CN105434579A - Traditional Chinese medicine for treating bone rarefaction - Google Patents

Traditional Chinese medicine for treating bone rarefaction Download PDF

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CN105434579A
CN105434579A CN201610042817.4A CN201610042817A CN105434579A CN 105434579 A CN105434579 A CN 105434579A CN 201610042817 A CN201610042817 A CN 201610042817A CN 105434579 A CN105434579 A CN 105434579A
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chinese medicine
kidney
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bone
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董春玲
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Qingdao Huazhicao Medical Technology Co Ltd
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Abstract

The invention discloses a traditional Chinese medicine for treating bone rarefaction, and belongs to the technical field of medicines. The traditional Chinese medicine is prepared from epimedium, oysters, rhizoma cibotii, cornus officinalis, cynomorium, fructus cnidii, cornu cervi, radix cynanchi panicullati, drynaria total flavonoids, cistanche salsa, clove, papaya, monkshood and spina date seeds. The traditional Chinese medicine is reasonable in medicine composition and excellent in compatibility and depends on the traditional Chinese medicine theory, namely, the principle that liver governs tendons and kidney governs bones. The effects of tonifying qi, kidney and spleen, invigorating blood circulation and nourishing liver are achieved at the same time. Thus, the internal functions of human bodies are stimulated, and the aim of treating bone rarefaction is achieved in a real sense.

Description

One is used for the treatment of osteoporotic Chinese medicine
The application is the divisional application of the application for a patent for invention (denomination of invention is: one is used for the treatment of osteoporotic Chinese medicine and preparation method thereof, and application number is: 2014106685962, and the applying date is: on November 21st, 2014) that applicant Cui Hefang proposes.
Technical field
The present invention relates to medical art, particularly relate to one and be used for the treatment of osteoporotic Chinese medicine.
Background technology
Osteoporosis is the common a kind of bone metabolism disease of old people, and there is trend in advance at the current age, has become one of international public health problem.Its pathogenesis is always also very not clear and definite, and the change be commonly considered as because of factors such as hormone regulating and controlling (estrogen, parathyroid hormone, calcitonin and activated vitamin D), nutritional status (calcium, phosphorus, protein and fat etc.), physical factor (motion, daylight), immunologic function and heredity is closely related.Show human endocrine Developmental and Metabolic Disorder, the bone amount minimizing of skeleton, bone fine structure destroy, and bone biomechanical property declines, with the disease of bones quality and quantity.Osteoporotic site of pathological change is that human body axial bone and long bone of limbs are key, and maximum harm is fracture, and most common sympton is pain, common with lumbago and backache, accounts for 70%-80%.Osteoporotic fracture has a very long preclinical phase before occurring, period the most outstanding performance is exactly osteodynia, comprise back and extremities joint ache, weak etc., pain spreads along spinal column to both sides, pain relief when dorsal position or seat, stretch after upright or standing for a long time, sitting time the pain increased, pain relief in the daytime, night and early morning increase the weight of when waking up, and bend over, muscular movement, cough, stool increase the weight of when exerting oneself.
The Western medicine of current protect against osteoporosis mainly contains estrogen, calcitonin, diphosphate, Calcium and vitamin D class etc.Wherein estrogen is longer for medicine time, and may cause breast carcinoma and carcinoma of endometrium, prolonged application toxic and side effects is larger simultaneously.Calcitonin has certain curative effect to osteoporosis, but expensive, is difficult to for extensive patients accepts.
By theory of Chinese medical science, osteoporosis belongs to the sick categories such as the atrophic debility of bones, rheumatism involving the bone, lumbago.Kidney governing bones, the raw marrow of store essential substances, blood stored in the liver, profit muscle Shugu.The sick atrophic debility of bones again over seventy-seven, caused by caused by liver and kidney deficiency.Rheumatism involving the bone or lumbago, if its pain is very acute, or by blood stasis or have a cold caused by turbid damp exopathogen, meridian qi and blood is obstructed, stagnation of QI and blood may bring about pain.Primary disease be detected in there is nonviolent fracture time, pain is not indistinct under normal circumstances, light or heavy, continues endlessly, genus muscles and bones the moon blood cervical carcinoma with cachexia, flourish and bitterly.After the lid middle age, the deficiency of vital energy of Liver and kidney declines, before this as " Plain Questions ancient times innocent by " say " irritability declines, the tendon being unable to move ", muscle arteries and veins take out pull, muscles and bones slacks off, continuous and kidney essense decline, can not fill bone by spermatogenesis marrow, withered bone with deficient medulla, muscles and bones lack moisten in essence and blood foster, the existing lumbar and back pain of disease, aching and limp weak.Also dizzy tinnitus is seen, the diseases such as loss of hairs luxated tooth, hypomnesis by caused by liver and kidney deficiency.If patient's post menopausal is early stage, then or Liver and kidney the moon point not enough, asthenic fire is disturbed and existing women's head-ornaments are warmed, are easy to irritated etc.Once showed the case 819 illustration type investigation meeting diagnosis of primary osteoporosis, what belong to deficiency of both the liver and kidney accounts for 96.2%, wherein, has negative and positive two person of losing 16.2% concurrently, negative and positive loss unconspicuous 19.1%; 58.2% has deficiency of YIN symptom concurrently, yang deficiency loss person 2.7%.Therefore, the Therapeutic Principle no matter understanding of Chinese medical theory to primary disease etiology and pathogenesis draws, or from the rule for the treatment of that determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs principle draws, all suitable invigorating the kidney and strengthening the bones, and the kidney invigorating should take into account nourishing kidney-yin, kidney tonifying sun.
Summary of the invention
The invention provides one and be used for the treatment of osteoporotic Chinese medicine and preparation method thereof.
The technical scheme that the present invention takes is:
Of the present invention to be used for the treatment of osteoporotic Chinese medicine be made up of the raw material of following weight portion: Herba Epimedii 100-200 part, Concha Ostreae 100-200 part, Rhizoma Cibotii 90-200 part, Fructus Corni 100-200 part, Herba Cynomorii 100-180 part, Fructus Cnidii 75-150 part, Cornu Cervi Pantotrichum 90-190 part, Radix Cynanchi Paniculati 50-160 part, Rhizoma Drynariae 60-160 part, Herba Cistanches 50-150 part, Flos Caryophylli 50-150 part, Fructus Chaenomelis 50-100 part, Radix Aconiti Lateralis Preparata 30-100 part, Semen Ziziphi Spinosae 40-80 part.
It is preferably above-mentioned that to be used for the treatment of osteoporotic Chinese medicine be made up of the raw material of following weight portion: Herba Epimedii 100-180 part, Concha Ostreae 120-200 part, Rhizoma Cibotii 100-200 part, Fructus Corni 110-190 part, Herba Cynomorii 130-170 part, Fructus Cnidii 80-150 part, Cornu Cervi Pantotrichum 90-170 part, Radix Cynanchi Paniculati 70-160 part, Rhizoma Drynariae 80-160 part, Herba Cistanches 50-120 part, Flos Caryophylli 70-130 part, Fructus Chaenomelis 60-100 part, Radix Aconiti Lateralis Preparata 30-80 part, Semen Ziziphi Spinosae 40-70 part.
One of preferred technical scheme: Chinese medicine of the present invention is made up of the raw material of following weight portion: Herba Epimedii 100 parts, Concha Ostreae 200 parts, Rhizoma Cibotii 100 parts, Fructus Corni 190 parts, Herba Cynomorii 130 parts, Fructus Cnidii 150 parts, 90 parts, Cornu Cervi Pantotrichum, Radix Cynanchi Paniculati 160 parts, Rhizoma Drynariae 80 parts, Herba Cistanches 120 parts, Flos Caryophylli 70 parts, Fructus Chaenomelis 100 parts, Radix Aconiti Lateralis Preparata 30 parts, Semen Ziziphi Spinosae 70 parts.
Preferred technical scheme two: Chinese medicine of the present invention is made up of the raw material of following weight portion: Herba Epimedii 180 parts, Concha Ostreae 120 parts, Rhizoma Cibotii 200 parts, Fructus Corni 110 parts, Herba Cynomorii 170 parts, Fructus Cnidii 80 parts, 170 parts, Cornu Cervi Pantotrichum, Radix Cynanchi Paniculati 70 parts, Rhizoma Drynariae 160 parts, Herba Cistanches 50 parts, Flos Caryophylli 130 parts, Fructus Chaenomelis 60 parts, Radix Aconiti Lateralis Preparata 80 parts, Semen Ziziphi Spinosae 40 parts.
Preferred technical scheme three: Chinese medicine of the present invention is made up of the raw material of following weight portion: Herba Epimedii 140 parts, Concha Ostreae 160 parts, Rhizoma Cibotii 150 parts, Fructus Corni 160 parts, Herba Cynomorii 150 parts, Fructus Cnidii 120 parts, 130 parts, Cornu Cervi Pantotrichum, Radix Cynanchi Paniculati 110 parts, Rhizoma Drynariae 120 parts, Herba Cistanches 90 parts, Flos Caryophylli 120 parts, Fructus Chaenomelis 80 parts, Radix Aconiti Lateralis Preparata 50 parts, Semen Ziziphi Spinosae 60 parts.
The dosage form being used for the treatment of osteoporotic Chinese medicine of the present invention is tablet, capsule, pill, granule, injection, oral liquid or decoction.
The concrete steps that the present invention is used for the treatment of the preparation method of osteoporotic Chinese medicine are as follows:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, cross 100 mesh sieves after pulverizing, then it is for subsequent use to carry out being mixed to get fine drug powder;
(2) add in decoction pot by fine drug powder prepared by step (1), decoct with water twice, first time adds water as the 5-12 times amount of initial drug weight, decocting time is 3-6h, and second time amount of water is the 3-8 times amount of initial drug weight, and decocting time is 1-3h, merge decoction liquor, filter;
(3) filter complete, to filtrate carry out heating concentrate, being condensed into relative density at 60 DEG C is the extractum of 1.08-1.13, then makes finished product according to a conventional method.
In step (2), preferably first time adds water is 9 times amount, and decocting time is 4h, and second time amount of water is 5 times amount, and decocting time is 2h.
In step (3), preferably carry out heating to filtrate and concentrate, being condensed into relative density at 60 DEG C is the extractum of 1.10.
Theory of Chinese medical science thinks treatment, and osteoporosis is substantially main starts with from the following aspects:
One, the kidney invigorating: the traditional Chinese medical science is thought, kidney be first this, the motive power that kidney essense is body parts growth, growth is hidden by its institute, and the relation of itself and bone is particularly close: " Plain Questions declares five gas sections " says " kidney governing bones ", and " ancient Chinese medical classics essential ideas " is said: " kidney storing essence, the raw marrow of essence; therefore bone person; also, marrow person, the institute of essence give birth to also; essence foot then marrow is sufficient; marrow is in bone, and marrow is sufficient, and then bone is strong in the conjunction of kidney ", the growth of skeleton, growth, all bad kidney essense of reparation change the nourishing of raw bone marrow.Kidney essense is sufficient, then bone marrow fills, and skeleton is healthy and strong strong; Otherwise deficiency of kidney-essence, bone marrow is hollow, then easily cause skeleton development bad.In " Plain Questions flaccidity opinion " " heat in the kidney is failure of the spinal column to keep in upright position then, and bone is withered and marrow subtracts, and sends out as the atrophic debility of bones "; In " Plain Questions vital QI of the body connecting with natural QI opinion " " thus powerful, kidney qi is wound, and processus styloideus radii is bad ", all indicate and first injure kidney, and then and the morbidity of bone pass through." Plain Questions innocence in ancient times opinion " is pointed out, people is from childhood to old age, and experienced by kidney essense from lacking at the most, the middle age reaches its height, the natural process of old exhaustion gradually.Old people is along with the exhaustion of each organ, and kidney qi is weak, and bone marrow biochemistry is passive, and skeleton can not get nourishing, and more easily occurs " hollow in bone ", sends out as " atrophic debility of bones ".Therefore the treatment to senile osteoporosis, the kidney invigorating is the method that must go.
Two, spleen invigorating: Chinese medicine osteoporosis is normal in the past to be focused on the kidney invigorating and ignores spleen invigorating, thus hinders Chinese medicine to the further raising of osteoporosis therapy.Spleen and osteoporotic relation are mainly reflected in the transportation capabilities of spleen, and namely water paddy turns to precise and tiny by spleen, cereal nutrient are absorbed the physiological function of transferring to whole body.Nutrient substance that skeleton also will transfer by spleen nourishes can strong, nimbly and freely.The each organ failure of old people, dysfunction of the spleen in transportation, the raw insufficient raw material of Skeleton, directly causes osteoporotic generation.Secondly, spleen and osteoporotic relation are also embodied in the relation of taste and kidney, more old people has and suffers from a deficiency of the kidney, insufficiency of primordial QI, and the vigour of kidney only have constantly obtain taste change the nourishing of raw essence of water and grain, spleen invigorating the effect of " kidney governing bones " can be given full play to, so can promote that kidney is to the effect of skeleton indirectly.Moreover " spleen governing muscles " and skeleton also have substantial connection." Plain Questions " say " the spleen controlling the muscles of whole body ", " modern dysfunction of the spleen in transporting essential substances from the stomach to the whole body, extremity must not report water essence derived from food, and gas day, sering was unfavorable to decline, muscles and bones muscle all depletion of QI with life, therefore need not here ".Dysfunction of the spleen in transportation, wasting and atrophy of muscle, is difficult nourishing bone; Clear YANG failing to distribute, then, there is fatigue and weakness in extremity undernutrition, need not even flaccidity is weak.Finally, " the spleen transporting the nutritious substance in the stomach ", taste owner body digestive and absorptive functions, the strong fortune of taste, can strengthen the absorption to calcium, vitamin D and various nutrient substance, thus the symptom of mitigating osteoporosis.
Three, invigorate blood circulation: pain is the most common, the topmost clinical symptoms of primary osteoporosis, the most common with lumbago and backache, is also the first cause of patient assessment.Motherland's medical science is thought " stagnation of QI and blood may bring about pain, pain is then obstructed ", causes the one of the main reasons of " obstructed " to be in blood stasis errors in Medicine Corrected and also explicitly points out " the pain not place of moving " or " all arthromyodynia pain " " surely having blood stasis ".The topmost clinical symptoms pain of osteoporosis is the result of blood stasis.In clinical investigation, find that most of primary osteoporosis patient is except " localized pain ", also have Sublingual venation varicose, purplish tongue, other support the performance of syndrome of blood stasis ecchymosis etc., show further osteoporotic generation and blood stasis closely related.Document shows, osteoporotic morbidity is nothing more than " void ", " stasis of blood ".Old people has the deficiency of vital energy more, and the deficiency of vital energy then blood is unable, and comparatively youngster is easier causes the stasis of blood because of void.There are some researches show again, there is the exception of Hemorheology in Patients with Kidney Deficiency Type, and suffering from a deficiency of the kidney also can the hyperamization stasis of blood, and suffer from a deficiency of the kidney be exactly most old people institute inevitably.Blood stasis can affect bone metabolism, causes osteodystrophy.Its pathologic basis is that skeletal system blood stasis causes microcirculation disturbance in bone trabecula, be unfavorable for that cell carries out effective mass exchange, the calcium in blood and nutrient substance can not enter skeleton normal through havers' system, finally cause skeleton and lose foster, fragility increases, and osteoporosis occurs.
Four, nourishing the liver: liver and osteoporosis also have certain relation, the pass being mainly reflected in liver and muscle is fastened: " source of endurance, main profit penis "." Plain Questions lose consciousness opinion " is said " heat in the liver then gallbladder drain port is bitter, and fascia does .. ", and muscle invests bone, and the dry then skeleton of fascia lacks and nourishes, and involves in bone." Plain Questions five gas generates a section " is said " the tissue connected with the liver being tendon, its flourish pawl also ", and pawl is " after bone ", and irritability is sufficient, and fascia is tough and tensile, and bone is foster to some extent, and onyx is sharp; Deficiency of liver-QI, fascia relaxes, and bone is become homeless foster, and onyx is intense darkness without light.Secondly, " The liver and the kidney have a common source ", blood stored in the liver, kidney storing essence, liver blood, kidney essense can transform mutually, and then kidney is also not easily empty by force for liver, indirectly promotes the effect of " kidney governing bones ", prevents and treats osteoporotic generation.Finally, liver controlling conveyance and dispersion, association's Regulating ascending and descending of the spleen and stomach, the transportation capabilities of spleen are healthy and vigorous, and QI and blood biochemistry is active, and bone is foster to some extent, namely prevents and treats osteoporosis by spleen invigorating.
The present invention on the basis of differential diagnosis in tcm, according to above-mentioned Therapeutic Principle, choose reasonable medicine, and carry out prescription according to the principle of traditional Chinese medical science monarch.Choose Herba Epimedii, Concha Ostreae, Rhizoma Cibotii, Fructus Corni, Herba Cynomorii as monarch drug; Herba Epimedii has kidney invigorating and YANG supporting, effect of expelling wind and removing dampness; Concha Ostreae has effect of strengthening by means of tonics, mind tranquilizing and the heart calming, strengthening the tendons and bones; Rhizoma Cibotii has invigorating the liver and kidney, wind-damp dispelling, strong waist foot, the effect in sharp joint; Fructus Corni has liver and kidney tonifying; The solid de-effect of convergence; Herba Cynomorii has effect of the kidney invigorating intestine moistening.
Be chosen for Fructus Cnidii, Cornu Cervi Pantotrichum, Radix Cynanchi Paniculati, Rhizoma Drynariae ministerial drug; Fructus Cnidii has warming the kidney to invigorate YANG, dampness, the effect of dispeling the wind; Cornu Cervi Pantotrichum has invigorating kidney-YANG, mends marrow, effect of bone and muscle strengthening; Radix Cynanchi Paniculati has effect of expelling wind and cold, removing damp and stopping pain; Rhizoma Drynariae has the kidney invigorating, invigorates blood circulation, effect of hemostasis.
Choose Herba Cistanches, Flos Caryophylli, Fructus Chaenomelis be adjuvant drug; Herba Cistanches has kidney-replenishing; Benefiting essence-blood; The effect in intestine moistening road; Flos Caryophylli has warming middle-JIAO to send down the adverse QI, effect of warming the kidney to activate YANG; Fructus Chaenomelis has suppressing the hyperactive liver, relaxing muscles and tendons, and spleen, effect of removing dampness.
Choose Radix Aconiti Lateralis Preparata, Semen Ziziphi Spinosae for making medicine; Radix Aconiti Lateralis Preparata has recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, effect of dispelling cold and removing dampness; Semen Ziziphi Spinosae has mind tranquilizing and the heart calming; Nourishing the liver; Effect of arresting sweating.
Medicament composing prescription of the present invention is reasonable, and compatibility is superior, according to theory of Chinese medical science: the principle of liver governing tendons, kidney governing bones.Taken into account QI invigorating, the kidney invigorating, spleen reinforcing, invigorated blood circulation, the effect of nourishing the liver.Thus the inherent function of exciting human, from truly reaching the osteoporotic object for the treatment of.Medicine energy of the present invention invigorating the liver and kidney, reuniting the fractured tendons and bones, blood circulation regulating, can improve the symptom of aching pain in waist and back, the foot and knee being feeble.Can bone density be significantly improved, bone mineral content, there is the osteoporotic curative effect of significant treatment.Curative effect of medication of the present invention is remarkable, little to other organ-tissue toxic and side effects, can long-term taking, have keep fit, strong bone function, all have significant curative effect to diseases such as osteoporosis, fracture, osteoarthritis.
Detailed description of the invention
The following examples describe in further detail of the present invention.
One, the preparation of medicine
Embodiment 1
1.1 raw materials composition (g):
Herba Epimedii 100, Concha Ostreae 200, Rhizoma Cibotii 100, Fructus Corni 190, Herba Cynomorii 130, Fructus Cnidii 150, Cornu Cervi Pantotrichum 90, Radix Cynanchi Paniculati 160, Rhizoma Drynariae 80, Herba Cistanches 120, Flos Caryophylli 70, Fructus Chaenomelis 100, Radix Aconiti Lateralis Preparata 30, Semen Ziziphi Spinosae 70.
1.2 preparation methoies:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, cross 100 mesh sieves after pulverizing, then it is for subsequent use to carry out being mixed to get fine drug powder;
(2) then add in decoction pot by fine drug powder prepared by step (1), decoct with water twice, it is 5 times amount that first time adds water, and decocting time is 3h, and second time amount of water is 3 times amount, and decocting time is 1h, merges decoction liquor, filters;
(3) filter complete, to filtrate carry out heating concentrate, being condensed into relative density at 60 DEG C is the extractum of 1.08, then makes capsule according to a conventional method.
Embodiment 2
2.1 raw materials composition (g):
Herba Epimedii 180, Concha Ostreae 120, Rhizoma Cibotii 200, Fructus Corni 110, Herba Cynomorii 170, Fructus Cnidii 80, Cornu Cervi Pantotrichum 170, Radix Cynanchi Paniculati 70, Rhizoma Drynariae 160, Herba Cistanches 50, Flos Caryophylli 130, Fructus Chaenomelis 60, Radix Aconiti Lateralis Preparata 80, Semen Ziziphi Spinosae 40.
2.2 preparation methoies:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, cross 100 mesh sieves after pulverizing, then it is for subsequent use to carry out being mixed to get fine drug powder;
(2) then add in decoction pot by fine drug powder prepared by step (1), decoct with water twice, it is 12 times amount that first time adds water, and decocting time is 6h, and second time amount of water is 8 times amount, and decocting time is 3h, merges decoction liquor, filters;
(3) filter complete, to filtrate carry out heating concentrate, being condensed into relative density at 60 DEG C is the extractum of 1.13, then makes tablet according to a conventional method.
Embodiment 3
3.1 raw materials composition (g):
Herba Epimedii 140, Concha Ostreae 160, Rhizoma Cibotii 150, Fructus Corni 160, Herba Cynomorii 150, Fructus Cnidii 120, Cornu Cervi Pantotrichum 130, Radix Cynanchi Paniculati 110, Rhizoma Drynariae 120, Herba Cistanches 90, Flos Caryophylli 120, Fructus Chaenomelis 80, Radix Aconiti Lateralis Preparata 50, Semen Ziziphi Spinosae 60.
3.2 preparation methoies:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, cross 100 mesh sieves after pulverizing, then it is for subsequent use to carry out being mixed to get fine drug powder;
(2) then add in decoction pot by fine drug powder prepared by step (1), decoct with water twice, it is 9 times amount that first time adds water, and decocting time is 4h, and second time amount of water is 5 times amount, and decocting time is 2h, merges decoction liquor, filters;
(3) filter complete, to filtrate carry out heating concentrate, being condensed into relative density at 60 DEG C is the extractum of 1.10, then makes granule according to a conventional method.
Two, pharmacodynamic study
1, experimental technique
Be that the pentobarbital sodium of 40mg/Kg does intraperitoneal injection of anesthesia to SD rat with dosage, sterile working, excision bilateral ovaries, by 10 other each one piece of fatty tissue para-position matched groups (sham operated rats) of SD rat excision bilateral ovaries, removal ovary SD rat was divided into four groups at random in postoperative 45 days: dosage group (0.4g/Kg), medicine low dose group of the present invention (0.2g/Kg), model group (isometric(al) normal saline) in medicine high dose group (0.8g/Kg) of the present invention, medicine of the present invention, add matched group (isometric(al) normal saline) totally five groups.Divide into groups the same day, each group SD rat is by respective medicine and dosage gastric infusion, and once a day, continuous 90 days, the secondary daily dose after last administration was that the pentobarbital sodium of 40mg/Kg does intraperitoneal injection of anesthesia, surveys bone density with Dual-energy X-rays absorptionmetry.
2, experimental result
Table 1 experimental result
With model group than * P < 0.05, * * P < 0.01.
As can be seen from Table 1: relative to matched group, the thigh of model group SD rat, basin bone, spinal column and Whole Body Bone Scanning even density decline in various degree, and illustrate that SD rat shows detailed osteoporosis, model is successfully established.Compared with model group, three dosage groups of medicine of the present invention can improve osteoporosis in varying degrees, wherein, the high dose group of medicine of the present invention is improved particularly evident to dosage group in thigh, spinal column and whole body skeleton and medicine of the present invention to the bone density of whole body skeleton, it can be said that bright, medicine of the present invention has the osteoporotic curative effect of good treatment.
Three, clinical efficacy
1.1 MethodsThe cases enrolled diagnostic criterias
Adopt the mode that disease combines, selection Western medicine diagnose is osteoporosis, and Chinese medical discrimination is that deficiency of the liver and kindey card patient is as the object of observation.
1. Western medicine diagnose standard: with reference to " Chinese's osteoporosis suggestion diagnostic criteria (the second original text) " (Chinese osteoporosis magazine of Aged in China association's osteoporosis committee Criteria of Osteoporosis subject group in October, 1999 formulation, 6th volume the 1st phase in 2000,1-3 page) and " new Chinese medicine guideline of clinical investigations " (trial version in 2002), determine that the diagnostic criteria of this test is as follows:
Diagnosis principle: it is basic foundation that Diagnosis of osteoporosis should reduce more than 2 standard deviations with bone density, must differentiate it is primary osteoporosis or secondary osteoporosis.Can consider with reference to age, medical history, fracture and lab testing etc. during clinical diagnosis.
Diagnostic criteria: possess overall pain is main mainly with lumbar and back pain, and aching and limp unable, increase the weight of gradually, microtrauma can cause fracture; Scheuermann kyphosis deformity; Bone density reduces by 2 above persons of standard deviation.
Note: A, bone density refer to measures the meansigma methods of lumbar vertebra 2-4 vertebral bone density or the bone density value of hip with Dual-energy X-rays absorptionmetry (DEXA), as long as one of them reaches lower than 2 above persons of standard deviation.B pain is modal, the topmost symptom of osteoporosis.Clinical the most common with lumbago and backache, for spinous process or have tenderness and percussion pain, with whole body skeleton pain.The C diagnostic index that standard deviation represents is suitable for lumbar vertebra, and hip position can refer to execution.When standard deviation inconvenience application, available lumbar vertebra Percentage of bone loss (%) diagnostic index.
2. Liver of TCM kidney deficiency card diagnostic criteria: require to formulate according to the evaluation of " guideline of clinical investigations of new Chinese medicine treatment osteoporosis " of " new Chinese medicine guideline of clinical investigations " (trial version in 2002).Show as: lumbar vertebrae pain, aching and limp few power, walk with difficulty, the vertigo, can not be prudent, body of the tongue or partially red or light, the symptoms such as thin lingual fur or thin white, deep-thready pulse, osteoporosis is shown in above-mentioned disease person.
1.2 physical data
All selected patients are divided into two groups at random, treatment group 298 example, wherein male patient 155 example, female patient 143 example; Matched group 200 example, wherein male patient 82 example, female patient 118 example.
1.3 Excluded cases standards
(1) secondary osteoporosis and other serious complication persons such as hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma is had; Or late deformity, maimed person, disability person;
(2) severe primary such as cardiovascular and hemopoietic system disease patient is associated with;
(3) liver function ALT is more than 1.5 times of upper limits of normal; Renal function serum creatinine > 133umol/L;
(4) psychosis or old dementia patients;
(5) adopt hormone replacement therapy (HRT) in nearly three months and take calcitonin (as Calcitonin and elcatonin), having continuous 15 days in nearly six months and apply Diphosphonate person;
1.4 Therapeutic Method
1.4.1 treatment group takes granule prepared by the embodiment of the present invention 3, each 10g, one day three times, three months courses for the treatment of.
1.4.2 matched group takes calcium that very, an a slice, one day twice, three months courses for the treatment of.
1.5 evaluation of clinical curative effect standards
Osteoporosis bone density efficacy determination
First calculating bone density changing value=(after treatment the front bone density of bone density-treatment)/treat front bone density × 100%
Divide three grades to judge:
Effective: bone density rate of change is more than or equal to the minimum significant change value of bone density;
Effective: bone density rate of change is between the minimum significant change value of positive and negative bone density;
Invalid: bone density rate of change is less than the minimum significant change value of negative bone density.
Wherein bone density minimum significant change value=2.77 × (%CV), the CV-coefficient of variation.
Total effective rate=(effective+effectively)/total case load × 100%
1.6 therapeutic outcome
Two groups of therapeutic outcomes are as shown in table 2.
Table 2 liang group therapeutic effect contrast
1.7 conclusion
From the above results, compared to calcium, you very better can treat osteoporosis to medicine of the present invention.
Although illustrate and describe embodiments of the invention, for the ordinary skill in the art, be appreciated that and can carry out multiple change, amendment, replacement and modification to these embodiments without departing from the principles and spirit of the present invention, scope of the present invention is by claims and equivalents thereof.

Claims (3)

1. be used for the treatment of an osteoporotic Chinese medicine, it is characterized in that being made up of the raw material of following weight portion: Herba Epimedii 140 parts, Concha Ostreae 160 parts, Rhizoma Cibotii 150 parts, Fructus Corni 160 parts, Herba Cynomorii 150 parts, Fructus Cnidii 120 parts, 130 parts, Cornu Cervi Pantotrichum, Radix Cynanchi Paniculati 110 parts, Rhizoma Drynariae 120 parts, Herba Cistanches 90 parts, Flos Caryophylli 120 parts, Fructus Chaenomelis 80 parts, Radix Aconiti Lateralis Preparata 50 parts, Semen Ziziphi Spinosae 60 parts.
2. be used for the treatment of osteoporotic Chinese medicine as claimed in claim 1, it is characterized in that: described Chinese medicine can be made into tablet, capsule, pill, granule, injection, oral liquid or decoction.
3. be used for the treatment of osteoporotic Chinese medicine as claimed in claim 1, it is characterized in that being obtained by following processing step:
(1) first take traditional Chinese medicinal material raw materials by proportioning, then put into Chinese medicine grinder respectively and pulverize, cross 100 mesh sieves after pulverizing, then it is for subsequent use to carry out being mixed to get fine drug powder;
(2) add in decoction pot by fine drug powder prepared by step (1), decoct with water twice, first time adds water as the 5-12 times amount of initial drug weight, decocting time is 3-6h, and second time amount of water is the 3-8 times amount of initial drug weight, and decocting time is 1-3h, merge decoction liquor, filter;
(3) filter complete, to filtrate carry out heating concentrate, being condensed into relative density at 60 DEG C is the extractum of 1.08-1.13, then makes finished product according to a conventional method.
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