CN1827123A - Chinese traditional medicine for treating osteoporosis - Google Patents
Chinese traditional medicine for treating osteoporosis Download PDFInfo
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- CN1827123A CN1827123A CNA2005100097718A CN200510009771A CN1827123A CN 1827123 A CN1827123 A CN 1827123A CN A2005100097718 A CNA2005100097718 A CN A2005100097718A CN 200510009771 A CN200510009771 A CN 200510009771A CN 1827123 A CN1827123 A CN 1827123A
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Abstract
Disclosed is a Chinese traditional medicine for treating osteoporosis, which is prepared from drynaria 15-25 parts, pilose asiabell root 15-25 parts, dipsacus root 15-25 parts, oyster 25-35 parts, tortoise shell 5-15 parts, and root of red rooted saliva 15-25 parts through the steps of disintegrating, water immersing, watering and boiling, filtering, concentrating, charging tortoise shell fines and mixing homogeneously, charging starch gum, obtaining granules and drying, finally carrying out dressing.
Description
Technical field: the present invention relates to Chinese medicine, particularly treat the Chinese medicine of middle-aged and senile osteoporosis.
Background technology: at present to be used on the Therapeutic Principle of middle-aged and senile osteoporosis be to adopt to suppress osteoclast to doctor trained in Western medicine, and stimulating osteoblast promotes the formation of bone.At present, both at home and abroad medicines such as hormones, vitamin D, calcium preparation, ipriflavone, calcitonin that adopt more, these curative effect of medication are imprecise, and it is big to take side effect for a long time.The curative effect of medication of Chinese traditional treatment osteoporosis does not also occur significantly, and addressing this problem becomes urgent need.
The content of invention: overcome the deficiency that prior art exists, propose that a kind of therapeutic effect is splendid, short treating period, can prevent effectively and the development of osteoporosis, the bone amount of having lost is restored, thus the Chinese medicine of radical cure osteoporosis.This Chinese medicine is made of following composition: Rhizoma Drynariae, Radix Codonopsis, Radix Dipsaci, Concha Ostreae, Carapax et Plastrum Testudinis, Radix Salviae Miltiorrhizae; The weight proportion of its each composition is: Rhizoma Drynariae 15-25 part, Radix Codonopsis 15-25 part, Radix Dipsaci 15-25 part, Concha Ostreae 25-35 part, Carapax et Plastrum Testudinis 5-15 part, Radix Salviae Miltiorrhizae 15-25 part.Its production technology is: a, Carapax et Plastrum Testudinis is cleaned the back oven dry, it is standby to be ground into 100 order fine powders; B, five medicines such as Rhizoma Drynariae, Radix Codonopsis, Radix Dipsaci, Concha Ostreae, Radix Salviae Miltiorrhizae are added the water logging bubble 6 hours of 8 times of amounts, heating decocts three times, each 1.5 hours, merges three times decoction liquor, filter, be concentrated into density 1.1--1.3 (80% heat survey) condensed cream, the Carapax et Plastrum Testudinis fine powder is added wherein mix homogeneously, adds 95% ethanol and stir the back in right amount and add an amount of dextrin, make granule, oven dry, dried granule coating is dried, packing, every bag of 6g.Chinese medicine of the present invention is relevant according to Chinese medicine " kidney storing essence, main bone is given birth to marrow " theory, in the kidney invigorating, replenish the calcium and without any side effects, prevention and treatment osteoporosis are had fabulous curative effect, statistics shows that effective percentage reaches more than 96%.
The specific embodiment: get Rhizoma Drynariae 15g, Radix Codonopsis 15g, Radix Dipsaci 15g, Concha Ostreae 25g, Carapax et Plastrum Testudinis 5g, Radix Salviae Miltiorrhizae 25g.Its production technology is: a, Carapax et Plastrum Testudinis is cleaned the back oven dry, it is standby to be ground into 100 order fine powders; B, five medicines such as Rhizoma Drynariae, Radix Codonopsis, Radix Dipsaci, Concha Ostreae, Radix Salviae Miltiorrhizae are added the water logging bubble 6 hours of 8 times of amounts, heating decocts three times, each 1.5 hours, merges three times decoction liquor, filter, be concentrated into density 1.1--1.3 (80% heat survey) condensed cream, the Carapax et Plastrum Testudinis fine powder is added wherein mix homogeneously, adds 95% ethanol and stir the back in right amount and add an amount of dextrin, make granule, oven dry, dried granule coating is dried, packing, every bag of 6g.
The second embodiment of the present invention is got Rhizoma Drynariae 25g, Radix Codonopsis 25g, Radix Dipsaci 25g, Concha Ostreae 35g, Carapax et Plastrum Testudinis 15g, Radix Salviae Miltiorrhizae 15g.Its production technology is with embodiment one.
In order to estimate the clinical medicine safety of Chinese medicine of the present invention, it has been carried out toxicity test research, be reported as follows:
1. be subjected to test product: a kind of Chinese medicine every day for the treatment of osteoporosis 1 time, each 6 grams.
2. experimental animal: the white mice of Kunming kind, body weight 18-22 gram, male and female dual-purpose.
3. the preparation of dosage and test drug: get Chinese medicine 6 grams of a kind of treatment osteoporosis, put and add the 10.0ml distilled water in the mortar and be uniformly dispersed, make solution.Administering mode is a gastric infusion.
One, the mensuration of median lethal dose(LD 50)
Get 9 of mices, divide three groups, but fail to find out the dosage of 100% animal dead.
Select 50 of the healthy mices of body weight 20 ± 2g for use, male and female half and half are divided into five groups at random, an oral administration gavage administration, and dosage is by geometric progression, and maximum dose level calculates with the maximum volume that can accept.Observed 7 days none death as a result after the administration.
Two, mtd test
Select 20 of healthy mices, male and female half and half, normally raise 1 after, administration is 1 time in 24 hours, observes continuously 7, does not see untoward reaction and death condition, can think the oral avirulence of this medicine.
Maximum tolerated dose multiple result of calculation is 240 times of normal clinical dosage, illustrates that a kind of Chinese medicine of treatment osteoporosis has safety.
Pharmacodynamic experiment:
One, experimental technique
(1) the Amur molding method is adopted in modeling
[3]Select 80 4 month female wistar rats, wherein 72 usefulness 1.5% are defended barbital sodium anesthesia, the sterile working enters rat abdominal cavity dorsal part through lumbar vertebra escribe mouth, and the two ovaries of rat are excised hemostatic suture fully.Surplus not spay of 8 rat, as the blank group, postoperative ingest and drink water as before, will test rat after 1 week and be divided into eight groups at random promptly: Chinese medicine one group of (low dosage Chinese drug-treated group), Chinese medicine two groups of (middle dosage Chinese drug-treated group), Chinese medicine three groups of (high dose Chinese drug-treated group), model group, nilestriol group, normal saline group, prevention and health care group, blank group.The prevention and health care group is promptly given Chinese medicine 2ml/ Mus/time/day after castration.Three groups of Chinese drug-treated group, nilestriol group and normal saline groups all after castration, began in three months to clothes bone pine health liquid 0.8ml/ Mus/
(2) inferior/day, 2.4ml/ Mus/time/day, 4.8ml/ Mus/time/day, Nilestriol Tablets (diluent) 0.01mg/ Mus/week and normal saline 2.5ml/ Mus/day.Below all adopt the administration by gavage administration, normal group, not administration of model group, each treated animal is all taken a sample after three days in postoperative drug withdrawal in six months, observes and measures every index.
Two, experimental result
(1) the urine biochemical indicator is measured
Model group, saline group all are higher than normal group; Health care group, Chinese drug-treated group, nilestriol group all are lower than model and saline group.
Table 1 urine calcium (Ca), phosphorus (P) and hydroxyproline (HOP) assay result (X ± S)
Ca(mg) | P(mg) | HOP(mg) | |
Normal group model group salt solution group Chinese medicine I group Chinese medicine II group Chinese medicine III group health care group Nilestriol group | 0.5425±0.0951 3.8875±0.7259** 3.36±0.9894** 0.6575±0.1451 ▲▲△ 0.6475±0.1819 ▲▲△ 0.5888±0.2064 ▲▲△ 0.4788±0.2142 ▲▲△ 0.4788±0.1009 ▲▲△ | 0.3713±0.062 0.7363±0.0626* 0.725±0.0598* 0.3225±0.0742 ▲△ 0.345±0.0639 ▲△ 0.3588±0.0645 ▲△ 0.3687±0.0594 ▲△ 0.365±0.0644 ▲△ | 282.1125±48.3841 390.525±51.0604* 357.85±63.902* 303.5.±65.2845 ▲△ 282.625.±69.692 ▲△ 294.825.±40.1534 ▲ 279.825.±37.423 ▲△ 278.9.±31.5561 ▲△ |
Annotate: model group, saline group and normal group compare: * P<0.05 * * P<0.01
Health care group, Chinese drug-treated group, nilestriol group and saline group compare: ▲ P<0.05 ▲ ▲ P<0.01
Chinese drug-treated group. health care group, nilestriol group and normal group compare: △ P>0.05
(2) blood parameters is measured
Blood calcium: change not statistically significant between each group.Serium inorganic phosphorus: Chinese medicine I group, Chinese medicine II group, Chinese medicine III group, health care group are significantly higher than other group (P<0.01).Serum ALP activity: model group, saline group are significantly higher than normal group (P<0.01); Chinese medicine III group does not have significant difference (P>0.05) with normal group.
Table 2 blood calcium (Ca), phosphorus (P) and alkali phosphatase (ALP) assay result (X ± S)
The example number | Blood calcium (mmol/L) | Serium inorganic phosphorus (mmol/L) | ALP(U/L) | |
Normal group | 8 | 2.525±0.271 | 1.675±0.345 | 101.63±20.19 |
Model group salt solution group Chinese medicine I group Chinese medicine II group Chinese medicine III group health care group Nilestriol | 9 9 9 8 9 8 10 | 2.267±0.394 2.330±0.371 2.471±0.588 2.338±0.213 2.350±0.487 2.343±0.162 2.444±0.279 | 1.533±0.574 1.630±0.283 2.457±0.721** ▲▲□□ 2.575±0.686** ▲▲□□ 2.688±0.412** ▲▲□□ 2.657±0.424** ▲▲□□ 1.656±0.447 | 154.44±17.66** 148.90±13.61** 149.71±16.93** 124.63±19.65** 107.63±18.85 ▲▲□ 110.71±15.32 ▲▲ 132.44±19.04 |
* and normal group be P<0.01 relatively, ▲ ▲ compare P<0.01 with the saline group, with nilestriol group P<0.05; and nilestriol group be P<0.01 relatively
(3) serum E2 measures
Model group, saline group significantly are lower than normal group (P<0.01); Chinese medicine III group, health care group are significantly higher than saline group (P<0.01); The nilestriol group is significantly higher than normal group (P<0.01); Chinese drug-treated group, health care group significantly are lower than nilestriol group (P<0.01);
Table 3 serum E2 measurement result (X ± S)
Group | The example number | Blood E2 (pg/ml) |
Normal group model group salt solution group Chinese medicine I group Chinese medicine II group Chinese medicine III group health care group Nilestriol | 8 9 9 9 8 9 8 10 | 14.63±2.62 7.44±1.81** 7.50±2.07** 7.43±1.72□□ 9.00±1.85□□ 13.25±2.82 ▲▲□□ 13.29±3.15 ▲▲□□ 49.56±3.21** |
* and normal group than P<0.01 ▲ ▲ with the saline group than P<0.01 and nilestriol group than P<0.01
(3) bone densitometry the results are shown in Table 4
Measurement result shows: model group, saline group are starkly lower than normal group (P all<0.01); Nilestriol group, health care group are significantly higher than saline group (P all<0.01); Chinese drug-treated group is apparently higher than saline group (P all<0.05); Chinese drug-treated group, health care group, nilestriol group and normal group be not statistically significant (P all>0.05) relatively.
Each treated animal bone densitometry result (g/cm of table 4
2) (X ± S)
Number of animals (n) | Bone density (RMC) | |
Normal group model group salt solution group Chinese medicine I group Chinese medicine II group Chinese medicine III group health care group Nilestriol group | 8 8 8 8 8 8 8 8 | 0.2188±0.0101 0.1594±0.0146** 0.178±0.0209** 0.2274±0.0479 0.2206±0.0308 0.2235±0.033 ▲△ 0.2294±0.0197 ▲▲△ 0.2099±0.0159 ▲▲△ |
Annotate: * * and normal group comparison P<0.01 ▲ compare P<0.05 with the saline group
△ and normal group comparison P>0.05 ▲ ▲ P<0.01 compared with the saline group
(5) sclerotin inorganic elements measurement result sees Table 5
The result shows: model group, saline group sclerotin Ca, Mg, Mn, Cu content are starkly lower than normal group (P all<0.05), and Chinese medicine III group, nilestriol group, health care group are significantly higher than saline group (P all<0.01); Chinese medicine III group, health care group, nilestriol group and normal group be not statistically significant (P all>0.05) relatively.
Each treated animal sclerotin of table 5 does not have relatively (ug/g X ± S) of cellulose content
n | Ca | Mg | Mn | Cu | |
Normal group model group salt solution group Chinese medicine I group Chinese medicine II group Chinese medicine III group health care group Nilestriol group | 8 8 8 8 8 8 8 8 | 130594.5±11234.09 102702.2±9161.106* 104658.6±8319.438* 104019.7±9003.519 ▲▲△ 108931.5±9359.58 ▲▲△△ 131239.3±7963.528 ▲△ 128984.8±10777.49 ▲△ 124309.6±8760.155 ▲△ | 1.0513±0.1618 0.8626±0.1259* 0.7788±0.1226* 0.8509±0.1106 ▲▲△ 0.8378±0.1495 ▲▲△ 0.9569±0.1128 ▲△ 0.9509±0.096 ▲△ 0.9475±0.1214 ▲△ | 2.2625±0.8038 1.3329±0.5891* 1.347±0.4692* 1.3874±0.4459 ▲▲△ 1.5611±0.4559 ▲▲▲ 2.1246±0.5635 ▲△ 2.2135±0.7169 ▲△ 1.9366±0.5201 ▲△ | 2872.172±193.9971 2484.429±200.6703* 2473.054±153.4759* 2443.438±195.6805 ▲▲△△ 2589.939±183.3874 ▲▲△△ 2713.749±142.6664 ▲△ 2723.458±108.3223 ▲△ 2757.983±193.0537 ▲△ |
Annotate: model group, saline group and normal group compare: * P<0.05
Health care group, Chinese drug-treated group, nilestriol group and saline group compare: ▲ P<0.05 ▲ ▲ P>.0.05
Chinese drug-treated group, health care group, nilestriol group and normal group compare: △ P>0.05 △ △ P<0.05
(6) histopathology observed result
The osseous tissue morphological observation shows: model group and saline group bone trabecula are obviously thinning to be dredged, the cortical bone attenuation, and medullary cavity enlarges relatively, and the subregion bone trabecula disappears.Normal group, Chinese medicine III group and health care group, nilestriol group bone trabecula enrich the cortical bone densification.
Clinical research:
One, data and method
1, object of study
Roll over luxuriant PMD diagnostic criteria of starting proposition according to the professor of Tokyo Univ Japan, choose 80 routine patients altogether, minimum 48 years old of age, maximum 76 years old, average 56 years old; The menopause time is the shortest 8 months, and is the longest 32 years; Natural menopause 62 examples, operation back menopause 15 examples.The single at random blind method of 80 routine patients is divided into treatment organizes 50 examples, matched group 30 examples.
2, method
(1) biochemical markers of bone metabolism is measured with putting the method for exempting from and is surveyed blood E
2Measure urine C with the arsenazo III method
a ++Measure urine HYP with the chloramine-T oxidizing process.
(2) bone densitometry is surveyed 1/3 place's bone density far away in the non-advantage side forearm chi oar.The single photon bone ore deposit analyser that adopts the Beijing Nuclear Instrument Factory to produce, radioactive source are 241 to fawn on.
(3) treatment and observational technique treatment group be with the loose health electuary 15g (being provided by the Drug Manufacturing Room of Heilongjiang University of Chinese Medicine) of bone, and every day 1 time is oral, and 1 month was 1 course of treatment, serve on 3 months.Matched group is taken Nilestriol Tablets (being produced by Fourth Ring, Beijing pharmaceutical factory), each 2mg, and two weeks clothes 1 time serve on 3 months.Added medroxyprogestetone acetate 7-10 day in per 3 months, every day 8mg.
Respectively at before the medication and measure after the medication treatment and matched group bone density, urinate C
a ++, urine HYP, blood E
2Change before and after observing medication, take statistics to learn and handle.
Three, result
1, criterion of therapeutical effect was with reference to first international bone metabolism academic conference required standard in 1992.Produce effects: any one all changes to the bone compound direction in bone density, the bone metabolism index; Effectively: any one equal no change in bone density, the bone metabolism index; Invalid: any one all changes to the bone resorption direction in bone density, the bone metabolism index.
2, efficacy analysis sees Table 1, and treatment group and matched group total effective rate are respectively 96%, 93.3%, analyzes difference nonsignificance (P>0.05) through Ridit.
Table 1 liang group curative effect relatively
Group | The example number | Produce effects | Effectively | Invalid | Effective percentage |
Treatment group matched group | 50 30 | 36 21 | 12 8 | 2 2 | 96% 93.3% |
Annotate: Ridit analytic process P>0.05
3, there is rising bone density measurement bone density average treatment back for two groups, with more all there were significant differences before the treatment (P all<0.05).See Table 2.
(g/cm is compared in the change of bone density before and after the table 2 liang group medication
2, X ± S)
Project | Treatment group (50 example) | Matched group (30 example) | ||
Before the medication | After the medication | Before the medication | After the medication | |
The ulna radius | 0.4349± 0.035 0.4284± 0.030 | 0.5410±0.044 *△ 0.5311±0.040 *△ | 0.440±0.1492 0.4251±0.1381 | 0.493±0.051 * 0.4806±0.055 * |
Annotate: and △ P<0.05 relatively between * P<0.05 group relatively before the treatment
4, biochemical markers of bone metabolism is measured and is seen Table 3, and treatment group, matched group are in the back urine C that takes medicine
a ++, urine HYP all obviously descends.
5, E
2Mensuration see Table 3, treatment back E
2Decrease, but with treatment before relatively do not have significant difference (P>0.05), matched group with treat before remarkable reduction is relatively arranged (P<0.05=does not relatively have significant difference (P>0.05) but treat between the average group of back.
Bone metabolism index and hematuria E before and after the table 3 liang group medication
2Situation of change (M ± SD)
Project | Treatment group (50 example) | Matched group (30 example) | ||
Before the medication | After the medication | Before the medication | After the medication | |
Urine Ca (mmol/L) urine HYP (mmol/L) E 2(pq/ml) | 2.88±0.51 0.20±0.04 12.03± 0.36 | 2.09±0.50 *△ 0.13±0.02 * 10.80±3.10 ▲▲▲ | 3.75±0.46 0.23±0.03 15.20±0.23 | 2.48±0.30 * 0.12±0.05 * 10.85±0.221 * |
Annotate: with * P<0.05 before the treatment ▲ ▲ P>0.05; Compare △ P<0.05 ▲ P>0.05 between group
All do inspection before and after the treatment, the result shows that the treatment group effective percentage of taking Chinese medicine of the present invention is 96%, and matched group does not have obvious effects.
Claims (2)
1, a kind of Chinese medicine for the treatment of osteoporosis is characterized in that this Chinese medicine is made of following composition: Rhizoma Drynariae, Radix Codonopsis, Radix Dipsaci, Concha Ostreae, Carapax et Plastrum Testudinis, Radix Salviae Miltiorrhizae; The weight proportion of its each composition is: Rhizoma Drynariae 15-25 part, Radix Codonopsis 15-25 part, Radix Dipsaci 15-25 part, Concha Ostreae 25-35 part, Carapax et Plastrum Testudinis 5-15 part, Radix Salviae Miltiorrhizae 15-25 part.
2, the Chinese medicine of treatment osteoporosis as claimed in claim 1 is characterized in that its production technology is: a, Carapax et Plastrum Testudinis is cleaned the back oven dry, it is standby to be ground into 100 order fine powders; B, five medicines such as Rhizoma Drynariae, Radix Codonopsis, Radix Dipsaci, Concha Ostreae, Radix Salviae Miltiorrhizae are added the water logging bubble 6 hours of 8 times of amounts, heating decocts three times, each 1.5 hours, merges three times decoction liquor, filter, be concentrated into density 1.1--1.3 (80% heat survey) condensed cream, the Carapax et Plastrum Testudinis fine powder is added wherein mix homogeneously, adds 95% ethanol and stir the back in right amount and add an amount of dextrin, make granule, oven dry, dried granule coating is dried, packing, every bag of 6g.
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CNA2005100097718A CN1827123A (en) | 2005-02-28 | 2005-02-28 | Chinese traditional medicine for treating osteoporosis |
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CNA2005100097718A CN1827123A (en) | 2005-02-28 | 2005-02-28 | Chinese traditional medicine for treating osteoporosis |
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