CN104547750A - Traditional Chinese medicine composition for treating senile osteoporosis - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating senile osteoporosis, and belongs to the technical field of traditional Chinese medicines. The effective ingredients of the traditional Chinese medicine are prepared from the following raw materials: wolfberries, Chinese yam, poria cocos, coix seed, herba epimedii, rhizoma drynariae, fructus cnidii, teasel root, fructus psoraleae, radix achyranthis bidentatae, eucommia ulmoides, dogwood, cornua cervi pantotrichum, cistanche, salvia miltiorrhiza, pseudo-ginseng, rheum officinale, corydalis tuber, radix polygoni multiflori, astragalus membranaceus, radix polygoni multiflori, chrysanthemum, Chinese date and liquorice. The traditional Chinese medicine disclosed by the invention is based on the traditional Chinese medicine mechanism of osteoporosis, focuses on tonifying kidney, benefiting liver, tonifying spleen, promoting circulation and removing stasis and improving the whole organism of body, and treats senile osteoporosis from a source. The traditional Chinese medicine disclosed by the invention is capable of improving a treatment effect on senile osteoporosis in case of being taken with a common calcium source product and vitamin D.

Description

A kind of Chinese medicine composition for the treatment of senile osteoporosis

Technical field

The present invention relates to a kind of Chinese medicine composition for the treatment of senile osteoporosis, belong to technical field of Chinese medicines.

Background technology

Senile osteoporosis is also called II type osteoporosis, is to reduce with bone amount and osseous tissue microscopic mechanism degenerates that (Grafting Cancellous Bone Bolt girder attenuates, rupture, quantity minimizing; The many skies of cortical bone, thinning) be feature, so that the fragility of bone increases, and the intensity of bone reduces, a kind of systemic skeletal disease that fracture risk increases.Senile osteoporosis is a kind of Special Manifestations of biological decay in skeleton, and mainly increasing relevant with the age, is one of degenerative diseases of aged.Clinical main manifestations is lumbar and back pain, movable unfavorable; Height shortens, bow-backed; Easily to fracture, have a strong impact on the life quality of old people.Osteoporosis has been classified as one of three large infirmitiess of age by World Health Organization (WHO) (WHO).

Calcium preparation and vitamin D are the basic medications of prevention and therapy senile osteoporosis in the market.Calcium takes in the loss that can slow down bone, improves bone mineralising.And vitamin d is conducive to calcium absorbs at gastrointestinal.Conventional calcium preparation is divided into the large class of inorganic calcium organic calcium two.Inorganic calcium comprises (1) calcium carbonate: with shell, eggshell for raw material, calcium content is higher, but poor solubility, if lack enough gastric acid to make its ionizing, then absorbance is low; (2) activated calcium, through high-temperature calcination, alkalescence is strong, large to gastrointestinal irritation; (3) calcium hydroxy phosphate, be raw material with animal fresh bone, calcium content is medium.These are all not too applicable to old people and take.Calcium of organic acid salt has calcium lactate, calcium gluconate, calcium citrate etc., and calcium content is slightly low, but intestinal absorption rate can reach 20%-40%, and does not need too many gastric acid just to be absorbed well, thus concerning gastric acid compares the old man of shortage, more suitable.

Summary of the invention

For senile osteoporosis, inventor thinks that supplementary calcium preparation and vitamin D are the basic measures of protect against osteoporosis, but limited use, needs the inherent traditional Chinese medical science mechanism from this disease and other osteosporosis resistant medicament use in conjunction, could more effectively treat this disease.The invention provides a kind of Chinese medicine composition for the treatment of senile osteoporosis.This Chinese medicine composition is taken together with vitamin D with common calcium product-derived, can improve the therapeutic effect of senile osteoporosis.Another object of the present invention is to provide the preparation method of this sick Chinese medicine composition for the treatment of.

Technical scheme of the present invention is:

Treat a Chinese medicine composition for senile osteoporosis, said composition is made up of effective ingredient and pharmaceutically acceptable adjuvant, it is characterized in that, described effective ingredient is made up of the Chinese medicine of following weight portion:

Fructus Lycii 8-20, Rhizoma Dioscoreae 8-20, Poria 8-20, Semen Coicis 8-20, Herba Epimedii 8-20, Rhizoma Drynariae 8-20, Fructus Cnidii 8-20, Radix Dipsaci 8-20, Fructus Psoraleae 8-20, Radix Achyranthis Bidentatae 8-20, Cortex Eucommiae 8-20, Fructus Corni 8-20, Cornu Cervi Pantotrichum 8-20, Herba Cistanches 8-20, Radix Salviae Miltiorrhizae 5-16, Radix Notoginseng 5-16, Radix Et Rhizoma Rhei 5-16, Rhizoma Corydalis 5-16, Radix Polygoni Multiflori 5-16, Radix Astragali 5-16, Flos Chrysanthemi 2-10, Fructus Jujubae 2-10, Radix Glycyrrhizae 1-5.

Preferably, described effective ingredient is made up of the Chinese medicine of following weight portion:

Fructus Lycii 15, Rhizoma Dioscoreae 15, Poria 15, Semen Coicis 15, Herba Epimedii 15, Rhizoma Drynariae 15, Fructus Cnidii 15, Radix Dipsaci 15, Fructus Psoraleae 15, Radix Achyranthis Bidentatae 15, the Cortex Eucommiae 15, Fructus Corni 15, Cornu Cervi Pantotrichum 15, Herba Cistanches 15, Radix Salviae Miltiorrhizae 10, Radix Notoginseng 10, Radix Et Rhizoma Rhei 10, Rhizoma Corydalis 10, the Radix Polygoni Multiflori 10, the Radix Astragali 10, Flos Chrysanthemi 6, Fructus Jujubae 6, Radix Glycyrrhizae 3.

Effective ingredient in Chinese medicine composition of the present invention can prepare in accordance with the following methods:

(1) raw material is taken by above-mentioned weight portion;

(2) Fructus Lycii taken in step (1), Rhizoma Dioscoreae, Poria, Semen Coicis, Herba Epimedii, Rhizoma Drynariae, Fructus Cnidii, Radix Dipsaci, Fructus Psoraleae, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Corni, Cornu Cervi Pantotrichum, Herba Cistanches, Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Et Rhizoma Rhei, Rhizoma Corydalis, the Radix Polygoni Multiflori, the Radix Astragali, Flos Chrysanthemi, Fructus Jujubae, Radix Glycyrrhizae are put into marmite, add 6-8 times amount water soaking 1-2 hour, heating decoction 1.5 hours, filters; Medicinal residues add 4-6 times of water gaging heating decoction 1 hour again, filter, merge twice filtrate, leave standstill 1 hour, pour out supernatant; Obtaining relative density during supernatant concentration to 60 DEG C is 1.08-1.10 clear paste, drying under reduced pressure; Pulverize solid content, after sieving, obtain fine powder, the i.e. active component of this Chinese medicine composition.

The active component of above-mentioned gained Chinese medicine composition, those skilled in the art can according to the common technology of this area, choose the various customary adjuvant needed when preparing different dosage form, adjuvant as conventional in lubricant, binding agent, disintegrating agent etc., common Chinese medicine preparation formulation is made, as tablet, capsule, granule etc. by the preparation method of Chinese medicine preparation conventional in prior art.

The pharmacological action of each medicine:

Fructus Lycii: sweet is flat.Return liver, kidney channel.Nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, vertigo and tinnitus, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.

Rhizoma Dioscoreae: sweet, flat.Return spleen, lung, kidney channel.Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.For insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, and deficiency-heat is quenched one's thirst.Rhizoma Dioscoreae (parched with bran) spleen reinforcing stomach invigorating.

Poria: sweet, light is flat.GUIXIN, lung, spleen, kidney channel.Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.

Semen Coicis: sweet, light, cool.Return spleen, stomach, lung meridian.Spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal, clearing away heat and discharging pus.

Herba Epimedii: acrid in the mouth, sweet, warm in nature, returns liver, kidney channel.There is effect of kidney invigorating and YANG supporting; Modern pharmacology experiment shows, Herba Epimedii has the promotion osteoblastic proliferation of In vitro culture and the effect of mineralising.In addition, Herba Epimedii dose-dependently can also suppress the differentiation-inducing formation osteoclast-like cell of medullary cell and then suppress bone resorption.Recently, Institute of Medical Plants of China Concord Medical Science University of the Chinese Academy of Medical Sciences and City University of Hong Kong, Shenzhen Research Institute have studied Herba Epimedii 95% ethanol extraction each extract part and 50% ethanol extract, water extract part to the impact of marrow stromal cell Osteoblast Differentiation, find that ethyl acetate part has the effect promoting stromal cell Osteoblast Differentiation.

Rhizoma Drynariae: warm in nature, bitter in the mouth, returns kidney, Liver Channel.Having the kidney invigorating, invigorate blood circulation, stop blooding, continue effect of wound, is orthopedics department common medicine.Whole animal research finds, osteomiosis complementary energy is significantly prevented and treated OP.Rhizoma Drynariae extract can also suppress osteoclastic bone resorption, is in particular in Bone resoiption pit number and area all in dose-dependently reducing.

Fructus Cnidii: warm in nature nontoxic, acrid in the mouth is bitter, returns kidney channel.There is kidney invigorating and YANG supporting, dampness, dispel the wind, the effect series of studies result of parasite killing shows; the Coumarins composition contained in Fructus Cnidii can have obvious therapeutical effect to the OP model using glucocorticoid and spay to cause; separately there are some researches show, Fructus Cnidii total coumarins is also by the protective effect suppressing the differentiation of osteoclast and bone resorption function and then play bone.

Radix Dipsaci: the bitter tepor of property, sweet in the mouth is pungent, returns liver, kidney channel.Effects such as there is invigorating the liver and kidney, bone and muscle strengthening, promoting the circulation of blood arteries and veins, continuous injured, stop metrorrhagia, be antiabortive.Modern study shows, the bone loss that Radix Dipsaci reversible ovariectomized rats causes.

Fructus Psoraleae: the large temperature of property, bitter in the mouth is pungent, returns spleen, kidney channel.There is kidney invigorating and YANG supporting, controlling nocturnal emission with astringent drugs reducing urination, warming spleen and stopping diarrha effect.Pharmacological evaluation shows, the nonpolar moiety of Fructus Psoraleae acetone extract can increase rat bone intensity, improves inorganic phosphate salt level in blood.Experiment in vitro shows, the alcohol extracts of Fructus Psoraleae, ethyl acetate extraction position and monomer flavone corylin wherein and Coryfolin all can promote osteoblast like UMR106 cells to breed and differentiation.Fructus Psoraleae can also suppress formation and the expansion of osteoclastic bone resorption lacuna, and inhibitory action is relevant with Fructus Psoraleae concentration.

Radix Achyranthis Bidentatae: property acid is flat, and bitter in the mouth, returns liver, kidney channel.There are the effects such as invigorating the liver and kidney, bone and muscle strengthening, eliminating blood stasis and inducing menstruation, conducting blood to flow downwards.Research shows, radix Achyranthis Bidentataeethanol extract can increase trabecular bone density, area, cumulative volume and Compact bone area, reduce medullary cavity area, the loss of the rat bone mineral nitrogen stoping retinoic acid to cause.Also a kind of viewpoint is had to think, radix Achyranthis Bidentataepromoting bone growing is due to containing magnesium ion, and its participates in all energy metabolisms in body, activates or catalysis 325 enzyme systems, promoting bone growing.

The Cortex Eucommiae: warm in nature, sweet in the mouth is micro-pungent, enters Liver and kidney warp.Cure mainly waist and knee.Folium Eucommiae separate section can promote proliferation of osteoblast-like cells in vitro and metabolism, promotes Alkaline Phosphatase simultaneously.The Cortex Eucommiae is also by the protective effect suppressing osteoclast activity and then play bone.

Fructus Corni: slightly warm in nature, sour-puckery flavor, returns liver, kidney channel.There is effect of invigorating the liver and kidney, arresting seminal emission gas, solid collapse.Modern pharmacology experiment shows, Fructus Corni water extract obviously can improve the OP situation of mice, significantly increases bone trabecula area, cortex thickness of bone.

Cornu Cervi Pantotrichum: sweet, salty, temperature.Return kidney, Liver Channel.Function cures mainly: invigorating kidney-YANG, benefiting essence-blood, bone and muscle strengthening, adjusts punching to appoint, holder sore.Active hairy antler (i.e. the pilose antler active composition of freeze drying technology process) has the effect of the good bone loss caused by control ovariectomized female rats.Isolated experiment shows, antler polypeptide is very strong mitogen, is synthesized, accelerating union of bone fracture by promotion bone, chondrocyte DNA.

Herba Cistanches: sweet, salty, temperature.Return kidney, large intestine channel.Function cures mainly: kidney-replenishing, benefiting essence-blood, loosening bowel to relieve constipation.The betanin contained in Herba Cistanches and acteoside can increase the weight of the gonophores such as seminal vesicle prostate and without the side effect making atrophy of thymus gland, be presumed to the main active of its Andrin-like action.Have and report that its extract can suppress the bone loss caused by ovariectomized female rats, therefrom be separated the monoterpenes monomer (2E obtained, 6R)-8-hydroxyl-2,6-dimethyl-2-octenoic acid [(R)-HDOA] is considered to one of active component of anti-OP.

Radix Salviae Miltiorrhizae: property is bitter, and taste tepor, enters the heart, Liver Channel.For the product of " stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness ".Research in recent years finds, radix Salviae Miltiorrhizae water extract can be effective, promotes osteoblast activity, promotes bone matrix to be formed and suppresses osteoclastic bone resorption function, control bone loss.TANSHINONES can suppress the rat bone caused by removal ovary to be lost.Clinical trial results shows, TANSHINONES effectively reduces Biological indicators relevant to bone resorption in OP patient's blood in menopause, reduces bone turnover rate, delays or block the effect of the quick bone loss of post menopausal.

Radix Notoginseng: property is put down, and taste is micro-sweet, enters liver, kidney, stomach warp.There is the merit of blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain.Up-to-date pharmacological evaluation shows, Radix Notoginseng total glycosides can promote propagation and the differentiation of rat osteoblast.

Radix Et Rhizoma Rhei: cold in nature, bitter in the mouth, returns spleen, stomach, large intestine, liver, pericardium channel.Effect of tool pathogenic fire purging relieving constipation, blood circulation promoting and blood stasis dispelling.Modern pharmacology experiment shows, Radix Et Rhizoma Rhei can suppress osteoclastic bone resorption.

Rhizoma Corydalis: pungent, bitter, temperature.Return liver, spleen channel.Invigorate blood circulation, promoting the circulation of QI, pain relieving.

The Radix Polygoni Multiflori: property is sweet, puckery, tepor, returns liver, kidney channel." detailed outline " is called: " temperature compensation liver, can restrain vital essence for this thing temperature bitter and puckery flavor, bitter the kidney invigorating, so the liver benefiting that can nourish blood, and controlling nocturnal emission with astringent drugs kidney tonifying, muscle reinforcing and bone strengthening, not warm not dry." " book on Chinese herbal medicine justice " then claim it " specially enter Liver and kidney, take a tonic or nourishing food to build up one's health Kidney-Yin, and taste is admittedly very thick, slightly hold concurrently pained, property is then gentle, and the reason of all seal Tibetan with the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels meets, therefore energy replenishing essence QI invigorating, and tool negative and positive put down secret effect." " Chongqing hall random notes " record " Radix Polygoni Multiflori, interior QI and blood regulating, the nearly Radix Angelicae Sinensis of merit, also gas medicine in blood ".

The Radix Astragali: sweet, temperature.Return lung, spleen channel.Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Have report Radix Astragali water extract to have therapeutical effect to the rat OP that steroid causes, experiment in vitro shows, the Radix Astragali not only can suppress the bone resorption function of osteoclast, and bone absorption rate is reduced, and promoting bone growing.

Flos Chrysanthemi: sweet, bitter, is slightly cold.Return lung, Liver Channel.Loose wind heat clearing away, suppressing the hyperactive liver improving eyesight." book on Chinese herbal medicine justice ": " all main advocation catharsis of all flowers, only Flos Chrysanthemi is then taken the photograph and is received declines, can suppressing the hyperactive liver fire, puts out endogenous wind, but the perverse and unreasonable manner of wood gas.

Fructus Jujubae: sweet, temperature.Return spleen, stomach warp.Really (Fructus Jujubae): invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.For insufficiency of the spleen lack of appetite, weak loose stool, woman hysteria.

Radix Glycyrrhizae: sweet, flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.

Osteoporosis belongs to Chinese medicine " atrophic debility of bones " category.Theory of Chinese medical science thinks liver controlling conveyance and dispersion, maintains the operation of QI and blood, body fluid.The tune that the catharsis function of liver directly affects mechanism of qi is smooth; Gas is the power of blood operation, and the capable then blood of gas, the stagnation of QI is blood stasis then.If the liver failing to maintain the normal flow of QI, then qi depression to blood stasis can be caused; The main gas of spleen, hemopoietic, the transportation capabilities of spleen are not enough or imbalance will cause the deficiency of vital energy, and the deficiency of vital energy is not enough to promote blood, and insufficiency of the spleen being difficult of QI and blood is raw in addition, and sanguification source scarcity then must become blood stasis; " the kidney being the origin of congenital constitution ", " kidney governing bones, store essential substances, essence can give birth to marrow, and marrow is hidden in bone cavity with nutrition skeleton ".Kidney essense is sufficient, then bone marrow fills, and skeleton obtains the abundant nourishing of bone marrow, then effectively firm.If kidney-jing deficiency is few, the change source of bone marrow is not enough, can not nutrition skeleton, and skeleton is just relatively fragile, or kidney yang declines tired, warm dereliction of duty, phlegm stagnancy, and hematogenous blockage, stays and form the stasis of blood; Or deficiency of kidney yin, asthenic fire is burnt Tianjin, and body fluid condenses, and blockage of vessel forms blood stasis.The void that blood stasis can increase the weight of internal organs declines and causes precise and tiny not cloth, and causes " bone is not hard ", and Traditional Chinese Medicine thinks that the nourishing of QI and blood to skeleton is the key that skeleton maintains normal morphology and function, and once stagnation of blood stasis, venation is obstructed, and bone flatus blood nourishes, and must send out as " atrophic debility of bones ".And there is scholar to utilize bone ore deposit instrument to study in recent years, find that bone mineral content has with the Changing Pattern at age and the change of the essence in kidney prosperity and decline of the traditional Chinese medical science surprising consistent, further demonstrate that the science of this theory of Chinese medical science.

Patients with senile osteoporosis punching is appointed empty, exhaustion of kidney-essence with promoting reproductive function, liver-blood deficiency, and kidney essense declines few, deficiency of kidney-QI, insufficiency of primordial QI, unablely agitates blood vessels, and blood operation is slow, and the venation stasis of blood is stagnant obstructed, causes blood stasis due to qi deficiency.Once stagnation of blood stasis, venation is obstructed, and essence of water and grain can not get taking a walk, and internal organs are the exhaustion because moistening foster deficiency then, and bone also flatus blood nourishes and sends out as the atrophic debility of bones.Therefore, inventor thinks that blood stasis is the inherent key factor causing senile osteoporosis, is also the factor causing this disease to increase the weight of; And the formation of blood stasis is the result of the dirty imbalance of human body liver,spleen,kidney three.Therefore, control senile osteoporosis should be started with from soothing the liver, spleen invigorating, the kidney invigorating, supplements calcium preparation and vitamin D simultaneously, inside and outside take into account, treating both the principal and the secondary aspects of a disease at the same time.

The invention discloses a kind of Chinese medicine composition for the treatment of senile osteoporosis, its effective ingredient is with the kidney invigorating, spleen invigorating, the liver benefiting, and the Fructus Lycii of bone and muscle strengthening, Rhizoma Dioscoreae, Poria, Semen Coicis, Herba Epimedii, Rhizoma Drynariae, Fructus Cnidii, Radix Dipsaci, Fructus Psoraleae, the Cortex Eucommiae, Radix Achyranthis Bidentatae, Fructus Corni, Cornu Cervi Pantotrichum, Herba Cistanches are monarch drug; With the Radix Salviae Miltiorrhizae of promoting flow of QI and blood, invigorating the spleen and replenishing QI, Radix Notoginseng, Rhizoma Corydalis, the Radix Astragali for ministerial drug; Match with YIN nourishing, the Radix Polygoni Multiflori of nourishing blood to tranquillize the mind, Flos Chrysanthemi, Fructus Jujubae adjuvant drug; With Radix Glycyrrhizae for making medicine; When treating senile osteoporosis, patient takes the Chinese medicine composition in the present invention and coordinates and takes Calcium and vitamin D, effectively can improve therapeutic effect.

The invention has the beneficial effects as follows:

1, the present invention is based on the traditional Chinese medical science mechanism of senile osteoporosis, start with from the kidney invigorating, the liver benefiting, spleen invigorating, object is the orderly and clearly whole body mechanism of qi of dredging, and blood circulation promoting and blood stasis dispelling, treats this disease from source.Effect of selected monarch drug is spleen invigorating liver-kidney tonifying, three dirty normal operations, and systemic blood runs unobstructed, and blood stasis is eliminated, and skeleton is nourished, and osteoporosis just can improve; Ministerial drug, from blood circulation promoting and blood stasis dispelling, is regulated the flow of vital energy in living and is started with, auxiliary monarch drug treatment primary symptom; Adjuvant drug is intended to that negative and positive are taken into account, nourishing blood to tranquillize the mind, the mitigation property of medicine, makes the cool heat of this medicine property of medicine proper and is tending towards gentle; Make medicinal come coordinating the actions of various ingredients in a prescription, and guide all medicines to go directly diseased region; Monarch, minister, help, make to cooperatively interact, treating both the principal and secondary aspects of a disease, drug effect synergism increases greatly;

2, this invention Chinese medicine composition contains abundant trace element, can promote the synthesis of bone matrix and the precipitation of bone mineral, is the essential condition of osteogenesis and calcification.As Flos Chrysanthemi and Fructus Lycii contain abundant calcium and magnesium; The Cortex Eucommiae, Radix Glycyrrhizae contain abundant ferrum, zinc and copper; Magnesium is closely related with the absorption of calcium, lacks and also can cause osteoporosis; Zinc is the active center of hundreds of enzyme, is the key factor of normal activity of sustaining life, most important to enhancing body immunity; Copper participates in hematopoiesis, and ferrum is the necessary main trace element of human body hemopoietic, lacks copper, ferrum, and whole body can be in weak state;

3, Fructus Lycii, Flos Chrysanthemi, Semen Coicis, Rhizoma Dioscoreae, Poria etc. in this invention Chinese medicine composition all contain abundant Polydextrose, have effect of loosening bowel to relieve constipation, can improve the ubiquitous constipation symptom of patients with senile osteoporosis.On the one hand, the calcium preparation that patient forms undissolved hard material because the oxalic acid of long-term taking easily in food, phosphoric acid are combined can cause constipation; On the other hand, old people itself is gone down due to digestion power, gastrointestinal emptying rate reduction, and intestinal peristalsis promoting ability declines also can cause constipation.

Below in conjunction with clinical data and model case, beneficial effect of the present invention is further illustrated.

One, clinical observation

1, clinical data:

Inclusive criteria: 1. clear and definite low-back pain, Whole Body Bone Scanning pain, the weak history of lower limb, affect quality of life; 2. imaging examination is shown in that bone density reduces, cortical bone is thinning, obvious with hip, lumbar vertebra place. the visible wedge shape pathological changes of vertebral body etc.; 3. bone density (BMD) <-2SD.Senile osteoporosis is diagnosed as according to symptom, sign, lab testing and bone density inspection.Exclusion standard: the trauma history such as 1. clear and definite traffic accident, high falling; 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. the medicine person affecting bone metabolism is used in nearly 3 months; 5. prolapse of lumbar intervertebral disc, lumbar spinal stenosis, lumbar spondylolisthesis etc. may merge the disorder of lumbago and backache;

Patient 70 example is included in this research altogether in, and patient is divided into two groups at random.Treatment group 35 example, wherein man 14 example, female 21 example, 59 ~ 75 years old age, the course of disease 9 ~ 43 months; Matched group 35 example, wherein man 12 example, female 23 example, at 61 ~ 79 years old age, the course of disease 8 ~ 45 months, two groups of clinical datas have comparability.

2, diagnostic criteria: " diagnostic criteria of primary osteoporosis for Chinese people " (the trying) of formulating by the diagnosis index subject group of osteoporosis committee of Aged in China association osteoporosis

Normal: BMD value is not less than normal young adult bone density 1 standard deviation (T value >=-1SD); Bone loss: BMD value is lower than bone density 110-215 the standard deviation (T value is-110 ~-215SD) of normal Young Adults; Osteoporosis: BMD value is less than or equal to normal youngster 215 standard deviations (T value≤-215SD), and merging fracture person is serious osteoporosis.

3, Therapeutic Method:

The routine case of matched group 35 all carries out conventional therapy measure, oral calcium preparation Gaierqi D (vitamin D3 and calcium carbonate) (Jiangsu Wyeth pharmaceuticals), oral a slice every day (being equivalent to calcium 600mg, vitamin D1 25 iu), within 30 days, be a course for the treatment of, treat four courses for the treatment of altogether.

Experimental group 35 example, on the basis of conventional therapy, carries out therapy of combining Chinese and Western medicine, oral calcium preparation Gaierqi D (vitamin D3 and calcium carbonate) (Jiangsu Wyeth pharmaceuticals), the same matched group of consumption usage; Chinese prescription is by Chinese medicine composition allotment disclosed by the invention.The parts by weight of Chinese prescription and prepare instructions of taking with embodiment 3,30 days are a course for the treatment of, treat four courses for the treatment of altogether.

Two groups of patients coordinate reinforcement dietetic nutrition all simultaneously, increase outdoor sunshine, suitably take exercise and rest.

4, efficacy assessment standard:

Dual-energy X-rays absorptionmetry (DEXA) is adopted to carry out bone density measurement for the lumbar vertebra (L2, L3, L4) of patient and hip (neck of femur, Ward ' S district, greater trochanter).Effective: pain disappears completely, BMD increases; Effective: pain is obviously alleviated, have no BMD and decline; Invalid: to compare each side all without improving with before treatment.

5, therapeutic outcome

1, treatment group: treatment before and treatment 4 months after BMD change be respectively (0.74 ± 0.12), (0.88 ± 0.14) g/cm, matched group BMD change is respectively (0.73 ± 0.11), (0.82 ± 0.13) g/cm, all has significant difference (P<0.05) after BMD comparatively treats front and treatment of control group after treatment group treatment.

2, clinical efficacy: treatment group is effective 11 examples, effective 24 examples, invalid 0 example, and total effective rate is 100%; Matched group be respectively effective is 4 example, effective 17 example, invalid be 14 example, total effective rate is 60%.Treatment group is better than matched group.

More than can find out, clinical treatment senile osteoporosis adopts Chinese medicine composition disclosed by the invention and coordinates conventional therapy measure to take calcium preparation and vitamin D treatment effectively can increase bone density, releasing osteoporosis symptom.

Two, model case

Case 1: Liu so-and-so, female, 62 years old, peasant.Patient because there is lumbar and back pain before 3 years and along the diffusion of spinal column both sides, lie on the back or seat time pain relief, time upright or sitting time the pain increased, pain is light in the daytime, increases the weight of when night and early morning wake up.Result of ultrasonography is: moderate osteohalsiteresis; Thoracolumbar disk sheet shows: joint osteoporosis, sees that mottled, density alleviates.The weight relation of each medical material of traditional Chinese medical science administration and prepare instructions of taking with embodiment 3: simultaneously advise patient's oral calcium gluconate every day oral liquid (600mg every day) and vitamin D (500IU every day), cooperation is taken exercises, increase Exposure to Sunlight, suitably have a rest.Pay a return visit patient after taking medicine 4 months to tell, pain is comparatively before clearly better; After half a year, take the photograph the display of Thoracolumbar disk sheet: bone density improves, loose patch shape region diminishes; Patients symptomatic disappears substantially.

Case 2: Lee, female 76 years old, peasant.Patient occurred that before 10 years low-back pain is uncomfortable, and increased the weight of gradually with limited range of motion, sitting, heavy burden postemphasis, was in always and took the pain relieving of oral pain alleviating sheet medicine; Before three months, accidentally sprain waist, occur that above-mentioned symptom increases the weight of, walk, stand, sitting difficulty, the oral drugs and lying up of being always in, are not clearly better.Hospital's Thoracolumbar disk sheet display: vertebral bone girder atrophy, Vertebral Compression is out of shape, flexion of vertebral column, and thoracic vertebra shortens; It is oral that the traditional Chinese medical science gives prescription pill disclosed by the invention, each medical material proportion relation and prepare instructions of taking with embodiment 2, advises oral calcium lactate patient's every day (600mg every day) and vitamin D (500IU every day) simultaneously, coordinates Exposure to Sunlight, strengthen nutrition, suitably have a rest and take exercise.

After taking medicine 3 months pay a return visit, patient's low-back pain is comparatively before clearly better, can stand, sitting, walking, but the time is not long; Continue half a year of taking medicine, pain disappears substantially, and quality of life is improved significantly.

Case 3: Zhu, man, 82 years old, retired employees of enterprise.Before 10 years, health check-up invention bone amount reduces, lumbago 1 year after bending over to stand up; Walking before three months slips accidentally once there is spinal fracture, occurred lumbago suddenly after other day sneeze, cough, time movable or increase the weight of.The bone density T of bone density inspection prompting lumbar vertebra 1-4, neck of femur and full hip scores all between-1.0 to-2.5, and the bone density check criteria recommended according to WHO belongs to the category that bone amount reduces.Lumbar vertebra MRI points out osteoporosis, and waist 1 and waist 3 compression fracture of vertabral body, consider that patient once occurred fragility fractures, be thought of as serious senile osteoporosis.It is oral that the traditional Chinese medical science gives prescription pill disclosed by the invention, each medical material proportion relation and prepare instructions of taking with embodiment 2, advises patient's every day oral calitriol 0.25-0.5 microgram/day simultaneously.And vitamin D (600IU every day), coordinate Exposure to Sunlight, strengthen nutrition, suitably have a rest and take exercise.

After medication, lumbago takes a turn for the better for one month, checks blood bone turnover markers blood CTX level and significantly decline after three months, and within 1 year, checking bone density lumbar vertebra afterwards increases by 6.3%.

Detailed description of the invention

Embodiment 1:

Fructus Lycii 4Kg, Rhizoma Dioscoreae 4Kg, Poria 4Kg, Semen Coicis 4Kg, Herba Epimedii 4Kg, Rhizoma Drynariae 4Kg, Fructus Cnidii 4Kg, Radix Dipsaci 4Kg, Fructus Psoraleae 4Kg, Radix Achyranthis Bidentatae 4Kg, Cortex Eucommiae 4Kg, Fructus Corni 4Kg, Cornu Cervi Pantotrichum 4Kg, Herba Cistanches 4Kg, Radix Salviae Miltiorrhizae 2.5Kg, Radix Notoginseng 2.5Kg, Radix Et Rhizoma Rhei 2.5Kg, Rhizoma Corydalis 2.5Kg, Radix Polygoni Multiflori 2.5Kg, Radix Astragali 2.5Kg, Flos Chrysanthemi 1Kg, Fructus Jujubae 1Kg, Radix Glycyrrhizae 0.5Kg.

Preparation and instructions of taking:

Marmite put into by above-mentioned medical material, adds 8 times amount water soaking 1 hour, and heating decoction 1.5 hours, filters; Medicinal residues add 6 times of water gaging heating decoctions 1 hour again, filter, merge twice filtrate, leave standstill 1 hour, pour out supernatant; Obtaining relative density during supernatant concentration to 60 DEG C is 1.08-1.10 clear paste, drying under reduced pressure; Pulverize solid content, after sieving, obtain fine powder; Add 4Kg lactose and 0.8Kg microcrystalline Cellulose, spray into 1% Carboxymethyl cellulose sodium solution, make granule, add magnesium stearate 20g, tablet made by tabletting.

Each serving with 5, every agreement that contracts a film or TV play to an actor or actress 1g, 3 times on the one.

Embodiment 2:

Fructus Lycii 4Kg, Rhizoma Dioscoreae 4Kg, Poria 4Kg, Semen Coicis 4Kg, Herba Epimedii 4Kg, Rhizoma Drynariae 4Kg, Fructus Cnidii 4Kg, Radix Dipsaci 4Kg, Fructus Psoraleae 4Kg, Radix Achyranthis Bidentatae 4Kg, Cortex Eucommiae 4Kg, Fructus Corni 4Kg, Cornu Cervi Pantotrichum 4Kg, Herba Cistanches 4Kg, Radix Salviae Miltiorrhizae 3Kg, Radix Notoginseng 3Kg, Radix Et Rhizoma Rhei 3Kg, Rhizoma Corydalis 3Kg, Radix Polygoni Multiflori 3Kg, Radix Astragali 3Kg, Flos Chrysanthemi 2Kg, Fructus Jujubae 2Kg, Radix Glycyrrhizae 1Kg.

Preparation and instructions of taking:

Marmite put into by above-mentioned medical material, adds 6 times amount water soaking 1 hour, and heating decoction 1.5 hours, filters; Medicinal residues add 4 times of water gaging heating decoctions 1 hour again, filter, merge twice filtrate, leave standstill 1 hour, pour out supernatant; Obtaining relative density during supernatant concentration to 60 DEG C is 1.08-1.10 clear paste, drying under reduced pressure; Pulverize solid content, after sieving, obtain fine powder; Add 1.5Kg dextrin, mixing, incapsulates, obtains capsule.

Each serving with 5, every about 1g, 3 times on the one.

Embodiment 3

Fructus Lycii 5Kg, Rhizoma Dioscoreae 5Kg, Poria 5Kg, Semen Coicis 5Kg, Herba Epimedii 5Kg, Rhizoma Drynariae 5Kg, Fructus Cnidii 5Kg, Radix Dipsaci 5Kg, Fructus Psoraleae 5Kg, Radix Achyranthis Bidentatae 5Kg, Cortex Eucommiae 5Kg, Fructus Corni 5Kg, Cornu Cervi Pantotrichum 5Kg, Herba Cistanches 5Kg, Radix Salviae Miltiorrhizae 3Kg, Radix Notoginseng 3Kg, Radix Et Rhizoma Rhei 3Kg, Rhizoma Corydalis 3Kg, Radix Polygoni Multiflori 3Kg, Radix Astragali 3Kg, Flos Chrysanthemi 2Kg, Fructus Jujubae 2Kg, Radix Glycyrrhizae 1kg.

Preparation and instructions of taking:

Marmite put into by above-mentioned medical material, adds 7 times amount water soaking 1 hour, and heating decoction 1.5 hours, filters; Medicinal residues add 5 times of water gaging heating decoctions 1 hour again, filter, merge twice filtrate, leave standstill 1 hour, pour out supernatant; Obtaining relative density during supernatant concentration to 60 DEG C is 1.08-1.10 clear paste, drying under reduced pressure; Pulverize solid content, after crossing 40 mesh sieves, obtain fine powder; Add 1Kg dextrin, mix homogeneously, spray into 5% starch slurry 2Kg, make granule.

Each serving with 1 bag, often wrap about 5g, 3 times on the one.

Claims (3)

1. treat a Chinese medicine composition for senile osteoporosis, said composition is made up of effective ingredient and pharmaceutically acceptable adjuvant, it is characterized in that, described effective ingredient is made up of the Chinese medicine of following weight portion:

Fructus Lycii 8-20, Rhizoma Dioscoreae 8-20, Poria 8-20, Semen Coicis 8-20, Herba Epimedii 8-20, Rhizoma Drynariae 8-20, Fructus Cnidii 8-20, Radix Dipsaci 8-20, Fructus Psoraleae 8-20, Radix Achyranthis Bidentatae 8-20, Cortex Eucommiae 8-20, Fructus Corni 8-20, Cornu Cervi Pantotrichum 8-20, Herba Cistanches 8-20, Radix Salviae Miltiorrhizae 5-16, Radix Notoginseng 5-16, Radix Et Rhizoma Rhei 5-16, Rhizoma Corydalis 5-16, Radix Polygoni Multiflori 5-16, Radix Astragali 5-16, Flos Chrysanthemi 2-10, Fructus Jujubae 2-10, Radix Glycyrrhizae 1-5.

2. Chinese medicine composition according to claim 1, said composition is made up of effective ingredient and pharmaceutically acceptable adjuvant, it is characterized in that, described effective ingredient is made up of the Chinese medicine of following weight portion:

Fructus Lycii 15, Rhizoma Dioscoreae 15, Poria 15, Semen Coicis 15, Herba Epimedii 15, Rhizoma Drynariae 15, Fructus Cnidii 15, Radix Dipsaci 15, Fructus Psoraleae 15, Radix Achyranthis Bidentatae 15, the Cortex Eucommiae 15, Fructus Corni 15, Cornu Cervi Pantotrichum 15, Herba Cistanches 15, Radix Salviae Miltiorrhizae 10, Radix Notoginseng 10, Radix Et Rhizoma Rhei 10, Rhizoma Corydalis 10, the Radix Polygoni Multiflori 10, the Radix Astragali 10, Flos Chrysanthemi 6, Fructus Jujubae 6, Radix Glycyrrhizae 3.

3. a preparation method for Chinese medicine composition according to claim 1 and 2, is characterized in that, the preparation method of the effective ingredient of this Chinese medicine composition comprises the following steps:

(1) raw material is taken by the weight portion described in claim 1 or 2;

(2) Fructus Lycii taken in step (1), Rhizoma Dioscoreae, Poria, Semen Coicis, Herba Epimedii, Rhizoma Drynariae, Fructus Cnidii, Radix Dipsaci, Fructus Psoraleae, Radix Achyranthis Bidentatae, the Cortex Eucommiae, Fructus Corni, Cornu Cervi Pantotrichum, Herba Cistanches, Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Et Rhizoma Rhei, Rhizoma Corydalis, the Radix Polygoni Multiflori, the Radix Astragali, Flos Chrysanthemi, Fructus Jujubae, Radix Glycyrrhizae are put into marmite, add 6-8 times amount water soaking 1-2 hour, heating decoction 1.5 hours, filters; Medicinal residues add 4-6 times of water gaging heating decoction 1 hour again, filter, merge twice filtrate, leave standstill 1 hour, pour out supernatant; Obtaining relative density during supernatant concentration to 60 DEG C is 1.08-1.10 clear paste, drying under reduced pressure; Pulverize solid content, after sieving, obtain fine powder, the i.e. effective ingredient of this Chinese medicine composition.