CN105311094A - Application of pharmaceutical composition containing folium artemisiae argyi in preparing medicine for treating osteoporosis - Google Patents

Application of pharmaceutical composition containing folium artemisiae argyi in preparing medicine for treating osteoporosis Download PDF

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CN105311094A
CN105311094A CN201510792992.0A CN201510792992A CN105311094A CN 105311094 A CN105311094 A CN 105311094A CN 201510792992 A CN201510792992 A CN 201510792992A CN 105311094 A CN105311094 A CN 105311094A
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parts
pharmaceutical composition
radix
artemisiae argyi
folium artemisiae
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王一飞
任哲
利奕成
刘秋英
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Jinan University
University of Jinan
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Abstract

The invention belongs to the field of a traditional Chinese medicine, and relates to application of a pharmaceutical composition containing folium artemisiae argyi in preparing a medicine for treating osteoporosis. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 20-30 parts of eucommia bark, 40-60 parts of radix achyranthis bidentatae, 20-30 parts of folium artemisiae argyi, 20-30 parts of radix dipsaci, 10-20 parts of radix astragali, 10-20 parts of bighead atractylodes rhizome and 15-25 parts of carthamus tinctorius. The medicine disclosed by the invention is reasonable in prescription and strong in synergistic effect; the medicine is used for treating the osteoporosis in combination; and upon clinical verification, the medicine achieves a quite significant effect.

Description

The purposes of pharmaceutical composition containing Folium Artemisiae Argyi in preparation treatment medicine for treating osteoporosis
Technical field
The invention belongs to the field of Chinese medicines, particularly relate to the purposes of pharmaceutical composition in preparation treatment medicine for treating osteoporosis containing Folium Artemisiae Argyi.
Background technology
Osteoporosis is a kind of with bone amount minimizing, and the fine structure of bone destroys as feature, and the fragility causing bone increases, and is easy to a kind of general osteopathia of fracturing.Osteoporosis can be divided into three major types: primary osteoporosis, secondary osteoporosis and idiopathic osteoporosis.First kind primary osteoporosis can be divided into again osteoporosis (I type) and the senile osteoporosis (II type) of menopausal women; Equations of The Second Kind is secondary osteoporosis, and it is by other diseases (as renal failure, excess thyroid hormone or leukemia), or some factors such as medicine (as steroid) the osteoporosis of being brought out; 3rd class is idiopathic osteoporosis, and be more common in teenager or the adult in 8-14 year, mostly have hereditary family history, women is more than male, and the osteoporosis that forepart pregnant women and age of sucking occur also can list idiopathic osteoporosis in.
Chinese invention patent 200810198306 discloses a kind of compositions of the Effective Component of Chinese Medicine for preventing and treating diseased associated with cerebral ischemia injury, but openly not may be used for treating other diseases.
Chinese patent application 201410797516.3 discloses a kind of medicine being used for the treatment of osteoporosis, and this Chinese medicine composition is obtained by following raw material: Ramulus et Folium Psychotriae Serpentis 24-48 part, Carnis Coturnicis japonicae 22-47 part, Radix calophylli membranacei 20-44 part, Radix seu Caulis Verntilaginis Leiocarpae 20-44 part, Herba Thesii 17-42 part, Mytilus 16-40 part, Herba Sambuci Adnatae 16-40 part, Radix Flemingiae Philippinensis 15-35 part, Parmelia saxatilis Ach. 15-35 part, Herba Hoyae lancilimbae 14-32 part, Radix Angelicae Sinensis 14-32 part, Caulis Piperis Boehmeriaefolii 12-30 part.This Chinese medicine composition has keeps fit effect of strong bone, blood yiqi, but this traditional Chinese medicine composite not easily obtains, and preparation technology is more complicated, is unfavorable for batch, produces fast.
Chinese patent application 200910230776.1 discloses a kind of Chinese medicine composition for the treatment of osteoporosis, this Chinese medicine composition is obtained by following raw material: Herba Epimedii 15-20g, Cortex Eucommiae 10-15g, Radix Notoginseng 5-10g, Radix Astragali 10-15g, Ramulus Cinnamomi 10-15g, Rhizoma Chuanxiong 5-10g, Radix Rehmanniae Preparata 5-10g, Radix Angelicae Sinensis 10-15g, Rhizoma Drynariae 10-15g, Radix Angelicae Dahuricae 10-15g.It is simple, reasonable that this Chinese medicine composition has preparation, the advantages such as good effect, but strengthening the tendons and bones, blood nourishing and calcium replenishing aspect effect are not very remarkable.
Summary of the invention
The technical problem to be solved in the present invention is to provide the purposes of a kind of pharmaceutical composition containing Folium Artemisiae Argyi in preparation treatment medicine for treating osteoporosis, this pharmaceutical composition has effect of invigorating the kidney and strengthening the bones, blood circulation promoting and blood stasis dispelling and replenishing QI to invigorate the spleen, also there is good effect, cost is low, preparation technology is simple, the advantages such as cure rate is high, taking convenience.Described pharmaceutical composition can utilize modern pharmaceutical technology to make to facilitate easy-to-use finished product preparation.
Prove through the test of pesticide effectiveness, pharmaceutical composition of the present invention can also treat osteoporosis, and therapeutic effect is obvious, toxic and side effects is little, the therapeutic effect persistent period is long, slow down the misery of patients with osteoporosis greatly, significantly improve the compliance of sufferers of osteoporosis face, and improve the quality of life of patient.
This pharmaceutical composition comprises the raw materials of following parts by weight: Cortex Eucommiae 20-30 part, Radix Achyranthis Bidentatae 40-60 part, Folium Artemisiae Argyi 20-30 part, Radix Dipsaci 20-30 part, Radix Astragali 10-20 part, Rhizoma Atractylodis Macrocephalae 10-20 part Flos Carthami 15-25 part.
Preferably, described pharmaceutical composition comprises the raw materials of following parts by weight: the Cortex Eucommiae 20 parts, Radix Achyranthis Bidentatae 40 parts, Folium Artemisiae Argyi 20 parts, Radix Dipsaci 20 parts, the Radix Astragali 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts of Flos Carthami 15 parts.
Preferably, described pharmaceutical composition comprises the raw materials of following parts by weight: the Cortex Eucommiae 30 parts, Radix Achyranthis Bidentatae 60 parts, Folium Artemisiae Argyi 30 parts, Radix Dipsaci 30 parts, the Radix Astragali 20 parts, the Rhizoma Atractylodis Macrocephalae 20 parts of Flos Carthami 25 parts.
Preferably, described pharmaceutical composition comprises the raw materials of following parts by weight: the Cortex Eucommiae 26 parts, Radix Achyranthis Bidentatae 50 parts, Folium Artemisiae Argyi 28 parts, Radix Dipsaci 26 parts, the Radix Astragali 18 parts, the Rhizoma Atractylodis Macrocephalae 16 parts of Flos Carthami 22 parts.
Preferably, described pharmaceutical composition is made into capsule, tablet, granule or pill.
Accordingly, the preparation technology of pharmaceutical composition of the present invention comprises the following steps:
S1: get the Cortex Eucommiae, Radix Achyranthis Bidentatae, Folium Artemisiae Argyi, Radix Dipsaci, the Radix Astragali, Rhizoma Atractylodis Macrocephalae Flos Carthami, pulverize after cleaning, drying, add the water soaking 30-60 minute of medical material gross weight 8-12 times amount, reflux, extract, 2-3 time, each 1-3 hour, filter and retain filtering residue, merging filtrate, obtaining Aqueous extracts;
S2: adding medical material gross weight 8-12 times amount volume fraction in the filtering residue in S1 is the ethanol of 60-85%, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge described Aqueous extracts and alcohol extract, after stirring, leaves standstill 12-24 hour, the centrifugal 15-30 minute of 12000g, gets supernatant, carries out hyperfiltration treatment, temperature is 20-40 DEG C, feed liquid PH is 6-8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1-0.2MPa, when feed liquid stock solution reduces 1/10-1/5, then ultrafiltration 1-2 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.10-1.25 by relative density at described ultrafiltrate vacuum-concentrcted to 60 DEG C, drying under reduced pressure, pulverizes, and crosses 80-100 mesh sieve, to obtain final product.
Found the impact of rat bone density experiment by pharmaceutical composition of the present invention, pharmaceutical composition of the present invention has and improves osteoporosis, improves effect of bone density.This experiment adopts QIANGGU JIAONANG as a control group, the main component of QIANGGU JIAONANG comprises Process of Total Flavonoids in Drynaria Fortunei, there is effect of the kidney invigorating, bone strengthening, strong muscle, pain relieving, be used for the treatment of the Kidney-Yang Deficiency Syndrome of primary osteoporosis, bone amount minimizing patient, by treating comparing of the therapeutic effect in osteoporosis with pharmaceutical composition of the present invention, embodying the curative effect of pharmaceutical composition of the present invention in treatment osteoporosis.In addition, to rat oral gavage retinoic acid, retinoic acid is the growth of the metabolic intermediate of vitamin A in human body, major effect bone, passes through injectable drug, and measure the bone density of rat, can find out medicine for treatment osteoporosis rat effect, another inventor surprisingly, the femur volume of the rat of medicine group of the present invention is compared with model group, have the difference of remarkable shape, femur dry weight, ash weight, bone calcium and bone density then have extremely significant difference compared with model group; In addition, the femur volume of the rat of BUSHEN JIANGU JIAONANG matched group and medicine group of the present invention, dry weight, ash is heavy, bone calcium is suitable with bone density.Visible, the rat bone loss that pharmaceutical composition of the present invention can obviously suppress retinoic acid to cause, improves osteoporosis, improves bone density.
Found the clinical observation on the therapeutic effect of osteoporosis clinical volunteers patient by pharmaceutical composition of the present invention, pharmaceutical composition of the present invention has good effect, obvious effective rate advantages of higher.The patient of this clinical trial be 20-80 year patient, because osteoporosis can occur in all age group, so the larger patient of the range of choice is as subjects, at present, the drug main for the treatment of osteoporosis will comprise calcium preparation, chemical drugs and Chinese patent medicine, this test adopts BUSHEN JIANGU JIAONANG as a control group, and the main component of BUSHEN JIANGU JIAONANG comprises Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, Rhizoma Cibotii, Herba Epimedii, Radix Angelicae Sinensis, Rhizoma Alismatis, Cortex Moutan, Poria and Concha Ostreae, have nourishing the liver and kidney, effect of strengthening the tendons and bones, for the symptom such as deficiency of the liver and kindey of primary osteoporosis, by comparing with medicine composite for curing effect of the present invention, embody the curative effect of pharmaceutical composition of the present invention in treatment osteoporosis, make inventor surprisingly, the obvious effective rate of pharmaceutical composition of the present invention is 82%, and total effective rate is 95%, far above matched group, visible, pharmaceutical composition good effect of the present invention, obvious effective rate is high, can as the drug use for the treatment of osteoporosis.
Compared with prior art, the present invention has following technical advantage:
1, pharmaceutical composition of the present invention is in treatment osteoporosis, and have increase bone density, the effect of bone calcium, the patient of each age group all can use;
2, pharmaceutical composition of the present invention is natural pure Chinese medicinal preparation, and toxic and side effects is little;
3, pharmaceutical composition of the present invention has effect of invigorating the kidney and strengthening the bones, blood circulation promoting and blood stasis dispelling and replenishing QI to invigorate the spleen, also has good effect, and cost is low, and preparation technology is simple, the advantages such as obvious effective rate is high, taking convenience.
Detailed description of the invention
It will be understood by those skilled in the art that technology disclosed in following examples represents the technology playing good action in the practice of the invention of the present inventor's discovery.But, many changes can be made in disclosed specific embodiments, and still obtain same or analogous result, and not depart from the spirit and scope of the present invention.
part I drug combination preparation of the present invention and preparation method thereof
embodiment 1
Raw material is taken: the Cortex Eucommiae 20 parts, Radix Achyranthis Bidentatae 40 parts, Folium Artemisiae Argyi 20 parts, Radix Dipsaci 20 parts, the Radix Astragali 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts of Flos Carthami 15 parts by following parts by weight.
Preparation method:
S1: get the Cortex Eucommiae, Radix Achyranthis Bidentatae, Folium Artemisiae Argyi, Radix Dipsaci, the Radix Astragali, Rhizoma Atractylodis Macrocephalae Flos Carthami, pulverize after cleaning, drying, add the water soaking 60 minutes of medical material gross weight 8 times amount, reflux, extract, 2 times, each 3 hours, filters and retains filtering residue, merging filtrate, obtaining Aqueous extracts;
S2: adding medical material gross weight 8 times amount volume fraction in the filtering residue in S1 is the ethanol of 60%, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, obtains alcohol extract;
S3: merge described Aqueous extracts and alcohol extract, after stirring, leaves standstill 12 hours, centrifugal 15 minutes of 12000g, gets supernatant, carries out hyperfiltration treatment, temperature is 20 DEG C, feed liquid PH is 6, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1MPa, when feed liquid stock solution reduces 1/10, then the ultrafiltration 2 times that adds water, merge ultrafiltrate;
S4: be the extractum of 1.10 by relative density at described ultrafiltrate vacuum-concentrcted to 60 DEG C, drying under reduced pressure, pulverizes, and crosses 80 mesh sieves, to obtain final product.
Add starch, 5% gelatin solution and distilled water, be pressed into thin slice, be ground into granule, obtain the granule of pharmaceutical composition.
embodiment 2
Raw material is taken: the Cortex Eucommiae 30 parts, Radix Achyranthis Bidentatae 60 parts, Folium Artemisiae Argyi 30 parts, Radix Dipsaci 30 parts, the Radix Astragali 20 parts, the Rhizoma Atractylodis Macrocephalae 20 parts of Flos Carthami 25 parts by following parts by weight.
Preparation method:
S1: get the Cortex Eucommiae, Radix Achyranthis Bidentatae, Folium Artemisiae Argyi, Radix Dipsaci, the Radix Astragali, Rhizoma Atractylodis Macrocephalae Flos Carthami, pulverize after cleaning, drying, add the water soaking 60 minutes of medical material gross weight 12 times amount, reflux, extract, 3 times, each 1 hour, filters and retains filtering residue, merging filtrate, obtaining Aqueous extracts;
S2: adding medical material gross weight 12 times amount volume fraction in the filtering residue in S1 is the ethanol of 85%, reflux, extract, 3 times, each 1 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge described Aqueous extracts and alcohol extract, after stirring, leaves standstill 24 hours, centrifugal 30 minutes of 12000g, gets supernatant, carries out hyperfiltration treatment, temperature is 40 DEG C, feed liquid PH is 8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.2MPa, when feed liquid stock solution reduces 1/5, then the ultrafiltration 2 times that adds water, merge ultrafiltrate;
S4: be the extractum of 1.25 by relative density at described ultrafiltrate vacuum-concentrcted to 60 DEG C, drying under reduced pressure, pulverizes, and crosses 100 mesh sieves, to obtain final product.
Add starch, lactose, 20% gelatin solution, dried starch and distilled water, add lubricant after combination drying, tabletting, coating, obtain the tablet of pharmaceutical composition.
embodiment 3
Raw material is taken: the Cortex Eucommiae 26 parts, Radix Achyranthis Bidentatae 50 parts, Folium Artemisiae Argyi 28 parts, Radix Dipsaci 26 parts, the Radix Astragali 18 parts, the Rhizoma Atractylodis Macrocephalae 16 parts of Flos Carthami 22 parts by following parts by weight.
Preparation method:
S1: get the Cortex Eucommiae, Radix Achyranthis Bidentatae, Folium Artemisiae Argyi, Radix Dipsaci, the Radix Astragali, Rhizoma Atractylodis Macrocephalae Flos Carthami, pulverize after cleaning, drying, add the water soaking 40 minutes of medical material gross weight 10 times amount, reflux, extract, 2 times, each 3 hours, filters and retains filtering residue, merging filtrate, obtaining Aqueous extracts;
S2: adding medical material gross weight 10 times amount volume fraction in the filtering residue in S1 is the ethanol of 75%, reflux, extract, 2 times, each 3 hours, filter, merging filtrate, obtains alcohol extract;
S3: merge described Aqueous extracts and alcohol extract, after stirring, leaves standstill 24 hours, centrifugal 20 minutes of 12000g, gets supernatant, carries out hyperfiltration treatment, temperature is 30 DEG C, feed liquid PH is 7, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.2MPa, when feed liquid stock solution reduces 1/10, then the ultrafiltration 2 times that adds water, merge ultrafiltrate;
S4: be the extractum of 1.20 by relative density at described ultrafiltrate vacuum-concentrcted to 60 DEG C, drying under reduced pressure, pulverizes, and crosses 100 mesh sieves, to obtain final product.
Add starch, lactose, 5% gelatin solution, dried starch and distilled water, mixing, dry, pulverize into fine powder, incapsulates in shell, obtain the capsule preparations of pharmaceutical composition.
part II pharmaceutical composition pharmacodynamic study of the present invention
pharmaceutical composition of the present invention is tested the impact of rat bone density
1, experiment material:
(1) laboratory animal: SD rat, 180 ~ 220g, male and female half and half, are provided by Zhongshan University's Experimental Animal Center.
(2) Experimental agents: the pharmaceutical composition that the embodiment of the present invention 1 ~ 3 prepares; QIANGGU JIAONANG (Beijing Chinese medicine pharmaceutical Co. Ltd, accurate word Z20030007, the 0.25*30 grain/bottle of traditional Chinese medicines).
(3) experimental apparatus: UMSP-30 type microscope spectrophotometer, VIDAS Image analysis system.
2, experimental technique:
Get SD rat 60, be divided into 6 groups at random, often organize 10, be respectively blank group, model group (isometric(al) normal saline), medicine A group (embodiment 1 pharmaceutical composition 2.28g/kg ﹒ d), medicine B group (embodiment 2 pharmaceutical composition 2.28g/kg ﹒ d), medicine C group (embodiment 3 pharmaceutical composition 2.28g/kg ﹒ d) and QIANGGU JIAONANG matched group (0.9g/kg ﹒ d); Except blank group, the retinoic acid of rats difference gavage 0.06g/kg that every day is respectively organized to other, stop using after two weeks, and the simultaneously corresponding medicine of gavage, blank group and model group be gavage isometric(al) normal saline then, continuous use surrounding (retinoic acid stop using after, continue medication two weeks), after surrounding, by rat sacrificed by decapitation, take a blood sample, get bone, under fluorescence irradiates, with microscope spectrophotometer, tibia sectioning image is all inputted Image analysis system, in computer, carry out data and image procossing.
3, experimental result
Table 1 respectively group rat femur meterological change
Note: compare with blank group, p ﹤ 0.05, △ △p ﹤ 0.01; Compare with model group, p ﹤ 0.05, ▲ ▲p ﹤ 0.01.
4, conclusion
This experiment adopts QIANGGU JIAONANG as a control group, the main component of QIANGGU JIAONANG comprises Process of Total Flavonoids in Drynaria Fortunei, there is effect of the kidney invigorating, bone strengthening, strong muscle, pain relieving, be used for the treatment of the Kidney-Yang Deficiency Syndrome of primary osteoporosis, bone amount minimizing patient, by treating comparing of the therapeutic effect in osteoporosis with pharmaceutical composition of the present invention, embodying the curative effect of pharmaceutical composition of the present invention in treatment osteoporosis.In addition, to rat oral gavage retinoic acid, retinoic acid is the growth of the metabolic intermediate of vitamin A in human body, major effect bone, passes through injectable drug, and measure the bone density of rat, can find out medicine for treatment osteoporosis rat effect, another inventor surprisingly, the femur volume of the rat of medicine A, B, C group of the present invention is compared with model group, have the difference of significance, femur dry weight, ash weight, bone calcium and bone density then have extremely significant difference compared with model group; In addition, model group, compared with blank group, all has the difference of significance in femur volume, dry weight, ash weight, bone calcium and bone density; In addition, the femur volume of the rat of BUSHEN JIANGU JIAONANG matched group and medicine A, B, C group of the present invention, dry weight, ash is heavy, bone calcium is suitable with bone density.Visible, the rat bone loss that pharmaceutical composition of the present invention can obviously suppress retinoic acid to cause, improves osteoporosis, improves bone density.
pharmaceutical composition of the present invention is to the clinical observation on the therapeutic effect of osteoporosis clinical volunteers patient
(1) case and diagnostic criteria
1, Western medicine diagnose standard:
With reference to " Chinese's osteoporosis suggestion diagnostic criteria " (the second original text) and " new Chinese medicine guideline of clinical investigations ", determining that the diagnostic criteria of this test is as follows: possess overall pain, is main mainly with lumbar and back pain, aching and limp unable, increase the weight of gradually, microtrauma can cause fracture; Scheuermann kyphosis deformity; Bone density reduces by 2 above persons of standard deviation.
Note: (1) bone density refers to measures the meansigma methods of lumbar vertebra 2-4 vertebral bone density or the bone density value of hip with Dual-energy X-rays absorptionmetry (DEXA), as long as one of them reaches lower than 2 above persons of standard deviation.
(2) pain is modal, the topmost symptom of osteoporosis.Clinical the most common with lumbago and backache, for spinous process or have tenderness and percussion pain, with whole body skeleton pain.
(3) be suitable for lumbar vertebra by the diagnostic index that standard deviation represents, hip position can refer to execution.When standard deviation inconvenience application, available lumbar vertebra Percentage of bone loss (%) diagnostic index.
2, tcm diagnosis standard:
Evaluation with reference to " guideline of clinical investigations of new Chinese medicine treatment osteoporosis " of " new Chinese medicine guideline of clinical investigations " (2002) requires to formulate.Diagnostic criteria is: lumbar vertebrae pain, aching and limp few power, walk with difficulty, the vertigo, can not be prudent, body of the tongue or partially red or light, thin lingual fur or thin white, deep-thready pulse etc.
3, Excluded cases standard: 1) have secondary osteoporosis and other serious complication persons such as hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma; Or late deformity, maimed person, disability person; 2) severe primary such as cardiovascular and hemopoietic system disease patient is associated with; 3) liver function ALT is more than 1.5 times of upper limits of normal; Renal function serum creatinine > 133umol/L; 4) psychosis or old dementia patients; 5) adopt hormone replacement therapy (HRT) in nearly three months and take calcitonin (as Calcitonin and elcatonin), having continuous 15 days in nearly six months and apply Diphosphonate person.
Two, clinical trial
1, physical data
Clinical volunteers patient of all selected fracture being loosened is divided into two groups at random, treatment group 100 example, wherein male patient 50 example, female patient 30 example; Matched group 100 example, wherein male patient 54 example, female patient 46 example.Age is 20 ~ 80 years old, 49 years old mean age.Two groups of influence factors such as age, symptom, through statistical procedures, there was no significant difference, meets a point set condition.
2, Therapeutic Method
Treatment group: take the capsule (0.3g*100 grain/bottle) that embodiment 3 prepares, every day 3 times, each 4, serve on 3 months;
Matched group: take BUSHEN JIANGU JIAONANG (Wuhan JianMin Pharmaceutical Group Co., Ltd, accurate word Z20020056, the 0.58g*36 grain/box of traditional Chinese medicines), each 4,3 times on the one, serve on 3 months.
3, evaluation of clinical curative effect standard
Osteoporosis bone density efficacy determination
First calculating bone density changing value=(after treatment the front bone density of bone density-treatment)/treat front bone density × 100%
Effective: bone density rate of change is more than or equal to the minimum significant change value of bone density;
Effective: bone density rate of change is between the minimum significant change value of positive and negative bone density;
Invalid: bone density rate of change is less than the minimum significant change value of negative bone density.
Wherein bone density minimum significant change value=2.77 × (%CV), the CV-coefficient of variation.
Total effective rate=(effective+effectively)/total case load × 100%
4, therapeutic outcome, as shown in table 2.
Table 2 therapeutic effect
5, conclusion
The patient of this clinical trial is the patient of 20 ~ 80 years old, because osteoporosis can occur in all age group, so the larger patient of the range of choice is as subjects, by comparing with medicine composite for curing effect of the present invention, embody the curative effect of pharmaceutical composition of the present invention in treatment osteoporosis, make inventor surprisingly, the obvious effective rate of pharmaceutical composition of the present invention is 82%, total effective rate is 95%, far above matched group, visible, pharmaceutical composition good effect of the present invention, obvious effective rate is high, can as the drug use for the treatment of osteoporosis.
Owing to describing the present invention by above preferred embodiment, in spirit of the present invention and/or scope, any for replacement/of the present invention or combination implement the present invention, be all apparent for a person skilled in the art, and be included among the present invention.

Claims (6)

1. the purposes of the pharmaceutical composition containing Folium Artemisiae Argyi in preparation treatment medicine for treating osteoporosis, it is characterized in that, described pharmaceutical composition comprises the raw materials of following parts by weight: Cortex Eucommiae 20-30 part, Radix Achyranthis Bidentatae 40-60 part, Folium Artemisiae Argyi 20-30 part, Radix Dipsaci 20-30 part, Radix Astragali 10-20 part, Rhizoma Atractylodis Macrocephalae 10-20 part Flos Carthami 15-25 part.
2. purposes according to claim 1, is characterized in that, described pharmaceutical composition comprises the raw materials of following parts by weight: the Cortex Eucommiae 20 parts, Radix Achyranthis Bidentatae 40 parts, Folium Artemisiae Argyi 20 parts, Radix Dipsaci 20 parts, the Radix Astragali 10 parts, the Rhizoma Atractylodis Macrocephalae 10 parts of Flos Carthami 15 parts.
3. purposes according to claim 1, is characterized in that, described pharmaceutical composition comprises the raw materials of following parts by weight: the Cortex Eucommiae 30 parts, Radix Achyranthis Bidentatae 60 parts, Folium Artemisiae Argyi 30 parts, Radix Dipsaci 30 parts, the Radix Astragali 20 parts, the Rhizoma Atractylodis Macrocephalae 20 parts of Flos Carthami 25 parts.
4. purposes according to claim 1, is characterized in that, described pharmaceutical composition comprises the raw materials of following parts by weight: the Cortex Eucommiae 26 parts, Radix Achyranthis Bidentatae 50 parts, Folium Artemisiae Argyi 28 parts, Radix Dipsaci 26 parts, the Radix Astragali 18 parts, the Rhizoma Atractylodis Macrocephalae 16 parts of Flos Carthami 22 parts.
5., according to the arbitrary described purposes of claim 1-4, it is characterized in that, described pharmaceutical composition is made into capsule, tablet, granule or pill.
6., according to the arbitrary described purposes of claim 1-4, it is characterized in that, the preparation technology of described pharmaceutical composition comprises the following steps:
S1: get the Cortex Eucommiae, Radix Achyranthis Bidentatae, Folium Artemisiae Argyi, Radix Dipsaci, the Radix Astragali, Rhizoma Atractylodis Macrocephalae Flos Carthami, pulverize after cleaning, drying, add the water soaking 30-60 minute of medical material gross weight 8-12 times amount, reflux, extract, 2-3 time, each 1-3 hour, filter and retain filtering residue, merging filtrate, obtaining Aqueous extracts;
S2: adding medical material gross weight 8-12 times amount volume fraction in the filtering residue in S1 is the ethanol of 60-85%, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, obtains alcohol extract;
S3: merge described Aqueous extracts and alcohol extract, after stirring, leaves standstill 12-24 hour, the centrifugal 15-30 minute of 12000g, gets supernatant, carries out hyperfiltration treatment, temperature is 20-40 DEG C, feed liquid PH is 6-8, and inlet pressure is 0.3MPa, the low 0.35kPa of liquid outlet pressure ratio inlet pressure, the pressure wave moment of periodic pressure fluctuation is 0.1-0.2MPa, when feed liquid stock solution reduces 1/10-1/5, then ultrafiltration 1-2 time that adds water, merge ultrafiltrate;
S4: be the extractum of 1.10-1.25 by relative density at described ultrafiltrate vacuum-concentrcted to 60 DEG C, drying under reduced pressure, pulverizes, and crosses 80-100 mesh sieve, to obtain final product.
CN201510792992.0A 2015-11-18 2015-11-18 Application of pharmaceutical composition containing folium artemisiae argyi in preparing medicine for treating osteoporosis Withdrawn CN105311094A (en)

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