CN102552766A - Traditional Chinese medicine used for treating postmenopausal osteoporosis, preparation method thereof, and administration method thereof - Google Patents
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Abstract
The invention provides a traditional Chinese medicine composition used for treating postmenopausal osteoporosis. The medicine composition comprises twotoothed achyranthes root, dipsacus asper, dried human placenta, common burreed tuber, colored mistlitoe herb, yerbadetajo herb, medlar, salvia miltiorrhiza, dragon's blood, licorice root, and ligusticum. When the traditional Chinese medicine composition is used for treating postmenopausal osteoporosis, advantages such as small side effect, good treatment effect, low cost, high curative rate, no medicine resistance, and convenient administration are provided.
Description
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 to treat osteoporosis.
Background technology
Osteoporosis is meant the absolute minimizing (ratio of mineralizer and bone matrix is normal in the bone) of osseous tissue total amount in the unit volume; The 26S Proteasome Structure and Function of bone is changed; So that skeleton fragility increases, thereby the systemic skeletal diseases that extremity lumbar and back pain, pathologisch Bruch, figure's distortion etc. show appears.Primary disease mainly is divided into two big types of constitutional and Secondary cases, and primary osteoporosis comprises (high conversion type, I type) and senile (hanging down conversion type, the II type) osteoporosis after the menopause.Primary osteoporosis is the modern medicine title, and the title that is similar to primary disease in motherland's medical science has that myopathy, bone are withered, bone exhaustion, the atrophic debility of bones etc., and wherein qualitative, location surely belongs to the atrophic debility of bones more accurately.
Postmenopausal osteoporosis (PMOP I type osteoporosis) refers to main by the low osteoporosis that causes of postmenopausal estrogen level; Be mainly in after the menopause more than 2 years, the women below 70 years old belongs to primary osteoporosis; It is common clinically refractory disease; It reduces with the bone amount and osseous tissue micro structure destruction causes bone fragility to increase and be easy to fracture, especially marrow fracturing, and sickness rate is high, mortality rate is high, it is higher to spend.Postmenopausal osteoporosis constitutes a serious threat to the health of global middle aged and aged women, becomes the outstanding problem of social hygiene's health care.
The menopausal women osteoporosis is the general metabolism property osteopathia that a kind of multifactor too many levels causes.Modern medicine and Chinese medicine have different recognition and research to its pathogeny and treatment.Modern medicine is thought ovarian hypofunction after morbidity and the menopause of menopausal women osteoporosis, and the inducing action of decrease in estrogen and cytokine is closely related.Our Chinese medicine is then from the idea of human body integral, and what think the menopausal women osteoporosis is the disease that imbalance caused of a plurality of internal organs and function thereof, and deficient five internal organs and QI and blood dysfunction are its pathogenesis basis.The traditional Chinese medical science thinks, kidney governing bones and give birth to marrow, and deficiency of both the liver and kidney, the weak blood deficiency of spleen, obstruction of collaterals by blood stasis is the basic mechanism of menopausal women osteoporosis morbidity.And be not very to confirm to the therapeutic effect of menopausal women osteoporosis now, in clinical treatment, doctor trained in Western medicine is mainly used the medicine that suppresses bone absorption, promotes sclerotin to form medicine and can be promoted sclerotin mineralising class medicine.These medicines have certain curative effect in clinical treatment, but the side effect of Western medicine unstability big, clinical efficacy also is insurmountable always problem, has brought great burden to patient.So; Utilization differentiation of tcm, disease are closed the thought of ginseng, and the advantageous advantage of performance Chinese medicine strives to find the pathogenesis research of menopausal women osteoporosis and the meeting point of Chinese medicine; Thereby improve its clinical control rate, bring Fu Yin to patient.
Summary of the invention
Technical problem to be solved by this invention is; Overcome the deficiency of existing treatment; Utilize the traditional theory of Chinese medical science 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 that in order to solve above-mentioned technology the invention provides a kind of Chinese medicine composition that is used to treat postmenopausal osteoporosis, it comprises: Radix Achyranthis Bidentatae, Radix Dipsaci, Placenta Hominis, triangular, Herba Visci, Herba Ecliptae, Fructus Lycii, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis.
Wherein, The ratio of weight and number of each component in the said Chinese medicine composition is Radix Achyranthis Bidentatae 20～26 weight portions, Radix Dipsaci 30～40 weight portions, Placenta Hominis 19～25 weight portions, triangular 12～18 weight portions, Herba Visci 9～13 weight portions, Herba Ecliptae 15～20 weight portions, Fructus Lycii 16～20 weight portions, Radix Salviae Miltiorrhizae 13～17 weight portions, Sanguis Draxonis 9～14 weight portions, Radix Glycyrrhizae 10～15 weight portions, Radix Angelicae Sinensis 11～15 weight portions.
Wherein, The ratio of weight and number of each component in the said Chinese medicine composition is Radix Achyranthis Bidentatae 23～26 weight portions, Radix Dipsaci 35～40 weight portions, Placenta Hominis 22～25 weight portions, triangular 15～18 weight portions, Herba Visci 11～13 weight portions, Herba Ecliptae 17～20 weight portions, Fructus Lycii 18～20 weight portions, Radix Salviae Miltiorrhizae 15～17 weight portions, Sanguis Draxonis 12～14 weight portions, Radix Glycyrrhizae 12～15 weight portions, Radix Angelicae Sinensis 13～15 weight portions.
Wherein, the dosage form of the said Chinese medicine composition that is used to treat postmenopausal osteoporosis can be honey refining pill, hydration pill, drop pill, capsule, tablet, powder, decoct, oral liquid, tincture etc.
Wherein, the dosage form of said Chinese medicine composition is a capsule, and its preparation method comprises:
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and was concentrated into the clear paste of relative density 1.28～1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～50 weight portion starch mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate are in the gelatine capsule of packing into then.
Wherein, the dosage form of said Chinese medicine composition is a tablet, and its preparation method comprises:
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and filtrating merges, and was concentrated into the clear paste of relative density 1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～30 weight portion microcrystalline Cellulose, mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate, then with the granule compacting in flakes with decompressor.
For solving the problems of the technologies described above, the present invention also provides the method for preparing of above-mentioned Chinese medicine composition:
When the dosage form of said Chinese medicine composition was capsule, it comprised,
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and was concentrated into the clear paste of relative density 1.28～1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～50 weight portion starch mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate are in the gelatine capsule of packing into then.
For solving the problems of the technologies described above, the present invention also provides the method for preparing of above-mentioned Chinese medicine composition:
When the dosage form of said Chinese medicine composition was tablet, it comprised,
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and filtrating merges, and was concentrated into the clear paste of relative density 1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～30 weight portion microcrystalline Cellulose, mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate, then with the granule compacting in flakes with decompressor.
For solving the problems of the technologies described above, it is oral that the present invention also provides the administering mode of above-mentioned Chinese medicine composition.
Beneficial effect of the present invention:
With respect to the medicine that is used to treat 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
Chinese medicine composition of the present invention comprises following component: Radix Achyranthis Bidentatae, Radix Dipsaci, Placenta Hominis, triangular, Herba Visci, Herba Ecliptae, Fructus Lycii, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis.
Modern medicine thinks, osteoporosis is because the bone metabolism imbalance, bone lose reconstruction greater than bone; The result causes bone loss; Trabecular bone structure is destroyed, and bone strength descends, and causes the degeneration skeletal diseases of a kind of generalized metabolic disorder of risk of bone fracture rising.Clinical manifestation is back limbs pain, deformity, fracture etc.The traditional Chinese medical science does not have this name of disease, belongs to categories such as " atrophic debility of bones ", " rheumatism involving the bone ", " lumbago ", " bone is withered ", " bone exhaustion ".
The traditional Chinese medical science thinks that the kidney being the origin of congenital constitution, and the kidney generating marrow and dominating bone, weakly all has confidential relation with the prosperity and decline of kidney essense at the growth of bone, growth.The kidney essense abundance is " dental transition is sent out long " then, and bone marrow biochemistry is active, and bone is able to nourish and strong strong, otherwise then can produce " atrophic debility of bones ", " rheumatism involving the bone ", " lumbago ", " bone is withered ", " bone exhaustion ".And the spleen being the foundation of acquired constitution, main bones of the body collectively is source of generating QI and blood." interior warp " said: " hereat carefully coordinating five kinds of flavor in foodstuff, then solid skeleton and pliable tendons; QI-blood circulating regularly, one's pores will be fine in texture, essence derived from food is with essence in this way ".Congenital essence depends on little the supplementing nutrition of the transporting and transforming function of the spleen and stomach foodstuff essence day after tomorrow, like the weakness of the spleen and stomach day after tomorrow, transformation failure of spleen; Make congenital essence be difficult to supplement nutrition, the damage of essence marrow that is bound to is empty, and the bones of the body collectively flaccidity is useless; Therefore, the traditional Chinese medical science thinks that " deficiency of the kidney is insufficiency of the spleen " is the basic cause of disease of " bone is withered ", " atrophic debility of bones ".Theory of Chinese medical science matches about the relation of growth, growth and the kidney of bone and the modern medicine study Changing Pattern to the human body osteogenesis; The traditional Chinese medical science is stressed to start with from the spleen kidney to the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of osteoporosis; With the invigorating the kidney and spleen is method, is the key of treatment primary disease but control from the kidney opinion.
Suffering from a deficiency of the kidney is the basic reason that osteoporosis takes place.The traditional Chinese medical science thinks that the powerful and fragility of bone is the important symbol of essence in kidney prosperity and decline.Modern medicine thinks that the essence of suffering from a deficiency of the kidney is that disorder has taken place hypothalamic pituitary gonadal axis, and then causes that osteogenesis function descends, and osteoporosis takes place; Insufficiency of the spleen is the key factor that osteoporosis takes place.If spleen and stomach function decline, then essence and blood loses emptyly, and damage of essence can not be irrigated, and blood deficiency can not nutrition, is difficult to give birth to marrow nourishing bone, and causes osteoporosis; QI and blood is the material base of all histoorgan physiological activities of human body.If qi depression to blood stasis, obstruction of collaterals by blood stasis must cause the generation of disease.
Chinese medicine composition of the present invention is main, tonifying both YIN and YANG and to cooperate invigorating the spleen and benefiting QI, blood circulation promoting and blood stasis dispelling be principle with the kidney invigorating; The function that its treatment mechanism mainly is to regulate hypothalamic-pituitary-ovarian axis; Improve sex hormone level in postmenopausal women's body, it is active to increase osteoblast, suppresses the osteoclast activity; Prevent and treat unusual bone loss, regulate the bone metabolism effect.Other there are some researches prove it improve in addition intestinal to the absorption of calcium, correct negative calcium balance and hormone imbalances; Regulate effect inhibition bone resorption such as organismic internal environment trace element balance, and through the general of body, the regulating action of too many levels are reached the purpose of treatment.Radix Achyranthis Bidentatae, Radix Dipsaci, Placenta Hominis, Herba Ecliptae, Fructus Lycii nourishing the liver and kidney in the side, tonifying both YIN and YANG, triangular, Sanguis Draxonis and Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling; Herba Visci bone and muscle strengthening, wind-damp dispelling, Radix Glycyrrhizae invigorating the spleen and benefiting QI, Radix Angelicae Sinensis blood circulation promoting and enriching; All medicines are in harmonious proportion, and play the effect of tonifying both YIN and YANG, invigorating the spleen and benefiting QI, blood circulation promoting and blood stasis dispelling.
Radix Achyranthis Bidentatae: bitter in the mouth, acid, property is flat, goes into liver, kidney channel.Radix Achyranthis Bidentatae is used for invigorating the liver and kidney, bone and muscle strengthening, promoting blood circulation to restore menstrual flow; Ignite (blood) descending; Inducing diuresis for treating stranguria syndrome cures mainly soreness of waist and knee joint; Flaccidity and weakness of the lower limbs; Amenorrhea due to stagnation of blood; Dysmenorrhea; Puerperal abdominal pain due to blood stasis; Lump in the abdomen; Retention of placenta; Pyretic stranguria; Stranguria with blood; Traumatic injury; Blood circulation promoting and blood stasis dispelling." Bencao Jingshu ": Radix Achyranthis Bidentatae, to walk and can mend, property is kind descending, so go into Liver and kidney.Main cold-damp flaccidity syndrome and arthralgia syndrome, spasm of the limbs, gonalgia unable to flex and stretch the extremities person, the liver spleen is suffered from a deficiency of the kidney, and then the heresy visitor's of cold-damp forms numbness, and sick spasm of the limbs, gonalgia unable to flex and stretch the extremities.This property of medicine is walked and descending, and it can be by cold-damp and eliminating impediment also must.Top capping liver then muscle is relaxed, the descending knee joint of then managing, and promoting the circulation of blood then pain ends.By vim and vigour, can ventilate stagnates blood clotting also.The fire of getting mildewed in warm conditions is mashed, the shrivelled disease of blood also, blood is capable and lives, oneself ends pain.Go into the liver promoting the circulation of blood, so induced abortion.The damaging the spleen and stomach weak breath, man's the moon disappears, and the old man loses the person that drowns, and all the time of kidney deficiency is also.The brain being the reservoir of the marrow, brain are discontented with then empty and pain.Waist is the internal organs of kidney, and the logical marrow of ridge is in brain, and the marrow of suffering from a deficiency of the kidney is few, then pain along the spinal column; Blood deficiency and heat is then turned white.Empty win is fatigued, then hinders exhausted.Blood stored in the liver, kidney storing essence, high invigorating the liver and kidney, then hemapodium is and smart full, and all cards are from recover.The capable then month water of blood is from logical, and blood agglomeration is from loosing.
Radix Dipsaci: bitter in the mouth, suffering, slightly warm in nature is gone into liver, kidney channel; Have invigorating the liver and kidney, bone and muscle strengthening, blood circulation regulating, continuous folding wound, the only effect of metrorrhagia, be used for the soreness of waist and knee joint of deficiency of the liver and kindey, insufficiency of kidney-YANG, impotence and seminal emission, enuresis frequent micturition, the frequent fetal movement of suffering from a deficiency of the kidney, vaginal bleeding during pregnancy hematochezia; Traumatic injury; Cards such as fracture, the broken property of loosing of this article suffering temperature, kind ability blood circulation promoting and blood stasis dispelling; The merit of sweet temperature compensation benefit again can the strong muscle of bone strengthening, and reunion of fractured tendons and bones is arranged, the ability of the pain relieving of curing the wound.With controlling traumatic injury, swelling and pain due to blood stasis, injury of tendon and muscle fracture.
Placenta Hominis: sweet in the mouth, salty, warm in nature, have the kidney invigorating and essence nourishing, the effect of invigorating qi and benefiting blood is used for deficiency of kidney-QI, and essence and blood is empty to be lost, impotence and seminal emission, soreness of waist tinnitus, or infertile; Deficiency of both the lung and kidney, dyspnea and shortness of breath; Insufficiency of vital energy and blood, few food of becoming thin, fatigue and asthenia, or puerperal, breast waited card less. " Bencao Jingshu ": plancenta hominis is a medicine of mending deficiency of both YIN and YANG, and the also merit of unit of anti-basis is arranged.Yet deficiency of YIN essence dries up, and water failing to restrain blazing fire is sent out to cough and spitted blood, cards such as hectic fever due to YIN-deficiency night sweat, and this belongs to overabundance of YANG leading to deficiency of YIN, and method work as strengthening renal yin to inhibit predominant yang, with system sunlight, should not obey this also agent of benefit, to consume the moon that will exhaust also.Stomach-fire toothache, method are also avoided it.
Triangular: bitter in the mouth, property is flat, has removing blood stasis, circulation of qi promoting, the effect of removing food stagnancy analgesic is used for the blood stasis amenorrhea, dysmenorrhea, the stasis of blood stagnated and suffered from abdominal pain puerperal, and stagnation of QI due to dyspepsia is played cards such as abdominal distention and pain.
Herba Visci: bitter in the mouth, sweet, property is flat, goes into liver, kidney channel, has invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive effect; Be used for the soreness of waist and knee joint due to the deficiency of the liver and kindey, the muscles and bones flaccidity is soft, the foot and knee being feeble; Rheumatic arthralgia, the cards such as frequent fetal movement that articular instability, asthenia of renal qi cause.
Herba Ecliptae: sweet in the mouth, acid, cold in nature, return liver, kidney channel, play liver and kidney tonifying, the effect of cooling blood for hemostasis is used for having a dizzy spell due to the hepatic and renal YIN deficiency, blurring of vision, soreness of the waist and knees; Be suitable for the deficiency of YIN hot person is arranged; Be used for treating the haematemesis of the long-pending heat of stomach; Symptoms such as the hemoptysis of injury of blood vessel of the lung by heat, Herba Ecliptae has inhibitory action to staphylococcus aureus, Bacillus typhi, Song Shi dysentery bacterium, bacillus pyocyaneus, obviously enhancing non-specific immunity and cellular immune function.
Fructus Lycii: sweet in the mouth, property is flat, returns Liver Channel, kidney channel, lung meridian, and it has nourishing the liver and kidney, beneficial intensive culture blood, the removing nebula that makes eye bright, the effect of nourishing the lung to arrest cough.Cure mainly the atrophic debility of bones of suffering from a deficiency of the kidney, impotence and seminal emission, fertility for a long time, senilism senilism, early whitening of beard and hair; Blood deficiency and yellow complexion, puerperal, breast was few, poor vision, interior external oculopathy eye, interior-heat is quenched one's thirst; The consumptive fever hectic fever due to YIN-deficiency, chronic consumptive disease cough, diseases such as the few expectorant of dry cough, " book on Chinese herbal medicine is just ": Fructus Lycii; Highly seasoned and pure, so the ability nourishing YIN has sun in the moon, so can QI invigorating.So YIN nourishing and unlikely the moon declines is supporing yang and can make Yang Wang.The a thousand li though the proverb cloud is left home is not eaten Fructus Lycii, but calls its supporing yang ear, seemingly also must be yet.This thing is little supporing yang and do not have moving property, thus use to help Radix Rehmanniae Preparata the most wonderful.Its merit is improve visual and auditory acuity then, adds smart solid marrow, strengthens the muscle and bone, and the kind impairment caused by overstrain of mending is especially only quenched one's thirst, and Kidney-Yin void umbilicus abdomen gnawing pains take no rest person uses the magical effect more.
Radix Salviae Miltiorrhizae: bitter in the mouth, cold in nature, go into the heart, Liver Channel, the effect of blood circulation promoting and blood stasis dispelling, promoting tissue regeneration by removing blood stasis, removing heat from blood mind calming is arranged, be mainly used in the ambition of stagnation of QI and blood, the twinge of the breast side of body, sensation of oppression over the chest with shortness of breath, abdominal distention; The menoxenia of women's disharmony between QI and blood, the dysmenorrhoea amenorrhea; Stagnation of QI-blood, symptoms such as trusted subordinate's pain, Radix Salviae Miltiorrhizae has inhibitory action to staphylococcus aureus, bacillus pyocyaneus, escherichia coli, Bacillus proteus, Bacillus typhi, dysentery bacterium.
Sanguis Draxonis: sweet in the mouth, salty, property is flat, goes into the heart, liver, spleen channel, promoting blood circulation to remove blood stasis for oral administration, analgesic therapy, the external hemostasia and promoting granulation is held back skin ulcer, cures mainly congestion amenorrhea, dysmenorrhea, postpartum stagnation; The lump in the abdomen mass in the abdomen, breast ventral spine pain; Traumatic injury, congestion swells and ache; Traumatic hemorrhage, cards such as ulcer being unable to heal.
Radix Glycyrrhizae: property is flat, and sweet in the mouth is gone into 12 warps, has invigorating the spleen and replenishing QI; Heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, the effect of coordinating the actions of various ingredients in a prescription; Be used for insufficiency of heart-QI, severe palpitation, irregularly intermittent and regularly intermittent pulse and deficiency of spleen-QI and stomach-QI, fatigue and weakness, ulcer sores, laryngopharynx swelling and pain, asthma and cough is in harmonious proportion the strong of some drugs; " book on Chinese herbal medicine converges and says ": Radix Glycyrrhizae and middle QI invigorating, the medicine of tonify deficiency detoxifcation also.Strengthening the spleen and stomach, Gu the void of middle gas is won, association's negative and positive and uncomfortable battalion defend.So control the strain internal injury, deficiency-weakness of spleen-QI, first YANG deficiency, the lung qi void that declines, its Gan Wenping mends, and effect and ginseng, stilbene are also also.Laryngopharynx swelling and pain and for example, assistant Fructus Aurantii Immaturus, Mus are sticking, can lung heat clearing open pharynx; Sputum cough, Fructus Perillae, two old altogether, can expectorant pleasant.The assistant Radix Astragali, windproof can be transported poison and walk table, is varioliform exanthema QI and blood deficiency person, the agent that head and the tail must be supported.Get Radix Scutellariae, Radix Paeoniae Alba, end dysentery stomachache; Get Flos Lonicerae, Herba Violae, all furunculosiss disappear; Get Rhizoma Coptidis, separate fetal toxicosis at the beginning of life is arranged; Get Fructus Forsythiae, the acute pyogenic infection of perineum of loosing is when drawing close to successful conclusion.The pure cold medicine of the pure heat of all usefulness must use Radix Glycyrrhizae with slow its gesture, the medicine that cold and heat are assorted mutually, must use Radix Glycyrrhizae with its property.High first ancient cooking vessel cloud, it is real that completely to avoid Radix Glycyrrhizae solid, if middle empty five sun cloth not, so that the QI rising in reverse order is full and stagnate not down, seven doses in clothes Radix Glycyrrhizae is promptly logical.
Radix Angelicae Sinensis: sweet in the mouth, suffering, hardship, warm in nature, go into liver, the heart, spleen channel, to enrich blood and invigorate blood circulation, regulating menstruation relieves the pain, the effect of loosening bowel to relieve constipation.The head who is mainly used in the treatment deficiency of heart-blood is giddy, fatigue and weakness, shortness of breath and palpitation, and other syndrome of deficiency of blood; The sea of blood is hollow, and symptoms such as the phase of spreading out are less measured in the menoxenia of the cold and deficiency of CHONG and REN meridians or congestion retardance, and Radix Angelicae Sinensis has effects such as anti-platelet aggregation and antithrombotic, resisting myocardial ischemia, blood vessel dilating, blood fat reducing, and can promote liver cell regeneration and recovery.
The Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, Radix Angelicae Sinensis and blood are enriched blood, and both match, and can be widely used in all cards of blood stasis blood deficiency.
Further preferred, the said Chinese medicine composition that is used to treat postmenopausal osteoporosis only is made up of said components.
The said Chinese medicine composition that is used for treating postmenopausal osteoporosis, the ratio of weight and number of various components can be preferably: Radix Achyranthis Bidentatae 20～26 weight portions, Radix Dipsaci 30～40 weight portions, Placenta Hominis 19～25 weight portions, triangular 12～18 weight portions, Herba Visci 9～13 weight portions, Herba Ecliptae 15～20 weight portions, Fructus Lycii 16～20 weight portions, Radix Salviae Miltiorrhizae 13～17 weight portions, Sanguis Draxonis 9～14 weight portions, Radix Glycyrrhizae 10～15 weight portions, Radix Angelicae Sinensis 11～15 weight portions.
The said Chinese medicine composition that is used for treating postmenopausal osteoporosis, the ratio of weight and number of various components also can further be preferably: Radix Achyranthis Bidentatae 23～26 weight portions, Radix Dipsaci 35～40 weight portions, Placenta Hominis 22～25 weight portions, triangular 15～18 weight portions, Herba Visci 11～13 weight portions, Herba Ecliptae 17～20 weight portions, Fructus Lycii 18～20 weight portions, Radix Salviae Miltiorrhizae 15～17 weight portions, Sanguis Draxonis 12～14 weight portions, Radix Glycyrrhizae 12～15 weight portions, Radix Angelicae Sinensis 13～15 weight portions.
The dosage form of the said Chinese medicine composition that is used to treat postmenopausal osteoporosis can for: honey refining pill, hydration pill, drop pill, capsule, tablet, powder, decoct, oral liquid, tincture etc., administering mode is preferably oral.
When the dosage form of Chinese medicine composition of the present invention was capsule, its preparation method may further comprise the steps:
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and was concentrated into the clear paste of relative density 1.28～1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step, said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; 5～7 weight portion carboxymethyl starch sodium, 5～50 weight portion starch mix homogeneously; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation, drying, granulate; Add mixture subsequently with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; 3～5 weight portion magnesium stearate in the gelatine capsule of packing into then, promptly get medicine capsule of the present invention.
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 by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and filtrating merges, and was concentrated into the clear paste of relative density 1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step, said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently with respect to said volatile oil inclusion of 100 weight portions and dried cream powder; 5～7 weight portion carboxymethyl starch sodium, 5～30 weight portion microcrystalline Cellulose, mix homogeneously; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation, drying, granulate; Add mixture subsequently with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; 3～5 weight portion magnesium stearate with decompressor with the granule compacting in flakes, promptly get medicinal tablet of the present invention then.
Said Chinese medicine composition in use, if take with capsule, the specification of the capsule that makes is 0.25g/ grain～0.35g/ grain, every day 3 times; Morning, noon and afternoon each once, each 3 capsules, per 7 days is a course of treatment, if with tablets; The specification of the tablet that makes is that weight is 0.1g/ sheet～0.2g/ sheet, can per 12 be a plate, every day 3 times; Morning, noon and afternoon, respectively once each 3, per 7 days was a course of treatment.
Below adopt embodiment to specify embodiment of the present invention, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can make much of and implement according to this.
Embodiment 1 acute toxicity testing and long term toxicity test
The experiment medicine:
26g Radix Achyranthis Bidentatae, 20g Herba Ecliptae and 20g Fructus Lycii are mixed, add the water extraction volatile oil of 200g, the volatile oil that obtains is used beta-cyclodextrin inclusion compound, the ratio of volatile oil and beta-schardinger dextrin-is 1: 7, stirs 40 minutes, and 40 ℃ of temperature get volatile oil clathrate compound, and are subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.17 (60 ℃); 40g Radix Dipsaci and 25g Placenta Hominis are mixed, add determining alcohol and be 65% ethanol 320g reflux, extract, 3 times, each 2 hours, to filter, filtrating merges, and reclaims ethanol, is concentrated into the clear paste of relative density 1.22 (60 ℃), and is subsequent use; 18g is triangular, 13g Herba Visci, 17g Radix Salviae Miltiorrhizae, 14g Sanguis Draxonis, 15g Radix Glycyrrhizae and 15g Radix Angelicae Sinensis mix, and add 560g water, boil 6 hours, filter, and are concentrated into the clear paste of relative density 1.30 (60 ℃); The clear paste of top acquisition is mixed, and 65 ℃ of following reduced vacuum are dry, and powder gets dry extract; Volatile oil clathrate compound and dried cream powder that the front is obtained fully mix, and add 12g carboxymethyl starch sodium, 100g starch mix homogeneously subsequently, and adding the 300g determining alcohol is 90% alcohol granulation; Dry; Granulate adds the 10g magnesium stearate subsequently, in the gelatine capsule of packing into then; Promptly get medicine capsule, the specification of capsule is the 0.30g/ grain.
Test method:
40 of Application of I CR mices (Beijing Vital River Experimental Animals Technology Co., Ltd. provides), body weight is carried out acute toxicity testing at 25～30 grams.Mice is divided into two groups at random, and promptly matched group and administration group are tested preceding fasting 12 hours; The Chinese medicinal composition capsules suspension (capsule is dissolved in the outstanding liquid that mixes of acquisition in the water, and concentration is 5.36g crude drug/ml, maximum concentration) that gives the invention described above is then irritated stomach; Irritate the stomach volume and be 4ml/kg (be that single-dose dosage is that the 21.44g crude drug/kg), matched group gives the equivalent normal saline, administration in 1 day 2 times; Delivery time 6 hours; Observed 14 days continuously after the administration, and toxic reaction and the death toll of record mice, specifically see table 1 for details.Experimental result shows: with matched group relatively, mice does not see notable difference after the administration, experiment was observed 20 days continuously, the mice overall health of patients, ingest, drinking-water, body weight gain is all normal.Mice oral administration gavage capsule LD of the present invention
50＞21.44g crude drug/kg, every day, maximum dosage-feeding was 42.88g crude drug/kg/ day.Chinese medicine composition clinical application amount of the present invention is 2.3g crude drug/day/people, becomes body weight for humans in 60kg, and average dosage is 0.038g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 20g) oral administration gavage Chinese medicine composition of the present invention is 1128 times of clinical consumption.Therefore Chinese medicine composition acute toxicity of the present invention is low, clinical drug safety.
Table 1: the The acute toxicity tests of the oral filling clothes of mice Chinese medicinal composition capsules of the present invention
The long term toxicity test of Chinese medicine composition of the present invention
Select 132 of female sd inbred rats for use, SPF level, body weight 80～100g; Provide by Guangdong Medical Lab Animal Center; Be divided into 4 groups at random by body weight, promptly matched group, the basic, normal, high dose groups of Chinese medicinal composition capsules suspension of the present invention (7.6,25.8,63.6g crude drug/kg), 33 every group.The administration group receives reagent once every day, successive administration 3 months, 6 months and put to death each 11 of matched groups, basic, normal, high dose groups rat, totally 44 after convalescent period (drug withdrawal 1 month) respectively.Duration of test is observed outward appearance, general behavior, body weight change, the amount of drinking water of ingesting of animal, and 3,6 months and 1 month (convalescent period) of drug withdrawal carry out hematology's (RBC, HCT, MCV, MCH, MCHC, HB, PLT, CT, WBC and classification, reticulocyte, clotting time etc.) and check with indexs such as serum biochemistry (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, GLOB, A/G, TG, CHOL etc.), organ coefficient, histopathology after the administration.Result of the test shows: each treated animal general state is good, all no abnormal variation of outward appearance sign, behavioral activity, body weight gain; Three dose groups and matched group are learned inspection all in normal range at administration 3,6 months and drug withdrawal hematological examination after 1 month, blood biochemical, do not have significant difference between group; Each is organized main organs and organizes and do not see that pathology relevant with medicine change.Show according to result of the test: basic, normal, high three dosage of Chinese medicine composition of the present invention (7.6,25.8, the 63.6g crude drug/kg) administration in continuous 3,6 months does not have obvious influence to rat; No clear and definite toxicity target organ and sensitive indicator; Convalescent period observes and does not also see the retardance toxic reaction; Therefore the long term toxicity of Chinese medicine composition of the present invention is low, and the dosage safety property of clinical practice is high.
The capsule of embodiment 2 Chinese medicine composition preparations of the present invention
26g Radix Achyranthis Bidentatae, 20g Herba Ecliptae and 20g Fructus Lycii are mixed, add the water extraction volatile oil of 200g, the volatile oil that obtains is used beta-cyclodextrin inclusion compound, the ratio of volatile oil and beta-schardinger dextrin-is 1: 7, stirs 40 minutes, and 40 ℃ of temperature get volatile oil clathrate compound, and are subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.17 (60 ℃); 40g Radix Dipsaci and 25g Placenta Hominis are mixed, add determining alcohol and be 65% ethanol 320g reflux, extract, 3 times, each 2 hours, to filter, filtrating merges, and reclaims ethanol, is concentrated into the clear paste of relative density 1.22 (60 ℃), and is subsequent use; 18g is triangular, 13g Herba Visci, 17g Radix Salviae Miltiorrhizae, 14g Sanguis Draxonis, 15g Radix Glycyrrhizae and 15g Radix Angelicae Sinensis mix, and add 560g water, boil 6 hours, filter, and are concentrated into the clear paste of relative density 1.30 (60 ℃); The clear paste of top acquisition is mixed, and 65 ℃ of following reduced vacuum are dry, and powder gets dry extract; Volatile oil clathrate compound and dried cream powder that the front is obtained fully mix, and add 12g carboxymethyl starch sodium, 100g starch mix homogeneously subsequently, and adding the 300g determining alcohol is 90% alcohol granulation; Dry; Granulate adds the 10g magnesium stearate subsequently, in the gelatine capsule of packing into then; Promptly get medicine capsule, the specification of capsule is the 0.30g/ grain.
The tablet of embodiment 3 Chinese medicine composition preparations of the present invention
23g Radix Achyranthis Bidentatae, 17g Herba Ecliptae and 18g Fructus Lycii are mixed, add the water extraction volatile oil of 230g, the volatile oil that obtains is used beta-cyclodextrin inclusion compound, the ratio of volatile oil and beta-schardinger dextrin-is 1: 8, stirs 50 minutes, and 50 ℃ of temperature get volatile oil clathrate compound, and are subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.16 (60 ℃); 35g Radix Dipsaci and 22g Placenta Hominis are mixed, add the 285g determining alcohol and be 60% alcohol reflux 3 times, each 2 hours, to filter, filtrating merges, and reclaims ethanol, is concentrated into the clear paste of relative density 1.21 (60 ℃), and is subsequent use; 15g is triangular, 11g Herba Visci, 15g Radix Salviae Miltiorrhizae, 12g Sanguis Draxonis, 12g Radix Glycyrrhizae and 13g Radix Angelicae Sinensis mix, and add 470g water, boil 6 hours, filter, and are concentrated into the clear paste of relative density 1.30 (60 ℃); The clear paste that the front is obtained mixes, and 65 ℃ of following reduced vacuum are dry, and powder gets dry extract; The said volatile oil clathrate compound and the dried cream powder that obtain are fully mixed, add 9g carboxymethyl starch sodium, 50g microcrystalline Cellulose, mix homogeneously subsequently, adding the 300g determining alcohol is 85% alcohol granulation; Dry; Granulate adds the 8g magnesium stearate subsequently, then with decompressor with the granule compacting in flakes; Promptly get medicinal tablet of the present invention, the specification of tablet is the 0.1g/ sheet.
Clinical experiment
1 clinical data
1.1 case is selected
205 examples are examines the patients with postmenopausal osteoporosis of prescription on individual diagnosis at my gate in June, 2010～2011 year May, 60～82 years old age, average (68 ± 2.1) year, adopt single at random blind counter point, will observe case and be divided into observation group's 135 examples, matched group 70 examples.2 groups at aspects such as age, the menopause time limit, height, body weight and bone density values through statistical analysis, the equal not statistically significant of difference (P＞0.05) has comparability.
1.2 diagnostic criteria
Draft the diagnostic criteria about primary osteoporosis according to " new Chinese medicine clinical research guideline " standard: (1) has the general weakness osteodynia, how is obviously with the low-back pain, increase the weight of gradually that the scheuermann kyphosis deformity can be arranged, and microtrauma can cause fracture; (2) X line performance: sclerotin is generally sparse, and is obvious with vertebra, pelvis, proximal femur.It is the most special that spinal column changes, and fish tail appearance double concave can appear in vertebral body, and intervertebral space broadening has Schmor l tuberosity, and thoracic vertebra is Wedging, the vertebral body pilosity of getting involved, is dispersed in; (3) peak bone mass of the more same sex of dual intensity X ray examination mensuration bone density, agnate health adult reduces more than or equal to 2.5 standard deviations.The dialectical standard [1] of the traditional Chinese medical science: (1) primary symptom: 1. lumbar vertebrae pain or whole body osteodynia; 2. soreness of the waist and knees.(2) inferior disease: 1. vertebral body is kowtowed pain or tenderness; 2. can not be prudent; 3. lower limb are thin soft or numb; 4. vertigo and tinnitus; 5. body of the tongue is red partially or light; 6. deep-thready pulse or thin.Possess 2 in the primary symptom, in the inferior disease in 1.～4. one gets final product.
1.3 exclusion standard
Get rid of the serious primary diseases of important organ such as merging the heart, brain, kidney and influence the bone metabolic disease person, take and influence bone metabolism medicine person nearly half a year, merges the fresh fracture person.
2 Therapeutic Method
Be for 15 weeks 2 groups of courses of treatment.
The treatment group:
Take the tablet of the Chinese medicine composition 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 of treatment.
Matched group
With salmon calcitonin see calcimar injection (Beijing Shuanglu Pharmaceutical Co., Ltd., the accurate word H20020694 of traditional Chinese medicines), after the skin test feminine gender, the 1st week: every day 1 time, each 50U, intramuscular injection; The 2nd week: the next day 1 time, each 50U, intramuscular injection; The 3rd～12 week: 1 time weekly, each 50U, intramuscular injection.
3 results
3.1 curative effect determinate standard
Draft according to " new Chinese medicine clinical research guideline " standard.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.All adopt the dual-energy x-ray absorption process to measure the bone density (BMD) of lumbar vertebra and fl neck before and after all patient treatments.Bone density criterion of therapeutical effect computational methods: (T score value percentage ratio before T score value percentage ratio one treatment of treatment back) * 100%.
3.2 result
3.2.1
2 groups of Comparison of therapeutic: treatment group total effective rate is 91.1%, and the matched group total effective rate is 62.8%; 2 groups of comparing differences are obvious, and statistical significance (P＜0.05) is arranged.The result sees table 1.
2 groups of curative effects of table 1 relatively
| Group | The example number | Recovery from illness | Effectively | Invalid | Effectively total | Total effective rate (%) |
| The treatment group | 135 | 76 | 47 | 12 | 123 | 91.1 |
| Matched group | 70 | 19 | 25 | 26 | 44 | 62.8 |
Compare Δ P＜0.05 with matched group
3.2.2
BMD testing result contrast before and after 2 groups of treatments: with preceding relatively P＜0.05 of this group treatment; With comparison P＜0.05 after the treatment of control group.Difference all has statistical significance.The result sees table 2.
BMD testing result contrast (gcm before and after 2 groups of treatments of table 2
-2, x ± s)
| Group | The example number | Time | Lumbar vertebra | Neck of femur |
| The treatment group | 135 | Before the treatment | 0.75±0.20 | 0.56±0.13 |
| After the treatment | 0.99±0.18 | 0.74±0.17 | ||
| Matched group | 70 | Before the treatment | 0.78±0.25 | 0.57±0.19 |
| After the treatment | 0.97±0.30 | 0.69±0.12 |
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 professional and technical personnel of being familiar with possibly utilize the technology contents of above-mentioned announcement to change or be modified as the equivalent embodiment of equivalent variations.But everyly do not break away from technical scheme content of the present invention, to any simple modification, equivalent variations and remodeling that above embodiment did, still belong to the protection domain of technical scheme of the present invention according to technical spirit of the present invention.
Claims (9)
1. a Chinese medicine composition that is used to treat postmenopausal osteoporosis is characterized in that, comprising: Radix Achyranthis Bidentatae, Radix Dipsaci, Placenta Hominis, triangular, Herba Visci, Herba Ecliptae, Fructus Lycii, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis.
2. Chinese medicine composition as claimed in claim 1; It is characterized in that: the ratio of weight and number of each component in the said Chinese medicine composition is Radix Achyranthis Bidentatae 20～26 weight portions, Radix Dipsaci 30～40 weight portions, Placenta Hominis 19～25 weight portions, triangular 12～18 weight portions, Herba Visci 9～13 weight portions, Herba Ecliptae 15～20 weight portions, Fructus Lycii 16～20 weight portions, Radix Salviae Miltiorrhizae 13～17 weight portions, Sanguis Draxonis 9～14 weight portions, Radix Glycyrrhizae 10～15 weight portions, Radix Angelicae Sinensis 11～15 weight portions.
3. according to claim 1 or claim 2 Chinese medicine composition; It is characterized in that: the ratio of weight and number of each component in the said Chinese medicine composition is Radix Achyranthis Bidentatae 23～26 weight portions, Radix Dipsaci 35～40 weight portions, Placenta Hominis 22～25 weight portions, triangular 15～18 weight portions, Herba Visci 11～13 weight portions, Herba Ecliptae 17～20 weight portions, Fructus Lycii 18～20 weight portions, Radix Salviae Miltiorrhizae 15～17 weight portions, Sanguis Draxonis 12～14 weight portions, Radix Glycyrrhizae 12～15 weight portions, Radix Angelicae Sinensis 13～15 weight portions.
4. like the described Chinese medicine composition of claim 1 to 3, it is characterized in that: the dosage form of the said Chinese medicine composition that is used to treat postmenopausal osteoporosis can be honey refining pill, hydration pill, drop pill, capsule, tablet, powder, decoct, oral liquid, tincture etc.
5. like the described Chinese medicine composition of claim 1 to 4, it is characterized in that: the dosage form of said Chinese medicine composition is a capsule, and its preparation method comprises,
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and was concentrated into the clear paste of relative density 1.28～1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～50 weight portion starch mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate are in the gelatine capsule of packing into then.
6. like the described Chinese medicine composition of claim 1 to 4, it is characterized in that: the dosage form of said Chinese medicine composition is a tablet, and its preparation method comprises,
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and filtrating merges, and was concentrated into the clear paste of relative density 1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～30 weight portion microcrystalline Cellulose, mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate, then with the granule compacting in flakes with decompressor.
7. the method for preparing of the said Chinese medicine composition of claim 1 to 4 is characterized in that:
When the dosage form of said Chinese medicine composition was capsule, it comprised,
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and was concentrated into the clear paste of relative density 1.28～1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～50 weight portion starch mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate are in the gelatine capsule of packing into then.
8. the method for preparing of the said Chinese medicine composition of claim 1 to 4 is characterized in that:
When the dosage form of said Chinese medicine composition was tablet, it comprised,
The first step by said mixed, adds the water extraction volatile oil with respect to 3～5 times in mixture with Radix Achyranthis Bidentatae, Herba Ecliptae and Fructus Lycii; The volatile oil that obtains is used beta-cyclodextrin inclusion compound; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7～9, stirs 40 ℃～50 ℃ of temperature 40 minutes～50 minutes; Get volatile oil clathrate compound, subsequent use; In addition aqueous extract is concentrated into the clear paste of relative density 1.15～1.17 (60 ℃);
Second step, Radix Dipsaci and Placenta Hominis are mixed, add that to measure determining alcohol with respect to 4 times～6 times in mixture be 55%～65% alcohol reflux 2 times～4 times; Each 2 hours～3 hours, to filter, filtrating merges; Reclaim ethanol, be concentrated into the clear paste of relative density 1.20～1.22 (60 ℃), subsequent use;
The 3rd step with triangular, Herba Visci, Radix Salviae Miltiorrhizae, Sanguis Draxonis, Radix Glycyrrhizae and Radix Angelicae Sinensis proportional mixing, added with respect to 6～8 times of water gagings of mixture, boiled 4～6 hours, filtered, and filtrating merges, and was concentrated into the clear paste of relative density 1.30 (60 ℃);
The 4th step, with the clear paste mixing in the first step, second step, the 3rd step, 55 ℃～65 ℃ reduced vacuum dryings, powder gets dry extract;
The 5th step; Said volatile oil clathrate compound of the first step and dried cream powder are fully mixed, add mixture subsequently, 5～7 weight portion carboxymethyl starch sodium, 5～30 weight portion microcrystalline Cellulose, mix homogeneously with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder; Adding 150～200 weight portion determining alcohols is 80%～90% alcohol granulation; Drying, granulate adds the mixture with respect to said volatile oil clathrate compound of 100 weight portions and dried cream powder subsequently; 3～5 weight portion magnesium stearate, then with the granule compacting in flakes with decompressor.
9. the administering mode of each described Chinese medicine composition of claim 1 to 8 is oral.
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| CN106266932A (en) * | 2015-06-11 | 2017-01-04 | 成都九芝堂金鼎药业有限公司 | A kind of new application of the kidney invigorating teeth consolidating Chinese medicine composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899479A (en) * | 2006-07-05 | 2007-01-24 | 王悦 | Chinese medicine compound preparation for treating osteoporosis after menopause and its preparation |
| CN101537093A (en) * | 2008-03-21 | 2009-09-23 | 北京中泰天和科技有限公司 | Chinese traditional medicine for preventing and curing osteoporosis and preparation method thereof |
| CN101953993A (en) * | 2010-08-27 | 2011-01-26 | 高燕 | Medicament for treating osteoporosis |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1899479A (en) * | 2006-07-05 | 2007-01-24 | 王悦 | Chinese medicine compound preparation for treating osteoporosis after menopause and its preparation |
| CN101537093A (en) * | 2008-03-21 | 2009-09-23 | 北京中泰天和科技有限公司 | Chinese traditional medicine for preventing and curing osteoporosis and preparation method thereof |
| CN101953993A (en) * | 2010-08-27 | 2011-01-26 | 高燕 | Medicament for treating osteoporosis |
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| 刘文轩等: "中药治疗绝经后骨质疏松症研究进展", 《临床医学工程》 * |
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| 陈韶坤等: "中医药治疗原发性骨质疏松的研究进展", 《河南中医》 * |
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| CN106266932A (en) * | 2015-06-11 | 2017-01-04 | 成都九芝堂金鼎药业有限公司 | A kind of new application of the kidney invigorating teeth consolidating Chinese medicine composition |
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