CN105194131A - Traditional Chinese medicine composition for treating osteoporosis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating osteoporosis and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicinal composition for treating osteoporosis, which belongs to the field of traditional Chinese medicine. The traditional Chinese medicinal composition comprises the following preparation raw materials by weight: 12 to 26 parts of spatholobus stem, 14 to 28 parts of Radix Astragali, 14 to 22 parts of Dangshen, 12 to 20 parts of safflower, 10 to 20 parts of fructus psoraleae, 8 to 16 parts of prepared rehmannia root, 8 to 12 parts of root of kudzu vine, 8 to 14 parts of rhizoma curculiginis, 6 to 10 parts of eucommia bark, 8 to 12 parts of dodder seed and 4 to 8 parts of licorice root. The composition is reasonable, has good synergistic effect, is used as a drug for treating osteoporosis and presents substantial treatment effect according to clinical verification.
Description
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine composition for the treatment of osteoporosis and preparation method thereof.
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, is more common in teenager or adult, often has hereditary family history, and women is more than male, and the osteoporosis that forepart pregnant women and age of sucking occur also can list idiopathic osteoporosis in.
Chinese patent application 201410797516.3 discloses a kind of Chinese medicine composition being used for the treatment of osteoporosis, and this Chinese medicine composition is obtained by following raw material: Ramulus et Folium Psychotriae Serpentis, Carnis Coturnicis japonicae, Radix calophylli membranacei, Radix seu Caulis Verntilaginis Leiocarpae, Herba Thesii, Mytilus, Herba Sambuci Adnatae, Radix Flemingiae Philippinensis, Parmelia saxatilis Ach., Herba Hoyae lancilimbae, Radix Angelicae Sinensis, Caulis Piperis Boehmeriaefolii.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, and this Chinese medicine composition is obtained by following raw material: Herba Epimedii, the Cortex Eucommiae, Radix Notoginseng, the Radix Astragali, Ramulus Cinnamomi, Rhizoma Chuanxiong, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Rhizoma Drynariae, the Radix Angelicae Dahuricae.
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 osteoporosis, this Chinese medicine composition has vigorate qi and replenish the blood, the effect of bone strengthening of replenishing the calcium, and also has that cure rate is high, efficacy stability, applied widely, toxic and side effects is little and be easy to advantages such as applying.In addition, the present invention also provides corresponding manufacturing process to be made and facilitate easy-to-use finished product preparation under the prerequisite ensureing curative effect by this Chinese medicine.
This Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 12 ~ 26 parts, the Radix Astragali 14 ~ 28 parts, Radix Codonopsis 14 ~ 22 parts, 12 ~ 20 parts, Flos Carthami, Fructus Psoraleae 10 ~ 20 parts, Radix Rehmanniae Preparata 8 ~ 16 parts, Radix Puerariae 8 ~ 12 parts, Rhizoma Curculiginis 8 ~ 14 parts, the Cortex Eucommiae 6 ~ 10 parts, Semen Cuscutae 8 ~ 12 parts and 4 ~ 8 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 12 parts, the Radix Astragali 14 parts, Radix Codonopsis 14 parts, 12 parts, Flos Carthami, Fructus Psoraleae 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Puerariae 8 parts, Rhizoma Curculiginis 8 parts, the Cortex Eucommiae 6 parts, Semen Cuscutae 8 parts and 4 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 26 parts, the Radix Astragali 28 parts, Radix Codonopsis 22 parts, 20 parts, Flos Carthami, Fructus Psoraleae 20 parts, Radix Rehmanniae Preparata 16 parts, Radix Puerariae 12 parts, Rhizoma Curculiginis 14 parts, the Cortex Eucommiae 10 parts, Semen Cuscutae 12 parts and 8 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 22 parts, the Radix Astragali 24 parts, Radix Codonopsis 18 parts, 16 parts, Flos Carthami, Fructus Psoraleae 14 parts, Radix Rehmanniae Preparata 12 parts, Radix Puerariae 10 parts, Rhizoma Curculiginis 12 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 10 parts and 6 parts, Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is made into granule, powder, tablet or capsule.
Accordingly, the preparation method of Chinese medicine composition of the present invention comprises following step:
S1: get Caulis Spatholobi, wash away impurity, crushed after being dried, cross 80-100 mesh sieve, adding Caulis Spatholobi coarse powder gross weight 8-10 times amount volume fraction is the ethanol of 60-80%, add the cellulase of Caulis Spatholobi coarse powder total amount 0.8-1.2% again, lixiviate 1-2 hour at 38-45 DEG C, then at 85-95 DEG C of reflux, extract, 1-2 hour, filters and retains Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.25, obtains Caulis Spatholobi extract;
S2: get the Radix Astragali, Radix Codonopsis, Flos Carthami, Fructus Psoraleae, Radix Rehmanniae Preparata, Radix Puerariae, Rhizoma Curculiginis, the Cortex Eucommiae, Semen Cuscutae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step S1 mix, add the water of above-mentioned coarse powder total amount 15-20 times amount, soak 20-30 minute, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, concentrate filtrate at 60 DEG C and survey the extractum that relative density is 1.10-1.20, cooling, slowly add ethanol while stirring and reach 40-60% to alcohol content, 4 DEG C of standing 12-24 hour, filter and retain filtering residue, obtain filtrate A,
S3: it is the ethanol of 40-60% that the filtering residue obtained by step S2 slowly adds filtering residue weight 4-6 times amount volume fraction while stirring, 4 DEG C of standing 3-5 hour, filters, obtains liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture;
S4: step S2 is obtained filtrate A and obtain liquor B with step S3 and cleaning mixture mixes, survey the extractum that relative density is 1.20-1.25 under being evaporated to 60 DEG C of conditions after mixing;
S5: the extractum that the Caulis Spatholobi extract obtained by step S1 and step S4 obtain is mixed homogeneously, carries out spraying dry, inlet temperature 80-120 DEG C, outlet temperature 45-80 DEG C, wind speed 5-10m/s, pressure 0.02-0.1kPa; Dried powder is crossed 100-200 mesh sieve, to obtain final product.
Source, the nature and flavor of the present invention's component used, return through and effect:
Caulis Spatholobi: this product is the plant of pulse family Millettia, bitter in the mouth, sweet, warm in nature; Return liver, kidney channel; Enrich blood, invigorate blood circulation, dredging collateral; Relaxing muscles and tendons to promote blood circulation, nourishing blood for regulating menstruation.
The Radix Astragali: this product is the root of leguminous plant Radix Hedysari multijugi; Sweet in the mouth, warm in nature; GUIXIN, lung, spleen, kidney channel; Invigorating QI to consolidate the body surface resistance, diuresis, expelling pus and toxin by strengthening QI, promoting tissue regeneration and ulcer healing.
Radix Codonopsis: this product is the dry root of Campanulaceae Radix Codonopsis; Sweet in the mouth, property is put down; Return spleen, lung meridian; Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.
Flos Carthami: this product is the dried floral of feverfew Flos Carthami; Acrid in the mouth, warm in nature; GUIXIN, Liver Channel; Promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.
Fructus Psoraleae: this product is the dry mature fruit of legumes psoraleae; Acrid in the mouth, hardship, warm in nature; Return kidney, spleen channel; Warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI, antidiarrheal.
Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae; Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.
Radix Puerariae: this product is the dry root of legume pueraria lobata or Radix Puerariae rattan; Sweet in the mouth, pungent, cool in nature; Return spleen, stomach warp; Expelling pathogenic factors from muscles for reducing heat, promotes the production of body fluid, rash, yang invigorating antidiarrheal.
Rhizoma Curculiginis: this product is the dry rhizome of amrallid Rhizoma Curculiginis; Acrid in the mouth, hot in nature; Return kidney,liver,spleen warp; Kidney-replenishing, bone and muscle strengthening, dispelling cold and dampness.
The Cortex Eucommiae: this product is the dry bark of the Eucommiaceae plant Cortex Eucommiae; Sweet in the mouth, warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, antiabortive.
Semen Cuscutae: this product is the dry mature seed of convolvulus cuscuta plant; Sweet in the mouth, warm in nature; Return liver,kidney,spleen warp; Nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L.; 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, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of Chinese prescription of the present invention:
Chinese prescription of the present invention is with Caulis Spatholobi, Radix Codonopsis, the Radix Astragali for monarch drug, benefiting QI and nourishing blood, blood nourishing and calcium replenishing, enriching yin and nourishing kidney; With Fructus Psoraleae, Semen Cuscutae, Radix Rehmanniae Preparata for ministerial drug, invigorating QI to consolidate the body surface resistance, promoting blood circulation to restore menstrual flow, menstruction regulating and pain relieving, with Flos Carthami, Radix Puerariae, the Cortex Eucommiae, Rhizoma Curculiginis for adjuvant drug, relaxing muscles and tendons to promote blood circulation, nourishing blood for regulating menstruation, strong bone of replenishing the calcium, invigorating blood circulation analgesia; With Radix Glycyrrhizae for making medicine, coordinating the actions of various ingredients in a prescription, makes all medicines arrange in pairs or groups, synergism, jointly reaches vigorate qi and replenish the blood, effect of bone strengthening of replenishing the calcium, nourishing yin and promoting blood circulation and spleen invigorating nourishing the liver, has very significant therapeutic effect to treatment osteoporosis.
Compared with prior art, the present invention has following beneficial effect:
1, Chinese medicine composition of the present invention has good effect in treatment osteoporosis, and healing time waits soon and treats advantage significantly, also has that cure rate is high, efficacy stability, applied widely, toxic and side effects is little and be easy to advantages such as applying.
2, confirm by experiment, Chinese medicine composition of the present invention significantly can increase the bone density of rat, femur dry weight and bone calcium, effectively improves the bone amount of rat, has significant effect for treatment osteoporosis.
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.
embodiment 1
The embodiment of the present invention 1 Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 12 parts, the Radix Astragali 14 parts, Radix Codonopsis 14 parts, 12 parts, Flos Carthami, Fructus Psoraleae 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Puerariae 8 parts, Rhizoma Curculiginis 8 parts, the Cortex Eucommiae 6 parts, Semen Cuscutae 8 parts and 4 parts, Radix Glycyrrhizae.
Preparation method is as follows:
S1: get Caulis Spatholobi, wash away impurity, crushed after being dried, cross 80 mesh sieves, adding Caulis Spatholobi coarse powder gross weight 8 times amount volume fraction is the ethanol of 60%, add the cellulase of Caulis Spatholobi coarse powder total amount 0.8% again, lixiviate 1 hour at 38 DEG C, then 85 DEG C of reflux, extract, 1 hour, filters and retains Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10, obtains Caulis Spatholobi extract;
S2: get the Radix Astragali, Radix Codonopsis, Flos Carthami, Fructus Psoraleae, Radix Rehmanniae Preparata, Radix Puerariae, Rhizoma Curculiginis, the Cortex Eucommiae, Semen Cuscutae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step S1 mix, add the water of above-mentioned coarse powder total amount 15 times amount, soak 20 minutes, reflux, extract, 2 times, each 1 hour, filter, merging filtrate, concentrates filtrate at 60 DEG C and surveys the extractum that relative density is 1.10, cooling, slowly add ethanol while stirring and reach 40% to alcohol content, 4 DEG C leave standstill 12 hours, filter and retain filtering residue, obtaining filtrate A;
S3: it is the ethanol of 40% that the filtering residue obtained by step S2 slowly adds filtering residue weight 4 times amount volume fraction while stirring, 4 DEG C leave standstill 3 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 2 times of 40% again, collects and merges cleaning mixture;
S4: step S2 is obtained filtrate A and obtain liquor B with step S3 and cleaning mixture mixes, survey the extractum that relative density is 1.20 under being evaporated to 60 DEG C of conditions after mixing;
S5: the extractum that the Caulis Spatholobi extract obtained by step S1 and step S4 obtain is mixed homogeneously, carries out spraying dry, inlet temperature 80 DEG C, outlet temperature 45 DEG C, wind speed 5m/s, pressure 0.02kPa; Dried powder is crossed 100 mesh sieves, obtains Chinese medicine composition powder;
S6: the filler Icing Sugar adding equivalent toward above-mentioned Chinese medicine composition powder, wetting agent distilled water, disintegrating agent hydroxypropyl starch and lubricant Pulvis Talci, mix homogeneously, obtain soft material processed, soft material processed is put into rotary extrusion type granulator, obtain wet granular, dry under 60 DEG C of conditions, obtain dry granule, cross 20 mesh sieve removing big particles, make uniform particles, add lubricant Pulvis Talci and disintegrating agent hydroxypropyl starch again, wherein granule and lubricant, the amount ratio of disintegrating agent is 1:0.5:0.5, mix homogeneously, tabletting, obtain tablet, carry out quality inspection, through after the assay was approved, encapsulation, obtain Chinese medicine composition tablet.
embodiment 2
The embodiment of the present invention 2 Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 26 parts, the Radix Astragali 28 parts, Radix Codonopsis 22 parts, 20 parts, Flos Carthami, Fructus Psoraleae 20 parts, Radix Rehmanniae Preparata 16 parts, Radix Puerariae 12 parts, Rhizoma Curculiginis 14 parts, the Cortex Eucommiae 10 parts, Semen Cuscutae 12 parts and 8 parts, Radix Glycyrrhizae.Preparation method is with embodiment 1.
embodiment 3
The embodiment of the present invention 3 Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 22 parts, the Radix Astragali 24 parts, Radix Codonopsis 18 parts, 16 parts, Flos Carthami, Fructus Psoraleae 14 parts, Radix Rehmanniae Preparata 12 parts, Radix Puerariae 10 parts, Rhizoma Curculiginis 12 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 10 parts and 6 parts, Radix Glycyrrhizae.
Preparation method is as follows:
S1: get Caulis Spatholobi, wash away impurity, crushed after being dried, cross 100 mesh sieves, adding Caulis Spatholobi coarse powder gross weight 10 times amount volume fraction is the ethanol of 80%, add the cellulase of Caulis Spatholobi coarse powder total amount 1.2% again, lixiviate 2 hours at 45 DEG C, then 95 DEG C of reflux, extract, 2 hours, filters and retains Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.25, obtains Caulis Spatholobi extract;
S2: get the Radix Astragali, Radix Codonopsis, Flos Carthami, Fructus Psoraleae, Radix Rehmanniae Preparata, Radix Puerariae, Rhizoma Curculiginis, the Cortex Eucommiae, Semen Cuscutae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step S1 mix, add the water of above-mentioned coarse powder total amount 20 times amount, soak 30 minutes, reflux, extract, 3 times, each 3 hours, filter, merging filtrate, concentrates filtrate at 60 DEG C and surveys the extractum that relative density is 1.20, cooling, slowly add ethanol while stirring and reach 60% to alcohol content, 4 DEG C leave standstill 24 hours, filter and retain filtering residue, obtaining filtrate A;
S3: it is the ethanol of 60% that the filtering residue obtained by step S2 slowly adds filtering residue weight 6 times amount volume fraction while stirring, 4 DEG C leave standstill 5 hours, filter, obtain liquor B and filtering residue; Filtering residue uses the washing with alcohol 3 times of 60% again, collects and merges cleaning mixture;
S4: step S2 is obtained filtrate A and obtain liquor B with step S3 and cleaning mixture mixes, survey the extractum that relative density is 1.25 under being evaporated to 60 DEG C of conditions after mixing;
S5: the extractum that the Caulis Spatholobi extract obtained by step S1 and step S4 obtain is mixed homogeneously, carries out spraying dry, inlet temperature 120 DEG C, outlet temperature 80 DEG C, wind speed 10m/s, pressure 0.1kPa; Dried powder is crossed 200 mesh sieves, obtains Chinese medicine composition powder;
S6: the water-soluble base polyethylene glycol 6000 adding its weight 5 times toward above-mentioned Chinese medicine composition powder, mix homogeneously, heating, emulsifying obtains medicinal liquid, puts into pill dripping machine and makes drop, adds the condensed fluid liquid paraffin of fine powder weight 1/6, obtained pellet, wherein, condensed fluid and substrate are not miscible, after drop pill molding, removing liquid paraffin, and dry arrangement, carry out quality inspection, after qualified on inspection, packaging, obtains the drop pill of Chinese medicine composition.
chinese medicine composition of the present invention is tested the impact of rat bone amount
1, experiment purpose and method
Object: according to the requirement of " new Chinese medicine pharmaceutical research guide ", the zoopery of research Tablets in protect against osteoporosis, observe the high, medium and low dosage of the obtained Chinese medicine composition of the embodiment of the present invention 1,3 to the impact of rat bone amount, bone amount evaluates osteoporosis treatment effect " goldstandard " at present, and bone density, calcium content of bone can distinguish never ipsilateral reflection bone amount.
Method: do intraperitoneal injection of anesthesia to 64 SD rats with pentobarbital sodium, wherein 56 excision bilateral ovaries, 8 other each one piece of fatty tissuees of SD rat excision bilateral ovaries compare group (sham operated rats).Postoperative 45 days, removal ovary SD rat is divided into 7 groups at random, the high dose group (1.2g/kg) of the Chinese medicine composition obtained by embodiment 1,3, middle dosage group (0.8g/kg), low dose group (0.4g/kg and model group (isometric(al) normal saline) administration, using sham operated rats as blank group (isometric(al) normal saline) administration, once a day, continuous 90 days.
2, experimental result: as shown in table 1, table 2.
Table 1 medicine is to rat body bone mineral density result
Note: compare with blank group,
##p<0.01; Compare with model group,
▲ ▲p<0.01.
Table 2 medicine is on the impact of rat femur dry weight and bone calcium
Note: compare with blank group,
##p<0.01; Compare with model group,
▲ ▲p<0.01.
3, conclusion
From table 1 and table 2, treat the bone density of A group and treatment B group, femur dry weight and bone calcium significantly to increase, have extremely significant difference (P<0.01) compared with model group, visible, Chinese medicine composition of the present invention has significant effect in treatment osteoporosis.
chinese medicine composition of the present invention is to the clinical observation on the therapeutic effect of osteoporosis clinical volunteers patient
One, 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 " that osteoporosis committee of Aged in China association Criteria of Osteoporosis subject group is formulated, determine that the diagnostic criteria of this test is as follows:
Diagnosis principle: it is basic foundation that Diagnosis of osteoporosis should reduce more than 2 standard deviations with bone density, must differentiate it is primary osteoporosis or secondary osteoporosis.Can consider with reference to age, medical history, fracture and lab testing etc. during clinical diagnosis.
Diagnostic criteria: possess overall pain is main mainly with lumbar and back pain, and 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.
2, tcm diagnosis standard:
Require to formulate according to the evaluation of " guideline of clinical investigations of new Chinese medicine treatment osteoporosis " of " new Chinese medicine guideline of clinical investigations " (2002).Show as: 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, the symptoms such as thin lingual fur or thin white, deep-thready pulse, osteoporosis is shown in above-mentioned disease person.
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 120 example, and matched group 120 example, the age is 18 years old-79 years old, 48 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, drug administration
Treatment group: the tablet that embodiment 2 prepares, 2 times on the one, serve on 3 months by each 2;
Matched group: take calcium that strange (the accurate word H10950029 of traditional Chinese medicines), each 2,2 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 3.
Table 3 therapeutic effect
| Group | Number of cases | Effective (rate) | Effectively | Invalid | Total effective rate |
| Treatment group | 120 | 97（80.8%） | 14 | 9 | 92.5% |
| Matched group | 120 | 73（60.8%） | 14 | 33 | 72.5% |
5, conclusion
The drug main for the treatment of osteoporosis at present on the market will comprise calcium preparation, chemical drugs and Chinese patent medicine, and calcium is taked in this test, and you are strange as a control group, by comparing with the therapeutic effect of Chinese medicine composition of the present invention, highlight the curative effect of Chinese medicine composition of the present invention; The standard of clinical efficacy is then evaluated by bone density changing value, as shown in Table 3, the obvious effective rate of Chinese medicine composition of the present invention is greater than 80%, total effective rate is greater than 90%, far above obvious effective rate and the total effective rate of matched group, visible, Chinese medicine composition of the present invention is evident in efficacy, total effective rate is high, can be used as the osteoporotic drug use for the treatment of.
In 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. treat a Chinese medicine composition for osteoporosis, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 12 ~ 26 parts, the Radix Astragali 14 ~ 28 parts, Radix Codonopsis 14 ~ 22 parts, 12 ~ 20 parts, Flos Carthami, Fructus Psoraleae 10 ~ 20 parts, Radix Rehmanniae Preparata 8 ~ 16 parts, Radix Puerariae 8 ~ 12 parts, Rhizoma Curculiginis 8 ~ 14 parts, the Cortex Eucommiae 6 ~ 10 parts, Semen Cuscutae 8 ~ 12 parts and 4 ~ 8 parts, Radix Glycyrrhizae.
2. the Chinese medicine composition for the treatment of osteoporosis as claimed in claim 1, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 12 parts, the Radix Astragali 14 parts, Radix Codonopsis 14 parts, 12 parts, Flos Carthami, Fructus Psoraleae 10 parts, Radix Rehmanniae Preparata 8 parts, Radix Puerariae 8 parts, Rhizoma Curculiginis 8 parts, the Cortex Eucommiae 6 parts, Semen Cuscutae 8 parts and 4 parts, Radix Glycyrrhizae.
3. the Chinese medicine composition for the treatment of osteoporosis as claimed in claim 1, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 26 parts, the Radix Astragali 28 parts, Radix Codonopsis 22 parts, 20 parts, Flos Carthami, Fructus Psoraleae 20 parts, Radix Rehmanniae Preparata 16 parts, Radix Puerariae 12 parts, Rhizoma Curculiginis 14 parts, the Cortex Eucommiae 10 parts, Semen Cuscutae 12 parts and 8 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition for the treatment of osteoporosis as claimed in claim 1, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight:
Caulis Spatholobi 22 parts, the Radix Astragali 24 parts, Radix Codonopsis 18 parts, 16 parts, Flos Carthami, Fructus Psoraleae 14 parts, Radix Rehmanniae Preparata 12 parts, Radix Puerariae 10 parts, Rhizoma Curculiginis 12 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 10 parts and 6 parts, Radix Glycyrrhizae.
5. the Chinese medicine composition of the treatment osteoporosis as described in as arbitrary in claim 1-4, it is characterized in that, described Chinese medicine composition is made into granule, powder, tablet, drop pill or capsule.
6. the preparation method of the Chinese medicine composition of the treatment osteoporosis as described in as arbitrary in claim 1-4, it is characterized in that, the preparation method of described Chinese medicine composition comprises following step:
S1: get Caulis Spatholobi, wash away impurity, crushed after being dried, cross 80-100 mesh sieve, adding Caulis Spatholobi coarse powder gross weight 8-10 times amount volume fraction is the ethanol of 60-80%, add the cellulase of Caulis Spatholobi coarse powder total amount 0.8-1.2% again, lixiviate 1-2 hour at 38-45 DEG C, then at 85-95 DEG C of reflux, extract, 1-2 hour, filters and retains Caulis Spatholobi filtering residue, at filtrate reduced in volume to 60 DEG C, relative density is the extractum of 1.10-1.25, obtains Caulis Spatholobi extract;
S2: get the Radix Astragali, Radix Codonopsis, Flos Carthami, Fructus Psoraleae, Radix Rehmanniae Preparata, Radix Puerariae, Rhizoma Curculiginis, the Cortex Eucommiae, Semen Cuscutae and Radix Glycyrrhizae, wash away impurity, crushed after being dried, the Caulis Spatholobi medicinal residues obtained with step S1 mix, add the water of above-mentioned coarse powder total amount 15-20 times amount, soak 20-30 minute, reflux, extract, 2-3 time, each 1-3 hour, filter, merging filtrate, concentrate filtrate at 60 DEG C and survey the extractum that relative density is 1.10-1.20, cooling, slowly add ethanol while stirring and reach 40-60% to alcohol content, 4 DEG C of standing 12-24 hour, filter and retain filtering residue, obtain filtrate A,
S3: it is the ethanol of 40-60% that the filtering residue obtained by step S2 slowly adds filtering residue weight 4-6 times amount volume fraction while stirring, 4 DEG C of standing 3-5 hour, filters, obtains liquor B and filtering residue; Filtering residue uses the washing with alcohol 2-3 time of 40-60% again, collects and merges cleaning mixture;
S4: step S2 is obtained filtrate A and obtain liquor B with step S3 and cleaning mixture mixes, survey the extractum that relative density is 1.20-1.25 under being evaporated to 60 DEG C of conditions after mixing;
S5: the extractum that the Caulis Spatholobi extract obtained by step S1 and step S4 obtain is mixed homogeneously, carries out spraying dry, inlet temperature 80-120 DEG C, outlet temperature 45-80 DEG C, wind speed 5-10m/s, pressure 0.02-0.1kPa; Dried powder is crossed 100-200 mesh sieve, to obtain final product.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105267413A (en) * | 2015-10-28 | 2016-01-27 | 叶宗耀 | Traditional Chinese medicine composition for treating osteoporosis and preparation method thereof |
| CN115919950A (en) * | 2022-12-16 | 2023-04-07 | 广东药科大学 | Traditional Chinese medicine for improving atherosclerosis and osteoporosis and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105267413A (en) * | 2015-10-28 | 2016-01-27 | 叶宗耀 | Traditional Chinese medicine composition for treating osteoporosis and preparation method thereof |
| CN115919950A (en) * | 2022-12-16 | 2023-04-07 | 广东药科大学 | Traditional Chinese medicine for improving atherosclerosis and osteoporosis and preparation method thereof |
| CN115919950B (en) * | 2022-12-16 | 2024-01-30 | 广东药科大学 | Traditional Chinese medicine for improving atherosclerosis and osteoporosis and preparation method thereof |
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Application publication date: 20151230 |