CN102233028B - Composite preparation for treating osteoporosis - Google Patents
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Abstract
The invention relates to a composite preparation for treating osteoporosis, which belongs to the technical field of oral preparations. The composite preparation is made from the following raw materials in part by weight: 5 to 50 parts of safflower, 30 to 120 parts of pseudo-ginseng root, 6 to 60 parts of astragalus, 10 to 100 parts of ginseng, 10 to 80 parts of bark of eucommia and 5 to 50 parts of dried tangerine. The preparation can be formed into the following formulations: capsules, patches, granules, spray, tablets, pills, mixture and the like. The product has the effects of improving blood circulation and micro circulation, tonifying liver and kidney, activating blood and tonifying qi. According to treatment based on syndrome differentiation, the bark of eucommia is mainly used for tonifying kidney and yin, strengthening bone and promoting marrow growth; the ginseng and the astragalus are used for tonifying qi, blood and spleen; the pseudo-ginseng root and safflower are used for activating blood; and the dried tangerine is used for unblocking collaterals. The medicines are used in combination to regulate the yin and yang balance in human body, promote marrow growth and strengthen bone. The results of pharmacodynamic and clinic tests indicate the product invented has remarkable treatment effect on osteoporosis and is safe and reliable when used continuously.
Description
Technical field
The invention belongs to technical field of oral preparation, is a kind of medicine that can treat osteoporosis specifically.
Technical background
Osteoporosis is a kind ofly to reduce with the bone amount, and the osseous tissue microstructure is impaired, causes the systemic skeletal diseases that skeleton fragility increases and fracture risk increases then.Osteoporosis is that sickness rate, mortality rate and health subsidies are consumed big disease, be known as " silent epidemic diseases " in the world as common metabolic disease.Along with aging population increase and the life-span prolongation, osteoporosis and fracture complication thereof are the trend of rising.
The medicine of treatment osteoporosis is many, and product how to select to treat osteoporosis is most important.Western medicine mainly contains the medicine that suppresses bone resorption, and like the calcitonin class, bis phosphoric acid class, estrogen etc. promote the bone formation medicine like fluoride, vitamin D etc.But research conclusion is also inconsistent, is used to promote osteoplastic medicine still few so far clinically, and wherein the Statins curative effect is limited, and fluoride is prone to cause fluorosis, does not still have competent evidence to show that which kind of medicine is better.
Osteoporosis is a multigenic disease, and the effect characteristics of performance Chinese herb compound multicomponent, many target spots are treated more scientific and effective of osteoporosis on the basis that is directed against bone formation and bone resorption, more meet the ADFR therapy.A-activation: increase the number that the new position of bone point that produces promptly is called bone structure unit (BSU).D-suppresses: the osteoclast activity that mainly suppresses the bone resorption phase.F-removes: remove the inhibition of bone resorption, promote osteoblastic formation.R-is repeatedly: repeat the process of front, through activation → inhibitions → releasing → repeatedly, promptly the ADFR process increases new bone, treat osteoporosis.
Summary of the invention
The object of the invention is to provide a kind of compound preparation of treating osteoporosis.
The research and development of compound preparation of the present invention are to be guiding with the traditional medicine, form in conjunction with the modern science and technology exploitation.The traditional Chinese medical science thinks that kidney qi prosperity and decline and bone firm strong has confidential relation; Because kidney storing essence master bone is given birth to marrow; Osteoporosis often shows that deficiency of kidney-essence, kidney yin are deficient, the different syndromes of insufficiency of kidney-YANG clinically, and the traditional Chinese medical science is reused Cortex Eucommiae the kidney invigorating and essence nourishing yin nourishing bone strengthening according to determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs and given birth to marrow; Radix Ginseng, the Radix Astragali QI invigorating spleen invigorating of enriching blood; Radix Notoginseng, Flos Carthami are invigorated blood circulation; The Pericarpium Citri Reticulatae collateral dredging.All medicines share mediator's yin-yang, mend the marrow bone strengthening, play positive role to preventing and treating osteoporosis, and the touch upon marrow of traditional medicine of the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of fully having showed Chinese medicine is that western medicine can't be substituted.
Compound preparation of the present invention be characterised in that by following weight portion proportioning raw material process:
Flos Carthami 5-50 part, Radix Notoginseng 30-120 part, Radix Astragali 6-60 part,
Radix Ginseng 10-100 part, Cortex Eucommiae 10-80 part, Pericarpium Citri Reticulatae 5-50 part.
The product of further optimizing of the present invention is processed by the following weight parts proportion raw material:
Flos Carthami 10-40 part, Radix Notoginseng 20-90 part, Radix Astragali 10-45 part,
Radix Ginseng 10-45 part, Cortex Eucommiae 10-45 part, Pericarpium Citri Reticulatae 5-25 part.
Best product of the present invention is processed by the following weight parts proportion raw material:
15 parts on Flos Carthami, 30 parts of Radix Notoginseng, 40 parts of the Radixs Astragali,
20 parts of Radix Ginsengs, 30 parts of the Cortexs Eucommiae, 10 parts of Pericarpium Citri Reticulataes.
The preferred dosage form of the present invention is a capsule, also can be other dosage forms, as: patch, granule, spray, tablet, pill, mixture.
The capsular method for preparing of product of the present invention is: get Flos Carthami, Radix Notoginseng, the Radix Astragali, Radix Ginseng, the Cortex Eucommiae and Pericarpium Citri Reticulatae, through selection, soak, with water extraction, filtration, concentrate system extractum, make thick paste, drying, pulverizing, granulation be encapsulated.
Below be the toxicity test of product of the present invention, pharmacodynamics test and clinical trial situation.
The acute toxicity test in mice of product
One, material
Tried thing: the capsule that embodiment one makes, 500mg/ grain.
Laboratory animal: ICR mice
Animal quality certification numbering: 0000265
Animal is provided by animal housing of natural drug pharmacology key lab of unming Medical College.
Two, method
Animal divides into groups: select 60 of healthy mices for use, body weight 18-22g divides three groups at random, and 20 every group, male and female half and half.
Dosage design and administration: establish high dose group (25.5g/kg), middle dose groups (17.9g/kg), low dose group (12.8g/kg).Animal fasting 12h before the administration.Each is organized mice and gives above-mentioned various dose respectively, is once to irritate stomach and give.Observe the reaction of animal, continuous seven days every day after the administration.
Three, result
Mice does not see the toxic reaction and the phenomena of mortality after once irritating stomach, all animal subjects in order, and are movable normal, and hair color is smooth.Reach 25.5g/kg so once irritate this product dosage of stomach for mice, (press the body surface area conversion, be equivalent to 21.5 times of clinical Coming-of-Age Day consumption, is Coming-of-Age Day 180 times of consumption according to the weight) can not be measured median lethal dose(LD 50).
Four, the mensuration of maximum dosage-feeding
Select 20 of above-mentioned qualified mices for use, male and female half and half behind the fasting 12h, are once irritated the 25.5g/kg that stomach gives high dose, every at a distance from 8 hours once, in one day totally three times.Daily total amount is that (be scaled 64.5 times of Coming-of-Age Day dosing by body surface area, convert by body weight, then be Coming-of-Age Day 540 times of dosing to 76.5g/kg.) after the administration every day observe reaction of animals, fortnight continuously.The healthy survival of the whole animal subjects of result,, diet smooth by hair is movable normal, does not find the overt toxicity reaction.
Five, estimate
Give mouse stomach, dosage reaches 25.5g/kg, and mice median lethal dose(LD 50) (LD50) can not be measured.The maximum dosage-feeding result of the test shows, mice day dosing reach 76.5g/kg, press body surface area and convert; Be 64.5 times of clinical people Coming-of-Age Day dosing; Converting by body weight then be Coming-of-Age Day 540 times of dosing, does not see the laboratory animal phenomena of mortality yet, points out the maximum dosage-feeding＞76.5/kg of product.So the dosage of clinical this product of use is safe.
The long term toxicity test of product
One, test objective
Medicine is carried out the relevant requirements of long term toxication according to State Food and Drug Administration's " medicine registration management way " (office makes No. 28); Product is carried out the research of rat long term toxicity test; 90 days (for 6 courses of treatment of the clinical application) back of being intended to observe continuous use is to reaction, poisoning symptom and the toxic action target organ of laboratory animal generation.So that for the clinical application safety assessment provides experimental basis.
Two, material
(1) tried thing: the capsule that embodiment one makes, 500mg/ grain.This natural drug pharmaceutical Co. Ltd provides by the Yunnan Cray, and lot number is 090910.Dosage adopts high, medium and low three dose groups, that is: four times, two times clinical, clinical application amounts.
(2) laboratory animal: the SD rat, body weight 121 ± 6.8g, male and female half and half are provided by Yunnan Province animal housing of natural drug pharmacology key lab, animal quality quality certification numbering: №: 0000457.
(3) test apparatus and reagent
1, the full-automatic blood counting instrument of CEU-DYN1600 type (production of U.S. Abott company)
2, OLYMPUS-AU600 automatic clinical chemistry analyzer (Japanese import)
3, biochemical reagents: provide by giving birth to company in Shanghai Long March company and Beijing.
Three, test method
(1) dosage design and medication
This experimental drug treated animal is established high, medium and low three dose groups, 20 of every group of rats, male and female half and half.Each is organized rat and irritates product that feed to give four times, two times and clinical application amount respectively, by clinical application method, administration every day secondary, and continuous use 90 days (administration is 180 times altogether, is 6 courses of treatment of clinical application).Other establishes a matched group, irritates and gives distilled water, and animal condition and administration (distilled water) methods are with the administration group.Each treated animal weighing once in per two weeks before medication and after the medication, and change corresponding adjustment dosage with body weight.
The index of (two) observing and detecting
Behind the rat continuous use 90 days,, put to death animal simultaneously through the femoral artery blood sampling.Carry out the hematology respectively, each item indexs such as blood biochemical and histopathology detect
[2]
(3) statistical method:
Experimental data adopts method of analysis of variance to carry out statistical procedures.
Four, observation item, result and statistical analysis
(1) overview
In the test period except that high dose group animal experiment initial stage appetite descends to some extent, the outward appearance of each treated animal, hair color, behavior, extremity activity and the equal no abnormality seen of feces.Compare the weight of animals variation between each administration group and matched group comparison and each administration group group and all do not see notable difference.The result sees the following form 1.
Table 1 product is irritated stomach 90 days influences X ± SD (g) n=20 to what rat body weight increased
Reach each administration group and matched group between administration group group relatively, the P value is all greater than 0.05 (P＞0.05)
(2) hematology detects and the result
The hematology detects index and comprises erythrocyte (RBC) counting, leukocyte (WBC) counting and differential counting, hemoglobin (Hb), platelet (PLT) counting, reticulocyte (Ret) counting and coagulation time test etc.The result shows between three administration group groups and each administration group and matched group comparison, and medicine is not all observed in what influence has to laboratory animal hematology aspect.(table 2-3)
Table 2 gives rat oral gavage product 90 days to its hematological X ± SD-n=12 that influences
Reach each administration group and matched group between three administration group groups relatively: the P value is all greater than 0.05 (P＞0.05)
Table 3 is given the rat oral gavage product influence to its hematological indices in 90 days
n=12
Each administration group and matched group are relatively between three administration group groups: the P value is all greater than 0.05 (P＞0.05)
(3) blood biochemical is learned and is detected and the result:
Blood biochemical is learned and is detected observation index: blood glucose (GLu), glutamate pyruvate transaminase (ALT), ten of glutamic oxaloacetic transaminase, GOT (AST), alkali phosphatase (AKP), total protein (TP), albumin (ALB), blood urea nitrogen (BUN), T-CHOL (ChoL), STB (TB) and creatinines (Cr) etc.The result sees table 4-5.The result shows that this product of rat oral gavage 90 days does not have obvious influence to each item blood parameters that is detected, and through statistical procedures, the P value is all greater than 0.05, and detected value is all in the range of normal value of detection animal.
Table 4 is given the influence that rat oral gavage product sky learns its blood biochemical (n=12 of X ± SD)
Reach each administration group and matched group between three administration group groups relatively: the P value is all greater than 0.05 (P＞0.05)
Table 5 learned for the rat oral gavage product in 90 days to its blood biochemical influence
n=12
Reach each administration group and matched group between three administration group groups relatively: the P value is all greater than 0.05 (P＞0.05)
(4) system's obduction and histopathologic examination:
1, system becomes celestial and organ coefficient calculating: off-test, adopt femoral artery sacrificed by exsanguination animal.Blood sample send and does the hematology, blood biochemical is learned and detected, and animal is carried out careful gross anatomy comprehensively.Histoorgans such as the heart, liver, spleen, lung, kidney, brain, adrenal gland, testis (uterus, ovary), prostate, stomach, 12 fat intestinal 、 Kong rotation intestinal, colon, thyroid, thymus, bladder and lymph node are examined.Simultaneously important organ is weighed, calculate organ coefficient.Result's all no abnormal (table 6).
Table 6 is irritated to rat and is fed the product influence to its organ coefficient in 90 days (x ± SDg/100g body weight) n=20
Reach each administration group and matched group between three administration group groups relatively: the P value is all greater than 0.05 (P＞0.05)
2, histopathologic examination: by relevant requirements; Randomly draw matched group and high dose group rat 1/2nd (female, hero half and half); Do the heart, liver, spleen, lung, kidney, adrenal gland, thyroid, thymus, stomach, the prostatic histological examination of testis (uterus, ovary); The preservation of drawing materials of other dose groups has when unusual in high dose group, checks again.Administration group does not as a result find all that with matched group the histopathology relevant with medication changes.
Five, evaluation of result
Product rat long term toxicity test 90 days is 6 courses of treatment of clinical application.High, medium and low three medication group doses reach 52 times, 26 times, 13 times (by heavily converting) of clinical adult's medication, none death of animal of whole test cycle respectively.In the process of the test, cage is looked on and is examined, and does not find tangible toxic reaction.Rat body weight growth and hematology, blood biochemical are learned between check result, each administration group and matched group comparison, administration group group does not more all have significant difference, the data that detect all in range of normal value (P＞0.05).Organ coefficient result of calculation shows, more also no significant difference between each group.
To matched group and the histopathologic examination of each important organ of high dose group animal, all discovery pathological change of being extracted relevant with medicine.Clinical Coming-of-Age Day, dosing was 2g, was merely 1/52 (according to the weight) of this experiment administration high dose group, and 1/13 (according to the weight) of lowest dose level group is so be safe by this dosage continuous use.
The pharmacodynamics test of product
Oral retinoic acid is caused the preventive and therapeutic effect of rats with osteoporosis.60 of Wistar male rats are divided into 6 groups at random: the normal saline matched group, and model group (retinoic acid 70mg/kg) is irritated clothes; Every day 1 time, totally 2 weeks), XIANLING GUBAO group (5g/kg), the capsule that this group of products makes for embodiment one (0.5; 1.0 3 dose groups of 1.5/100g are irritated and are fed).The test group animal bushing beyond the region of objective existence of taking medicine is irritated clothes 2 weeks of retinoic acid simultaneously, withdraw retinoic acid after, continue 4 weeks of administration.0.5h tail vein is got hematometry serum Ca, P and alkali phosphatase (ALP) activity after the last administration.Get blood next day with rat with pentobarbital anesthesia after, take pictures through X-ray, observe and respectively organize the rat bony structures (the X-ray condition is 25mA; 50kV 0.1s), then puts to death rat; Strip rat femur, on borne densitometers, measure rat femur upper end (through greater trochanter), the bone density of lower end.Get the femoral head position and measure bone Ca, P content with plasma light quantity appearance.The result sees table 8～10, and this group of products and XIANLING GUBAO all can make experimental osteoporosis rat femur and serum Ca, (P＜0.01=, the ALP vigor then descends P content, and promotes the pathological changes bone density to recover apparently higher than model group.The X-ray sheet shows that the model group rat is compared with normal rats, degrees of osteoporotic occurs, and cortical bone is thin, and density reduces in the spongy bone, serves as obvious with vertebra, femur especially.Osteoporosis is respectively organized in medication has improvement in various degree.
The influence of table 7 couple Serum from Model Rats with Osteoporosis Ca, P and ALP (
n=8)
The influence of table 8 pair osteoporosis rat model femoral bmd (
n=6)
The influence of Ca, P content in the table 9 pair osteoporosis rat model femur (
n=6)
This product is processed through refining the refinement by Flos Carthami, Pericarpium Citri Reticulatae, Radix Notoginseng, the Radix Astragali, Radix Ginseng, the Cortex Eucommiae.Through experimentation: in the loose model of rat bone that retinoic acid causes, this product of various dose can make rat blood serum Ca, P content increase (1), and ALP is active to be reduced, and femoral bmd gos up, and Ca, P content increase.X-ray sheet osteoporosis symptom alleviates.Point out this product that osteoporosis is truly had better preventive and therapeutic effect, can reach the regeneration of promotion bone trabecula, enhance bone intensity, improve bone density, thereby effectively treat osteoporosis.
The clinical research of product
Use embodiment 1 products obtained therefrom that 60 routine bone patients with osteoporosis are carried out clinical observation to see its curative effect from year October in March, 2010 to 2010, the result is following:
One, data and method
(1) data
Osteoporosis group 60 examples are seen table 10.
Table 10: the clinical classification of treatment osteoporosis
(2) method of administration
Once oral 2, every day, secondary was taken after the supper in 1 hour, and totally 30 times is a course of treatment.All need accomplish 6 course of therapy.
(3) standard of result evaluation:
1. doing well,improving situation before and after taking medicine:
A. the degree of pain be divided into gently, in, heavy
Slightly: pain can be born, and is accidental
Moderate: influence activity, few sending out
Severe: obviously influence activity, pilosity often need be taken analgesic drug product
B. the evaluation of bone density value variation.
C. the variation of function.
2. curative effect is judged:
The person that all do not change before and after a, b, three of c take medicine is produce effects
It is effective that a, b binomial have the improver
Only one or the equal no change person of binomial are invalid among a, the b
Two, result
In (one) 60 osteoporosis, the course of disease the shortest August, the longest 10 years.
Change before and after the treatment and see table 11.
Variation (example) before and after the routine osteoporosis treatment of table 1160
(2) treatment 60 routine osteoporosis clinical effectivenesses are seen table 12.
Table 12 treatment 60 routine clinical effectivenesses
(3) case
● female patient, suffered from osteoporosis 4 years, taken a lot of calcium complement agents and every day and all will walk, but the state of an illness never takes a turn for the better in order to avoid sb.'s illness took a turn for the worse.Hip Fracture has also been done the hipbone replacement operation.Bone scanning confirms that bone density has reduced.Take product after six months, bone scanning again shows that bone density improves, again with the T value method for measuring analyze before the treatment with treat after the bone health situation.The result confirms that the raising of bone density is indubitable.
● patient Chen, the man, 69 years old, because of suffering from the intracranial benign tumor, after the underwent operative treatment, right side upper and lower extremities hemiplegia was walked and need the people be held up, and can't take care of oneself long-term bed.Nearly half a year of normal sense lumbar and back pain, and expand with joint aches, extremity acid, the time picotement is arranged, two lower limb are soft and unable, with dual intensity X line absorption measurement method (DEXA) sweep measuring reactive bone amounts such as lumbar vertebra, hip reduced, and are diagnosed as osteoporosis.Take product and feel aching pain in waist and back after two months and alleviate, obey three month after, lumbar and back pain obviously alleviates, obey five month after, joint and lower limb are ached and are disappeared basically, lower limb begin effectively.After taking 6 months, with dual intensity X line absorption measurement method (DEXA) sweep measuring reactive bone amounts such as lumbar vertebra, hip are obviously increased again.
● female patient, 45 years old, normal sense whole body arthralgia since 2008; Lower limb acid expands, numb, feel like jelly unablely, be difficult to stand for a long time walking for a long time, (DEXA) carries out the bone density sweep measuring through dual energy X-ray absorptiometry; Conclusion shows that the bone amount obviously reduces, and bone density reduces, and is diagnosed as serious osteoporosis.Take product of the present invention in March, 2010, take first quarter moon pain and just alleviate to some extent, aching pain in waist and back is alleviated, took continuously 3 months, the pain complete obiteration, take 8 months again after, can normally walk, can squat down, stair activity, function is recovered fully.Obviously increase through DEXA sweep measuring reactive bone amount again.
Three, side effect and toxic reaction
1, toxic and side effects appears in none example in this paper 60 example treatments, and routine blood test is normal before and after the treatment, does not see that platelet, leukocyte descend, and bleeding tendency do not occur yet.Blood biochemicals etc. are checked also Non Apparent Abnormality.
2, occur xerostomia, dizziness after small number of patients is taken medicine, need not handle and to die away.
Four, drug dose
2/inferior, every day 2 times, treatment continuously.
Five, discuss
According to theory of Chinese medical science " kidney governing bones ", " reparation of bone at first relies on the growth of QI and blood ", think osteoporosis, getting to the bottom of sb.'s illness is deficiency of the liver and kindey; Muscles and bones is slack lazy, shows as back and limbs pain, migratory pain; Joint stuffiness, numb limbs and tense tendons, qi depression to blood stasis; The muscle arteries and veins loses and supports is its main pathogenesis, and its control should be set about from the kidney invigorating.The invention product has the effect that improves blood circulation and microcirculation, tonifying liver, the kidney invigorating, activating blood circulation and supplementing qi.Reuse Cortex Eucommiae the kidney invigorating and essence nourishing yin nourishing bone strengthening according to determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs and give birth to marrow; Radix Ginseng, the Radix Astragali QI invigorating spleen invigorating of enriching blood; Radix Notoginseng, Flos Carthami are invigorated blood circulation; The Pericarpium Citri Reticulatae collateral dredging.All medicines share mediator's yin-yang, mend the marrow bone strengthening, play positive role to preventing and treating osteoporosis, and the touch upon marrow of traditional medicine of the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of fully having showed Chinese medicine is that western medicine can't be substituted.The invention product has special effect to the treatment osteoporosis, and this product indication has vast market prospect.
Prescription proportioning campaign
Since compound preparation of the present invention by following weight portion proportioning raw material process: Flos Carthami 5-50 part, Radix Notoginseng 30-120 part, Radix Astragali 6-60 part, Radix Ginseng 10-100 part, Cortex Eucommiae 10-80 part, Pericarpium Citri Reticulatae 5-50 part, above prescription ratio range has also been carried out following campaign one (weight portion).
One, Flos Carthami changes
(1), the Flos Carthami lower limit, promptly during 5 parts on Flos Carthami:
1, all the other upper limits, i.e. 120 parts of Radix Notoginseng, 60 parts of the Radixs Astragali, 100 parts of Radix Ginsengs, 80 parts of the Cortexs Eucommiae, 50 parts of Pericarpium Citri Reticulataes.
2, about all the other intermediate values, i.e. 70 parts of Radix Notoginseng, 30 parts of the Radixs Astragali, 55 parts of Radix Ginsengs, 45 parts of the Cortexs Eucommiae, 22 parts of Pericarpium Citri Reticulataes.
3, all the other lower limits, 30 parts of Radix Notoginseng, 6 parts of the Radixs Astragali, 10 parts of Radix Ginsengs, 10 parts of the Cortexs Eucommiae, 5 parts of Pericarpium Citri Reticulataes.
(2), about the Flos Carthami intermediate value, promptly during 23 parts on Flos Carthami:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(3), the Flos Carthami upper limit, promptly during 50 parts on Flos Carthami:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
Two, Pericarpium Citri Reticulatae changes
(1), the Pericarpium Citri Reticulatae lower limit, promptly during 5 parts of Pericarpium Citri Reticulataes:
1, all the other upper limits, i.e. 50 parts on Flos Carthami, 100 parts of Radix Notoginseng, 50 parts of the Radixs Astragali, 50 parts of Radix Ginsengs, 30 parts of Cortex schizophragmatis integrifolii radiciss, 50 parts of the Cortexs Eucommiae.
2, about all the other intermediate values, i.e. 23 parts on Flos Carthami, 120 parts of Radix Notoginseng, 60 parts of the Radixs Astragali, 100 parts of Radix Ginsengs, 80 parts of the Cortexs Eucommiae.
3, all the other lower limits, i.e. 5 parts on Flos Carthami, 30 parts of Radix Notoginseng, 6 parts of the Radixs Astragali, 10 parts of Radix Ginsengs, 10 parts of the Cortexs Eucommiae.
(2), about the Pericarpium Citri Reticulatae intermediate value, promptly during 23 parts of Pericarpium Citri Reticulataes:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(3), the Pericarpium Citri Reticulatae upper limit, promptly during 50 parts of Pericarpium Citri Reticulataes:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
Three, Radix Notoginseng changes
(1), the Radix Notoginseng lower limit, promptly during 30 parts of Radix Notoginseng:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(2), about the Radix Notoginseng intermediate value, promptly during 75 parts of Radix Notoginseng:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(3), Radix Notoginseng
limit, promptly during Radix Notoginseng
part:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
Four, the Radix Astragali changes
(1), Radix Astragali lower limit, promptly during 6 parts of the Radixs Astragali:
1, all the other upper limits.
2, about all the other intermediate values.
1, all the other lower limits.
(2), about Radix Astragali intermediate value, promptly during 33 parts of the Radixs Astragali:
1, all the other upper limits.
2, about all the other intermediate values.
2, all the other lower limits.
(3), the Radix Astragali upper limit, promptly during 60 parts of the Radixs Astragali:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
Five, Radix Ginseng changes
(1), the Radix Ginseng lower limit, promptly during 10 parts of Radix Ginsengs:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(2), about the Radix Ginseng intermediate value, promptly during 55 parts of Radix Ginsengs:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(3), the Radix Ginseng upper limit, promptly during 100 parts of Radix Ginsengs:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
Six, the Cortex Eucommiae changes
(1), Cortex Eucommiae lower limit, promptly during 10 parts of the Cortexs Eucommiae:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
(2), about Cortex Eucommiae intermediate value, promptly during 45 parts of the Cortexs Eucommiae:
1, all the other upper limits.
2, about all the other intermediate values.
2, all the other lower limits.
(3), the Cortex Eucommiae
limit, promptly during 0 part of the Cortex Eucommiae
:
1, all the other upper limits.
2, about all the other intermediate values.
3, all the other lower limits.
Also be since compound preparation of the present invention by following weight portion proportioning raw material process: Flos Carthami 5-50 part, Radix Notoginseng 30-120 part, Radix Astragali 6-60 part, Radix Ginseng 10-100 part, Cortex Eucommiae 10-80 part, Pericarpium Citri Reticulatae 5-50 part, so above prescription ratio range has also been carried out following campaign two (weight portion):
1, to six kinds of medical materials in the product prescription of the present invention, change and to get wherein two kinds, to take off when limiting the quantity of when these two kinds, all the other four kinds capping amounts are respectively got about intermediate value, take off and limit the quantity of.
2, to six kinds of medical materials in the product prescription of the present invention, change and to get wherein three kinds, to take off when limiting the quantity of when these three kinds, its excess-three kind is capping amount respectively, gets about intermediate value, takes off and limits the quantity of.
3, to six kinds of medical materials in the product prescription of the present invention, change and to get wherein four kinds, to take off when limiting the quantity of when these four kinds, all the other two kinds capping amounts are respectively got about intermediate value, take off and limit the quantity of.
Concrete proportioning in the above campaign is if there is repetition, and the test that every proportioning is identical is same test, does not repeat.
Result of the test shows that the product of said ratio all has obvious curative effects to the treatment osteoporosis.
Good effect of the present invention: the advantage of performance traditional medicine, utilization modern science and technology, science compatibility; Meticulously prescription is developed a kind of compound preparation of treating osteoporosis, and this product meets fully the treatment of osteoporosis and more meets the ADFR therapy; Through activation → inhibition → releasing → repeatedly; Be the ADFR process, increase new bone, the treatment osteoporosis.More traditional Drug therapy osteoporosis is science, safer, effective more.
The specific embodiment
Embodiment 1: by weight selection 15 parts on Flos Carthami, 30 parts of Radix Notoginseng, 40 parts of the Radixs Astragali, 20 parts of Radix Ginsengs, 30 parts of the Cortexs Eucommiae, 10 parts of Pericarpium Citri Reticulataes, soak, with water extraction, filtration, concentrate system extractum, make thick paste, drying, pulverizing, granulation be encapsulated.Use shows that the product of present embodiment has significant curative effect to the treatment osteoporosis.
Embodiment 2: by weight selection 35 parts on Flos Carthami, 40 parts of Radix Notoginseng, 15 parts of the Radixs Astragali, 45 parts of Radix Ginsengs, 12 parts of the Cortexs Eucommiae, 20 parts of Pericarpium Citri Reticulataes, soak, with water extraction, filtration, concentrate system extractum, allocate solvent into, add cause condensate, be coated with cream, the lid lining, cutting into slices promptly gets this product patch.Use shows that the product of present embodiment has significant curative effect to the treatment osteoporosis.
Embodiment 3: by weight selection 10 parts on Flos Carthami, 22 parts of Radix Notoginseng, 25 parts of the Radixs Astragali, 12 parts of Radix Ginsengs, 20 parts of the Cortexs Eucommiae, 25 parts of Pericarpium Citri Reticulataes, soak, promptly get the spray product with water extraction, filtration, concentrated, dosing, static, filtration, fill.Use shows that products obtained therefrom has significant curative effect to the treatment osteoporosis.
Embodiment 4: by weight selection 25 parts on Flos Carthami, 850 parts of Radix Notoginseng, 12 parts of the Radixs Astragali, 40 parts of Radix Ginsengs, 25 parts of the Cortexs Eucommiae, 5 parts of Pericarpium Citri Reticulataes, soak, with water extraction, filtration, concentrate the system clear paste, add auxiliary materials and mixing, make granule, be drying to obtain this product.Use shows that products obtained therefrom has significant curative effect to the treatment osteoporosis.
Embodiment 5: by weight 40 parts on Flos Carthami of selection, 20 parts of Radix Notoginseng, 45 parts of the Radixs Astragali, 10 parts of Radix Ginsengs, 45 parts of the Cortexs Eucommiae, 25 parts of Pericarpium Citri Reticulataes, soak, promptly get the tablet product with water extraction, filtration, concentrated system clear paste, system thick paste, drying, pulverizing, tabletting.Use shows that products obtained therefrom has significant curative effect to the treatment osteoporosis.
Embodiment 6: by weight selection 30 parts on Flos Carthami, 30 parts of Radix Notoginseng, 30 parts of the Radixs Astragali, 30 parts of Radix Ginsengs, 30 parts of the Cortexs Eucommiae, 22 parts of Pericarpium Citri Reticulataes, soak, with water extraction, filtration, concentrate the system clear paste, make thick paste, drying, pulverize, sieve, mixing adds the adjuvant pill and promptly gets the pill product.Use shows that products obtained therefrom is to having significant curative effect to the treatment osteoporosis.
Embodiment 7: by weight selection 40 parts on Flos Carthami, 90 parts of Radix Notoginseng, 45 parts of the Radixs Astragali, 45 parts of Radix Ginsengs, 45 parts of the Cortexs Eucommiae, 25 parts of Pericarpium Citri Reticulataes, soak, promptly get the mixture product with water extraction, filtration, concentrated, dosing, fill.Use shows that products obtained therefrom is to having significant curative effect to the treatment osteoporosis.
Above embodiment only is for this method is described further, and this method usage range is not received the limitation of the embodiment that lifts.
Claims (5)
1. compound preparation of treating osteoporosis is characterized in that being processed by following raw materials in weight portion:
Flos Carthami 5-50 part, Radix Notoginseng 30-120 part, Radix Astragali 6-60 part,
Radix Ginseng 10-100 part, Cortex Eucommiae 10-80 part, Pericarpium Citri Reticulatae 5-50 part.
2. like the compound preparation of the said treatment osteoporosis of claim 1, it is characterized in that processing by the following weight parts proportion raw material:
Flos Carthami 10-40 part, Radix Notoginseng 20-90 part, Radix Astragali 10-45 part,
Radix Ginseng 10-45 part, Cortex Eucommiae 10-45 part, Pericarpium Citri Reticulatae 5-25 part.
3. like the compound preparation of the said treatment osteoporosis of claim 2, it is characterized in that processing by the following weight parts proportion raw material:
15 parts on Flos Carthami, 30 parts of Radix Notoginseng, 40 parts of the Radixs Astragali,
20 parts of Radix Ginsengs, 30 parts of the Cortexs Eucommiae, 10 parts of Pericarpium Citri Reticulataes.
4. like the compound preparation of the said treatment osteoporosis of claim 1, it is characterized in that dosage form is a capsule.
5. like the compound preparation of the said treatment osteoporosis of claim 1, it is characterized in that dosage form is patch or granule or spray or tablet or pill or mixture.
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| CN1559589A (en) * | 2004-03-10 | 2005-01-05 | 山东师范大学 | Medicinal liquid for treating osteoporosis and its preparation method |
| CN101057907A (en) * | 2006-04-17 | 2007-10-24 | 吴英萍 | Traditional Chinese medicinal capsule and its quality control method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1559589A (en) * | 2004-03-10 | 2005-01-05 | 山东师范大学 | Medicinal liquid for treating osteoporosis and its preparation method |
| CN101057907A (en) * | 2006-04-17 | 2007-10-24 | 吴英萍 | Traditional Chinese medicinal capsule and its quality control method |
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