CN109700918A - Traditional Chinese medicine composition for treating postmenopausal osteoporosis - Google Patents
Traditional Chinese medicine composition for treating postmenopausal osteoporosis Download PDFInfo
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- CN109700918A CN109700918A CN201910083733.9A CN201910083733A CN109700918A CN 109700918 A CN109700918 A CN 109700918A CN 201910083733 A CN201910083733 A CN 201910083733A CN 109700918 A CN109700918 A CN 109700918A
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Abstract
The invention relates to a traditional Chinese medicine composition. The traditional Chinese medicine composition has the effects of tonifying kidney, replenishing essence, strengthening bones and generating marrow, can regulate the decline of the function of generating marrow of climacteric women caused by kidney qi deficiency and qi and blood deficiency, and can prevent and treat osteoporosis. A traditional Chinese medicine composition for treating postmenopausal osteoporosis is prepared from the following effective pharmaceutical ingredients in parts by weight: 0.75-3 parts of prepared rehmannia root, 0.41-0.84 part of dodder, 0.75-2.25 parts of achyranthes root, 6-9 parts of tortoise-plastron glue, 6-9 parts of deerhorn glue, 0.6-1.2 parts of Chinese yam, 0.3-1.5 parts of dogwood, 1.81-4.55 parts of medlar, 0.3-0.75 part of epimedium herb and 0.3-1.5 parts of glossy privet fruit.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, specifically, be related to it is a kind of for treating in postmenopausal osteoporosis
Drug composition.
Background technique
The World Health Organization is defined as the bone density at Dual X-ray (DEXA) to osteoporosis and is lower than normal value 2.5
It is more than standard deviation.The illness rate of postmenopausal women's generation osteoporosis is 4 times of male.Postmenopausal Osteoporosis is a kind of
Common disease related with aging, occurs mainly in postmenopausal women, and the shortage of estrogen causes Postmenopausal Osteoporosis
One of the main reasons, estrogen can promote early stage osteoblast differentiation, and stimulation collagen simultaneously inhibits osteoclast activity.Menopause
Estrogen wretched insufficiency afterwards causes osteoclast activity to increase, and bone density reduces, and increases bone conversion ratio, influences calcium deposition, make bone
Ablation increases, and a large amount of bone loss eventually lead to Postmenopausal Osteoporosis.
Postmenopausal Osteoporosis is divided into two classes: 1, post menopausal early stage osteoporosis, with the characteristics of being lost rapidly by bone amount, with
Postmenopausal estrogen decline is related；2, postmenopausal women with advanced osteoporosis occurs for post menopausal 10~20 years, and bone loss is slow, and
Old secondary parathyroid hormone is hyperfunction, deteriorates Postmenopausal Osteoporosis further.
Since estrogen deficiency leads to bone amount reduction and bone structure variation, increases bone brittleness and be easy to fracture, and
There is complication in pain, textured bone caused by fracturing, or even the problems such as death, the body for severely impacting the elderly is strong
Health and quality of life, or even shorten the service life, increase country and family's financial resources and manpower burden.Caused by postmenopausal osteoporosis
In severe complication, there is 12%~14% people to be in dying of circulation, breathing, digestion etc. in latter year of fracturing in Hip Fracture
The various complication of system, 50% is handicapped in survivor.Osteoporosis relevant to menopause has been very important important
Health care project.
Postmenopausal Osteoporosis is treated in doctor trained in Western medicine at present mainly has: 1, hormone replacement therapy.Numerous studies confirmation, menopause
Women can prevent the loss of bone amount using estrogen afterwards, and the dosage and curative effect of estrogen have obvious relation, however are still eager to excel
It adjusts and uses minimum effective dose, be otherwise easy to cause side effect, and once stop being easy recurrence.2, calcium agent is supplemented.Although mending
Calcium is comparatively safe, but still it is noted that monitoring blood, calcium concentration in urine, in order to avoid there is kidney or vesical calculus.3, replenishing vitamins
D.Elderly woman supplements 400U vitamine D3 daily can slightly reduce parathyroid hormone, increase femoral neck bone density, but bone
The biochemical indicator of conversion has no variation.
However TCM Therapy has its unique advantage in prevention and treatment Postmenopausal Osteoporosis, Chinese medicine thinks that women is exhausted
After, menopause, kidney qi declines, then marrow cannot expire, and the kidney qi then blood fortune that declines is powerless, can gradually cause to become silted up.Therefore in excavating, explore and use
Medical means have important practical significance to treat Postmenopausal Osteoporosis.
Summary of the invention
The object of the present invention is to provide a kind of for treating the Chinese medicine composition of postmenopausal osteoporosis, fills out with kidney tonifying
The effect of essence, the raw marrow of bone strengthening, adjustable climacteric women because of kidney qi virtual loss, insufficiency of vital energy and blood and caused by raw marrow function reduction,
Prevent and treat osteoporosis.
The purpose of the present invention is what is be achieved through the following technical solutions:
It is a kind of for treating the Chinese medicine composition of postmenopausal osteoporosis, be by following parts by weight drug effectively at
Point: Rehmannia glutinosa 0.75-3, Semen Cuscutae 0.41-0.84, radix achyranthis bidentatae 0.75-2.25, tortoise-shell glue 6-9, deer horn glue 6-9, Chinese yam 0.6-
1.2, the granule of Fructus Corni 0.3-1.5, fructus lycii 1.81-4.55, Herba Epimedii 0.3-0.75 and fruit of glossy privet 0.3-1.5 composition.
The Chinese medicine composition of the present invention for being used to treat postmenopausal osteoporosis, can use common preparation method
It obtains.As a kind of easy-to-use preparation method, may comprise steps of:
(1) in parts by weight are as follows: Rehmannia glutinosa 3-12, Semen Cuscutae 6-12, radix achyranthis bidentatae 3-9, tortoise-shell glue 6-9, deer horn glue 6-9, mountain
Medicine 6-12, Fructus Corni 3-15, fructus lycii 6-15, Herba Epimedii 6-15 and fruit of glossy privet 3-15 weigh bulk pharmaceutical chemicals, by weighed bulk pharmaceutical chemicals
Processing early period, effective component extracting are carried out respectively；(2) each effective ingredient extracted is done after low temperature concentration, spray drying
Method granulation, is made each effective ingredient particle；(3) each effective ingredient particle is mixed and made into granule.
Each process in above steps is operated by national Chinese medicine certification enterprise according to old process.
Since there may be the non-uniform situations of size for particle, it is preferable that the step (2) further includes respectively will be obtained
Each effective ingredient particle grinds bulky grain, the fine particle and fine powder under sieving can be packed to be checked by 12-14 mesh.
Most afterwards through examining qualified particle to be dispensed using automatic granular packaging machine, dry storage, storage.
It is of the present invention for treating the Chinese traditional medicine composition of postmenopausal osteoporosis in order to obtain superior technique effect
Object, the preferably effective ingredient by following parts by weight: Rehmannia glutinosa 1.5, Semen Cuscutae 0.63, radix achyranthis bidentatae 2.25, tortoise-shell glue 6,
The granule that deer horn glue 6, Chinese yam 0.9, Fructus Corni 0.9, fructus lycii 3.64, Herba Epimedii 0.5 and the fruit of glossy privet 1 form.
Granule composed by above-mentioned preferred embodiment can be obtained using common preparation method.As a kind of easy to be easy
Capable preparation method, may comprise steps of: (1) in parts by weight are as follows: Rehmannia glutinosa 6, Semen Cuscutae 9, radix achyranthis bidentatae 9, tortoise-shell glue 6,
Deer horn glue 6, Chinese yam 9, Fructus Corni 9, fructus lycii 12, Herba Epimedii 10 and the fruit of glossy privet 10 weigh bulk pharmaceutical chemicals, by weighed bulk pharmaceutical chemicals point
Not Jin Hang processing early period, effective component extracting；(2) each effective ingredient extracted is after low temperature concentration, spray drying, dry method
Granulation, is made each effective ingredient particle；(3) each effective ingredient particle is mixed and made into granule.
Each process in above steps is operated by national Chinese medicine certification enterprise according to old process.
The Chinese medicine composition as described above for being used to treat postmenopausal osteoporosis, the weight of every dose of granule are 11.66
Gram.
The traditional chinese medicine composition of the invention result in clinical application shows there is the raw marrow of kidney tonifying, essence replenishing, bone strengthening, adjustable
Climacteric women because of kidney qi virtual loss, insufficiency of vital energy and blood and caused by raw marrow function reduction, prevent and treat osteoporosis；Meanwhile this
Invention uses granular form, and every herbal medicine is individually processed, and takes preceding independent assortment, dosage is adjustable, avoids conventional particles agent
The nonadjustable drawback of project；It is easy to carry due to the form using granule, even it is also unrestricted to take civil aviaton's tool.
Specific embodiment
Below with reference to embodiment, description of specific embodiments of the present invention.
Embodiment 1
In parts by weight: 6 parts of Rehmannia glutinosa, 6 parts of Semen Cuscutae, 6 parts of radix achyranthis bidentatae, 6 parts of tortoise-shell glue, 6 parts of deer horn glue, 6 parts of Chinese yam, mountain
6 parts of the fruit of medicinal cornel, 6 parts of fructus lycii, 6 parts of Herba Epimedii, 6 parts of the fruit of glossy privet weigh bulk pharmaceutical chemicals, above-mentioned raw materials medicine is recognized by national Chinese medicine respectively
Enterprise is demonstrate,proved according to old process to above-mentioned progress processing early period.Different according to its effective component process by appropriate, extract it
After effective component after low temperature concentration, spray drying, granule is made.
Embodiment 2
Weigh by weight: 3 parts of Rehmannia glutinosa, 12 parts of Semen Cuscutae, 9 parts of radix achyranthis bidentatae, 9 parts of tortoise-shell glue, 9 parts of deer horn glue, 12 parts of Chinese yam,
6 parts of Fructus Corni, 12 parts of fructus lycii, 12 parts of Herba Epimedii, 15 parts of the fruit of glossy privet weigh bulk pharmaceutical chemicals, by above-mentioned raw materials medicine respectively by country
Medicine authenticates enterprise according to old process to above-mentioned progress processing early period.Different according to its effective component process by appropriate, mention
It is concentrated through low temperature, after spray drying after taking its effective component, granule is made.
Embodiment 3
It weighs by weight: 12 parts of Rehmannia glutinosa, 12 parts of Semen Cuscutae, 9 parts of radix achyranthis bidentatae, 9 parts of tortoise-shell glue, 9 parts of deer horn glue, Chinese yam 12
Part, 15 parts of Fructus Corni, 15 parts of fructus lycii, 15 parts of Herba Epimedii, 15 parts of the fruit of glossy privet weigh bulk pharmaceutical chemicals, by above-mentioned raw materials medicine respectively by state
Chinese medicine certification enterprise, family is according to old process to above-mentioned progress processing early period.Pass through appropriate big gun according to the difference of its effective component
System is concentrated, after spray drying through low temperature after extracting its effective component, granule is made.
Embodiment 4
It weighs by weight: 6 parts of Rehmannia glutinosa, 9 parts of Semen Cuscutae, 9 parts of radix achyranthis bidentatae, 6 parts of tortoise-shell glue, 6 parts of deer horn glue, 9 parts of Chinese yam, mountain
9 parts of the fruit of medicinal cornel, 12 parts of fructus lycii, 10 parts of Herba Epimedii, 10 parts of the fruit of glossy privet weigh bulk pharmaceutical chemicals, by above-mentioned raw materials medicine respectively by national Chinese medicine
Enterprise is authenticated according to old process to above-mentioned progress processing early period.Different according to its effective component process by appropriate, extract
After its effective component after low temperature concentration, spray drying.
Preparation method
Above-described embodiment 1-4 can be obtained using common preparation method.As a kind of easy-to-use preparation method,
It may comprise steps of: (1) weighing bulk pharmaceutical chemicals in parts by weight, weighed bulk pharmaceutical chemicals are subjected to processing early period respectively, extract
Effective component；(2) for each effective ingredient extracted after low temperature concentration, spray drying, it is effective that each drug is made in dry granulation
Ingredient granules grind bulky grain, the fine particle under sieving by each effective ingredient particle obtained by 12-14 mesh
It can be packed with fine powder to be checked；(3) each effective ingredient particle is mixed and made into granule.The weight of every dose of granule is
11.66 grams.Each effective component parts by weight in each granule are as follows: Rehmannia glutinosa 0.75-3, Semen Cuscutae 0.41-0.84, radix achyranthis bidentatae
0.75-2.25, tortoise-shell glue 6-9, deer horn glue 6-9, Chinese yam 0.6-1.2, Fructus Corni 0.3-1.5, fructus lycii 1.81-4.55, excessive sheep
Leaves of pulse plants 0.3-0.75, fruit of glossy privet 0.3-1.5.
Each process in above steps is operated by national Chinese medicine certification enterprise according to old process.
By taking Rehmannia glutinosa as an example, after bulk pharmaceutical chemicals selection, weight is weighed, suitably shreds or crushes, setting is suitable for decocting in container,
Add suitable quantity of water to make to submerge medicinal material, after impregnating suitable time, be heated to boiling, leaches certain time, separate fried liquid, the dregs of a decoction are decocted in accordance with the law
2-3 times out, each fried liquid is collected, after centrifuge separation or sedimentation filtration, the specific gravity that low temperature is concentrated into normal concentration thick paste is general
It is 1.30-1.35 that heat, which surveys (80-90 DEG C),.It is again that medicinal material leachate is spray-dried, moisture content is removed, solids is then comminuted into
Particle.It realizes wink-dry, it is therefore prevented that loss of effective components, while ensure that the homogeneity of particle and character, make particle
With more stable disintegration and dissolution, thus the solvent for overcoming wet granulation process remain, change colour, store it is unstable etc.
Disadvantage.
The effective ingredient of other bulk pharmaceutical chemicals equally can get using customary preparation methods, and it is effective that drug is respectively prepared
Ingredient granules.
Wherein embodiment 4 is a preferred embodiment of the invention, each effective component weight contained in granule obtained
Measure number are as follows: Rehmannia glutinosa 1.5, Semen Cuscutae 0.63, radix achyranthis bidentatae 2.25, tortoise-shell glue 6, deer horn glue 6, Chinese yam 0.9, Fructus Corni 0.9, fructus lycii
Sub 3.64, Herba Epimedii 0.5, the fruit of glossy privet 1.
Show the traditional chinese medicine composition of the invention to the therapeutic effect of postmenopausal osteoporosis below by way of clinical test.
Clinically, studying Bushen Prescription (using granule in the above embodiment of the present invention 4) combines Fosamax to treat bone
Matter osteoporosis patient pain, skeleton metabolism and bone density, the variation of kidney deficiency syndrome score level.
1. clinical data
The 1.1 OP patients of general information 613, patient are randomly divided into 2 groups, multiple from attached Yangpu hospital, Tongji University
Attached Huashan hospital, denier university and the community medical service center of Yangpu District three, are randomly divided into treatment group 326, age 55~82
Year, average (68.2 ± 7.2) year, control group 287, the age 56~78 years old, average (67.6 ± 6.9) year, two groups without conspicuousness
Difference (P > 0.05).
1.2 diagnostic criteria are formulated referring to the osteoporosis committee, Aged in China association Criteria of Osteoporosis subject group
" diagnostic criteria of primary osteoporosis for Chinese people ", Chinese medical discrimination are nephrasthenia syndrome.Cardinal symptom show as lumbago, ostalgia,
Out of strength, height shortens.Tcm diagnosis standard is referring to heumatism kidney deficiency CM syndrome differentiation criterion in Standards for Diagnosis and Curative Effect of Chinese Medical Symptom.
1. metabolic bone disease, Chronic Liver, kidney diaseases and autoimmune pathologies etc. interfere bone metabolism to 1.3 exclusion criterias
Disease.2. secondary osteoporosis patient, such as: suffer from severe diabetes mellitus, hyperthyroidism, in hyperparathyroidism
Secretory disease；Liver and kidney function is obviously abnormal；Once ovary was extractd；Suffer from rheumatoid arthritis；Suffer from bone tumour or Paget's
Disease.3. suffering from other Low BMD metabolic diseases and other serious Cardial or cerebral vascular diseases patients.
2 treatment methods
2.1 treatment group
Therapeutic scheme: the same period takes Fosamax, Bushen Prescription, bright enlightening piece.
Fosamax (Alendronate sodium) is commercially available medicine, and 1 tablet once (70mg), 1 times a week, is taken orally.Continuously take 1 year.
Bushen Prescription 2 times/d, stops 3 after continuously taking March using granule in the above embodiment of the present invention 4,1 bag/time
Month.6 months as a treatment course, totally 2 courses for the treatment of (1 year).
Bright 1.25 grams of every calcium carbonate of enlightening piece (being equivalent to 500 milligrams of calcium), 200 international unit of vitamine D3.Auxiliary material is
Mannitol, PVP K30, essence, aspartame, magnesium stearate, 2 times/day, take orally by 1 tablet/time, and 6 months are 1 course for the treatment of.Even
Continue two courses for the treatment of (1 year).
2.2 control group
Therapeutic scheme: the same period takes Fosamax, bright enlightening piece, does not take Bushen Prescription.
Fosamax, 1 tablet once (70mg), 1 times a week, takes orally.Continuously take 1 year.
Bright enlightening piece, 2 times/day, takes orally by 1 tablet/time；6 months are 1 course for the treatment of.Continuous two courses for the treatment of (1 year).
3 observation index
Bone mineral density: AM General HOLOGIC Dual-energy X-rays absorptionmetry detection assay L1-4 centrum bone density is applied
BMD mean value；2. serum Bone markers measure: parathyroid hormone (PTH, Pg/ml), 25-hydroxycholecalciferol (VIID-T,
ng/ml)；Osteocalcin (TSHH, ng/ml)；I procollagen type carboxypropeptide (TPENPO, ng/ml)；β Collagen Type VI special sequence
(S-CTX,ng/ml)；3. pain scores；4. kidney deficiency syndrome of Traditional Chinese Medicine waits integral.
4 treatment results
The variation (x ± s) of 1 two groups of pretherapy and post-treatment bone densities of table
Illustrate: in being organized after treatment relatively, P < 0.05**P < 0.01 *
#P < 0.05 compared with the control group
Table 1 shows that, by the treatment of above two method, the bone density of two groups of patients has the improvement of highly significant, and
And Bushen Prescription treatment group is better than control group.
The variation (x ± s) of 2 two groups of pretherapy and post-treatment Bone markers of table
Illustrate: compared with pre-treatment, P < 0.05**P < 0.01 *
#P < 0.05 compared with the control group
As can be seen from Table 2, the case treated through two methods, Bone metabolite has significant improvement before relatively treating, and demonstrate,proves
Bright two methods are effective, but comparison among groups, and three indexs of Bushen Prescription treatment group are better than control group (TPENPO, PTH, S-
CTX)。
The variation (x ± s) of 3 two groups of table pretherapy and post-treatment pain integrals
Illustrate: comparison among groups after treatment,#P<0.05
Table 3 is shown, by the treatment of above two method, the pain integral of two groups of patients has the improvement of highly significant,
And Bushen Prescription treatment group is better than control group.
The variation (x ± s) of 4 two groups of table pretherapy and post-treatment kidney deficiency syndrome integrals
Illustrate: comparison among groups after treatment,##P<0.01
Table 4 shows that, by the treatment of above two method, the kidney deficiency syndrome integral of two groups of patients has changing for highly significant
It is kind, and Bushen Prescription treatment group is better than control group, illustrates the main mechanism of Bushen Prescription.
Claims (7)
1. a kind of for treating the Chinese medicine composition of postmenopausal osteoporosis, which is characterized in that be by the medicine of following parts by weight
Object effective component: Rehmannia glutinosa 0.75-3, Semen Cuscutae 0.41-0.84, radix achyranthis bidentatae 0.75-2.25, tortoise-shell glue 6-9, deer horn glue 6-9, mountain
Of medicine 0.6-1.2, Fructus Corni 0.3-1.5, fructus lycii 1.81-4.55, Herba Epimedii 0.3-0.75 and fruit of glossy privet 0.3-1.5 composition
Granula.
2. as described in claim 1 for treating the Chinese medicine composition of postmenopausal osteoporosis, which is characterized in that the Chinese medicine
Composition is made by following methods:
(1) in parts by weight are as follows: Rehmannia glutinosa 3-12, Semen Cuscutae 6-12, radix achyranthis bidentatae 3-9, tortoise-shell glue 6-9, deer horn glue 6-9, Chinese yam 6-
12, Fructus Corni 3-15, fructus lycii 6-15, Herba Epimedii 6-15 and fruit of glossy privet 3-15 weigh bulk pharmaceutical chemicals, and weighed bulk pharmaceutical chemicals are distinguished
Carry out processing early period, effective component extracting；
(2) for each effective ingredient extracted after low temperature concentration, spray drying, each effective ingredient is made in dry granulation
Particle；
(3) each effective ingredient particle is mixed and made into granule.
3. as claimed in claim 2 for treating the Chinese medicine composition of postmenopausal osteoporosis, it is characterised in that: the step
It (2) further include obtaining each effective ingredient small respectively by each effective ingredient particle obtained by 12-14 mesh
Grain.
4. as described in claim 1 for treating the Chinese medicine composition of postmenopausal osteoporosis, which is characterized in that be by following
The effective ingredient of parts by weight: Rehmannia glutinosa 1.5, Semen Cuscutae 0.63, radix achyranthis bidentatae 2.25, tortoise-shell glue 6, deer horn glue 6, Chinese yam 0.9,
The granule that Fructus Corni 0.9, fructus lycii 3.64, Herba Epimedii 0.5 and the fruit of glossy privet 1 form.
5. as claimed in claim 4 for treating the Chinese medicine composition of postmenopausal osteoporosis, which is characterized in that the Chinese medicine
Composition is made by following methods:
(1) in parts by weight are as follows: Rehmannia glutinosa 6, Semen Cuscutae 9, radix achyranthis bidentatae 9, tortoise-shell glue 6, deer horn glue 6, Chinese yam 9, Fructus Corni 9, fructus lycii
Son 12, Herba Epimedii 10 and the fruit of glossy privet 10 weigh bulk pharmaceutical chemicals, and weighed bulk pharmaceutical chemicals are carried out processing early period respectively, extract effectively at
Point；
(2) for each effective ingredient extracted after low temperature concentration, spray drying, each effective ingredient is made in dry granulation
Particle；
(3) each effective ingredient particle is mixed and made into granule.
6. as claimed in claim 5 for treating the Chinese medicine composition of postmenopausal osteoporosis, it is characterised in that: the step
It (2) further include obtaining each effective ingredient small respectively by each effective ingredient particle obtained by 12-14 mesh
Grain.
7. the Chinese medicine composition for being used to treat postmenopausal osteoporosis as described in any claim in claim 1-6,
Be characterized in that: the granule, every dose of weight are 11.66 grams.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112755113A (en) * | 2021-03-18 | 2021-05-07 | 盛常斌 | Medicine for nourishing yin and suppressing excessive yang and its preparation method |
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| CN103211948A (en) * | 2012-01-21 | 2013-07-24 | 上海中医药大学附属龙华医院 | Compound preparation for treating primary osteoporosis and preparation method |
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| CN112755113B (en) * | 2021-03-18 | 2022-04-22 | 盛常斌 | Medicine for nourishing yin and suppressing excessive yang and its preparation method |
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Application publication date: 20190503 |