CN105412587A - Method for preparing medicine composition for treating female postmenopausal osteoporosis - Google Patents
Method for preparing medicine composition for treating female postmenopausal osteoporosis Download PDFInfo
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Abstract
The invention discloses a method for preparing a medicine composition for treating female postmenopausal osteoporosis and relates to the technical field of traditional Chinese medicine. The medicine composition is prepared from raspberries, rhizoma atractylodis macrocephalae, radix paeoniae alba, polygonum multiflorum, jujube kernels, angelica sinensis, codonopsis pilosula, morinda officinalis, acanthopanax, Chinese yam, poria cocos, radix rehmanniae preparata, kudzu vine roots, eucommia ulmoides, mint, polygonatum kingianum, glossy privet fruits, herba epimedii, fructus lycii, cornus officinalis, calcium lactate, semen cuscutae, bovine-derived bone, rhizoma drynariae and liquorice. The medicine composition can increase the bone mineral density of patients suffering from postmenopausal osteoporosis and relieve secondary pains and inflammatory reactions caused by it. Pharmacology experiments and clinical experiments prove that the medicine composition has a remarkable postmenopausal osteoporosis treating effect, and thus having high medical promotion value.
Description
The application be applicant Wang Xueyan propose application for a patent for invention (denomination of invention is: a kind of pharmaceutical composition for the treatment of female postmenopausal osteoporosis and preparation method thereof, application number is: 2014100476179, and the applying date is: on February 11st, 2014) divisional application.
Technical field
The invention belongs to technical field of Chinese medicines, relate to a kind of method preparing the pharmaceutical composition for the treatment of female postmenopausal osteoporosis.
Background technology
Osteoporosis is common ailment of middle-aged and old, frequently-occurring disease, have a strong impact on the Health and Living quality of such crowd, osteoporosis and the fracture caused thereof occupy the 7th in current common disease, during serious threat, the health of old people, make it the public health problem becoming the whole world.At present, aged tendency of population is day by day serious, improves and has very important significance to the control consciousness of osteoporosis.Osteoporosis reduces with bone amount, comprise the minimizing of bone mineral and substrate equal proportion, osseous tissue microstructure deteriorates to feature, show as trabecular bone structure to destroy, attenuate and rupture, and then cause the fragility of bone to increase, biomechanics of bone intensity declines, load holding capacity reduces, and is easy to a kind of systemic skeletal disease that capillary fracture or complete fracture occur.Patients with osteoporosis cardinal symptom is lumbar and back pain, hunchback, easily fractures clinically, and many with performance of suffering from a deficiency of the kidney, and as lumbar and back pain, hyposexuality etc., has had a strong impact on life and quality of life.According to the United Nations's statistics aging, oneself becomes 21 century irreversible worldwide trend.And China entered aging society in 1999.Chinese society's aging speed is faster than country's total population growth rate, according to incompletely statistics, the senile osteoporosis disease sickness rate of China more than 60 years old is about 59.89%, therefore increases bone density, effectively treatment osteoporosis and has become the important topic of people's extensive concern.
In the world's osteoporosis conference in 2004 of international osteoporosis foundation (IOF), Univ Sheffield UK's WHO metabolic osteopathy research center Johnell etc. analyzes 12 clinical researches, and 30,000 9 thousand people in 12 cohort studies are included in this research in.Find that bone density value is lower, the probability of osteoporotic fracture (with all kinds fracture) is higher, and this situation rule in 65 years old age group is the most obvious.Bone density (BMD) full name is bone mineral density, and be an important indicator of bone strength, the intensity of osseous tissue has 75%-85% relevant with bone density.The bone density of bone density phalanges unit are, refers to and the tightness degree that osseous tissue combines is often referred to bone mineral content.Be weigh an osteoporotic index objectively quantized at present, be also an index of reflection bone amount, its unit is g/cm2, and bone density is higher, and sclerotin intensity is better.It is relevant to factors such as skeletal structure, bone amount, bone mineral contents.
Postmenopausal osteoporosis is a kind of commonly encountered diseases relevant with aging, mainly occur in postmenopausal women, because estrogen deficiency causes bone amount to reduce and bone structure change, bone fragility is increased and is easy to fracture, and pain, the textured bone to cause by fracturing, there is complication, so the problem such as death, seriously affect the healthy of old people and quality of life, even shorten the life-span, increase country and family's financial resources and manpower burden.The osteoporosis relevant to menopause has been very important important health care problem.Postmenopausal osteoporosis is multifactor property disease, and heredity, life style, nutrition etc. are all relevant with morbidity.There is following high risk factor person and easily suffer from postmenopausal osteoporosis: white man and Asia women, osteoporosis family history or have the special gene affecting bone amount women, calcium Deficiency of Intake, lack physical exertion, a large amount of smoking and drink, early menopause or menopause move ahead Bilateral oophorectomy patient.Whether there is osteoporosis, depend on the speed of its peak bone mass and bone loss thereof, peak bone mass high and (or) the slow person of bone loss, not easily occur, peak bone mass low and (or) the fast person of bone loss easily occurs.
The difference of producing cause and the mechanism of action is lacked according to bone density, diverse ways can be selected to increase bone density, current clinical treatment many employings calcium preparation, activated vitamin D, gonadal hormone, calcitonin, diphosphonate and fluoride etc., though there is certain curative effect, but side effect is large, somewhat expensive, and cure the symptoms, not the disease.In treatment, western medicine still lacks measure effectively, and medicinal application is also very limited.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 is run off calcareous and can consolidate and prevent bone amount to run off and safe without toxic side effect, thus fundamentally solves osteoporotic medicine and become the problem urgently needing to solve.
Chinese medicine is of long standing and well established, its treatment osteoporosis with in have accumulated abundant clinical practice and theory of Chinese medical science, as being instruct with theory of Chinese medical science, then having kidney invigorating and YANG supporting, replenishing QI to invigorate the spleen, invigorating blood circulation and adjusting the method such as liver.The traditional Chinese medical science thinks that bone density decline cause has two, and one is deficiency of kidney-essence, has saying of " kidney governing bones, raw marrow fill brain, its Hua Fa " in tcm theory, thus deficiency of kidney-essence then muscles and bones is unable; Two is spleen deficiency of kidney-QI, the merit then deficiency of kidney-essence of insufficiency of the spleen mistake transporting, and skeleton loses supports, so fragile unable.
Summary of the invention
In prior art, chemicals is cured the symptoms, not the disease, and easily produces hormonal medicaments toleration, and poisonous side effect of medicine is large, and it is fixed that Chinese medicine then exists uncertain therapeutic efficacy, lacks relative medicine preparation.In order to overcome above-mentioned the deficiencies in the prior art, the object of this invention is to provide and a kind ofly effectively can treat postmenopausal osteoporosis and instant effect, short treating period, Chinese medicine that cure rate is high.
For realizing object of the present invention, existing according to following technical scheme, Chinese medicine of the present invention is made up of the raw material of following weight:
Fructus Rubi 8-20 part, Rhizoma Atractylodis Macrocephalae 5-15 part, Radix Paeoniae Alba 5-15 part, Radix Polygoni Multiflori 3-10 part, Semen Ziziphi Spinosae 10-25 part, Radix Angelicae Sinensis 5-15 part, Radix Codonopsis 10-20 part, Radix Morindae Officinalis 3-10 part, Radix Et Caulis Acanthopanacis Senticosi 10-20 part, Rhizoma Dioscoreae 5-15 part, Poria 8-20 part, Radix Rehmanniae Preparata 5-12 part, Radix Puerariae 10-20 part, Cortex Eucommiae 3-10 part, Herba Menthae 5-15 part, Rhizoma Polygonati 3-10 part, Fructus Ligustri Lucidi 3-10 part, Herba Epimedii 5-12 part, Fructus Lycii 10-15 part, Fructus Corni 10-20 part, calcium lactate 3-10 part, Semen Cuscutae 5-15 part, Os Bovis seu Bubali powder 5-15 part, Rhizoma Drynariae 5-25 part, Radix Glycyrrhizae 10-20 part,
According to the difference of Chinese medicine composition to postmenopausal osteoporosis therapeutic effect, above-mentioned Chinese medicine composition basis is preferably as follows:
(1) Fructus Rubi 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Radix Polygoni Multiflori 7 parts, Semen Ziziphi Spinosae 18 parts, Radix Angelicae Sinensis 10 parts, Radix Codonopsis 15 parts, Radix Morindae Officinalis 7 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Rhizoma Dioscoreae 10 parts, 14 parts, Poria, 9 parts, Radix Rehmanniae Preparata, Radix Puerariae 15 parts, the Cortex Eucommiae 7 parts, Herba Menthae 10 parts, Rhizoma Polygonati 7 parts, Fructus Ligustri Lucidi 6 parts, Herba Epimedii 8 parts, Fructus Lycii 13 parts, Fructus Corni 15 parts, calcium lactate 7 parts, Semen Cuscutae 10 parts, Os Bovis seu Bubali powder 10 parts, Rhizoma Drynariae 20 parts, 15 parts, Radix Glycyrrhizae.
(2) Fructus Rubi 8 parts, the Rhizoma Atractylodis Macrocephalae 5 parts, the Radix Paeoniae Alba 5 parts, Radix Polygoni Multiflori 3 parts, Semen Ziziphi Spinosae 10 parts, Radix Angelicae Sinensis 5 parts, Radix Codonopsis 10 parts, Radix Morindae Officinalis 3 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Rhizoma Dioscoreae 5 parts, 8 parts, Poria, 5 parts, Radix Rehmanniae Preparata, Radix Puerariae 10 parts, the Cortex Eucommiae 3 parts, Herba Menthae 5 parts, Rhizoma Polygonati 3 parts, Fructus Ligustri Lucidi 3 parts, Herba Epimedii 5 parts, Fructus Lycii 10 parts, Fructus Corni 10 parts, calcium lactate 3 parts, Semen Cuscutae 5 parts, Os Bovis seu Bubali powder 5 parts, Rhizoma Drynariae 5 parts, 10 parts, Radix Glycyrrhizae.
(3) Fructus Rubi 20 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, the Radix Paeoniae Alba 15 parts, Radix Polygoni Multiflori 10 parts, Semen Ziziphi Spinosae 25 parts, Radix Angelicae Sinensis 15 parts, Radix Codonopsis 20 parts, Radix Morindae Officinalis 10 parts, Radix Et Caulis Acanthopanacis Senticosi 20 parts, Rhizoma Dioscoreae 15 parts, 20 parts, Poria, 12 parts, Radix Rehmanniae Preparata, Radix Puerariae 20 parts, the Cortex Eucommiae 10 parts, Herba Menthae 15 parts, Rhizoma Polygonati 10 parts, Fructus Ligustri Lucidi 10 parts, Herba Epimedii 12 parts, Fructus Lycii 15 parts, Fructus Corni 20 parts, calcium lactate 10 parts, Semen Cuscutae 15 parts, Os Bovis seu Bubali powder 15 parts, Rhizoma Drynariae 25 parts, 20 parts, Radix Glycyrrhizae.
(4) Fructus Rubi 12 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 10 parts, Radix Polygoni Multiflori 5 parts, Semen Ziziphi Spinosae 16 parts, Radix Angelicae Sinensis 18 parts, Radix Codonopsis 13 parts, Radix Morindae Officinalis 6 parts, Radix Et Caulis Acanthopanacis Senticosi 20 parts, Rhizoma Dioscoreae 10 parts, 10 parts, Poria, 8 parts, Radix Rehmanniae Preparata, Radix Puerariae 16 parts, the Cortex Eucommiae 6 parts, Herba Menthae 10 parts, Rhizoma Polygonati 5 parts, Fructus Ligustri Lucidi 8 parts, Herba Epimedii 7 parts, Fructus Lycii 10 parts, Fructus Corni 14 parts, calcium lactate 10 parts, Semen Cuscutae 5 parts, Os Bovis seu Bubali powder 15 parts, Rhizoma Drynariae 15 parts, 17 parts, Radix Glycyrrhizae.
In order to express Chinese medicine composition of the present invention better, Chinese medicine composition of the present invention can be prepared into dosage form conventional clinically, such as, the preparations such as powderous preparations, 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 conveniently preparation technology be prepared into powder, water preparation, tablet or capsule.
Present invention also offers a kind of preparation method of Chinese medicine composition described above, it mainly comprises following step: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, the alcoholic solution that volumetric concentration is 40%-95% is doubly added according to the 4-9 of coarse powder gross weight, reflux, extract, three times, return time is 2-5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Those skilled in the art can technically prepare conventional Chinese medicine pharmaceutical dosage form clinically, as tablet, capsule etc. in this preparation method.
The present invention also asks to protect the purposes of above-mentioned Chinese medicine composition in preparation treatment postmenopausal osteoporosis medicine.Pharmaceutical composition of the present invention, when treating postmenopausal osteoporosis, demonstrates the activity that remarkable anti-inflammatory and antalgic also significantly can increase bone density.Test examples 7 of the present invention shows, give positive drug and Chinese medicine composition of the present invention 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 pole 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 significantly will be better than positive controls.Test examples 8 mice of the present invention licks foot response latency time showing, compare with model group, after administration after 1h and 2h, the incubation period that the mice of each administration group of Chinese medicine composition of the present invention adds foot reaction is all greater than model group, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).What illustrate that this Chinese medicine composition of the present invention can extend that mice stimulates hot plate adds the sufficient response latency, has certain analgesic activity.Under same experiment condition, positive control QIANGGU JIAONANG group (1h,
p< 0.05; 2h,
p< 0.01) also extend the incubation period that mice adds 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, and model group compares with blank group, and the BMD of left tibia, right tibia, lower neck bone and lumbar vertebra all has significant difference, shows that the bone mineral content that retinoic acid causes osteoporosis rat obviously declines.Compare with model group, QIANGGU JIAONANG group and Chinese medicine composition of the present invention are respectively organized and all can be raised rat bone mineral content.Wherein low, high, the middle dosage group of Chinese medicine composition of the present invention compares with model group, significantly improve the BMD of model mouse left tibia, right tibia, lower neck bone and lumbar vertebra, show that the Chinese medicine composition of doses obviously can increase the bone mineral content content that retinoic acid causes osteoporosis model, and high, middle dosage group has significance compared with QIANGGU JIAONANG group to the bone mineral content content of osteoporosis model difference.
In a word, Chinese medicine composition of the present invention, in treatment postmenopausal osteoporosis, compared with prior art has following advantage:
1) compared with the chemotherapeutic agent of Current therapeutic, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, significantly improve the compliance of postmenopausal osteoporotic patients, and improve the quality of life of patient;
2) multi-medicament component is contained in Chinese medicine composition of the present invention, action target spot is numerous, pharmacological evaluation shows it and has significant blood circulation promoting and blood stasis dispelling, anti-inflammatory and antalgic, rising bone density isoreactivity, efficiently solve the morbidity root of postmenopausal osteoporosis, it serves the effect for the treatment of both the principal and secondary aspects of a disease to the therapeutic effect of postmenopausal osteoporosis;
3) 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 this medicine has unique curative effect to the postmenopausal osteoporosis that a variety of causes causes, this medicine compatibility science, curative effect is rapid, the advantage that instant effect, short treating period, cure rate are high, expense is little.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but those skilled in the art should know, described embodiment does not also limit the present invention in any way.
one) example of formulations part
embodiment 1 Chinese medicine composition of the present invention and preparation technology
Prescription is composed as follows:
Fructus Rubi 8 parts, the Rhizoma Atractylodis Macrocephalae 5 parts, the Radix Paeoniae Alba 5 parts, Radix Polygoni Multiflori 3 parts, Semen Ziziphi Spinosae 10 parts, Radix Angelicae Sinensis 5 parts, Radix Codonopsis 10 parts, Radix Morindae Officinalis 3 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Rhizoma Dioscoreae 5 parts, 8 parts, Poria, 5 parts, Radix Rehmanniae Preparata, Radix Puerariae 10 parts, the Cortex Eucommiae 3 parts, Herba Menthae 5 parts, Rhizoma Polygonati 3 parts, Fructus Ligustri Lucidi 3 parts, Herba Epimedii 5 parts, Fructus Lycii 10 parts, Fructus Corni 10 parts, calcium lactate 3 parts, Semen Cuscutae 5 parts, Os Bovis seu Bubali powder 5 parts, Rhizoma Drynariae 5 parts, 10 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, add according to 4 times of coarse powder gross weight the alcoholic solution that volumetric concentration is 40%, reflux, extract, three times, return time is 5h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Chinese medical concrete is pulverized and adds preparation and commonly use adjuvant and be prepared into tablet or capsule.
embodiment 2 Chinese medicine composition of the present invention and preparation technology
Prescription is composed as follows:
Fructus Rubi 20 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, the Radix Paeoniae Alba 15 parts, Radix Polygoni Multiflori 10 parts, Semen Ziziphi Spinosae 25 parts, Radix Angelicae Sinensis 15 parts, Radix Codonopsis 20 parts, Radix Morindae Officinalis 10 parts, Radix Et Caulis Acanthopanacis Senticosi 20 parts, Rhizoma Dioscoreae 15 parts, 20 parts, Poria, 12 parts, Radix Rehmanniae Preparata, Radix Puerariae 20 parts, the Cortex Eucommiae 10 parts, Herba Menthae 15 parts, Rhizoma Polygonati 10 parts, Fructus Ligustri Lucidi 10 parts, Herba Epimedii 12 parts, Fructus Lycii 15 parts, Fructus Corni 20 parts, calcium lactate 10 parts, Semen Cuscutae 15 parts, Os Bovis seu Bubali powder 15 parts, Rhizoma Drynariae 25 parts, 20 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, add according to 5 times of coarse powder gross weight the alcoholic solution that volumetric concentration is 90%, reflux, extract, three times, return time is 3h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Chinese medical concrete is pulverized and adds preparation and commonly use adjuvant and be prepared into tablet or capsule.
embodiment 3 Chinese medicine composition of the present invention and preparation technology
Prescription is composed as follows:
Fructus Rubi 15 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Radix Polygoni Multiflori 7 parts, Semen Ziziphi Spinosae 18 parts, Radix Angelicae Sinensis 10 parts, Radix Codonopsis 15 parts, Radix Morindae Officinalis 7 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Rhizoma Dioscoreae 10 parts, 14 parts, Poria, 9 parts, Radix Rehmanniae Preparata, Radix Puerariae 15 parts, the Cortex Eucommiae 7 parts, Herba Menthae 10 parts, Rhizoma Polygonati 7 parts, Fructus Ligustri Lucidi 6 parts, Herba Epimedii 8 parts, Fructus Lycii 13 parts, Fructus Corni 15 parts, calcium lactate 7 parts, Semen Cuscutae 10 parts, Os Bovis seu Bubali powder 10 parts, Rhizoma Drynariae 20 parts, 15 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, add according to 5 times of coarse powder gross weight the alcoholic solution that volumetric concentration is 70%, reflux, extract, three times, return time is 4h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Chinese medical concrete is pulverized and adds preparation and commonly use adjuvant and be prepared into tablet or capsule.
embodiment 4 Chinese medicine composition of the present invention and preparation technology
Prescription is composed as follows:
Fructus Rubi 8 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, the Radix Paeoniae Alba 15 parts, Radix Polygoni Multiflori 3 parts, Semen Ziziphi Spinosae 25 parts, Radix Angelicae Sinensis 15 parts, Radix Codonopsis 10 parts, Radix Morindae Officinalis 10 parts, Radix Et Caulis Acanthopanacis Senticosi 10 parts, Rhizoma Dioscoreae 10 parts, 16 parts, Poria, 12 parts, Radix Rehmanniae Preparata, Radix Puerariae 10 parts, the Cortex Eucommiae 3 parts, Herba Menthae 5 parts, Rhizoma Polygonati 10 parts, Fructus Ligustri Lucidi 10 parts, Herba Epimedii 7 parts, Fructus Lycii 10 parts, Fructus Corni 15 parts, calcium lactate 3 parts, Semen Cuscutae 10 parts, Os Bovis seu Bubali powder 10 parts, Rhizoma Drynariae 10 parts, 10 parts, Radix Glycyrrhizae.
Preparation method: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, add according to 5 times of coarse powder gross weight the alcoholic solution that volumetric concentration is 70%, reflux, extract, three times, return time is 4h, filters, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying; Adding ethanol to alcohol content is 75%(v/v), leave standstill 24 hours, get supernatant, reclaim ethanol and concentrate, 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
Prescription is composed as follows:
Fructus Rubi 12 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, the Radix Paeoniae Alba 10 parts, Radix Polygoni Multiflori 5 parts, Semen Ziziphi Spinosae 16 parts, Radix Angelicae Sinensis 18 parts, Radix Codonopsis 13 parts, Radix Morindae Officinalis 6 parts, Radix Et Caulis Acanthopanacis Senticosi 20 parts, Rhizoma Dioscoreae 10 parts, 10 parts, Poria, 8 parts, Radix Rehmanniae Preparata, Radix Puerariae 16 parts, the Cortex Eucommiae 6 parts, Herba Menthae 10 parts, Rhizoma Polygonati 5 parts, Fructus Ligustri Lucidi 8 parts, Herba Epimedii 7 parts, Fructus Lycii 10 parts, Fructus Corni 14 parts, calcium lactate 10 parts, Semen Cuscutae 5 parts, Os Bovis seu Bubali powder 15 parts, Rhizoma Drynariae 15 parts, 17 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 4.
embodiment 6 Chinese medicine composition of the present invention and preparation technology
Prescription is composed as follows:
Fructus Rubi 14 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 13 parts, Radix Polygoni Multiflori 6 parts, Semen Ziziphi Spinosae 20 parts, Radix Angelicae Sinensis 15 parts, Radix Codonopsis 20 parts, Radix Morindae Officinalis 3 parts, Radix Et Caulis Acanthopanacis Senticosi 16 parts, Rhizoma Dioscoreae 9 parts, 11 parts, Poria, 7 parts, Radix Rehmanniae Preparata, Radix Puerariae 16 parts, the Cortex Eucommiae 7 parts, Herba Menthae 11 parts, Rhizoma Polygonati 5 parts, Fructus Ligustri Lucidi 10 parts, Herba Epimedii 12 parts, Fructus Lycii 15 parts, Fructus Corni 16 parts, calcium lactate 10 parts, Semen Cuscutae 15 parts, Os Bovis seu Bubali powder 12 parts, Rhizoma Drynariae 18 parts, 17 parts, Radix Glycyrrhizae.
Preparation technology is with embodiment 4.
(2) test examples part
the antiinflammatory action of embodiment 7 Chinese medicine composition xylol of the present invention induced mice inflammatory model
Hydrocortisone has stronger anti-inflammatory activity, be synthetic be also naturally occurring glucocorticoid, after hydrocortisone enters cell, activate cytoplasmic receptor, nucleus is entered after allosteric, be combined with DNA response element, cause suppression or the induction of genetic transcription, the expression of inflammation related proteins is changed.
1, experimental technique
50 KM mices, male and female half and half, body weight 25-30 gram, five groups are divided at random by body weight, i.e. dosage group, compositions low dose group, positive controls in model control group, compositions high dose group, compositions, often organize 10, each administration group mice gives following medicine respectively:
Model control group: gavage gives the normal saline of same volume;
Positive controls: gavage gives the hydrocortisone drug solution of 5mg/kg;
Compositions high dose group: gavage gives 50mg/kg embodiment 1 Chinese medicine composition, and Chinese medicine composition presses crude drug gauge;
Dosage group in compositions: gavage gives 20mg/kg embodiment 1 Chinese medicine composition, and Chinese medicine composition presses crude drug gauge;
Compositions low dose group: gavage gives 5mg/kg embodiment 1 Chinese medicine composition, and Chinese medicine composition presses crude drug gauge.
Each administration group is administered once every day, successive administration 7d.Get dimethylbenzene 20 μ l after last administration, be applied to each mouse right ear.Get after 30 minutes and be respectively evenly applied to mouse right ear respectively by reagent 0.03ml, auris dextra is put to death after 3.5 hours to dimethylbenzene, measures 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, 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 the antiphlogistic effects that each experimental mice ear method of double differences evaluates each medication group medicine.Measurement result is in table 1.
Table 1 each experimental mice ear method of double differences compares
Compare with model control group,
* p< 0.05; Compare with model control group,
* p< 0.01;
Compare with positive controls,
# p< 0.05; Compare with positive controls,
## p< 0.01.
Result display gives positive drug and Chinese medicine composition of the present invention 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 pole 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 significantly will be better than positive controls.
embodiment 8 Chinese medicine composition of the present invention affects mouse hot-plate analgesic
1, mouse hot-plate pain model makes
About body weight 20g female mice is placed on hot plate dolorimeter, screen qualified ♀ mice 90 (to lick metapedes time < 5s or > 30s to throw aside, scald for preventing foot, also deadline should be established, be generally 60s), the incubation period of metapedes reaction is added for threshold of pain index with mice, get 60 jennies, be divided into 5 groups, 12/group, i.e. model group, QIANGGU JIAONANG group, Chinese medicine composition of the present invention (obtaining by Chinese medicine composition prescription described in embodiment 1 and preparation technology) low dose group, middle dosage group and high dose group.Each group is gastric infusion, 1 times/day, and after successive administration 14d, after measuring last medicine, 60min, 120min add the time of foot reaction.
2, Chinese medicine composition of the present invention is on the impact of licking the foot response latency in mouse hot-plate analgesic experiment
Mice licks foot response latency time showing, compare with model group, after administration after 1h and 2h, the incubation period that the mice of each administration group of Chinese medicine composition of the present invention adds foot reaction is all greater than model group, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).What illustrate that this Chinese medicine composition of the present invention can extend that mice stimulates hot plate adds the sufficient response latency, has certain analgesic activity.Under same experiment condition, positive control QIANGGU JIAONANG group (1h,
p< 0.05; 2h,
p< 0.01) also extend the incubation period that mice adds 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 (
)
Note: compare with model group, *
p< 0.05, * *
p< 0.01.
embodiment 9 Chinese medicine composition of the present invention is to the therapeutical effect of retinoic acid rats with osteoporosis
1, model rat with osteoporosis makes and administration
60 female sd inbred rats, each batch of rat is divided into 6 groups all at random, often organizes 10, and each component cage is fed.1st group is blank group, gavages a certain amount of distilled water every day; 2nd group is model group, gavages a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) every day; 3rd group is QIANGGU JIAONANG group, gavages a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) and a certain amount of QIANGGU JIAONANG 1% carboxyl methyl cellulose sodium suspension (12mg/kg) every day; 4th, 5,6 groups are respectively the basic, normal, high dosage group of Chinese medicine composition, gavage the Carboxymethyl cellulose sodium suspension (being equivalent to raw medicinal herbs 5mg/kg, 20mg/kg, 50mg/kg respectively) of a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) and Chinese medicine composition every day, after gavaging 14d continuously, continue after changing retinoic acid suspension into distilled water to gavage to 30d and stop.
Observation item and method: after last administration 24h, take body weight, anaesthetize with pentobarbital sodium (30mg/kg), the whole body of each group of rat is scanned with xR-36 type dynamic filtration dual intensity x line bone density diagnostic apparatus, measure left and right tibia respectively, the bone density (bonemineraldensityBMD) of lower neck bone and lumbar vertebra.
2, result of the test
Each group of data are all used (
) represent, carry out t with SPSS software kit 10.0 and check significance analysis.Chinese medicine composition is on as shown in table 3 on the impact of BMD.
Table 3 Chinese medicine composition is on the impact of the bone density of osteoporosis model
Compare with blank group, * * P < 0.01; Contrast with model group, #P < 0.05, ##P < 0.01.
Model group compares with blank group, and the BMD of left tibia, right tibia, lower neck bone and lumbar vertebra all has significant difference, shows that the bone mineral content that retinoic acid causes osteoporosis rat obviously declines.Compare with model group, QIANGGU JIAONANG group and Chinese medicine composition of the present invention are respectively organized and all can be raised rat bone mineral content.Wherein low, high, the middle dosage group of Chinese medicine composition of the present invention compares with model group, significantly improve the BMD of model mouse left tibia, right tibia, lower neck bone and lumbar vertebra, show that the Chinese medicine composition of doses obviously can increase the bone mineral content content that retinoic acid causes osteoporosis model, and high, middle dosage group has significance compared with QIANGGU JIAONANG group to the bone mineral content content of osteoporosis model difference.
the clinical therapeutic efficacy of embodiment 10 Chinese medicine composition of the present invention
For showing the therapeutic effect of Chinese medicine of the present invention to postmenopausal osteoporosis, the present inventor is to 200 routine case clinical observations, Osteoporosis 72 example, all measure through U.S. Luner company DPS-L type Dual-energy X-rays absorptionmetry, bone density (BMD) is lower than corresponding normal age section peak bone mass two standard deviations, age is 52 years old-88 years old, average out to (64.3 ± 12.1) year.All experimenters are through physical examination, and hepatic and renal function is normal, without endocrinopathy and Ca,P metabolism disorder, do not have metabolic osteopathy medical history in the past, do not take hormone medicine.All cases all have lumbago in various degree and osteoarthrosis pain, 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 36 example, man 18 example, female 18 example, 64 years old mean age; Matched group 36 example, man 18 example, female 18 example, 67 years old mean age.There is between group comparability P > 0.05.
Experimental group uses embodiment 3 gained Chinese medicine capsules, one day twice, and each 20mg/kg takes sooner or later after meal every day half an hour.Matched group intramuscular injection calcitonin (Novartis Norvatis produces, and 50IU/ props up), first week 50IU, 1/d, later intramuscular injection 50IU2 time weekly.Two groups was all 1 course for the treatment of with 30 days, evaluated curative effect after 3 courses for the treatment of.
Curative effect situation criterion: 1, fully recover: 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.
After taking medicine of the present invention, 26 people cure, and cure rate reaches 72.2%, and 8 people are effective, and total effective rate reaches 94.4%.To group healing 25 example, effective 5 examples, cure rate is 69.4%, and total effective rate is 83.3%.
Claims (2)
1. prepare the method for the pharmaceutical composition for the treatment of female postmenopausal osteoporosis for one kind, it is characterized in that comprising following processing step: take Fructus Rubi 15 parts by weight, the Rhizoma Atractylodis Macrocephalae 10 parts, the Radix Paeoniae Alba 10 parts, Radix Polygoni Multiflori 7 parts, Semen Ziziphi Spinosae 18 parts, Radix Angelicae Sinensis 10 parts, Radix Codonopsis 15 parts, Radix Morindae Officinalis 7 parts, Radix Et Caulis Acanthopanacis Senticosi 15 parts, Rhizoma Dioscoreae 10 parts, 14 parts, Poria, 9 parts, Radix Rehmanniae Preparata, Radix Puerariae 15 parts, the Cortex Eucommiae 7 parts, Herba Menthae 10 parts, Rhizoma Polygonati 7 parts, Fructus Ligustri Lucidi 6 parts, Herba Epimedii 8 parts, Fructus Lycii 13 parts, Fructus Corni 15 parts, calcium lactate 7 parts, Semen Cuscutae 10 parts, Os Bovis seu Bubali powder 10 parts, Rhizoma Drynariae 20 parts, 15 parts, Radix Glycyrrhizae, above-mentioned Chinese crude drug is broken into coarse powder, doubly adds according to the 4-9 of coarse powder gross weight the alcoholic solution that volumetric concentration is 40%-95%, reflux, extract, three times, return time is 2-5h, and filter, filtrate recycling ethanol, cold filtration, washes with water, namely obtains Chinese medical concrete after drying.
2. the method for the pharmaceutical composition of preparation treatment female postmenopausal osteoporosis as claimed in claim 1, is characterized in that: described pharmaceutical composition is powder, water preparation, tablet or capsule.
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| CN108042786A (en) * | 2017-12-25 | 2018-05-18 | 高安友 | A kind of compound oral drink of giant salamander polypeptide powder for being used to increase bone density |
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| CN104127683A (en) * | 2014-08-12 | 2014-11-05 | 崔银方 | Traditional Chinese medicine composition for treating or preventing female postmenopausal osteoporosis |
| CN104258294A (en) * | 2014-10-11 | 2015-01-07 | 青岛华仁技术孵化器有限公司 | Bone-strengthening powder |
| CN104524524B (en) * | 2015-01-04 | 2015-07-08 | 侯丽君 | Medicine treating osteoporosis and preparing method |
| CN104758534A (en) * | 2015-04-29 | 2015-07-08 | 赵振荣 | Medicine for treating osteoporosis and preparing method thereof |
| CN105249463A (en) * | 2015-11-19 | 2016-01-20 | 哈尔滨圣吉药业股份有限公司 | Health food with function of enhancing bone mineral density and production method thereof |
| CN105412584A (en) * | 2015-12-21 | 2016-03-23 | 暨南大学 | Traditional Chinese medicine composition for treating female postmenopausal osteoporosis and preparation method thereof |
| CN108938989B (en) * | 2018-10-22 | 2020-10-30 | 河南中医药大学 | A kind of Fufenjingjiangu powder for treating osteoporosis |
| CN110754664A (en) * | 2019-12-05 | 2020-02-07 | 北京凯能婷干细胞科技研究院有限公司 | Composition for preventing osteoporosis |
| CN111068044B (en) * | 2020-01-06 | 2022-03-08 | 新疆华圣元医药科技有限公司 | Pharmaceutical composition with bone mineral density increasing effect and preparation thereof |
| CN114129661B (en) * | 2020-09-03 | 2024-09-17 | 刘敏如女科医系研究院(深圳)有限公司 | Traditional Chinese medicine composition for promoting perimenopausal female to supplement calcium |
| CN114129660A (en) * | 2020-09-03 | 2022-03-04 | 刘敏如女科医系研究院(深圳)有限公司 | Special calcium tablet for perimenopausal women and preparation method thereof |
| CN114651980A (en) * | 2022-03-29 | 2022-06-24 | 马玉芝 | Composition and preparation for increasing bone mineral density of climacteric women and preparation method |
| CN114712489B (en) * | 2022-04-06 | 2024-10-22 | 江苏康缘药业股份有限公司 | Composition for relieving bone joint pain and preparation method and application thereof |
| CN119139419A (en) * | 2024-10-23 | 2024-12-17 | 一力制药股份有限公司 | Kidney-tonifying and bone-tonifying oral liquid and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405573A (en) * | 2013-07-30 | 2013-11-27 | 河南省洛阳正骨医院 | Cancellous bone-invigorating formula for treating osteoporosis and preparation technology thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103041282B (en) * | 2013-01-29 | 2014-08-13 | 王鹤成 | Traditional Chinese medicine for treating deficiency of spleen and kidney and preparation method of medicine |
| CN103550476B (en) * | 2013-11-13 | 2015-09-16 | 崔合芳 | A kind of pharmaceutical composition for the treatment of postmenopausal osteoporosis and preparation method thereof |
-
2014
- 2014-02-11 CN CN201610020128.3A patent/CN105412587A/en not_active Withdrawn
- 2014-02-11 CN CN201610020127.9A patent/CN105456711A/en not_active Withdrawn
- 2014-02-11 CN CN201410047617.9A patent/CN103751529A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103405573A (en) * | 2013-07-30 | 2013-11-27 | 河南省洛阳正骨医院 | Cancellous bone-invigorating formula for treating osteoporosis and preparation technology thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108042786A (en) * | 2017-12-25 | 2018-05-18 | 高安友 | A kind of compound oral drink of giant salamander polypeptide powder for being used to increase bone density |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103751529A (en) | 2014-04-30 |
| CN105456711A (en) | 2016-04-06 |
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Application publication date: 20160323 |