CN1907424A - Orthopaedics disease treating and preventing medicinal composition - Google Patents
Orthopaedics disease treating and preventing medicinal composition Download PDFInfo
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- CN1907424A CN1907424A CN 200510088837 CN200510088837A CN1907424A CN 1907424 A CN1907424 A CN 1907424A CN 200510088837 CN200510088837 CN 200510088837 CN 200510088837 A CN200510088837 A CN 200510088837A CN 1907424 A CN1907424 A CN 1907424A
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Abstract
The invention provides a Chinese medicinal composition for the effective prevention and treatment of orthopaedic diseases, which comprises longspur epimedium and asphonin, and has better effect than single constituent.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of prevention and treatment orthopaedic disease, specifically the pharmaceutical composition of Herba Epimedii and Rhizoma Anemarrhenae effective extract composition.
Background technology
Orthopaedic disease be one worldwide, more and more cause the health problem that people pay attention to.For example, about 200,000,000 people in the whole world suffer from osteoporosis at present, and its sickness rate has leapt to commonly encountered diseases, frequently-occurring disease the 7th.Current research shows that in fact the osteoporosis in that China is considered to the peculiar disease of old people always just exists in the Childhood.Along with aged tendency of population becomes clear day by day, as the degenerative disease of person in middle and old age's pilosity--osteoporosis and complication thereof have become a social health problem and have enjoyed geriatrist's concern, and caused social great attention.Safe and effective radical cure method is not medically also arranged at present, help loose skeleton to restore to the original state.The orthopaedics aspect also has the sickness rate of arthritis, hyperosteogeny diseases also more and more higher, has had a strong impact on the raising of people's quality of life.Therefore, a kind of medicine that can effectively prevent and treat orthopaedic disease of exploitation has important medical and social meaning.
Herba Epimedii is the leaf of Berberidaceae barrenwort Herba Epimedii.Compendium of Material Medica is put down in writing it and is had effects such as " beneficial vital essence, hard muscles and bones are mended the waist knee joint, heart tonifying power "; The action range of Herba Epimedii, as to cardiovascular system, central nervous system, blood system, immune system, antiinflammatory, osteoporosis, defying age, antitumor etc. all with the effect.Herba Epimedii is traditional kidney invigorating and YANG supporting Chinese medicine, all contains Herba Epimedii in the Chinese medicine in the prescription of many treatment osteoporosis.Modern pharmacology studies have shown that the main chemical compositions of Herba Epimedii is flavone and polysaccharide, the effective site of a large amount of research surface barrenwort for treating osteoporosis is flavone (Chinese natural drug, 2004,7,2 (4), 235-239), it can promote osteoblastic proliferation and (or) strengthen its mineralization ability, effectively preventing osteoporosis.
The Rhizoma Anemarrhenae is the liliaceous plant Rhizoma Anemarrhenae (Anemarrhena asphodeloides) rhizome, and bitter but sweet flavor is cold in nature, go into lung, stomach, kidney channel.Have clearing away heat-fire, promote the production of body fluid and effect such as moisturize.Rhizoma Anemarrhenae chemical constituent be mainly steroidal saponin, two benzene pyrrones (chimonin, Isomangiferin), lignanoids, polysaccharide (that anemaran A ~ D), organic acid (nicotinic acid, tannic acid etc.), a large amount of phlegmatic temperament, trace do not have is plain (ferrum, zinc, copper, manganese, cobalt, nickel etc., wherein the highest with ferrum, zinc content), other (pentacosane vinyl acetate, cupreol, beta-stigmasterol).Rhizoma Anemarrhenae master contains saponin, and rhizome contains saponin about 6%.Rhizoma Anemarrhenae chimonin has significant antiinflammatory action.Animal model confirm Rhizoma Anemarrhenae total polysaccharides (TPA) to the acute capillary permeability that multiple proinflammatory agent causes increase, inflammatory exudation increases and tissue edema all has the obvious suppression effect.The chronic granuloma hypertrophy there is remarkable inhibitory action.Research thinks that TPA can strengthen adrenal gland's function, minimizing ACTH secretion, release, and suppress synthesizing or release of PGE.
The medicine of treatment orthopaedic disease normally contains estrogenic chemicals in the modern medicine, and drug side effect is big during clinical use, and Chinese medicine is because of its special effect and the little favor of firmly getting doctor and patient of side effect.Retrieval existing literature and patent find that the Herba Epimedii and the Rhizoma Anemarrhenae are widely used in Chinese traditional treatment osteoporosis and the antiphlogistic prescription, and multi-flavor even tens flavor Chinese medicines use simultaneously but it is write out a prescription normally, and using method is generally simple pill and powder.We discover that the prescription that two kinds of drug extracts of Herba Epimedii and the Rhizoma Anemarrhenae are only formed just can well bring into play their synergism, and using mutually separately with their, specific energy improves drug effect and clinical efficacy significantly.After deliberation, I make advanced clinically capsule, injection and freeze-dried powder injection with this pharmaceutical composition, have improved drug effect also for clinical use provides a kind of rapid-action, the brand-new Chinese medicine of treatment orthopaedic disease that curative effect is clear and definite.Simplified prescription and process for preparing medicine simultaneously and be convenient to industrial implementation and clinical practice, for clinical prevention and treatment orthopaedic disease provide a kind of new effective drug regimen.
Summary of the invention
Through us a large amount of scientific researches and clinical trial, the compositions of having found Herba Epimedii extract and Rhizoma Anemarrhenae extract has the effect of very strong prevention and treatment orthopaedic disease, and this invention has been done further perfect, this compositions made be convenient to the pharmaceutical preparation that clinical implementation is used.
An object of the present invention is to provide and a kind ofly can effectively prevent and treat the Herba Epimedii extract of orthopaedic disease and the pharmaceutical composition of Rhizoma Anemarrhenae extract, it is more more effective than using the Herba Epimedii and the Rhizoma Anemarrhenae separately to prove its effect through pharmacology and clinical trial.
Another object of the present invention provides a kind of production technology for preparing above compositions.
Take by weighing Herba Epimedii 5kg, add 70% ethanol extraction 3 times of 10 times of amounts, each 1.5 hours, reclaim ethanol, water-bath concentrates, and evaporate to dryness gets Herba Epimedii total flavones.
Get Rhizoma Anemarrhenae dry rhizome with 80 ~ 90 ℃ water logging 3 times.Each 5h merges infusion, concentrates.Concentrated solution is collected 10% ~ 70% ethanol elution part through the broken column chromatography of macroporous resin, reclaims solvent to doing, and gets Rhizoma Anemarrhenae total saponins.
The prescription of pharmaceutical composition of the present invention is as follows:
Herba Epimedii extract: 1-99 weight ratio Rhizoma Anemarrhenae extract: 1-99 weight ratio
Adopt the preparation technique in existing medical industry field, the pharmaceutical composition of above-mentioned prescription can be made the various pharmaceutical dosage forms that are fit to clinical use.
Following content is the pharmacology test result of checking pharmaceutical composition of the present invention:
(1) this product is to the influence of experimental osteoporosis
Experimental animal: 60 of Wistar rats, female, 16 ages in week, body weight 220 ~ 240g.
Experimental apparatus: dual intensity X line bone density detection limit instrument: U.S. Nodand company produces, instrument model: XR226.
Experimental technique
Rat experiment osteoporosis experiment: each organizes the rat sub-cage rearing in the stainless steel metal cage, 5 in every cage, and room temperature is adjusted in 22-26 ℃, and humidity is controlled at 50% ~ 70%, free diet and take the photograph water.Animal is weighed, and adopts the stratified random method that 60 of rats are divided into 6 groups, i.e. the blank group: 0.9% sodium chloride injection (10ml/kg); Model control group: 0.9% sodium chloride injection (10ml/kg); This product: heavy dose of group (500mg/Kg); This product: middle dosage group (250mg/Kg); This product: small dose group (125mg/Kg); Treatment medicine for treating osteoporosis matched group: GUSONGBAO KELIJI (2.7g/Kg).
Weigh once for every group in the experimentation, regulate dosage according to rat body weight.Blank group is only given the equivalent normal saline in whole experiment, model group, GUSONGBAO KELIJI group, each dosage group of this product capsule all gave retinoic acid (70mgg on the 1st ~ 15 day in experiment
-1Dd
-1) the filling stomach, the GUSONGBAO KELI group adds GUSONGBAO KELI simultaneously, and this product group adds each corresponding dosage of this product, the inactive retinoic acid of each group behind the 14d, blank group, model group award the equivalent normal saline, the administration group continues to give institute's reagent thing, and dosage is constant, the 29th day, anesthetized animal and abdominal aortic blood, separation of serum is measured blood calcium, serium inorganic phosphorus with full automatic biochemical apparatus, puts to death animal, has separated complete femur, the 2nd ~ 4 lumbar vertebra in both sides and has carried out the detection of bone density.
Result of the test:
Table 1: the influence that this product capsule changes rat bone density (x ± s, n=10)
Group | Dosage | Femoral bmd (gcm -2) | Lumbar spine bmd (gcm -2) |
Blank group model matched group GUSONGBAO group this product high dose group | 10ml/kg - 2.7g/kg 500mg/kg | 0.156±0.068** 0.102±0.038 0.126±0.077** 0.152±0.113** | 0.159±0.045** 0.104±0.034 0.128±0.041** 0.157±0.026** |
Dosage group this product low dose group in this product | 250mg/kg 125mg/kg | 0.140±0.069** 0.125±0.046* | 0.141±.052** 0.130±0.104* |
Annotate: compare * P<0.05 with model control group; * P<0.01
This product is to the influence of rat bone density: the bone density that the high, medium and low dosage group of this product causes the experimental rat osteoporosis reduces obvious inhibitory action, can the raise effect (P<0.05 ~ 0.001) of rat femur and lumbar spine bmd, GUSONGBAO also has the effect (P<0.05) of rising rat femur and lumbar spine bmd.
Table 2 this product capsule to the influence of rat blood calcium, serium inorganic phosphorus (x ± s, n=10)
Group | Dosage | Blood calcium (mgL -1) | Serium inorganic phosphorus (mgL -1) |
Dosage group this product low dose group in blank group model matched group GUSONGBAO group this product high dose group this product | 10mL/Kg - 2.7g/Kg 500mg/Kg 250mg/Kg 125mg/Kg | 126.4±8.5** 97.9±5.14 108.5±4.63* 123.1±6.54** 119.4±5.40* 108.9±5.53 | 52.34±6.33** 37.66±4.57 43.12±5.28* 50.15±4.65** 46.28±5.04* 40.95±3.92 |
This product is to the influence of rat blood calcium, serium inorganic phosphorus: three dosage groups of this product cause the calcium level of Osteoporosis Rats that significant rising effect is arranged to retinoic acid, relatively there were significant differences (P<0.05) with model group, and GUSONGBAO also has the effect (P<0.05) of rising rat blood calcium, serium inorganic phosphorus.This product does not have obvious effect to the rat serium inorganic phosphorus.
(2) analgesic activity:
2.1 causing, mice chemical stimulation method intends pain reaction (writhing method) experiment
60 of one-level ICR mices, body weight 18~22g is divided into 5 groups at random, and 12 every group, male and female half and half, grouping and administration situation see Table 3.
Table 3 Dichlorodiphenyl Acetate causes the influence test administration and the grouping situation of mouse writhing reaction
Group | Number of animals | Dosage (mg/kg) | Dosage (ml/kg) | Quite clinical multiple |
Dosage group low dose group in the blank positive control high dose group | 12 12 12 12 12 | Distilled water pethidine 33mg/kg 500 250 125 | i.g.20 i.p.10 i.g.20 i.g.20 i.g.20 | - 10 20 10 5 |
Each treated animal removes the positive and organizes 15min disposable celiac drug administration by injection before injection acetic acid by last table administration, and other respectively organizes administration every day 1 time, continuous 7 days, 45min after the last administration, each Mus lumbar injection 0.6% acetic acid 0.2ml/ only observe each animal writhing response number of times in the 15min.Calculate medicine analgesia percentage rate.
The results are shown in Table 4
Table 4 Dichlorodiphenyl Acetate causes the influence of mouse writhing reaction
Group | Number of animals | Dosage (mg/kg) | Turn round body number of times (x ± s) | Analgesia rate (%) |
Dosage group low dose group in the blank positive control high dose group | 12 12 12 12 12 | Distilled water pethidine 33mg/kg 500 250 125 | 35.46±7.98 9.10±6.52*** 14.63±8.23*** 21.25±9.75** 27.84±6.52 | - 74.34 58.74 40.07 21.49 |
Annotate: compare * * * p<0.001 with the blank group; * p<0.01.
Table 4 is the result show, this specialty product Dichlorodiphenyl Acetate causes the mouse writhing reaction and has obvious inhibitory action, compare with the blank group, and high dose group p<0.001, middle dosage group p<0.01, prompting this product Dichlorodiphenyl Acetate causes pain and has obvious analgesic effect.
2.2 conduction of heat causes mice plan pain reaction (hot plate method) experiment
One-level ICR mice, body weight 18~22g, female; RB-200 intelligence hot-plate instrument, 55 ± 0.5 ℃ of program control temperatures, lick metapedes for causing the pain index with mice, the used time is its pain threshold when occurring licking metapedes, measure the normal pain threshold of each Mus, 50 of the normal mice of pain threshold between 5~30s in choosing pool are divided into 5 groups at random, every group 10, grouping and administration situation see Table 5.
Table 5 pair mice hot plate causes the influence test administration and the grouping situation of pain
Group | Number of animals | Dosage (mg/kg) | Dosage (ml/kg) | Quite clinical multiple |
Dosage group low dose group in the blank positive control high dose group | 10 10 10 10 10 | Distilled water pethidine 33mg/kg 500 250 125 | i.g.20 i.p.10 i.g.20 i.g.20 i.g.20 | - 10 20 10 5 |
After measuring normal pain threshold, each treated animal is by last table administration, after the administration 30,60,90min (pethidine group be 15,60,90min) measures pain threshold after each Mus administration respectively, calculates the threshold of pain and improves percentage rate.
Statistical procedures: adopt SPSS10.0 software one factor analysis of variance to add up, data result is added and subtracted standard deviation (x ± s) expression with mean.
The results are shown in Table 6.
Table 6 pair mice hot plate causes the influence of pain
Group | Number of animals | Threshold of pain raising percentage rate (x ± s) | ||
30min | 60min | 90min | ||
Dosage group low dose group in the blank positive control high dose group | 10 10 10 10 10 | 0.01±0.20 1.58±0.84*** 1.37±0.29 0.83±0.56 0.41±0.41 | 0.04±0.26 1.63±0.30** 1..42±0.54** 1.01±0.27** 0.44±0.53** | 0.05±0.29 1.52±0.40 1.39±0.41* 0.80±0.35* 0.30±0.25 |
Compare * * * p<0.001 with the blank group; * p<0.01; * p<0.05.
Table 6 is the result show, this product can obviously improve the pain threshold that hot plate causes the pain mice, compares senior middle school's low dose group p<0.01 during 60min, height, middle dosage group p<0.05 during 90min with the blank group.Prompting this product causes the pain mice to hot plate tangible analgesic effect.
(3): this product capsule anti-inflammatory experimentation
3.1 xylol causes the influence of mice auricle swelling
60 of male ICR mouses are divided into model control group, positive controls at random by body weight, the high, medium and low dosage group of this product capsule, totally 5 groups, 12 every group.Senior middle school low dose group rat is irritated stomach respectively and gives this product 500,250,125mg/kg, positive controls is irritated stomach and is given dexamethasone acetate tablets 1.0mg/kg, model group gives the equal-volume normal saline, every big 1 time, continuous 7 days, after the last administration 1 hour, 50 μ l dimethylbenzene are applied to two sides before and after every mouse right ear.Taking off neck after 4 hours and put to death, cut ears, is that 8mm rustless steel punching pin sweeps away left and right sides auricle with diameter, weigh, as the index of weighing the swelling degree, antiinflammatory action intensity is carried out statistical analysis with suppression ratio (%) expression with the SPSS11.5 software kit with the difference of two auricle weight.The results are shown in Table 7.
The influence of table 7 pair mice ear (x ± s)
Group | Number of animals (only) | Swelling degree (mg) | Suppression ratio (%) |
The model control group positive controls | 12 12 | 14.38±2.16 2.19±0.99*** | -- 84.77 |
Dosage group low dose group in the high dose group | 12 12 12 | 3.56±1.78** 6.21±1.82* 10.15±2.52* | 75.24 56.82 29.42 |
Compare with model control group: * p<0.05, * * p<0.01, * * * p<0.001
Experimental result shows that this product capsule xylol causes mice auricle swelling obvious inhibitory action, and its high dose group and model group relatively have utmost point significant difference.
3.2 inhibitory action to the rising of mouse peritoneal capillary permeability
60 of male ICR mouses are divided into model control group, positive controls at random by body weight, the high, medium and low dosage group of this product capsule, totally 5 groups, 12 every group.Senior middle school low dose group rat is irritated stomach respectively and gives this product 500,250,125mg/kg, positive controls is irritated stomach and is given dexamethasone acetate tablets 1.0mg/kg, model group gives the equal-volume normal saline, every day 1 time, continuous 7 days, 30min after the last administration, tail vein injection 0.5% azovan blue solution 0.1ml/10g body weight, lumbar injection 0.6% glacial acetic acid solution 0.2ml/ is only immediately.Behind the 20min, cut off abdominal cavity skin,, on 751 type spectrophotometers, measure its light absorption value with 5ml normal saline flushing abdominal cavity, the whole abdominal cavities of sucking-off washing liquid.With its abdominal cavity capillary permeability situation of OD value reflection.The results are shown in Table 8.
The influence that table 8 pair mouse peritoneal capillary permeability increases (x ± s)
Group | Number of animals (only) | The OD value |
Dosage group low dose group positive controls in the model control group high dose group | 12 12 12 12 12 | 0.514±0.126 0.176±0.113* 0.235±0.244 0.381±0.352 0.174±0.249** |
Compare with model control group: * p<0.05, * * p<0.01.
Annotate: number of animals is for injecting successfully, include in the number of mice of statistical analysis in the table.
Last table result shows that this product capsule Dichlorodiphenyl Acetate causes the increase of mouse peritoneal capillary permeability and has the obvious suppression effect, and relatively there were significant differences for high dose group and model control group.
Specific embodiment
Below in conjunction with the specific embodiment to the further detailed description that the present invention did, the present invention is not imposed any restrictions:
Embodiment 1: capsule prescription and technology
Prescription (by 1000)
Herba Epimedii extract 20g
Rhizoma Anemarrhenae extract 20g
Starch 150ml
Micropowder silica gel 10g
Make 1000
Take by weighing Herba Epimedii 5kg, add 70% ethanol extraction 3 times of 10 times of amounts, each 1.5 hours, reclaim ethanol, water-bath concentrates, and evaporate to dryness gets Herba Epimedii total flavones.
Get Rhizoma Anemarrhenae dry rhizome with 80 ~ 90 ℃ water logging 3 times.Each 5h merges infusion, concentrates.Concentrated solution is collected 10% ~ 70% ethanol elution part through the broken column chromatography of macroporous resin, reclaims solvent to doing, and gets Rhizoma Anemarrhenae total saponins.
Get recipe quantity Herba Epimedii extract, Rhizoma Anemarrhenae extract, starch, micropowder silica gel is mixed, and is encapsulated.
Embodiment 2: powder pin prescription and technology
Prescription (by 1000 bottles)
Herba Epimedii extract 10g
Rhizoma Anemarrhenae extract 5g
Mannitol 250g
Make 1000 bottles
Extracting method is the same.Moulding process is: get recipe quantity Herba Epimedii extract, Rhizoma Anemarrhenae extract, mannitol, PEG400, the dissolving of 80% recipe quantity water for injection; Just filter back reuse 0.2um microporous filter membrane fine straining; Supply water for injection to full dose; Packing; Lyophilizing; Packing.
Example 3: injection formula and technology
Prescription (by 1000 bottles)
Herba Epimedii extract 10g
Rhizoma Anemarrhenae extract 5g
Water for injection adds to 2000ml
Make 1000 bottles
Extracting method is the same.Moulding process is: get recipe quantity Herba Epimedii extract, Rhizoma Anemarrhenae extract, the dissolving of 50% recipe quantity water for injection; Active carbon is just filtered back reuse 0.2um microporous filter membrane fine straining; Supply water for injection to full dose; Measure content; Packing; Sterilization; Lamp inspection; Packing.
Example 4: tablet formulation and technology
Prescription (by 1000)
Herba Epimedii extract 20g
Rhizoma Anemarrhenae extract 20g
Starch 150g
Hydroxypropyl cellulose 7g
Sodium Hydroxymethyl Stalcs 7g
Micropowder silica gel 10g
Make 1000
Extracting method is the same.Moulding process is: get recipe quantity Herba Epimedii extract, Rhizoma Anemarrhenae extract, starch, carboxymethyl starch sodium is made adhesive with 5% hydroxypropyl cellulose, the system soft material, and 20 mesh sieves are granulated, and 60 ℃ of dryings add the micropowder silica gel granulate, tabletting.
Example 5: pill prescription and technology
Prescription (by 1000)
Herba Epimedii extract 20g
Rhizoma Anemarrhenae extract 20g
Polyethylene glycol 6000 200g
Make 1000
Extracting method is the same.Moulding process is: taking polyethylene glycol 6000 is heated to 90-100 ℃ in oil bath, after treating all dissolvings, add Herba Epimedii extract and Rhizoma Anemarrhenae extract and be stirred to dissolving, be transferred in the reservoir, airtight and be incubated again 80-90 ℃, regulate the dropping liquid quantitative valve, splash in 10-15 ℃ the liquid paraffin, the drop pill that forms is drained and the erasing liquor paraffin body drying.
Claims (7)
1, the pharmaceutical composition of a kind of prevention and treatment orthopaedic disease is characterized in that the prescription of this pharmaceutical composition is: Herba Epimedii extract 1-99 weight ratio, Rhizoma Anemarrhenae extract 1-99 weight ratio.
2, the pharmaceutical composition of a kind of prevention and treatment orthopaedic disease is characterized in that the prescription of this pharmaceutical composition is: Herba Epimedii extract 55-70 weight ratio, Rhizoma Anemarrhenae extract 30-45 weight ratio.
3, according to the pharmaceutical composition of described prevention of claim 1 and treatment section disease, it is characterized in that Herba Epimedii extract can replace with the Herba Epimedii crude drug, Rhizoma Anemarrhenae extract can replace with Rhizoma Anemarrhenae crude drug.
4, according to the pharmaceutical composition of described prevention of claim 1 and treatment section disease, it is characterized in that the Herba Epimedii total flavones weight ratio is 10-100 in the Herba Epimedii extract, the Rhizoma Anemarrhenae total saponins weight ratio is 10-100 in the Rhizoma Anemarrhenae extract.
5,, it is characterized in that it is applicable to treatment osteoporosis, joint disease, hyperosteogeny, orthopaedic diseases such as osteomyelitis and bones and tendons injury pain clinically according to the pharmaceutical composition of described prevention of claim 1 and treatment orthopaedic disease.
6, according to the described prevention of claim 1 and treatment osteoporosis and antiphlogistic pharmaceutical composition, it is characterized in that: its dosage form is any pharmaceutical dosage form in the acceptable dosage form on the pharmaceuticss such as the injection (comprising transfusion, freeze-dried powder) that is fit to clinical practice, pill, drop pill, tablet (comprising dispersible tablet, oral cavity disintegration tablet etc.), slow releasing tablet, capsule, soft capsule, granule, powder, lozenge, soft extract, oral liquid (mixture), syrup, ointment, liniment, liniment.
7, the preparation of drug combination method of a kind of prevention and treatment orthopaedic disease is characterized in that it may further comprise the steps:
(1) take by weighing Herba Epimedii 5kg, add 70% ethanol extraction 3 times of 10 times of amounts, each 1.5 hours, reclaim ethanol, water-bath concentrates, and evaporate to dryness gets Herba Epimedii extract;
(2) get Rhizoma Anemarrhenae dry rhizome with 80 ~ 90 ℃ water logging 3 times.Each 5h merges infusion, concentrates.Concentrated solution is collected 10% ~ 70% ethanol elution part through the broken column chromatography of macroporous resin, reclaims solvent to doing, and gets Rhizoma Anemarrhenae extract;
(3) get 10g Herba Epimedii extract, 5g Rhizoma Anemarrhenae extract, the dissolving of 50% recipe quantity water for injection; Active carbon is just filtered back reuse 0.2um microporous filter membrane fine straining; Supply water for injection to full dose; Measure content; Packing; Sterilization; Lamp inspection; Packing is made 1000 bottles of Chinese medicines of the present invention.
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Open date: 20070207 |