CN103405524B - Cancellous bone-reinforcing formula for treating osteoporosis and preparation technology of same - Google Patents
Cancellous bone-reinforcing formula for treating osteoporosis and preparation technology of same Download PDFInfo
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Abstract
The invention mainly relates to a cancellous bone-reinforcing formula for treating osteoporosis and a preparation technology of the cancellous bone-reinforcing formula. The formula comprises the following active ingredients in parts by weight: 25-35 parts of astragalus membranaceus, 9-11 parts of radix aconiti lateralis preparata, 16-20 parts of cornu cervi degelatinatum, 15-21 parts of radix polygoni multiflori, 14-16 pars of epimedium brevicornum maxim, 13-17 parts of rhizoma drynariae, 4-6 parts of notoginseng powder and 13-17 parts of radix puerariae. The cancellous bone-reinforcing formula has the effects of tonifying qi and the kidney, strengthening tendons and bones, warming yang and dredging vessels, and regulating qi to alleviate pain, can effectively treat primary and secondary osteoporosis, and has significant curative effects on back and waist or whole body cold pain, soreness and weakness of waist and knees, severe pain in cold weather, pant and weakness, incapability of lifting heavy weights and sitting for a long time, tongue somberness, a white tongue coating, deep and thin pulse, sluggish stringy pulse and the like. In the preparation technology, one half of astragalus membranaceus as well as epimedium brevicornum maxim and rhizoma drynariae is decocted; the other half of astragalus membranaceus as well as radix aconiti lateralis preparata, cornu cervi degelatinatum, radix polygoni multiflori and notoginseng powder are made into powder. Thus, the drug effect of the prepared cancellous bone-reinforcing formula is significant. The cancellous bone-reinforcing formula and the manufacturing technology are suitable for popularization and application.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of osteoporotic bone pine bone strengthening formula and preparation technology thereof for the treatment of.
Background technology
Osteoporosis is the common frequently-occurring diseases of person in middle and old age, is a kind of sclerotin degeneration state, be take in bone that loss, the osseous tissue microstructure of calcium is impaired, the minimizing of bone amount, sclerotin attenuation, bone fragility increases and risk of bone fracture degree raises is the sclerotin change of feature.Osteoporosis is mainly divided into constitutional and Secondary cases, and its basic pathology mechanism is that in bone metabolism process, defect appears in bone resorption and osteoplastic coupling, causes the alcium and phosphor metabolization in human body uneven, bone density is reduced gradually and the clinical symptoms that causes.Clinical manifestation is pain, and height shortens, hunchback, fracture, respiratory function declines, these symptoms have been brought great misery to patient, also to life, have brought a lot of inconvenience, and when treatment taken Western medicine, as estrogen, calcitonin etc., not only uncertain therapeutic efficacy is cut, and treatment cost is high, cures the symptoms, not the disease, curative effect is undesirable, and relapse rate is high.
Summary of the invention
The object of this invention is to provide a kind of osteoporotic bone pine bone strengthening formula and preparation technology thereof for the treatment of, this bone pine bone strengthening formula has vital energy benefiting and the kidney invigorating, bone and muscle strengthening, warming YANG and promoting blood circulation, the effect of regulating QI to relieve pain, can effectively treat constitutional, secondary osteoporosis, to the back of being caused by insufficiency of kidney-YANG blood stasis or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the disease effect such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse is remarkable.
The technical scheme that the present invention realizes above-mentioned purpose employing is: a kind of loose bone strengthening formula of osteoporotic bone for the treatment of, described formula is comprised of crude drug Radix Astragali 25-35 part, Radix Aconiti Lateralis Preparata 9-11 part, Cornu Cervi Degelatinatum 16-20 part, Radix Polygoni Multiflori 15-21 part, Herba Epimedii 14-16 part, Rhizoma Drynariae 13-17 part, Radix Notoginseng powder 4-6 part and Radix Puerariae 13-17 part according to parts by weight.
A preparation technology who treats osteoporotic bone pine bone strengthening formula, comprises the following steps:
Step 1, according to parts by weight, get crude drug Radix Astragali 25-35 part, Radix Aconiti Lateralis Preparata 9-11 part, Cornu Cervi Degelatinatum 16-20 part, Radix Polygoni Multiflori 15-21 part, Herba Epimedii 14-16 part, Rhizoma Drynariae 13-17 part, Radix Notoginseng powder 4-6 part and Radix Puerariae 13-17 part, standby;
Step 2, get 1/2 of the Radix Astragali that step 1 obtains and be placed in decocting device, the Herba Epimedii and the Rhizoma Drynariae that add again step 1 to obtain, then add the water of 10 times of the Radix Astragali in decocting device, Herba Epimedii and Rhizoma Drynariae crude drug gross weights to decoct, after decocting 2h, leach medicinal liquid, then to the continuous water that adds 8 times of crude drug gross weights in decocting device in medicinal residues, decoct again 1.5h, filter to obtain medicinal liquid, discard medicinal residues, merge medicinal liquid twice, being concentrated into relative density under 80 ℃ of conditions of medicinal liquid is 1.03, obtain concentrated solution, standby;
The Radix Astragali of step 3, the Radix Aconiti Lateralis Preparata that step 1 is obtained, Cornu Cervi Degelatinatum, the Radix Polygoni Multiflori, Radix Notoginseng powder and Radix Puerariae and residue 1/2 weight is placed in super micron mill and pulverizes, and after pulverizing finishes, takes out 200 mesh sieves, obtains Chinese medicinal powder, standby;
The Chinese medicinal powder that step 4, the concentrated solution that step 2 is obtained obtain with step 3 mixes, and then carries out preparation, i.e. the preparation of the osteoporotic bone pine of completed treatment bone strengthening formula.
Beneficial effect of the present invention
One, a kind of loose bone strengthening formula of osteoporotic bone for the treatment of provided by the invention have vital energy benefiting and the kidney invigorating, bone and muscle strengthening, warming YANG and promoting blood circulation, the effect of regulating QI to relieve pain, can effectively treat constitutional, secondary osteoporosis, to the back of being caused by insufficiency of kidney-YANG blood stasis or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the disease such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse is evident in efficacy, to preventing that bone density from declining, reduce bone conversion, improve balanced capacity successful.
Two, preparation technology of the present invention is simple, and production cost is low, and in technique, half and Herba Epimedii of the Radix Astragali and Rhizoma Drynariae decoct, and extract the effective ingredient in medical material, the main vital energy benefiting and the kidney invigorating of triplicity, strengthening the tendons and bones, nourishing the liver to improve visual acuity comprehensively; Half and Radix Aconiti Lateralis Preparata, Cornu Cervi Degelatinatum, the Radix Polygoni Multiflori, Radix Notoginseng powder and Radix Puerariae are mixed and made into powder, the mutual compatibility master of mixed-powder nourish blood the liver benefiting, supporing yang kidney tonifying, strengthening the tendons and bones, after these powder enter human body, drug effect performance effect is remarkable, and can avoid effective ingredient in high temperature decoction process to run off, therefore the concentrated solution again decoction being obtained mixes with Chinese medicinal powder, the bone pine bone strengthening prescription drug bioavailability that makes to prepare is high, drug effect is more remarkable, is suitable for applying.
The specific embodiment
Treat an osteoporotic bone pine bone strengthening formula, described formula is comprised of crude drug Radix Astragali 25-35 part, Radix Aconiti Lateralis Preparata 9-11 part, Cornu Cervi Degelatinatum 16-20 part, Radix Polygoni Multiflori 15-21 part, Herba Epimedii 14-16 part, Rhizoma Drynariae 13-17 part, Radix Notoginseng powder 4-6 part and Radix Puerariae 13-17 part according to parts by weight.
A preparation technology who treats osteoporotic bone pine bone strengthening formula, comprises the following steps:
Step 1, according to parts by weight, get crude drug Radix Astragali 25-35 part, Radix Aconiti Lateralis Preparata 9-11 part, Cornu Cervi Degelatinatum 16-20 part, Radix Polygoni Multiflori 15-21 part, Herba Epimedii 14-16 part, Rhizoma Drynariae 13-17 part, Radix Notoginseng powder 4-6 part and Radix Puerariae 13-17 part, standby;
Step 2, get 1/2 of the Radix Astragali that step 1 obtains and be placed in decocting device, the Herba Epimedii and the Rhizoma Drynariae that add again step 1 to obtain, then add the water of 10 times of the Radix Astragali in decocting device, Herba Epimedii and Rhizoma Drynariae crude drug gross weights to decoct, after decocting 2h, leach medicinal liquid, then to the continuous water that adds 8 times of crude drug gross weights in decocting device in medicinal residues, decoct again 1.5h, filter to obtain medicinal liquid, discard medicinal residues, merge medicinal liquid twice, being concentrated into relative density under 80 ℃ of conditions of medicinal liquid is 1.03, obtain concentrated solution, standby;
The Radix Astragali of step 3, the Radix Aconiti Lateralis Preparata that step 1 is obtained, Cornu Cervi Degelatinatum, the Radix Polygoni Multiflori, Radix Notoginseng powder and Radix Puerariae and residue 1/2 weight is placed in super micron mill and pulverizes, and after pulverizing finishes, takes out 200 mesh sieves, obtains Chinese medicinal powder, standby;
The Chinese medicinal powder that step 4, the concentrated solution that step 2 is obtained obtain with step 3 mixes, and then carries out preparation, i.e. the preparation of the osteoporotic bone pine of completed treatment bone strengthening formula.
below in conjunction with specific embodiment, the present invention will be further described:
embodiment 1:
Treat an osteoporotic bone pine bone strengthening formula, described formula is comprised of 13 parts of 35 parts of the crude drug Radixs Astragali, 9 parts of Radix Aconiti Lateralis Preparata, 16 parts of Cornu Cervi Degelatinatums, 15 parts of the Radixs Polygoni Multiflori, 14 parts of Herba Epimedii, 13 parts of Rhizoma Drynariae, 4 parts of Radix Notoginseng powder and Radix Puerariaes according to parts by weight.
A preparation technology who treats osteoporotic bone pine bone strengthening formula, comprises the following steps:
Step 1, according to the parts by weight in above-mentioned formula, get the crude drug Radix Astragali, Radix Aconiti Lateralis Preparata, Cornu Cervi Degelatinatum, the Radix Polygoni Multiflori, Herba Epimedii, Rhizoma Drynariae, Radix Notoginseng powder and Radix Puerariae, standby;
Step 2, get 1/2 of the Radix Astragali that step 1 obtains and be placed in decocting device, the Herba Epimedii and the Rhizoma Drynariae that add again step 1 to obtain, then add the water of 10 times of the Radix Astragali in decocting device, Herba Epimedii and Rhizoma Drynariae crude drug gross weights to decoct, after decocting 2h, leach medicinal liquid, then to the continuous water that adds 8 times of crude drug gross weights in decocting device in medicinal residues, decoct again 1.5h, filter to obtain medicinal liquid, discard medicinal residues, merge medicinal liquid twice, being concentrated into relative density under 80 ℃ of conditions of medicinal liquid is 1.03, obtain concentrated solution, standby;
The Radix Astragali of step 3, the Radix Aconiti Lateralis Preparata that step 1 is obtained, Cornu Cervi Degelatinatum, the Radix Polygoni Multiflori, Radix Notoginseng powder and Radix Puerariae and residue 1/2 weight is placed in super micron mill and pulverizes, and after pulverizing finishes, takes out 200 mesh sieves, obtains Chinese medicinal powder, standby;
The general ball of Chinese medicinal powder that 80% and step 3 of step 4, the concentrated solution that first obtains by step 2 obtains, general ball diameter is 5-6mm, then be no more than under the condition of 80 ℃ dry, the concentrated solution polishing of residue 20% for the dry dry ball obtaining, again be no more than under the condition of 60 ℃ dry, make the osteoporotic bone pine for the treatment of bone strengthening pill, the name of product of batch production is " bone pine bone strengthening ball ".
embodiment 2:
Treat an osteoporotic bone pine bone strengthening formula, described formula is comprised of 17 parts of 25 parts of the crude drug Radixs Astragali, 11 parts of Radix Aconiti Lateralis Preparata, 20 parts of Cornu Cervi Degelatinatums, 21 parts of the Radixs Polygoni Multiflori, 16 parts of Herba Epimedii, 17 parts of Rhizoma Drynariae, 6 parts of Radix Notoginseng powder and Radix Puerariaes according to parts by weight.
A kind of preparation technology who treats osteoporotic bone pine bone strengthening formula, the preparation of concentrated solution and Chinese medicinal powder is with embodiment 1, the Chinese medicinal powder of preparation is placed in to blender, then add concentrated solution, under the condition that low whipping speed is 28r/min, mix 4-6 time, each 7-9min, after mix homogeneously, cross 14 mesh sieves and granulate, after oven dry, with 16 mesh sieve granulate; Granule after granulate is packed in capsulae vacuus, make the osteoporotic bone pine for the treatment of bone strengthening capsule, the name of product of batch production is " bone pine bone strengthening capsule ".
embodiment 3:
Treat an osteoporotic bone pine bone strengthening formula, described formula is comprised of 15 parts of 30 parts of the crude drug Radixs Astragali, 10 parts of Radix Aconiti Lateralis Preparata, 18 parts of Cornu Cervi Degelatinatums, 18 parts of the Radixs Polygoni Multiflori, 15 parts of Herba Epimedii, 15 parts of Rhizoma Drynariae, 5 parts of Radix Notoginseng powder and Radix Puerariaes according to parts by weight.
A kind of preparation technology who treats osteoporotic bone pine bone strengthening formula, the preparation of concentrated solution and Chinese medicinal powder, with embodiment 1, is placed in blender by the Chinese medicinal powder of preparation, then adds concentrated solution, low whipping speed is to mix 4-6 time under the condition of 28r/min, each 7-9min, after mix homogeneously, crosses 14 mesh sieves and granulates, oven dry makes soft material, by the soft material making tablet machine tabletting, make the osteoporotic bone pine for the treatment of bone strengthening tablet, the name of product of batch production is " bone pine bone strengthening sheet ".
clinical testing data
The bone pine bone strengthening pill preparing for embodiment 1 carries out the clinical trial about curative effect, and the instructions of taking of Chinese medicine bone strengthening ball is twice, one time on the one 6g, within 15th, is a course for the treatment of:
In osteoporosis section of Henan Luoyang Bone Setting Hospital, select 76 routine patients, patient suffers from respectively constitutional, secondary osteoporosis and osteomalacia, show as back or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the symptom such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse, in 76 routine patients, having 48 examples to take the osteoporotic Chinese medicine bone strengthening for the treatment of provided by the invention ball is test group, it is matched group that 28 routine patients take the osteoporotic similar medicine for the treatment of, and other treatment environment is just the same.
Test group and treatment of control group are carried out therapeutic effect analysis after four months, result is as follows:
One, Comparison of therapeutic before and after treatment
Criterion of therapeutical effect:
Effective: back or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the symptom such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse disappears substantially;
Effective: back or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the symptom such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse obviously alleviates;
Invalid: above symptom is all obviously alleviated.
By statistics, result is as shown in table 1:
Table 1:
As shown in Table 1, the obvious effective rate of bone pine bone strengthening ball provided by the invention is 22.92%, total effective rate 85.42%, the obvious effective rate of matched group is 7.14%, total effective rate 28.57%, illustrate bone pine bone strengthening formula can effectively improve back or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the symptom such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse, prevent that bone density from declining, and more remarkable treatment effect.
Two, relatively, statistical result is as shown in table 2 for the osteodynia scoring before and after test group and treatment of control group, tcm clinical practice symptom score and the scoring of Berg balance scale:
Table 2:
As shown in Table 2, test group is compared with matched group, and osteodynia scoring, tcm clinical practice symptom score, the scoring of Berg balance scale improve more obvious, illustrates that bone pine bone strengthening formula can effectively improve patient's pain and various clinical symptoms, improve balanced capacity, therapeutic equivalence is remarkable.
Three, bone metabolism index mutation analysis (bone alkaline phosphatase (BALP), the crosslinked C end peptide of NTx (β-CTX) are relatively) before and after test group and treatment of control group, statistical result is as shown in table 3:
Table 3:
As shown in Table 3, it is more obvious that experiment group B ALP declines, medication be described after calcium precipitation increase, the β of test group-CTX declines obvious, be that bone pine bone strengthening formula can effectively suppress bone resorption, illustrate that bone pine bone strengthening formula can effectively reduce the bone conversion that deficiency of the kidney yin syndrome of blood stasis causes.
Four, the bone density mutation analysis before and after test group and treatment of control group, according to the performance of skeleton x line, clinical judgment is effective, effective and invalid, and by statistics, result is as shown in table 4:
Table 4:
As shown in Table 4, the obvious effective rate of test group is 16.67%, total effective rate 83.33%, and the obvious effective rate of matched group is 3.57%, total effective rate 50%; Illustrate that bone pine bone strengthening formula efficiency provided by the invention prevents that bone density from declining, and evident in efficacy.
Five, the fragility fractures Incidence before and after test group and treatment of control group, by statistics, result is as shown in table 5:
Table 5:
As shown in Table 5, after treatment, the fracture incidence rate of test group obviously declines, and bone pine bone strengthening formula can effectively reduce fragility fractures incidence rate, and particular significant effect.
Six, safety evaluatio
After medication, patient's vital sign comprises that blood pressure, heart rate, breathing, body temperature compares with before medication, has no significant change.In process of the test, obviously extremely or extremely increasing the weight of does not appear in test group routine blood test, liver function, renal function, electrocardiogram.
In sum:
Bone pine bone strengthening formula can effectively improve back that patient's insufficiency of kidney-YANG blood stasis causes or whole body cold type of pain, soreness of the waist and knees, pain exaggerated by catching cold, shortness of breath and fatigue, can not be prudent, can not sitting, the symptom such as tongue is dull, tongue fur is white, deep-thready pulse, stringy and hesitant pulse, reduce bone conversion, prevent that bone density from declining, reduce fragility fractures incidence rate, evident in efficacy.
Claims (1)
1. a preparation technology who treats osteoporotic bone pine bone strengthening formula, is characterized in that: described formula is comprised of crude drug Radix Astragali 25-35 part, Radix Aconiti Lateralis Preparata 9-11 part, Cornu Cervi Degelatinatum 16-20 part, Radix Polygoni Multiflori 15-21 part, Herba Epimedii 14-16 part, Rhizoma Drynariae 13-17 part, Radix Notoginseng powder 4-6 part and Radix Puerariae 13-17 part according to parts by weight;
The preparation technology of the osteoporotic bone pine of described treatment bone strengthening formula, comprises the following steps:
Step 1, according to parts by weight, get crude drug Radix Astragali 25-35 part, Radix Aconiti Lateralis Preparata 9-11 part, Cornu Cervi Degelatinatum 16-20 part, Radix Polygoni Multiflori 15-21 part, Herba Epimedii 14-16 part, Rhizoma Drynariae 13-17 part, Radix Notoginseng powder 4-6 part and Radix Puerariae 13-17 part, standby;
Step 2, get 1/2 of the Radix Astragali that step 1 obtains and be placed in decocting device, the Herba Epimedii and the Rhizoma Drynariae that add again step 1 to obtain, then add the water of 10 times of the Radix Astragali in decocting device, Herba Epimedii and Rhizoma Drynariae crude drug gross weights to decoct, after decocting 2h, leach medicinal liquid, then to the continuous water that adds 8 times of crude drug gross weights in decocting device in medicinal residues, decoct again 1.5h, filter to obtain medicinal liquid, discard medicinal residues, merge medicinal liquid twice, being concentrated into relative density under 80 ℃ of conditions of medicinal liquid is 1.03, obtain concentrated solution, standby;
The Radix Astragali of step 3, the Radix Aconiti Lateralis Preparata that step 1 is obtained, Cornu Cervi Degelatinatum, the Radix Polygoni Multiflori, Radix Notoginseng powder, Radix Puerariae and residue 1/2 weight is placed in super micron mill and pulverizes, and after pulverizing finishes, takes out 200 mesh sieves, obtains Chinese medicinal powder, standby;
The Chinese medicinal powder that step 4, the concentrated solution that step 2 is obtained obtain with step 3 mixes, and then carries out preparation, i.e. the preparation of the osteoporotic bone pine of completed treatment bone strengthening formula.
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