CN103301195A - Traditional Chinese medicine composition for treating osteoporosis and its preparation method - Google Patents

Traditional Chinese medicine composition for treating osteoporosis and its preparation method Download PDF

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CN103301195A
CN103301195A CN2012100605560A CN201210060556A CN103301195A CN 103301195 A CN103301195 A CN 103301195A CN 2012100605560 A CN2012100605560 A CN 2012100605560A CN 201210060556 A CN201210060556 A CN 201210060556A CN 103301195 A CN103301195 A CN 103301195A
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史传道
汶医宁
杨晓航
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Shaanxi University of Chinese Medicine
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Abstract

The invention discloses a traditional Chinese medicine composition for treating osteoporosis. The composition comprises the following components by weight: 25 to 30% of epimedium, 20 to 25% of the bark of eucommia, 10 to 25% of achyranthes root, 10 to 20% of bighead atractylodes rhizome and 20 to 30% of red sage root, wherein the weight percents of the above-mentioned components sum to 100%. The composition provided by the invention has the advantages of simple composition, rich medicine sources, easy preparation, convenient use, obvious curative effects, a low price and no side effects and is a safe, effective, economical and practical traditional Chinese medicine composition.

Description

A kind of Chinese medicine composition for the treatment of osteoporosis and preparation method thereof
Technical field
The invention belongs to the Chinese drug preparation technique field, relate to a kind of Chinese medicine composition for the treatment of osteoporosis and preparation method thereof.
Background technology
Osteoporosis (OP) is to deteriorate to feature with the minimizing of bone amount, bone microstructure, causes the fragility increase of bone and a kind of general skeletal diseases that is easy to fracture.Present osteoporotic sickness rate is up to 7%, and the status in commonly encountered diseases, frequently-occurring disease rises to the 7th gradually, and wherein 50-60 year sickness rate is 21%, and 60-70 year is almost to be 100% more than 58%, 70 years old, and especially postmenopausal women's sickness rate is higher.Investigation shows that the man and the woman above 40 years old that surpass 50 years old have degrees of osteoporotic.Along with China enters aging society, this sick sickness rate will constantly rise.So the further investigation of osteoporosis has been become at present a hot issue of medical circle.
At present, the medicine that is usually used in both at home and abroad treating osteoporosis clinically has bone resorption inhibitor, bone formation-promoter and bone mineralising medicine etc.But all there are certain shortcomings and deficiencies in various medicines, are the most frequently used medicines of postmenopausal osteoporosis as estrogen, strong inhibition bone resorption is arranged, promote osteoplastic effect, bring out dangerous side effect such as mastocarcinoma, carcinoma of endometrium but have simultaneously; There is the physiological absorption limit in the independent use of calcium preparation; Activated vitamin D can cause hypercalcemia; Calcitonin can cause shock; Though the protein anabolic hormone is kept by the bone amount and the enhancing of muscle has facilitation, can cause arteriosclerosis; It is very strong that two microcosmic salts suppress bone resorption, but the effect of long term administration also has a question.Other expensive medicines also have problem economically.Said circumstances impels the drug research, and the person seeks from Chinese medicine effectively and the little medicine of toxic and side effects, and it is eager and important to seem.
Primary disease belongs to categories such as Chinese medicine " rheumatism involving the bone ", " bone withers ", the modern Chinese medicine theory think osteoporotic generation mainly with suffer from a deficiency of the kidney, insufficiency of the spleen, three factors of blood stasis are relevant.Suffering from a deficiency of the kidney is osteoporotic main pathogenesis, and insufficiency of the spleen is osteoporotic important pathogenesis, and blood stasis is osteoporotic increasing the weight of or promoting factor.Method for the treatment of is worked as with the kidney invigorating, spleen invigorating, invigorated blood circulation is principle for the treatment of.Chinese medicine has a clear superiority in respect to western medicine, and it both can suppress bone resorption, can promote osteogenesis again, has tangible dual regulation, and its Therapeutic Method no pain, not damaged can effectively improve patient's symptom.
Chinese medicine (medical herbs) compound treatment osteoporosis has multicomponent, many target spots, good, the few side effects of safety, both can suppress bone resorption simultaneously, can promote osteogenesis again, has characteristics such as tangible dual regulation, has become the focus of research at present.At present, the osteoporotic Chinese patent medicine of existing treatment is many based on kidney and spleen invigorating, for increasing the weight of or the treatment effectively and timely of promoting factor " blood stasis " shortage, causes the state of an illness to improve or further to increase the weight of.Therefore, develop the comprehensive Chinese medicine preparation for the treatment of and have more urgency.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of osteoporosis, solved that existing western medicine target spot is single, side effect is many, expensive, and existing treatment by Chinese herbs not comprehensively, the problem of DeGrain.
Another object of the present invention is to, a kind of preparation method for the treatment of the Chinese medicine composition of osteoporosis is provided, guarantee drug effect, simplify production technology, reduce cost of manufacture, conveniently take.
The invention provides a kind of Chinese medicine composition for the treatment of osteoporosis, composed of the following components by weight percentage, Herba Epimedii 25~30%, the Cortex Eucommiae 20~25%, Radix Achyranthis Bidentatae 10~25%, the Rhizoma Atractylodis Macrocephalae 10~20%, Radix Salviae Miltiorrhizae 20~30%, the percentage by weight summation of above each component is 100%.
Pharmaceutical composition of the present invention is preparation like this, and Herba Epimedii, the Cortex Eucommiae, Radix Achyranthis Bidentatae, the Rhizoma Atractylodis Macrocephalae, the Radix Salviae Miltiorrhizae of getting above-mentioned recipe quantity add the water of 8~12 times of amounts, and merceration 2~4h decocts 1.0~1.5h, filters filtrate for later use; Medicinal residues add 8~10 times of water gagings, decoct 0.5~1.0h, filter filtrate for later use; Medicinal residues add 6~8 times of water gagings, decoct 0.5~1.0h, filter, and merge three times filtrate, be concentrated into every 1ml and be equivalent to medical material 2.0~2.5g, add 95% ethanol of 1.5~3 times of amounts, stir evenly, leave standstill 24h, filter, decompression filtrate recycling ethanol, being concentrated into relative density is 1.10~1.30 (80 ℃) clear paste; By clear paste: dextrin: Icing Sugar is to mix at 1: 2: 2, granulates 80 ℃ of dryings, granulate, packing.
In order to verify drug effect of the present invention, carried out following pharmacodynamic experiment
1, to the influence of osteoporosis model rat bone density and bone biomechanical:
Animal grouping and modeling: 60 rat adaptabilities are divided into sham operated rats (10) and castration group (50) after feeding for 1 week at random.The castration group is divided 5 groups at random according to table of random number after 1 week, and 10 every group, namely model group, nilestriol group, Chinese medicine composition small dose group of the present invention, middle dosage group, heavy dose are organized.Except sham operated rats, all the other 5 groups of rats underwent ovarian resections modelings.The sham operated rats otch is the same, enter the abdominal cavity after, do not excise after finding ovary, only the left and right sides omentum majus of excision and bilateral ovaries similar weight is each one section, debridement and suturing and postoperative are disposed identical with ovariectomized group.
Medication: the large, medium and small dosage treatment group of Chinese medicine composition of the present invention gives Chinese medicine composition suspension 0.4g/ml of the present invention, 0.2g/ml, 0.1g/ml respectively, 2ml/d, and every day 1 time is totally 12 weeks.The nilestriol group gives Nilestriol Tablets (1mg/kg body weight), is made into the 0.15mg/ml suspension, 1 week 1 time, and each 2ml, 6 the filling stomaches of surplusing are identical with sham operated rats, totally 12 weeks.Model group and sham operated rats are irritated stomach, every day 1 time, totally 12 weeks with normal saline (8ml/kg body weight).Weigh weekly once in the process of the test, adjust dosage according to body weight.
Test item: each treated animal under aseptic, anesthesia, is got lumbar vertebra and bilateral femur all after 12 weeks of medication, peels off and reject tissues such as muscle.Lumbar vertebra and a side distal part of femur adopt dual intensity X line borne densitometers to measure bone density.The opposite side femur adopts electronic universal tester to make the femur three point bending test.
Result of the test: compare with model group, the lumbar vertebra of the big or middle dosage group of Chinese medicine composition of the present invention and distal femur bone density all have significance to increase (P<0.01), see Table 1; Compare with model group, the maximum load of the big or middle dosage group of Chinese medicine composition of the present invention and nilestriol group significantly increases (P<0.01), but low dose of no significant difference (p>0.05); Fracture amount of deflection each dosage group of Chinese medicine composition of the present invention and model group relatively though rising trend is arranged, do not have significant change (p>0.05); With model group relatively, the flexional significance of nilestriol group, the heavy dose of group of Chinese medicine composition of the present invention increases (P<0.01), though in, small dose group has rising trend, do not have significant change (p>0.05), sees Table 2.
Table 1: rat lumbar vertebra, distal femur bone density change
Annotate: compare with model group, *P<0.01; Compare with sham operated rats, P<0.01; Compare with model group,
Figure BSA00000681525000042
Table 2: rat bone biomechanics index changes
Figure BSA00000681525000043
Annotate: compare with model group, *P<0.01; Compare with sham operated rats ' P<0.01; Compare with model group,
Figure BSA00000681525000044
Chinese medicine composition of the present invention can improve bone density and bone biomechanical property, recovers the bone metabolism balance, thereby reaches the osteoporotic effect of control.
2, to the influence of osteoporosis model rat bone tissue morphological change:
Animal grouping and modeling: 60 rat adaptabilities are divided into sham operated rats (10) and castration group (50) after feeding for 1 week at random.The castration group is divided 5 groups at random according to table of random number after 1 week, and 10 every group, namely model group, nilestriol group, Chinese medicine composition small dose group of the present invention, middle dosage group, heavy dose are organized.Except sham operated rats, all the other 5 groups of rats underwent ovarian resections modelings.The sham operated rats otch is the same, enter the abdominal cavity after, do not excise after finding ovary, only the left and right sides omentum majus of excision and bilateral ovaries similar weight is each one section, debridement and suturing and postoperative are disposed identical with ovariectomized group.
Medication: the large, medium and small dosage treatment group of Chinese medicine composition of the present invention gives Chinese medicine composition suspension 0.4g/ml of the present invention, 0.2g/ml, 0.1g/ml respectively, 2ml/d, and every day 1 time is totally 12 weeks.The nilestriol group gives Nilestriol Tablets (1mg/kg body weight), is made into the 0.15mg/ml suspension, 1 week 1 time, and each 2ml, 6 the filling stomaches of surplusing are identical with sham operated rats, totally 12 weeks.Model group and sham operated rats are irritated stomach, every day 1 time, totally 12 weeks with normal saline (8ml/kg body weight).Weigh weekly once in the process of the test, adjust dosage according to body weight.
Collection of specimens: every treated animal carries out tetracycline marker, 30mg/Kg.d before putting to death.First administration before execution the 14th day, the 2nd time before execution the 5th day.After nursing to 12 week, with 10% chloral hydrate 400mg/Kg, lumbar injection after anesthesia comes into force, is got the right side tibia, peels off and reject surrounding soft tissue, and it is fixing to put into 80% ethanol immediately.
Preparation of specimen: (1) is fixing; (4) infiltration; (5) embedding; (6) section; (7) Toluidine blue staining.
Index detects and method: (1) Trabecula Bone Volume percentage ratio (TBV%); (2) bone trabecula sorbent surface percentage ratio (TRS%); (3) bone trabecula forms surface percentage (TFS%); (4) bone trabecula mineralization rate (MAR); (5) osteoid mean breadth (OSW): the mean breadth of cortex inner surface osteoid; (6) cortical bone mineralization rate (mAR).Detection method: with made undecalcified bone slice, the thick section observed under fluorescence microscope, slice is respectively with after the Toluidine blue staining, uses the full-automatic image analysis system of Leiea Q-Win Stander V2.3 to carry out image analysis, draws the data of each parameter and calculates.
Experimental result: bone aspect graph picture shows that intuitively sham operated rats rat bone trabecularism is arranged closely in order, connects between bone trabecula and closely is netted; Model group rat bone trabecularism is arranged loose, and quantity obviously reduces, and loses connection between bone trabecula, and the bone trabecula cecum significantly increases, and presents button shape bone trabecula.Under the cryptoscope, more area of tetracycline label line appears in the bone trabecula edge; The bone trabecular quantity of nilestriol group rat obviously increases than model group, and bone trabecula connects tightr, can be observed certain network structure; Relatively increasing degree is less for Chinese medicine composition small dose group rat bone girder of the present invention and model group, loses connection between bone trabecula, and cecum increases; The big or middle dosage group of Chinese medicine composition of the present invention rat bone girder and model group significantly increase, and bone trabecula is arranged tightr, can be observed netted connection between bone trabecula, and bone trabecula thickness increases obviously (seeing Fig. 1-6).
Compare with model group, the big or middle dosage group of Chinese medicine composition of the present invention bone trabecula significantly increases, and bone trabecula is arranged tightr, visible netted connection between bone trabecula, and bone trabecula thickness increases; With the sham operated rats ratio, model group is than the obvious decline of Trabecula Bone Volume percentage ratio (TBV%) (P<0.01); The nilestriol group, Chinese medicine composition of the present invention is big or middle and model group relatively, TBV obviously increases (p<0.01), and is certain dose dependent.Model group obviously increases (p<0.01) than sham operated rats bone resorption parameter (TRS), bone formation parameter (TFS); With big or middle bone resorption parameter TRS, bone formation parameter (TFS), MAR, mAR and the osw (P<0.01 or P<0.05) of all reducing of model group Chinese medicine composition more of the present invention.See Table 3 and see Table 4.
Table 3 is respectively organized the morphologic comparison of osseous tissue
Figure BSA00000681525000061
Figure BSA00000681525000062
Annotate: compare with model group, *P<0.01; Compare with sham operated rats, P<0.01
Table 4 is respectively organized the comparison of cortical bone inner surface tectology
Figure BSA00000681525000071
Figure BSA00000681525000072
Annotate: compare with model group, *P<0.01, P<0.05,
Figure BSA00000681525000073
Chinese medicine composition of the present invention can improve bone norphometry mathematic(al) parameter, and osteoporosis is had certain therapeutical effect.
3, to the influence of TNF-α and NO in the osteoporosis model rat blood serum:
Animal grouping and modeling: the rat adaptability fed for 2 weeks, the modeling of row ovarian resection.Sham operated rats, only the left and right sides omentum majus of excision and bilateral ovaries similar weight is each one section.The rat of removal ovary is divided into 5 groups at random, 12 every group, add 12 of normal rats, be divided into: (1) sham operated rats; (2) model group; (3) Neil
Female alcohol group; (4) Chinese medicine composition small dose group; (5) dosage group in the Chinese medicine composition; (6) the heavy dose of group of Chinese medicine composition.
Medication: the large, medium and small dosage treatment group of Chinese medicine composition gives Chinese medicine composition suspension 2.78g/ml, 1.39g/ml, 0.70g/ml respectively, 2ml/d, every day 1 time, 6 times weekly, totally 12 weeks.The nilestriol group gives Nilestriol Tablets (1mg/kg body weight), is made into 0.15mg/ml suspension oral gavage 1 week 1 time, irritates stomach weekly altogether 6 times, surpluss that to irritate stomaches for 5 times identical with sham operated rats, totally 12 weeks.Model group and sham operated rats are irritated stomach with normal saline (6.67ml/kg body weight), every day 1 time, 6 times weekly, totally 12 weeks.Claim body weight in the process of the test weekly one time, adjust dosage according to body weight.
Handle and index determining: each treated animal all after 12 weeks of medication, at the descending 10% chloral hydrate intraperitoneal injection of anesthesia of aseptic condition, separates jugular vein or carotid artery and gets blood, separation of serum.Measure TNF-α and NO content (with reference to tumor necrosis factor (TNF-α) test kit and nitric oxide (NO) test kit description operation) in the serum respectively with double-antibody sandwich enzyme linked immunosorbent assay (ELISA) and nitrate reductase method.
Result of the test: TNF-α, NO content in the serum, Chinese medicine composition small dose group of the present invention and model group no significant difference (P>0.05); The big or middle dosage group of Chinese medicine composition of the present invention and nilestriol group and model group relatively have utmost point significant difference (P<0.01), and the big or middle dosage group of Chinese medicine composition of the present invention and nilestriol group be no significant difference (P>0.05) relatively.See Table 5.
Table 5 is respectively organized rat blood serum TNF-α, NO content relatively
Figure BSA00000681525000081
Figure BSA00000681525000082
Annotate: * and sham operated rats compare, p<0.01; * and model group compare, p<0.01; Compare p>0.05 with model group; Compare p>0.05 with the nilestriol group.
Chinese medicine composition of the present invention is by reducing TNF-alpha content in the serum, and balance serum NO content suppresses the activity of osteoclast, improves bone metabolism and reaches the effect of control postmenopausal osteoporosis.
4, to the influence of TGF β 1 and BMP-2 in the castration osteoporosis rat serum:
Animal grouping and modeling: the rat adaptability fed for 2 weeks, the modeling of row ovarian resection.Sham operated rats, only the left and right sides omentum majus of excision and bilateral ovaries similar weight is each one section.The rat of removal ovary is divided into 5 groups at random, 12 every group, add 12 of normal rats, be divided into: (1) sham operated rats; (2) model group; (3) nilestriol group; (4) Chinese medicine composition small dose group; (5) dosage group in the Chinese medicine composition; (6) the heavy dose of group of Chinese medicine composition.
Medication: the large, medium and small dosage treatment group of Chinese medicine composition gives Chinese medicine composition suspension 2.78g/ml, 1.39g/ml, 0.70g/ml respectively, 2ml/d, every day 1 time, 6 times weekly, totally 12 weeks.The nilestriol group gives Nilestriol Tablets (1mg/kg body weight), is made into 0.15mg/ml suspension oral gavage 1 week 1 time, irritates stomach weekly altogether 6 times, surpluss that to irritate stomaches for 5 times identical with sham operated rats, totally 12 weeks.Model group and sham operated rats are irritated stomach with normal saline (6.67ml/kg body weight), every day 1 time, 6 times weekly, totally 12 weeks.Claim body weight in the process of the test weekly one time, adjust dosage according to body weight.
Handle and index determining: each treated animal all after 12 weeks of medication, at the descending 10% chloral hydrate intraperitoneal injection of anesthesia of aseptic condition, separates jugular vein or carotid artery and gets blood, separation of serum.Measure TGF β 1 and BMP-2 content (with reference to transforminggrowthfactor-(TGF β 1) test kit and bone morphogenesis protein-2 (BMP-2) test kit description operation) in the serum with double-antibody sandwich enzyme linked immunosorbent assay (ELISA).
Result of the test: TGF β 1, BMP-2 content in the serum, Chinese medicine composition small dose group of the present invention and model group no significant difference (P>0.05); The big or middle dosage group of Chinese medicine composition of the present invention and nilestriol group and model group relatively have utmost point significant difference (P<0.01), and the big or middle dosage group of Chinese medicine composition of the present invention and nilestriol group be no significant difference (P>0.05) relatively.See Table 6.
Table 6 is respectively organized rat blood serum TGF β 1, BMP-2 content relatively
Figure BSA00000681525000091
Figure BSA00000681525000092
Annotate: * and sham operated rats compare, p<0.01; * and model group compare, p<0.01; Compare p>0.05 with model group; ▲ ▲Compare p>0.05 with the nilestriol group.
Chinese medicine composition of the present invention is the activity that suppresses osteoclast by TGF β 1 in the rising serum, BMP-2 content, increases the osteoblast activity, improves bone metabolism and reaches the effect of control postmenopausal osteoporosis.
5, to the influence of castration osteoporosis rat bone alkaline phosphatase, urinary hydroxyproline:
Animal grouping and modeling: rat is divided into sham operated rats, model group, nilestriol group, the large, medium and small dosage group of Chinese medicine composition (15 every group) immediately.With rat with 2% pentobarbital sodium (dosage is 60mg/kg) intraperitoneal injection of anesthesia after, the position of bowing is fixing, at spinal column both sides, back otch, extracts bilateral ovaries as the osteoporosis rat model under aseptic condition, the sham operated rats bilateral excises a fritter fat.
Medication: postoperative 3 months, each is organized rat and is irritated stomach respectively, sham operated rats, model group give normal saline 8ml/kg/d every day and irritate stomach, the nilestriol group gives nilestriol 1mg/kg and irritates stomach, be made into suspension (concentration is 0.125mg/ml) before using, 1 time/week, all the other times give distilled water 8ml/kg/d and irritate stomach.The large, medium and small dosage component of Chinese medicine composition gives the large, medium and small dosage group of Chinese medicine composition suspension 8ml/kg/d for 2 times.Irritate stomach and put to death animal after 3 months.
Handle and index determining: it is standby that 24h urine was also collected in the 4d fasting respectively before experiment finished, and measures urinary hydroxyproline with the sample alkali hydrolysis method.Each is organized rat and finishes the back sacrificed by decapitation in the 12nd week, gets blood immediately, separation of serum, and the ELISA method is measured serum BALP content (with reference to BALP test kit description operation).
Result of the test: the content of Chinese medicine composition small dose group bone alkaline phosphatase of the present invention, urinary hydroxyproline and model group there was no significant difference (P>0.05), big or middle dosage group and nilestriol group and model group relatively have significant difference (P<0.05); The heavy dose of group of Chinese medicine composition of the present invention bone alkaline phosphatase, urinary hydroxyproline content and nilestriol group be there was no significant difference (P>0.05) relatively.See Table 7.
The content that table 7 is respectively organized rat bone alkali phosphatase, urinary hydroxyproline compares
Figure BSA00000681525000101
Figure BSA00000681525000102
Annotate: Compare P<0.01 with sham operated rats; Compare P<0.05 with model group; With the model group ratio; , P>0.05; Compare P>0.05 with the nilestriol group.
Chinese medicine composition of the present invention reduces the serum bone alkaline phosphatase, urinary hydroxyproline content is one of mechanism of control postmenopausal osteoporosis.
Clinical observation
(1) method: 1. case collection: 76 examples are divided into treatment and organize 40 examples, matched group 36 examples.Maximum 77 years old age of wherein treatment group, minimal ages 49 years old, the mean age is 61.7 years old; The course of disease is the longest 19 years, and is the shortest 4 months, average course of disease 6.5 years.Maximum 78 years old age of matched group, minimal ages 48 years old, the mean age is 62.7 years old; The course of disease is the longest 20 years, and is the shortest 3 months, average course of disease 6.6 years.Two groups at many indexs such as age, the menopause time limit, the state of an illness, vital signs relatively, and there are no significant for difference (P>0.05), two groups of symptoms and syndrome relatively there are no significant difference.2. diagnostic criteria: " osteoporosis " according to Liu Zhonghou formulated: menolipsis had lumbar and back pain or whole body osteodynia more than 1 year; The bone amount is low 2.5 more than the standard deviation than normal person group; Phosphorus, alkali phosphatase and blood calcium are all normal; Eliminating is caused a disease because suffering from incretion diseases such as thyroid, hyperparathyroidism and diabetes, and does not have serious diseases such as Liver and kidney; Not used hormone or other influence the medicine of bone metabolism in half a year.3. curative effect determinate standard: draft according to " new Chinese medicine clinical research guideline " standard.Recovery from illness: no pain, soreness of the waist and knees, lower limb are short soft unable, and the vertigo and tinnitus symptom is obviously improved, and bone density value improves more than 2%.Effectively: pain obviously alleviates, soreness of the waist and knees, and short soft unable, the vertigo and tinnitus symptom of lower limb is partly improved, and bone density value improves between (0-2) %.Invalid: each side does not all have improvement.All adopt dual intensity X line bone densitometry instrument to measure lumbar vertebra (L before and after all patient treatments 2~L 4) and the bone density (BMD) of fl neck.Bone density criterion of therapeutical effect computational methods: (T score value percentage ratio before treatment back T score value percentage ratio-treatment) * 100%.2. Therapeutic Method: the treatment group gives Chinese medicine composition composition granule of the present invention, each 10g (being equivalent to crude drug 13.2 grams), every day 3 times, warm boiled water.The oral Gaierqi D (vitamin D3 and calcium carbonate) of matched group, each 1, once a day.6 months whole courses for the treatment of.
The result: 1. two groups for the treatment of front and back bone densities contrast (gcm -2,
Figure BSA00000681525000121
): the preceding two groups of patient vertebral body (L of medication 2~L 4) and femoral neck bone bone density there was no significant difference (P>0.05), all than obviously increasing (P<0.05) before the medication, and treatment group bone density changes than matched group significantly (P<0.05) after the medication.See Table 8.
Bone density changes before and after table 8 treatment
Figure BSA00000681525000122
2. treat front and back Comparison of therapeutic treatment group total effective rates 87.5% for two groups, 75.0%, two group of comparing difference of matched group total effective rate has statistical significance (P<0.05).See Table 9.
Curative effect changes before and after table 9 treatment
Figure BSA00000681525000123
(3) conclusion: the curative effect of Chinese medicine composition of the present invention is better than Gaierqi D (vitamin D3 and calcium carbonate), and low price, therefore is worth further research promotion.
Description of drawings
Fig. 1: sham operated rats
Fig. 2: model group
Fig. 3: the heavy dose of group of Chinese medicine composition of the present invention
Fig. 4: dosage group in the Chinese medicine composition of the present invention
Fig. 5: Chinese medicine composition small dose group of the present invention
Fig. 6: double labelling line on the bone trabecula
The specific embodiment
Embodiment 1
Herba Epimedii, the Cortex Eucommiae, Radix Achyranthis Bidentatae, the Rhizoma Atractylodis Macrocephalae, the Radix Salviae Miltiorrhizae of getting above-mentioned recipe quantity add the water of 12 times of amounts, and merceration 4h decocts 1.0h, filters filtrate for later use; Medicinal residues add 10 times of water gagings, decoct 0.5h, filter filtrate for later use; Medicinal residues add 8 times of water gagings, decoct 0.5h, filter, and merge three times filtrate, be concentrated into every 1ml and be equivalent to medical material 2.5g, add 95% ethanol of 1.5 times of amounts, stir evenly, leave standstill 24h, filter, decompression filtrate recycling ethanol, being concentrated into relative density is 1.10~1.30 (80 ℃) clear paste; By clear paste: dextrin: Icing Sugar is to mix at 1: 2: 2, granulates 80 ℃ of dryings, granulate, packing.
Embodiment 2
Herba Epimedii, the Cortex Eucommiae, Radix Achyranthis Bidentatae, the Rhizoma Atractylodis Macrocephalae, the Radix Salviae Miltiorrhizae of getting above-mentioned recipe quantity add the water of 10 times of amounts, and merceration 3h decocts 1.5h, filters filtrate for later use; Medicinal residues add 8 times of water gagings, decoct 1.0h, filter filtrate for later use; Medicinal residues add 6 times of water gagings, decoct 1.0h, filter, and merge three times filtrate, be concentrated into every 1ml and be equivalent to medical material 2.0~2.5g, add 95% ethanol of 2 times of amounts, stir evenly, leave standstill 24h, filter, decompression filtrate recycling ethanol, being concentrated into relative density is 1.10~1.30 (80 ℃) clear paste; By clear paste: dextrin: Icing Sugar is to mix at 1: 2: 2, granulates 80 ℃ of dryings, granulate, packing.
Embodiment 3
Herba Epimedii, the Cortex Eucommiae, Radix Achyranthis Bidentatae, the Rhizoma Atractylodis Macrocephalae, the Radix Salviae Miltiorrhizae of getting above-mentioned recipe quantity add the water of 8 times of amounts, and merceration 2h decocts 1.0h, filters filtrate for later use; Medicinal residues add 9 times of water gagings, decoct 1.0h, filter filtrate for later use; Medicinal residues add 7 times of water gagings, decoct 0.5h, filter, and merge three times filtrate, be concentrated into every 1ml and be equivalent to medical material 2.0~2.5g, add 95% ethanol of 2.5 times of amounts, stir evenly, leave standstill 24h, filter, decompression filtrate recycling ethanol, being concentrated into relative density is 1.10~1.30 (80 ℃) clear paste; By clear paste: dextrin: Icing Sugar is to mix at 1: 2: 2, granulates 80 ℃ of dryings, granulate, packing.
Embodiment 4
Herba Epimedii, the Cortex Eucommiae, Radix Achyranthis Bidentatae, the Rhizoma Atractylodis Macrocephalae, the Radix Salviae Miltiorrhizae of getting above-mentioned recipe quantity add the water of 10 times of amounts, and merceration 4h decocts 1.5h, filters filtrate for later use; Medicinal residues add 8 times of water gagings, decoct 0.5h, filter filtrate for later use; Medicinal residues add 6 times of water gagings, decoct 0.5h, filter, and merge three times filtrate, be concentrated into every 1ml and be equivalent to medical material 2.0~2.5g, add 95% ethanol of 3 times of amounts, stir evenly, leave standstill 24h, filter, decompression filtrate recycling ethanol, being concentrated into relative density is 1.10~1.30 (80 ℃) clear paste; By clear paste: dextrin: Icing Sugar is to mix at 1: 2: 2, granulates 80 ℃ of dryings, granulate, packing.

Claims (2)

1. a Chinese medicine composition for the treatment of osteoporosis is characterized in that, and is composed of the following components by weight percentage, Herba Epimedii 25~30%, the Cortex Eucommiae 20~25%, Radix Achyranthis Bidentatae 10~25%, the Rhizoma Atractylodis Macrocephalae 10~20%, Radix Salviae Miltiorrhizae 20~30%, the percentage by weight summation of above each component is 100%.
2. the preparation method of the described Chinese medicine composition of claim 1 is characterized in that, Herba Epimedii, the Cortex Eucommiae, Radix Achyranthis Bidentatae, the Rhizoma Atractylodis Macrocephalae, the Radix Salviae Miltiorrhizae of getting above-mentioned recipe quantity add the water of 8~12 times of amounts, and merceration 2~4h decocts 1.0~1.5h, filters filtrate for later use; Medicinal residues add 8~10 times of water gagings, decoct 0.5~1.0h, filter filtrate for later use; Medicinal residues add 6~8 times of water gagings, decoct 0.5~1.0h, filter, and merge three times filtrate, be concentrated into every 1ml and be equivalent to medical material 2.0~2.5g, add 95% ethanol of 1.5~3 times of amounts, stir evenly, leave standstill 24h, filter, decompression filtrate recycling ethanol, being concentrated into relative density is 1.10~1.30 (80 ℃) clear paste; By clear paste: dextrin: Icing Sugar is to mix at 1: 2: 2, granulates 80 ℃ of dryings, granulate, packing.
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CN104127861A (en) * 2014-07-31 2014-11-05 漳州片仔癀药业股份有限公司 Pharmaceutical composition with bone mineral density increasing function and preparation method thereof
CN104382990A (en) * 2014-11-21 2015-03-04 江苏鹏鹞药业有限公司 Composition of herba epimedii, eucommia ulmoides and salviae miltiorrhizae and application of composition

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104127861A (en) * 2014-07-31 2014-11-05 漳州片仔癀药业股份有限公司 Pharmaceutical composition with bone mineral density increasing function and preparation method thereof
CN104127861B (en) * 2014-07-31 2016-08-17 漳州片仔癀药业股份有限公司 A kind of have pharmaceutical composition increasing bone density effect and preparation method thereof
CN104382990A (en) * 2014-11-21 2015-03-04 江苏鹏鹞药业有限公司 Composition of herba epimedii, eucommia ulmoides and salviae miltiorrhizae and application of composition

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