CN104127683A - Traditional Chinese medicine composition for treating or preventing female postmenopausal osteoporosis - Google Patents
Traditional Chinese medicine composition for treating or preventing female postmenopausal osteoporosis Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating or preventing female postmenopausal osteoporosis and belongs to the technical field of the traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials: bighead atractylodes thizome, white peony root, angelica sinensis, radix codonopsis, eucommia ulmoides, raspberry, radix rehmanniae preparata, lucid ganoderma, achyranthes bidentata, dogwood, Chinese yam, poria cocos, puerarin, polygonatum kingianum, glossy privet fruit, epimedium wushanense, barbary wolfberry fruit, semen cuscutae and liquorice. The composition is capable of increasing the bone density of osteoporotic patients, and relieving secondary pain and inflammatory response caused by osteoporosis; proven by pharmacological experiments and clinical experiments, the traditional Chinese medicine composition has remarkable effect and thus has wide medical popularization value.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to the Chinese medicine composition of a kind for the treatment of or prevention of osteoporosis disease.
Background technology
Osteoporosis is one group of osteopathia that many reasons causes, osseous tissue has normal calcification, and calcium salt and substrate are normal ratio, and the metabolic osteopathy that is reduced to feature with unit volume internal skeleton tissue mass becomes.In most osteoporosises, due to the minimizing of osseous tissue increases mainly due to bone absorption.Taking skeleton pain, be easy to fracture as feature.Clinical manifestation is the following aspects:
1. the modal symptom of pain primary osteoporosis, common with lumbago and backache, accounts for 70%～80% in pain patients.Pain spreads to both sides along spinal column, lies on the back or pain relief when seat, stretches after when upright or the pain increased when standing for a long time, sitting, bends over, cough, defecates and increase the weight of while exerting oneself.When above, can there is osteodynia in general bone loss 12%.When senile osteoporosis, Vertebral Compression distortion, flexion of vertebral column, muscle fatigue is spasm even, produces pain.Recently compressed fracture of thoracic vertebra and lumber vertebra, also can produce acute pain, and the spinous process of corresponding site can have strong tenderness and percussion pain.Can produce extremity radiating pain, two lower limb sensorimotor obstacle, intercostal neuralgia, the similar angina pectoris of retrosternal pain if oppress corresponding spinal nerves.If compressing spinal cord, cauda equina nerve also affect bladder, rectum function
2. height shortens, hunchback is many occurs after pain.The anterior loading weight of vertebra vertebral body is large, especially the 11st, 12 thoracic vertebras and the 3rd lumbar vertebra, loading is larger, easily compression, vertebra is leaned forward, form hunchback, with age, osteoporosis increases the weight of, bow-backed curvature strengthens, Vertebral Compression when senile osteoporosis, every vertebral body shortens 2 millimeter, 3～6 centimetres of height shorten in averages.
3. fracture is the most common and the most serious complication of degeneration osteoporosis.
4. respiratory function decline breast, compression fracture of lumbar vertebra, vertebra palintrope, chest deformity, can make vital capacity and maximal breathing capacity significantly reduce, the symptom such as that patient often can occur is uncomfortable in chest, breathe hard, dyspnea.
Osteoporosis is common ailment of middle-aged and old, frequently-occurring disease, has a strong impact on such crowd's Health and Living quality.At present, aged tendency of population is day by day serious, improves the control consciousness of osteoporosis is had very important significance.
Lack the difference that produces reason and the mechanism of action according to bone density, can select diverse ways to increase bone density, clinical treatment adopts calcium preparation, activated vitamin D, gonadal hormone, calcitonin, diphosphonate and fluoride etc. more at present, though there is certain curative effect, but side effect is large, somewhat expensive, and cure the symptoms, not the disease.Aspect treatment, simple replenishing the calcium only can delay but can not stop the loss of bone amount, therefore a kind of efficient supplementing of research and development run off calcareous and can consolidate and prevent that bone amount runs off and safe without toxic side effect, become and urgently needs the problem that solves thereby fundamentally solve osteoporotic medicine.
Chinese medicine treatment or prevention of osteoporosis disease with aspect accumulated abundant clinical practice and theory of Chinese medical science, treat osteoporotic Chinese medicine as CN101843690A discloses one, adopt the raw materials such as the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Notoginseng, Radix Rehmanniae Preparata, Ganoderma, Radix Achyranthis Bidentatae, Fructus Corni to make.
CN101862398A discloses one and has treated osteoporotic Chinese medicine, adopts the raw materials such as Colla cornus cervi, Radix Notoginseng, Radix Rehmanniae Preparata, Colla Plastri Testudinis, Ganoderma, Fructus Lycii, Radix Angelicae Sinensis to make.
CN102125645A discloses that a kind of to treat osteoporotic Chinese medicine preparation be to be made up of the raw material of Chinese medicine of following parts by weight: 6 parts, 2 parts of Herba Epimedii, 2 parts of the Cortexs Eucommiae, 3 parts of Radix Achyranthis Bidentataes, 3 parts of Rhizoma Dioscoreaes, 3 parts of Radix Codonopsis, 3 parts of Fructus Lycii, 3 parts of Caulis Spatholobis and Radix Rehmanniae Preparata.
CN103006853A discloses one and has treated osteoporotic Chinese medicine, and the weight proportion of its each raw material components is: Radix Astragali 6-10, Fructus Schisandrae Chinensis 8-12, Fructus Aurantii Immaturus 6-10, Herba Epimedii 4-8, Radix Cyathulae 6-10, Squama Manis 8-12, Semen Cuscutae 4-8, Caulis Spatholobi 13-17, Radix Polygoni Multiflori Preparata 8-12, only angle cattle 6-10, gravelstone pine 4-8, Lignum Acronychiae 13-17, Semen Trigonellae 8-12, Flos Rosae Rugosae 1-5, Rhizoma Drynariae 13-17.
Taking theory of Chinese medical science as guidance, there is kidney invigorating and YANG supporting, replenishing QI to invigorate the spleen, the methods such as adjusting liver of invigorating blood circulation.The traditional Chinese medical science thinks that bone density decline cause has two, one to be deficiency of kidney-essence, has saying of " kidney governing bones, raw marrow fills brain, its Hua Fa ", therefore muscles and bones is unable for deficiency of kidney-essence in tcm theory; Two is spleen deficiency of kidney-QI, deficiency of kidney-essence of the merit of insufficiency of the spleen mistake transporting, and skeleton loses supports, so fragile unable.
Summary of the invention
The object of this invention is to provide and a kind ofly can more effectively treat or prevent postmenopausal osteoporosis and instant effect, short treating period, Chinese medicine that cure rate is high.
For achieving the above object, the invention provides the Chinese medicine composition of a kind for the treatment of or prevention female postmenopausal osteoporosis, its raw material by following weight portion makes: Rhizoma Atractylodis Macrocephalae 5-7 part, Radix Paeoniae Alba 5-7 part, Radix Angelicae Sinensis 5-9 part, Radix Codonopsis 7-10 part, Cortex Eucommiae 7-9 part, Fructus Rubi 8-10 part, Radix Rehmanniae Preparata 8-10 part, Ganoderma 10-12 part, Radix Achyranthis Bidentatae 5-7 part, Fructus Corni 10-12 part, Rhizoma Dioscoreae 5-9 part, Poria 8-12 part, Radix Puerariae 12-15 part, Rhizoma Polygonati 3-5 part, Fructus Ligustri Lucidi 5-7 part, Epimedium wushanense 7-9 part, Fructus Lycii 10-12 part, Semen Cuscutae 5-8 part, Radix Glycyrrhizae 10-15 part.
Difference according to Chinese medicine composition to postmenopausal osteoporosis treatment or preventive effect is preferably as follows: 5 parts of the Rhizoma Atractylodis Macrocephalaes, 3 parts of the Radix Paeoniae Albas, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 9 parts of Fructus Rubies, 80 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 6 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 6 parts of Rhizoma Dioscoreaes, 9 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae on above-mentioned Chinese medicine composition basis.
The Radix Paeoniae Alba enters liver, spleen channel, has nourishing blood to suppress the hyperactive liver, slow middle pain relieving, and yin fluid astringing is received effect of antiperspirant.Cure mainly the breast abdomen pain over the hypochondriac region, dysentery stomachache, spontaneous sweating, fever due to yin deficiency, menoxenia, metrorrhagia, is with inferior disease.Herba Menthae is one of Chinese conventional Chinese medicine.It is pungent cool property sweating antipyretic medicine, controls influenza, headache, conjunctival congestion, fever of the body, throat, the dental bed disease such as swell and ache.External can training the mind dysmenorrhoea, skin pruritus, erythra and eczema etc.The Herba Menthae of light friend Greenhouse Fruit Picking is again the fresh vegetable on dining table in the Spring Festival.Clearly good to eat.Usually with Herba Menthae for tea, improving eyesight clears away heart-fire.Modern medicine proves that Herba Menthae has very strong antiviral and antibacterial activity, and has certain antiallergic activity.
Radix Achyranthis Bidentatae is the dry root of amaranthaceous plant Radix Achyranthis Bidentatae Achyranthes bidentata Bl..Excavate when stem and leaf is withered winter, removes fibrous root and silt, is bundled into wisp, shines as for after wrinkle, and top is trimmed, and dries.Nature and flavor hardship, sweet, sour, flat.Return liver, kidney channel.Energy eliminating blood stasis and inducing menstruation, invigorating the liver and kidney, bone and muscle strengthening, inducing diuresis for treating stranguria syndrome, conducting blood to flow downwards.For amenorrhea, dysmenorrhea, soreness of waist and knee joint, muscles and bones is unable, stranguria, edema, headache, dizzy, toothache, day skin ulcer, spits blood, epistaxis.
Poria is the dry sclerotia of On Polyporaceae Poria Poria cocos (Schw.) Wolf.Excavate more than 7～JIUYUE, after digging out, remove silt, bank up after " diaphoresis ", spread out and dry in the air to dry tack free, then " diaphoresis ", after extremely now wrinkle, the large portion of internal moisture scatter and disappear for several times repeatedly, dry in the shade, be called " Poria "; Or fresh Poria is pressed to different parts cutting, and dry in the shade, be called " Poria piece " and " Poria sheet ".Nature and flavor are sweet, light, flat.GUIXIN, lung, spleen, kidney channel.Function promoting diuresis to eliminate damp pathogen, spleen invigorating, mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
The Cortex Eucommiae is the dry bark of Eucommiaceae plant Cortex Eucommiae Eucommza ulmoides Oliv..The 4-6 month strips, and scrapes off rough bark, and " diaphoresis " to the endothelium of banking up is puce, dries.Cortex Eucommiae nature and flavor are sweet, temperature.Return liver, kidney channel.Energy invigorating the liver and kidney, bone and muscle strengthening, antiabortive.For deficiency of the liver and kindey, soreness of waist and knee joint, muscles and bones is unable, have a dizzy spell, and blood leaking in gestation, frequent fetal movement.
Epimedium wushanense is the dried leaves of Berberidaceae plant Epimedium wushanense Epimedium wushanenseT.S.Ying.When summer, autumn, stem and leaf was luxuriant, gather, remove impurity, dry or dry in the shade.Nature and flavor acrid, sweet, warm.Return liver, kidney channel.Energy kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For kidney yang deficiency, impotence and seminal emission, muscles and bones flaccidity is soft, rheumatic arthralgia, and numbness contracture, menopause is dizzy.
Fructus Ligustri Lucidi is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi Ligustrum lucidum Ait..Gather when fruit maturation winter, removes branch and leaf, after slightly steaming or putting and slightly scald in boiling water, dry; Or convection drying.Nature and flavor sweet, bitter, cold.Return liver, kidney channel.Energy nourishing the liver and kidney, improving eyesight black hair.For the hepatic and renal YIN deficiency, dizzy ear toot, soreness of the waist and knees, beard and hair drought is white, poor vision, interior-heat is quenched one's thirst, osteopyrexia and fever.
In order to express better Chinese medicine composition of the present invention, Chinese medicine composition of the present invention can be prepared into conventional clinically dosage form.Such as, the preparations such as powderous preparations, mixture, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsule, described pharmaceutical preparation all can prepare according to Chinese medicine preparation preparation method well-known to those skilled in the art.Preferably, Chinese medicine composition of the present invention is prepared into mixture, powder, tablet or capsule according to conventional preparation technology.
The present invention also provides a kind of preparation method of Chinese medicine composition described above, it mainly comprises following step: get traditional Chinese medicinal material raw materials and be broken into coarse powder, doubly adding volumetric concentration according to the 4-9 of coarse powder gross weight is the alcoholic solution of 40%-95%, reflux, extract, 2-3 time, return time is 1-5h, filters, filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method, as tablet, capsule etc.
The present invention also asks to protect the purposes of above-mentioned Chinese medicine composition in preparation treatment or prevention of osteoporosis medicine.Chinese medicine composition of the present invention is in the time for the treatment of or prevention of osteoporosis, and demonstrating remarkable anti-inflammatory and antalgic also can significantly increase the activity of bone density.Drug effect embodiment 7 of the present invention shows, give positive drug and Chinese medicine composition of the present invention and all can obtain significant antiphlogistic effects, wherein the antiphlogistic effects of Chinese medicine composition high dose group of the present invention and positive controls have utmost point significant difference, Chinese medicine composition low dose group and positive controls have significant difference, and this shows that the high dose group of Chinese medicine composition of the present invention and the antiphlogistic effects of low dose group will significantly be better than positive controls.Drug effect embodiment 8 mices of the present invention lick foot response latency time showing, with model group comparison, after administration after 1h and 2h, all be greater than model group the incubation period that the mice of each administration group of Chinese medicine composition of the present invention is added foot reaction, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).Illustrate this Chinese medicine composition of the present invention can extend mice to hot plate stimulate add the sufficient response latency, have certain analgesic activity.Under same experiment condition, positive control drug cydiodine group (
p< 0.05) and Huanglianshangqing Tablet group (1h,
p< 0.05; 2h,
p< 0.01) also extend the incubation period that mice is added foot reaction, there is certain analgesic activity, but its analgesic effect and model group there was no significant difference.The embodiment of the present invention 9 shows, relatively, the BMD of left tibia, right tibia, lower neck bone and lumbar vertebra all has significant difference for model group and blank group,, show that the bone mineral content that retinoic acid causes osteoporosis rat obviously declines.With model group comparison, each group of rat bone mineral content that all can raise of bone strengthening Capsules group and Chinese medicine composition of the present invention.Wherein low, high, the middle dosage group of Chinese medicine composition of the present invention and model group comparison, significantly improve the BMD of model mouse left tibia, right tibia, lower neck bone and lumbar vertebra, the Chinese medicine composition that shows doses can obviously increase retinoic acid and cause the bone mineral content content of osteoporosis model, and difference high, middle dosage group has significance compared with bone strengthening Capsules group to the bone mineral content content of osteoporosis model.
Postmenopausal osteoporosis is a kind of and old and feeble relevant commonly encountered diseases, mainly occur in postmenopausal women, because estrogen deficiency causes bone amount to reduce and bone structure variation, bone fragility is increased and be easy to fracture, and the pain being caused by fracture, textured bone, there is the problems such as complication, healthy and the quality of life that seriously affects old people, even shorten the life-span.Find that in practice the above-mentioned traditional Chinese medicine composition for treating of the present invention and prevention postmenopausal osteoporosis have excellent effect.
In a word, Chinese medicine composition of the present invention, aspect treatment or prevention of osteoporosis, compared with prior art has following advantage:
1) in Chinese medicine composition of the present invention, contain multi-medicament component, action target spot is numerous, and therapeutic effect is better; Meanwhile, pharmacological evaluation shows that it has significant blood circulation promoting and blood stasis dispelling, anti-inflammatory and antalgic, rising bone density isoreactivity, has played the effect for the treatment of both the principal and secondary aspects of a disease.
2) the present invention is that inventor is on the basis of secret prescription handed down in the family from generation to generation, in conjunction with the summary of clinical experience for many years, obtain through repeatedly testing, therefore the postmenopausal osteoporosis that this medicine causes a variety of causes has unique curative effect, this medicine compatibility science, curative effect is rapid, instant effect, short treating period, the advantage that cure rate is high, expense is little.
Detailed description of the invention
Further describe the present invention by specific embodiment below, but those skilled in the art should know, described embodiment does not also limit the present invention in any way.
(1) example of formulations part
Embodiment 1 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows:
5 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of the Radix Paeoniae Albas, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 9 parts of Fructus Rubies, 8 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 6 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 6 parts of Rhizoma Dioscoreaes, 9 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, adding volumetric concentration according to 4 times of coarse powder gross weight is 95% alcoholic solution, reflux, extract, 2 times, return time is 5h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet.
Embodiment 2 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows:
5 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of the Radix Paeoniae Albas, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 9 parts of Fructus Rubies, 8 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 6 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 6 parts of Rhizoma Dioscoreaes, 9 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 80% alcoholic solution, reflux, extract, three times, return time is 1h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into capsule.
Embodiment 3 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows:
5 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of the Radix Paeoniae Albas, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 9 parts of Fructus Rubies, 8 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 6 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 6 parts of Rhizoma Dioscoreaes, 9 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, adding volumetric concentration according to 9 times of coarse powder gross weight is 40% alcoholic solution, reflux, extract, three times, return time is 4h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into powder.
Embodiment 4 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows:
5 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of the Radix Paeoniae Albas, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 9 parts of Fructus Rubies, 8 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 6 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 6 parts of Rhizoma Dioscoreaes, 9 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 70% alcoholic solution, reflux, extract, three times, return time is 3h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Adding ethanol is 75%(v/v to containing alcohol amount), leave standstill 24 hours, get supernatant, reclaim ethanol concentrated, add water to 1000ml, stir evenly, subpackage, flowing steam sterilization 35min, obtains mixture.
Embodiment 5 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows:
5 parts of the Rhizoma Atractylodis Macrocephalaes, 7 parts of the Radix Paeoniae Albas, 5 parts of Radix Angelicae Sinensis, 10 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 10 parts of Fructus Rubies, 8 parts, Radix Rehmanniae Preparata, 12 parts of Ganodermas, 5 parts of Radix Achyranthis Bidentataes, 12 parts of Fructus Corni, 5 parts of Rhizoma Dioscoreaes, 12 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 9 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 8 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 4.
Embodiment 6 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows:
7 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of the Radix Paeoniae Albas, 9 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 9 parts of the Cortexs Eucommiae, 8 parts of Fructus Rubies, 10 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 7 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 9 parts of Rhizoma Dioscoreaes, 8 parts, Poria, 15 parts of Radix Puerariaes, 3 parts of Rhizoma Polygonatis, 7 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 12 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 15 parts, Radix Glycyrrhizae.
Preparation technology is with embodiment 4.
(2) drug effect embodiment part
The therapeutical effect of embodiment 7 Chinese medicine composition of the present invention to retinoic acid rats with osteoporosis
1, model rat with osteoporosis is made and administration
36 SD female rats, each batch of rat is divided into 6 groups all at random, and 6 every group, each component cage is fed.The 1st group is blank group, gavages a certain amount of distilled water every day; The 2nd group is model group, gavages a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) every day; The 3rd group is bone strengthening Capsules group, gavages a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) and a certain amount of bone strengthening capsule 1% carboxyl methyl cellulose sodium suspension (12 mg/kg) every day; 4th, 5,6 groups are respectively the basic, normal, high dosage group of Chinese medicine composition (embodiment 4 gained), gavage the Carboxymethyl cellulose sodium suspension (being equivalent to respectively raw medicinal herbs 5 mg/kg, 20 mg/kg, 50 mg/kg) of a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80 mg/kg) and Chinese medicine composition every day, gavage continuously after 14 d, by retinoic acid suspension change into continue to gavage after distilled water to 30 d only.
Observation item and method: after last administration 24 h, take body weight, anaesthetize with pentobarbital sodium (30 mg/kg), scan the whole body of each group of rat with xR-36 type dynamic filtration dual intensity x line bone density diagnostic apparatus, measure respectively left and right tibia, the bone density (bone mineral density BMD) of lower neck bone and lumbar vertebra
2, result of the test
Each group data all use that (x scholar s) represents, carries out t check significance analysis with SPSS software kit 10.0.Chinese medicine composition is as shown in table 1 on the impact on BMD.
The impact of the bone density of table 1 Chinese medicine composition on osteoporosis model
With the comparison of blank group, * * P < 0.01; With model group contrast, #P < 0.05, ##P < 0.01.
Relatively, the BMD of left tibia, right tibia, lower neck bone and lumbar vertebra all has significant difference for model group and blank group, shows that the bone mineral content that retinoic acid causes osteoporosis rat obviously declines.With model group comparison, each group of rat bone mineral content that all can raise of bone strengthening Capsules group and Chinese medicine composition of the present invention.Wherein low, high, the middle dosage group of Chinese medicine composition of the present invention and model group comparison, significantly improve the BMD of model mouse left tibia, right tibia, lower neck bone and lumbar vertebra, the Chinese medicine composition that shows doses can obviously increase retinoic acid and cause the bone mineral content content of osteoporosis model, and difference high, middle dosage group has significance compared with bone strengthening Capsules group to the bone mineral content content of osteoporosis model.
The impact of embodiment 8 Chinese medicine composition of the present invention on mice hot-plate analgesia
1 mice hot plate pain model is made
Body weight 190-220g female mice is placed on hot plate dolorimeter, screen 45 of qualified female mices and (lick metapedes time < 5 s or > 30 s throw aside, scald for preventing foot, also should establish deadline, be generally 60s), the incubation period of adding metapedes reaction taking mice is as threshold of pain index, get 36 jennies, be divided into 6 groups, 6/group, it is Chinese medicine composition of the present invention (making by Chinese medicine composition prescription and preparation technology described in embodiment 4) low dose group, middle dosage group and high dose group, model group, cydiodine, Huanglianshangqing Tablet group.Each group is gastric infusion, and 1 times/day, dosage is as shown in table 2, after successive administration 14d, and the time that after mensuration last medicine, 60 min, 120 min add foot reaction.
2 Chinese medicine compositions of the present invention are on licking the impact of foot response latency in the experiment of mice hot-plate analgesia
Mice licks foot response latency time showing, with model group comparison, after administration after 1h and 2h, be all greater than model group the incubation period that the mice of each administration group of Chinese medicine composition of the present invention is added foot reaction, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).Illustrate this Chinese medicine composition of the present invention can extend mice to hot plate stimulate add the sufficient response latency, have certain analgesic activity.Under same experiment condition, positive control drug cydiodine group (
p< 0.05) and Huanglianshangqing Tablet group (1h,
p< 0.05; 2h,
p< 0.01) also extend the incubation period that mice is added foot reaction, there is certain analgesic activity, but its analgesic effect and model group there was no significant difference.The results are shown in Table 2.
Table 2 mice lick foot response latency timetable (
±
s)
Note: with model group comparison, *
p< 0.05, * *
p< 0.01.
The antiinflammatory action of embodiment 9 Chinese medicine composition xylol of the present invention induced mice inflammatory model
Hydrocortisone has stronger anti-inflammatory activity, that synthetic is also naturally occurring glucocorticoid, hydrocortisone enters after cell, activate cytoplasmic receptor, after allosteric, enter nucleus, be combined with DNA response element, cause inhibition or the induction of genetic transcription, the expression of inflammation associated protein is changed.
1, experimental technique:
35 KM mices, male and female half and half, body weight 250-310 gram, be divided at random four groups by body weight, dosage group, compositions low dose group, model control group, positive controls in i.e. combination group high dose group, compositions, 7 every group, each administration group mice gives respectively following medicine:
Compositions high dose group: gavage gives 50mg/kg embodiment 1 Chinese medicine composition Chinese medicine composition by crude drug amount;
Dosage group in compositions: gavage gives 20 mg/kg embodiment 1 Chinese medicine compositions, and Chinese medicine composition is by crude drug amount;
Compositions low dose group: gavage gives 5 mg/kg embodiment 1 Chinese medicine compositions, and Chinese medicine composition is by crude drug amount;
Model control group: gavage gives the normal saline of same volume;
Positive controls: gavage gives the hydrocortisone drug solution of 5mg/kg;
Each administration group is administered once every day, successive administration 7d.After last administration, get dimethylbenzene 20 μ l, be applied to each mouse right ear.After 30 minutes, get and be respectively subject to reagent 0.03 ml to be evenly applied to respectively mouse right ear, auris dextra is put to death after 3.5 hours to dimethylbenzene, measures the each group of mice left and right ear method of double differences.Ear method of double differences assay method: place cuts two ears along auricle baseline, lays auricle with 8mm card punch at the same position of left and right ear, weighs, and the ear method of double differences=auris dextra sheet weight-left auricle weight.The ear method of double differences can be used as evaluates antiinflammatory index.
2, experimental result:
Measure each experimental mice ear method of double differences and evaluate the antiphlogistic effects of each medication group medicine.Measurement result is in table 3.
The comparison of the each experimental mice ear of table 3 method of double differences
With model control group comparison,
* p< 0.05; With model control group comparison,
* p< 0.01;
With positive controls comparison,
# p< 0.05; With positive controls comparison,
## p< 0.01.
Result demonstration gives positive drug and Chinese medicine composition of the present invention all can be obtained significant antiphlogistic effects, wherein the antiphlogistic effects of Chinese medicine composition high dose group of the present invention and positive controls have utmost point significant difference, Chinese medicine composition low dose group and positive controls have significant difference, and this shows that the high dose group of Chinese medicine composition of the present invention and the antiphlogistic effects of low dose group will significantly be better than positive controls.
The clinical therapeutic efficacy of embodiment 10 Chinese medicine compositions of the present invention
For showing the therapeutic effect of Chinese medicine of the present invention to postmenopausal osteoporosis, the inventor is to 90 routine case clinical observations, Osteoporosis 60 examples, all measure through the U.S. DPS-L of Luner company type dual intensity X line borne densitometers, bone density (BMD) is lower than two standard deviations of corresponding normal age section peak bone mass, age is 50 years old-86 years old, average out to (63.1 ± 12.3) year.All experimenters are through physical examination, and hepatic and renal function is normal, without endocrinopathy and calcium, disorders of phosphorus metabolism, do not have in the past metabolic osteopathy medical history, do not take hormone medicine.All cases all have lumbago and osteoarthrosis pain in various degree, and the course of disease is all within 1 year.According to patient age, sex, bone density, pain degree pairing is divided into 2 groups at random.Treatment group 30 examples, male 14 examples, female's 16 examples, 65 years old mean age; Matched group 30 examples, male 12 examples, female's 18 examples, 61 years old mean age.Between group, there is comparability P>0.05
Experimental group uses embodiment 2 gained Chinese medicine capsules, and one day twice, each 10mg/kg, took every day sooner or later after meal half an hour.Matched group intramuscular injection calcitonin (Novartis Norvatis produce, 50 IU/ prop up), first week 50 IU, 1/d, later intramuscular injection 50 IU 2 times weekly.Two groups all taking 30 days as 1 course for the treatment of, after 3 courses for the treatment of, evaluates curative effect.
Curative effect situation criterion: 1, recovery from illness: clinical symptom disappearance.2, effective: symptom takes an evident turn for the better.3, effective: symptom takes a turn for the better to some extent.4, invalid: symptom, sign are without improvement.5. long-lasting: in 1 year, not recur.
Take after medicine of the present invention, 21 people cure, and it is effective that cure rate reaches 70.0%, 7 people, and total effective rate reaches 93.3%; In 27 people 1 year, do not recur long-lasting 90.0%.Matched group is cured 19 examples, effective 9 examples, and cure rate is 63.3%, total effective rate is 93.3%; In 18 people 1 year, do not recur long-lasting 60.0%.The cure rate of the present composition and the long-lasting matched group that is significantly higher than.
Claims (5)
1. a Chinese medicine composition for treatment or prevention female postmenopausal osteoporosis, is characterized in that being made by the raw material of following weight portion: Rhizoma Atractylodis Macrocephalae 5-7 part, Radix Paeoniae Alba 5-7 part, Radix Angelicae Sinensis 5-9 part, Radix Codonopsis 7-10 part, Cortex Eucommiae 7-9 part, Fructus Rubi 8-10 part, Radix Rehmanniae Preparata 8-10 part, Ganoderma 10-12 part, Radix Achyranthis Bidentatae 5-7 part, Fructus Corni 10-12 part, Rhizoma Dioscoreae 5-9 part, Poria 8-12 part, Radix Puerariae 12-15 part, Rhizoma Polygonati 3-5 part, Fructus Ligustri Lucidi 5-7 part, Epimedium wushanense 7-9 part, Fructus Lycii 10-12 part, Semen Cuscutae 5-8 part, Radix Glycyrrhizae 10-15 part.
2. the Chinese medicine composition for the treatment of or prevent as claimed in claim 1 female postmenopausal osteoporosis, is characterized in that being made by the raw material of following weight portion: 5 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of the Radix Paeoniae Albas, 7 parts of Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of the Cortexs Eucommiae, 9 parts of Fructus Rubies, 8 parts, Radix Rehmanniae Preparata, 10 parts of Ganodermas, 6 parts of Radix Achyranthis Bidentataes, 10 parts of Fructus Corni, 6 parts of Rhizoma Dioscoreaes, 9 parts, Poria, 12 parts of Radix Puerariaes, 5 parts of Rhizoma Polygonatis, 5 parts of Fructus Ligustri Lucidi, 7 parts of Epimedium wushanense, 10 parts of Fructus Lycii, 5 parts of Semen Cuscutae, 10 parts, Radix Glycyrrhizae.
3. the Chinese medicine composition for the treatment of or prevent as claimed in claim 1 or 2 female postmenopausal osteoporosis, is characterized in that: described Chinese medicine composition is mixture, powder, tablet or capsule.
4. prepare the method for the Chinese medicine composition for the treatment of as claimed in claim 1 or 2 or prevention female postmenopausal osteoporosis for one kind, it is characterized in that comprising the steps: to get traditional Chinese medicinal material raw materials is broken into coarse powder, doubly adding volumetric concentration according to the 4-9 of coarse powder gross weight is the alcoholic solution of 40%-95%, reflux, extract, 2-3 time, return time is 1-3h, filters, filtrate recycling ethanol, cold filtration, washes with water, dry after and get final product.
5. described in claim 1 or 2, treat or prevent the Chinese medicine composition of female postmenopausal osteoporosis in the purposes of preparing in postmenopausal osteoporosis medicine.
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| CN104800836A (en) * | 2015-05-21 | 2015-07-29 | 临沂欣宇辉生物科技有限公司 | Fish collagen protein as well as production method and application thereof |
| CN104826095A (en) * | 2015-05-21 | 2015-08-12 | 临沂欣宇辉生物科技有限公司 | Chondroitin co-produced protein powder as well as production method and application thereof |
| CN108402460A (en) * | 2018-05-11 | 2018-08-17 | 中国医科大学 | A kind of multifunctional food composition and preparation method thereof increasing bone density |
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| CN103751529A (en) * | 2014-02-11 | 2014-04-30 | 王雪雁 | Traditional Chinese medicine composition for treating female postmenopausal osteoporosis and preparation method thereof |
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| CN103751529A (en) * | 2014-02-11 | 2014-04-30 | 王雪雁 | Traditional Chinese medicine composition for treating female postmenopausal osteoporosis and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104800836A (en) * | 2015-05-21 | 2015-07-29 | 临沂欣宇辉生物科技有限公司 | Fish collagen protein as well as production method and application thereof |
| CN104826095A (en) * | 2015-05-21 | 2015-08-12 | 临沂欣宇辉生物科技有限公司 | Chondroitin co-produced protein powder as well as production method and application thereof |
| CN108402460A (en) * | 2018-05-11 | 2018-08-17 | 中国医科大学 | A kind of multifunctional food composition and preparation method thereof increasing bone density |
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