CN102526326B - Traditional Chinese medicine for treating postmenopausal osteoporosis and preparation method thereof - Google Patents

Traditional Chinese medicine for treating postmenopausal osteoporosis and preparation method thereof Download PDF

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CN102526326B
CN102526326B CN 201210027652 CN201210027652A CN102526326B CN 102526326 B CN102526326 B CN 102526326B CN 201210027652 CN201210027652 CN 201210027652 CN 201210027652 A CN201210027652 A CN 201210027652A CN 102526326 B CN102526326 B CN 102526326B
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刘思娟
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Rugao Binjiang Urban Construction Investment Co Ltd
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Abstract

The invention provides a traditional Chinese medicine composition for treating postmenopausal osteoporosis. The traditional Chinese medicine composition comprises medicinal cyathula root, morinda officinalis, drynaria rhizome, cuscuta chinensis, walnut kernel, tortoise shell, herba epimedii, parasitic loranthus, cortex acanthopanacis, fructus ligustri lucidi, hematoxylon, bighead atractylodes rhizome, prepared rehmannia root and ligusticum wallichii. After being adopted for treating postmenopausal osteoporosis, the traditional Chinese medicine composition has the advantages that the side effect is small, the curative effect is good, the cost is low, the cure rate is high, the drug resistance is avoided, the taking is convenient, and the like.

Description

Be used for the treatment of Chinese medicine of postmenopausal osteoporosis and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicines, relate in particular to a kind of Chinese medicine composition that is used for the treatment of osteoporosis.
Background technology
(Osteoporosis is a kind of with the minimizing of bone amount OP) to osteoporosis, and the micro structure of bone is destroyed and is feature, causing bone fragility increases, a kind of metabolic osteopathy that is easy to fracture, the whole world has nearly 200,000,000 populations to suffer from this disease at present, and its sickness rate has occupied commonly encountered diseases, frequently-occurring disease the 7th.Nineteen forty-one Albright is clear and definite first osteoporotic concept on the JAMA magazine, its substance is that skeletonization reduction, class bone formation and calcium, phosphorus take advantage of the occasion to reduce, ratio and the normal bone indifference of bone mineral nitrogen, organic matter, the visible bone trabecula of histology narrows down, attenuation, interruption, knowing the bone amount by inference reduces, cause of disease difference according to the osteoporosis morbidity, be broadly divided into three classes: 1, primary osteoporosis, it can be divided into postmenopausal osteoporosis (PMOP I type osteoporosis) and senile osteoporosis (OP II type osteoporosis) again; 2, secondary osteoporosis refers to the osteoporosis that various protopathy or some drugs cause; 3, idiopathic osteoporosis disease, primary osteoporosis be in, old people's commonly encountered diseases, frequently-occurring disease, prolongation along with aged tendency of population and human average life, the primary osteoporosis prevalence raises just year by year, prevalence can be up to 50% among the crowd more than 60 years old, and prevalence obviously increases along with the increase at age.
Postmenopausal osteoporosis (postmenopausal osteoporosis PMOP) refers to the postmenopausal women because the ovarian function decline, decrease in estrogen, bone resorption is greater than bone formation, the microstructure with low bone amount and osseous tissue that occurs is moved back shape property and is become feature, and clinical manifestation is a kind of metabolic disease that bone fragility and fracture susceptibility increase.Osteoporosis is a kind of commonly encountered diseases of postmenopausal women, and it is present the most common bone metabolism dysfunctional disease.Menopause, estrogen decrease can increase the content of osteoclast and cytokine, may be the one of the main reasons of accelerating the postmenopausal women bone loss.At present, the 50 years old osteoporotic prevalence of later women in China different regions is between 25.0%～51.2%, and postmenopausal women's prevalence is more than 48%.
Modern medicine is thought, osteoporosis is one of the skeletal system that causes of multiple reason, metabolic osteopathy, its cause of disease and pathogenesis complexity are summarised as the unusual of hormone regulating and controlling, trophic factor, physical factor, inherited genetic factors, and relevant with the some drugs influence.Its pathological change is that sclerotin and bone mineral content reduce, because the bone amount reduces, calcification process is normal substantially, and bone becomes fragile and easily fractures.Western medicine medicine to osteoporosis treatment has: 1) short bone formation medicine: androgen, protein stimulatory synthetic hormone, vitamin K, trace element, Statins lipid regulating agent; 2) anti-bone resorption medicine: estrogen, estrogen antagonist agent, calcitonin, diphosphonate; 3) have inhibition bone resorption and promotion bone formation medicine concurrently: plant estrogen medicine, vitamin D and derivant thereof; 4) other: parathyroid hormone, phenothiazine drug.Wherein, calcium preparation is most widely used medicine in the osteoporosis treatment for the osteoporotic Primary Care medication for the treatment of.But said medicine all has tangible toxic action because of life-time service, easily causes complication or fixed because of uncertain therapeutic efficacy, and dosage is difficult to grasp or because price is difficult to popularize etc., the ideal medicament of non-osteoporosis treatment.
Summary of the invention
Technical problem to be solved by this invention is, overcome the deficiency of existing treatment, utilize the traditional Chinese medicine of China, provide that a kind of side effect is little, good effect, cost is low, cure rate is high, have no drug resistance, the Chinese medicine composition of the treatment postmenopausal osteoporosis of taking convenience, can fundamentally treat postmenopausal osteoporosis.
Ask in order to solve above-mentioned technology, the invention provides a kind of Chinese medicine composition that is used for the treatment of postmenopausal osteoporosis, it comprises: Radix Cyathulae, Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Semen Juglandis, Carapax Et Plastrum Testudinis, Herba Epimedii, Herba Taxilli, Cortex Acanthopancis, Fructus Ligustri Lucidi, Lignum Sappan, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata and Rhizoma Chuanxiong.
Wherein, the ratio of weight and number of each component in the described Chinese medicine composition is Radix Cyathulae 12～18 weight portions, Radix Morindae Officinalis 15～20 weight portions, Rhizoma Drynariae 30～40 weight portions, Semen Cuscutae 20～26 weight portions, Semen Juglandis 22～28 weight portions, Herba Epimedii 27～35 weight portions, Carapax Et Plastrum Testudinis 25～30 weight portions, Fructus Ligustri Lucidi 19～23 weight portions, Herba Taxilli 10～16 weight portions, Cortex Acanthopancis 13～17 weight portions, Lignum Sappan 12～16 weight portions, the Rhizoma Atractylodis Macrocephalae 9～13 weight portions, Radix Rehmanniae Preparata 12～16 weight portions, Rhizoma Chuanxiong 6～10 weight portions.
Wherein, the ratio of weight and number of each component in the described Chinese medicine composition is Radix Cyathulae 15～18 weight portions, Radix Morindae Officinalis 17～20 weight portions, Rhizoma Drynariae 35～40 weight portions, Semen Cuscutae 23～26 weight portions, Semen Juglandis 25～28 weight portions, Herba Epimedii 32～35 weight portions, Carapax Et Plastrum Testudinis 27～30 weight portions, Fructus Ligustri Lucidi 21～23 weight portions, Herba Taxilli 13～16 weight portions, Cortex Acanthopancis 15～17 weight portions, Lignum Sappan 14～16 weight portions, the Rhizoma Atractylodis Macrocephalae 11～13 weight portions, Radix Rehmanniae Preparata 14～16 weight portions, Rhizoma Chuanxiong 8～10 weight portions.
Wherein, can also add Radix Angelicae Pubescentis and Radix Clematidis in the described Chinese medicine composition, described Radix Angelicae Pubescentis and the described Radix Clematidis weight fraction in described Chinese medicine composition is than being Radix Angelicae Pubescentis 3～5 weight portions, Radix Clematidis 4～6 weight portions.
Wherein, can also add Radix Puerariae and Rhizoma Et Radix Notopterygii in the described Chinese medicine composition, described Radix Puerariae and the Rhizoma Et Radix Notopterygii weight fraction in described Chinese medicine composition is than being Radix Puerariae 5～7 weight portions, Rhizoma Et Radix Notopterygii 2～3 weight portions.
The described dosage form that is used for the treatment of the Chinese medicine composition of postmenopausal osteoporosis can be tablet, capsule, granule, pill, suspensoid, Emulsion, solution, syrup, tincture or injection etc.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition was decoct, it may further comprise the steps:
The first step is mixed in proportion described component, pulverizes and be screened into 100 orders～150 purpose powder;
Second step obtained powder with the first step and adds in the cold water and soaked 16 hours～20 hours, and with slow fire boiling, decocting time is 2 hours～3 hours, and decoction liquor is filtered, and obtains first filtrate, and the quality that institute adds water is 3～5 times of powder quality of first step acquisition;
In the 3rd step, the filtering residue that second step filter was obtained adds in the cold water again, with slow fire boiling 2 hours～3 hours, filters and obtains second filtrate, identical in the quality of the water that adds and second step;
The 4th step merged filtrate twice, concentrated and removed part water, obtained described decoct, and crude drug content is preferably 2g/ml～3g/ml.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition was tablet, it may further comprise the steps:
The first step, it is 85～95% alcohol reflux 2～4 times that Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Herba Epimedii and Semen Juglandis are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.23～1.25 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
Second step, it is 75～80% alcohol reflux 2～4 times that Carapax Et Plastrum Testudinis and Fructus Ligustri Lucidi are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.19～1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
The 3rd step, Radix Cyathulae, Lignum Sappan, Cortex Acanthopancis, Herba Taxilli, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae and Radix Rehmanniae Preparata are mixed in proportion, decoct with water and extract 2～4 times, each decocting time is 1～2 hour, and merge extractive liquid, filters, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.14～1.16 (60 ℃), and the quality that adds water is 4～6 times of mixture quality;
The 4th step, the thick paste and the 3rd that the first step, second step are obtained goes on foot the clear paste mixing that obtains, crushed after being dried also is screened into 50 orders～100 purpose fine powders, adding starch and determining alcohol is 60%～75% ethanol, heating is concentrated into pasty state, put into baking oven, control is at 70 ℃～90 ℃, the cooling of oven dry back, film-making, drying, molding, the mass ratio of the hybrid subdivision that the quality of the ethanol that adds and the 4th step obtain is 1: 1～1: 3, and the mass ratio of the hybrid subdivision that the quality of the starch of adding and the 4th step obtain is 1: 3～1: 5.
For solving the problems of the technologies described above, the present invention also provides the preparation method of above-mentioned Chinese medicine composition, and when the dosage form of described Chinese medicine composition was syrup, it may further comprise the steps:
The first step, it is 85～95% alcohol reflux 2～4 times that Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Herba Epimedii and Semen Juglandis are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.23～1.25 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
Second step, it is 75～80% alcohol reflux 2～4 times that Carapax Et Plastrum Testudinis and Fructus Ligustri Lucidi are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.19～1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
The 3rd step, Radix Cyathulae, Lignum Sappan, Cortex Acanthopancis, Herba Taxilli, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae and Radix Rehmanniae Preparata are mixed in proportion, decoct with water and extract 2～4 times, each decocting time is 1～2 hour, and merge extractive liquid, filters, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.14～1.16 (60 ℃), and the quality that adds water is 4～6 times of mixture quality;
The 4th step, with the first step, the clear paste that the thick paste that second step obtained and the 3rd step obtain mixes, crushed after being dried also is screened into 50 orders～100 purpose fine powders, with fine powder and the saccharin sodium that obtains, correctives and antiseptic mix and are dissolved in the water, sodium carboxymethyl cellulose is dispersed in the hot water, cooling, then with contain extract powder, saccharin sodium, the aqueous suspension of correctives and antiseptic mixes, become volume required preparing solution and mix homogeneously, concentrate, sterilization back packing, namely get syrup, with respect to the mixture fine powder of 100 weight portions, the weight fraction of described saccharin sodium is 2～4 weight portions, and the weight fraction of described sodium carboxymethyl cellulose is 3～5 weight portions, correctives 0.5～1 weight portion, antiseptic 0.5～1 weight portion, water 1000～10000 weight portions, crude drug content is preferably 2g/ml～3g/ml in the described syrup
Beneficial effect of the present invention:
With respect to the medicine that is used for the treatment of postmenopausal osteoporosis of the prior art, adopt this Chinese medicine composition to postmenopausal osteoporosis treatment have that side effect is little, good effect, advantages such as cost is low, cure rate is high, have no drug resistance, taking convenience.
The specific embodiment
Postmenopausal osteoporosis is the modern medicine noun, and is a complexity disease, and classical symptoms such as soft unable, stature shortening, the deformity of spine of withering according to its limbs are judged, surely belonged to categories such as traditional Chinese medical science bone withers, rheumatism involving the bone, lumbago.The pathogenesis of postmenopausal osteoporosis is main relevant with deficiency of both the liver and kidney, the weak blood deficiency of spleen, the obstruction of collaterals by blood stasis of working hard.
Theory of Chinese medical science thinks that the kidney being the origin of congenital constitution, the root of life, the strong longevity of dying young of people's disease is all relevant with natural endowment, " ancient Chinese medical classics essential ideas " point out " kidney storing essence; the smart marrow of giving birth to, marrow nourishing bone, so the bone person, kidney close also the marrow person; the institute of essence gives birth to also, and the sufficient then marrow of essence is sufficient, and marrow is in bone, and marrow is sufficient, and then bone is strong., " illustrating between kidney, bone, the marrow three that close physiological relation is arranged, the growth promoter of bone is powerful weak in close relations with the kidney essense prosperity and decline.Then bone marrow biochemistry is active for the kidney essense abundance, and it is foster and strong strong that bone gets institute; Then bone marrow biochemistry is passive for deficiency of kidney-essence, and bone is become homeless foster and withered soft unable." the non-wind of Jing Yue's complete work " is added: " muscle has the disease of emergency, and bone has the weak disease of withering, and is always lost by essence and blood and hinders and right." this shows that Liver and kidney is the source of essence and blood, caused by liver and kidney deficiency is then sent out withering and osteoporosis for muscles and bones.For the women, whether the vital essence abundance of Liver and kidney concerns the prosperity and decline of ovarian function, if deficiency of both the liver and kidney, ovarian function decline, the hormonal readiness disorder, bone formation and bone resorption are unbalance to be osteoporosis.
The weak blood deficiency of spleen is postmenopausal osteoporosis morbidity key link, and the spleen being the foundation of acquired constitution is led fortuneization, muscle extremity, the lucid yang sending up and had blood under one's command.The abundance of keeping gentle hemospermia liquid of every vital movement all depends on the fortuneization of the spleen, so spleen claims source of generating QI and blood again." element asks LINGLAN secret allusion quotation opinion " said: " here taste barn organs, the five tastes go out." so the normal operation of the normal growth promoter of woman and every vital movement; also depend on the normal performance of the biochemical QI and blood function of spleen; congenital essence (essence of Liver and kidney) depends on constantly supplementing nutrition of the day after tomorrow again; so; the function of spleen is healthy and vigorous, as " Ling Shu Miraculous Pivot or Divine Axis determine gas " institute's cloud, and could " paddy goes into fullness caused by stagnant QI, annotate in bone in the mire pool ", keep the normal function of bone.The menopausal women spleen is hindered for the fortuneization function, and the weak blood deficiency of spleen is near and congenital essence can not get abundance, and bone is become homeless foster, and fragile unable is osteoporosis.Modern study shows, the insufficiency of the spleen blood of the traditional Chinese medical science is weak except about the digestive system, also relevant with multisystem functions such as immunity of organism, hemopoietic, endocrine, body fluid, nerves, so it has had influence on the absorption of bone minerals such as bone calcium, phosphorus, magnesium, albumen and trace element zinc, fluorine directly or indirectly, thereby brings out the generation of menopausal women osteoporosis.
" element is asked the regulating menstruation opinion " said: " the passages through which vital energy circulates person, so promoting the circulation of blood arteries and veins and seek negative and positive moistens muscles and bones, sharp joint also.Hereat blood and, then passages through which vital energy circulates is popular, the multiple negative and positive of battalion, muscles and bones is powerful, the clear profit in joint also." growth promoter of skeleton, it is foster to be unable to do without moistening of qi-blood-body fluid.And blood stasis be pathological product is paathogenic factor, increases the weight of the on the decline of spleen kidney, precise and tiny not cloth, and " bone is not hard ", and osteodynia is also fixing does not move." blood stasis " pathological change of postmenopausal osteoporosis various degrees, " blood stasis " is to cause one of osteoporotic main pathogenesis of menopausal women.The menopausal women deficiency of both the liver and kidney, spleen and stomach function is hindered, and the weak blood deficiency of spleen causes the stasis of blood by void, or simulataneous insufficiency and excessive, finally causes the qi-blood-body fluid deficiency, and bone is become homeless and is supported and induced osteoporosis.
Traditional Chinese medical science pathogenesis " characteristics of multiple deficiency and stasis " according to postmenopausal osteoporosis, theory is thought: 1) suffering from a deficiency of the kidney is immunocompromised, cell, humoral immunization and complement system appear, the reticuloendothelial system function is low in various degree, influence bone metabolism part adjustment factor; Endocrine regulation when 2) suffering from a deficiency of the kidney, hypothalamic pituitary gonadal axis dysfunction, the disorder in various degree of target gland link; Trace element is taken in and is changed when 3) suffering from a deficiency of the kidney, and influences the metabolism of bone ore deposit, thereby can cause osteoporosis.
The traditional Chinese medical science think suffer from a deficiency of the kidney be postmenopausal osteoporosis main diseases because of, the Chinese medicine prevention osteoporosis is a kind of adjustment process to animal economy, acts on a plurality of links, thereby reaches the effect of correcting body hormone imbalances and negative calcium balance effect.Show on the therapeutic effect that it can suppress bone resorption, promotes osteogenesis again.
Based on this, the present invention centers on the theory of traditional Chinese medical science the kidney generating marrow and dominating bone tightly for the Chinese medicine composition of postmenopausal osteoporosis treatment, adopt the kidney invigorating nourishing the liver, spleen strengthening and blood enriching, blood circulation promoting and blood stasis dispelling is its Therapeutic Principle, Radix Morindae Officinalis in the side, Rhizoma Drynariae, Semen Cuscutae, Herba Epimedii and Semen Juglandis energy kidney-replenishing, bone and muscle strengthening, improve blood calcium serium inorganic phosphorus level, activate osteoblast, improve capital bone density, be the principal agent for the treatment of osteoporosis, Carapax Et Plastrum Testudinis and Fructus Ligustri Lucidi nourishing YIN for suppressing the hyperactive YANG, kidney tonifying adds essence, Radix Cyathulae, the Lignum Sappan blood circulation promoting and blood stasis dispelling, Cortex Acanthopancis and Herba Taxilli wind-damp dispelling, invigorating the liver and kidney, the Rhizoma Chuanxiong blood-activating and qi-promoting, Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, Radix Rehmanniae Preparata is enriched blood and is invigorated blood circulation, all medicine combinations of inner and outside, synergism, play the kidney invigorating nourishing the liver, spleen strengthening and blood enriching, the effect of blood circulation promoting and blood stasis dispelling, thereby treatment postmenopausal osteoporosis.
Chinese medicine composition of the present invention has the effect that improves ovarian function, and the generation of this effect may be the function realization by excited hypothalamic-pituitary-ovarian axis; Proliferation and differentiation of osteoblasts had direct facilitation; The osteoclast proliferation and differentiation had direct repression; Increase intestinal absorbing calcium; The balance that can regulate the internal milieu trace element promotes osteogenesis.
Based on above-mentioned theory and principle, Chinese medicine composition of the present invention comprises following component: Radix Cyathulae, Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Semen Juglandis, Carapax Et Plastrum Testudinis, Herba Epimedii, Herba Taxilli, Cortex Acanthopancis, Fructus Ligustri Lucidi, Lignum Sappan, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae Preparata and Rhizoma Chuanxiong.
The concrete pharmacology analysis of each component is as follows:
Radix Cyathulae: sweet in the mouth, little hardship, property is flat, goes into liver, kidney channel, has the effect of blood circulation promoting and blood stasis dispelling, sharp joint, strong waist knee joint, inducing diuresis for treating stranguria syndrome, is used for the blood stasis amenorrhea, dysmenorrhea, treating swelling and pain by traumatic injury, Fengshi Guanjie pain, soreness of the waist and knees with the passing of time, cards such as pyretic stranguria, stranguria with blood, hematuria.
Radix Morindae Officinalis: acrid in the mouth, sweet, slightly warm in nature, go into liver, kidney channel, effect with kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, be used for impotence due to deficiency of the kidney, seminal emission premature ejaculation, few abdomen cold type of pain, cold womb is infertile, cards such as the muscles and bones flaccidity due to the deficiency of the liver and kindey is soft, chills and pain of the waist and kness, Radix Morindae Officinalis can promote the effect of adrenocortical hormone significantly, strengthens the short yellow functional activity of hypothalamic-pituitary-ovarian.
Rhizoma Drynariae: bitter in the mouth, warm in nature, go into liver, kidney channel, have invigorating the kidney and strengthening the bones, continuous effect of hindering pain relieving, be used for suffering from a deficiency of the kidney soreness of waist and knee joint, flaccidity and weakness of the lower limbs, the hepatic and renal YIN deficiency, empty positive rising and the deafness and tinnitus that causes, odontoseisis pain or gingiva oozing of blood, asthenia of both the spleen and kidney and cause chronic diarrhea, chronic dysentery, cards such as traumatic injury, fracture.
Semen Cuscutae: sweet in the mouth, suffering, property is flat, goes into the liver,kidney,spleen warp, and the kidney invigorating and essence nourishing is arranged, and the effect of nourishing the liver to improve visual acuity is mainly used in the sexual impotence of insufficiency of kidney-YANG, seminal emission premature ejaculation, frequent micturition, dizziness and tinnitus; The pain in the lumbar region of suffering from a deficiency of the kidney, married woman's leukorrhagia, nausea is solid; Dim-sighted, the blurring of vision of the binocular of both liver and kidney deficiency, deficiency of liver-blood; The loose stool stomachache of asthenia of both the spleen and kidney, symptoms such as aqueous-grainy diarrhea.
Semen Juglandis: sweet in the mouth, warm in nature, go into kidney, lung, large intestine channel, has the kidney invigorating and essence nourishing, warming the lung Dingchuan, the effect of loosening bowel to relieve constipation, the lumbago lower limb that loses void for kidney qi is soft, dizzy weak, the frequent micturition seminal emission is quenched one's thirst, the cough with asthma of deficiency of both the lung and kidney, old people's deficiency of vital energy and the few and dryness of the intestine constipation that causes in anemia Tianjin in puerperal, traumatic injury, cards such as skin infection carbuncle.
Carapax Et Plastrum Testudinis: distinguish the flavor of into, sweet, cold nature is gone into kidney, the heart, Liver Channel, and nourishing YIN for suppressing the hyperactive YANG is arranged, and kidney tonifying adds essence, the effect that Gu Chong only collapses.The head who is mainly used in the hepatic and renal YIN deficiency, excessive rising of liver-YANG is dizzy; The hectic fever due to YIN-deficiency chronic cough of yin asthenia generating intrinsic heat, night sweat seminal emission, thin and weak weak breath; Insufficiency of heart-YIN, the severe palpitation of disturbing on the phlegm-fire; The soreness of waist foot of asthenia of essence and blood is soft, children's's walking retardation in children; The metrorrhagia of deficiency of YIN heat in blood, the impairment of chong and ren channels, it is more than to pass through; The inferior symptom of the red and white leukorrhea of deficiency of YIN damp invasion of lower energizer, Carapax Et Plastrum Testudinis have enrich blood, the effect of antipyretic-antalgic, can reduce the thyroxine level in the animal body.
Herba Epimedii: acrid in the mouth, sweet, warm in nature, go into liver, kidney channel, have kidney-replenishing, bone and muscle strengthening, the effect of wind-damp dispelling is used for impotence due to deficiency of the kidney, seminal emission premature ejaculation, soft, the cold extremities with aversion to cold of waist knee joint flaccidity; Cards such as arthralgia due to cold-dampnes or spasm of the limbs numbness, Herba Epimedii is traditional kidney invigorating and YANG supporting Chinese medicine, is rich in flavone compound, has gonadotropic Effect, directly suppresses bone resorption and promotes bone formation, makes organism metabolism be in bone formation greater than the positive balance state of bone resorption.
Herba Taxilli: bitter in the mouth, sweet, property is flat, goes into liver, kidney channel, effect with invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit is used for the soreness of waist pain due to the deficiency of the liver and kindey, and the muscles and bones flaccidity is soft, the foot and knee being feeble, deficiency of the liver and kindey, essence and blood is empty to lose the frequent fetal movement of liability to abortion, cards such as waist abdomen pain.
Cortex Acanthopancis: acrid in the mouth, hardship, little sweet, warm in nature, go into liver, kidney channel, have wind-damp dispelling, invigorating the liver and kidney, the effect of bone and muscle strengthening is mainly used in rheumatism and arthritis, and the muscles and bones flaccidity is soft, traumatic injury, fracture, edema, the fragile card that waits has gonadotropic Effect, can promote sexual accessory gland to grow.
Fructus Ligustri Lucidi: sweet in the mouth, hardship, be slightly cold, go into liver, kidney channel, strong liver kidney tonifying is arranged, the effect of clearing away heat to improve acuity of vision is mainly used in treating hepatic and renal YIN deficiency, and the head loses foster dizzy tinnitus, symptoms such as yin asthenia generating intrinsic heat.Fructus Ligustri Lucidi can promote leukocyte, strengthens the effect of immunologic function, and staphylococcus aureus, dysentery bacterium are had stronger inhibitory action.Modern medicine study proves that Fructus Ligustri Lucidi includes ursolic acid, mannitol, glucose, fatty wet goods, and heart tonifying, diuresis and hepatoprotective effect are arranged, and the leukopenia quantity that causes because of chemotherapy is raise, and staphylococcus aureus, escherichia coli are had inhibitory action.
Lignum Sappan: sweet in the mouth, one-tenth, property is flat, goes into the heart, liver, large intestine channel, has blood circulation promoting and blood stasis dispelling, and the effect of reducing swelling and alleviating pain is used for the blood stasis amenorrhea, dysmenorrhea, the stasis of blood stagnated and suffered from abdominal pain puerperal, traumatic injury, cards such as fracture carbuncle sore tumefacting virus.
The Rhizoma Atractylodis Macrocephalae: bitter in the mouth, sweet, warm in nature, go into spleen, stomach warp, has invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive effect, be used for weakness of the spleen and stomach, lack of appetite distension, fatigue and weakness, have loose bowels, water-damp retention, phlegm retention, edema, cards such as exterior deficiency spontaneous perspiration, the Rhizoma Atractylodis Macrocephalae have adjust gastrointestinal motility function, antiulcer, protect the liver, effects such as enhancing human body immunity function, anti-stress, enhancing hemopoietic function; Its dampness diuretic effect is relevant with diuresis; And antiabortive effect is relevant with the effect of inhibition uterine contraction.The Rhizoma Atractylodis Macrocephalae also has effects such as antioxidation, slow down aging, blood sugar lowering, anticoagulation, antitumor.
Radix Rehmanniae Preparata: have another name called Radix Rehmanniae Preparata, sweet in the mouth, slightly warm in nature is gone into liver, kidney channel, has the YIN nourishing of enriching blood, and beneficial essence is filled out the effect of marrow, is used for blood deficiency and yellow complexion; Dizzy, cardiopalmus, insomnia, menoxenia is collapsed more than; Hepatic and renal YIN deficiency, night sweat, sufficient knee joint pain, soreness of the waist and knees, Hiccough and deaf, the head is dim-sighted; The seminal emission sexual impotence; Infertility; Menoxenia; Metrostaxis; Early whitening of beard and hair; Quench one's thirst; Constipation; The cards such as dyspnea with rapid and short breath of suffering from a deficiency of the kidney, medicine justice " cloud arranged: Radix Rehmanniae Preparata, mat wine cooks, and bitter in the mouthization is sweet, alternating temperature cool in nature, special messenger's liver is enriched blood.Bitter anxious because of liver, delay it with sweet, the main warm gallbladder of holding concurrently can beneficial painstaking effort, more the kidney invigorating water.All internal injury deficiencies, bitter will is a tax on one's mind, and the suffering wound is clamored, and the consumption of indulging in sensual pleasures is smart, and the regulating menstruation tire produces, and all should use this.Settling five organs, and blood vessels, the profit skin nourishes heart and dashes, peaceful soul, nourish Kidney-Yin, packing bone marrow, for panacea also, it is dense to get its abnormal smells from the patient, for turbid product in turbid, stares at kidney with benefit, so all living Radix Rehmanniaes Preparata are coveted.Radix Rehmanniae Preparata can promote anemia animal erythrocyte, hemoglobin to recover, and accelerates the propagation of hematopoietic stem cell, bone marrow hemopoietic progenitor cell of red blood cell line, differentiation.
Rhizoma Chuanxiong: acrid in the mouth, warm in nature, go into liver, gallbladder, pericardium channel, have blood-activating and qi-promoting, the effect of wind-expelling pain-stopping is used for all cards of stagnation of QI and blood, headache, rheumatic arthralgia, cards such as traumatic injury.
Further preferred, the described Chinese medicine composition that is used for the treatment of the menopause osteoporosis only is made of said components.
In the described Chinese medicine composition that is used for the treatment of the menopause osteoporosis, the ratio of weight and number of various components can be preferably: Radix Cyathulae 12～18 weight portions, Radix Morindae Officinalis 15～20 weight portions, Rhizoma Drynariae 30～40 weight portions, Semen Cuscutae 20～26 weight portions, Semen Juglandis 22～28 weight portions, Herba Epimedii 27～35 weight portions, Carapax Et Plastrum Testudinis 25～30 weight portions, Fructus Ligustri Lucidi 19～23 weight portions, Herba Taxilli 10～16 weight portions, Cortex Acanthopancis 13～17 weight portions, Lignum Sappan 12～16 weight portions, the Rhizoma Atractylodis Macrocephalae 9～13 weight portions, Radix Rehmanniae Preparata 12～16 weight portions, Rhizoma Chuanxiong 6～10 weight portions.
In the described Chinese medicine composition that is used for the treatment of the menopause osteoporosis, the ratio of weight and number of various components can be preferably: Radix Cyathulae 15～18 weight portions, Radix Morindae Officinalis 17～20 weight portions, Rhizoma Drynariae 35～40 weight portions, Semen Cuscutae 23～26 weight portions, Semen Juglandis 25～28 weight portions, Herba Epimedii 32～35 weight portions, Carapax Et Plastrum Testudinis 27～30 weight portions, Fructus Ligustri Lucidi 21～23 weight portions, Herba Taxilli 13～16 weight portions, Cortex Acanthopancis 15～17 weight portions, Lignum Sappan 14～16 weight portions, the Rhizoma Atractylodis Macrocephalae 11～13 weight portions, Radix Rehmanniae Preparata 14～16 weight portions, Rhizoma Chuanxiong 8～10 weight portions.
If patient's rheumatism disease is comparatively serious, can also add Radix Angelicae Pubescentis and Radix Clematidis in the described Chinese medicine composition.
Radix Angelicae Pubescentis: acrid in the mouth, hardship, slightly warm in nature is gone into kidney, and urinary bladder channel has wind-damp dispelling, pain relieving, the effect of inducing sweat is used for anemofrigid-damp arthralgia, soreness of waist and knee joint, and the headache due to the affection of exogenous wind-cold folder is wet is nose heave to wait card.
Radix Clematidis: acrid in the mouth, one-tenth, warm in nature, go into urinary bladder channel, have expelling wind and removing dampness, the effect of removing obstruction in the collateral to relieve pain is used for rheumatic arthralgia, articular instability, numb limbs and tense tendons, edema is gathered enclosed mass, cards such as deficiency of vital energy body fluid deficiency.
Described Radix Angelicae Pubescentis and the described Radix Clematidis weight fraction ratio in described Chinese medicine composition is: Radix Angelicae Pubescentis 3～5 weight portions, Radix Clematidis 4～6 weight portions.
If it is strong that patient has person's back concurrently, it is ineffective to change one's position, and can also add Radix Puerariae and Rhizoma Et Radix Notopterygii in the described Chinese medicine composition.
Radix Puerariae: sweet in the mouth, suffering, cool in nature, go into spleen, stomach warp, have relieving muscles diaphoresis, rash, analgesicly promote the production of body fluid, the effect of yang invigorating antidiarrheal, be used for fever caused by exogenous pathogens, headache stiffness of the nape; Measles from the beginning of, saturating send out cards such as not smooth.
Rhizoma Et Radix Notopterygii: acrid in the mouth, hardship, warm in nature, go into bladder, kidney channel, have the effect of the cold expelling that induces sweat, expelling wind and dampness, pain relieving, be used for the wet sign of wind and cold folder; Cards such as anemofrigid-damp arthralgia.
Described Radix Puerariae and the Rhizoma Et Radix Notopterygii weight fraction ratio in described Chinese medicine composition is: Radix Puerariae 5～7 weight portions, Rhizoma Et Radix Notopterygii 2～3 weight portions.
The described dosage form that is used for the treatment of the Chinese medicine composition of postmenopausal osteoporosis can be tablet, capsule, granule, pill, suspensoid, Emulsion, solution, syrup, tincture or injection etc.
The described administering mode that is used for the treatment of the Chinese medicine composition of postmenopausal osteoporosis is oral or injection, and described injection can be in intravenous injection, intravenous drip, intramuscular injection or the subcutaneous injection etc. one or more.
When the dosage form of Chinese medicine composition of the present invention is decoct, its preparation method may further comprise the steps:
The first step is mixed in proportion described component, pulverizes and be screened into 100 orders～150 purpose powder;
Second step obtained powder with the first step and adds in the cold water and soaked 16 hours～20 hours, and with slow fire boiling, decocting time is 2 hours～3 hours, and decoction liquor is filtered, and obtains first filtrate, and the quality that institute adds water is 3～5 times of powder quality of first step acquisition;
In the 3rd step, the filtering residue that second step filter was obtained adds in the cold water again, with slow fire boiling 2 hours～3 hours, filters and obtains second filtrate, identical in the quality of the water that adds and second step;
The 4th step merged filtrate twice, concentrated and removed part water, obtained described decoct, and crude drug content is preferably 2g/ml～3g/ml.
Described Chinese medicine composition in use, if take with decoct, 3 doses of every days, the morning, noon and afternoon each once, every dose of decocting is obeyed at twice, per 7 days is a course for the treatment of.
When the dosage form of Chinese medicine composition of the present invention was tablet, its preparation method may further comprise the steps:
The first step, it is 85～95% alcohol reflux 2～4 times that Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Herba Epimedii and Semen Juglandis are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.23～1.25 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
Second step, it is 75～80% alcohol reflux 2～4 times that Carapax Et Plastrum Testudinis and Fructus Ligustri Lucidi are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.19～1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
The 3rd step, Radix Cyathulae, Lignum Sappan, Cortex Acanthopancis, Herba Taxilli, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae and Radix Rehmanniae Preparata are mixed in proportion, decoct with water and extract 2～4 times, each decocting time is 1～2 hour, and merge extractive liquid, filters, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.14～1.16 (60 ℃), and the quality that adds water is 4～6 times of mixture quality;
The 4th step, the thick paste and the 3rd that the first step, second step are obtained goes on foot the clear paste mixing that obtains, crushed after being dried also is screened into 50 orders～100 purpose fine powders, adding starch and determining alcohol is 60%～75% ethanol, heating is concentrated into pasty state, put into baking oven, control is at 70 ℃～90 ℃, the cooling of oven dry back, film-making, drying, molding, the mass ratio of the hybrid subdivision that the quality of the ethanol that adds and the 4th step obtain is 1: 1～1: 3, and the mass ratio of the hybrid subdivision that the quality of the starch of adding and the 4th step obtain is 1: 3～1: 5.
Described Chinese medicine composition in use, if with tablets, the specification of the tablet that makes is 0.2g/ sheet～0.4g/ sheet, every day 3 times, the morning, noon and afternoon each once, each 3, per 7 days is a course for the treatment of.
When the dosage form of Chinese medicine composition of the present invention was syrup, its preparation method may further comprise the steps:
The first step, it is 85～95% alcohol reflux 2～4 times that Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Herba Epimedii and Semen Juglandis are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.23～1.25 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
Second step, it is 75～80% alcohol reflux 2～4 times that Carapax Et Plastrum Testudinis and Fructus Ligustri Lucidi are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.19～1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density, and the quality that adds ethanol is 3～5 times of mixture quality;
The 3rd step, Radix Cyathulae, Lignum Sappan, Cortex Acanthopancis, Herba Taxilli, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae and Radix Rehmanniae Preparata are mixed in proportion, decoct with water and extract 2～4 times, each decocting time is 1～2 hour, and merge extractive liquid, filters, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.14～1.16 (60 ℃), and the quality that adds water is 4～6 times of mixture quality;
The 4th step, with the first step, the clear paste that the thick paste that second step obtained and the 3rd step obtain mixes, crushed after being dried also is screened into 50 orders～100 purpose fine powders, with fine powder and the saccharin sodium that obtains, correctives and antiseptic mix and are dissolved in the water, sodium carboxymethyl cellulose is dispersed in the hot water, cooling, then with contain extract powder, saccharin sodium, the aqueous suspension of correctives and antiseptic mixes, become volume required preparing solution and mix homogeneously, concentrate, sterilization back packing, namely get syrup, with respect to the mixture fine powder of 100 weight portions, the weight fraction of described saccharin sodium is 2～4 weight portions, and the weight fraction of described sodium carboxymethyl cellulose is 3～5 weight portions, correctives 0.5～1 weight portion, antiseptic 0.5～1 weight portion, water 1000～10000 weight portions, crude drug content is preferably 2g/ml～3g/ml in the described syrup.
Described Chinese medicine composition in use, if take with syrup, 3 doses of every days, the morning, noon and afternoon each once, each 1 dose, per 7 days is a course for the treatment of.
Below adopt embodiment to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implements according to this.
Acute toxicity testing and the long term toxicity test of embodiment 1 Chinese medicine composition of the present invention
Acute toxicity testing
The experiment medicine:
18g Radix Cyathulae, 20g Radix Morindae Officinalis, 40g Rhizoma Drynariae, 26g Semen Cuscutae, 28g Semen Juglandis, 35g Herba Epimedii, 30g Carapax Et Plastrum Testudinis, 23g Fructus Ligustri Lucidi, 16g Herba Taxilli, 17g Cortex Acanthopancis, 16g Lignum Sappan, the 13g Rhizoma Atractylodis Macrocephalae, 16g Radix Rehmanniae Preparata, 18g Rhizoma Chuanxiong are mixed, pulverize and be screened into 100 purpose powder; To obtain to soak 20 hours in the powder adding 1800g cold water, with slow fire boiling, decocting time is 3 hours, and decoction liquor is filtered, and obtains first filtrate; Add again in the 1800g cold water filtering the filtering residue that obtains, with slow fire boiling 3 hours, filter and obtain second filtrate; Merge filtrate twice, concentrate and remove part water, obtain described decoct, crude drug content is 3g/ml.
Process of the test:
Get 50 of ICR mices (Beijing Vital River Experimental Animals Technology Co., Ltd. provides), body weight is at 25～30 grams, to the mouse stomach decoct, to the median lethal dose(LD 50) (LD of administration 50) carried out test determination, but do not measure LD 50, therefore carried out mtd test.Result: with Cmax (60%), maximum dosage-feeding (120ml/kg, dividing in one day and give for four times) 100g/kg irritates stomach, be equivalent to crude drug amount 60g/kg, 300 times (pressing 75kg) of the daily dosage of clinical plan are equivalent to be grown up, none death of mice in seven days is put to death each internal organs of mice anatomic observation and is not found toxic reaction, and administration group and control group mice do not have any difference.
Long term toxicity test
The test medication:
It is 95% ethanol 800g reflux, extract, 3 times that 20g Radix Morindae Officinalis, 40g Rhizoma Drynariae, 26g Semen Cuscutae, 35g Herba Epimedii and 28g Semen Juglandis are mixed, add determining alcohol, the time of each reflux is 1 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is the thick paste of 1.25 (60 ℃) that concentrating under reduced pressure becomes relative density; It is 80% ethanol 210g reflux, extract, 3 times that 30g Carapax Et Plastrum Testudinis and 23g Fructus Ligustri Lucidi are mixed, add determining alcohol, and the time of each reflux is 2 hours, and merge extractive liquid, filters, and leaves standstill, and gets the upper strata stillness of night, and it is 1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density; 18g Radix Cyathulae, 16g Lignum Sappan, 17g Cortex Acanthopancis, 16g Herba Taxilli, 10g Rhizoma Chuanxiong, the 13g Rhizoma Atractylodis Macrocephalae and 16g Radix Rehmanniae Preparata are mixed, add the 630g water boiling and extraction 4 times, each decocting time is 1 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.16 (60 ℃); The thick paste and the clear paste that obtain are mixed, and crushed after being dried also is screened into 50 purpose fine powders, and adding 80g starch and determining alcohol are 75% ethanol 500g, heating is concentrated into pasty state, puts into baking oven, and control is at 90 ℃, the cooling of oven dry back, film-making, drying, molding, the specification of tablet is the 0.1g/ sheet.
Process of the test:
Application Wistar rat (Beijing Vital River Experimental Animals Technology Co., Ltd. provides) will be tested medicine and will be set at high, medium and low three dosage, be respectively tablet 36g/kg, 18g/kg, 9g/kg.Calculate by human (60kg is standard) dosage 0.3g/kg/ days, be 120 times, 60 times and 30 times of human effective dose; Other establishes a matched group, and gastric infusion 90 days, 180 days and the drug withdrawal of part animal were observed the influence to the every physiology of rat, biochemical indicator after 10 days continuously.Experimental result shows: gave the rat continuous oral 180 days with various dose, food-intake and the body weight gain of rat all do not had influence.Hepatic and renal function is not all found the overt toxicity effect.Routine blood test, blood biochemistry, urine biochemistry and bone marrow sheet etc. be there is no obvious influence, compare no significant difference with matched group between each group.
The decoct of embodiment 2 Chinese medicine composition preparations of the present invention
18g Radix Cyathulae, 20g Radix Morindae Officinalis, 40g Rhizoma Drynariae, 26g Semen Cuscutae, 28g Semen Juglandis, 35g Herba Epimedii, 30g Carapax Et Plastrum Testudinis, 23g Fructus Ligustri Lucidi, 16g Herba Taxilli, 17g Cortex Acanthopancis, 16g Lignum Sappan, the 13g Rhizoma Atractylodis Macrocephalae, 16g Radix Rehmanniae Preparata, 18g Rhizoma Chuanxiong are mixed, pulverize and be screened into 100 purpose powder; To obtain to soak 20 hours in the powder adding 1800g cold water, with slow fire boiling, decocting time is 3 hours, and decoction liquor is filtered, and obtains first filtrate; Add again in the 1800g cold water filtering the filtering residue that obtains, with slow fire boiling 3 hours, filter and obtain second filtrate; Merge filtrate twice, concentrate and remove part water, obtain described decoct, crude drug content is 3g/ml.
The tablet of embodiment 3 Chinese medicine composition preparations of the present invention
It is 95% ethanol 800g reflux, extract, 3 times that 20g Radix Morindae Officinalis, 40g Rhizoma Drynariae, 26g Semen Cuscutae, 35g Herba Epimedii and 28g Semen Juglandis are mixed, add determining alcohol, the time of each reflux is 1 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is the thick paste of 1.25 (60 ℃) that concentrating under reduced pressure becomes relative density; It is 80% ethanol 210g reflux, extract, 3 times that 30g Carapax Et Plastrum Testudinis and 23g Fructus Ligustri Lucidi are mixed, add determining alcohol, and the time of each reflux is 2 hours, and merge extractive liquid, filters, and leaves standstill, and gets the upper strata stillness of night, and it is 1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density; 18g Radix Cyathulae, 16g Lignum Sappan, 17g Cortex Acanthopancis, 16g Herba Taxilli, 10g Rhizoma Chuanxiong, the 13g Rhizoma Atractylodis Macrocephalae and 16g Radix Rehmanniae Preparata are mixed, add the 630g water boiling and extraction 4 times, each decocting time is 1 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.16 (60 ℃); The thick paste and the clear paste that obtain are mixed, and crushed after being dried also is screened into 50 purpose fine powders, and adding 80g starch and determining alcohol are 75% ethanol 500g, heating is concentrated into pasty state, puts into baking oven, and control is at 90 ℃, the cooling of oven dry back, film-making, drying, molding, the specification of tablet is the 0.1g/ sheet.
The syrup of embodiment 4 Chinese medicine composition preparations of the present invention
It is 95% ethanol 700g reflux, extract, 4 times that 17g Radix Morindae Officinalis, 35g Rhizoma Drynariae, 23g Semen Cuscutae, 32g Herba Epimedii and 25g Semen Juglandis are mixed, add determining alcohol, the time of each reflux is 1 hour, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, it is 1.25 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density; It is 80% ethanol 190g reflux, extract, 3 times that 27g Carapax Et Plastrum Testudinis and 21g Fructus Ligustri Lucidi are mixed, add determining alcohol, and the time of each reflux is 2 hours, and merge extractive liquid, filters, and leaves standstill, and gets the upper strata stillness of night, and it is 1.22 (60 ℃) thick paste that concentrating under reduced pressure becomes relative density; 15g Radix Cyathulae, 14g Lignum Sappan, 15g Cortex Acanthopancis, 13g Herba Taxilli, 8g Rhizoma Chuanxiong, the 11g Rhizoma Atractylodis Macrocephalae and 14g Radix Rehmanniae Preparata are mixed, add the 580g water boiling and extraction 2 times, each decocting time is 2 hours, merge extractive liquid,, filter, leave standstill, get the upper strata stillness of night, concentrating under reduced pressure becomes the clear paste of relative density 1.16 (60 ℃); The thick paste and the clear paste that obtain are mixed, crushed after being dried also is screened into 50 purpose fine powders, the fine powder that obtains is mixed with 12g saccharin sodium, 3g Mel and 3g antiseptic and be dissolved in the 3000g water, the 10g sodium carboxymethyl cellulose is dispersed in the hot water, cool off, mix with the aqueous suspension that contains extract powder, saccharin sodium, correctives and antiseptic then, become volume required preparing solution and mix homogeneously, concentrate, sterilization back packing, namely get syrup, crude drug content is 3g/ml in the described syrup.
Zoopery
1.1 experiment material
1.1.1 laboratory animal
72 of SPF level Healthy female SD rats, 6 monthly ages, body constitution amount 260～290g.All SD rats are all fed in the cleaning ambient of constant temperature, constant humidity, and ambient temperature is (25 ± 1) ℃, and humidity 70% guarantees 12h illumination every day.
1.1.2 experiment medicine
The Chinese medicine composition decoct of embodiment 2 preparations, crude drug content is 3g/ml, is equivalent to 20 times of clinical dosages.Positive control drug uses nilestriol to be provided by pharmaceutical factory, Hua Lian, Shanghai, and lot number is: 060501.This experiment reagent box is provided by U.S. RB company.Lot number: 130407, valid until in December, 2010.
1.2 modeling method
Adopt simple randomized controlled trial design.All rats are divided into 2 groups at random: one group is sham operated rats, is 24; One group is 48 for the operation group.Press the 0.33ml/100g lumbar injection with 10% chloral hydrate solution, behind the 5min, anesthesia is complete, and the operation group adopts the modeling of dorsal part approach bilateral ovaries excising operation.The sham-operation of sham operated rats row, operation pathway be with the operation group, ovary is proposed from the abdominal cavity and do not excise, and only closes wound immediately behind the little fat tissue around the excision, splashes into a spot of benzylpenicillin sodium solution in the wound, skin suture, the wound of sterilizing, postoperative sub-cage rearing.Row operation is selected the inspection of 12 rats underwent bone densities from two groups respectively after 3 months at random, to determine the modeling success.After definite modeling success, operation group residue rat is divided into 3 groups at random, 12 every group, be respectively: surgery models group, estrogen group, Chinese drug-treated group.
1.3 Therapeutic Method
Oophorectomize postoperative March, the success of postmenopausal osteoporosis animal model, the treatment of beginning gastric infusion, the gastric infusion volume is 10mL/kg, sham operated rats, surgery models group gavage distilled water; Chinese drug-treated group gavages Chinese medicine composition decoct of the present invention, and medicine is settled to desired concn with distilled water, and namely 10ml/kg gavages administration, every day 1 time; The estrogen group gives nilestriol 1mg/kg and irritates stomach, is made into suspension (concentration is 0.167mg/ml) before using, and 1 time/week, all the other times give distilled water 10ml/kg and irritate stomach.3 months by a definite date treatment time, and behind last perfusion 2h, get the animal serum index that experimentizes and detect.
1.4 index determining
Serum estradiol (estrogen, E 2), serum I procollagen type carboxypropeptide (PICP) PICP detects by Traditional Chinese Medicine University Of Guangzhou's the 3rd Affiliated Hospital osteoporosis laboratory.Serum levels of ALP is detected by the biochemical chamber of No.1 Hospital Affiliated to Zhongshan Univ..
1.5 statistical method
(variance analysis is relatively used in the expression of x ± s), many groups of measurement datas, and (analysis of variance, ANOVA), The data SPSS13.0 statistical software handles experimental data with mean ± standard deviation.
1.6 result
1.6.1
3 months operation groups of postoperative compare with non-operation group bone density comparison model group and blank group, and whole body, waist bone density reduce (P＜0.05), and difference has statistical significance, proves modeling successful (table 1).
3 months operation groups of table 1 postoperative with take the comparison of operation group bone density (x ± s, g/cm 2)
Group The example number The whole body bone density The waist bone density
Blank group 12 0.142±0.019 0.235±0.0241
Matched group 10 0.123±0.0151 1) 0.182±0.041 1)
1) two groups are compared P＜0.05
1.6.2
Chinese medicine composition decoct of the present invention is to rat blood serum E 2The model group that influences of level compares serum E with blank group 2Content reduces, and difference has statistical significance (P＜0.05).Chinese drug-treated group and model group compare, E 2Level raises, and difference has statistical significance (P＜0.05), and the Chinese medicine composition decoct of the present invention E that raises to a certain extent is described 2Level.Chinese drug-treated group and estrogen group compare, and difference not statistically significant (P＞0.05) illustrates that Chinese medicine composition decoct of the present invention and nilestriol are to rat blood serum E 2Effect zero difference (table 2).
Table 2 is respectively organized rat blood serum E 2, ALP, PICP comparison (x ± s)
Group The example number E 2(pg/ml) ALP(U/l) PICP(ug/l)
Blank group 12 79±23 1.17±0.12 79±14
Model group 10 58±151 1) 1.04±0.05 1) 82±9
Chinese drug-treated group 11 78±18 2) 1.13±0.06 2) 94±12 2)
The estrogen group 11 82±19 1) 1.13±0.05 3) 96±17
1) compares P＜0.05 with blank group; 2) compare P＜0.05 with model group
1.6.3
Chinese medicine composition decoct of the present invention compares with blank group the model group that influences of rat blood serum ALP level, and difference has statistical significance (P＜0.05), and serum levels of ALP content reduces.Chinese drug-treated group and model group relatively, the ALP level raises, difference has statistical significance (P＜0.05), and the Chinese medicine composition decoct of the present invention ALP level that can raise is described.Chinese drug-treated group and estrogen group compare, and difference not statistically significant (P＞0.05) illustrates that Chinese medicine composition decoct of the present invention and nilestriol are to the effect zero difference (table 2) of rat blood serum ALP.
1.6.4
Chinese medicine composition decoct of the present invention compares difference not statistically significant (P＜0.05) to the model group that influences of rat blood serum PICP level with blank group.Chinese drug-treated group and model group relatively, PICP raises, difference has statistical significance (P＜0.05), and the Chinese medicine composition decoct of the present invention PICP level that can raise is described.Chinese drug-treated group and estrogen group compare, and difference not statistically significant (P＞0.05) illustrates that Chinese medicine composition decoct of the present invention and nilestriol are to the effect zero difference (table 2) of rat blood serum PICP.
Clinical experiment
1.1 clinical data
187 examples are examines the patients with postmenopausal osteoporosis of prescription on individual diagnosis, 45～65 years old age, 58.9 ± 3.86 years old mean age, the average menopause time limit 6.95 ± 4.37 at my gate in May, 2010～2011 year March.
1.2 diagnostic criteria
1.2.1 bone density: dual intensity X line bone density meter (QDR-4000 type, U.S. HOLOGIC company produce), it is diagnostic criteria that the bone amount of recommending with WHO is lower than others two standard deviations of group's peak bone mass of the same sex.
1.2.2 differential diagnosis in tcm: with reference to " the dialectical reference standard of Chinese medicine deficiency-syndrome " " syndrome of deficiency of kidney-YANG " dialectical standard.Cardinal symptom soreness of the waist and knees, aversion to cold and cold limbs, by the score of its symptom degree, symptom continues and severe patient meter 3 minutes, and is heavy or often send out the author repeatedly and counted 2 fens when light during symptom, symptom slightly or the accidental person of appearance counted 1 fen, asymptomatic person counted 0 fen.
1.2.3 clinical manifestation: many places chronic pains such as back are cardinal symptom.
1.3 exclusion standard
1.3.1 the patient causes the various endocrinopathy persons (low as Cushing's disease, hyperthyroidism, hyperparathyroidism, thyroid function, diabetes etc.) of secondary osteoporosis.
1.3.2 other serious disease is disturbed the bone metabolism person.
1.3.3 in 1 year fracture person is arranged.
1.3.4 fracture person is taken place during treating.
1.4 the standard of including in
Meet above-mentioned diagnostic criteria.
1.5 experiment grouping
This experimental study is according to the principle of randomized controlled, and 183 routine patients are divided into two groups, is respectively to take traditional Chinese medicine composition for treating group 100 examples of the present invention and take Western medicine Gaierqi D (vitamin D3 and calcium carbonate) matched group 83 examples.
1.6 experiment medicine and administering mode
The treatment group: the Chinese medicine composition tablet of the embodiment of the invention 3, every day 3 times, the morning, noon and afternoon, respectively once each 3, per 7 days was a course for the treatment of, takes 9 courses for the treatment of continuously.
Matched group: Western medicine Gaierqi D (vitamin D3 and calcium carbonate) (Wyeth Wyeth pharmaceuticals, every calcic 600mg, vitamin D 125 ius), 1 time/d, each 1, play (medicine) being taken before meal morning, be used in conjunction for 10 weeks, both in kind measure lumbar spine bmd.
1.7 observation index
(1) bone density: detect lumbar vertebra normotopia and lateral lumber spine with dual intensity X line borne densitometers, respectively survey 1 time before the medication and when finishing the course for the treatment of.(2) clinical symptoms and tcm syndrome scoring: observe symptoms such as whole body osteodynia, soreness of waist and knee joint, breast lumbar vertebra body percussion pain, aversion to cold and cold limbs, lower limb are aching and limp, more than the scoring index, is carried out clinical symptoms every month and is marked with tcm syndrome to seriously being respectively 0～6 fen from slightly.Recovery from illness: no pain, soreness of the waist and knees, flaccidity and weakness of the lower limbs is unable, and the vertigo and tinnitus symptom is obviously improved, and bone density value improves more than 2%.Effectively: pain obviously alleviates, soreness of the waist and knees, and flaccidity and weakness of the lower limbs is unable, the vertigo and tinnitus symptom is partly improved, and bone density value improves between (0～2) %.Invalid: each side does not all have improvement.(3) safety observation index: reach when finishing the course for the treatment of before blood, routine urinalysis and liver, renal function, the electrocardiogram etc., medication and respectively detect 1 time.
1.8 statistical method
The measurement data employing (x ± s); Two groups of clinical efficacies relatively adopt Ridit to analyze; Paired t-test is adopted in the tcm syndrome integral mean value of two groups for the treatment of front and back, the variation of bone density value index.
1.9 therapeutic outcome (seeing Table 3, table 4 and table 5)
Table 3 treatment group and treatment of control group postmenopausal osteoporosis BMD change relatively (gcm -2, x ± s)
Figure BSA00000667204800191
Table 4 liang group tcm syndrome integral mean value relatively
Figure BSA00000667204800192
The table 5 liang group traditional Chinese medical science is waited the card curative effect relatively
Group Number Produce effects Effectively Invalid Effective percentage
The treatment group 100 67 28 5 95％
Matched group 83 31 19 33 60.2％
From table 3 to table 5 as can be seen, Chinese medicine composition of the present invention has significant curative effect with respect to Western medicine to the treatment postmenopausal osteoporosis.
Model case
Lee, woman, 55 years old.With lumbar and back pain 1 year.Go to a doctor on May 17th, 2010.Patient's frequent unable, dizzy, tired back sx constantly of lumbar and back pain, the soft knee joint acid of shin, walking over nearly 1 year has lower limb to knot during night.Check: waist, extremity do not have obvious tenderness, and activity still can.Biochemistry detection: three big routines, liver, renal function and electrocardiogram are all normal; X-ray film shows: the medium hyperosteogeny of lumbar vertebra, bone trabecula are sparse; The close instrument testing result prompting of dual intensity X line bone: lumbar vertebra L2～L4 bone density is 0.840g/cm, (1.53SD), femoral neck bone density 0.713g/cm accounts for peak bone mass 73% (2.42SD) to account for peak bone mass 83%, femoral greater trochanter bone density 0.656g/cm accounts for peak bone mass 82% (1.28SD); Light red, the yellow and thin fur of body of the tongue, wiry and frequent pulse is postmenopausal osteoporosis after diagnosing, and it is all undesirable to take various Chinese medicine and western medicine effects, the Chinese medicine composition syrup of back clothes embodiment 4,3 doses of every days, the morning, noon and afternoon each once, each 1 dose, per 7 days is a course for the treatment of, through 10 courses for the treatment of, the complete obiteration of osteoporosis symptom is followed up a case by regular visits to and is not recurred half a year.
This intellectual property of primary enforcement that all are above-mentioned is not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.

Claims (6)

1. Chinese medicine composition that is used for the treatment of postmenopausal osteoporosis, it is characterized in that: the weight portion of each component in the described Chinese medicine composition is Radix Cyathulae 12～18 weight portions, Radix Morindae Officinalis 15～20 weight portions, Rhizoma Drynariae 30～40 weight portions, Semen Cuscutae 20～26 weight portions, Semen Juglandis 22～28 weight portions, Herba Epimedii 27～35 weight portions, Carapax Et Plastrum Testudinis 25～30 weight portions, Fructus Ligustri Lucidi 19～23 weight portions, Herba Taxilli 10～16 weight portions, Cortex Acanthopancis 13～17 weight portions, Lignum Sappan 12～16 weight portions, the Rhizoma Atractylodis Macrocephalae 9～13 weight portions, Radix Rehmanniae Preparata 12～16 weight portions, Rhizoma Chuanxiong 6～10 weight portions.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that: the weight portion of each component in the described Chinese medicine composition is Radix Cyathulae 15～18 weight portions, Radix Morindae Officinalis 17～20 weight portions, Rhizoma Drynariae 35～40 weight portions, Semen Cuscutae 23～26 weight portions, Semen Juglandis 25～28 weight portions, Herba Epimedii 32～35 weight portions, Carapax Et Plastrum Testudinis 27～30 weight portions, Fructus Ligustri Lucidi 21～23 weight portions, Herba Taxilli 13～16 weight portions, Cortex Acanthopancis 15～17 weight portions, Lignum Sappan 14～16 weight portions, the Rhizoma Atractylodis Macrocephalae 11～13 weight portions, Radix Rehmanniae Preparata 14～16 weight portions, Rhizoma Chuanxiong 8～10 weight portions.
3. Chinese medicine composition as claimed in claim 1, it is characterized in that: the dosage form of described Chinese medicine composition is tablet, capsule, granule, pill, suspensoid, Emulsion, solution, syrup, tincture or injection.
4. Chinese medicine composition as claimed in claim 1 is characterized in that: the administering mode of described Chinese medicine composition is oral or injection.
5. the preparation method of claim 1 or 2 described Chinese medicine compositions is characterized in that, the dosage form of described Chinese medicine composition is decoct, and it may further comprise the steps:
The first step is mixed in proportion described component, pulverizes and be screened into 100 orders～150 purpose powder;
Second step obtained powder with the first step and adds in the cold water and soaked 16 hours～20 hours, and with slow fire boiling, decocting time is 2 hours～3 hours, and decoction liquor is filtered, and obtains first filtrate, and the quality that institute adds water is 3～5 times of powder quality of first step acquisition;
In the 3rd step, the filtering residue that second step filter was obtained adds in the cold water again, with slow fire boiling 2 hours～3 hours, filters and obtains second filtrate, identical in the quality of the water that adds and second step;
The 4th step merged filtrate twice, concentrated and removed part water, obtained described decoct, and crude drug content is 2g/ml～3g/ml.
6. the preparation method of claim 1 or 2 described Chinese medicine compositions is characterized in that, the dosage form of described Chinese medicine composition is tablet, and it may further comprise the steps:
The first step, it is 85～95% alcohol reflux 2～4 times that Radix Morindae Officinalis, Rhizoma Drynariae, Semen Cuscutae, Herba Epimedii and Semen Juglandis are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the supernatant, relative density was 1.23～1.25 thick paste when concentrating under reduced pressure became 60 ℃, and the quality that adds ethanol is 3～5 times of mixture quality;
Second step, it is 75～80% alcohol reflux 2～4 times that Carapax Et Plastrum Testudinis and Fructus Ligustri Lucidi are mixed in proportion, add determining alcohol, the time of each reflux is 1～2 hour, merge extractive liquid,, filter, leave standstill, get the supernatant, relative density was 1.19～1.22 thick paste when concentrating under reduced pressure became 60 ℃, and the quality that adds ethanol is 3～5 times of mixture quality;
The 3rd step, Radix Cyathulae, Lignum Sappan, Cortex Acanthopancis, Herba Taxilli, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae and Radix Rehmanniae Preparata are mixed in proportion, decoct with water and extract 2～4 times, each decocting time is 1～2 hour, and merge extractive liquid, filters, leave standstill, get the supernatant, the clear paste of relative density 1.14～1.16 when concentrating under reduced pressure becomes 60 ℃, the quality that adds water is 4～6 times of mixture quality;
The 4th step, the thick paste and the 3rd that the first step, second step are obtained goes on foot the clear paste mixing that obtains, crushed after being dried also is screened into 50 orders～100 purpose fine powders, adding starch and determining alcohol is 60%～75% ethanol, heating is concentrated into pasty state, put into baking oven, control is at 70 ℃～90 ℃, the cooling of oven dry back, film-making, drying, molding, the mass ratio of the mixing fine powders that the quality of the ethanol that adds and the 4th step obtain is 1:1～1:3, and the mass ratio of the mixing fine powders that the quality of the starch of adding and the 4th step obtain is 1:3～1:5.
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CN103705831B (en) * 2013-12-27 2016-06-15 柳州市妇幼保健院 A kind of pharmaceutical composition treating menopausal syndrome and preparation method thereof
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CN104940540A (en) * 2015-06-17 2015-09-30 杨风霞 Traditional Chinese medicine preparation for treating postmenopausal osteoporosis and preparation method thereof
CN105395806A (en) * 2015-12-12 2016-03-16 杨献美 A traditional Chinese medicine preparation for treating osteoporosis in postmenopausal women
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