CN103550476A - Medicine composition for treating postmenopausal osteoporosis, and preparation method thereof - Google Patents
Medicine composition for treating postmenopausal osteoporosis, and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating postmenopausal osteoporosis, belonging to the field of traditional Chinese medicines. For overcoming the shortcomings of the prior art, the invention provides a traditional Chinese medicine that can increase the bone mineral density of a postmenopausal osteoporosis patient and also can relieve secondary pain and inflammatory response caused by postmenopausal osteoporosis. The traditional Chinese medicine composition is prepared from the following raw materials: black false hellebore, ligusticum wallichii, radix paeoniae alba, polygonum multiflorum, radix angelicae, angelica sinensis, codonopsis pilosula, gynostemma pentaphylla, acanthopanax root, the root of red-rooted salvia, poria cocos, prepared rhizome of rehmannia, the root of kudzu vine, asarum, mentha haplocalyx, xanthium sibiricum, glossy privet fruit, herba epimedii, the fruit of Chinese wolfberry, dogwood, radices sileris, the seed of Chinese dodder, bovine-derived power, astragalus membranaceus and liquorice. Pharmacology experiments and clinical experiments prove that the traditional Chinese medicine composition has a remarkable effect for treating postmenopausal osteoporosis, so the traditional Chinese medicine composition has a wide medical promotional value.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of pharmaceutical composition for the treatment of postmenopausal osteoporosis.
Background technology
Osteoporosis is common ailment of middle-aged and old, frequently-occurring disease, have a strong impact on such crowd's Health and Living quality, osteoporosis and the fracture causing thereof occupy the 7th in current common disease, during serious threat, old people's health, make it to become global public health problem.At present, aged tendency of population is day by day serious, improves the control consciousness of osteoporosis is had very important significance.Osteoporosis is to reduce with bone amount, the minimizing, the osseous tissue microstructure that comprise bone mineral and substrate equal proportion deteriorate to feature, showing as trabecular bone structure destroys, attenuates and rupture, and then cause the fragility of bone to increase, biomechanics of bone intensity decreases, load holding capacity reduces, and is easy to occur a kind of general skeletal diseases of capillary fracture or complete fracture.Patients with osteoporosis cardinal symptom is lumbar and back pain, hunchback, easily fractures clinically, and how with the performance of suffering from a deficiency of the kidney, 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 irreversible worldwide trend of 21st century.And China has entered aging society in 1999.Chinese society's aging speed is faster than country's total population growth rate, according to incompletely statistics, the above senile osteoporosis disease sickness rate of China 60 years old is about 59.89%, therefore increases bone density, effectively treats the important topic that osteoporosis has become people's extensive concern.
In international osteoporosis foundation (IOF) world's osteoporosis conference in 2004, 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 skeleton mineral density, is an important indicator of bone strength, and it is 75%～85% relevant with bone density that the intensity of osseous tissue has.The bone density of bone density phalanges unit are, refers to and the tightness degree of osseous tissue combination is often referred to bone mineral content.Being to weigh at present an osteoporotic index objectively quantizing, is also that an index ，Qi unit of reflection bone amount is g/c ㎡, and bone density is higher, and sclerotin intensity is better.The factor analysis such as it and skeletal structure, bone amount, bone mineral content.
Postmenopausal osteoporosis is a kind of and old and feeble relevant commonly encountered diseases, mainly occur in postmenopausal women group, because estrogen deficiency causes bone amount to reduce and bone structure variation, bone fragility is increased and be easy to fracture, and the pain being caused by fracture, textured bone, there is complication, so the problem such as dead, seriously affect healthy and quality of life of old people, 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, have osteoporosis family history or have the special gene that affects 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, be difficult for to occur, peak bone mass low and (or) the fast person of bone loss easily occurs.
According to bone density, lack the difference that produces reason and the mechanism of action, can select diverse ways to increase bone density, clinical treatment adopts calcium preparation, activated vitamin D, gonadal hormone, calcitonin, diphosphonate and fluoride etc. more at present, though there is certain curative effect, but side effect is large, somewhat expensive, and cure the symptoms, not the disease.Aspect treatment, 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 research and develop a kind of efficient supplementing and run off calcareous and can consolidate and prevent that bone amount runs off and safe without toxic side effect, thereby fundamentally solve osteoporotic medicine, become and urgently need the problem that solves.
Chinese medicine is of long standing and well established, and it is having abundant clinical practice and theory of Chinese medical science aspect treatment osteoporosis, as take theory of Chinese medical science as guidance, has kidney invigorating and YANG supporting, replenishing QI to invigorate the spleen, the methods such as adjusting liver of invigorating blood circulation.The traditional Chinese medical science thinks that bone density decline cause has two, one to be deficiency of kidney-essence, has saying of " kidney governing bones, raw marrow fills brain, its Hua Fa ", therefore muscles and bones is unable for deficiency of kidney-essence in tcm theory; Two is spleen deficiency of kidney-QI, and the merit of insufficiency of the spleen mistake transporting is deficiency of kidney-essence, 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 Chinese medicine exists uncertain therapeutic efficacy fixed, lacks relative medicine preparation.In order to overcome above-mentioned the deficiencies in the prior art, the invention provides and a kind ofly can effectively treat postmenopausal osteoporosis and instant effect, short treating period, Chinese medicine composition that cure rate is high.
For realizing object of the present invention, existing according to following technical scheme:
Chinese medicine composition of the present invention is to be made by following weight portion raw material: Rhizoma et radix veratri (Radix Rhizoma Veratri) 8-20 part, Rhizoma Chuanxiong 5-15 part, Radix Paeoniae Alba 5-15 part, Radix Polygoni Multiflori 3-10 part, Radix Angelicae Dahuricae 10-25 part, Radix Angelicae Sinensis 5-15 part, Radix Codonopsis 10-20 part, Herb Gynostemmae Pentaphylli 3-10 part, Radix Et Caulis Acanthopanacis Senticosi 10-20 part, Radix Salviae Miltiorrhizae 5-15 part, Poria 8-20 part, Radix Rehmanniae Preparata 5-12 part, Radix Puerariae 10-20 part, Herba Asari 3-10 part, Herba Menthae 5-15 part, Herba Xanthii 3-10 part, Fructus Ligustri Lucidi 3-10 part, Herba Epimedii 5-12 part, Fructus Lycii 10-15 part, Fructus Corni 10-20 part, Radix Saposhnikoviae 3-10 part, Semen Cuscutae 5-15 part, Os Bovis seu Bubali powder 5-15 part, Radix Astragali 5-25 part, Radix Glycyrrhizae 10-20 part.
Difference according to Chinese medicine composition to postmenopausal osteoporosis therapeutic effect is preferably as follows on above-mentioned Chinese medicine composition basis:
(1) 15 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 10 parts of Rhizoma Chuanxiongs, 10 parts of the Radix Paeoniae Albas, 7 parts of Radix Polygoni Multiflori, 18 parts of the Radixs Angelicae Dahuricae, 10 parts of Radix Angelicae Sinensis, 15 parts of Radix Codonopsis, 7 parts of Herb Gynostemmae Pentaphylli, 15 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 14 parts, Poria, 9 parts, Radix Rehmanniae Preparata, 15 parts of Radix Puerariaes, 7 parts of Herba Asaris, 10 parts of Herba Menthaes, 7 parts of Herba Xanthiis, 6 parts of Fructus Ligustri Lucidi, 8 parts of Herba Epimedii, 13 parts of Fructus Lycii, 15 parts of Fructus Corni, 7 parts of Radix Saposhnikoviaes, 10 parts of Semen Cuscutae, 10 parts of Os Bovis seu Bubali powder, 20 parts of the Radixs Astragali, 15 parts, Radix Glycyrrhizae.
(2) 8 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 5 parts of Rhizoma Chuanxiongs, 5 parts of the Radix Paeoniae Albas, 3 parts of Radix Polygoni Multiflori, 10 parts of the Radixs Angelicae Dahuricae, 5 parts of Radix Angelicae Sinensis, 10 parts of Radix Codonopsis, 3 parts of Herb Gynostemmae Pentaphylli, 10 parts of Radix Et Caulis Acanthopanacis Senticosis, 5 parts of Radix Salviae Miltiorrhizaes, 8 parts, Poria, 5 parts, Radix Rehmanniae Preparata, 10 parts of Radix Puerariaes, 3 parts of Herba Asaris, 5 parts of Herba Menthaes, 3 parts of Herba Xanthiis, 3 parts of Fructus Ligustri Lucidi, 5 parts of Herba Epimedii, 10 parts of Fructus Lycii, 10 parts of Fructus Corni, 3 parts of Radix Saposhnikoviaes, 5 parts of Semen Cuscutae, 5 parts of Os Bovis seu Bubali powder, 5 parts of the Radixs Astragali, 10 parts, Radix Glycyrrhizae.
(3) 20 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 15 parts of Rhizoma Chuanxiongs, 15 parts of the Radix Paeoniae Albas, 10 parts of Radix Polygoni Multiflori, 25 parts of the Radixs Angelicae Dahuricae, 15 parts of Radix Angelicae Sinensis, 20 parts of Radix Codonopsis, 10 parts of Herb Gynostemmae Pentaphylli, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 15 parts of Radix Salviae Miltiorrhizaes, 20 parts, Poria, 12 parts, Radix Rehmanniae Preparata, 20 parts of Radix Puerariaes, 10 parts of Herba Asaris, 15 parts of Herba Menthaes, 10 parts of Herba Xanthiis, 10 parts of Fructus Ligustri Lucidi, 12 parts of Herba Epimedii, 15 parts of Fructus Lycii, 20 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 15 parts of Semen Cuscutae, 15 parts of Os Bovis seu Bubali powder, 25 parts of the Radixs Astragali, 20 parts, Radix Glycyrrhizae.
(4) 12 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 12 parts of Rhizoma Chuanxiongs, 10 parts of the Radix Paeoniae Albas, 5 parts of Radix Polygoni Multiflori, 16 parts of the Radixs Angelicae Dahuricae, 13 parts of Radix Angelicae Sinensis, 13 parts of Radix Codonopsis, 6 parts of Herb Gynostemmae Pentaphylli, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 10 parts, Poria, 8 parts, Radix Rehmanniae Preparata, 16 parts of Radix Puerariaes, 6 parts of Herba Asaris, 10 parts of Herba Menthaes, 5 parts of Herba Xanthiis, 8 parts of Fructus Ligustri Lucidi, 7 parts of Herba Epimedii, 12 parts of Fructus Lycii, 14 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 5 parts of Semen Cuscutae, 15 parts of Os Bovis seu Bubali powder, 15 parts of the Radixs Astragali, 17 parts, Radix Glycyrrhizae.
In order to express better Chinese medicine composition of the present invention, Chinese medicine composition of the present invention can be prepared into conventional clinically dosage form, such as preparations such as powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsules, described pharmaceutical preparation all can prepare according to Chinese medicine preparation preparation method well-known to those skilled in the art.Preferably, Chinese medicine composition of the present invention is prepared into powder, water preparation, tablet or capsule according to conventional preparation technology.
The present invention also provides a kind of preparation method of Chinese medicine composition described above, it mainly comprises following step: get above-mentioned recipe quantity Chinese crude drug and be broken into coarse powder, according to 4～9 times of coarse powder gross weight, adding volumetric concentration is 40%～95% alcoholic solution, reflux, extract, three times, return time is 2～5h, filters, filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method, as tablet, capsule etc.
The present invention also asks for protection the purposes of above-mentioned Chinese medicine composition in preparation treatment postmenopausal osteoporosis medicine.Pharmaceutical composition of the present invention is when treatment postmenopausal osteoporosis, and demonstrating remarkable anti-inflammatory and analgesic effect also can significantly increase the activity of bone density.Drug effect embodiment 7 of the present invention shows, give positive drug and Chinese medicine composition of the present invention all can be obtained significant antiphlogistic effects, wherein the antiphlogistic effects of Chinese medicine composition high dose group of the present invention and positive controls have utmost point significant difference, Chinese medicine composition low dose group and positive controls have significant difference, and this shows that the high dose group of Chinese medicine composition of the present invention and the antiphlogistic effects of low dose group will significantly be better than positive controls.Drug effect embodiment 8 mices of the present invention lick foot response latency time showing, with model group comparison, after administration after 1h and 2h, all be greater than model group the incubation period that the mice of each administration group of Chinese medicine composition of the present invention is added foot reaction, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).Illustrate that Chinese medicine composition of the present invention can extend adding the sufficient response latency that mice stimulates hot plate, has certain analgesic activity.Under same experiment condition, positive control drug cydiodine group (
p< 0.05) and Huanglianshangqing Tablet group (1h,
p< 0.05; 2h,
p< 0.01) also extended the incubation period that mice is added foot reaction, there is certain analgesic activity, but its analgesic effect and model group there was no significant difference.The embodiment of the present invention 9 shows, relatively, the BMD value of left tibia, right tibia, lower neck bone and lumbar vertebra all has significant difference for model group and blank group, shows that the bone mineral content that retinoic acid causes osteoporosis rat obviously declines.With model group comparison, each organizes the rat bone mineral content that all can raise bone strengthening Capsules group and Chinese medicine composition of the present invention.Wherein low, high, the middle dosage group of Chinese medicine composition of the present invention and model group comparison, significantly improved the BMD value of model mouse left tibia, right tibia, lower neck bone and lumbar vertebra, the Chinese medicine composition of the present invention that shows doses can obviously increase the bone mineral content content that retinoic acid causes osteoporosis model, and high, middle dosage group is compared the difference with significance to the bone mineral content content of osteoporosis model with bone strengthening Capsules group.
In a word, Chinese medicine composition of the present invention, aspect treatment postmenopausal osteoporosis, compared with prior art has following advantage:
1) compare with current chemotherapeutic agent, 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 improved the compliance of postmenopausal osteoporotic patients, and improved patient's quality of life.
2) in Chinese medicine composition of the present invention, contain multi-medicament component, action target spot is numerous, pharmacological evaluation shows that it has significant blood circulation promoting and blood stasis dispelling, anti-inflammatory and antalgic, rising bone density isoreactivity, the morbidity root that has effectively solved postmenopausal osteoporosis, its therapeutic effect to postmenopausal osteoporosis has played the effect for the treatment of both the principal and secondary aspects of a disease.
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, through repeatedly testing, obtain, therefore the postmenopausal osteoporosis that this medicine causes a variety of causes has unique curative effect, this medical instrument has compatibility science, curative effect is rapid, instant effect, short treating period, the advantage that cure rate is high, expense is little.
The specific embodiment
By specific embodiment, further describe the present invention below, 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
Write out a prescription composed as follows: 8 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 5 parts of Rhizoma Chuanxiongs, 5 parts of the Radix Paeoniae Albas, 3 parts of Radix Polygoni Multiflori, 10 parts of the Radixs Angelicae Dahuricae, 5 parts of Radix Angelicae Sinensis, 10 parts of Radix Codonopsis, 3 parts of Herb Gynostemmae Pentaphylli, 10 parts of Radix Et Caulis Acanthopanacis Senticosis, 5 parts of Radix Salviae Miltiorrhizaes, 8 parts, Poria, 5 parts, Radix Rehmanniae Preparata, 10 parts of Radix Puerariaes, 3 parts of Herba Asaris, 5 parts of Herba Menthaes, 3 parts of Herba Xanthiis, 3 parts of Fructus Ligustri Lucidi, 5 parts of Herba Epimedii, 10 parts of Fructus Lycii, 10 parts of Fructus Corni, 3 parts of Radix Saposhnikoviaes, 5 parts of Semen Cuscutae, 5 parts of Os Bovis seu Bubali powder, 5 parts of the Radixs Astragali, 10 parts, Radix Glycyrrhizae.
Preparation method: get above-mentioned recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 4 times of coarse powder gross weight is 40% alcoholic solution, reflux, extract, three times, return time is 5h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet or capsule.
embodiment 2 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: 20 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 15 parts of Rhizoma Chuanxiongs, 15 parts of the Radix Paeoniae Albas, 10 parts of Radix Polygoni Multiflori, 25 parts of the Radixs Angelicae Dahuricae, 15 parts of Radix Angelicae Sinensis, 20 parts of Radix Codonopsis, 10 parts of Herb Gynostemmae Pentaphylli, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 15 parts of Radix Salviae Miltiorrhizaes, 20 parts, Poria, 12 parts, Radix Rehmanniae Preparata, 20 parts of Radix Puerariaes, 10 parts of Herba Asaris, 15 parts of Herba Menthaes, 10 parts of Herba Xanthiis, 10 parts of Fructus Ligustri Lucidi, 12 parts of Herba Epimedii, 15 parts of Fructus Lycii, 20 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 15 parts of Semen Cuscutae, 15 parts of Os Bovis seu Bubali powder, 25 parts of the Radixs Astragali, 20 parts, Radix Glycyrrhizae.
Preparation method: get above-mentioned recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 90% alcoholic solution, reflux, extract, three times, return time is 3h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet or capsule.
embodiment 3 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: 15 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 10 parts of Rhizoma Chuanxiongs, 10 parts of the Radix Paeoniae Albas, 7 parts of Radix Polygoni Multiflori, 18 parts of the Radixs Angelicae Dahuricae, 10 parts of Radix Angelicae Sinensis, 15 parts of Radix Codonopsis, 7 parts of Herb Gynostemmae Pentaphylli, 15 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 14 parts, Poria, 9 parts, Radix Rehmanniae Preparata, 15 parts of Radix Puerariaes, 7 parts of Herba Asaris, 10 parts of Herba Menthaes, 7 parts of Herba Xanthiis, 6 parts of Fructus Ligustri Lucidi, 8 parts of Herba Epimedii, 13 parts of Fructus Lycii, 15 parts of Fructus Corni, 7 parts of Radix Saposhnikoviaes, 10 parts of Semen Cuscutae, 10 parts of Os Bovis seu Bubali powder, 20 parts of the Radixs Astragali, 15 parts, Radix Glycyrrhizae.
Preparation method: get above-mentioned recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 70% alcoholic solution, reflux, extract, three times, return time is 4h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet or capsule.
embodiment 4 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: 8 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 15 parts of Rhizoma Chuanxiongs, 15 parts of the Radix Paeoniae Albas, 3 parts of Radix Polygoni Multiflori, 25 parts of the Radixs Angelicae Dahuricae, 15 parts of Radix Angelicae Sinensis, 10 parts of Radix Codonopsis, 10 parts of Herb Gynostemmae Pentaphylli, 10 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 16 parts, Poria, 12 parts, Radix Rehmanniae Preparata, 10 parts of Radix Puerariaes, 3 parts of Herba Asaris, 5 parts of Herba Menthaes, 10 parts of Herba Xanthiis, 10 parts of Fructus Ligustri Lucidi, 7 parts of Herba Epimedii, 10 parts of Fructus Lycii, 15 parts of Fructus Corni, 3 parts of Radix Saposhnikoviaes, 10 parts of Semen Cuscutae, 10 parts of Os Bovis seu Bubali powder, 10 parts of the Radixs Astragali, 10 parts, Radix Glycyrrhizae.
Preparation method: get above-mentioned recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 70% alcoholic solution, reflux, extract, three times, return time is 4h, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Adding ethanol is 75%(v/v to containing alcohol amount), standing 24 hours, get supernatant, reclaim ethanol concentrated, add water to 1000ml, stir evenly, packing, flowing steam sterilization 35min, obtains mixture.
embodiment 5 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: 12 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 12 parts of Rhizoma Chuanxiongs, 10 parts of the Radix Paeoniae Albas, 5 parts of Radix Polygoni Multiflori, 16 parts of the Radixs Angelicae Dahuricae, 13 parts of Radix Angelicae Sinensis, 13 parts of Radix Codonopsis, 6 parts of Herb Gynostemmae Pentaphylli, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 10 parts, Poria, 8 parts, Radix Rehmanniae Preparata, 16 parts of Radix Puerariaes, 6 parts of Herba Asaris, 10 parts of Herba Menthaes, 5 parts of Herba Xanthiis, 8 parts of Fructus Ligustri Lucidi, 7 parts of Herba Epimedii, 12 parts of Fructus Lycii, 14 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 5 parts of Semen Cuscutae, 15 parts of Os Bovis seu Bubali powder, 15 parts of the Radixs Astragali, 17 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 4.
embodiment 6 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: 14 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 10 parts of Rhizoma Chuanxiongs, 13 parts of the Radix Paeoniae Albas, 6 parts of Radix Polygoni Multiflori, 20 parts of the Radixs Angelicae Dahuricae, 15 parts of Radix Angelicae Sinensis, 20 parts of Radix Codonopsis, 3 parts of Herb Gynostemmae Pentaphylli, 16 parts of Radix Et Caulis Acanthopanacis Senticosis, 9 parts of Radix Salviae Miltiorrhizaes, 11 parts, Poria, 7 parts, Radix Rehmanniae Preparata, 16 parts of Radix Puerariaes, 7 parts of Herba Asaris, 11 parts of Herba Menthaes, 5 parts of Herba Xanthiis, 10 parts of Fructus Ligustri Lucidi, 12 parts of Herba Epimedii, 15 parts of Fructus Lycii, 16 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 15 parts of Semen Cuscutae, 12 parts of Os Bovis seu Bubali powder, 18 parts of the Radixs Astragali, 17 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 4.
(2) drug effect embodiment 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, that synthetic is also naturally occurring glucocorticoid, hydrocortisone enters after cell, activate cytoplasmic receptor, after allosteric, enter nucleus, be combined with DNA response element, cause inhibition or the induction of genetic transcription, the expression of inflammation associated protein is changed.
, experimental technique:
40 KM mices, male and female half and half, body weight 25-30 gram, by body weight, be divided at random four groups, i.e. dosage group in model control group, compositions high dose group, compositions, compositions low dose group, positive controls, every group 10, each administration group mice gives respectively following medicine:
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 Chinese medicine composition by crude drug amount;
Dosage group in compositions: gavage gives 20 mg/kg embodiment 1 Chinese medicine compositions, and Chinese medicine composition is by crude drug amount;
Compositions low dose group: gavage gives 5 mg/kg embodiment 1 Chinese medicine compositions, and Chinese medicine composition is by crude drug amount;
Each administration group is administered once every day, successive administration 7d.After last administration, get dimethylbenzene 20 μ l, be applied to each mouse right ear.After 30 minutes, get and be respectively subject to reagent 0.03 ml to be evenly applied to respectively mouse right ear, auris dextra is put to death after 3.5 hours to dimethylbenzene, measures and respectively organizes the mice left and right ear method of double differences.Ear method of double differences assay method: place cuts two ears along auricle baseline, lays auricle with 8mm card punch at the same position of left and right ear, weighs, and the ear method of double differences=auris dextra sheet weight-left auricle weight.The ear method of double differences can be used as evaluates antiinflammatory index, and its ear method of double differences is less, and curative effect is better.
, experimental result:
Measure each experimental mice ear method of double differences and evaluate the antiphlogistic effects of each medication group medicine.Measurement result is in Table 1.
Each experimental mice ear method of double differences comparison of table 1
With model control group comparison,
* p< 0.05; With model control group comparison,
* p< 0.01;
With positive controls comparison,
# p< 0.05; With positive controls comparison,
## p< 0.01.
Result demonstration gives positive drug and Chinese medicine composition of the present invention all can be obtained significant antiphlogistic effects, wherein the antiphlogistic effects of Chinese medicine composition high dose group of the present invention and positive controls have utmost point significant difference, Chinese medicine composition low dose group and positive controls have significant difference, and this shows that the high dose group of Chinese medicine composition of the present invention and the antiphlogistic effects of low dose group will significantly be better than positive controls.
the impact of embodiment 8 Chinese medicine composition of the present invention on mice hot-plate analgesia
1 mice hot plate pain model is made
Body weight 20g left and right female mice is placed on hot plate dolorimeter, screen 90 of qualified ♀ mices and (lick metapedes time < 5 s or > 30 s throw aside, for preventing foot, scald, also should establish deadline, be generally 60s), be the threshold of pain index incubation period that the mice of take is added metapedes reaction, get 60 jennies, be divided into 5 groups, 12/group, i.e. model group, bone strengthening Capsules group, Chinese medicine composition of the present invention (making by Chinese medicine composition prescription and preparation technology described in embodiment 1) low dose group, middle dosage group and high dose group.Each group is gastric infusion, and 1 times/day, dosage is as shown in table 2, after successive administration 14d, and the time that after mensuration last medicine, 60 min, 120 min add foot reaction.
2 Chinese medicine compositions of the present invention are on licking the impact of foot response latency in the experiment of mice hot-plate analgesia
Mice licks foot response latency time showing, with model group comparison, after administration after 1h and 2h, be all greater than model group the incubation period that the mice of each administration group of Chinese medicine composition of the present invention is added foot reaction, there is dose-dependence, and be significantly greater than the incubation period of high dose group model group (
p< 0.05).Illustrate that this Chinese medicine composition of the present invention can extend adding the sufficient response latency that mice stimulates hot plate, has certain analgesic activity.Under same experiment condition, positive control bone strengthening Capsules group (
p< 0.05) also extended the incubation period that mice is added foot reaction, there is certain analgesic activity, but its analgesic effect and model group there was no significant difference.The results are shown in Table 2.
Table 2 mice lick foot response latency timetable (
)
Note: with model group comparison, *
p< 0.05, * *
p< 0.01.
the therapeutical effect of embodiment 9 Chinese medicine composition of the present invention to retinoic acid rats with osteoporosis
1, model rat with osteoporosis is made and administration
60 SD female rats, each batch of rat is divided into 6 groups all at random, and 10 every group, each component cage is fed.The 1st group is blank group, gavages a certain amount of distilled water every day; The 2nd group is model group, gavages a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) every day; The 3rd group is bone strengthening Capsules group, gavages a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80mg/kg) and a certain amount of bone strengthening capsule 1% carboxyl methyl cellulose sodium suspension (12 mg/kg) every day; 4th, 5,6 groups are respectively the basic, normal, high dosage group of Chinese medicine composition, gavage the Carboxymethyl cellulose sodium suspension (being equivalent to respectively raw medicinal herbs 5mg/kg, 20 mg/kg, 50 mg/kg) of a certain amount of retinoic acid 1% Carboxymethyl cellulose sodium suspension (80 mg/kg) and Chinese medicine composition every day, gavage continuously after 14 d, by retinoic acid suspension change into continue to gavage after distilled water to 30 d only.
Observation item and method: after last administration 24 h, take body weight, with pentobarbital sodium (30mg/kg), anaesthetize, with the scanning of xR-36 type dynamic filtration dual intensity x line bone density diagnostic apparatus, respectively organize the whole body of rat, measure respectively left and right tibia, the bone density of lower neck bone and lumbar vertebra (bone mineral density BMD).
2, result of the test
Each is organized data and all uses (x ± s) to represent, with SPSS software kit 10.0, carries out t check significance analysis.Chinese medicine composition is as shown in table 3 on the impact on BMD.
The impact of table 3 Chinese medicine composition on the bone density of osteoporosis model
With the comparison of blank group, * * P < 0.01; With model group contrast, #P < 0.05, ##P < 0.01.
Relatively, the BMD of left tibia, right tibia, lower neck bone and lumbar vertebra all has significant difference for model group and blank group, shows that the bone mineral content that retinoic acid causes osteoporosis rat obviously declines.With model group comparison, each organizes the rat bone mineral content that all can raise bone strengthening Capsules group and Chinese medicine composition of the present invention.Wherein low, high, the middle dosage group of Chinese medicine composition of the present invention and model group comparison, significantly improved the BMD of model mouse left tibia, right tibia, lower neck bone and lumbar vertebra, the Chinese medicine composition that shows doses can obviously increase the bone mineral content content that retinoic acid causes osteoporosis model, and high, middle dosage group is compared the difference with significance to the bone mineral content content of osteoporosis model with bone strengthening Capsules group.
the clinical therapeutic efficacy of embodiment 10 Chinese medicine compositions of the present invention
For showing the therapeutic effect of Chinese medicine composition of the present invention to postmenopausal osteoporosis, the inventor is to 200 routine case clinical observations, Osteoporosis 72 examples, the Jun Jing U.S. DPS-L of Luner company type dual intensity X line borne densitometers is measured, bone density (BMD) is lower than two standard deviations of corresponding normal age section peak bone mass, 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 calcium, disorders of phosphorus metabolism, do not have in the past metabolic osteopathy medical history, do not take hormone medicine.All cases all have lumbago and osteoarthrosis pain in various degree, and the course of disease is all within 1 year.According to patient age, sex, bone density, pain degree pairing is divided into 2 groups at random.Treatment group 36 examples, male 18 examples, female's 18 examples, 64 years old mean age; Matched group 36 examples, male 18 examples, female's 18 examples, 67 years old mean age.Between group, there is comparability P>0.05.
Experimental group is used embodiment 3 gained Chinese medicine capsules, and one day twice, each 20mg/kg, took every day sooner or later after meal half an hour.Matched group intramuscular injection calcitonin (Novartis Norvatis produce, 50 IU/ prop up), first week 50 IU1 time/d, later intramuscular injection 50 IU 2 times weekly.All take 30 days as 1 course for the treatment of, after 3 courses for the treatment of, evaluate curative effect for two groups.
Curative effect situation criterion: 1, recovery from illness: clinical symptom disappearance.2, effective: symptom takes an evident turn for the better.3, effective: symptom takes a turn for the better to some extent.4, invalid: symptom, sign are without improvement.
Take after medicine of the present invention, treatment group 26 people cure, and it is effective that cure rate reaches 72.2%, 8 people, and total effective rate reaches 94.5%.Matched group is cured 25 examples, effective 5 examples, and cure rate is 69.4, total effective rate is 83.4%.
Claims (8)
1. a Chinese medicine composition for the treatment of postmenopausal osteoporosis, it is characterized in that being made by the raw material of following weight portion: Rhizoma et radix veratri (Radix Rhizoma Veratri) 8-20 part, Rhizoma Chuanxiong 5-15 part, Radix Paeoniae Alba 5-15 part, Radix Polygoni Multiflori 3-10 part, Radix Angelicae Dahuricae 10-25 part, Radix Angelicae Sinensis 5-15 part, Radix Codonopsis 10-20 part, Herb Gynostemmae Pentaphylli 3-10 part, Radix Et Caulis Acanthopanacis Senticosi 10-20 part, Radix Salviae Miltiorrhizae 5-15 part, Poria 8-20 part, Radix Rehmanniae Preparata 5-12 part, Radix Puerariae 10-20 part, Herba Asari 3-10 part, Herba Menthae 5-15 part, Herba Xanthii 3-10 part, Fructus Ligustri Lucidi 3-10 part, Herba Epimedii 5-12 part, Fructus Lycii 10-15 part, Fructus Corni 10-20 part, Radix Saposhnikoviae 3-10 part, Semen Cuscutae 5-15 part, Os Bovis seu Bubali powder 5-15 part, Radix Astragali 5-25 part, Radix Glycyrrhizae 10-20 part.
2. the Chinese medicine composition for the treatment of postmenopausal osteoporosis as claimed in claim 1, it is characterized in that being made by the raw material of following weight portion: 15 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 10 parts of Rhizoma Chuanxiongs, 10 parts of the Radix Paeoniae Albas, 7 parts of Radix Polygoni Multiflori, 18 parts of the Radixs Angelicae Dahuricae, 10 parts of Radix Angelicae Sinensis, 15 parts of Radix Codonopsis, 7 parts of Herb Gynostemmae Pentaphylli, 15 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 14 parts, Poria, 9 parts, Radix Rehmanniae Preparata, 15 parts of Radix Puerariaes, 7 parts of Herba Asaris, 10 parts of Herba Menthaes, 7 parts of Herba Xanthiis, 6 parts of Fructus Ligustri Lucidi, 8 parts of Herba Epimedii, 13 parts of Fructus Lycii, 15 parts of Fructus Corni, 7 parts of Radix Saposhnikoviaes, 10 parts of Semen Cuscutae, 10 parts of Os Bovis seu Bubali powder, 20 parts of the Radixs Astragali, 15 parts, Radix Glycyrrhizae.
3. the Chinese medicine composition for the treatment of postmenopausal osteoporosis as claimed in claim 1, it is characterized in that being made by the raw material of following weight portion: 8 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 5 parts of Rhizoma Chuanxiongs, 5 parts of the Radix Paeoniae Albas, 3 parts of Radix Polygoni Multiflori, 10 parts of the Radixs Angelicae Dahuricae, 5 parts of Radix Angelicae Sinensis, 10 parts of Radix Codonopsis, 3 parts of Herb Gynostemmae Pentaphylli, 10 parts of Radix Et Caulis Acanthopanacis Senticosis, 5 parts of Radix Salviae Miltiorrhizaes, 8 parts, Poria, 5 parts, Radix Rehmanniae Preparata, 10 parts of Radix Puerariaes, 3 parts of Herba Asaris, 5 parts of Herba Menthaes, 3 parts of Herba Xanthiis, 3 parts of Fructus Ligustri Lucidi, 5 parts of Herba Epimedii, 10 parts of Fructus Lycii, 10 parts of Fructus Corni, 3 parts of Radix Saposhnikoviaes, 5 parts of Semen Cuscutae, 5 parts of Os Bovis seu Bubali powder, 5 parts of the Radixs Astragali, 10 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition for the treatment of postmenopausal osteoporosis as claimed in claim 1, it is characterized in that being made by the raw material of following weight portion: 20 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 15 parts of Rhizoma Chuanxiongs, 15 parts of the Radix Paeoniae Albas, 10 parts of Radix Polygoni Multiflori, 25 parts of the Radixs Angelicae Dahuricae, 15 parts of Radix Angelicae Sinensis, 20 parts of Radix Codonopsis, 10 parts of Herb Gynostemmae Pentaphylli, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 15 parts of Radix Salviae Miltiorrhizaes, 20 parts, Poria, 12 parts, Radix Rehmanniae Preparata, 20 parts of Radix Puerariaes, 10 parts of Herba Asaris, 15 parts of Herba Menthaes, 10 parts of Herba Xanthiis, 10 parts of Fructus Ligustri Lucidi, 12 parts of Herba Epimedii, 15 parts of Fructus Lycii, 20 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 15 parts of Semen Cuscutae, 15 parts of Os Bovis seu Bubali powder, 25 parts of the Radixs Astragali, 20 parts, Radix Glycyrrhizae.
5. the Chinese medicine composition for the treatment of postmenopausal osteoporosis as claimed in claim 1, it is characterized in that being made by the raw material of following weight portion: 12 parts of Rhizoma et radix veratri (Radix Rhizoma Veratri)s, 12 parts of Rhizoma Chuanxiongs, 10 parts of the Radix Paeoniae Albas, 5 parts of Radix Polygoni Multiflori, 16 parts of the Radixs Angelicae Dahuricae, 13 parts of Radix Angelicae Sinensis, 13 parts of Radix Codonopsis, 6 parts of Herb Gynostemmae Pentaphylli, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 10 parts of Radix Salviae Miltiorrhizaes, 10 parts, Poria, 8 parts, Radix Rehmanniae Preparata, 16 parts of Radix Puerariaes, 6 parts of Herba Asaris, 10 parts of Herba Menthaes, 5 parts of Herba Xanthiis, 8 parts of Fructus Ligustri Lucidi, 7 parts of Herba Epimedii, 12 parts of Fructus Lycii, 14 parts of Fructus Corni, 10 parts of Radix Saposhnikoviaes, 5 parts of Semen Cuscutae, 15 parts of Os Bovis seu Bubali powder, 15 parts of the Radixs Astragali, 17 parts, Radix Glycyrrhizae.
6. the Chinese medicine composition of the treatment postmenopausal osteoporosis as described in as arbitrary in claim 1-5, is characterized in that: described Chinese medicine composition is powder, water preparation, tablet or capsule.
7. the preparation method of the Chinese medicine composition for the treatment of postmenopausal osteoporosis as described in as arbitrary in claim 1-5, it is characterized in that comprising the steps: taking by weight traditional Chinese medicinal material raw materials and be broken into coarse powder, according to 4～9 times of coarse powder gross weight, adding volumetric concentration is 40%～95% alcoholic solution, reflux, extract, three times, return time is 2～5h, filters, filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method.
8. the purposes of the Chinese medicine composition of the treatment postmenopausal osteoporosis as described in as arbitrary in claim 1-5 in preparing postmenopausal osteoporosis medicine.
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| CN103751529A (en) * | 2014-02-11 | 2014-04-30 | 王雪雁 | Traditional Chinese medicine composition for treating female postmenopausal osteoporosis and preparation method thereof |
| CN105232634A (en) * | 2015-10-12 | 2016-01-13 | 临沂草之美医药科技有限公司 | Application of pharmaceutical composition for preparing osteoporosis treating drug |
| 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 |
| CN108079185A (en) * | 2017-12-12 | 2018-05-29 | 广东广发制药有限公司 | A kind of Radix Astragali gynostemma pentaphylla dried cream powder, the Chinese medicine preparation and preparation method of anti-osteoporosis |
| DE102018111325A1 (en) * | 2018-05-11 | 2019-11-14 | Shanghai Boling Man Cosmetic CO., LTD | A medicine for the treatment of osteoporosis and a process for its production |
| CN114145456A (en) * | 2021-11-12 | 2022-03-08 | 西北工业大学 | Solid beverage for increasing bone mineral density and preparation method thereof |
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| CN1559589A (en) * | 2004-03-10 | 2005-01-05 | 山东师范大学 | Medicinal liquid for treating osteoporosis and its preparation method |
| CN1895504A (en) * | 2006-06-05 | 2007-01-17 | 辽宁好护士药业（集团）有限责任公司 | Chinese medicine for treating osteoporosis and its preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103751529A (en) * | 2014-02-11 | 2014-04-30 | 王雪雁 | Traditional Chinese medicine composition for treating female postmenopausal osteoporosis and preparation method thereof |
| CN105456711A (en) * | 2014-02-11 | 2016-04-06 | 青岛华之草医药科技有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating postmenopausal osteoporosis |
| CN105232634A (en) * | 2015-10-12 | 2016-01-13 | 临沂草之美医药科技有限公司 | Application of pharmaceutical composition for preparing osteoporosis treating drug |
| 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 |
| CN108079185A (en) * | 2017-12-12 | 2018-05-29 | 广东广发制药有限公司 | A kind of Radix Astragali gynostemma pentaphylla dried cream powder, the Chinese medicine preparation and preparation method of anti-osteoporosis |
| DE102018111325A1 (en) * | 2018-05-11 | 2019-11-14 | Shanghai Boling Man Cosmetic CO., LTD | A medicine for the treatment of osteoporosis and a process for its production |
| CN114145456A (en) * | 2021-11-12 | 2022-03-08 | 西北工业大学 | Solid beverage for increasing bone mineral density and preparation method thereof |
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| CN103550476B (en) | 2015-09-16 |
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