CN105012507A - Traditional Chinese medicine composition for treating osteoporosis and preparation method of traditional Chinese medicine composition - Google Patents

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating osteoporosis. The traditional Chinese medicine composition is prepared from the following raw materials: a chickpea sprout extract, astragalus membranaceus, radix codonopsitis, carthamus tinctorius, fructus psoraleae, prepared rehmannia root, oyster, common curculigo rhizome, eucommia ulmoides, semen cuscutae, deerhorn glue and liquorice. The traditional Chinese medicine composition is reasonable, and strong in synergistic effect, and can serve as an osteoporosis treatment medicine for compatible application; clinical trials prove that the treatment effect of the traditional Chinese medicine composition is very remarkable.

Description

A kind of Chinese medicine composition for the treatment of osteoporosis and preparation method thereof

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, 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 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.

Chickpea has medical value widely, has continued to use more than 2500 year in the medical science of Uighur.It contains the nutrition of the abundant needed by human such as phytoprotein, lysine, crude fibre, linoleic acid, vitamin and magnesium, calcium, ferrum being easily absorbed by the body and digesting.There is the effects such as invigorating the spleen and replenishing QI, warming the kidney to invigorate YANG, nourishing the lung to arrest cough, building body, memory reinforcing, treatment diabetes and pneumonopathy.Especially having original curative effect to chest pain, pleuritic treatment, and have removing toxic substances, antiinflammatory, skin care, antidotal effect, is the food of the edible for a long time a kind of high protein of applicable middle-aged and elderly people, low starch, pure natural, is described as " king in the flower of nutrition, bean ".

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: chickpea bean sprout extract 5-30 part, Radix Astragali 6-15 part, Radix Codonopsis 9-30 part, Flos Carthami 3-9 part, Fructus Psoraleae 6-10 part, Radix Rehmanniae Preparata 9-15 part, Concha Ostreae 9-30 part, Rhizoma Curculiginis 2-5 part, Cortex Eucommiae 6-10 part, Semen Cuscutae 6-12 part, Colla cornus cervi 3-6 part and Radix Glycyrrhizae 1-10 part.

Preferably, described Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 10-20 part, Radix Astragali 10-15 part, Radix Codonopsis 10-20 part, Flos Carthami 4-6 part, Fructus Psoraleae 8-10 part, Radix Rehmanniae Preparata 10-15 part, Concha Ostreae 10-20 part, Rhizoma Curculiginis 3-5 part, Cortex Eucommiae 7-9 part, Semen Cuscutae 7-10 part, Colla cornus cervi 3-5 part and Radix Glycyrrhizae 5-10 part.

Preferably, described Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 15 parts, the Radix Astragali 12 parts, Radix Codonopsis 15 parts, 5 parts, Flos Carthami, Fructus Psoraleae 9 parts, Radix Rehmanniae Preparata 12 parts, Concha Ostreae 15 parts, Rhizoma Curculiginis 4 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 8 parts, Colla cornus cervi 4 parts and 8 parts, Radix Glycyrrhizae.

Preferably, described Chinese medicine composition is made into granule, powder, tablet, drop pill or capsule.

Accordingly, the preparation method of Chinese medicine composition of the present invention comprises the steps:

1) chickpea bean sprout extract is prepared: germinateed through 3-4 days by chickpea, pluck bean sprout, dry, be ground into coarse powder, adding coarse powder weight 15-20 times concentration is the ethanol water of 60-70%, be heated to 90 DEG C, reflux, extract, 2-3 time, each 1-2 hour, filter extracting solution, decompression filtrate recycling ethanol, through macroporous adsorptive resins absorption 6-8h, with distilled water and ethanol elution to colourless, at 60 DEG C, concentrating under reduced pressure under-0.1Mpa condition, pulverize, cross 80-100 mesh sieve, obtain chickpea bean sprout extract;

2) take Radix Codonopsis, Radix Rehmanniae Preparata, Rhizoma Curculiginis, Semen Cuscutae, pulverize, mix homogeneously, for subsequent use;

3) toward step 2) to add medicated powder weight 4-9 times concentration be the alcoholic solution of 60%-95% to Chinese medicine powder, reflux, extract, 2-3 time, return time is 2-5h, merging filtrate, retains filtering residue, filtrate recycling ethanol, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve after pulverizing, obtains extractum fine powder;

4) take the Radix Astragali, Flos Carthami, Fructus Psoraleae, Concha Ostreae, the Cortex Eucommiae, Radix Glycyrrhizae, pulverize, mix homogeneously, for subsequent use;

5) take Colla cornus cervi, add boiled water and melt, for subsequent use;

6) get step 4) Chinese medicine powder, add the Colla cornus cervi of filtering residue in step 3) and step 5), mixing, obtain mixture, add mixture weight 5-8 distilled water doubly, soak 12-24 hour, backflow decocts 1-3 hour, filters, and filtering residue adds mixture weight 5-6 distilled water doubly again, backflow decocts 1-2 hour, filters, merging filtrate, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve after pulverizing, obtains extractum fine powder;

7) by extractum fine powder mixing in extractum fine powder in chickpea bean sprout extract, step 3) in step 1) and step 6), stir, obtain Chinese medicine composition of the present invention.

Source, the nature and flavor of the present invention's component used, return through and effect:

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.

Concha Ostreae: this product is the shell of the long Concha Ostreae of Ostreidae animal; Salty in the mouth, cold nature; Return liver, gallbladder, kidney channel; Tranquillization with heavy prescription, YANG hyperactivity suppressing nourishing YIN, hard masses softening and resolving.

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.

Colla cornus cervi: for Cornu Cervi is endured through decocting, concentrated the solid gum made; Sweet in the mouth, salty, warm in nature; Return kidney, Liver Channel; Temperature compensation Liver and kidney, beneficial intensive culture blood.

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 chickpea bean sprout extract, Radix Codonopsis, the Radix Astragali for monarch drug, benefiting QI and nourishing blood, blood nourishing and calcium replenishing, enriching yin and nourishing kidney; With Concha Ostreae, 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 Fructus Psoraleae, Flos Carthami, the Cortex Eucommiae, Colla cornus cervi, 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 technical advantage:

1, Chinese medicine composition of the present invention have employed chickpea bean sprout extract, chickpea is rich in folic acid, potassium, magnesium, phosphorus, zinc, copper and vitamin B1, nicotinic acid also containing some, vitamin B6, pantothenic acid, calcium and fiber, by the synergism of chickpea bean sprout extract and other Chinese medicinal components, in vigorate qi and replenish the blood and replenishing the calcium is kept fit, effect is better;

2, 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;

3, 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 preparation of tablet

The embodiment of the present invention 1 Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 5 parts, the Radix Astragali 6 parts, Radix Codonopsis 9 parts, 3 parts, Flos Carthami, Fructus Psoraleae 6 parts, Radix Rehmanniae Preparata 9 parts, Concha Ostreae 9 parts, Rhizoma Curculiginis 2 parts, the Cortex Eucommiae 6 parts, Semen Cuscutae 6 parts, Colla cornus cervi 3 parts and 1 part, Radix Glycyrrhizae.

Preparation method is as follows:

1) prepare chickpea bean sprout extract: germinateed through 3 days by chickpea, pluck bean sprout, dry, be ground into coarse powder, adding coarse powder weight 15 times of concentration is the ethanol water of 60%, is heated to 90 DEG C, reflux, extract, 2 times, each 2 hours, filters extracting solution, decompression filtrate recycling ethanol, through macroporous adsorptive resins absorption 6h, with distilled water and ethanol elution to colourless, at 60 DEG C, concentrating under reduced pressure under-0.1Mpa condition, pulverize, cross 80 mesh sieves, obtain chickpea bean sprout extract;

2) take Radix Codonopsis, Radix Rehmanniae Preparata, Rhizoma Curculiginis, Semen Cuscutae, pulverize, mix homogeneously, for subsequent use;

3) toward step 2) to add medicated powder weight 4 times of concentration be the alcoholic solution of 60% to Chinese medicine powder, reflux, extract, 2 times, return time is 5h, merging filtrate, retains filtering residue, filtrate recycling ethanol, being evaporated to relative density under 65 DEG C of environment is the extractum of 1.20, drying under reduced pressure, crosses 80 mesh sieves after pulverizing, obtains extractum fine powder;

4) take the Radix Astragali, Flos Carthami, Fructus Psoraleae, Concha Ostreae, the Cortex Eucommiae, Radix Glycyrrhizae, pulverize, mix homogeneously, for subsequent use;

5) take Colla cornus cervi, add boiled water and melt, for subsequent use;

6) get step 4) Chinese medicine powder, add the Colla cornus cervi of filtering residue in step 3) and step 5), mixing, obtain mixture, add the distilled water of mixture weight 5 times, soak 12 hours, backflow decoction 1 hour, filter, filtering residue adds the distilled water of mixture weight 5 times again, backflow decoction 2 hours, filters, merging filtrate, being evaporated to relative density under 65 DEG C of environment is the extractum of 1.20, drying under reduced pressure, crosses 80 mesh sieves after pulverizing, obtains extractum fine powder;

7) by step 1) middle chickpea bean sprout extract, extractum fine powder mixing in extractum fine powder and step 6) in step 3), stir, the filler Icing Sugar of equivalent is added in mixture, 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 the Chinese medicine composition tablet of the embodiment of the present invention 1.

embodiment 2: the preparation of tablet

The embodiment of the present invention 2 Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 30 parts, the Radix Astragali 15 parts, Radix Codonopsis 30 parts, 9 parts, Flos Carthami, Fructus Psoraleae 10 parts, Radix Rehmanniae Preparata 15 parts, Concha Ostreae 30 parts, Rhizoma Curculiginis 5 parts, the Cortex Eucommiae 10 parts, Semen Cuscutae 12 parts, Colla cornus cervi 6 parts and 10 parts, Radix Glycyrrhizae.

Preparation method is with embodiment 1.

embodiment 3: the preparation of tablet

The embodiment of the present invention 3 Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 15 parts, the Radix Astragali 12 parts, Radix Codonopsis 15 parts, 5 parts, Flos Carthami, Fructus Psoraleae 9 parts, Radix Rehmanniae Preparata 12 parts, Concha Ostreae 15 parts, Rhizoma Curculiginis 4 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 8 parts, Colla cornus cervi 4 parts and 8 parts, Radix Glycyrrhizae.

Preparation method is with embodiment 1.

embodiment 4: the preparation of drop pill

The embodiment of the present invention 4 Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 5 parts, the Radix Astragali 6 parts, Radix Codonopsis 9 parts, 3 parts, Flos Carthami, Fructus Psoraleae 6 parts, Radix Rehmanniae Preparata 9 parts, Concha Ostreae 9 parts, Rhizoma Curculiginis 2 parts, the Cortex Eucommiae 6 parts, Semen Cuscutae 6 parts, Colla cornus cervi 3 parts and 1 part, Radix Glycyrrhizae.

Preparation method is as follows:

1) prepare chickpea bean sprout extract: germinateed through 4 days by chickpea, pluck bean sprout, dry, be ground into coarse powder, adding coarse powder weight 20 times of concentration is the ethanol water of 70%, is heated to 90 DEG C, reflux, extract, 3 times, each 1 hour, filters extracting solution, decompression filtrate recycling ethanol, through macroporous adsorptive resins absorption 8h, with distilled water and ethanol elution to colourless, at 60 DEG C, concentrating under reduced pressure under-0.1Mpa condition, pulverize, cross 100 mesh sieves, obtain chickpea bean sprout extract;

2) take Radix Codonopsis, Radix Rehmanniae Preparata, Rhizoma Curculiginis, Semen Cuscutae, pulverize, mix homogeneously, for subsequent use;

3) toward step 2) to add medicated powder weight 9 times of concentration be the alcoholic solution of 60% to Chinese medicine powder, reflux, extract, 3 times, return time is 2h, merging filtrate, retains filtering residue, filtrate recycling ethanol, being evaporated to relative density under 60 DEG C of environment is the extractum of 1.25, drying under reduced pressure, crosses 100 mesh sieves after pulverizing, obtains extractum fine powder;

4) take the Radix Astragali, Flos Carthami, Fructus Psoraleae, Concha Ostreae, the Cortex Eucommiae, Radix Glycyrrhizae, pulverize, mix homogeneously, for subsequent use;

5) take Colla cornus cervi, add boiled water and melt, for subsequent use;

6) get step 4) Chinese medicine powder, add the Colla cornus cervi of filtering residue in step 3) and step 5), mixing, obtain mixture, add the distilled water of mixture weight 8 times, soak 24 hours, backflow decoction 3 hours, filter, filtering residue adds the distilled water of mixture weight 6 times again, backflow decoction 2 hours, filters, merging filtrate, being evaporated to relative density under 60 DEG C of environment is the extractum of 1.25, drying under reduced pressure, crosses 100 mesh sieves after pulverizing, obtains extractum fine powder;

7) by step 1) middle chickpea bean sprout extract, extractum fine powder mixing in extractum fine powder and step 6) in step 3), stir, add the water-soluble base polyethylene glycol 6000 of mixture weight 5 times, mix homogeneously, heating, emulsifying obtains medicinal liquid, put into pill dripping machine and make drop, add 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, obtain the drop pill of the embodiment of the present invention 4 Chinese medicine composition.

embodiment 5: the preparation of drop pill

The embodiment of the present invention 5 Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 15 parts, the Radix Astragali 12 parts, Radix Codonopsis 15 parts, 5 parts, Flos Carthami, Fructus Psoraleae 9 parts, Radix Rehmanniae Preparata 12 parts, Concha Ostreae 15 parts, Rhizoma Curculiginis 4 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 8 parts, Colla cornus cervi 4 parts and 8 parts, Radix Glycyrrhizae.

Preparation method is with embodiment 4.

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 embodiment of the present invention 1,3 tablet 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 80 SD rats with pentobarbital sodium, wherein 70 excision bilateral ovaries, 10 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, by the high dose group (dosage 2.4g/Kg) of embodiment 1,3 tablet, middle dosage group (dosage 1.2g/Kg), low dose group (dosage 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:

This experiment makes laboratory animal with 80 rats, wherein 70 excision bilateral ovaries, and after excision bilateral ovaries, the hormone secretion of rat can change, other 10 then as blank group.Bone amount evaluates osteoporosis treatment effect " goldstandard " at present, bone density, calcium content of bone can distinguish never ipsilateral reflection bone amount, 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, there is 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.

Note: A, bone density refer 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.

B, pain are modal, the topmost symptoms of osteoporosis.Clinical the most common with lumbago and backache, for spinous process or have tenderness and percussion pain, with whole body skeleton pain.

C, 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:

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 110 example, and matched group 110 example, the age is 18 years old-79 years old, 48.5 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 (0.3g/ grain) that embodiment 3 prepares, 2 times on the one, serve on 3 months by each 2;

Matched group: take calcium that strange (Wyeth pharmaceuticals, 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

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.

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 (5)

1. treat the Chinese medicine composition of osteoporosis for one kind, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 5-30 part, Radix Astragali 6-15 part, Radix Codonopsis 9-30 part, Flos Carthami 3-9 part, Fructus Psoraleae 6-10 part, Radix Rehmanniae Preparata 9-15 part, Concha Ostreae 9-30 part, Rhizoma Curculiginis 2-5 part, Cortex Eucommiae 6-10 part, Semen Cuscutae 6-12 part, Colla cornus cervi 3-6 part and Radix Glycyrrhizae 1-10 part.

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: chickpea bean sprout extract 10-20 part, Radix Astragali 10-15 part, Radix Codonopsis 10-20 part, Flos Carthami 4-6 part, Fructus Psoraleae 8-10 part, Radix Rehmanniae Preparata 10-15 part, Concha Ostreae 10-20 part, Rhizoma Curculiginis 3-5 part, Cortex Eucommiae 7-9 part, Semen Cuscutae 7-10 part, Colla cornus cervi 3-5 part and Radix Glycyrrhizae 5-10 part.

3. the Chinese medicine composition for the treatment of osteoporosis as claimed in claim 2, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight: chickpea bean sprout extract 15 parts, the Radix Astragali 12 parts, Radix Codonopsis 15 parts, 5 parts, Flos Carthami, Fructus Psoraleae 9 parts, Radix Rehmanniae Preparata 12 parts, Concha Ostreae 15 parts, Rhizoma Curculiginis 4 parts, the Cortex Eucommiae 8 parts, Semen Cuscutae 8 parts, Colla cornus cervi 4 parts and 8 parts, Radix Glycyrrhizae.

4. the Chinese medicine composition of the treatment osteoporosis as described in as arbitrary in claim 1-3, is characterized in that: described Chinese medicine composition is made into granule, powder, tablet, drop pill or capsule.

5. prepare as arbitrary in claim 1-3 as described in the method for Chinese medicine composition for the treatment of osteoporosis, it is characterized in that comprising the steps:

1) chickpea bean sprout extract is prepared: germinateed through 3-4 days by chickpea, pluck bean sprout, dry, be ground into coarse powder, adding coarse powder weight 15-20 times concentration is the ethanol water of 60-70%, be heated to 90 DEG C, reflux, extract, 2-3 time, each 1-2 hour, filter extracting solution, decompression filtrate recycling ethanol, through macroporous adsorptive resins absorption 6-8h, with distilled water and ethanol elution to colourless, at 60 DEG C, concentrating under reduced pressure under-0.1Mpa condition, pulverize, cross 80-100 mesh sieve, obtain chickpea bean sprout extract;

2) take Radix Codonopsis, Radix Rehmanniae Preparata, Rhizoma Curculiginis, Semen Cuscutae, pulverize, mix homogeneously, for subsequent use;

3) toward step 2) to add medicated powder weight 4-9 times concentration be the alcoholic solution of 60%-95% to Chinese medicine powder, reflux, extract, 2-3 time, return time is 2-5h, merging filtrate, retains filtering residue, filtrate recycling ethanol, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve after pulverizing, obtains extractum fine powder;

4) take the Radix Astragali, Flos Carthami, Fructus Psoraleae, Concha Ostreae, the Cortex Eucommiae, Radix Glycyrrhizae, pulverize, mix homogeneously, for subsequent use;

5) take Colla cornus cervi, add boiled water and melt, for subsequent use;

6) get step 4) Chinese medicine powder, add the Colla cornus cervi of filtering residue in step 3) and step 5), mixing, obtain mixture, add mixture weight 5-8 distilled water doubly, soak 12-24 hour, backflow decocts 1-3 hour, filters, and filtering residue adds mixture weight 5-6 distilled water doubly again, backflow decocts 1-2 hour, filters, merging filtrate, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve after pulverizing, obtains extractum fine powder;

7) by extractum fine powder mixing in extractum fine powder in chickpea bean sprout extract, step 3) in step 1) and step 6), stir, obtain this Chinese medicine composition.