation of OC and suppressedly to regulate by OB and other factors again.The stromal cell of bone, osteoblast and the activation of Activated T-lymphocytes to OC play supporting function, are called as " supporting carefully to roar " (SC/OB).1. " sustenticular cell " secretes M-CSF (M-CSF) stimulates multipotency monocyte/macrophage pedigree to grow for OC precursor.2. " sustenticular cell " RANKL [nuclear factor-κ B (NF-κ B) receptor activation factor aglucon of secreting, also known as OPG aglucon (OPGL), OC differentiation factor] combine with the RANK [(NF-κ B) the receptor activation factor] on OC film, import signal into osteoclast precursor, make OC differentiation and maturation.3. " sustenticular cell " secretes again OPG (OPG, osteoprotection), fights for the combination of RANK with OPGL, thus suppresses the differentiation and maturation of OC.Various upstreams hormone is [as PTH, 17 β-E2, glucocorticoid, l, 25 (OH) 2D3, PGE2 etc.] or cytokine (as TGF-β, IL-1, IL-11, IL-17 and TNF etc.) act on the receptor of SC/OB, stimulate or suppress SC/OB to express RANKL or 0PG, thus regulating the activity of OC.Then osteoporosis is there is as OC is too active constantly.2. malnutrition: due to a variety of causes, can there is malnutrition in old people, adolescence and edge design.Protein undersupply may cause osteogenesis obstacle, but take in too much protein also make urine calcium discharge increase, cause calcium negative balance.The Deficiency of Intake of calcium and the in close relations of osteoporosis, low calcium diet can cause bone resorption to accelerate by Secondary cases PTH secretion increasing.Drink and glucocorticoid secretion is increased, urine calcium increases, and intestinal calcium absorption reduces; Long-term alcohol person hypogonadism, as concurrent liver cirrhosis also will affect the generation of 25-(OH) D3; Therefore the cause of disease of alcoholic-toxic osteoporosis is the consequence of many-sided comprehensive function.The factors such as the activity of old people reduces, sunshine lacks, gastrointestinal absorption function and reabsorption ability go down year by year, all may with osteoporosis be formed with certain relation.3. inherited genetic factors: stature, the girth of a garment, muscular degree are all relevant with heredity with gastrointestinal function.Easily there is osteoporosis in white people (Aisan also approximate white people), and osteoporosis not easily occurs for South Africa Bantu, Black people, and tall and thin stature person osteoporosis incidence rate is more much higher than podge.4. immune factor: osteoclast derives from large mononuclear cell, has potential immunologic function.During immunologic function disorder, accelerated bone absorbs by all means, delays osteogenesis and causes.

The prevention of osteoporosis: 1, discontinue the habit of smoking and drinking, drinks less containing coffee-type beverage.2, suitably carry out outdoor activities, expose to sunlight.3, physical exertion and exercise is strengthened.The function of skeletal system is born a heavy burden and motion.Musculation is more, and just reach all the more, skeleton is also more sturdy.Motion exercise can slow down aging, reduces bone calcium " overdraw ".4, be careful in one's diet allotment.Eat the food of rich in protein more, as milk, eggs, lean meat, poultry meat and fish and shrimp etc., and the food that calcium content is abundant, as milk, Radix Raphani, Caulis et Folium Brassicae junceae, Brassica oleracea L.var.capitata L., Caulis et Folium Brassicae capitatae and various bean product etc.Reduce Sal to take in, with calcareous in holding body, note Mg supplementation and manganese simultaneously.

The pathogenesis of osteoporosis: non-single factors is caused a disease.Participate in pathogenic comprising: 1. inherited genetic factors; 2. the shortage of calcium and vitamin D; 3. oestrogen deficiencies causes osteoporosis, and estrogen replacement curative effect is obviously recognized; 4. hypoandrogenism also participates in Male Osteoporosis; 5. old degenerative mechanism etc.The generation of senile osteoporosis is lacked of proper care with human endocrine, hypokinesia is relevant with bad life habits.Therefore, the bone loss rule occurred with age increase is understood significant to this disease of control.Therefore, bone condention just becomes the important means of research osseous lesion.Bone trabecula bone volume (TBV) is the important parameter that in reflection unit volume medullary cavity, bone volume is how many.TBV partly can only reflect the change that bone trabecula bone amount occurred with the age, because have certain overlap between each age group.The result that we measure shows, more than 50 years old group male TBV comparatively the right side of fifty group decreases about 1/4, and women declines more hurry up.Women's post menopausal reduces rapidly due to estrogen, and bone loss is accelerated, and this stage is called that bone amount lowers the phase rapidly.Average bone wall thickness (MWT) is another important parameter.Our result of study shows, this parameter increases with the age and declines, and women declines more obvious, therefore women's post menopausal male more of the same age more easily pathologisch Bruch occurs.

The drug treatment of osteoporosis: to the treatment of osteoporosis from the postponement generation of osteoporosis and the therapeutic advance of deterioration to the treatment recovering bone health energetically.What make " life expectancy of people can be made to extend 10-20 from the bone life-span " wants to be possibility in advance.Join for osteoporosis patients bone resorption and bone formation corner and lack of proper care, Drug therapy is divided into three major types: 1, bone resorption inhibitor, to reduce the further loss of bone amount: estrogen, calcitonin, diphosphate, ipriflavone all belong to this class; 2, bone formation-promoter, to increase bone amount, comprises fluoride, vitamin K, parathyroid hormone, androgen, growth hormone etc.; 3, bone mineralising promoter, promotes bone calcific deposit, and increase bone amount, this kind of medicine has vitamin D and calcium preparation.What need special proposition is, previously HRT(Hormone Replacement Therapy) Zeng Zuowei treatment female postmenopausal osteoporosis first-selection, but new research shows, at HRT(Hormone Replacement Therapy) as in a line medication of osteoporosis, risk-ratio of being benefited is undesirable.In the preventing and treating of osteoporosis, in European scale, HRT is not re-used as a gamma therapy of osteoporosis.

The western medicine therapy for the treatment of osteoporosis is: constitutional I type osteoporosis belongs to hypermetabolism type, is because postmenopausal estrogen reduces, makes that bone resorption is hyperfunction causes bone loss, bone resorption inhibitor therefore should be selected as estrogen, calcitonin, calcium preparation.Constitutional II type osteoporosis, its cause of disease is that application bone formation-promoter, as activated vitamin D, protein anabolic hormone (nandrolone phenylpropionate), calcium preparation, fluorization agent and Menaquinone K6 etc. because the increasing aging caused hormone imbalances that regulates in age makes bone formation low.1, estrogen: the choice drug being control postmenopausal osteoporosis.(1) estradiol 1-2mg/d.(2) diethylstilbestrol 0.25mg/ every night.(3) compound recipe estrogen 0.625mg/d.(4) nilestriol 2mg/ first quarter moon.(5) livial.2, calcitonin: (1) calcitonin.(2) elcatonin.(3) Calcitonin.3, Vir D: (1) Rocaltrol.(2) alfacalcidol.4, calcium preparation: (1) inorganic calcium: 1) calcium chloride.2) calcium carbonate.(2) organic calcium: 1) calcium gluconate.2) calcium lactate.3) C8H12CaN2O8.(3) activated calcium.(4) Gaierqi D (vitamin D3 and calcium carbonate).5, Diphosphonate: (1) clodronic acid disodium.(2) ethoxy diphosphate sodium.6, ipriflavone.

But western medicine: trace elements absorption situation is uncertain, affects appetite, cures the symptoms, not the disease, is unfavorable for treatment, and conventional there are dependency and side effect.

Summary of the invention

Technical problem to be solved by this invention is, a kind of pharmaceutical composition for the treatment of postmen opausal and preparation method thereof is provided, the present invention has benefiting QI and nourishing blood, effect of regulating qi-flowing for strengthening spleen and warming and recuperating the kidney-YANG, have the effect of strong muscles and bones, liver and kidney tonifying and bone strengthening pain relieving concurrently, have rapid-action, effective percentage is high, determined curative effect, treatment short treating period, have no side effect, the advantages such as price is low.

In order to solve the problems of the technologies described above, the invention provides a kind of pharmaceutical composition for the treatment of postmen opausal, wherein, following raw medicinal material is comprised: semen juglandis, Rhizoma Homalomenae, Pericarpium Citri Reticulatae, Fructus Ligustri Lucidi, Herba Ecliptae, Semen glycines sojae, Rhizoma Cibotii, Caulis Sargentodoxae, Rhizoma Drynariae, Radix Morindae Officinalis, Herba Epimedii, Rhizoma Curculiginis, Semen Canavaliae, Radix cynanchi wilfordii, Radix Aristolochiae, Ramulus Buxi Sinicae, Rhizoma Curcumae Longae, Semen oryzae sativae, Fructus Rosae Davuricae, Partition in Fructus Juglandis, Caulis Mappianthi Iodoidis, Fructus Hordei nudi Germinatus, Semen thlaspis are with Carex Kobomugi Ohwi.

In described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 10 ~ 40 parts, Rhizoma Homalomenae 12 ~ 22 parts, Pericarpium Citri Reticulatae 14 ~ 24 parts, Fructus Ligustri Lucidi 10 ~ 30 parts, Herba Ecliptae 15 ~ 25 parts, Semen glycines sojae 13 ~ 33 parts, Rhizoma Cibotii 10 ~ 20 parts, Caulis Sargentodoxae 17 ~ 31 parts, Rhizoma Drynariae 15 ~ 45 parts, Radix Morindae Officinalis 12 ~ 42 parts, Herba Epimedii 14 ~ 24 parts, Rhizoma Curculiginis 3 ~ 5 parts, Semen Canavaliae 10 ~ 30 parts, Radix cynanchi wilfordii 15 ~ 25 parts, Radix Aristolochiae 10 ~ 20 parts, Ramulus Buxi Sinicae 14 ~ 34 parts, 11 ~ 21 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 17 ~ 36 parts, Fructus Rosae Davuricae 15 ~ 25 parts, Partition in Fructus Juglandis 10 ~ 35 parts, Caulis Mappianthi Iodoidis 18 ~ 45 parts, Fructus Hordei nudi Germinatus 10 ~ 20 parts, Semen thlaspis 11 ~ 31 Fen is with Carex Kobomugi Ohwi 15 ~ 40 parts.

In described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 25 parts, Rhizoma Homalomenae 20 parts, Pericarpium Citri Reticulatae 15 parts, Fructus Ligustri Lucidi 25 parts, Herba Ecliptae 15 parts, Semen glycines sojae 20 parts, Rhizoma Cibotii 17 parts, Caulis Sargentodoxae 30 parts, Rhizoma Drynariae 45 parts, Radix Morindae Officinalis 25 parts, Herba Epimedii 15 parts, Rhizoma Curculiginis 3 parts, Semen Canavaliae 15 parts, Radix cynanchi wilfordii 22 parts, Radix Aristolochiae 18 parts, Ramulus Buxi Sinicae 26 parts, 20 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 24 parts, Fructus Rosae Davuricae 15 parts, Partition in Fructus Juglandis 22 parts, Caulis Mappianthi Iodoidis 35 parts, Fructus Hordei nudi Germinatus 14 parts, Semen thlaspis 21 Fen is with Carex Kobomugi Ohwi 35 parts.

In described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 30 parts, Rhizoma Homalomenae 16 parts, Pericarpium Citri Reticulatae 22 parts, Fructus Ligustri Lucidi 12 parts, Herba Ecliptae 18 parts, Semen glycines sojae 30 parts, Rhizoma Cibotii 15 parts, Caulis Sargentodoxae 20 parts, Rhizoma Drynariae 35 parts, Radix Morindae Officinalis 40 parts, Herba Epimedii 22 parts, Rhizoma Curculiginis 3 parts, Semen Canavaliae 25 parts, Radix cynanchi wilfordii 17 parts, Radix Aristolochiae 15 parts, Ramulus Buxi Sinicae 32 parts, 15 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 33 parts, Fructus Rosae Davuricae 21 parts, Partition in Fructus Juglandis 30 parts, Caulis Mappianthi Iodoidis 45 parts, Fructus Hordei nudi Germinatus 12 parts, Semen thlaspis 28 Fen is with Carex Kobomugi Ohwi 31 parts.

In described pharmaceutical composition, each raw medicinal material also comprises: Radix Fissistigmatis Oldhamii, Radix Osbeckiae Crinitae, Fructus Trapae qudricaudatae and Rhizoma et radix smilacis santis.

In described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 30 parts, Rhizoma Homalomenae 16 parts, Pericarpium Citri Reticulatae 22 parts, Fructus Ligustri Lucidi 12 parts, Herba Ecliptae 18 parts, Semen glycines sojae 30 parts, Rhizoma Cibotii 15 parts, Caulis Sargentodoxae 20 parts, Rhizoma Drynariae 35 parts, Radix Morindae Officinalis 40 parts, Herba Epimedii 22 parts, Rhizoma Curculiginis 3 parts, Semen Canavaliae 25 parts, Radix cynanchi wilfordii 17 parts, Radix Aristolochiae 15 parts, Ramulus Buxi Sinicae 32 parts, 15 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 33 parts, Fructus Rosae Davuricae 21 parts, Partition in Fructus Juglandis 30 parts, Caulis Mappianthi Iodoidis 45 parts, Fructus Hordei nudi Germinatus 12 parts, Semen thlaspis 28 parts, Carex Kobomugi Ohwi 31 parts, Radix Fissistigmatis Oldhamii 14 parts, Radix Osbeckiae Crinitae 32 parts, Fructus Trapae qudricaudatae 22 parts and Rhizoma et radix smilacis santis 15 parts.

When the dosage form of described pharmaceutical composition is granule, its preparation method comprises the following steps:

The first step, each for described pharmaceutical composition raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 4 ~ 8 times, mixture is the ethanol of 85% ~ 95%, be heated to boiling reflux 3 ~ 5 hours, filter, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, when being evaporated to 50 ~ 60 DEG C subsequently under vacuum 0.06 ~ 0.09Mpa, relative density is the mastic of 1.04 ~ 1.10, spraying dry, the inlet temperature 160 ~ 175 DEG C of spray dryer, leaving air temp 80 ~ 85 DEG C, is ground into powder subsequently, makes dried cream powder;

Second step, adds the dextrin of cane sugar powder relative to dried cream powder quality 0.2 ~ 0.4 times and 0.1 ~ 0.2 times, makes granule in the dried cream powder obtained, and in 40 ~ 50 DEG C of dryings, obtains granule.

When the dosage form of described pharmaceutical composition is capsule, its preparation method comprises the following steps:

The first step, is mixed in proportion each for described pharmaceutical composition raw medicinal material, and adding relative to the determining alcohol of mixture quality 2 ~ 4 times is the ethanol of 85 ~ 95%, reflux 1 ~ 3 hour, extracts, and filters acquisition first extracting solution; It is the ethanol of 85 ~ 95% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 1 ~ 2 times again, reflux 1 ~ 3 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize, sieve, obtain 300 order ~ 400 object micropowders;

3rd step, adds Pulvis Talci, magnesium stearate successively in the micropowders that second step obtains, and carries out mixing process, obtains capsule 's content; Described micropowders, magnesium stearate and talcous weight ratio are 100: 0.15 ~ 0.5:0.15 ~ 0.5, incapsulate in housing by described capsule 's content, obtain capsule finished product.

When the dosage form of described pharmaceutical composition is tablet, its preparation method comprises the following steps:

The first step, is mixed in proportion each for described pharmaceutical composition raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 85% ~ 95%, reflux 4 ~ 6 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 90% ~ 95% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 ~ 4 times again, reflux 1 ~ 3 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 3 hour, pulverize, sieve, obtain 400 order ~ 500 object micropowders;

3rd step, by the micropowders that second step obtains, add relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.2 times, 0.15 ~ 0.3 times of lactose, the starch of 0.2 ~ 0.3 times, sieve, mix homogeneously, granulate, drying, adds relative to micropowders quality 0.025 ~ 0.04 times of magnesium stearate, granulate, tabletting, makes.

The invention has the beneficial effects as follows: the present invention has benefiting QI and nourishing blood, effect of regulating qi-flowing for strengthening spleen and warming and recuperating the kidney-YANG, have the effect of strong muscles and bones, liver and kidney tonifying and bone strengthening pain relieving concurrently, have rapid-action, effective percentage is high, determined curative effect, treatment short treating period, have no side effect, the advantages such as price is low.

Detailed description of the invention

The present invention is with benefiting QI and nourishing blood, regulating qi-flowing for strengthening spleen and warming and recuperating the kidney-YANG are primary treatment principle, treatment postmen opausal, wherein, following raw medicinal material is comprised: semen juglandis, Rhizoma Homalomenae, Pericarpium Citri Reticulatae, Fructus Ligustri Lucidi, Herba Ecliptae, Semen glycines sojae, Rhizoma Cibotii, Caulis Sargentodoxae, Rhizoma Drynariae, Radix Morindae Officinalis, Herba Epimedii, Rhizoma Curculiginis, Semen Canavaliae, Radix cynanchi wilfordii, Radix Aristolochiae, Ramulus Buxi Sinicae, Rhizoma Curcumae Longae, Semen oryzae sativae, Fructus Rosae Davuricae, Partition in Fructus Juglandis, Caulis Mappianthi Iodoidis, Fructus Hordei nudi Germinatus, Semen thlaspis, Carex Kobomugi Ohwi, Radix Fissistigmatis Oldhamii, Radix Osbeckiae Crinitae, Fructus Trapae qudricaudatae and Rhizoma et radix smilacis santis.

Wherein, the pharmacology of above-mentioned raw materials medical material is as follows:

Semen juglandis: source: " detailed outline ".Nature and flavor: sweet, temperature.1. " seven volume cuisine canons ": " sweet in the mouth, temperature." 2. " Bencao Tujing ": " is hot in nature." 3. " medical center bun is wanted ": " is sweet and micro-pungent, and gross weight is puckery." return through: enter kidney, lung meridian.1. " detailed outline ": " enter kidney, lung." 2. " Thunder God concocts property of medicine solution ": " enters lung, liver, kidney three warp." 3. " book on Chinese herbal medicine is looked for the truth ": " enters the gate of vitality, double enter lung, large intestine." 4. " book on Chinese herbal medicine brief points ": " enters bright, the meridian of Hand-TAI YIN of foot sun." cure mainly: tonifying the kidney to consolidate the essence, warming the lung Dingchuan, intestine moistening, controlling suffers from a deficiency of the kidney breathes heavily and coughs, lumbago flaccidity of the lower limbs, sexual impotence, seminal emission, frequent micturition, stranguria caused by urinary stone, constipation due to dry stool.1. the Meng numerous: " black beard and hair, informal dress kindred is fine and smooth smooth for qualcomm meridian, profit blood vessels." 2. Cui Yu stannum " cuisine canon ": " therapeutic method to keep the adverse QI flowing downwards, main sore throat, kills tapeworm.Making us of " 3. supplement to the Herbal: " food is fertile strong." 4. " Kaibao Bencao ": " polyphagia diuresis, goes five hemorrhoid." 5. " seven volume cuisine canons ": " removes pneumatosis." 6. " detailed outline ": " benefiting qi and nourishing blood, moistening the lung and resolving the phlegm, the beneficial gate of vitality, profit three is burnt, warming the lung intestine moistening.Control deficiency and coldness to breathe heavily and cough, the heavy pain of waist foot, trusted subordinate's colic, dysentery hemorrhoidal hamorrhage, loose toxic swelling, sends out variola, and copper processed is malicious." 7. " medical center bun is wanted ": " the kidney invigorating, the profit gate of vitality, controlling nocturnal emission with astringent drugs, profit large intestine, logical functional constipation, only diarrhea due to cold pathogen diarrhea of deficiency type." 8. " Bencao Congxin ": " controls flaccidity, reinforcing YIN-essence."

Rhizoma Homalomenae: nature and flavor: bitter, pungent, temperature.Gui Jing: return liver, kidney channel.Cure mainly: wind-damp dispelling, muscle reinforcing and bone strengthening, promoting blood circulation and stopping pain.For anemofrigid-damp arthralgia, chills and pain of the waist and kness, lower limb contracture is numb.

Pericarpium Citri Reticulatae: nature and flavor: bitter, pungent, temperature.Gui Jing: return lung, spleen channel.Cure mainly: regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.

Fructus Ligustri Lucidi: nature and flavor: sweet, bitter, cold.Gui Jing: return liver, kidney channel.Cure mainly: nourishing the liver and kidney, improving eyesight black hair.For vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision.

Herba Ecliptae: nature and flavor: sweet, sour, cold.Gui Jing: return kidney, Liver Channel.Cure mainly: nourishing the liver and kidney, cooling blood for hemostasis.For odontoseisis, early whitening of beard and hair, vertigo and tinnitus, soreness of the waist and knees, YinXuXueRe, haematemesis, epistaxis, hematuria, dysentery, metrostaxis, traumatic hemorrhage.

Semen glycines sojae: source: " decoction pieces is newly joined ".Nature and flavor: sweet are cool.1. " book on Chinese herbal medicine converges and says ": " sweet-bitter flavor is salty, and gas is trembled with fear, nontoxic." 2. " book on Chinese herbal medicine is through separating ": " gas is put down, and sweet in the mouth is nontoxic." 3. " Chinese herbal medicine is commonly used in Shanghai ": " is sweet, is slightly cold." return through: 1. " herbal classic is met former ": " enters kidney channel blood system." 2. " book on Chinese herbal medicine is through separating ": " enters lung meridian, spleen meridian." cure mainly: liver and kidney tonifying, removing toxic substances of dispeling the wind.Control and cloudy lose blurred vision, lumbago due to renal deficiency, night sweat, bones and muscles pain, puerperal puerperal tetanus, infant malnutrition.1. " book on Chinese herbal medicine converges and says ": " separate interior-heat to quench one's thirst, only night sweat due to yin deficiency." 2. essentials of Matea Medica: " per morning, saline gulped down or saline is cooked, the kidney invigorating." 3. " book on Chinese herbal medicine is through separating ": " is raw grinds painting carbuncle." 4. " Shen Shi efficacious prescriptions ": " suppressing the hyperactive liver fire.Control infantile malnutrition, order disease." 5. " BAICAO mirror ": " white subcutaneous ulcer of harnessing the Yellow River." 6. " thing parent states and sees ": " tonifying five ZANG-organs, in benefit, helps the twelve regular channels, in tune, and warm the intestines and stomach, relaxing muscles and tendons." 7. " detailed outline is picked up any lost article from the road ": " strengthening bone and muscle, only night sweat, invigorating kidney, promoting blood circulation, improving eyesight benefit essence.Liquor takes, and separates crow, attached poison." 8. " book on Chinese herbal medicine is new again ": " spleen invigorating is except wind, inducing diuresis and reducing edema." 9. " decoction pieces is newly joined ": " supports lung suppressing the hyperactive liver, refresh oneself." 10. " Chinese herbal medicine is commonly used in Shanghai ": " suppressing the hyperactive liver, improving eyesight, has again strong effect.Control dizzy order flower."

Rhizoma Cibotii: nature and flavor: bitter, sweet, temperature.Gui Jing: return liver, kidney channel.Cure mainly: invigorating the liver and kidney, strong spinal column, wind-damp dispelling.For soreness of the waist and knees, weakness of the lower extremities, rheumatic arthralgia.

Caulis Sargentodoxae: source: " simple and easy medical herbs ".Nature and flavor: bitter are flat.1. " Zhejiang traditional herbal medicine ": " property is put down, sour-puckery flavor." 2. " Traditional Chinese Medicine in Sichuan will ": " is cool in nature, and bitter in the mouth is nontoxic." return through: " Traditional Chinese Medicine in Sichuan will ": " enters liver.Large intestine two warp." cure mainly: relieve internal heat eliminating carbuncle, promoting blood circulation to remove obstruction in the collateral, wind dispelling insecticide.Control acute and chronic appendicitis, rheumatic arthralgia, bloody dysentery, stranguria with blood, menoxenia, infantile malnutrition, worm pain, injury from falling down.Heat-clearing and toxic substances removing, invigorates blood circulation, and dispels the wind.Pain is flutterred for abdominalgia with intestinal abscess, amenorrhea dysmenorrhea, rheumatic arthralgia, traumatic injury." simple and easy medical herbs ": " control bones and muscles pain, chase after wind, strong waist knee joint, tonifying YANG thing." " Hunan medicine will ": " is stimulated the menstrual flow and is enriched blood, bone and muscle strengthening, anthelmintic.Control traumatic injury, rheumatalgia, bruise, stranguria with blood, bones and muscles pain, furuncle, filaricide."

Rhizoma Drynariae: nature and flavor: bitter, temperature.Gui Jing: return kidney, Liver Channel.Cure mainly: the kidney invigorating bone strengthening, continue and hinder pain relieving.For lumbago due to renal deficiency, Hiccough and deaf, odontoseisis, falling winks frustrates, injured bone; External treatment alopecia areata, vitiligo.

Radix Morindae Officinalis: nature and flavor: sweet, pungent, tepor.Gui Jing: return kidney, Liver Channel.Cure mainly: kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For impotence and seminal emission, cold womb is infertile, menoxenia, and few abdomen cold type of pain, rheumatic arthralgia, muscles and bones flaccidity is soft.

Herba Epimedii: nature and flavor: acrid, sweet, warm.Gui Jing: return liver, kidney channel.Cure mainly: kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For impotence and seminal emission, muscles and bones flaccidity is soft, rheumatic arthralgia, numbness contracture; Climacteric hypertension.

Rhizoma Curculiginis: nature and flavor: pungent, heat; Poisonous.Gui Jing: return kidney,liver,spleen warp.Cure mainly: kidney-replenishing, bone and muscle strengthening, dispelling cold and dampness.For sexual impotence cold sperm, muscles and bones flaccidity is soft, the cold numbness of waist knee joint, yang deficiency cold diarrhea.

Semen Canavaliae: source: herbal for Relief of Famines.Nature and flavor: sweet, temperature.1. " detailed outline ": " sweet, flat, nontoxic." 2. " Bencao Congxin ": " is sweet, temperature." return through: " book on Chinese herbal medicine brief points ": " starts with, Foot yangming Channel." cure mainly: warming the middle warmer and descending qi, kidney tonifying complement.Control deficiency and coldness singultus, vomiting, abdominal distention, lumbago due to renal deficiency, phlegm dyspnea.1. " the southern regions of the Yunnan Province book on Chinese herbal medicine ": " spleen invigorating." 2. " detailed outline ": " warming the middle warmer and descending qi, sharp the intestines and stomach, only singultus, kidney tonifying complement." 3. " Chinese crude drug handbook ": " the kidney invigorating, cold expelling, the therapeutic method to keep the adverse QI flowing downwards, sharp the intestines and stomach, anti-nausea.Control kidney qi deficient, the intestines and stomach is got along well, vomiting, abdominal distention, vomits and diarrhoea." 4. " Traditional Chinese Medicine in Sichuan will ": " controls thoracic fullness and stomachache, treats kidney qi and does not return unit and dysentery."

Radix cynanchi wilfordii: source: " detailed outline ".Nature and flavor: 1. " Kweiyang medicinal herbs among the people ": " sweetness and bitterness, flat, nontoxic." 2. " Shaanxi Chinese herbal medicine ": " Gan Weixin is flat." cure mainly: yin nourishing tonify deficiency, strengthening the spleen to promote digestion.Control deficient impairment caused by overstrain, dysentery, infantile malnutrition, have a stomachache glutted, leucorrhea, skin ulcer tinea.1. " detailed outline ": " main abdominal distention stagnates." 2. " vegetation is side just ": " vinegar mill is coated with tinea." 3. " classifying herbal ": " helps digestion long-pending, and stimulating milk secretion, tonify deficiency is weak.Sore, lymphogranuloma inguinale are controlled in " " Guizhou side's medicine among the people collection ": " external." 5. " Shaanxi Chinese herbal medicine ": " nourishing YIN and benefiting blood, spleen invigorating is pleasant, sedation-analgesia, lactogenic.To treat for stomachache abdominal distention, asthenia, lumbago due to renal deficiency, sexual impotence, the abdominal lump of chilren, leucorrhea, hypogalactia." 6. " south mainly contains poisonous plant ": " controls oedema due to nephritis, gastric and duodenal ulcers." 7. " Jiangxi medical herbs ": " heat-clearing and toxic substances removing, pleasant dysentery relieving."

Radix Aristolochiae: nature and flavor: pungent, bitter, cold.Gui Jing: attach to the lung and stomach meridians.Cure mainly: suppressing the hyperactive liver pain relieving, removing toxic substances and promoting subsidence of swelling.For dizziness and headache, chest and abdomen swelling and pain, carbuncle furuncle, snake bite and insect sting.

Ramulus Buxi Sinicae: source: " detailed outline ".Nature and flavor: " Traditional Chinese Medicine in Sichuan will ": " property is put down, and bitter in the mouth is nontoxic." cure mainly: wind-damp dispelling, regulate the flow of vital energy, pain relieving.Dispelling the wind and dampness pathogens pain, breast abdomen flatulence, toothache, colic, traumatic injury.1. " classify herbal ": " control all rheumatism, headache, nine kinds of pain due to disorder of QI, red Hakuri." 2. " Traditional Chinese Medicine in Sichuan will ": " dispelling the wind and dampness pathogens, toothache, pain due to disorder of QI, mausoleum pain, breast abdomen flatulence, traumatic injury, married woman have difficult labour, and the summer-heat moon furuncle."

Rhizoma Curcumae Longae: nature and flavor: pungent, bitter, temperature.Gui Jing: return spleen, Liver Channel.Cure mainly: removing blood stasis circulation of qi promoting, inducing menstruation to relieve menalgia.Twinge for the breast side of body, amenorrhea ， WEIJIA, rheumatism shoulder arm pain, tumbling and swelling.

Semen oryzae sativae: source: " not Lu ".Nature and flavor: sweet are flat.1. " not Lu ": " bitter in the mouth, flat, nontoxic, " 2. " a thousand pieces of gold dietetic therapy ": " works hard, flat, nontoxic.Survivor is cold, the person's of burning heat." 3. " seven volume cuisine canons ": " sweet in the mouth, is slightly cold." 4. " detailed outline ": " northern round-grained rice: cool, southern round-grained rice: temperature, red round-grained rice: heat, white round-grained rice: cool, evening is round-grained rice in vain: cold, new round-grained rice: heat, old round-grained rice: cool." return through: " book on Chinese herbal medicine is looked for the truth ": " enters spleen, stomach warp." cure mainly: invigorating the spleen and replenishing QI, invigorating the spleen and regulating the stomach, relieving thirst and restlessness, antidiarrheal dysentery.1. " not Lu ": " main QI invigorating, only tired, stopping leak." 2. " a thousand pieces of gold dietetic therapy ": " flat gastric qi, longue meat." 3. the Meng numerous: " warming middle-JIAO, QI invigorating, mends lower unit." 4. " Japan hanako materia medica ": " strengthening bone and muscle, mends the intestines and stomach." 5. " the southern regions of the Yunnan Province book on Chinese herbal medicine ": " controls weakness, and reinforcing YIN-essence bone strengthening, promotes the production of body fluid, improving eyesight, long intelligence." 6. " detailed outline ": " Semen oryzae sativae medicated porridge: diuresis, only excessive thirst, support the intestines and stomach." " parched rice soup: stomach reinforcing dehumidifies."

Fructus Rosae Davuricae: source: " Heilungkiang Chinese medicine ".Cure mainly: 1. " Heilungkiang Chinese medicine ": " aid digestion.Control food stagnation of child." 2. " Chinese herbal medicine handbook is commonly used in northeast ": " spleen invigorating is regulated the flow of vital energy, nourishing blood for regulating menstruation.Control dyspepsia, the stagnation of QI is suffered from diarrhoea, stomachache, menoxenia."

Partition in Fructus Juglandis: source: " Shanxi Chinese medicinal herbal ".Nature and flavor: " book on Chinese herbal medicine is new again ": " bitter and puckery flavor, property is put down, nontoxic." return through: " book on Chinese herbal medicine is new again ": " enters spleen, kidney two warp." cure mainly: reinforcing the kindey to control nocturnal emission.Control seminal emission lingering diarrhea, gonorrhea, hematuria, incontinence of urine, metrorrhagia, leukorrhagia, dysentery.1. " book on Chinese herbal medicine is new again ": " spleen benefiting and strengthen kidney." 2. Chen Nian ancestral: " astringent therapy vital essence." 3. " Shanxi Chinese medicinal herbal ": " diuresis heat clearing away.Control gonorrhea hematuria, summer-heat dysentery." 4. " Chinese crude drug handbook ": " controls incontinence of urine, metrorrhagia hematochezia." 5. " Shaanxi Chinese medicinal herbal ": " controls deafness." 6. " Tianjin Chinese herbal medicine ": " astringent or styptic treatment for spontaneous sweating convergence.Control seminal emission, frequent micturition, leukorrhagia."

Caulis Mappianthi Iodoidis: source: " register planted by Guangxi medicine ".Nature and flavor: " choosing of Simao, Yunnan Chinese herbal medicine ": " bitter, cool." cure mainly: regulating menstruation and activating blood, expelling wind and removing dampness.Control menoxenia, dysmenorrhea, amenorrhea, rheumatic arthralgia.1. " register planted by Guangxi medicine ": " Herb: dispel the wind.Treating snakebite, infirmities and diseases." 2. " choosing of Simao, Yunnan Chinese herbal medicine ": " regulating menstruation and activating blood, hemostasis, pain relieving, centering, dehumidifying.Control menoxenia, dysmenorrhea, amenorrhea, puerperal blood deficiency, uterine contraction pain.Nervous cardiopalmus, rheumatic arthralgia, rheumatoid arthritis, the cruel arthralgia pain of waist, traumatic hemorrhage."

Fructus Hordei nudi Germinatus: source: " not Lu ".Nature and flavor: 1. " not Lu ": " temperature." 2. " detailed outline ": " is salty, temperature, nontoxic." cure mainly: help digestion, and in.Control food stagnation distension, inappetence, vomiting is had loose bowels.1. " not Lu ": " help digestion and in." 2. " property of medicine opinion ": " breaks cold air, removes trusted subordinate's distension." 3. " Japan hanako materia medica ": " whets the appetite, only cholera, and except unhappy, expectorant is drunk, and broken disease is amassed, and can expedite the emergence of tire." 4. Zhang Yuansu: " spleen reinforcing insufficiency of stomach, the wide intestinal therapeutic method to keep the adverse QI flowing downwards, borborygmus person uses it." 5. " detailed outline ": " digests all fruit food stagnations of all rice and flour."

Semen thlaspis: source: " herbal classic ".Nature and flavor: pungent, tepor.1. " herbal classic ": " acrid in the mouth, tepor." 2. " not Lu ": " be nontoxic." cure mainly: control conjunctival congestion and swelling pain and shed tears.1. " herbal classic ": " eliminating impediment, tonifying five ZANG-organs, benefit is with nothing left for main improving eyesight, ophthalmalgia lacrimation." 2. " not Lu ": " treats trusted subordinate's lumbago." 3. " property of medicine opinion ": " treating the liver man gather, and eyes is red swollen."

Carex Kobomugi Ohwi: source: " Haiyao Bencao, Oversea Materia Medica ".Nature and flavor: supplement to the Herbal: " sweet in the mouth is flat, nontoxic." return through: " book on Chinese herbal medicine brief points ": " enters that brothers are lunar, Yangming Channel.The thin weary damage of " curing mainly: " Haiyao Bencao, Oversea Materia Medica ": " main tonify deficiency, warming intestines and stomach, preventing or arresting vomiting is inverse, for a long time the strong people of food."

Radix Fissistigmatis Oldhamii: nature and flavor: micro-pungent, temperature.Cure mainly: expelling wind and activating blood circulation, analgesia.Cure mainly sciatica, arthritis, traumatic injury.

Radix Osbeckiae Crinitae: source: Kweiyang medicinal herbs among the people ".Nature and flavor: " Kweiyang medicinal herbs among the people ": " sour and astringent, be slightly cold, nontoxic." cure mainly: tonify deficiency kidney tonifying, astringing to arrest bleeding.Control the cough of consumptive disease wound to spit blood, dysentery, lower limb are aching and limp, muscles and bones contracture, urinary incontinence, nebulousurine leucorrhea.1. " Zhiwu Mingshi Tukao ": " control the inferior portion's void soft, nourishing YIN divides." 2. " conventional glossary of Herbs and Drugs among the people ": " kidney tonifying cough-relieving." 3. " Kweiyang medicinal herbs among the people ": " heat clearing away astringing to arrest bleeding.Control dysentery, void is coughed, spitting of blood."

Fructus Trapae qudricaudatae: source: " detailed outline is picked up any lost article from the road ".Nature and flavor: " detailed outline is picked up any lost article from the road ": " sweet in the mouth, property is put down, nontoxic." curing mainly: " detailed outline is picked up any lost article from the road ": " eats spleen reinforcing stomach invigorating raw, slakes thirst and help produce saliva, suppressing the hyperactive liver gas, and logical kidney water, beneficial blood helps digestion.The old cooks, spleen invigorating, stopping leak dysentery."

Rhizoma et radix smilacis santis: source: " Gansu Chinese herbal medicine handbook ".Nature and flavor: 1. " Gansu Chinese herbal medicine handbook ": " pungent salty, temperature." 2. " Henan economic plants will ": " bitter in the mouth, property is put down, nontoxic." cure mainly: expelling wind and removing dampness, activating blood cirulation to regulate QI flow, pain relieving.Dispelling the wind and dampness pathogens pain, traumatic injury, traumatic hemorrhage, fishbone bone stuck in the throat.1. " Gansu Chinese herbal medicine handbook ": " expelling wind and removing dampness, removing obstruction in the collateral to relieve pain.Dispelling the wind and dampness pathogens waist knee joint limbs pain is not healed for a long time, fishbone bone stuck in the throat." 2. " Henan economic plants will ": " promoting blood circulation and stopping pain.Control injured, wound." 3. " China's economic flora ": " pleasant analgesia."

Embodiment 1 granule

The manufacturing process of granule of the present invention is: get semen juglandis 250g, Rhizoma Homalomenae 200g, Pericarpium Citri Reticulatae 150g, Fructus Ligustri Lucidi 250g, Herba Ecliptae 150g, Semen glycines sojae 200g, Rhizoma Cibotii 170g, Caulis Sargentodoxae 300g, Rhizoma Drynariae 450g, Radix Morindae Officinalis 250g, Herba Epimedii 150g, Rhizoma Curculiginis 30g, Semen Canavaliae 150g, Radix cynanchi wilfordii 220g, Radix Aristolochiae 180g, Ramulus Buxi Sinicae 260g, Rhizoma Curcumae Longae 200g, Semen oryzae sativae 240g, Fructus Rosae Davuricae 150g, Partition in Fructus Juglandis 220g, Caulis Mappianthi Iodoidis 350g, Fructus Hordei nudi Germinatus 140g, Semen thlaspis 210g is with Carex Kobomugi Ohwi 350g,

The first step, mixed in described ratio by each for described pharmaceutical composition raw medicinal material, adding relative to the determining alcohol of 7 times, mixture is the ethanol of 90%, is heated to boiling reflux 4 hours, filter, adopt percolation with the speed of 1.5ml per minute slowly percolation, collect percolate, when being evaporated to 55 DEG C subsequently under vacuum 0.07Mpa, relative density is the mastic of 1.08, spraying dry, the inlet temperature 170 DEG C of spray dryer, leaving air temp 80 DEG C, is ground into powder subsequently, makes dried cream powder;

Second step, adds the dextrin of cane sugar powder relative to dried cream powder quality 0.3 times and 0.15 times, makes granule in the dried cream powder obtained, and in 45 DEG C of dryings, obtains granule.

Embodiment 2 capsule

The manufacturing process of capsule of the present invention is: get semen juglandis 300g, Rhizoma Homalomenae 160g, Pericarpium Citri Reticulatae 220g, Fructus Ligustri Lucidi 120g, Herba Ecliptae 180g, Semen glycines sojae 300g, Rhizoma Cibotii 150g, Caulis Sargentodoxae 200g, Rhizoma Drynariae 350g, Radix Morindae Officinalis 400g, Herba Epimedii 220g, Rhizoma Curculiginis 30g, Semen Canavaliae 250g, Radix cynanchi wilfordii 170g, Radix Aristolochiae 150g, Ramulus Buxi Sinicae 320g, Rhizoma Curcumae Longae 150g, Semen oryzae sativae 330g, Fructus Rosae Davuricae 210g, Partition in Fructus Juglandis 300g, Caulis Mappianthi Iodoidis 450g, Fructus Hordei nudi Germinatus 120g, Semen thlaspis 280g is with Carex Kobomugi Ohwi 310g,

The first step, is mixed in proportion each for described pharmaceutical composition raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 85%, reflux 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 2 times again, reflux 2 hours, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1.5 hours, pulverize, sieve, obtain 350 object micropowders;

3rd step, adds Pulvis Talci, magnesium stearate successively in the micropowders that second step obtains, and carries out mixing process, obtains capsule 's content; Described micropowders, magnesium stearate and talcous weight ratio are 100: 0.3:0.5, incapsulate in housing by described capsule 's content, obtain capsule finished product.

Embodiment 3 tablet

The manufacturing process of tablet of the present invention is: get semen juglandis 300g, Rhizoma Homalomenae 160g, Pericarpium Citri Reticulatae 220g, Fructus Ligustri Lucidi 120g, Herba Ecliptae 180g, Semen glycines sojae 300g, Rhizoma Cibotii 150g, Caulis Sargentodoxae 200g, Rhizoma Drynariae 350g, Radix Morindae Officinalis 400g, Herba Epimedii 220g, Rhizoma Curculiginis 30g, Semen Canavaliae 250g, Radix cynanchi wilfordii 170g, Radix Aristolochiae 150g, Ramulus Buxi Sinicae 320g, Rhizoma Curcumae Longae 150g, Semen oryzae sativae 330g, Fructus Rosae Davuricae 210g, Partition in Fructus Juglandis 300g, Caulis Mappianthi Iodoidis 450g, Fructus Hordei nudi Germinatus 120g, Semen thlaspis 280g, Carex Kobomugi Ohwi 310g, Radix Fissistigmatis Oldhamii 140g, Radix Osbeckiae Crinitae 320g, Fructus Trapae qudricaudatae 220g and Rhizoma et radix smilacis santis 150g,

The first step, is mixed in proportion each for described pharmaceutical composition raw medicinal material, and adding relative to the determining alcohol of mixture quality 4 times is the ethanol of 85%, reflux 5 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 90% that the medicinal residues that filtration obtains add relative to the determining alcohol of described medicinal residues quality 3 times again, reflux 2 hours, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 3 hours, pulverize, sieve, obtain 450 object micropowders;

3rd step, by the micropowders that second step obtains, adds relative to the microcrystalline Cellulose of its quality 0.15 times, 0.2 times of lactose, the starch of 0.3 times, sieves, mix homogeneously, granulates, dry, adds relative to micropowders quality 0.025 times of magnesium stearate, granulate, tabletting, makes.

Acute toxicity test: application NIH mice 40, S recovery from illness F level, male and female half and half, body weight 18 ~ 25g, carries out acute toxicity test.Mice is divided into two groups at random, often organizes 20, i.e. matched group and administration group, fasting 12 hours before experiment; The tablet dissolved prepared by embodiments of the invention 3 is in water, (concentration is 5.74g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg(and unit dosage form is 28.7 crude drugs/kg), matched group gives normal saline, administration in a day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage tablet LD50>28.7 crude drug/kg of the present invention, every day, maximum dosage-feeding was 57.4 crude drugs/kg/ day.Pharmaceutical composition clinical application amount of the present invention be 4.6g crude drug/day/people, adult body weight in 60KG, average dosage is 0.077g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 21g) oral administration gavage pharmaceutical composition of the present invention is 745 times of quantity.Therefore pharmaceutical composition acute toxicity of the present invention is low, clinical drug safety.

Long term toxicity test: the granule of the embodiment of the present invention 1 is pressed 6.43,15.72 and 36.41g crude drug/kg continuous use 16 weeks (1.0ml/100g body weight to mice, every day 2 times) and drug withdrawal after 4 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of pharmaceutical composition of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 16 weeks and drug withdrawal are after 4 weeks, and Organs of Mice is all without obviously changing.Illustrate that pharmaceutical composition of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.

Cumulative toxicity test is reported: test method: select 20 healthy mices, female, each 10 of hero, with the capsule of the embodiment of the present invention 2 for object, dose design is first phase in every 5 days, each issue dosage is respectively 0.10LD50,0.15LD50,0.22LD50,0.34LD 50,0.50LD50, the LD 50 that is female, male mice of this sample be 5000m part/k part BW (five dosage is 500,750,1100,1700,2500m part/k part BW).Within every 5 days, weigh once, adjustment dosage, by 0.1ml/10 part BW per os gavage.After 20 days, animal occurs without death condition, off-test, and by ascending-dose to tested material after 20 days, female, buck all occurs without death condition.

Clinical data:

Case selection: the 200 routine postmen opausal patients selecting in July, 2013 to 2014 year outpatient service in July or be in hospital, age 55-70 year, average (57.2 ± 4.5) year, the course of disease 5 months to 2 years half; 200 routine patients meet following condition: get rid of the caused Secondary cases OP such as hyperparathyroidism, multiple myeloma, prolonged application glucocorticoid; Within nearly 3 months, do not use and affect bone metabolism medicine, as vitamin D, estrogen, calcium preparation, diphosphate etc.; Without severe cardiac, liver, nephropathy.There is menostaxis and persistence vaginal hemorrhage one and a half months in above-mentioned 200 routine patients, also with shallow complexion, malaise, the symptom such as nervous and breathe hard, after menopause, CT level reduces on inspection, estrogen is lower than level during health, and diagnostic criteria adopts 1999 " Chinese's osteoporosis suggestion diagnostic criteria (the second original text) "; Granules in Treating group, capsule treatment group, tablet in treatment group and matched group are divided at random to 200 routine patients, each experimental group 50 people.

Diagnostic criteria: with reference to " Chinese's osteoporosis suggestion diagnostic criteria (the second original text) ", must possess overall pain, be that obviously microtrauma can cause fracture mainly with lumbar and back pain, or scheuermann kyphosis deformity, or bone density (BMD) reduces by 2 above persons of standard deviation.

1. inclusive criteria has typical OP clinical symptoms, meets OP diagnostic criteria; 2. age person between 55-70 year; 3. voluntary as study subject, signature Informed Consent Form, and energy reception test pharmaceutical dosage form, ensured person's course for the treatment of.

1. exclusion standard has secondary osteoporosis and other serious complication persons such as hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma; 2. obviously bow-backed deformity, disabled and disability person is presented; 3. severe cardiac cerebrovascular is suffered from, liver, kidney, lung and hemopoietic system primary disease person; 4. within the observation period course for the treatment of, due to a variety of causes, as gone out, residence migration etc. can not obtain the person of following up a case by regular visits on request; 5. to this drug allergy person or to multi-medicament allergy sufferers; 6. psychosis or patients with Alzheimer disease; 7. duration of test is failed by regulation medication or the person of dropping by the wayside.

Therapeutic Method:

In medicine composite for curing group:

Granules in Treating group: use the embodiment of the present invention 1 to prepare granule, every day 3 times, once a bag, every bag of 6g every 30 days is 1 course for the treatment of;

Capsule treatment group: take the embodiment of the present invention 2 prepare capsule, every day 3 times, one time 1, within every 30 days, be a course for the treatment of;

Tablet in treatment group: use the embodiment of the present invention 3 prepare tablet, every day 3 times, one time 1, within every 30 days, be a course for the treatment of.

Matched group: take alfacalcidol sheet, every day 3 times, one time 1, within every 30 days, be a course for the treatment of.

The standard of curative effect evaluation: according to " new Chinese medicine guideline of clinical investigations " Beijing: China Medical Science Press, author: Zheng Xiao cornel; Formulate criterion of therapeutical effect.Effective: pain disappears completely, check display bone density increase, CT level and estrogen level normal; Effective: pain is obviously alleviated, check that having no bone density declines, CT level and estrogen level improve; Invalid: to compare with before treatment, each side is all without improvement.

Therapeutic outcome:

See table 1 and table 2, as can be seen from Table 1, adopt Drug therapy osteoporosis of the present invention, relative to conventional medicament on therapeutic effect, there is significant improvement; As can be seen from Table 2, adopt Drug therapy matter of the present invention loosen, relative to conventional medicament, treatment the course for the treatment of on significantly shorten.

After each group of table 1 treats 4 courses for the treatment of respectively, Clinical efficacy comparison is routine

Table 2 Four composition is effective and efficiently individual quantity time comparative example (%) after not treating 4 courses for the treatment of

According to the clinical statistics in above table, medicine provided by the invention have rapid-action, effective percentage is high, determined curative effect, safety are high, have no side effect; 147 example and the effective and effective 43 routine follow-up of patients 1 year half of matched group of and efficiently individual quantity effective to treatment group simultaneously, result is added up, and in Granules in Treating group 48 example, effective 46 examples are without recurring, and without 1 case relapsed in effective 2 examples, relapse rate is 2.1%; In capsule treatment group 49 example, effective 48 examples are without recurrence, 1 case relapsed in effective 1 example, and relapse rate is 2.0%; In tablet in treatment group 50 example in effective 50 all without recurrence, relapse rate is 0%; Matched group is effective and efficiently individual quantity 43 routine, recurs 7 examples in effective 31 routine patients, recurs 9 examples, relapse rate 37.2% in effective 12 routine patients; Above-mentioned recurrence refer to patient outcomes reach effective or effectively after, in 1 year half of following up a case by regular visits to, obviously there is the symptom before treatment.

Model case: Wang, 58 years old, there is menostaxis and persistence vaginal hemorrhage one and a half months in women, with shallow complexion, malaise, the symptom such as nervous and breathe hard, on inspection, CT level reduces, and estrogen, lower than level during health, is diagnosed as postmen opausal.Take the tablet of pharmaceutical composition embodiment 3 of the present invention, every day 3 times, one time 1, medication is cured a course for the treatment of substantially, continues medication two weeks and cures, follow up a case by regular visits to and do not recur for 1 year half.

The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.

Claims

1. treat the pharmaceutical composition of postmen opausal for one kind, it is characterized in that, comprise following raw medicinal material: semen juglandis, Rhizoma Homalomenae, Pericarpium Citri Reticulatae, Fructus Ligustri Lucidi, Herba Ecliptae, Semen glycines sojae, Rhizoma Cibotii, Caulis Sargentodoxae, Rhizoma Drynariae, Radix Morindae Officinalis, Herba Epimedii, Rhizoma Curculiginis, Semen Canavaliae, Radix cynanchi wilfordii, Radix Aristolochiae, Ramulus Buxi Sinicae, Rhizoma Curcumae Longae, Semen oryzae sativae, Fructus Rosae Davuricae, Partition in Fructus Juglandis, Caulis Mappianthi Iodoidis, Fructus Hordei nudi Germinatus, Semen thlaspis are with Carex Kobomugi Ohwi.

2. the pharmaceutical composition for the treatment of postmen opausal according to claim 1, it is characterized in that, in described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 10 ~ 40 parts, Rhizoma Homalomenae 12 ~ 22 parts, Pericarpium Citri Reticulatae 14 ~ 24 parts, Fructus Ligustri Lucidi 10 ~ 30 parts, Herba Ecliptae 15 ~ 25 parts, Semen glycines sojae 13 ~ 33 parts, Rhizoma Cibotii 10 ~ 20 parts, Caulis Sargentodoxae 17 ~ 31 parts, Rhizoma Drynariae 15 ~ 45 parts, Radix Morindae Officinalis 12 ~ 42 parts, Herba Epimedii 14 ~ 24 parts, Rhizoma Curculiginis 3 ~ 5 parts, Semen Canavaliae 10 ~ 30 parts, Radix cynanchi wilfordii 15 ~ 25 parts, Radix Aristolochiae 10 ~ 20 parts, Ramulus Buxi Sinicae 14 ~ 34 parts, 11 ~ 21 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 17 ~ 36 parts, Fructus Rosae Davuricae 15 ~ 25 parts, Partition in Fructus Juglandis 10 ~ 35 parts, Caulis Mappianthi Iodoidis 18 ~ 45 parts, Fructus Hordei nudi Germinatus 10 ~ 20 parts, Semen thlaspis 11 ~ 31 Fen is with Carex Kobomugi Ohwi 15 ~ 40 parts.

3. the pharmaceutical composition for the treatment of postmen opausal according to claim 1 and 2, it is characterized in that, in described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 25 parts, Rhizoma Homalomenae 20 parts, Pericarpium Citri Reticulatae 15 parts, Fructus Ligustri Lucidi 25 parts, Herba Ecliptae 15 parts, Semen glycines sojae 20 parts, Rhizoma Cibotii 17 parts, Caulis Sargentodoxae 30 parts, Rhizoma Drynariae 45 parts, Radix Morindae Officinalis 25 parts, Herba Epimedii 15 parts, Rhizoma Curculiginis 3 parts, Semen Canavaliae 15 parts, Radix cynanchi wilfordii 22 parts, Radix Aristolochiae 18 parts, Ramulus Buxi Sinicae 26 parts, 20 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 24 parts, Fructus Rosae Davuricae 15 parts, Partition in Fructus Juglandis 22 parts, Caulis Mappianthi Iodoidis 35 parts, Fructus Hordei nudi Germinatus 14 parts, Semen thlaspis 21 Fen is with Carex Kobomugi Ohwi 35 parts.

4. the pharmaceutical composition of the treatment postmen opausal according to any one of claim 1-3, it is characterized in that, in described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 30 parts, Rhizoma Homalomenae 16 parts, Pericarpium Citri Reticulatae 22 parts, Fructus Ligustri Lucidi 12 parts, Herba Ecliptae 18 parts, Semen glycines sojae 30 parts, Rhizoma Cibotii 15 parts, Caulis Sargentodoxae 20 parts, Rhizoma Drynariae 35 parts, Radix Morindae Officinalis 40 parts, Herba Epimedii 22 parts, Rhizoma Curculiginis 3 parts, Semen Canavaliae 25 parts, Radix cynanchi wilfordii 17 parts, Radix Aristolochiae 15 parts, Ramulus Buxi Sinicae 32 parts, 15 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 33 parts, Fructus Rosae Davuricae 21 parts, Partition in Fructus Juglandis 30 parts, Caulis Mappianthi Iodoidis 45 parts, Fructus Hordei nudi Germinatus 12 parts, Semen thlaspis 28 Fen is with Carex Kobomugi Ohwi 31 parts.

5. the pharmaceutical composition of the treatment postmen opausal according to any one of claim 1-4, is characterized in that, in described pharmaceutical composition, each raw medicinal material also comprises: Radix Fissistigmatis Oldhamii, Radix Osbeckiae Crinitae, Fructus Trapae qudricaudatae and Rhizoma et radix smilacis santis.

6. the pharmaceutical composition of the treatment postmen opausal according to any one of claim 1-5, it is characterized in that, in described pharmaceutical composition, the ratio of weight and number of each raw medicinal material is: semen juglandis 30 parts, Rhizoma Homalomenae 16 parts, Pericarpium Citri Reticulatae 22 parts, Fructus Ligustri Lucidi 12 parts, Herba Ecliptae 18 parts, Semen glycines sojae 30 parts, Rhizoma Cibotii 15 parts, Caulis Sargentodoxae 20 parts, Rhizoma Drynariae 35 parts, Radix Morindae Officinalis 40 parts, Herba Epimedii 22 parts, Rhizoma Curculiginis 3 parts, Semen Canavaliae 25 parts, Radix cynanchi wilfordii 17 parts, Radix Aristolochiae 15 parts, Ramulus Buxi Sinicae 32 parts, 15 parts, Rhizoma Curcumae Longae, Semen oryzae sativae 33 parts, Fructus Rosae Davuricae 21 parts, Partition in Fructus Juglandis 30 parts, Caulis Mappianthi Iodoidis 45 parts, Fructus Hordei nudi Germinatus 12 parts, Semen thlaspis 28 parts, Carex Kobomugi Ohwi 31 parts, Radix Fissistigmatis Oldhamii 14 parts, Radix Osbeckiae Crinitae 32 parts, Fructus Trapae qudricaudatae 22 parts and Rhizoma et radix smilacis santis 15 parts.

7. the preparation method of the pharmaceutical composition of the treatment postmen opausal according to any one of claim 1-6, is characterized in that, when the dosage form of described pharmaceutical composition is granule, its preparation method comprises the following steps:

8. the preparation method of the pharmaceutical composition of the treatment postmen opausal according to any one of claim 1-6, is characterized in that, when the dosage form of described pharmaceutical composition is capsule, its preparation method comprises the following steps:

9. the preparation method of the pharmaceutical composition of the treatment postmen opausal according to any one of claim 1-6, is characterized in that, when the dosage form of described pharmaceutical composition is tablet, its preparation method comprises the following steps: