CN105434800A - Traditional Chinese medicine composition for treating geriatric fracture - Google Patents

Traditional Chinese medicine composition for treating geriatric fracture Download PDF

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CN105434800A
CN105434800A CN201511001701.8A CN201511001701A CN105434800A CN 105434800 A CN105434800 A CN 105434800A CN 201511001701 A CN201511001701 A CN 201511001701A CN 105434800 A CN105434800 A CN 105434800A
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chinese medicine
medicine composition
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刘学键
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Qingdao Huazhicao Medical Technology Co Ltd
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Qingdao Huazhicao Medical Technology Co Ltd
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Abstract

The invention discloses a traditional Chinese medicine composition for treating geriatric fracture, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials: folium mori, morinda officinalis, pyritum, chickpea, tinospora sinensis merr, jumble beads, ligusticum wallichii, stephania terandra, fructus schizandrae, allium macrostemon, radix cyathulae and liquorice. The traditional Chinese medicine composition is reasonable in component, simple in preparation technology and available in raw materials; animal and clinical experiments prove that the traditional Chinese medicine composition has a significant curative effect in the aspect of treatment of the geriatric fracture, is small in toxic or side effect, has the efficacies of promoting qi to activate blood, treating muscle and ligament, relaxing tendons, activating collaterals, benefiting qi and nourishing blood, and has an excellent treatment effect on the geriatric fracture.

Description

A kind of Chinese medicine composition for the treatment of senile fracture
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine composition for the treatment of senile fracture.
Background technology
Osteoporosis is the important diseases of a kind of very common serious harm senior health and fitness, and its serious consequence is the deformity and death of fracturing and fracturing caused by infectious-related complication, all brings white elephant to patient home and society.
Age is an important determiner of osteoporosis, and in an investigation in the recent period of the U.S., more than the 80 years old old people being greater than 30% suffers from osteoporosis, 60-64 year crowd in prevalence be 18.5%.In elderly population, weaken due to intestinal absorption ability the calcium deficiency that causes and Primary vitamin D lacks, cause bone mineralization ability to weaken, cause osteomalacia, bone fragility increases; Meanwhile, the shortage of calcium and vitamin D can cause Secondary hyperparathyroidism, thus causes bone amount to reduce, and bone fragility increases; Old people's gonadal hormone and growth hormone secretion reduce, and bone amount also can be caused to reduce.Above factor all makes bone resorption present negative balance, and along with the problem of an aging population is on the rise, urgently we pay attention to and solve the relevant issues of senile osteoporosis.
Current senile fracture incidence rate is also in continuous rising, and the health resources needed for it and the rate produced with fracture, the rising in gerontal patient is also especially obvious.Therefore, in senile osteoporosis crowd, keep bone health and reduce the important goal that fall risk all should be classified as prevention fracture.
The method of current treatment senile fracture, doctor trained in Western medicine generally adopts and is aided with the method for medicine for external use in necessity by after reduction with clamping plate or Gypsum Fibrosum extenal fixation, but patient suffering is large and healing is slow; The traditional Chinese medical science then more takes the Drug therapys such as Cortex torricelliae tiliifoliae, but medicine time is long, takes inconvenience, and curative effect is undesirable.
Because Chinese traditional treatment has abundant medication experience and Chinese medical theory basis, have the feature of dialectical not differential diagnosis of diseases, it often has special effect in treatment senile fracture.The traditional Chinese medical science is thought, due to old people's deficiency of the liver and kindey, muscles and bones is weak, and Whole Body Bone Scanning ilium amount reduces, and sclerotin is obviously loose compared with between twenty and fifty people, and it is slow to repair after bones and muscles injury.Therefore the treatment of senile fracture should based on liver and kidney tonifying, QI and blood regulating, reunion of bone.
Chinese patent application 201110292402.X discloses a kind of Chinese medicine composition for the treatment of senile fracture.Comprise the raw materials of following parts by weight: Radix Dipsaci, parasitism, the Cortex Eucommiae, Pyritum, Radix Notoginseng, Huai Shan, Radix Angelicae Sinensis, Fructus Lycii, SUNGU, Radix Glycyrrhizae, Fructus Psoraleae, Rhizoma Drynariae and Radix Pseudostellariae.But this invention Chinese medicine composition drug treatment time is long, decoct take cause the compliance of patient poor, take inconvenience.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition for the treatment of senile fracture, makes it give full play to the opsonic action of Chinese medicine, has significant therapeutic effect to senile fracture.In addition, the present invention also provides corresponding manufacturing process to be made and facilitate easy-to-use preparation under the prerequisite ensureing curative effect by this Chinese medicine composition.
For realizing object of the present invention, technical scheme of the present invention is: a kind of Chinese medicine composition for the treatment of senile fracture, and it is prepared from by the raw material of following parts by weight: Folium Mori 15-25 part, Radix Morindae Officinalis 9-15 part, Pyritum 8-12 part, chickpea 8-12 part, steathily muscle grass 6-10 part, Semen Phaseoli 3-9 part, Rhizoma Chuanxiong 3-9 part, Radix Stephaniae Tetrandrae 6-10 part, Fructus Schisandrae Chinensis 3-8 part, Bulbus Allii Macrostemonis 2-6 part, Radix Cyathulae 3-9 part and Radix Glycyrrhizae 1-10 part.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight: 15 parts, Folium Mori, Radix Morindae Officinalis 9 parts, Pyritum 8 parts, chickpea 8 parts, steathily muscle grass 6 parts, 3 parts, Semen Phaseoli, Rhizoma Chuanxiong 3 parts, Radix Stephaniae Tetrandrae 6 parts, Fructus Schisandrae Chinensis 3 parts, Bulbus Allii Macrostemonis 2 parts, Radix Cyathulae 3 parts and 1 part, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight: 20 parts, Folium Mori, Radix Morindae Officinalis 12 parts, Pyritum 10 parts, chickpea 10 parts, steathily muscle grass 8 parts, 6 parts, Semen Phaseoli, Rhizoma Chuanxiong 6 parts, Radix Stephaniae Tetrandrae 8 parts, Fructus Schisandrae Chinensis 6 parts, Bulbus Allii Macrostemonis 4 parts, Radix Cyathulae 6 parts and 5 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight: 25 parts, Folium Mori, Radix Morindae Officinalis 15 parts, Pyritum 12 parts, chickpea 12 parts, steathily muscle grass 10 parts, 9 parts, Semen Phaseoli, Rhizoma Chuanxiong 9 parts, Radix Stephaniae Tetrandrae 10 parts, Fructus Schisandrae Chinensis 8 parts, Bulbus Allii Macrostemonis 6 parts, Radix Cyathulae 9 parts and 10 parts, Radix Glycyrrhizae.
Correspondingly, present invention also offers a kind of preparation method of Chinese medicine composition of described treatment senile fracture, comprise the following steps:
(1): get Folium Mori, impurity is washed away, 50 DEG C of hot air dryings 5 hours, control moisture is 3-8%, pulverizes, and crosses 40-60 mesh sieve, obtain coarse powder, coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, micronizing is carried out respectively after drying, cross 800 mesh sieves, obtain Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Radix Morindae Officinalis, Pyritum, chickpea, steal muscle grass, Semen Phaseoli, Rhizoma Chuanxiong, Radix Stephaniae Tetrandrae, Fructus Schisandrae Chinensis, Bulbus Allii Macrostemonis, Radix Cyathulae and Radix Glycyrrhizae, add the distilled water immersion 3-6 hour of medical material total amount 3-7 times weight, boil 1-3 hour, filter, obtain filtrate and filtering residue, in filtering residue, add the purified water of initial medical material 3-5 times weight, boil 1-2 hour, filter and obtain filtrate and preserve filtering residue, merge twice filtrate, concentrated, obtaining detecting relative density at 65 DEG C is the extractum A of 1.10-1.25, for subsequent use;
(3): the ethanol adding the concentration 65-75% of 3-7 times of weight in the filtering residue of (2), reflux, extract, 1-2 time, each 3-5 hour, filters, merging filtrate, and distilling under reduced pressure removing ethanol is also concentrated, obtains the extractum B that 65 DEG C of relative densities are 1.10-1.25, for subsequent use;
(4): described extractum A mixed homogeneously with described extractum B, drying under reduced pressure, pulverizes, and crosses 100-200 mesh sieve, mixes with Ultra-fine Powder of Mulberry Leaves, adds adjuvant, utilizes modern general Chinese medicine preparation technology to make the finished product preparation of clinical needs.
Preferably, described Chinese medicine composition is made into tablet, capsule or powder.
Source, the nature and flavor of Chinese prescription of the present invention Chinese crude drug used, return through and effect:
Folium Mori: this product is the dried leaves of moraceae plants Mulberry; Nature and flavor are sweet, bitter, cold; Return lung, Liver Channel; Dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, liver heat removing and eyesight improving.
Radix Morindae Officinalis: this product is the dry root of Maguireothamnus speciosus Radix Morindae Officinalis; Sweet in the mouth, pungent, tepor; Return kidney, Liver Channel; Kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.
Pyritum: this product is sulfide-based mineral yellow iron mine race pyrite; Acrid in the mouth, property is put down; Return Liver Channel; Dissipating blood stasis, synthetism, pain relieving.
Chickpea: this product is the dry mature seed of chickpea platymiscium chickpea; Sweet in the mouth, property is put down; Return spleen, stomach warp; Invigorating the spleen and replenishing QI, the real intestinal of arresting seminal emission.
Steal muscle grass: this product is that Primulaceae steals muscle grass; Acrid in the mouth, slightly warm in nature; Promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain.
Semen Phaseoli: this product is the seed of leguminous plant Ormosia hosiei; Bitter in the mouth, property is put down; GUIXIN, small intestine meridian; Regulate the flow of vital energy, stimulate the menstrual flow.
Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong; Acrid in the mouth, warm in nature; Return liver, gallbladder, pericardium channel; Blood-activating and qi-promoting, wind-expelling pain-stopping.
Radix Stephaniae Tetrandrae: this product is the dry root of aristolochiaceae plant Radix Aristolochiae Fangchi; Bitter in the mouth, pungent, cold in nature; Return bladder, lung meridian; Wind-expelling pain-stopping, clearing away heat and promoting diuresis.
Fructus Schisandrae Chinensis: this product is the dry mature fruit of magnoliaceae schisandra or schisandra chinensis; Its sour in the mouth, sweet, warm in nature; Return lung, the heart, kidney channel; Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.
Bulbus Allii Macrostemonis: this product is the dry bulb of liliaceous plant Allium macrostemon or Chinese onion; Acrid in the mouth, hardship, warm in nature; Return lung, stomach, large intestine channel; Activating YANG and eliminating stagnation, circulation of qi promoting intestinal stasis relieving.
Radix Cyathulae: this product is the dry root of amaranthaceous plant Radix Cyathulae; Sweet in the mouth, micro-hardship, property is put down; Return liver, kidney channel; Eliminating blood stasis and inducing menstruation, easing joint movement, inducing diuresis for treating stranguria syndrome.
Radix Glycyrrhizae: this product is glycyrrhizic legume dry root; Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The compatibility analysis of Chinese medicine composition of the present invention: Chinese medicine composition prescription of the present invention to the dialectical cognition of senile fracture according to Chinese medicine rationale, is followed the compatibility theory of Chinese medicine, enhanced the use amount of medical material.This prescription is with Folium Mori and Radix Morindae Officinalis for monarch drug, promoting blood circulation to remove blood stasis, wind-expelling pain-stopping, kidney-replenishing, bone and muscle strengthening; With Pyritum, chickpea, steal muscle grass, Semen Phaseoli, Rhizoma Chuanxiong and Radix Stephaniae Tetrandrae for ministerial drug, detumescence and promoting granulation, removing blood stasis circulation of qi promoting, analgesia of calming the nerves, regulating the flow of QI to promote menstrual discharge; With Radix Stephaniae Tetrandrae, Fructus Schisandrae Chinensis, Bulbus Allii Macrostemonis and Radix Cyathulae for adjuvant drug, strengthening the tendons and bones, eliminating blood stasis and inducing menstruation, easing joint movement, supplementing QI for promoting the production of body fluid; With Radix Glycyrrhizae for making medicine, invigorating the spleen and replenishing QI, relieving spasm to stop pain, the coordinating the actions of various ingredients in a prescription property of medicine.All medicines coordinate, and complement each other, synergism, play network blood muscle alive altogether, removing stasis to stop bleeding, promoting blood circulation and stopping pain, removing toxic substances and promoting subsidence of swelling, the effects such as supplementing QI for promoting the production of body fluid, have very significant curative effect to treatment senile fracture.
Compared with prior art, Chinese medicine of the present invention has following advantage:
1, compared with the chemotherapeutic agent of Current therapeutic senile fracture, Chinese medicine composition of the present invention is made up of pure natural Chinese herbal medicine, all medicines work in coordination with, significantly reduce untoward reaction and toxic and side effects, have good effect, treating both the principal and secondary aspects of a disease, stress nurse one's health treatment advantage;
2, compared with positive control drug Gaierqi D (vitamin D3 and calcium carbonate), the effect of pharmaceutical composition of the present invention is more remarkable, this shows that Chinese medicine composition of the present invention has significant synergism in senile fracture treatment, significantly can not only improve the symptom of cervical spondylosis, the development of fracturing can also be delayed, reduce the generation of complication.
3, simple and easy to do, the efficacy stability of pharmaceutical composition preparation technology of the present invention, be easy to apply.
Therefore, the present invention's also application of claimed aforementioned pharmaceutical compositions in the medicine of preparation treatment senile fracture.
Detailed description of the invention
Below will the present invention is described further by specific embodiment, it will be understood by those skilled in the art that the present invention also can make other similar changes and obtains similar result and do not depart from content of the present invention and scope except following examples.
embodiment 1
The embodiment of the present invention 1 Chinese medicine composition is prepared from by the raw material of following parts by weight: 15 parts, Folium Mori, Radix Morindae Officinalis 9 parts, Pyritum 8 parts, chickpea 8 parts, steathily muscle grass 6 parts, 3 parts, Semen Phaseoli, Rhizoma Chuanxiong 3 parts, Radix Stephaniae Tetrandrae 6 parts, Fructus Schisandrae Chinensis 3 parts, Bulbus Allii Macrostemonis 2 parts, Radix Cyathulae 3 parts and 1 part, Radix Glycyrrhizae.
Preparation method:
(1): get Folium Mori, impurity is washed away, 50 DEG C of hot air dryings 5 hours, controlling moisture is 3%, pulverizes, and crosses 40 mesh sieves, obtain coarse powder, coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, micronizing is carried out respectively after drying, cross 800 mesh sieves, obtain Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Radix Morindae Officinalis, Pyritum, chickpea, steal muscle grass, Semen Phaseoli, Rhizoma Chuanxiong, Radix Stephaniae Tetrandrae, Fructus Schisandrae Chinensis, Bulbus Allii Macrostemonis, Radix Cyathulae and Radix Glycyrrhizae, add the distilled water immersion 3 hours of medical material total amount 3 times of weight, boil 1 hour, filter, obtain filtrate and filtering residue, in filtering residue, add the purified water of initial medical material 3 times of weight, boil 1 hour, filtration obtains filtrate and preserves filtering residue, merges twice filtrate, concentrated, obtaining detecting relative density at 65 DEG C is the extractum A of 1.10, for subsequent use;
(3): the ethanol adding the concentration 65% of 3 times of weight in the filtering residue of (2), reflux, extract, 1 time, each 3 hours, filters, merging filtrate, and distilling under reduced pressure removing ethanol is also concentrated, obtains the extractum B that 65 DEG C of relative densities are 1.10, for subsequent use;
(4): described extractum A mixed homogeneously with described extractum B, drying under reduced pressure, pulverizes, and crosses 100 mesh sieves, mixes with Ultra-fine Powder of Mulberry Leaves, adds adjuvant, utilizes modern general Chinese medicine preparation technology to make the tablet of clinical needs.
embodiment 2
The embodiment of the present invention 2 Chinese medicine composition is prepared from by the raw material of following parts by weight: 20 parts, Folium Mori, Radix Morindae Officinalis 12 parts, Pyritum 10 parts, chickpea 10 parts, steathily muscle grass 8 parts, 6 parts, Semen Phaseoli, Rhizoma Chuanxiong 6 parts, Radix Stephaniae Tetrandrae 8 parts, Fructus Schisandrae Chinensis 6 parts, Bulbus Allii Macrostemonis 4 parts, Radix Cyathulae 6 parts and 5 parts, Radix Glycyrrhizae.
Preparation method is as follows:
(1): get Folium Mori, impurity is washed away, 50 DEG C of hot air dryings 5 hours, controlling moisture is 6%, pulverizes, and crosses 50 mesh sieves, obtain coarse powder, coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, micronizing is carried out respectively after drying, cross 800 mesh sieves, obtain Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Radix Morindae Officinalis, Pyritum, chickpea, steal muscle grass, Semen Phaseoli, Rhizoma Chuanxiong, Radix Stephaniae Tetrandrae, Fructus Schisandrae Chinensis, Bulbus Allii Macrostemonis, Radix Cyathulae and Radix Glycyrrhizae, add the distilled water immersion 5 hours of medical material total amount 5 times of weight, boil 2 hours, filter, obtain filtrate and filtering residue, in filtering residue, add the purified water of initial medical material 4 times of weight, boil 1.5 hours, filter and obtain filtrate and preserve filtering residue, merge twice filtrate, concentrated, obtaining detecting relative density at 65 DEG C is the extractum A of 1.20, for subsequent use;
(3): the ethanol adding the concentration 75% of 5 times of weight in the filtering residue of (2), reflux, extract, 1 time, each 4 hours, filters, merging filtrate, and distilling under reduced pressure removing ethanol is also concentrated, obtains the extractum B that 65 DEG C of relative densities are 1.20, for subsequent use;
(4): described extractum A mixed homogeneously with described extractum B, drying under reduced pressure, pulverizes, and crosses 150 mesh sieves, mixes with Ultra-fine Powder of Mulberry Leaves, adds adjuvant, utilizes modern general Chinese medicine preparation technology to make the tablet of clinical needs.
embodiment 3
The embodiment of the present invention 3 Chinese medicine composition is prepared from by the raw material of following parts by weight: 25 parts, Folium Mori, Radix Morindae Officinalis 15 parts, Pyritum 12 parts, chickpea 12 parts, steathily muscle grass 10 parts, 9 parts, Semen Phaseoli, Rhizoma Chuanxiong 9 parts, Radix Stephaniae Tetrandrae 10 parts, Fructus Schisandrae Chinensis 8 parts, Bulbus Allii Macrostemonis 6 parts, Radix Cyathulae 9 parts and 10 parts, Radix Glycyrrhizae.
Preparation method is as follows:
(1): get Folium Mori, impurity is washed away, 50 DEG C of hot air dryings 5 hours, controlling moisture is 8%, pulverizes, and crosses 60 mesh sieves, obtain coarse powder, coarse powder is sucked air-stream type ultrafine pulverizer and carry out micronizing, pulverize pressure 0.5MPa, charging rate is 30mg/s, micronizing is carried out respectively after drying, cross 800 mesh sieves, obtain Ultra-fine Powder of Mulberry Leaves, for subsequent use;
(2): get Radix Morindae Officinalis, Pyritum, chickpea, steal muscle grass, Semen Phaseoli, Rhizoma Chuanxiong, Radix Stephaniae Tetrandrae, Fructus Schisandrae Chinensis, Bulbus Allii Macrostemonis, Radix Cyathulae and Radix Glycyrrhizae, add the distilled water immersion 6 hours of medical material total amount 7 times of weight, boil 3 hours, filter, obtain filtrate and filtering residue, in filtering residue, add the purified water of initial medical material 5 times of weight, boil 2 hours, filter and obtain filtrate and preserve filtering residue, merge twice filtrate, concentrated, obtaining detecting relative density at 65 DEG C is the extractum A of 1.25, for subsequent use;
(3): the ethanol adding the concentration 75% of 7 times of weight in the filtering residue of (2), reflux, extract, 2 times, each 5 hours, filters, merging filtrate, and distilling under reduced pressure removing ethanol is also concentrated, obtains the extractum B that 65 DEG C of relative densities are 1.25, for subsequent use;
(4): described extractum A mixed homogeneously with described extractum B, drying under reduced pressure, pulverizes, and crosses 200 mesh sieves, mixes with Ultra-fine Powder of Mulberry Leaves, adds adjuvant, utilizes modern general Chinese medicine preparation technology to make the powder of clinical needs.
chinese medicine composition pharmacodynamic study of the present invention
chinese medicine composition of the present invention is on the impact of osteoporosis type mice
1, experiment purpose:
According to the requirement of " new Chinese medicine pharmaceutical research guide ", study the Pharmacodynamics of traditional Chinese medicine composition for treating senile fracture of the present invention.
2, modeling and grouping administration is tested:
SAMP6 Mus Senescence-Accelerated Mouse (Senescenceacceleratedmouse, SAM) osteoporosis type, SAMP6(is called for short P6) mice is current only a kind of laboratory animal that can prove to increase rheological properties bone fragility fractures, is the more practical animal model of research senile osteoporosis.The ordinary life of rat is 2.5-3, and the rat of general use more than 1.5 years old is as aged rat model.P6 reaches Peak Bone Mass when 4 monthly age, and later bone amount is lost gradually, bone strength reduce, hardness strengthen, non-deformability and bone strength poor.The pathological manifestations of these features and the low bone density of senile osteoporosis patient, low bone strength is closely similar.
Getting the age is 1.6-2.0 year, body weight is the SAMP6 rat 80 of 150-180g, male and female half and half, be divided into 8 groups of 10/groups at random, be respectively: blank group, positive drug control group (Caltrate D tablet 1.0g/kg, the accurate word H10950029 of traditional Chinese medicines, Wyeth pharmaceuticals), it is high that the embodiment of the present invention 1 prepares tablet, in, low dose group, high dose group (1.2g/kg), middle dosage group (0.6g/kg) and low dose group (0.3g/kg), it is high that the embodiment of the present invention 2 prepares tablet, in, low dose group, high dose group (1.2g/kg), middle dosage group (0.6g/kg) and low dose group (0.3g/kg).The equal-volume normal saline process of blank group, all the other are respectively organized rat and use corresponding Drug therapy respectively.The medication of 8 groups of SAMP6 rats is a course for the treatment of 2 Mondays, totally 3 courses for the treatment of.After Drug therapy, detect the bone density of each group of mice.
3, experimental result is as table 1:
Table 1 Chinese medicine composition of the present invention is on the impact of osteoporosis type mice
Note: compared with blank group, * p<0.05, * * p<0.01, compared with positive controls, #p<0.05, ##p<0.01.
Table 1 result shows, SAMP6 rat is subject to after drug administration treatment, the embodiment of the present invention 1, embodiment 2 high dose group, middle dosage group and positive drug control group rat bone density all have and significantly increase, compared with positive controls, the embodiment of the present invention 1, embodiment 2 high dose group, middle dosage group all have significant change, and this shows that Chinese medicine composition of the present invention has good therapeutic effect to senile osteoporosis.
chinese medicine composition of the present invention is to the clinical observation on the therapeutic effect of senile fracture clinical volunteers patient
1, experiment purpose:
Pass through clinical research, evaluate the impact of Chinese medicine composition of the present invention on the change of the indexs such as senile fracture patients symptomatic, sign, estrogen, testosterone levels, bone density, hemorheology, serum calcium, serum paraoxonase, serum alkaline phosphatase, blood parathyroid hormone and calcitonin, and evaluate its Clinical efficacy and safety, for clinical practice provides objective basis.
2, basic document:
Choose senile fracture patient clinical volunteer 200 example of the 2-8 month in 2015 at Guangdong Province overseas Chinese hospital admission, basic age 40-85 year between, the mean age is 62 years old; Confirm to fracture through CT and X-ray, random point 4 groups, embodiment 1 group, embodiment 2 groups, embodiment 3 groups and matched group, often organize 50 people respectively, each group at age, sex, coincident with severity degree of condition without too big-difference, there is comparability.
3, Therapeutic Method:
Embodiment 1 group: take tablet prepared by embodiment 1, each 2 (containing crude drug amount 350mg/ gram), 2 times on the one 14 days is a course for the treatment of, takes 3 courses for the treatment of continuously;
Embodiment 2 groups: take tablet prepared by embodiment 2, each 2 (containing crude drug amount 350mg/ gram), 2 times on the one 14 days is a course for the treatment of, takes 3 courses for the treatment of continuously;
Embodiment 3 groups: take powder prepared by embodiment 3, each 3g(is containing crude drug amount 350mg/ gram), 2 times on the one 14 days is a course for the treatment of, takes 3 courses for the treatment of continuously;
Matched group: take Caltrate D tablet (the accurate word H10950029 of traditional Chinese medicines, Wyeth pharmaceuticals), each 3, every day 1 time 14 days is a course for the treatment of, takes 3 courses for the treatment of continuously;
4, health giving quality observation index:
(l) cardinal symptom: observe lumbar vertebrae pain or the migrans pain of whole body, aching and limp weak, can not be prudent, have a dizzy spell, Hiccough and deaf etc.;
(2) clinical dependent body seek peace tongue arteries and veins change;
(3) physico-chemical examination: estrogen, testosterone levels, bone density, serum calcium, serum paraoxonase, serum alkaline phosphatase, blood parathyroid hormone and calcitonin etc. before and after treatment.
5, criterion of therapeutical effect:
Draft with reference to related content in " the new Chinese medicine guideline of clinical investigations " of Zheng Xiaoying chief editor.Senile osteoporosis curative effect determinate standard:
Effective: pain relief more than 4 grades, or have at least 2 risings in the lab index such as blood calcium, serum alkaline phosphatase, blood PTH, calcitonin, estrogen, urine calcium, urine calcium/flesh join at least 1 reductions, or bone density inspection display bone density increase;
Effective: pain obviously alleviates more than 2 grades, or lab index has no significant change, or bone density inspection has no bone density decline;
Invalid: to compare with before treatment, pain is without improvement, or at least 2 declines in the lab index such as blood calcium, serum alkaline phosphatase, blood PTH, calcitonin, estrogen, urine calcium, liquor-saturated at least 1 risings of urine calcium/flesh, or bone density inspection points out bone density still to decline.
6, statistical method:
(1) employing SPSS17.O statistical analysis software calculates by statistical analysis,
(2) all statistical test all adopt two-sided test, and P<0.05 has statistical significance by being considered to checked difference,
(3) employing x scholar SD is carried out statistics description by different treatment group measurement data.Adopt difference before and after in paired t-test comparable group, independent samples t-test compares group difference.Before and after two groups of treatments, change adopts variance analysis (ANOVA) and Wileoxon rank test to compare,
(4) enumeration data that different treatment group is gone to a doctor for each time adopts frequency (constituent ratio) to carry out statistics and describes.
Therapeutic effect is as shown in table 2:
Table 2 clinical therapeutic efficacy
As seen from the above table, embodiment of the present invention 1-3 group total effective rate is all more than 90%, and far away higher than matched group, embodiment 2 groups is particularly remarkable, and as can be seen here, Chinese medicine composition of the present invention has significant effect in treatment senile osteoporosis.
(1) comparison for the treatment of front and back bone density
The comparison (X scholar SD) of bone density value before and after patient treatment respectively organized by table 3
Note: compared with before treatment, * p<0.05, * * p<0.01, compared with positive controls, #p<0.05, ##p<0.01.
As can be seen from Table 3, after treatment, embodiment 1-3 group bone density value all significantly raises and is obviously better than matched group, and embodiment 2 groups is particularly remarkable.
(2) comparison for the treatment of front and back estradiol, testosterone:
The comparison of estradiol, testosterone before and after patient treatment respectively organized by table 4
Note: compared with before treatment, * p<0.05, * * p<0.01, compared with positive controls, #p<0.05, ##p<0.01.
As can be seen from Table 4, after the treatment of embodiment of the present invention 1-3 group, estradiol, testosterone levels are all significantly increased before comparatively treating, and apparently higher than matched group, embodiment 2 groups is particularly remarkable.
(3) comparison for the treatment of front and back serum calcium, phosphorus:
The comparison of serum calcium before and after patient treatment respectively organized by table 5
Note: compared with before treatment, * p<0.05, * * p<0.01, compared with positive controls, #p<0.05, ##p<0.01.
As can be seen from Table 5, before and after the treatment of embodiment of the present invention 1-3 group, blood calcium and serium inorganic phosphorus compare, there is statistical significance (P<0.01), before and after treatment of control group, blood calcium and serium inorganic phosphorus more also have statistical significance (P<0.01), and before and after the treatment of embodiment of the present invention 1-3 group, blood calcium and serium inorganic phosphorus have statistical significance (P<0.05) compared with matched group.
7, untoward reaction: Chinese medicine composition of the present invention is during clinical treatment, and each patient is showed no untoward reaction.After treatment, patient's mental status is good, functional rehabilitation.
8, conclusion: in this clinical observation case 200 people, can find out from total effective rate, the total effective rate of Chinese medicine composition of the present invention reaches 94%, far above matched group total effective rate (76%), particularly the therapeutic effect of embodiment 2 groups is best, and has no untoward reaction during clinical treatment.By indexs such as estrogen, testosterone levels, bone density, serum calcium, serum paraoxonase, serum alkaline phosphatase, blood parathyroid hormone and calcitonins before and after physico-chemical examination treatment, all illustrate that Chinese medicine composition of the present invention has the advantage of its uniqueness in treatment senile fracture, safe and effective, have clinical generalization value.

Claims (5)

1. treat the Chinese medicine composition of senile fracture for one kind, it is characterized in that, described Chinese medicine composition is prepared from by the raw material of following parts by weight: Folium Mori 15-25 part, Radix Morindae Officinalis 9-15 part, Pyritum 8-12 part, chickpea 8-12 part, steathily muscle grass 6-10 part, Semen Phaseoli 3-9 part, Rhizoma Chuanxiong 3-9 part, Radix Stephaniae Tetrandrae 6-10 part, Fructus Schisandrae Chinensis 3-8 part, Bulbus Allii Macrostemonis 2-6 part, Radix Cyathulae 3-9 part and Radix Glycyrrhizae 1-10 part.
2. the Chinese medicine composition for the treatment of senile fracture according to claim 1, it is characterized in that, described Chinese medicine composition is prepared from by the raw material of following parts by weight: 15 parts, Folium Mori, Radix Morindae Officinalis 9 parts, Pyritum 8 parts, chickpea 8 parts, steathily muscle grass 6 parts, 3 parts, Semen Phaseoli, Rhizoma Chuanxiong 3 parts, Radix Stephaniae Tetrandrae 6 parts, Fructus Schisandrae Chinensis 3 parts, Bulbus Allii Macrostemonis 2 parts, Radix Cyathulae 3 parts and 1 part, Radix Glycyrrhizae.
3. the Chinese medicine composition for the treatment of senile fracture according to claim 1, it is characterized in that, described Chinese medicine composition is prepared from by the raw material of following parts by weight: 20 parts, Folium Mori, Radix Morindae Officinalis 12 parts, Pyritum 10 parts, chickpea 10 parts, steathily muscle grass 8 parts, 6 parts, Semen Phaseoli, Rhizoma Chuanxiong 6 parts, Radix Stephaniae Tetrandrae 8 parts, Fructus Schisandrae Chinensis 6 parts, Bulbus Allii Macrostemonis 4 parts, Radix Cyathulae 6 parts and 5 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition for the treatment of senile fracture according to claim 1, it is characterized in that, described Chinese medicine composition is prepared from by the raw material of following parts by weight: 25 parts, Folium Mori, Radix Morindae Officinalis 15 parts, Pyritum 12 parts, chickpea 12 parts, steathily muscle grass 10 parts, 9 parts, Semen Phaseoli, Rhizoma Chuanxiong 9 parts, Radix Stephaniae Tetrandrae 10 parts, Fructus Schisandrae Chinensis 8 parts, Bulbus Allii Macrostemonis 6 parts, Radix Cyathulae 9 parts and 10 parts, Radix Glycyrrhizae.
5. the Chinese medicine composition of the treatment senile fracture according to any one of claim 1-4, is characterized in that: described Chinese medicine composition is made into tablet, capsule or powder.
CN201511001701.8A 2015-12-29 2015-12-29 Traditional Chinese medicine composition for treating geriatric fracture Withdrawn CN105434800A (en)

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Citations (1)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104958429A (en) * 2015-08-04 2015-10-07 青岛蓝盛洋医药生物科技有限责任公司 Traditional Chinese medicinal composition for treating geriatric fracture and preparation method thereof

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