CN100394969C - Osteoporosis treating compound Chinese preparation and its preparing process - Google Patents
Osteoporosis treating compound Chinese preparation and its preparing process Download PDFInfo
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Abstract
The present invention discloses a traditional Chinese medicine compound preparation used for treating osteoporosis and a preparation method thereof. The present invention uses the following materials or extracts of the following materials as active ingredients, the extracts are extracted by alcohol, water or mixed liquor of the alcohol and the water, and the present invention is prepared from 400 to 1200g of prepared rehmannia root, 200 to 500g of yam, 50 to 600g of wolfberry fruit, 100 to 600g of eucommia bark, 50 to 650g of dodder seed, 50 to 380g of common curculigo rhizome, 40 to 350g of pilose asiabell root, 80 to 500g of milk vetch, 50 to 600g of red sage root, 30 to 400g of corydalis tuber processed with vinegar and 100 to 700g of calcined oyster. The extracts of the eleven raw materials are uniformly mixed, which are extracted by the alcohol, or the water or the mixed liquor of the alcohol and the water, and the required preparation type is prepared by adding proper auxiliary materials. The medicine performs the functions of nourishing the liver and the kidney, supplementing Qi and activating blood circulation. The present invention is used for symptoms of primary osteoporosis (symptom of insufficiency of the liver and the kidney), such as an aching whole body or the aching pelvic kidney, spasm of muscles and vessels, the limp, aching and hypodynamic lumbar spine, vertigo, dizziness, etc. The traditional Chinese medicine preparation has the advantages of exact curative effect, safe use and stable quality. The clinical test shows that the effective rate reaches 94%.
Description
Technical field
The present invention relates to a kind of compound Chinese medicinal preparation for the treatment of osteoporosis and preparation method thereof.
Background technology
Osteoporosis (Osteoporosis) is a kind of common metabolic osteopathy, and along with the raising of social senilization's degree, osteoporosis also will become one of worldwide sanitarian difficult problem.At present, treat the medicine of osteoporosis both at home and abroad, based on Western medicine, but Western medicine all has side effect in various degree.In addition, the morbidity of osteoporosis is systemic diseases multifactor, many target spots, and western medical treatment mostly is alternative medicine.
Summary of the invention
The invention provides a kind of compound Chinese medicinal preparation for the treatment of osteoporosis and preparation method thereof.
The present invention is a kind of compound Chinese medicinal preparation for the treatment of osteoporosis, it mainly by the alcohol of following traditional Chinese medicine raw or following traditional Chinese medicine raw or water or alcohol-water mixture extract as active component, raw material of Chinese medicine consists of:
Radix Rehmanniae Preparata 400-1200g, Rhizoma Dioscoreae 200-500g, Fructus Lycii 50-600g, Cortex Eucommiae 100-600g,
Semen Cuscutae 50-650g, Rhizoma Curculiginis 50-380g, Radix Codonopsis 40-350g, Radix Astragali 80-500g,
Radix Salviae Miltiorrhizae 50-600g, Rhizoma Corydalis (processed with vinegar) 30-400g, calcine Concha Ostreae 100-700g.
Raw material weight proportioning preferable in above-mentioned prescription is:
Radix Rehmanniae Preparata 588-1100g, Rhizoma Dioscoreae 285-450g, Fructus Lycii 98-500g, Cortex Eucommiae 165-500g,
Semen Cuscutae 90-480g, Rhizoma Curculiginis 100-300g, Radix Codonopsis 75-280g, Radix Astragali 100-420g,
Radix Salviae Miltiorrhizae 98-500g, Rhizoma Corydalis (processed with vinegar) 50-250g, calcine Concha Ostreae 180-500g.
Raw material weight proportioning better in above-mentioned prescription is:
Radix Rehmanniae Preparata 627g, Rhizoma Dioscoreae 313g, Fructus Lycii 209g, Cortex Eucommiae 313g, Semen Cuscutae 209g, Rhizoma Curculiginis 167g,
Radix Codonopsis 125g, Radix Astragali 209g, Radix Salviae Miltiorrhizae 209g, Rhizoma Corydalis (processed with vinegar) 105g, calcine Concha Ostreae 313g
Above-mentioned Chinese medicine preparation, can be the dosage form of recording in any pharmacopeia such as granule, capsule, tablet, oral liquid, syrup, pill or powder, the preparation of Chinese medicine preparation also can be carried out with reference to the method for conventional Chinese medicine preparation, but, reduce dosage in order to improve drug effect.
Compound Chinese medicinal preparation of the present invention adopts following preparation method:
(1) take by weighing following traditional Chinese medicines and make raw material:
Radix Rehmanniae Preparata 400-1200g, Rhizoma Dioscoreae 200-500g, Fructus Lycii 50-600g, Cortex Eucommiae 100-600g,
Semen Cuscutae 50-650g, Rhizoma Curculiginis 50-380g, Radix Codonopsis 40-350g, Radix Astragali 80-500g,
Radix Salviae Miltiorrhizae 50-600g, Rhizoma Corydalis (processed with vinegar) 30-400g, calcine Concha Ostreae 100-700g.
(2) with above-mentioned ten simply, except that Rhizoma Curculiginis, ten flavors such as all the other Radix Rehmanniae Preparata add alcohol, water or alcohol-water mixture and extract, and filter, and concentrating filter liquor is chilled to room temperature, adds ethanol, stirs, and places a few hours, filter, supernatant as active component I;
(3) Rhizoma Curculiginis is used alcohol or hydro-thermal reflux, extract,, the extracting solution that obtains is as active component II;
(4), add proper auxiliary materials and make required dosage form with above-mentioned active component I and II mix homogeneously.
Alcohol, water or alcohol-water mixture extract three times in its step (2), and extraction time is 2 hours for the first time, and second and third time is 1.5 hours.The hot reflux number of times is a secondary in its step (3), and hot reflux liquid is 40～90% alcoholic solution, and the hot reflux time is each 3 hours.
Compound Chinese medicinal preparation of the present invention adopts following another kind of preparation method:
(1) takes by weighing following traditional Chinese medicines and make raw material
Radix Rehmanniae Preparata 400-1200g Rhizoma Dioscoreae 200-500g Fructus Lycii 50-600g Cortex Eucommiae 100-600g
Semen Cuscutae 50-650g Rhizoma Curculiginis 50-380g Radix Codonopsis 40-350g Radix Astragali 80-500g
Radix Salviae Miltiorrhizae 50-600g Rhizoma Corydalis (processed with vinegar) 30-400g calcine Concha Ostreae 100-700g.
(2) take by weighing Rhizoma Curculiginis, Radix Salviae Miltiorrhizae, the Radix Astragali and Rhizoma Corydalis (vinegar system) four Chinese medicine material by above-mentioned weight proportion, use alcohol or alcohol-water mixture to reflux, get extracting solution, filter, filtrate recycling ethanol concentrates, and gets active component I.
(3) all the other medical material water reflux, extract, get extracting solution active component II.
(4) merge active component I and II, medicinal liquid is concentrated into the extractum of relative density 1.10-1.40 (55-60 ℃), and extractum is made required dosage form on request.
Extract three times with alcohol or alcohol-water mixture in its step (2), extraction time is 2 hours for the first time, and second and third time is 1 hour, and hot reflux liquid the best of its step (2) is 50%～80% alcoholic solution, and its step (3) water backflow number of times is 2-3 time.
The traditional Chinese medical science is for transferring therapy, focuses on integrally-regulatedly, transfers endogenous cause of ill, shown the characteristics and the advantage of Chinese traditional treatment osteoporosis.Adopt the modern Chinese medicine novel technology for extracting, extract the refining Chinese medicine preparation that forms, prove by clinical and experimentation: it can regulate the inside of human body function, nourishing the liver and kidney, benefiting QI for activating blood circulation improves bone density, strengthens the ballistic ability of femur external force resistance, improving the osteoporosis degree, is a kind of comparatively ideal Chinese patent medicine preparation.The chemical constituent of Radix Rehmanniae Preparata is based on glycoside, wherein again based on iridoid glycosides, and nourishing kidney, Kidney-Yin to fill out; Contain multiple dioscin in the Rhizoma Dioscoreae, grow beneficial the kidney invigorating; The Cortex Eucommiae mainly contains lignan component, can tonifying liver and kidney and strengthening bones and muscles; Radix Astragali strongly invigorating primordial QI is with the source of beneficial hemopoietic; Radix Salviae Miltiorrhizae, Rhizoma Corydalis nourshing blood and promoting blood circulation and removing obstruction in the collateral to relieve pain; Contain the glycosides compound curculigoside in the Rhizoma Curculiginis, the kidney warming sun, strengthening bone and muscle.
The specific embodiment
Below by embodiment, the present invention is further described:
Embodiment one is the preparation of Chinese medicinal granule a of the present invention:
1, press column weight amount proportioning and take by weighing each component:
Radix Rehmanniae Preparata 627g, Rhizoma Dioscoreae 313g, Fructus Lycii 209g, Cortex Eucommiae 313g, Semen Cuscutae 209g, Rhizoma Curculiginis 167g,
Radix Codonopsis 125g, Radix Astragali 209g, Radix Salviae Miltiorrhizae 209g, Rhizoma Corydalis (processed with vinegar) 105g, calcine Concha Ostreae 313g.
2, take by weighing except that Rhizoma Curculiginis by said ratio, ten flavor medical materials such as Radix Rehmanniae Preparata decoct with water three times, and decocting time is 3 hours for the first time, second and third time each 1 hour, and three water yields respectively are 7 times of amounts.The decoction liquor filtration gets filtrate, and concentrating filter liquor is chilled to room temperature to the clear paste of relative density 1.18-1.20 (65-70 ℃), and adding ethanol is 50% to containing the alcohol amount, stirs, and places 48 hours, filters, and gets supernatant I.
3, take by weighing Rhizoma Curculiginis by above-mentioned weight proportion, divide secondary back to extract with 7 times of amount 80% ethanol, each 3 hours, filter, merging filtrate gets alcohol extract II.
4, merge supernatant I and alcohol extract II, reclaim ethanol, medicinal liquid is concentrated into the thick paste of relative density 1.34-1.40 (55-60 ℃).
5, get above-mentioned thick paste, add dextrin and soluble starch, mixing adds 95% ethanol (being dissolved with stevioside) in right amount again, stirs, and gets soft material, granulate, and granulate, oven dry promptly gets the made granule of the present invention, every packed 9g, every g medicated powder is equivalent to raw medicinal herbs 2.8g.
Embodiment two is the preparation of Chinese medicinal granule b of the present invention:
1, press column weight amount proportioning and take by weighing each component:
Radix Rehmanniae Preparata 600g, Rhizoma Dioscoreae 280g, Fructus Lycii 200g, Cortex Eucommiae 280g, Semen Cuscutae 180g,
Rhizoma Curculiginis 200g, Radix Codonopsis 150g, Radix Astragali 200g, Radix Salviae Miltiorrhizae 200g, Rhizoma Corydalis (processed with vinegar) 100g,
Calcine Concha Ostreae 300g;
2, take by weighing Rhizoma Curculiginis, Radix Salviae Miltiorrhizae, the Radix Astragali and Radix Codonopsis by above-mentioned weight proportion, with 70% alcohol reflux three times, 2 hours for the first time, second and third time 1 hour, quantity of solvent is 8 times of amounts first time, second and third time respectively is 6 times of amounts, filter, merging filtrate gets alcohol extract, reclaim ethanol, get active component I;
3, take by weighing 7 flavor medical materials such as all the other Radix Rehmanniae Preparata by above-mentioned weight proportion, decoct with water three times, decocting time be 2 hours for the first time, second and third time 1.5 hours, and the first time, water was 7 times of amounts, second and third time respectively is 6 times of amounts.Decoction liquor filters, and gets filtrate as active component II;
4, merge active component I and II, be concentrated into the thick paste of relative density 1.34-1.40 (55-60 ℃);
5, get above-mentioned thick paste, add other adjuvants, mixing adds 95% ethanol (being dissolved with stevioside) in right amount, stirs, and gets soft material, and through granulating, granulate is dried, and promptly gets the made granule b of the present invention, every packed 9g, and every g medicated powder is equivalent to raw medicinal herbs 2.8g.
Embodiment three is the preparation of Chinese medicinal capsule of the present invention:
Press embodiment one described method, capsule is irritated in extract obtained granulation according to a conventional method, every 0.3g, and every g medicated powder is equivalent to the about 2.8g of raw medicinal herbs.
Embodiment four is the preparation of Chinese medicinal tablet of the present invention:
Press embodiment one described method, the extract obtained tablet of making according to a conventional method, every 0.5g, every 1g finished product is equivalent to the about 2.8g of raw medicinal herbs.
Embodiment five is the preparation of Chinese materia medica syrup of the present invention:
Press embodiment one described method, the extract obtained syrup of making according to a conventional method, every bottle of 100ml, every 10ml medicinal liquid is equivalent to the about 2.8g of raw medicinal herbs.
Embodiment six is the preparation of Chinese medicine oral liquid of the present invention:
Press embodiment one described method, the extract obtained oral liquid of making according to a conventional method, every 10ml, every 10ml medicinal liquid is equivalent to the about 2.8g of raw medicinal herbs.
Animal embodiment 1: the particulate animal acute toxicity test of the present invention
One, test method
Select healthy Kunming mouse, with once irritating the administration of stomach method, observe particulate extractum acute toxic reaction, the maximum tolerated dose＞20g/kg of this medicine as a result is equivalent to 317 times of clinical application amount.Prove that through trial test repeatedly this poison of drug property is very low, fail to measure LD50, use the maximum tolerated dose method instead and measure acute toxicity.Select 20 of healthy Kunming mouses, male and female half and half, fasting 12 hours (can't help water) before the administration, in addition extractum being made into maximum permissible concentration is 500mg/ml extractum (being equivalent to 50%), maximum administration capacity 0.4ml/10g, once irritate stomach after, observed seven days continuously, more than experiment repeats twice.
Two, experimental result
Twice experiment all do not have animal dead, and movable as usual after the mice administration, appetite is normal, and defecation is not abnormal color, hair luster, and nose, eye, the no abnormal secretions in oral cavity, experiment finishes the back average weight and increases identical with matched group.
Oral LD50＞the 20g/kg of extractum;
By the oral LD50＞158g/kg of crude drug;
Be equivalent to 317 times of clinical application amounts (20/0.063).
Animal embodiment 2: the particulate long-term toxicity test for animals of the present invention
One, test method
Selected animal is observed general situation in one week of laboratory rearing, and makes routine urianlysis, after rejecting doubtful unusual animal, be divided into 4 groups at random, 30 every group, male and female half and half are established three dosage groups, and low dose group is that 630mg/kg, middle dosage group are that 1260mg/kg, high dose group are 3150mg/kg.Three dosage groups are respectively 10 times, 20 times, 50 times of clinical administration amount, the design's low dose group is higher than drug effect high dose 608mg/kg, three administration groups be respectively with isoconcentration not, etc. the administration principle administration of capacity, irritate stomach every day once, inferior on every Saturdays, the capacity administration of pressing animal per 100g body weight administration 1ml, and with body weight growth adjustment dosage, total amount be no more than the 3ml/ Mus/time, successive administration six months.Matched group is used with the distilled water of volume and is irritated stomach, and the number of times time is with the administration group.Experimental session is weighed weekly once, observes and write down animal appearance sign, behavioral activity, hair color, feces character every day, and regular weighing food consumption quantity.Consider that the normal rat urine contains trace albumin, collect the urinary assay conventional index before the experiment, every urine protein is not used in experimentation the above person of 2+.Because this experimental period is 6 months, detect every index so high dose group and matched group are respectively put to death 6 rats in test mid-term (after the administration 3 months), administration was got 2/3 animal in 24 hours after the last administration after 6 months and is made tail vein blood, measured clotting time, hemoglobin, platelet, RBC number, leukocyte count and classification; 12 biochemical indicators such as serum AST are surveyed in the blood sampling of abdomen cardinal vein; Collect urine and make the routine urinalysis index determining; Weigh and 11 internal organs weight in wet bases such as liver, kidney, the heart, lung are obtained organ coefficient, put to death the back each treated animal internal organs is carried out careful system's postmortem, matched group and high dose group are carried out the heart, liver, spleen, lung, five parenchymal viscera histopathologic examinations of kidney.Simultaneously gross necropsy is found to have the organ of pathological changes also to draw materials to do section and carry out histopathologic examination.Other each main organs of dosage group draw materials preserve for future reference.Surplus 1/3 animal after drug withdrawal the above-mentioned every index of 4 all repetition measurements to observe administration degree of reversibility and tardy property toxic action.
Two, experimental result
1, general each experimental group animal appearance of situation, the no abnormal performance of hair, movable as usual; The feces character is normal, do not see just rare, anorexia are arranged, 6 months experiment periods of three administration groups are respectively at individual animal death (M ♂ 1, M ♂ 4, H ♀ 9, H ♂ 8) was arranged in the 18th, 21 weeks, rarely seen pulmonary congestion of naked eyes and local hemorrhage point during to the instant postmortem of dead animal, pathologic finding is not seen interstitial pneumonia, and other internal organs are not seen the lethal pathological change.Food consumption quantity and body weight change, each dosage group and matched group no significant difference.
2, different times hematological indices measurement result showed after hematological indices was measured the extractum administration, high dose group compares no significant difference in experiment periods (3 months) measurement result in mid-term and matched group, administration 6 months and drug withdrawal after 1 month the every physiochemical indice of each dosage group all in normal range, the platelet count meansigma methods of measuring when middle and high dosage group experiment finishes is than matched group, low dose group height, learn by statistics and handle P＜0.01, there were significant differences.6 months platelet meansigma methods of high dose group administration also high (P＜0.05) than 3 months, drug withdrawal is approaching with 3 months meansigma methods of administration after one month, the change of platelet numerical value like with certain relation of having taken medicine, but can not get rid of physiological fluctuation fully because the numerical value of measuring all rat normal range with interior (rat platelet normal value 128～448 * 109/L).
3, biochemical indicator is measured biochemical indicator automatic biochemistry analyzer (IL, Monarch2000U.S.A) measure, measurement result shows relatively no difference of science of statistics of 3 months high dose group of granule administration and matched group, two groups of every indexs all normal range with interior fluctuation, administration 6 months and convalescent period, each administration group was compared also zero difference with matched group, the every index average of each administration group all fluctuates no significant difference in normal range.
4, urinary assay is tested each stage measurement result and is not seen have unusually through to each group uroscopy, and urine protein (+) all has some in each administration group and matched group, is that rat normally shows, no pathology meaning.
5, organ coefficient is measured through each group each internal organs average weight of different time and organ coefficient are measured, and the result shows, does not see variant between administration group and matched group relatively reach and respectively organize.
6, have the pulmonary congestion except that the minority animal during 3 months, 6 months high dose group postmortem of histopathologic examination's administration, not seeing has macroscopic pathological changes.The check pathological section of each administration treated animal and matched group is rarely seen to have few part animal liver, kidney slight granular degeneration to occur, the time limit of its frequency of occurrences and lesion degree and administration and dosage are all irrelevant, convalescent period also has individual animal that above-mentioned variation is arranged, liver, nephrocyte granular degeneration are the common variations of normal rat, belong to normal range.
Animal embodiment 3: the particulate Pharmacodynamic test of active extract of the present invention
Strong osseous granules is to the effect of female castrated rats
One, test method
1, groups of grains: every day, dosage was 5 times, 10 times and 20 times of clinical adult (extractum 3.8g/50kg), i.e. concentrated extract 0.133g, 0.266g, 0.532g, quite granule 0.63g, 1.26g, 2.52g.
Administering mode: irritate stomach
Administration number of times: every day 1 time, 6 days weekly, continuous 12 weeks.
Experimental control
Blank: under etherization the play tricks castration operation of 10 month female rats is blank.Gavage tap water 2ml, every day 1 time, 6 times weekly, continuous 12 weeks.
The castration contrast: 10 month female rats under etherization do the castration operation and are the castration contrast.Gavage tap water 2ml, every day 1 time, 6 times weekly, continuous 12 weeks.
Positive drug contrast: 1. LONGMU ZHUANGGU CHONGJI, commercially available, this experiment positive control drug, the strong people pharmaceutical factory in Wuhan product.LONGMU ZHUANGGU CHONGJI is mixed with suspension, and every ml contains LONGMU ZHUANGGU CHONGJI 1.25g, and the LONGMU control rats gavages LONGMU ZHUANGGU CHONGJI suspension 2ml, every day 1 time, 6 days weekly, continuous 12 weeks.(every day, dosage was 10 times of clinical adult (30g/50kg))
2, calcium gluconate injection: commercially available, this experiment positive control drug, Wenzhou, Zhejiang pharmaceutical factory produces.Every 10ml contains calcium gluconate 1000mg.The calcium control rats gavages calcium gluconate injection 1.75ml, every day 1 time, 6 days weekly, continuous 12 weeks.(every day, dosage was 10 times of clinical adult (2.5g/50kg))
Two, result of the test
Statistical disposition: Various types of data is all made significance analysis with the t check.
Each position bone density result:
As seen from Table 1: (1) castration matched group is compared with the blank group, and whole body, lumbar vertebra and femoral bmd all obviously descend, and P difference＜0.01 and 0.05 shows that castrated rats bone mineral content content obviously descends.(2) Ca++ matched group, bone strengthening matched group are compared with the castration matched group, and the whole body bone density of Ca++ matched group and bone strengthening matched group rises, and lumbar vertebra and femoral bmd have no significant change.(3) strong 5,10,20 times of groups of bone are compared with the castration matched group, and 10 times of groups of granule whole body, lumbar vertebra and femoral bmd all obviously rise, and P all＜0.001.5 times of groups of granule lumbar vertebra, 10 times of groups of granule femoral bmd also has rising in various degree.Show that granule can obviously increase castrated rats bone mineral content content.
Table 1 granule is to the effect Mean ± SD (g/cm2) of castrated rats bone density
Compare with castration: * P＜0.05 * * P＜0.01 * * * P＜0.001
Strong osseous granules is to the effect of senile rat
One, test method
Dosage is provided with
Pharmaceutical quantities: every day, dosage was 5 times, 10 times and 20 times of clinical adult (extractum 3.8g/50kg), i.e. concentrated extract 0.171g, 0.342g, 0.684g, quite granule 0.81g, 1.62g, 3.24g.
Administering mode: irritate stomach
Administration number of times: every day 1 time, 6 days weekly, continuous 12 weeks.
Experimental control
Blank: 4 month female rats are the matched group of growing up.Gavage tap water 2ml, every day 1 time, 6 times weekly, continuous 12 weeks.
Old contrast: 18 month female rats are aged control.Gavage tap water 2ml, every day 1 time, 6 times weekly, continuous 12 weeks.
The positive drug contrast: LONGMU ZHUANGGU CHONGJI, commercially available, this experiment positive control drug, the strong people pharmaceutical factory in Wuhan produces.LONGMU ZHUANGGU CHONGJI is mixed with suspension, and every ml contains LONGMU ZHUANGGU CHONGJI 1.2g, and the LONGMU control rats gavages LONGMU ZHUANGGU CHONGJI suspension 2ml, every day 1 time, 6 days weekly, continuous 12 weeks.(every day, dosage was 10 times of clinical adult (30g/50kg))
Two, result of the test
Statistical disposition: Various types of data is all made significance analysis with the t check.
Each position bone density result:
As seen from Table 2: (1) aged control is compared lumbar spine bmd with adult matched group and is obviously descended, P＜0.01.(2) the LONGMU matched group is compared with aged control, and whole body, lumbar vertebra and femoral bmd all obviously raise.(3) 5,10,20 times of groups of granule are compared with aged control, 10 times of groups of granule, 20 times of group whole bodies, and lumbar vertebra and femoral bmd all obviously rise, P difference＜0.05 and 0.01.And 5 times of group whole bodies, lumbar vertebra and femoral bmd have no significant change.Show: LONGMU ZHUANGGU CHONGJI and granule all can increase senile rat bone mineral content content in various degree.
Table 2 granule is to the effect Mean ± SD (g/cmm2) of senile rat bone density
Compare with aged control: * P＜0.05 * * P＜0.01
Conclusion
Above-mentioned result of the test shows, granule acute toxicity maximum tolerated dose＞20g/kg (be equivalent to clinical application amount 317 times) fails to obtain LD50; The numerical value of each dosage group many index of rat long term toxicity test, repeatedly inspection all in normal range, is not found toxicity so fail to find out the toxic action target organ; Acute toxicity test and long term toxicity test there is no the overt toxicity reaction.
Can obviously the raise bone mineral content content of removal ovary rat body, lumbar vertebra and femur of granule can strengthen the elasticity and the external shock resistance ability of removal ovary rat femur; Can obviously the raise bone mineral content content of old female rats whole body, lumbar vertebra and femur can strengthen the ballistic ability of external force resistance of senile rat femur; The old female rats estradiol level that can obviously raise shows that granule can varian function enhancing.Therefore, this medical instrument has certain nourishing the liver and kidney, and benefiting QI for activating blood circulation improves the effect of osteoporosis degree.
Animal embodiment 4: the osteoporotic clinical effectiveness of granule therapy of the present invention
Adopt at random, double blinding, positive drug contrast (GUSONGBAO KELI), multi-center clinical trial method, observe patient's 218 examples altogether, wherein A organizes (test group) 108 examples, B organizes (matched group) 110 examples, go into to organize the patient and take granule and bone pine protection granules respectively, each 1 bag, every day secondary, six months is a course of treatment.11 examples that come off in the test are wherein lost and are visited 6 examples, adverse events 4 examples, other reason 1 example.Complete data person A organizes 101 examples, and B organizes 106 examples; The result shows osteoporosis bone density tcm syndrome curative effect effective percentage A group 82.2%, B group 77.4%; Adverse events incidence rate A group 0.8%, B group 0.9%.
By the clinical observation to granule therapy osteoporosis (deficiency of the liver and kindey disease), the result shows:
1, curative effect is determined, it is obvious to improve primary symptom, and the rising bone density value is had certain effect.And curative effect not statistically significant relatively between two groups of contrast medicine GUSONGBAO KELI.Granule is to the rising of femoral neck bone density value obviously (P＜0.05), and after the treatment of control group femoral neck bone density value do not had obvious improvement.The granule therapy primary osteoporosis is described, and effect is more excellent in some aspects.
2, safely, have no side effect, untoward reaction is less, and symptom is slight.By the clinical health check-up of patient before and after the treatment, blood, urine, just routine examination, the heart, liver, renal function detect all no abnormal, show that this medicine is to important organs such as the heart, liver, kidney, blood, the no obvious toxic-side effects of tissue.
3, in whole test, each is organized safety indexes there are no significant and changes, and shows all safety relatively of institute's trial drug.
Conclusion
This compound Chinese medicinal preparation has certain nourishing the liver and kidney, the function of benefiting QI for activating blood circulation.Be used for primary osteoporosis (deficiency of the liver and kindey disease), disease is seen whole body or waist kidney pain, the contracture of muscle arteries and veins, and spinal column is aching and limp weak, and dizziness is dizzy etc.It can regulate the inside of human body function, nourishing the liver and kidney, and benefiting QI for activating blood circulation improves bone density, strengthens the ballistic ability of femur external force resistance, improves the osteoporosis degree, is a kind of more novel Chinese patent medicine, has popularizing application prospect preferably.
Claims (10)
1. compound Chinese medicinal preparation for the treatment of osteoporosis, it is characterized in that it be alcohol, water or alcohol-water mixture extract by following traditional Chinese medicine raw or following traditional Chinese medicine raw as active component, raw material of Chinese medicine consists of:
Radix Rehmanniae Preparata 400-1200g, Rhizoma Dioscoreae 200-500g, Fructus Lycii 50-600g, Cortex Eucommiae 100-600g,
Semen Cuscutae 50-650g, Rhizoma Curculiginis 50-380g, Radix Codonopsis 40-350g, Radix Astragali 80-500g,
Radix Salviae Miltiorrhizae 50-600g, Rhizoma Corydalis (processed with vinegar) 30-400g, calcine Concha Ostreae 100-700g.
2. compound Chinese medicinal preparation according to claim 1 is characterized in that its raw material of Chinese medicine consists of:
Radix Rehmanniae Preparata 588-1100g, Rhizoma Dioscoreae 285-450g, Fructus Lycii 98-500g, Cortex Eucommiae 165-500g, Semen Cuscutae 90-480g, Rhizoma Curculiginis 100-300g, Radix Codonopsis 75-280g, Radix Astragali 100-420g, Radix Salviae Miltiorrhizae 98-500g, Rhizoma Corydalis (processed with vinegar) 50-250g, calcine Concha Ostreae 180-500g.
3. compound Chinese medicinal preparation according to claim 1 is characterized in that its raw material of Chinese medicine consists of:
Radix Rehmanniae Preparata 627g, Rhizoma Dioscoreae 313g, Fructus Lycii 209g, Cortex Eucommiae 313g, Semen Cuscutae 209g, Rhizoma Curculiginis 167g, Radix Codonopsis 125g, Radix Astragali 209g, Radix Salviae Miltiorrhizae 209g, Rhizoma Corydalis (processed with vinegar) 105g, calcine Concha Ostreae 313g.
4. preparation method for the treatment of the compound Chinese medicinal preparation of osteoporosis
One, takes by weighing following traditional Chinese medicines and make raw material
Radix Rehmanniae Preparata 400-1200g, Rhizoma Dioscoreae 200-500g, Fructus Lycii 50-600g, Cortex Eucommiae 100-600g, Semen Cuscutae 50-650g, Rhizoma Curculiginis 50-380g, Radix Codonopsis 40-350g, Radix Astragali 80-500g, Radix Salviae Miltiorrhizae 50-600g, Rhizoma Corydalis (processed with vinegar) 30-400g, calcine Concha Ostreae 100-700g;
Two, with above-mentioned ten simply, except that Rhizoma Curculiginis, ten flavors such as all the other Radix Rehmanniae Preparata add alcohol, water or alcohol-water mixture and extract, and filter, and concentrating filter liquor is chilled to room temperature, adds ethanol, stirs, and places a few hours, filter, supernatant as active component I;
Three, Rhizoma Curculiginis is used alcohol or hydro-thermal reflux, extract,, the extracting solution that obtains is as active component II;
Four, with above-mentioned active component I and II mix homogeneously, reclaim ethanol, concentrate, get extractum, extractum is made required dosage form according to a conventional method.
5. preparation method according to claim 4 is characterized in that alcohol, water or alcohol-water mixture extract three times in the step 2, and extraction time is 2 hours for the first time, and second and third time is 1.5 hours.
6. preparation method according to claim 4 is characterized in that the hot reflux number of times is a secondary in the step 3, and hot reflux liquid is 40～90% alcoholic solution, and the hot reflux time is each 3 hours.
7. preparation method for the treatment of the compound Chinese medicinal preparation of osteoporosis
One, takes by weighing following traditional Chinese medicines and make raw material
Radix Rehmanniae Preparata 400-1200g Rhizoma Dioscoreae 200-500g structure Fructus Lycii 50-600g Cortex Eucommiae 100-600g Semen Cuscutae 50-650g Rhizoma Curculiginis 50-380g Radix Codonopsis 40-350g Radix Astragali 80-500g Radix Salviae Miltiorrhizae 50-600g Rhizoma Corydalis (processed with vinegar) 30-400g calcine Concha Ostreae 100-700g;
Two, take by weighing Rhizoma Curculiginis, Radix Salviae Miltiorrhizae, the Radix Astragali and Rhizoma Corydalis (processed with vinegar) four Chinese medicine material by above-mentioned weight proportion, use alcohol or alcohol-water mixture to reflux, get extracting solution, filter, filtrate recycling ethanol concentrates, and gets active component I;
Three, all the other medical material water reflux, extract, get extracting solution active component II;
Four, merge active component I and II, it is 55-60 ℃ that medicinal liquid is concentrated into temperature, and relative density is the extractum of 1.10-1.40, and extractum is made required dosage form on request.
8. preparation method according to claim 7 is characterized in that extracting three times with alcohol or alcohol-water mixture in the step 2, and extraction time is 2 hours for the first time, and second and third time is 1 hour.
9. preparation method according to claim 7 is characterized in that step 3 water backflow number of times is 2-3 time.
10. preparation method according to claim 7, the hot reflux liquid that it is characterized in that step 2 are 50%～80% alcoholic solution.
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| CN104688932A (en) * | 2015-04-08 | 2015-06-10 | 房经武 | Traditional Chinese medicine preparation for postmenopausal osteoporosis and preparation method |
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| CN1150910A (en) * | 1996-04-18 | 1997-06-04 | 花茂时 | Osteophytosis pill and its compounding method |
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| 补肾为主治疗骨质疏松症. 王军.云南中医学院学报，第22卷第2期. 1999 |
| 补肾为主治疗骨质疏松症. 王军.云南中医学院学报，第22卷第2期. 1999 * |
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| 骨质疏松症的中医临床研究进展. 李晓春.中国社区医师，第7卷第18期. 2005 * |
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