CN1207041C - Medicine for treating osteoporosis and its preparing process - Google Patents

Medicine for treating osteoporosis and its preparing process Download PDF

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Publication number
CN1207041C
CN1207041C CN 03117768 CN03117768A CN1207041C CN 1207041 C CN1207041 C CN 1207041C CN 03117768 CN03117768 CN 03117768 CN 03117768 A CN03117768 A CN 03117768A CN 1207041 C CN1207041 C CN 1207041C
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powder
radix
medicine
kidney
rhizoma dioscoreae
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CN 03117768
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Chinese (zh)
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CN1448176A (en
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谢亚苏
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谢亚苏
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Abstract

The present invention relates to a medicine for treating osteoporosis, which is prepared from raw materials of the following parts by weight: 243 to 452 of radix polygoni multiflori preparata, 194 to 361 of epimedium herb, 243 to 452 of prepared rhizome of rehmannia, 146 to 271 of tortoise shell, 194 to 361 of radix morindae officinalis, 194 to 361 of eucommia bark, 194 to 361 of himalayan teasel root, 194 to 361 of fortune's drynaria rhizome, 146 to 271 of angelica and 194 to 361 of common yam rhizome. The preparation method for the medicine for treating osteoporosis comprises: pulverizing and sieving the common yam rhizome whose quantity is 1/3 time that in the prescription into powder for use; putting the rest common yam rhizome whose quantity is 2/3 time that in the prescription and other medicinal materials into a multifunctional extraction tank to be decocted; collecting volatile oil, combining, filtering and spray-drying the decoction solution to obtain dry paste powder; rectifying the liquid of the collected volatilize oil to obtain volatile oil; dissolving the volatile oil with a small amount of ethanol to be spayed in the powder of the common yam rhizome; drying the powder of the common yam rhizome at a low temperature; adding the dry paste powder into the powder of the common yam rhizome to be uniformly mixed and then encapsulated. The medicine for treating osteoporosis has the functions of liver and kidney nourishment, essence and blood metaplasia and tendon and bone enhancement, and has an obvious therapeutic effect on treating osteoporosis.

Description

A kind of medicine for the treatment of osteoporosis
Technical field
The present invention relates to a kind of medicine for the treatment of osteoporosis, specifically, is to be the Chinese patent medicine of feedstock production with Chinese medicine.
Technical background
Osteoporosis is a kind of disease that is reduced to feature, osseous tissue microstructure change and the increase of risk of fractures degree with the bone amount.Be subjected to the great attention of society and medical profession greatly because of its sickness rate height, harm in middle-aged and elderly people.Population is near 1.3 hundred million more than 60 years old in China, and according to conservative estimation, sufferers of osteoporosis face reaches more than 75,000,000.Country " 95 ", " 15 " Program for Tackling Key Problems are all classified osteoporosis as important subject.
Bigger to osteoporotic treatment difficulty at present, domestic and international some medicines such as calcium preparation, estrogen etc. that use, though certain curative effect is arranged, because of itself side effect is big, uncertain therapeutic efficacy is cut, clinical practice is subject to many limitations.Therefore, it is significant to seek safe and effective method of treatment at tcm field.
Summary of the invention
The object of the present invention is to provide a kind of medicine that has liver and kidney tonifying, changes the pure treatment by Chinese herbs osteoporosis of promoting generation of vital essence and blood, bone and muscle strengthening.
Analyze from China's Chinese medical theory and experience, the kidney being the origin of congenital constitution, store essential substances master bone.Essence in the kidney contains congenital essence and acquired essence.Kidney storing essence, smart marrow, the marrow nourishing bone of giving birth to.The essence that kidney is hidden has important function in the differentiation of generation, growth and the degeneration of bone.At first, the formation of bone relies the good fortune of congenital essence entirely; Secondly, the growth prosperity and decline of bone also relies on the nourishing of acquired essence.If because congenital deficiency of kidney-essence, or since the day after tomorrow essence become homeless fosterly, just it is empty to cause that essence in kidney loses, be not enough to the bone growth promoting nourishing bone, cause sclerotin to decompose generation greater than sclerotin, osteoporosis takes place.Kidney storing essence master bone, blood stored in the liver master muscle, The liver and the kidney have a common source is total to subordinate Jiao, the liver deficiency, child-organ disease involving its motherorgan must be suffered from a deficiency of the kidney, kidney deficiency, mother does not give birth to also deficiency of the liver of son, supports thereby Liver and kidney two empty consequently muscles and bones mistakes take place.Kidney is the interior environment of bone metabolism, and person in middle and old age suffer from a deficiency of the kidney, and skeleton is synthetic less than decomposition, the bone metabolism negative balance causes bone loss, and bone strength and toughness descend, and occurs weak, osteodynia even fractures, form osteoporosis, the clinical weak bone of suffering from a deficiency of the kidney that then shows as, the exhausted disease of deficiency of the liver muscle.
The pathogenesis that the present invention supports at osteoporosis deficiency of kidney-essence, muscles and bones mistake has just adopted the kidney invigorating and essence nourishing, the medicament composing prescription of the strong muscle of bone strengthening, and it is the medicament of being made by the raw material of following weight ratio:
Radix Polygoni Multiflori Preparata 243-452 Herba Epimedii 194-361 Radix Rehmanniae Preparata 243-452 Carapax Et Plastrum Testudinis 146-271 crust halberd 194-361 Cortex Eucommiae 194-361 Radix Dipsaci 194-361 Rhizoma Drynariae 194-361 Radix Angelicae Sinensis 146-271 Rhizoma Dioscoreae 194-361
Above-mentioned component is preferably: Radix Polygoni Multiflori Preparata 347.5 Herba Epimedii 277.5 Radix Rehmanniaes Preparata 347.5 Carapax Et Plastrum Testudiniss 208.5 crust halberds 277.5 Cortexs Eucommiae 277.5 Radix Dipsacis 277.5 Rhizoma Drynariae 277.5 Radix Angelicae Sinensis 208.5 Rhizoma Dioscoreaes 277.5
Above-mentioned medicament is a said dosage form on any pharmaceutics, is more excellent dosage form with capsule preparations.
Manufacturing method for above mentioned medicine is: get the Rhizoma Dioscoreae of prescription 1/3 amount, pulverize, cross 80 mesh sieves, powder is standby; In addition the Rhizoma Dioscoreae of 2/3 amount is put in the multipotency extraction pot with all the other 9 flavor medical materials and decocts with water, and collects volatile oil simultaneously, collecting decoction, filtration, the spray drying powder that gets dry extract; The volatilization oil-water fluid of collecting is told volatile oil through rectification, gets volatile oil and sprays in the Rhizoma Dioscoreae powder with the small amount of ethanol dissolving, and oven drying at low temperature is got dried cream powder and added Rhizoma Dioscoreae powder, and mixing incapsulates, promptly.
Medicine of the present invention is monarch with Radix Polygoni Multiflori Preparata, Herba Epimedii.Radix Polygoni Multiflori Preparata slightly warm in nature and bitter but sweet flavor is puckery is gone into liver, kidney channel, liver and kidney tonifying, and nourishing YIN and supplementing blood cures mainly caused by liver and kidney deficiency, waist knee joint weakness, muscles and bones disease such as ache; It is warm in nature for Herba Epimedii, and the sweet in the mouth suffering is returned liver, kidney two warps, function kidney-replenishing, bone and muscle strengthening.Essence in kidney comprises two aspects of kidney yin kidney yang, and the two mutual dependence for existence is refinforced each other, and finishes the function of kidney governing bones jointly.Radix Polygoni Multiflori Preparata, Herba Epimedii are monarch drug altogether, then can fully guarantee tonifying both YIN and YANG to grow mutually, thereby reach the monarch drug effect for the treatment of main sick main symptom.
Medicine of the present invention is a minister with Radix Rehmanniae Preparata, Carapax Et Plastrum Testudinis, crust halberd.Radix Rehmanniae Preparata sweet in the mouth slightly warm in nature is gone into kidney, Liver Channel, and function benefit essence is filled out marrow, nourishing YIN and supplementing blood; The Carapax Et Plastrum Testudinis cold nature, sweet-salty is gone into liver, kidney channel, belongs to the in love product of flesh and blood, and the function nourishing YIN for benefiting the kidney strengthens the muscle and bone; Crust halberd acrid-sweet flavor warm in nature is gone into liver, kidney channel, kidney-replenishing, beneficial vital essence, strengthening bone and muscle, and the treatment soreness of waist and knee joint, the muscles and bones flaccidity is soft, so three flavor ministerial drugs can be that the main auxiliary two flavor monarchs drug of approach strengthen the kidney invigorating and essence nourishing, the merit of nourishing bone bone strengthening from the kidney yin kidney yang respectively.
Medicine of the present invention is an assistant with the Cortex Eucommiae, Radix Dipsaci, Rhizoma Drynariae, Radix Angelicae Sinensis, Rhizoma Dioscoreae.The little suffering of Cortex Eucommiae sweet in the mouth warm in nature is gone into liver, kidney channel, and function invigorating the liver and kidney, bone and muscle strengthening cure mainly foot, shin, knee joint soreness; The Radix Dipsaci slightly warm in nature, the bitter in the mouth suffering is gone into liver, kidney channel, invigorating the liver and kidney, meridians are walked in bone and muscle strengthening, blood circulation regulating, treatment lumbar and back pain, the foot and knee being feeble, articular muscle activity are unfavorable; The Rhizoma Drynariae bitter in the mouth is warm in nature, goes into liver, kidney channel, and the function invigorating kidney, promoting blood circulation is used for the treatment of the pain in the lumbar region of suffering from a deficiency of the kidney; Radix Angelicae Sinensis is warm in nature, and the sweet in the mouth suffering is gone into the heart, liver, spleen channel, and function is enriched blood and invigorated blood circulation, the promoting the circulation of blood pain relieving; The Rhizoma Dioscoreae sweet in the mouth is flat, goes into spleen, lung, kidney three warps, but spleen invigorating, tonifying the lung, reinforce the kidney, benefit is smart.Principal drug assistance reaches the purpose of kidney-supplementing liver-boosting, the strong muscle of bone strengthening altogether.
Therefore from the compatibility of medicine of the present invention, it has following characteristics: 1, yin yang complementarity, the kidney invigorating and essence nourishing.Stress kidney-replenishing with Herba Epimedii, crust halberd, then activating QI is strong for the kidney yang foot; Stress nourishing YIN with Radix Polygoni Multiflori Preparata, Radix Rehmanniae Preparata, Carapax Et Plastrum Testudinis, cloudy must the taste like this, positive must helping, thus make essence in kidney biochemistry active.2, treating both the principal and the secondary aspects of a disease at the same time focuses on and effects a permanent cure.3, the kidney spleen is taken into account, and Liver and kidney is ruled together, and grows mutually.We use the Radix Polygoni Multiflori, Radix Rehmanniae Preparata etc., and consumption is heavier, and Carapax Et Plastrum Testudinis again merit arrogate to oneself nourishing essence-blood, the basic pathogenesis of this deficiency of kidney-essence that links closely beyond doubt.Many Liver and kidney of we's medicine essence and blood is also mended, and joins the Chinese angelica blood supplementing nourishing the liver, simultaneously with Rhizoma Dioscoreae key spleen QI invigorating, helps the defeated cloth of fortuneization of all medicines of its kidney invigorating, so can muscles and bones mend the essence and blood alternate together.4, residence leads in benefit tonify without causing stagnation.The Radix Dipsaci promoting the circulation of blood arteries and veins of holding concurrently in this medicine, Rhizoma Drynariae, the double promoting the circulation of blood of invigorating blood circulation of Radix Angelicae Sinensis can make the fluent internal organs muscles and bones of the tonification efficacy of a drug, so slow-witted the benefit mended in non-heap soil or fertilizer over and around the roots.
From the above, medicine of the present invention is that first negative and positive are ruled together, the essence and blood giving young employees remedial-courses in general knowledge and vocational skills, melt nourishing kidney liver spleen in one, give prominence to the key points, make a distinction between the important and the lesser one, level is orderly, structure the is careful and precise side of invigorating the kidney and strengthening the bones, with control card belong to deficiency of kidney-essence, muscles and bones mistake support due to osteoporosis, definite curative effect is arranged.
The present invention is through carrying out pharmacology, the toxicological test of this medicament on one's body rat, conclusion is as follows:
Test 1: take this medicament with 13.32 (height).6.99 (in).Cause osteoporosis rat for the excision bilateral ovaries with 3.33 (low) g (crude drug)/kg and gavage, every day 1 time, 6 times weekly, in continuous 12 weeks, show that each dosage all has the effect that similar estradiol stimulates the uterus, significantly increases uterus weight and uterus index; High, middle dosage significantly improves serium inorganic phosphorus content; In, low dosage significantly improves the blood alkaline phosphatase activities; Three equal tools of dosage significantly improve calcium in the bone, phosphorus content; High and low dose significantly improves the femur resistance to bending; The osseous tissue morphological observation shows that this medicament can enliven osteoblast, and Trabecula Bone Volume density and bone trabecula width are significantly higher than model group.These show that all this medicament has the stimulating osteoblast activity, promote the energy of making contributions again of bone, illustrate that it has the osteoporotic effect that certain anti-castrated rats causes.
Test 2: get this medicament and once irritate stomach with the Cmax maximum volume and observe continuously in 7 days, none dead generation, also find no other toxic reaction, so its maximum tolerated dose is 259g/kg (crude drug) (5.18g/ (crude drug)/20g*50), 1166.7 times of (1 time 4 capsules that are equivalent to clinical 1 consumption, body weight for humans is in 50kg, that is: 4*2.775/50, and clinical 1 dosage is 0.222g (crude drug)/kg); 388.9 times (3 times on the clinical 1st) of suitable one clinical 1 consumption per day.
Test 3: extractum 19.98 and 53.28g (crude drug)/kg 25 weeks of rat through gavaging this medicament, its behavioral activity and body weight gain are not made significant difference, only during high dose administration 10-15 week, weight increase is slow, but each week of administration does not subsequently relatively have significant difference with matched group.After 13 weeks of high dose administration, ALP vigor and GLU descend.In 25 weeks of administration, AST, ALP, GLU descend, and liver, prostate and testis organ coefficient descend, and cellular infiltration appears in interstitial lung and tiny trachea, matter minute blood vessel dilatation and congestion between part.All the other each internal organs are not seen tangible Histological change.After convalescent period after 4 weeks of drug withdrawal, it is normal that AST and GLU recover, and prostate and testis organ coefficient rise, and pulmonary is normal, but ALP regulating liver-QI coefficient is still on the low side.Low dose group, weight increase is normal, and it is all normal to reach organ coefficient hematology and the blood biochemical (except that GLU), and it is normal that blood glucose also recovered after 4 weeks of drug withdrawal, and pathological tissue is not seen obvious pathology medicine infringement.
In order further to show the therapeutic effect of medicine of the present invention to the treatment osteoporosis, the present invention has carried out clinical experiment to 32 routine patients, and situation and conclusion are as follows:
1, material and method:
1.1 clinical data:, accept patient's 32 examples altogether for medical treatment to be diagnosed as osteoporosis prescription on individual diagnosis patient as our clinical observation object.
1.2 method:
Medicament sources: adopt medicine of the present invention to make capsule by the inventive method.
Therapeutic Method: be diagnosed as the patient of osteoporosis, based on medicine of the present invention, cooperate corresponding Drug therapy, the instructions about how to take medicine of medicine of the present invention: every day 3 times, each 4 in conjunction with clinical symptoms.
2, result: accept 32 routine patients altogether for medical treatment.Wherein produce effects is 17 people, and obvious effective rate is 53%; Effectively be 14 people, effective percentage 49.8%; Invalid 1 people, total effective rate is 87.5%.Invalid 1 people is a lung cancer patient.
Specific embodiment:
Embodiment 1: take by weighing raw material (kg) by following proportioning
Radix Polygoni Multiflori Preparata 347.5 Herba Epimedii 277.5 Radix Rehmanniaes Preparata 347.5 Carapax Et Plastrum Testudiniss 208.5 crust halberds 277.5 Cortexs Eucommiae 277.5 Radix Dipsacis 277.5 Rhizoma Drynariae 277.5 Radix Angelicae Sinensis 208.5 Rhizoma Dioscoreaes 277.5
Preparation method is as follows: the Rhizoma Dioscoreae of 1/3 amount, pulverize, and cross 80 mesh sieves, powder is standby; In addition the Rhizoma Dioscoreae of 2/3 amount is put with all the other 9 flavor medical materials and decocts with water in the multipotency extraction pot 2 times, 6 times of water gagings for the first time, 5 times of water gagings for the second time, decocting time respectively 1 hour; Collect volatile oil simultaneously, collecting decoction filters, and filtrate is concentrated into about 1.10 (70 ℃) of relative density.Spray drying; The volatilization oil-water fluid of collecting is told volatile oil through rectification, gets volatile oil and sprays in the Rhizoma Dioscoreae powder with the small amount of ethanol dissolving, and low temperature (<65 ℃) oven dry is got dried cream powder and added Rhizoma Dioscoreae powder, and mixing incapsulates, promptly.
The instructions of taking of this medicine is: the prescription dosage was crude drug in whole 33.3g on 1st, made capsule, obeyed each 4 every day 3 times.
Embodiment 2: take by weighing raw material (kg) by following proportioning:
Radix Polygoni Multiflori Preparata 243 Herba Epimedii 194 Radix Rehmanniaes Preparata 243 Carapax Et Plastrum Testudiniss 146 crust halberds 194 Cortexs Eucommiae 194 Radix Dipsacis 194 Rhizoma Drynariae 194 Radix Angelicae Sinensis 146 Rhizoma Dioscoreaes 194
Preparation method is with example 1.
Embodiment 3: take by weighing raw material (kg) by following proportioning:
Radix Polygoni Multiflori Preparata 452 Herba Epimedii 361 Radix Rehmanniaes Preparata 452 Carapax Et Plastrum Testudiniss 271 crust halberds 361 Cortexs Eucommiae 361 Radix Dipsacis 361 Rhizoma Drynariae 361 Radix Angelicae Sinensis 271 Rhizoma Dioscoreaes 361
Preparation method is with example 1.
Embodiment 4: take by weighing raw material (kg) by following proportioning:
Radix Polygoni Multiflori Preparata 313 Herba Epimedii 250 Radix Rehmanniaes Preparata 313 Carapax Et Plastrum Testudiniss 188 crust halberds 250 Cortexs Eucommiae 250 Radix Dipsacis 250 Rhizoma Drynariae 250 Radix Angelicae Sinensis 188 Rhizoma Dioscoreaes 250
Preparation method is with example 1.

Claims (2)

1, a kind of medicine for the treatment of osteoporosis is characterized in that it is the medicament of being made by the raw material of following weight portion: Radix Polygoni Multiflori Preparata 243-452, Herba Epimedii 194-361, Radix Rehmanniae Preparata 243-452, Carapax Et Plastrum Testudinis 146-271, crust halberd 194-361, Cortex Eucommiae 194-361, Radix Dipsaci 194-361, Rhizoma Drynariae 194-361, Radix Angelicae Sinensis 146-271, Rhizoma Dioscoreae 194-361; Above-mentioned raw materials is prepared by the following method: get the Rhizoma Dioscoreae of prescription 1/3 amount, pulverize, sieve, powder is standby; In addition the Rhizoma Dioscoreae of 2/3 amount and all the other 9 flavor medical materials put decoct with water in the multipotency extraction pot inferior; Collect volatile oil simultaneously, collecting decoction filters, the spray drying powder that gets dry extract; The volatilization oil-water fluid of collecting is told volatile oil through rectification, gets volatile oil and sprays in the Rhizoma Dioscoreae powder with the small amount of ethanol dissolving, and oven drying at low temperature is got dried cream powder and added Rhizoma Dioscoreae powder, and mixing incapsulates, promptly.
2, the medicine of treatment osteoporosis according to claim 1 is characterized in that the weight portion of raw material is: Radix Polygoni Multiflori Preparata 347.5, Herba Epimedii 277.5, Radix Rehmanniae Preparata 347.5, Carapax Et Plastrum Testudinis 208.5. crust halberd 277.5, the Cortex Eucommiae 277, Radix Dipsaci 277.5, Rhizoma Drynariae 277.5, Radix Angelicae Sinensis 208.5, Rhizoma Dioscoreae 277.5.
CN 03117768 2003-04-24 2003-04-24 Medicine for treating osteoporosis and its preparing process CN1207041C (en)

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Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101370394B (en) * 2005-11-14 2014-12-10 国立阳明大学 Yam low-molecule extractive and preparation method thereof
CN1319546C (en) * 2005-01-06 2007-06-06 贵州富华药业有限责任公司 Delayed-releasing preparation for treating osteoporosis
CN101084968B (en) * 2007-06-27 2011-05-04 陕西盘龙制药集团有限公司 Health care food for increasing bone density
CN101890127B (en) * 2010-07-19 2012-07-04 东莞万成制药有限公司 New application of HuGu capsule in preventing glucocorticoid-induced osteoporosis
WO2016078147A1 (en) * 2014-11-19 2016-05-26 胡桂香 Tincture for prevention of osteoporosis and bone fracturing
CN108272943B (en) * 2018-03-08 2021-03-30 广东安诺药业股份有限公司 A pharmaceutical composition for treating osteoporotic fracture, and its preparation method
CN108186852B (en) * 2018-03-19 2021-01-29 广东安诺药业股份有限公司 Medicinal composition for preventing and treating femoral head necrosis and preparation method thereof
CN108310169A (en) * 2018-03-21 2018-07-24 广东安诺药业股份有限公司 Pharmaceutical composition and preparation method thereof for preventing osteoarthritis
CN108434299A (en) * 2018-06-02 2018-08-24 广东安诺药业股份有限公司 Pharmaceutical composition for cure scapulohumeral periarthritis and preparation method thereof and spray
CN108403906B (en) * 2018-06-05 2021-02-23 广东安诺药业股份有限公司 Pharmaceutical composition for preventing and treating rheumatoid arthritis and preparation method thereof

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