CN1839999A - Preparation for treating osteoporosis and preparation method thereof - Google Patents

Preparation for treating osteoporosis and preparation method thereof Download PDF

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CN1839999A
CN1839999A CN 200510130305 CN200510130305A CN1839999A CN 1839999 A CN1839999 A CN 1839999A CN 200510130305 CN200510130305 CN 200510130305 CN 200510130305 A CN200510130305 A CN 200510130305A CN 1839999 A CN1839999 A CN 1839999A
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preparation
gushukang
radix
salviae miltiorrhizae
auricularia
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CN100418553C (en
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王景刚
王锡娟
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Liaoning wohua Kangchen Pharmaceutical Co.,Ltd.
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KANGCHEN PHARMACETICAL DEVELOPMENT Co Ltd
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Abstract

The invention discloses a medicinal capsule for treating urinary system disease and preparation method, wherein the preparation comprises longspur epimedium 7.5-70%, prepared rehmannia root 6-50%, drynaria 5-65%, astragalus root 5-40%, radix salvia miltiorrhiza 5-60%, edible black fungus 3-20%, and cucumber seeds 5-30%.

Description

GUSHUKANG preparation and preparation method thereof
Technical field
The present invention relates to prescription of a kind of GUSHUKANG preparation and preparation method thereof, specifically relate to a kind of accelerating union of bone fracture and bone density improving and improve the prescription and preparation method thereof of the Chinese medicine of middle-aged and elderly people pain in the low back and legs.
Background technology
Osteoporosis is to be the absolute minimizing of bone amount with osseous tissue total amount in the unit volume, and the structural change of bone and function are changed, and a kind of systemic disease that causes the fragility of bone to increase and be easy to fracture is common ailment of middle-aged and old, frequently-occurring disease.Thought what calcium deficiency caused in the past, cause of disease complexity actually, the shortage of calcium only is its superficial phenomenon, actually with endocrine dysfunction, malnutrition, many-sided factor such as hypomotility is relevant.This sick method of treatment is various at present, but important breakthrough is not arranged as yet.
General domestic and international to prevention and treatment of osteoporosis, mainly to start with the promotion bone formation from suppressing bone resorption, the medicine that suppresses bone resorption has estrogen, calcitonin, activated vitamin D derivant, bis phosphoric acid salt etc.Promote osteoplastic medicine to have chloride, ketone steroid hormone, activated vitamin D derivant, first shape to divide glandular hormone (PTH) etc.These medicines or because of side effect is big, or very not definite because of curative effect, and or because of costing an arm and a leg, common people such as are difficult to take for a long time at shortcoming, so all imperfect medicine.A large amount of experiments and clinical research proof Chinese medicine osteoporosis have that curative effect is reliable, effect comprehensively, little, the low price of side effect, have Western medicine incomparable advantage.But the Chinese medicine for the treatment of osteoporosis in the market is less, and preparation is thicker, and how based on decoction, effective ingredient extracts fully as yet, and clinical efficacy is also not satisfied, and volume more very much not is easy to carry, and the research and development of dosage form remain dark step research.
Summary of the invention
The objective of the invention is to overcome above-mentioned the deficiencies in the prior art, prescription of a kind of GUSHUKANG preparation and preparation method thereof is provided.
The osteoporosis traditional Chinese medical science claims " atrophic debility of bones ".Pathogenesis mainly be suffer from a deficiency of the kidney, insufficiency of the spleen and blood stasis.Simultaneously the essence of osteoporosis is because of old and feeble institute causes, old and feeble with suffer from a deficiency of the kidney closely relatedly, use " nativism " understanding primary disease.
Osteoporosis is a kind of common bone metabolism disease, is that the osseous tissue total amount in the unit volume is the absolute minimizing of bone amount, osseous tissue microstructure and load dysfunction with the increase at age.Motherland's medical science thinks that the kidney being the origin of congenital constitution, the root of life, and kidney is won smart, and main bone is given birth to marrow, and suffering from a deficiency of the kidney is the basic reason that osteoporosis takes place.Powerful and the fragility of bone is the important symbol of essence in kidney prosperity and decline.The kidney essense abundance, then bone marrow is biochemical active, and skeleton just can obtain the abundant nourishing of bone marrow and firm strong, and if kidney essense should be lacked, the change source deficiency of bone marrow can not be moistened the nourishing bone bone, and it is weak the skeleton fragility just can to occur, causes osteoporosis.In recent years, domestic scholars discovers that the Changing Pattern of the essence in kidney prosperity and decline that bone mineral content is put down in writing along with the Changing Pattern and the Chinese medicine at age has surprising concordance.This theory that proves absolutely Chinese medicine relevant " kidney storing essence, main bone is given birth to marrow " is correct and science.Someone finds that with advancing age the incidence rate of nephrasthenia syndrome raises gradually, and bone mineral content but reduces gradually in the skeleton, and the prosperity and decline and the bone mineral content of kidney are closely related.Modern medicine studies show that kidney, person who suffer from deficiency of kidney Yang has going down of hypothalamus one hypophysis one gonad axis function, the essence of suffering from a deficiency of the kidney is that disorder has taken place hypothalamus one hypophysis one gonad axis, sex hormone level descends, and then can cause that osteogenesis function descends, unit volume internal skeleton tissue content is reduced, osteoporosis takes place.And some kidney-nourishing tcm drug (as Herba Epimedii, Rhizoma Drynariae etc.) can suppress or correct hypothalamus one hypophysis, one gonad axis hypofunction or disorderly generation, delaying senility process.As seen, suffering from a deficiency of the kidney is the major reason that osteoporosis takes place.
In addition, blood stasis and osteoporosis are also closely related, and the gas of human body and blood are circulated in whole body, are the material bases that all histoorgans such as internal organs meridians carry out physiological activity.If qi depression to blood stasis, obstruction of collaterals by blood stasis then must cause the generation of disease.The old people is because old, exhaustion of kidney-essence with promoting reproductive function, and internal organs underactivity is unfavorable for normally carrying out of bone metabolism, easily causes the generation of osteoporosis.Obstruction of collaterals by blood stasis also is the very important factor that osteoporosis takes place.With advancing age, kidney qi is gradually empty.The physiological and pathological of kidney changes, and directly affects the normal operation of blood.The insufficiency of primordial QI of suffering from a deficiency of the kidney, unable promotion blood is capable, whenever causes blood stasis due to qi deficiency; Insufficiency of kidney-YANG can not the replenishing vital QI with drugs of warm nature blood vessels, often make cold in blood and coagulate; Deficiency of kidney yin, asthenic fire refining liquid, but hyperamization is thick and stagnant.Modern medicine thinks that blood stasis makes the body microcirculation disturbance, changes pericellular environment, is unfavorable for that cell carries out mass exchange, causes calcium absorption bad, and it is foster that skeleton is lost, and fragility increases, and osteoporosis takes place.
According to above-mentioned pathogenesis and method of treatment, the GUSHUKANG preparation is based on invigorating the kidney and strengthening the bones, be aided with nourish blood, the product of YIN nourishing, beneficial essence fill out marrow, it is strong that marrow fills bone.Solve blood stasis so on the one hand, solved ischemia on the other hand again, and YIN nourishing has been strengthened the effect of invigorating the kidney and strengthening the bones again.Assistant is agitated the QI and blood dredging the meridian with benefiting QI for activating blood circulation, and the stasis of blood new life that dispels recovers the effect that normal QI-blood circulation is strengthened invigorating the kidney and strengthening the bones, and simultaneously, the product of relaxing muscles and tendons and activating QI and blood in the collateral can play the through sick institute of messenger drug again.In sum, we are the pathogenesis that hit, and select medicine and reasonably write out a prescription.
The GUSHUKANG preparation is the theory according to the traditional Chinese medical science " the kidney generating marrow and dominating bone ", in conjunction with modern medicine and Chinese medicine modern scientific research achievement, follows person in middle and old age's QI and blood Changing Pattern, adopts the ingenious compatibility of Chinese medicine and through the refining natural Chinese medicines preparation that forms of modern science technology.Function with invigorating the kidney and strengthening the bones, benefiting QI and nourishing blood is moistened the nourishing bone bone, removes the osteodynia of suffering from a deficiency of the kidney, and beneficial essence is filled out the marrow effect.This medicine can alleviate and remove back limb aching pain symptom rapidly, quickens to generate osteoblast, accelerating union of bone fracture.I scientific and technical personnel of company are extracting experience from the basis, utilize the modern crafts means, changed traditional coarse, backward pharmaceutical technology (tcd), be prepared into the GUSHUKANG preparation, the clinical practice curative effect is reliable, can not only eliminate pain, and a series of symptoms, sign that primary disease produced, good repair had for loose sclerotin.And dose is low, quality controllability is strong.
The Chinese medicine that the GUSHUKANG preparation is selected is proved not only that by modern pharmacology directly stimulating osteoblast is bred and strengthened its activity, and the effect that promotes the bone amount to recover and suppress bone resorption is arranged.The GUSHUKANG preparation sex hormone level that is significantly improved significantly raises to testosterone and estradiol level, illustrates that the GUSHUKANG preparation promotes bone formation by improving sex hormone level, to strengthen osteoblast active and suppress bone resorption.In addition, this good facilitation to gonad of GUSHUKANG preparation may be of some help to aging.The GUSHUKANG preparation can make hdl level significantly raise simultaneously, and prompting GUSHUKANG preparation has positive preventive and therapeutic effect to the control of cardiovascular and cerebrovascular disease.
In addition, according to the characteristics of primary disease, the Chinese medicine that the GUSHUKANG preparation is selected for use, high strong product such as nontoxic, no Da Xin, big heat, removing blood stasis, and be aided with nourish blood, the product assistance monarch drug of YIN nourishing, treating both the principal and secondary aspects of a disease.Than the local invigorating the kidney and strengthening the bones effect of simple attention is good.Simultaneously, assistant is agitated the QI and blood dredging the meridian with benefiting QI for activating blood circulation, and the stasis of blood new life that dispels recovers the effect that normal QI-blood circulation is strengthened invigorating the kidney and strengthening the bones, and simultaneously, the product of relaxing muscles and tendons and activating QI and blood in the collateral can play the through sick institute of messenger drug again.
The technical solution used in the present invention is: a kind of GUSHUKANG preparation, contain Herba Epimedii 7.5%-70% in the described GUSHUKANG preparation, Radix Rehmanniae Preparata 6%-50%, Rhizoma Drynariae 5%-65%, Radix Astragali 5%-40%, Radix Salviae Miltiorrhizae 5%-60%, Auricularia 3%-20%, Semen Cucumidis sativi 5%-30%.
Further, the preferred component proportioning of described GUSHUKANG preparation is Herba Epimedii 15%-70%, Radix Rehmanniae Preparata 6%-30%, Rhizoma Drynariae 5%-45%, Radix Astragali 5%-40%, Radix Salviae Miltiorrhizae 5%-60%, Auricularia 3%-20%, Semen Cucumidis sativi 5%-30%.
Further, described GUSHUKANG preparation optimal components proportioning is a Herba Epimedii 17.5%, Radix Rehmanniae Preparata 23.2%, Rhizoma Drynariae 11.6%, the Radix Astragali 17.5%, Radix Salviae Miltiorrhizae 11.6%, Auricularia 9.3%, Semen Cucumidis sativi 9.3%.
Further, described GUSHUKANG preparation formulation includes granule, aqueous solvent, water-honeyed pill, tablet, capsule.
The preparation method of described GUSHUKANG preparation, comprise following processing step: in described Herba Epimedii, Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali, Radix Salviae Miltiorrhizae, Auricularia, Semen Cucumidis sativi seven flavor medicine, the Semen Cucumidis sativi fragmentation, decoct with water 1---4 time with Auricularia, add water 3---20 doubly measures at every turn, the each decoction 1--4.5 hour, decocting liquid filters respectively, and filtrate decompression is concentrated into that relative density is about 1.00---1.35, temperature is 20 ℃--100 ℃ clear paste; Radix Salviae Miltiorrhizae adds ethanol 2--12 at every turn and doubly measures with alcohol reflux 1---4 time, and each reflux, extract, 1--4.5 hour, merging filtrate, recovery ethanol also is concentrated into that relative density is about 1.00---1.35, temperature is 20 ℃--100 ℃ clear paste; Radix Salviae Miltiorrhizae decoction dregs and Herba Epimedii, Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali decoct with water 1---6 time, add water 3--12 doubly measures at every turn, the each decoction 1--4.5 hour, collecting decoction left standstill 2--24 hour, got supernatant, adsorb through adsorbent resin, with 20%---95% concentration ethanol eluting, eluent reclaims ethanol, and to be concentrated into relative density be that 1.00---1.35, temperature are 20 ℃--100 ℃ clear paste; Get above-mentioned clear paste, drying is pulverized, and makes the GUSHUKANG preparation, packing, promptly.
The GUSHUKANG preparation is to extract preparation through the modern crafts means, has the technology advanced person, extracts fully, and curative effect is reliable, advantages such as volume is less, taking convenience.The GUSHUKANG preparation has the effect of invigorating the kidney and strengthening the bones, benefiting QI and nourishing blood.Be used for the osteoporosis double qi and blood deficiency of suffering from a deficiency of the kidney, performance lumbar and back pain, soreness of the waist and knees, lower limb flaccidity be weak, walk with difficulty, Mental fatigue, disease person such as dizzy.By improving endocrine function, raise immunity, adjustment bone metabolism, thereby bone density improving, improve bone biomechanical property, improve bone strength.Its main mechanism is mainly: the class gonadotropic Effect; 1,25 (OH) in the rising body 2D 3Level; Directly promote osteocyte propagation; Suppress osteoclast; Increase the Absorption of intestinal mucosa calcium.Treatment osteoporosis (1) osteoporosis curative effect (doctor judges that PP analyzes) obvious effective rate is 7.619%, and effective percentage is 98.095%; (2) osteoporosis Syndrome in TCM marquis curative effect (computer-made decision, PP analyzes) obvious effective rate is 15.238%, and effective percentage is 72.381%; (3) bone density curative effect (computer-made decision, PP analyzes) obvious effective rate is 78.095%, and effective percentage is 92.381%.
This medicament preparation technology is obviously different with conventional Chinese medicinal preparation method:
1, consider that Radix Salviae Miltiorrhizae contains a large amount of ester dissolubility active component, therefore, Radix Salviae Miltiorrhizae elder generation is through the technology of ethanol extraction Radix Salviae Miltiorrhizae quinones composition;
2, consider that Auricularia, Semen Cucumidis sativi active component are still not fully aware of, should follow former clinical experience usage, adopt the well-established law decocting to extract for 1---4 time, guarantee its clinical efficacy;
3, Radix Salviae Miltiorrhizae decoction dregs and residue flavour of a drug decocting are 1---6 time, handle ethanol elution through resin absorption, material after refining is inspected and results of pharmacodynamic test shows through thin layer, can adsorb its active component, reach the purpose of discarding the dross and selecting the essential, steady quality not only, and single oral dose is reduced greatly;
4, the resin absorption technology is the cutting edge technology of present purification of tcm technology, also is the key technology that active ingredient of Chinese herbs extracts.
5, the patient takes the GUSHUKANG amount of formulation at every turn and contains crude drug 28.56g, and contained crude drug amount is bigger, and refining back medicine single oral dose is but very little, makes to carry to take all conveniently, and preferably patient takes for a long time.To improving national bone health, expand export and earn foreign exchange, benefit the people of the world, have far reaching significance.
The specific embodiment
Embodiment 1: Herba Epimedii is 30%, Radix Rehmanniae Preparata is 15%, Rhizoma Drynariae is 10%, the Radix Astragali is 15%, Radix Salviae Miltiorrhizae is 10%, Auricularia is 12%, Semen Cucumidis sativi is 8%.
Embodiment 2: Herba Epimedii is 60%, Radix Rehmanniae Preparata is 6%, Rhizoma Drynariae is 10%, the Radix Astragali is 5%, Radix Salviae Miltiorrhizae is 12%, Auricularia is 10%, Semen Cucumidis sativi is 10%.
Embodiment 3: Herba Epimedii is 17.5%, Radix Rehmanniae Preparata is 23.2%, Rhizoma Drynariae is 11.6%, the Radix Astragali is 17.5%, Radix Salviae Miltiorrhizae is 11.6%, Auricularia is 9.3%, Semen Cucumidis sativi is 9.3%.
In described Herba Epimedii, Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali, Radix Salviae Miltiorrhizae, Auricularia, Semen Cucumidis sativi seven flavor medicine, the Semen Cucumidis sativi fragmentation, decoct with water secondary with Auricularia, add 8 times of amounts of water at every turn, decocted 2.5 hours for the first time, decocted 1.5 hours for the second time, decocting liquid filters respectively, and filtrate decompression is concentrated into the clear paste that relative density is about 1.18 (65 ℃); Radix Salviae Miltiorrhizae alcohol reflux secondary adds 4 times of amounts of ethanol at every turn, and reflux, extract, is 2 hours for the first time, and reflux, extract, is 1.5 hours for the second time, filters, and merging filtrate reclaims ethanol and is concentrated into the clear paste that relative density is about 1.18 (65 ℃); Flavour of a drug such as Radix Salviae Miltiorrhizae decoction dregs and Herba Epimedii, Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali decoct with water three times, add 8 times of amounts of water at every turn, decocted 1.5 hours for the first time, second and third time respectively decocted 1 hour, collecting decoction, left standstill 8 hours, get supernatant,, use 70% ethanol elution through adsorbent resin absorption, eluent reclaims ethanol, and is concentrated into the clear paste that relative density is about 1.18 (65 ℃); Get above-mentioned clear paste, drying is pulverized, and incapsulates, and makes 1000, packing, promptly.(or be pressed into 1000, or make granule 750g, or make pill 750g, packing, promptly.)
Clinical research methods and result
The II clinical trial phase of this medicine, according to State Food and Drug Administration's Clinical Researches of New Drugs official written reply requirement, according to " clinical drug trial management regulation " and " specification requirement of study of tcm new drug ", with reference to " new Chinese medicine clinical research guideline ", adopt randomized, double-blind dual analog, positive drug contrast, polycentric clinical trial method to carry out 6 months courses of treatment.All case is finished jointly by Fujian Institute of Traditional Chinese Medicine national drug clinical research base, Shanghai Univ. of Traditional Chinese Medicine SHUGUANG HOSPITAL national drug clinical research base, Changchun Traditional Chinese Medical College national drug clinical research base and Beijing Jishuitan Hospital.Case load totally 240 examples are gone into to organize in 4 tame research centers, and wherein 120 examples are organized in treatment, and matched group 120 examples, treatment group are finished several 105 examples of test, and 10 examples that come off are rejected 5 examples; Matched group is finished 105 examples, and 10 examples that come off are rejected 5 examples.Add up to and finish 210 examples.
Analysis of comparable before treating:
Age between treatment group and the matched group before the treatment, sex, systolic pressure, diastolic pressure, heart rate, body weight, breathing, height, the course of disease, whether menopause, lumbar and back pain, soreness of the waist and knees, lower limb pain, dizzy, Mental fatigue, lower limb flaccidity be weak, walk with difficulty, bone density, blood, urine, stool routine, blood biochemistry, hepatic and renal function, estradiol, electrocardiogram relatively there are no significant difference, has good comparability.
Clinical curative effect analysis:
1) osteoporosis general curative effect:
Treatment group total effective rate is 86.667%, and obvious effective rate is 7.619%; Matched group (GUSHUKANG KELI) total effective rate is 87.619%, and obvious effective rate is 10.476%.Curative effect there was no significant difference between group.
2) osteoporosis Syndrome in TCM marquis curative effect:
Treatment group total effective rate is 93.333%, clinical recovery rate 15.238%, cure-remarkable-effectiveness rate 72.381%; The matched group total effective rate is 94.286%, clinical recovery rate 12.381%, cure-remarkable-effectiveness rate 69.524%.Curative effect there was no significant difference between group.
3) Syndrome in TCM marquis primary symptom (lumbar and back pain) curative effect:
Treatment group total effective rate is 85.714%, and cure rate is 48.571%, and cure-remarkable-effectiveness rate is 61.905%; The matched group total effective rate is 85.714%, and cure rate is 40.000%, and cure-remarkable-effectiveness rate is 59.048%.Curative effect there was no significant difference between group.
4) general bone mineral density curative effect:
Treatment group total effective rate is 78.095%, and obvious effective rate is 14.286%; The matched group total effective rate is 80.000%, and obvious effective rate is 20.000%.Curative effect there was no significant difference between group.
5) bone density four position curative effects are estimated separately:
Lumbar vertebra L 2-L 4: treatment group total effective rate 72.381%, produce effects 25.714%, effective 46.667%.Matched group total effective rate 73.333%, produce effects 27.619%, effective 45.714%.Curative effect there was no significant difference between group.Neck of femur: treatment group total effective rate 73.333%, produce effects 32.381%, effective 40.952%.Matched group total effective rate 71.428%, produce effects 35.238%, effective 36.190%.Curative effect there was no significant difference between group.Word triangle: treatment group total effective rate 61.905%, produce effects 50.476%, effective 11.429%.Matched group total effective rate 61.905%, produce effects 49.524%, effective 12.381%.Curative effect there was no significant difference between group.Greater trochanter: treatment group total effective rate 76.333%, produce effects 42.857%, effective 33.333%.Matched group total effective rate 72.381%, produce effects 47.619%, effective 24.762%.Curative effect there was no significant difference between group.
420 positions of 105 routine patients bone density variation average case is organized in treatment: 159 positions of produce effects account for 37.857%; Effective 139 positions account for 33.095%; Invalid 122 positions account for 29.048%; Total effective rate is 70.952%.420 positions of matched group 105 routine patients bone density changes average case: 168 positions of produce effects account for 40.000%; Effective 125 positions account for 29.762%; Invalid 127 positions account for 30.238%; Total effective rate is 69.762%.Curative effect there was no significant difference between group.The average total effective rate 70.952% in 4 positions of treatment group, obvious effective rate 33.095%; The average total effective rate 69.762% in 4 positions of matched group, obvious effective rate 40.000%.
6) relation of bone density lesion degree and curative effect:
Test group: lumbar vertebra L 2-L 4The position of 1~2 SD of decline, greater trochanter are treated the position of preceding 2~3 SD of decline and the above position of 3 SD that descends before treating, and treat back bone density rising, and changing all has significant differences.Matched group: lumbar vertebra L 2-L 4The position of 1~2 SD of decline, greater trochanter are treated the position of preceding 2~3 SD of decline and the above position of 3 SD that descends before treating, and treat back bone density rising, and changing all has significant differences; The position of 3 SD of decline before the Ward triangle is treated, treatment back bone density all rises, and changing has significant difference.Illustrate that two groups of medicines reduce for lumbar vertebra position bone amount and the osteoporosis at greater trochanter position all has obvious curative effects.
7) Syndrome in TCM marquis single index is analyzed:
In the therapeutic process, compare there was no significant difference between each index group of tcm symptom.Symptoms such as lumbar and back pain, soreness of the waist and knees, lower limb pain, dizzy, Mental fatigue, lower limb flaccidity are weak, walk with difficulty, treatment group and matched group administration play and treat preceding comparison after 1 month, and symptom is obviously alleviated, and changing has significant difference.Prompting GUSHUKANG capsule and contrast medicine GUSHUKANG KELI thereof are rapid-action, and remission is obvious, two groups of Syndrome in TCM marquis therapeutic equivalences.
8) blood biochemical analysis:
Self compare before and after the blood calcium treatment, treatment group and matched group all rise, and changing has significant difference, compare there was no significant difference between group; Self compares before and after serium inorganic phosphorus and the alkaline phosphatase enzyme treatment, treatment group and matched group there was no significant difference.The result of study prompting, GUSHUKANG capsule and contrast medicine GUSHUKANG KELI thereof can increase blood calcium concentration.
9) estrogen level analysis:
63 examples are organized in treatment, matched group 63 routine female patients respectively detect estradiol 1 time before and after treatment, and the result organizes 44 routine estradiol levels for treatment and raises, and accounts for 69.841%, and matched group 34 routine estradiol levels raise, and account for 53.968%, two group of relatively there was no significant difference.Among the estrogen detection crowd, the age is organized 28 examples, matched group 19 examples women's treatment in 50~55 years old.Treat relatively there was no significant difference of preceding estradiol level for two groups.Compare estradiol level before and after the treatment of treatment group and raise, difference has the height statistical significance, relatively estradiol level rising before and after the treatment of control group, and difference has statistical significance.The result of study prompting, GUSHUKANG capsule and contrast medicine GUSHUKANG KELI thereof can improve body inner estrogen level.
10) compare before and after the treatment of X line: do not see obvious change.
Safety analysis:
Going into to organize case is 240 examples, and untoward reaction does not all take place two groups of patient's period in a medicine.
The safety observed result shows: test group is to blood, urine, stool routine examination, and situations such as ALT, BUN, Cr, electrocardiogram and human body vital sign all have no adverse effects.

Claims (5)

1, a kind of GUSHUKANG preparation is characterized in that: contain Herba Epimedii 7.5%-70% in the described GUSHUKANG preparation, Radix Rehmanniae Preparata 6%-50%, Rhizoma Drynariae 5%-65%, Radix Astragali 5%-40%, Radix Salviae Miltiorrhizae 5%-60%, Auricularia 3%-20%, Semen Cucumidis sativi 5%-30%.
2, GUSHUKANG preparation as claimed in claim 1 is characterized in that: contain Herba Epimedii 15%-70% in the described GUSHUKANG preparation, Radix Rehmanniae Preparata 6%-30%, Rhizoma Drynariae 5%-45%, Radix Astragali 5%-40%, Radix Salviae Miltiorrhizae 5%-60%, Auricularia 3%-20%, Semen Cucumidis sativi 5%-30%.
3, GUSHUKANG preparation as claimed in claim 1 is characterized in that: contain Herba Epimedii 17.5% in the described GUSHUKANG preparation, Radix Rehmanniae Preparata 23.2%, Rhizoma Drynariae 11.6%, the Radix Astragali 17.5%, Radix Salviae Miltiorrhizae 11.6%, Auricularia 9.3%, Semen Cucumidis sativi 9.3%.
4, as the described GUSHUKANG preparation of arbitrary claim in the claim 1 to 3, it is characterized in that: described preparation formulation includes granule, aqueous solvent, water-honeyed pill, tablet, capsule.
5, the preparation method of the described GUSHUKANG preparation of arbitrary claim in the claim 1 to 3 comprises following processing step:
(1) in described Herba Epimedii, Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali, Radix Salviae Miltiorrhizae, Auricularia, Semen Cucumidis sativi seven flavor medicine, the Semen Cucumidis sativi fragmentation, decoct with water 1---4 time with Auricularia, add water 3-20 doubly measures at every turn, the each decoction 1--4.5 hour, decocting liquid filters respectively, and filtrate decompression is concentrated into that relative density is about 1.00---1.35, temperature is 20 ℃--100 ℃ clear paste;
(2) Radix Salviae Miltiorrhizae adds ethanol 2--12 at every turn and doubly measures with alcohol reflux 1---4 time, and each reflux, extract, 1--4.5 hour, merging filtrate, recovery ethanol also is concentrated into that relative density is about 1.00---1.35, temperature is 20 ℃--100 ℃ clear paste;
(3) Radix Salviae Miltiorrhizae decoction dregs and Herba Epimedii, Radix Rehmanniae Preparata, Rhizoma Drynariae, the Radix Astragali decoct with water 1---6 time, add water 3--12 doubly measures at every turn, the each decoction 1--4.5 hour, collecting decoction left standstill 2--24 hour, got supernatant, adsorb through adsorbent resin, with 20%---95% concentration ethanol eluting, eluent reclaims ethanol, and to be concentrated into relative density be that 1.00---1.35, temperature are 20 ℃--100 ℃ clear paste;
(4) get above-mentioned clear paste, drying is pulverized, and makes the GUSHUKANG preparation, packing, promptly.
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CN103720892A (en) * 2013-12-12 2014-04-16 辽宁康辰药业有限公司 Traditional Chinese medicine composition comprising herba epimedii and preparation method of traditional Chinese medicine composition
CN104623064A (en) * 2015-02-18 2015-05-20 辽宁康辰药业有限公司 Gushukang preparation
CN106501397A (en) * 2016-10-19 2017-03-15 辽宁康辰药业有限公司 The method for building up for the treatment of osteoporosis preparation HPLC fingerprint pattern and purposes
CN114159506A (en) * 2021-12-28 2022-03-11 辽宁沃华康辰医药有限公司 Preparation method of Gushukang capsules

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CN1047082C (en) * 1992-05-15 1999-12-08 北京蓉生医药科技发展中心 Process of preparation of medicine tonifying kidney and bone
CN1284567C (en) * 2004-03-10 2006-11-15 山东师范大学 Medicinal liquid for treating osteoporosis and its preparation method

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CN103349674B (en) * 2013-08-05 2015-02-04 吉林农业大学 Tortoise shell rana japonica oil composition for increasing bone density and preventing osteoporosis
CN103720892A (en) * 2013-12-12 2014-04-16 辽宁康辰药业有限公司 Traditional Chinese medicine composition comprising herba epimedii and preparation method of traditional Chinese medicine composition
CN104623064A (en) * 2015-02-18 2015-05-20 辽宁康辰药业有限公司 Gushukang preparation
CN104623064B (en) * 2015-02-18 2017-11-14 辽宁康辰药业有限公司 A kind for the treatment of osteoporosis preparation
CN106501397A (en) * 2016-10-19 2017-03-15 辽宁康辰药业有限公司 The method for building up for the treatment of osteoporosis preparation HPLC fingerprint pattern and purposes
CN106501397B (en) * 2016-10-19 2019-04-09 辽宁康辰药业有限公司 The method for building up and purposes for the treatment of osteoporosis preparation HPLC fingerprint pattern
CN114159506A (en) * 2021-12-28 2022-03-11 辽宁沃华康辰医药有限公司 Preparation method of Gushukang capsules

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