CN100396325C - Compound medicine prepn. for treating osteoporosis, and its prepn. method - Google Patents
Compound medicine prepn. for treating osteoporosis, and its prepn. method Download PDFInfo
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Abstract
A Chinese medicine in the form of oral liquid, particle, capsule, tablet, or pill for treating osteoporosis is prepared from 10 Chinese-medicinal materials including prepared rehmannia root, fleece flower root, ground beetle, Chinese angelica root, etc. Its preparing process is also disclosed.
Description
One, technical field
The present invention relates to a kind of Chinese medicine preparation, especially relate to a kind of compound Chinese medicinal preparation for the treatment of osteoporosis and preparation method thereof.
Two, background technology
Osteoporosis is a kind of metabolic osteopathy of general, and the fine structure and the integrity of bone are damaged, and bone strength lowers and fragility increases, and the danger of fracture raises, and reduces as for the standard that below 0.15 serves as the diagnosis osteoporosis with bone density clinically.Osteoporosis can be divided into 3 big classes substantially: primary osteoporosis mainly refers to postclimacteric osteoporosis of women and senile osteoporosis; Secondary osteoporosis, often being secondary to other diseases such as hyperthyroidism, diabetes, hypercortisolism, gastroenteropathy, myeloma, leukemia etc., also may be owing to use due to the drug-induced side effect such as glucocorticoid, thyroxin, chemotherapeutic and heparin; Idiopathic osteoporosis is more common in 8～14 years old teenager, and majority has family history.
Age is to cause one of osteoporotic factor, and after the middle age, the new life of bone and absorption are unbalance, occur " negative balance ", and sclerotin begins to lose, the many visible osteoporosises of the National People's Congress more than 50 years old.Primary osteoporosis is a kind of mineralising bone loss relevant with the age, and along with the increase at age, the bone amount reduces, bone structure is damaged, bone fragility correspondingly increases, and people's bone marrow is becoming as porous sponge unconsciously, careless slightlyly will cause fracture.Hormone is to cause osteoporotic another factor, and an osteoporotic important feature is exactly to be mainly in the later women of menopause.Estrogen can pass through neurotransmitter, as growth hormone, somatostatin, vasopressin etc., influences bone metabolism postmenopausal women estrogen secretion suddenly to descend, thereby causes the reduction of calcitonin, and cause osteoporosis.Man's testosterone lacks can cause that osteoclast activity strengthens, and reduces the secretion of calcitonin, and makes the synthetic minimizing of activated vitamin D, and this is the osteoporotic major reason of male.Trophic factor, all influential as vitamin D, protein, calcium and phosphorus to sclerotin, inherited genetic factors, it is very few to move, smoking with drink, medicine toxicity and osteoporotic formation also have certain relation.
Osteoporosis is a kind of epidemic diseases that is forming, it is one of most important public health problem of developed country, it also is the more and more outstanding health threat that developing country faces, osteoporosis is emitted on same hypertension, arteriosclerosis, diabetes, the tumor position arranged side by side by international medical community, is one of five current big diseases.At present, the whole world has 200,000,000 people to suffer from osteoporosis approximately, and its sickness rate has leapt to commonly encountered diseases, frequently-occurring disease the 7th.Nearly 8,000,000 women suffer in the U.S., but osteoporosis absolutely not only constitutes harm to elderly woman, it also leaves a legacy of trouble to 2,000,000 men's health, the chief medical officers Richard H of NIH (NIH) Carmona (Richarh H.Cormaona) doctor points out that other has 3,400 ten thousand Americans to suffer from low bone density disease.I have investigation to show state's patients with osteoporosis near 100,000,000, present more than 40 years old the prevalence of osteoporosis be 16%, the male 11%, the women 20%.With advancing age, the crowd more than 60 years old especially, the prevalence of this disease rises to 23% rapidly.
Have data to show, the osteoporotic prevalence of urban population is far above the rural area, and osteoporosis has been approached the white-collar beauty.The medical expert proves that recently the women of thirty or forty year even two teens might suffer from this disease.Particularly serious is, also osteoporosis can occur among the child now, and the infant age is little of 5 to 7 years old, and the morbidity number of osteoporosis in the child is just increasing.
Osteoporosis is gradually a process slowly, can not have any clinical manifestation in early days, yet in case when the fracture phenomenon occurring, has been the serious stage, so medical circle claims that osteoporosis is soundless epidemic diseases.Pain is the modal symptom of primary osteoporosis, wherein sees so that lumbago and backache more.Fracture is the most common severe complications of osteoporosis, and it brings inconvenient activity and pain to the patient, and influences patient's the mental status and quality of life.Discover that 30% women and 12% man cause fracture can osteoporosis taking place in life in the American-European countries.The rate of increase of China's osteoporotic fracture accounts for the Asian countries first place, and according to China's Statistical, senile fracture's incidence rate is 6.3%～24.4%, especially with more than 80 years old advanced age the women for very.Osteoporosis continues development, may cause height shortening, hunchback, and respiratory function descends.
Complication such as osteoporosis can't bear the patient suffering, but also do not have safe and effective radical cure method at present, help loose skeleton to restore to the original state.But according to clinical findings, there is quite a few patient after 1 year, to check the demonstration bone density and rise, illustrates that treatment stops bone-loss, improve bone mass simultaneously, effect a permanent cure at positive rational therapy.The Therapeutic Principle of osteoporosis is now, if secondary osteoporosis, the prerequisite of treatment and key are to remove inducement.If primary osteoporosis can drug application be treated,, suppress the medicine of bone resorption and stimulate the bone formation medicine with calcium preparation and vitamin D, hormonal supplementation therapy.
At present, the medicine that can be used for treating osteoporosis roughly has following a few class: bone mineralising class medicine, as calcium preparation and vitamin D; Reduce the medicine of bone resorption, as: estrogens, calcitonin and diphosphate etc.; The stimulation of bone formation medicine, i.e. bone formation-promoter is as fluoride, growth hormone, insulin-like growth factor I and parathyroid hormone etc.; The absorption of bone can be reduced, the medicine of the formation of bone can be stimulated again; Chinese medicine is in the effect that its uniqueness is also arranged aspect the prophylactic treatment osteoporosis in addition.But in the bone formation-promoter, fluoride has greatly limited its clinical practice because of the increase that it has caused the fracture incidence rate; Statins (a kind of HMG CoA-reductase inhibitors) and Dentonin (DTN) etc. also are in development, though growth hormone and insulin-like growth factor I can promote the formation of bone, whether it can cause that the danger of tumor proliferative is still waiting to inquire into; Parathyroid hormone (PTH) is though be to treat the most promising class medicine of osteoporosis at present, and present existing PTH preparation costs an arm and a leg, and needs drug administration by injection, has limited its prolonged application.
Select safety, effectively, medicine is significant for prophylactic treatment osteoporosis, the quality of making the life better economically and reasonably.The Chinese herbal treatment osteoporosis has advantages such as untoward reaction is few, reasonable price, treating both the principal and secondary aspects of a disease, has become the research focus of domestic the world of medicine at present.The Chinese medicine osteoporosis is many based on invigorating the spleen and regulating the stomach, nourishing the liver and kidney, warming YANG nourishing YIN, promoting flow of QI and blood, and kidney and spleen invigorating then is the essential measure of treatment kidney matter osteoporosis.
In a word, research osteoporosis prevention and medicine for treatment thing were significant to the mankind's healthy and quality of life.
Three, summary of the invention
The object of the present invention is to provide a kind of prescription medication uniqueness, can prevent and treat the compound preparation of osteoporosis; Another object of the present invention provides the preparation method of this compound preparation.
The present invention ties up to the oral formulations that is prepared from through modern pharmacy research on the basis of clinical effective experience side of clinical treatment osteoporosis.This prescription derives from " latent generation old man " ancestors and is handed down in a direct line from the master, and originates from clearly in the period of Jiaqing, passes on from generation to generation so far, has kidney-nourishing and bone-strengthening, blood circulation invigorating efficacies.Be used for osteoporosis deficiency of the liver and kindey, syndrome of qi stagnation and blood stasis.
The compound preparation of treatment osteoporosis, made by following materials of weight proportions medicine:
Sea, side 1.0～20g, Radix Rehmanniae Preparata 2～10g, Radix Dipsaci 0.2～8g, Rhizoma Drynariae 0.5～10g, Radix Polygoni Multiflori Preparata 1～10g, Eupolyphaga Seu Steleophaga 1.0～8g, Pyritum (calcined) 0.5～3g, Radix Angelicae Sinensis 1.0～10g, Rhizoma Chuanxiong 1.0～10g, Rhizoma Curcumae 1.0～5g.
More than the optimization weight proportion of each component be:
Side extra large 6.48g, Radix Rehmanniae Preparata 5.40g, Radix Dipsaci 5.40g, Rhizoma Drynariae 3.6g, Radix Polygoni Multiflori Preparata 2.88g, Eupolyphaga Seu Steleophaga 2.88g, Pyritum (calcined) 2.88g, Radix Angelicae Sinensis 2.16g, Rhizoma Chuanxiong 2.16g, Rhizoma Curcumae 2.16g.
The side separates: according to Chinese medical theory, and kidney governing bones, nourishing kidney can bone strengthening, the replenishing essence marrow, longue meat, promoting generation of vital essence and blood promotes the growth of bone.At the characteristics of patients with osteoporosis deficiency of the kidney above middle age, kidney nourishing water, benefit is Kidney-Yin, invigorating kidney-YANG, the negative and positive two-ways regulation rightly, is beneficial to the growth of bone, the disease of eliminating osteoporosis with holding sense of propriety.
Principal agent in Radix Rehmanniae Preparata, Radix Dipsaci, Rhizoma Drynariae, the Radix Polygoni Multiflori Preparata side of being in the side, the energy kidney-nourishing and bone-strengthening, nourishing kidney is Kidney-Yin, invigorating kidney-YANG, the replenishing essence marrow, particularly the extra large regeneration power extra-heavy in side is the panacea of promote osteogenesis, so we reuse it.Eupolyphaga Seu Steleophaga, Pyritum (calcined) are the panacea of synthetism, kidney-nourishing and bone-strengthening, osteogenesis indispensable; Rhizoma Chuanxiong, Rhizoma Curcumae one are gas medicine in the blood, and one is blood medicine in the gas, the mutual reinforcement between compatibility, and QI and blood is sensible, and in the time of the nourishing kidney-yin invigorating kidney-YANG, QI and blood is sensible, tonify without causing stagnation.The Chinese angelica blood supplementing nourishing blood and promoting blood circulation, our removing blood stasis medicine and its mutual reinforcement between, blood trouble is not just hindered.The effect of the common performance in full side kidney-nourishing and bone-strengthening.
This compound extract adds suitable adjuvant and makes oral formulations, as oral liquid, granule, tablet, capsule, micropill etc.The compound preparation of treatment osteoporosis, its preparation methods steps is:
(1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation extraction volatile oil, gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby;
(2) sea, the side of getting, Eupolyphaga Seu Steleophaga decoct with water, and decocting liquid concentrates, and is standby;
(3) get Pyritum (calcined), add the acetic acid decocting and boil, decocting liquid filters, and filtrate concentrates, and is standby;
(4) get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract medicinal residues and low amounts of water extract behind the volatile oil, add alcohol reflux, alcohol extract, and concentrating under reduced pressure, standby;
(5) the concentrated solution merging with step (2), (3), (4) concentrates, and vacuum drying is pulverized, and gets dry extract;
(6) above-mentioned dry extract is added proper auxiliary materials, the volatile oil that adds step (1) is made oral formulations with conventional method, comprises oral liquid, granule, tablet, capsule, micropill etc.
To the process conditions of above-mentioned preparation method, be further described as follows:
(1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation and carry 6 hours and must get volatile oil, gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby;
(2) sea, the side of getting, Eupolyphaga Seu Steleophaga, the decocting that adds 10 times of amounts boils 3 times, and each 2h merges three decocting liquid and is concentrated into relative density 1.10 (60 ℃), and is standby;
(3) get Pyritum (calcined), the acetic acid decocting that adds the pH4 of 6 times of amounts boils 2 times, and each 2h merges decocting liquid, filters, and filtrate is concentrated into 60 ℃ of mensuration relative densities and is 1.10, and is standby;
(4) get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract medicinal residues and low amounts of water extract behind the volatile oil, adding 10 times of water gagings decocts 2 times, each 1.5 hours, it was 1.10 that collecting decoction is concentrated into 60 ℃ of mensuration relative densities, cooling, add ethanol to containing alcohol amount 70%, leave standstill cold preservation, filter, decompression filtrate recycling ethanol also is concentrated into 60 ℃ to measure relative densities is 1.30; Or add 10 times of amount alcohol reflux of 50% 2 times, and each 1.5h merges alcohol extract twice, and 0.075Mpa, 70 ℃ of decompression thin film concentration to 60 ℃ measure relative densities and be 1.10, and be standby;
(5) the concentrated solution merging with step (2), (3), (4) is concentrated into 60 ℃ of mensuration relative densities 1.30,0.08Mpa, and 65 ℃ of vacuum dryings are pulverized, and get extract powder;
(6) above-mentioned dry extract is added proper auxiliary materials, add the volatile oil of step (1), make oral formulations with conventional method.
This compound preparation has following characteristics:
(1) prescription sea, application side is one of monarch drug, medication uniqueness, determined curative effect;
(2) preparation technology is simple and feasible, and the pharmacology of preparation and safety evaluatio result show that this preparation safety is effective.
(3) it has anticoagulant, improves blood circulation, improves bone density, and promote osteogenesis is accelerated effects such as osteoporosis healing.
(4) this product has good preventing and therapeutical effect to the osteoporosis rat of hormone induction; Can obviously improve the osteoporosis rat bone biomechanical property; Can obviously promote the osteoporosis rat osseous tissue to form; Has good preventive and therapeutic effect to cutting the inductive osteoporosis rat of ovum; The serology experiment in vitro is the result show, the serum of pastille can make the multiplication capacity of cultured osteoblast-like cells in vitro, ALP activity obviously increase, and illustrates that the ingredient in the pastille serum has the effect that promotes osteoblastic proliferation and bone formation function.In the antalgic and inflammation relieving experiment, this preparation has obvious inhibitory action to mice by the body of turning round that acetic acid causes, and can obviously prolong the pain threshold of mice on hot plate simultaneously, has shown significant analgesia role; Mice auricle swelling for Oleum Tiglii causes also shows the obvious suppression effect, and antiinflammatory action is obvious.Aspect blood circulation promoting and blood stasis dispelling, show tangible expansion venule and arteriole blood vessel function, increase the open number of microcirculatory blood capillary.This preparation has the expansion microcirculation, strengthens arteriole, venule caliber, increases microvascular open number, makes blood flow unobstructed, thereby reaches the effect of blood circulation promoting and blood stasis dispelling.
Four, the specific embodiment
(1) embodiment of the compound Chinese medicinal preparation of treatment osteoporosis has:
Embodiment 1
The compound preparation of treatment osteoporosis, its weight proportion is:
Side extra large 6.48g, Radix Rehmanniae Preparata 5.40g, Radix Dipsaci 5.40g, Rhizoma Drynariae 3.6g, Radix Polygoni Multiflori Preparata 2.88g, Eupolyphaga Seu Steleophaga 2.88g, Pyritum (calcined) 2.88g, Radix Angelicae Sinensis 2.16g, Rhizoma Chuanxiong 2.16g, Rhizoma Curcumae 2.16g.
Embodiment 2
Substantially the same manner as Example 1, but the compound recipe weight proportion is: side extra large 10g, Radix Rehmanniae Preparata 5g, Radix Dipsaci 5g, Rhizoma Drynariae 6g, Radix Polygoni Multiflori Preparata 5g, Eupolyphaga Seu Steleophaga 3g, Pyritum (calcined) 3g, Radix Angelicae Sinensis 5g, Rhizoma Chuanxiong 5g, Rhizoma Curcumae 3g.
Embodiment 3
Substantially the same manner as Example 1, but the compound recipe weight proportion is: side extra large 15g, Radix Rehmanniae Preparata 8g, Radix Dipsaci 6g, Rhizoma Drynariae 8g, Radix Polygoni Multiflori Preparata 8g, Eupolyphaga Seu Steleophaga 5g, Pyritum (calcined) 3g, Radix Angelicae Sinensis 8g, Rhizoma Chuanxiong 8g, Rhizoma Curcumae 4g.
Embodiment 4
Substantially the same manner as Example 1, but the compound recipe weight proportion is: side extra large 20g, Radix Rehmanniae Preparata 10g, Radix Dipsaci 8g, Rhizoma Drynariae 10g, Radix Polygoni Multiflori Preparata 10g, Eupolyphaga Seu Steleophaga 8g, Pyritum (calcined) 3g, Radix Angelicae Sinensis 10g, Rhizoma Chuanxiong 10g, Rhizoma Curcumae 5g.
(2) preparation method of the compound preparation of treatment osteoporosis has:
Embodiment 5: the kidney-nourishing and bone-strengthening sheet
[prescription] side extra large 600g, Radix Dipsaci 450g, Radix Rehmanniae Preparata 450g, Rhizoma Drynariae 300g, Radix Polygoni Multiflori Preparata 240g, Eupolyphaga Seu Steleophaga 240g, Pyritum (calcined) 240g, Radix Angelicae Sinensis 180g, Rhizoma Chuanxiong 150g, Rhizoma Curcumae 150g make 1000 altogether.
[method for making] gets Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation extraction volatile oil, and gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby; Sea, the side of getting, Eupolyphaga Seu Steleophaga, the decocting that adds 10 times of amounts boils 3 times, and each 2h merges three decocting liquid and is concentrated into 60 ℃ of mensuration relative densities 1.10, and is standby; Get Pyritum (calcined), the acetic acid decocting that adds 6 times of amount pH4 boils 2 times, and each 2h merges decocting liquid, filters, and filtrate is concentrated into 60 ℃ of mensuration relative densities and is 1.10, and is standby; Get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract medicinal residues and low amounts of water extract behind the volatile oil, adding 10 times of water gagings decocts 2 times, each 1.5 hours, it was 1.10 that collecting decoction is concentrated into 60 ℃ of mensuration relative densities, cooling, add ethanol to containing alcohol amount 70%, leave standstill cold preservation, filter, decompression filtrate recycling ethanol also is concentrated into 60 ℃ to measure relative densities is 1.30; Or add 10 times of amount alcohol reflux of 50% 2 times, and each 1.5 hours, merge alcohol extract twice, 0.075Mpa, 70 ℃ of decompression thin film concentration to 60 ℃ measure relative densities and be 1.10, and be standby; It is 1.30 that above-mentioned all concentrated solutions merging are concentrated into 60 ℃ of mensuration relative densities, 0.08Mpa, and 65 ℃ of vacuum dryings are pulverized, and get extract powder; Get extract powder and add an amount of alcohol granulation, drying, granulate adds volatile oil, and is airtight, adds 0.5% magnesium stearate, mixing, tabletting, coating, packing is promptly.
Embodiment 6: the kidney-nourishing and bone-strengthening capsule
[prescription] side extra large 600g, Radix Dipsaci 450g, Radix Rehmanniae Preparata 450g, Rhizoma Drynariae 300g, Radix Polygoni Multiflori Preparata 240g, Eupolyphaga Seu Steleophaga 240g, Pyritum (calcined) 240g, Radix Angelicae Sinensis 180g, Rhizoma Chuanxiong 150g, Rhizoma Curcumae 150g make 1000 altogether.
[method for making] gets Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation extraction volatile oil, and gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby; Sea, the side of getting, Eupolyphaga Seu Steleophaga, the decocting that adds 10 times of amounts boils 3 times, and each 2h merges three decocting liquid and is concentrated into 60 ℃ of mensuration relative densities 1.10, and is standby; Get Pyritum (calcined), the pH4 acetic acid decocting that adds 6 times of amounts boils 2 times, and each 2h merges decocting liquid, filters, and filtrate is concentrated into 60 ℃ and measures relative density 1.10, and is standby; Get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract the medicinal residues behind the volatile oil, adding 10 times of water gagings decocts 2 times, each 1.5 hours, it was 1.10 that collecting decoction is concentrated into 60 ℃ of mensuration relative densities, cooling, add ethanol to containing alcohol amount 70%, leave standstill cold preservation, filter, decompression filtrate recycling ethanol also is concentrated into 60 ℃ to measure relative densities is 1.30; Or add 10 times of amount alcohol reflux of 50% 2 times, and each 1.5 hours, merge alcohol extract twice, 0.075Mpa, 70 ℃ of decompression thin film concentration to 60 ℃ measure relative densities 1.10, and be standby; It is 1.30 that above-mentioned all concentrated solutions merging are concentrated into 60 ℃ of mensuration relative densities, 0.08Mpa, and 65 ℃ of vacuum dryings are pulverized, and get extract powder; Get extract powder and add an amount of alcohol granulation, drying, granulate adds volatile oil, and airtight, filling, packing are promptly.
Embodiment 7: the kidney-nourishing and bone-strengthening granule
[prescription] side extra large 600g, Radix Dipsaci 450g, Radix Rehmanniae Preparata 450g, Rhizoma Drynariae 300g, Radix Polygoni Multiflori Preparata 240g, Eupolyphaga Seu Steleophaga 240g, Pyritum (calcined) 240g, Radix Angelicae Sinensis 180g, Rhizoma Chuanxiong 150g, Rhizoma Curcumae 150g make 1000g altogether.
[method for making] gets Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation extraction volatile oil, and gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby; Sea, the side of getting, Eupolyphaga Seu Steleophaga, the decocting that adds 10 times of amounts boils 3 times, and each 2h merges three decocting liquid and is concentrated into 60 ℃ of mensuration relative densities 1.10, and is standby; Get Pyritum (calcined), the pH4 acetic acid decocting that adds 6 times of amounts boils 2 times, and each 2h merges decocting liquid, filters, and filtrate is concentrated into 60 ℃ and measures relative density 1.10, and is standby; Get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract the medicinal residues behind the volatile oil, adding 10 times of water gagings decocts 2 times, each 1.5 hours, it was 1.10 that collecting decoction is concentrated into 60 ℃ of mensuration relative densities, cooling, add ethanol to containing alcohol amount 70%, leave standstill cold preservation, filter, decompression filtrate recycling ethanol also is concentrated into 60 ℃ to measure relative densities is 1.30; Or add 10 times of amount alcohol reflux of 50% 2 times, and each 1.5h merges alcohol extract twice, and 0.075Mpa, 70 ℃ of decompression thin film concentration to 60 ℃ measure relative densities 1.10, and be standby; Above-mentioned all concentrated solutions merging are concentrated into 60 ℃ measure relative densities 1.30,0.08Mpa, 65 ℃ of vacuum dryings are pulverized, and get extract powder; Get extract powder and add an amount of excipient and an amount of alcohol granulation, drying, granulate adds volatile oil, and airtight, packing is promptly.
Embodiment 8: the kidney-nourishing and bone-strengthening oral liquid
[prescription] side extra large 600g, Radix Dipsaci 450g, Radix Rehmanniae Preparata 450g, Rhizoma Drynariae 300g, Radix Polygoni Multiflori Preparata 240g, Eupolyphaga Seu Steleophaga 240g, Pyritum (calcined) 240g, Radix Angelicae Sinensis 180g, Rhizoma Chuanxiong 150g, Rhizoma Curcumae 150g make 1000ml altogether.
[method for making] gets Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation extraction volatile oil, and gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby; Sea, the side of getting, Eupolyphaga Seu Steleophaga, the decocting that adds 10 times of amounts boils 3 times, and each 2h merges three decocting liquid and is concentrated into 60 ℃ of mensuration relative densities 1.10, and is standby; Get Pyritum (calcined), the pH4 acetic acid decocting that adds 6 times of amounts boils 2 times, and each 2h merges decocting liquid, filters, and filtrate is concentrated into 60 ℃ and measures relative density 1.10, and is standby.Get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract the medicinal residues behind the volatile oil, adding 10 times of water gagings decocts 2 times, each 1.5 hours, it was 1.10 that collecting decoction is concentrated into 60 ℃ of mensuration relative densities, cooling, add ethanol to containing alcohol amount 70%, leave standstill cold preservation, filter, decompression filtrate recycling ethanol also is concentrated into 60 ℃ to measure relative densities is 1.30; Or add 10 times of amount alcohol reflux of 50% 2 times, and each 1.5h merges alcohol extract twice, and 0.075Mpa, 70 ℃ of decompression thin film concentration to 60 ℃ measure relative densities 1.10, and be standby; Above-mentioned all concentrated solutions merging are concentrated into 60 ℃ measure relative densities 1.30,0.08Mpa, 65 ℃ of vacuum dryings are pulverized, and get extract powder; Get extract powder and add an amount of correctives and pharmacy pure water, filter, volatile oil is scattered in the above-mentioned clear aqueous solution with an amount of dissolve with ethanol, mixing, and packing is promptly.
Embodiment 8. pharmacodynamic studies
The experiment of kidney-nourishing and bone-strengthening sheet main pharmacodynamics is provided with three dosage, carries out the glucocorticoid type and removes the effect of two kinds of osteoporosis rat experimental models evaluations of ovary type kidney-nourishing and bone-strengthening sheet main pharmacodynamics.
(1) the kidney-nourishing and bone-strengthening sheet is to the influence of glucocorticoid type osteoporosis rat experimental model
The glucocorticoid dexamethasone carries out rat when injecting back 3 months, and BMD, key heavy, ash heavily wait bone biomechanical indexs such as bone figureofmerit, femur three-point bending load and lumbar vertebra compressive load, significant change all occurs, and prompting DEX successfully induces osteoporosis model.In addition, DEX rat serum BGP and NS group relatively have downward trend, and the Pyd value presents increase trend, and prompting DEX induces the inhibition of bone formation ability, the bone resorption hyperfunctioning of osteoporosis model rat.
Preventatively give kidney-nourishing and bone-strengthening sheet treatment the osteoporosis rat of hormone induction had good preventive and therapeutic effect:
Osteoporosis rat is key heavy, ash is heavy and bone figureofmerit such as bone density presents and to a certain degree increases; The lumbar vertebra trabecularism has clear improvement, various dose kidney-nourishing and bone-strengthening sheet treatment group rat lumbar vertebra histopathology form show trabecular connectivity still can, and the increase of bone trabecula width, spacing and pulp cavity area reduce; Bone norphometry indexs such as bone trabecula area, width, spacing and mineralising deposition are obviously improved;
3 curved maximum loads of rat lumbar vertebra compressive load and femur obviously improve, and show that the treatment of kidney-nourishing and bone-strengthening sheet can obviously improve the osteoporosis rat bone biomechanical property; Bone formation index BGP value raises, and bone resorption marker Pyd value descends, and the kidney-nourishing and bone-strengthening sheet can obviously promote the osteoporosis rat osseous tissue to form.
(2) the kidney-nourishing and bone-strengthening sheet is extractd ovary rat postoperative in the time of 3 months to the influence of removing ovary type osteoporosis rat experimental model, uterus weight in wet base and E2 level all are starkly lower than matched group, BMD, backbone weigh, ash heavily waits the bone figureofmerit, bone biomechanical indexs such as femur three-point bending load and lumbar vertebra compressive load all obviously reduce than matched group.Bone pathology morphology result shows, extract ovary rat lumbar vertebra girder than the matched group group attenuate, gap broadening, quantity reduces, the bone trabecula area obviously reduces, bone mineralising deposition has necessarily and increases.Prompting is extractd the ovary rat and is occurred tangible osteoporosis symptom in the time of 3 months after surgery.In addition, extract ovary rat serum BGP, ALP and urine Pyd value and matched group and more all present increase trend, prompting is extractd ovary and is induced the high conversion type of showing as of osteoporosis model rat.
Osteoporosis Rats is key heavy, ash is heavy and bone figureofmerit such as bone density occurs presenting after the medication of kidney-nourishing and bone-strengthening sheet and to a certain degree increases;
The kidney-nourishing and bone-strengthening sheet has clear improvement for plucking ovary osteoporosis rat lumbar vertebra trabecularism, various dose kidney-nourishing and bone-strengthening sheet treatment group rat lumbar vertebra histopathology form shows that trabecular connectivity has better improvement, and the increase of bone trabecula width, spacing and pulp cavity area reduce; Bone norphometry indexs such as bone trabecula area, width, spacing and mineralising deposition are obviously improved; 3 curved maximum loads of lumbar vertebra compressive load and femur obviously improve, and show that the treatment of kidney-nourishing and bone-strengthening sheet can obviously improve the bone biomechanical property of plucking the ovary rat;
The kidney-nourishing and bone-strengthening sheet has good preventive and therapeutic effect to cutting the inductive osteoporosis rat of ovum.
The serology experiment in vitro is the result show, the serum that contains kidney-nourishing and bone-strengthening sheet Chinese medicine can make the multiplication capacity of cultured osteoblast-like cells in vitro, ALP activity obviously increase, and illustrates that the ingredient in the pastille serum has the effect that promotes osteoblastic proliferation and bone formation function.
(3) kidney-nourishing and bone-strengthening sheet anti-inflammatory and antalgic and function of promoting blood circulation to disperse blood clots research
In the antalgic and inflammation relieving experiment, the kidney-nourishing and bone-strengthening sheet has obvious inhibitory action to mice by the body of turning round that acetic acid causes, and can obviously prolong the pain threshold of mice on hot plate simultaneously, has shown kidney-nourishing and bone-strengthening sheet significant analgesia role; For the mice auricle swelling that Oleum Tiglii causes, the kidney-nourishing and bone-strengthening sheet also shows the obvious suppression effect, and antiinflammatory action is obvious.
The kidney-nourishing and bone-strengthening sheet shows tangible expansion venule and arteriole blood vessel function aspect blood circulation promoting and blood stasis dispelling, increase the open number of microcirculatory blood capillary.The kidney-nourishing and bone-strengthening sheet has the expansion microcirculation, strengthens arteriole, venule caliber, increases microvascular open number, makes blood flow unobstructed, thereby reaches the effect of blood circulation promoting and blood stasis dispelling.
Claims (9)
1. compound preparation for the treatment of osteoporosis is characterized in that it is made by following materials of weight proportions medicine:
Sea, side 1.0～20g, Radix Rehmanniae Preparata 2～10g, Radix Dipsaci 0.2～8g, Rhizoma Drynariae 0.5～10g, Radix Polygoni Multiflori Preparata 1～10g, Eupolyphaga Seu Steleophaga 1.0～8g, Pyritum (calcined) 0.5～3g, Radix Angelicae Sinensis 1.0～10g, Rhizoma Chuanxiong 1.0～10g, Rhizoma Curcumae 1.0～5g.
2. compound preparation for the treatment of osteoporosis is characterized in that it is made by following materials of weight proportions medicine:
Side extra large 6.48g, Radix Rehmanniae Preparata 5.40g, Radix Dipsaci 5.40g, Rhizoma Drynariae 3.6g, Radix Polygoni Multiflori Preparata 2.88g, Eupolyphaga Seu Steleophaga 2.88g Pyritum (calcined) 2.88g, Radix Angelicae Sinensis 2.16g, Rhizoma Chuanxiong 2.16g, Rhizoma Curcumae 2.16g.
3. according to the compound preparation of claim 1 or 2 described treatment osteoporosis, after it is characterized in that adding suitable adjuvant, make oral liquid, granule, tablet, capsule or micropill with conventional preparation method.
4. method for preparing the compound preparation of the described treatment osteoporosis of claim 1, its preparation methods steps is:
(1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae vapor distillation extraction volatile oil, gained volatile oil is standby, and medicinal residues and low amounts of water extract are standby;
(2) sea, the side of getting, Eupolyphaga Seu Steleophaga decoct with water, and decocting liquid concentrates, and is standby;
(3) get Pyritum (calcined), add the acetic acid decocting and boil, decocting liquid filters, and filtrate concentrates, and is standby;
(4) get Rhizoma Drynariae, Radix Polygoni Multiflori Preparata, Radix Dipsaci, Radix Rehmanniae Preparata, merging Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Curcumae extract medicinal residues and low amounts of water extract behind the volatile oil, decoct with water, and concentrate, and ethanol precipitation filters, and filtrate decompression concentrates, and is standby; Or add alcohol reflux, and alcohol extract, concentrating under reduced pressure, standby;
(5) the concentrated solution merging with step (2), (3), (4) concentrates, and vacuum drying is pulverized, and gets dry extract;
(6) with above-mentioned dry extract, add the volatile oil that suitable adjuvant adds step (1), make oral liquid, granule, capsule, tablet or micropill with conventional method.
5. the preparation method of compound preparation according to claim 4 is characterized in that the volatile oil extraction time in step (1) is 6 hours.
6. the preparation method of compound preparation according to claim 4 is characterized in that the decocting that adds 10 times of amounts in step (2) boils 3 times, and each 2 hours, merging three water boiling concentration to 60 ℃ mensuration relative densities was 1.10.
7. the preparation method of compound preparation according to claim 4 is characterized in that the acetic acid decocting that adds the pH4 of 6 times of amounts in step (3) boils 2 times, and each 2 hours, it was 1.10 that filtrate is concentrated into 60 ℃ of mensuration relative densities.
8. the preparation method of compound preparation according to claim 4, it is characterized in that adding in step (4) 10 times of water gagings decocts 2 times, each 1.5 hours, it is 1.10 that collecting decoction is concentrated into 60 ℃ of mensuration relative densities, cooling adds ethanol to containing alcohol amount 70%, leaves standstill cold preservation, filter, decompression filtrate recycling ethanol also is concentrated into 60 ℃ to measure relative densities is 1.30; Or add 10 times of amount alcohol reflux of 50% 2 times, and each 1.5 hours, merge alcohol extract twice, it is 1.10 that 0.075MPa, 70 ℃ of decompression thin film concentration to 60 ℃ measure relative densities.
9. the preparation method of compound preparation according to claim 4 is characterized in that in step (5), and being concentrated into 60 ℃ of mensuration relative densities is 1.30,65 ℃ of vacuum drying temperature, 0.08MP
a
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| CN108815292A (en) * | 2018-07-16 | 2018-11-16 | 中国人民解放军第四医院 | A kind of Chinese medicine compound prescription of recipe for healing bones and treating wound and its preparation process of preparation |
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Non-Patent Citations (4)
| Title |
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| 中药治疗骨质疏松症的临床研究现状. 田丙坤等.陕西中医学院学报，第22卷第4期. 1997 |
| 中药治疗骨质疏松症的临床研究现状. 田丙坤等.陕西中医学院学报，第22卷第4期. 1997 * |
| 骨疏康胶囊治疗老年性骨质疏松临床观察. 胡良臣.实用中医药杂志，第14卷第6期. 1998 |
| 骨疏康胶囊治疗老年性骨质疏松临床观察. 胡良臣.实用中医药杂志，第14卷第6期. 1998 * |
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