CN105055863A - Application of traditional Chinese medicine composition to preparation of medicine or health-care product for treating osteoporosis and osteonecrosis - Google Patents
Application of traditional Chinese medicine composition to preparation of medicine or health-care product for treating osteoporosis and osteonecrosis Download PDFInfo
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Abstract
The invention discloses application of a traditional Chinese medicine composition to preparation of medicine or a health-care product for treating osteoporosis and osteonecrosis. The traditional Chinese medicine composition is prepared from prepared radix polygoni multiflori, rhizoma polygonati, radix rehmanniae praeparata, gorgon euryale seeds, human placenta, black sesame seeds, milkvetch roots, poria cocos, Chinese yam, American ginseng, asparagus cochinchinensis, ophiopogon japonicus, pearls, amber, ossa draconis, cacumen biotae and black soybean. Pharmacological experiment researches show that the traditional Chinese medicine composition can increase the bone mineral density and the serum calcium and phosphorus content of model rats with osteoporosis, increase distribution of caput femoris blood capillary of model rats with hormonal caput femoris necrosis and reduce fat deposition in caput femoris bone tissue of the model rats with hormonal caput femoris necrosis, and clinical research results show that the traditional Chinese medicine composition has a good treatment effect on osteoporosis and caput femoris necrosis. The traditional Chinese medicine composition has the advantages of being good in treatment effect and little in side effect when being used for treating osteoporosis and osteonecrosis and has excellent clinical application prospects.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of comprise Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Euryales, Placenta Hominis, Semen Sesami Nigrum, the Radix Astragali, Poria, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Asparagi, Radix Ophiopogonis, Margarita, succinum, Os Draconis, Cacumen Platycladi, Semen sojae atricolor Chinese medicine composition for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product.
Background technology
Osteoporosis (osteoporosis, OP) be that one is destroyed as feature with the minimizing of general bone amount, loss of bone density and bone micro-structure, the increase of bone fragility and bone strength is caused to reduce the metabolic osteopathy being easy to fracture, this disease is with pain, height shortens, even deformity of spine, or occurs that fracture is for clinical manifestation, based on pain symptom, lower back is common.According to the pathogenic factor of osteoporosis, the large class of constitutional, Secondary cases and idiopathic osteoporosis 3 can be divided into.Wherein primary osteoporosis accounts for 90%, is divided into postmenopausal osteoporosis and senile osteoporosis.According to statistics, the whole world has suffers from osteoporosis more than 200,000,000 people, and its sickness rate has leapt to the 7th of the various common disease in the world.With China's aged tendency of population process, osteoporosis has become one of the most serious problem of harm China population publilc health.The existing aged of China about 1.3 hundred million, patients with osteoporosis reaches 8,400 ten thousand people, accounts for 6.6% of total population quantity, expects the year two thousand fifty, and China aged will reach 2.5 hundred million, and wherein 25% ~ 70% may suffer from osteoporosis.Therefore, protect against osteoporosis has become the major issue of mid-aged population.
The record of osteoporosis name of disease is there is no in Chinese dynasties medical book, but rather similar to osteoporosis to the description of withered etc. the clinical symptoms of bone fistula, rheumatism involving the bone, bone.Most scholar thinks, primary osteoporosis should belong to bone fistula.Successive dynasties traditional Chinese medical science scholar passes through the pathogenesis of bone fistula, rheumatism involving the bone and comprehensive research of clinical manifestation, and think that primary disease comes from and suffer from a deficiency of the kidney, in addition, insufficiency of the spleen, stagnation of liver-QI, blood stasis are also the important pathogenesis of developing osteoporosis.
At present, the primary treatment medicine of this disease has basic pharmaceutical (calcium preparation, vitamin D), suppresses bone conversion agent (diphosphonic acid salt, calcitonin, estrogen etc.), bone formation-promoter (parathyroid hormone, fluoride) and uncoupling agents (strontium salt).Wherein estrogen is longer for medicine time, and may cause breast carcinoma and carcinoma of endometrium, prolonged application toxic and side effects is larger simultaneously.Calcitonin has certain curative effect to osteoporosis, but expensive, is difficult to for extensive patients accepts.
Osteonecrosis is also called ischemic necrosis of bone.Modern society's commonly encountered diseases, frequently-occurring disease.A kind of cause bone cycle interruption, the disease of active mass's death of bone due to various factors.
Osteonecrosis can be divided into two classes according to paathogenic factor difference: traumatic necrosis of bone and atraumatic osteonecrosis.The former mainly patient suffer External Force Acting, after being particularly directly subjected to powerful violence, local blood circulation is caused directly to interrupt, osseous tissue can not get blood supply and causes osteoblast, medullary cell, adipose cell etc. that irreversible death occurs, and bone trabecula subsides, and bone lacuna is formed, the structural mechanics of bone changes, intra-osteal pressure increases, and finally forms sequestrum, causes osteonecrosis.Relevant epidemiologic research shows, in the femur head necrosis cause of disease constituent element that sickness rate is the highest, wound accounts for about 20%, and in Elderly patients (68-82 year), wound even accounts for the ratio of 2/3.And in the cause of disease causing the latter to fall ill, life-time service glucocorticoid occupies the majority, be secondly excessive drinking, also comprise wound, hypertension, vasculitis, suffer radiation, long-term Divers etc.Although traumatic necrosis of bone is different with atraumatic osteonecrosis paathogenic factor, two class osteonecrosis later stages were all due to local bone tissue hypoxic-ischemic, affected bone cell activity, finally caused osteocyte mortality, caused the generation of osteonecrosis.Find that glucocorticoid treatment and excessive drinking are the topmost risk factors of two osteonecrosis according to the extensive Epidemiological study of Japan, the patient of about 90% is relevant with it.
Any age bracket colony all can fall ill, and mainly concentrates on 30-50 year.All can fall ill in any position, wherein the highest with femoral head sickness rate, also can betide general joint skeleton, as portions such as shoulder joint, knee joint, ankle joint, carpal joint and vertebral bodys.
Femur head necrosis refers to and causes the interruption or impaired of femoral head blood circulation by Different types of etiopathogenises, what cause the femur skulls such as osteocyte, myeloid element, adipose cell has the dead to some extent of vigor composition, and downright bad and reparation is carried out simultaneously, the mechanical strength in femur head necrosis district declines gradually, then collapse of the femoral head is caused, finally developing into serious osteoarthritis, there is the symptom such as pain, dysfunction in hip joint.Femur head necrosis is the orthopaedic disease that a kind of clinical common disability rate is higher.Femur head necrosis is divided into the traumatic and large class of atraumatic two, and the former is mainly caused by the hip trauma such as fracture of femoral neck, dislocation of hip joint, and the latter is application and the excessive drinking of corticoid in the main cause of China.At present, result of study shows, and China's hormonal in the femur head necrosis cause of disease is formed accounts for 36.17%, and Alcoholic accounts for 28.72%, traumaticly accounts for 20.21%, and etiology unknown accounts for 14.90%, and hormone has become the main cause of femur head necrosis.Femur head necrosis belongs to the category such as the traditional Chinese medical science " osteomyelitis ", " atrophic debility of bones ", " rheumatism involving the bone ".Be combined effect due to endogenous cause of ill and exopathogenic factor and the yin-Yang that causes is unbalance and QI and blood is unbalance and fall ill.
According to statistics, the femur head necrosis case of China is 5,000,000-750 ten thousand, and annual new cases are 7.5 ten thousand-15 ten thousand.
At present in for osteonecrosis, early stage mainly takes conservative treatment, and late period then adopts artificial replacement's art, there is the shortcomings such as cost is high, the course for the treatment of is long, side effect is large, curative effect is undesirable.
Patent of invention: a kind of Chinese medicine composition and its preparation method and application with kidney tonifying, essence replenishing, benefiting QI and nourishing blood and vital base and primordial QI consolidating effect, number of patent application: 201310446092.1, discloses Chinese medicine composition Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Euryales, Placenta Hominis, Semen Sesami Nigrum, the Radix Astragali, Poria, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Asparagi, Radix Ophiopogonis, Margarita, succinum, Os Draconis, Cacumen Platycladi, that Semen sojae atricolor has Cure for insomnia is forgetful; Dizziness and tinnitus, spiritlessness and weakness, loss of appetite; Leukopenia after treatment Radiotherapy chemotherapy; Treatment hyperlipidemia; Improve the effect of immunity of organisms and ability of learning and memory.
Research worker of the present invention is being carried out in further research process to it, found by experimental study, Chinese medicine composition Radix Polygoni Multiflori Preparata of the present invention, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Euryales, Placenta Hominis, Semen Sesami Nigrum, the Radix Astragali, Poria, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Asparagi, Radix Ophiopogonis, Margarita, succinum, Os Draconis, Cacumen Platycladi, Semen sojae atricolor, not only there is kidney tonifying, essence replenishing, benefiting QI and nourishing blood, vital base and primordial QI consolidating, regulate the effects such as function, to insomnia forgetfulness, dizziness and tinnitus, spiritlessness and weakness, loss of appetite etc. have good curative effect, also there is treatment osteoporosis, the effect of osteonecrosis, determined curative effect.
Summary of the invention
Goal of the invention: the object of the present invention is to provide a kind of novelty teabag of Chinese medicine composition comprising Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Euryales, Placenta Hominis, Semen Sesami Nigrum, the Radix Astragali, Poria, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Asparagi, Radix Ophiopogonis, Margarita, succinum, Os Draconis, Cacumen Platycladi, Semen sojae atricolor, the application namely in the medicine for the preparation for the treatment of osteoporosis, osteonecrosis.
Technical scheme: the application of a kind of Chinese medicine composition in the medicine for the preparation for the treatment of osteoporosis, osteonecrosis.
Chinese medicine composition of the present invention comprises: Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Euryales, Placenta Hominis, Semen Sesami Nigrum, the Radix Astragali, Poria, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Asparagi, Radix Ophiopogonis, Margarita, succinum, Os Draconis, Cacumen Platycladi, Semen sojae atricolor medical material be totally 17 taste medical materials.
As preferred scheme, it comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 80 ~ 120 parts, Rhizoma Polygonati 80 ~ 120 parts, Radix Rehmanniae Preparata 80 ~ 120 parts, Semen Euryales 80 ~ 120 parts, Placenta Hominis 6 ~ 12 parts, Semen Sesami Nigrum 30 ~ 60 parts, the Radix Astragali 80 ~ 120 parts, 80 ~ 120 parts, Poria, Rhizoma Dioscoreae 40 ~ 50 parts, Radix Panacis Quinquefolii 10 ~ 20 parts, Radix Asparagi 40 ~ 60 parts, Radix Ophiopogonis 40 ~ 60 parts, Margarita 2 ~ 4 parts, succinum 6 ~ 9 parts, Os Draconis 20 ~ 30 parts, Cacumen Platycladi 40 ~ 60 parts, Semen sojae atricolor 90 ~ 110 parts.
As preferred scheme, it comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 90 parts, Rhizoma Polygonati 90 parts, Radix Rehmanniae Preparata 90 parts, Semen Euryales 90 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 40 parts, the Radix Astragali 90 parts, 90 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 14 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 40 parts, Margarita 3 parts, succinum 7 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 90 parts are made.
As preferred scheme, it comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 100 parts, Rhizoma Polygonati 100 parts, Radix Rehmanniae Preparata 100 parts, Semen Euryales 100 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 50 parts, the Radix Astragali 100 parts, 100 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 18 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 60 parts, Margarita 3 parts, succinum 8 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 80 parts.
As preferred scheme, it comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 120 parts, Rhizoma Polygonati 120 parts, Radix Rehmanniae Preparata 80 parts, Semen Euryales 80 parts, Placenta Hominis 6 parts, Semen Sesami Nigrum 60 parts, the Radix Astragali 80 parts, 120 parts, Poria, Rhizoma Dioscoreae 50 parts, Radix Panacis Quinquefolii 10 parts, Radix Asparagi 60 parts, Radix Ophiopogonis 40 parts, Margarita 4 parts, succinum 6 parts, Os Draconis 30 parts, Cacumen Platycladi 60 parts, Semen sojae atricolor 110 parts.
Preferably, the application of described Chinese medicine composition in the medicine for the preparation for the treatment of osteoporosis, osteonecrosis, is prepared into oral preparations by Chinese medicine composition.
Preferably, the application of described Chinese medicine composition in the medicine for the preparation for the treatment of osteoporosis, osteonecrosis, described oral preparations comprises pill, tablet, capsule, oral liquid and syrup.
Invention has been the research of described traditional Chinese medicine composition for treating osteoporosis drug effect, result shows, described Chinese medicine composition high dose group can significantly improve model group rats serum calcium, phosphorus content, compares have significant difference (P<0.05) with matched group.Described Chinese medicine composition high dose group, middle dosage group can significantly increase model group rats femur weight and bone density, compare have significant difference (P<0.05 or P<0.01) with matched group.Described Chinese medicine composition low dose group significantly can increase model group rats bone density (P<0.05).
Invention has been described traditional Chinese medicine composition for treating corticosteroid femur head necrosis pharmacodynamic study, after result shows to gavage various dose Chinese medicine composition, in femoral head, blood capillary almost recovers normal level, and gather in head blood capillary, arranges also comparatively rule.More all there were significant differences (P<0.05 or P<0.01) with model group for various dose Chinese medicine composition group fat tinctorial yield, and wherein to reduce fatty tinctorial yield effect the most remarkable for high dose group Chinese medicine composition.
Invention has been the osteoporotic clinical research of described traditional Chinese medicine composition for treating, result shows that described Chinese medicinal composition capsules treatment group total effective rate reaches 84.4%, and difference has significant (P < 0.05) compared with matched group.The improvement aspect for the treatment of group tcm syndrome has a clear superiority in, and total effective rate reaches 84.4%, obvious effective rate 44.4%, has significant difference (P < 0.05) compared with matched group.Chinese medicinal composition capsules treatment group all has good curative effect to deficiency of kidney-QI, deficiency of the liver and kidney osteoporosis.Meanwhile, treatment group patient bone mineral content and bone density all rise, and compare that there were significant differences (P < 0.01) with before treatment.Before and after treatment, safety indexes is normal, has no obvious adverse reaction.
The present invention also carries out the clinical research of described traditional Chinese medicine composition for treating femur head necrosis, result shows that described Chinese medicine composition can be alleviated the Patients with Aseptic Necrosis of Femoral hip arthralgia, walks with difficulty, joint stuffiness, fatigue and weak, soreness of the waist and knees clinical symptoms, and with matched group alleviating the hip arthralgia, joint stuffiness, fatigue and weak, soreness of the waist and knees 4 indexs have significant difference (P < 0.05).Effective 34 examples of traditional Chinese medicine composition for treating group, invalid 6 examples, total effective rate is 85.0%; Effective 29 examples of matched group, invalid 11 examples, total effective rate is 72.5%.Two groups are compared total effective rate and have significant difference (P < 0.05).Two groups are showed no obvious adverse reaction.
The present invention develops the application of a kind of Chinese medicine composition in the medicine for the preparation for the treatment of osteoporosis, osteonecrosis, has the advantage that good effect, side effect are little, has good potential applicability in clinical practice.
Detailed description of the invention
The present invention is illustrated further below in conjunction with specific embodiment, these embodiments should be understood only be not used in for illustration of the present invention and limit the scope of the invention, after having read the present invention, the amendment of those skilled in the art to the various equivalent form of value of the present invention has all fallen within the application's claims limited range.
Traditional Chinese medicine composition for treating osteoporosis drug effect research described in embodiment 1
1, material
1.1 laboratory animal
SD rat, body weight 180 ~ 220g.
1.2 medicines and reagent
Described Chinese medicinal composition capsules: prescription: Radix Polygoni Multiflori Preparata 90 parts, Rhizoma Polygonati 90 parts, Radix Rehmanniae Preparata 90 parts, Semen Euryales 90 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 40 parts, the Radix Astragali 90 parts, 90 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 14 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 40 parts, Margarita 3 parts, succinum 7 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 90 parts.Method for making: 1. get recipe quantity Radix Panacis Quinquefolii 70% ethanol 10 times amount and extract 2 times, each 1 hour, merge extractive liquid, filters, and reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii residue dry, pulverize into coarse powder, for subsequent use.2. get recipe quantity Semen Euryales, Margarita, Succinum powder be broken into fine powder.3. recipe quantity Rhizoma Polygonati, Semen Sesami Nigrum, the Radix Astragali, Poria, Radix Asparagi, Radix Ophiopogonis, Placenta Hominis, Os Draconis eight taste is got, 10 times amount that add water decoct 2 times, each 1 hour, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol 2 times amount, leaves standstill 20 hours, leaching supernatant, reclaim ethanol, be condensed into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C), for subsequent use; 4. recipe quantity Radix Rehmanniae Preparata, Semen sojae atricolor, Rhizoma Dioscoreae, Cacumen Platycladi, the Radix Polygoni Multiflori Preparata five tastes are got, by 70% ethanol 10 times amount heating and refluxing extraction 2 times, 4 hours first times, second time 3 hours.Merge extractive liquid, filters, and reclaims ethanol, is concentrated into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C).5. fine drug powder, Radix Panacis Quinquefolii coarse powder and above-mentioned clear paste are mixed, make paste block, dry, add adjuvant, make capsule.Specification: every dress 0.3g.Described Chinese medicine composition distilled water is mixed with variable concentrations gavage medicinal liquid.
QIANGGU JIAONANG, 0.25g/ grain, Beijing Qihuang Pharmaceutical Co., Ltd produces, lot number 140513.The medicinal distilled water of described positive control is mixed with for finite concentration gastric infusion medicinal liquid.Retinoic acid sheet, 10mg/ sheet, Shandong Liang Fu pharmaceutical Co. Ltd produces, lot number 130218.Used time and 0.5% CMC-Na suspendible.
1.3 instrument and equipment
Dual-energy x-ray absorptiometry, automatic biochemical inspection analyzer, electronic balance.
2, experimental technique
Get SD rat, body weight 180 ~ 200g, male and female half and half.It is divided into 6 groups at random, often organize 10, be respectively blank group, model group, positive controls (QIANGGU JIAONANG, 1.5g/kg), Chinese medicinal composition capsules three dosage groups (low dose group 0.8g crude drug in whole/kg, middle dosage group 1.6g crude drug in whole/kg, high dose group 3.2g crude drug in whole/kg).Blank group gavages the CMC-Na solution of 0.5% of same volume, and all the other each group gavaged retinoic acid (70mg/kg) to the 14th day on the 1st day in experiment.Within 14 days, respectively organize retinoic acid of stopping using afterwards, blank group, model group give same volume normal saline, and other each group gives relative medicine, successive administration 4 weeks.Last administration is taken a blood sample and is put to death animal, separation of serum for one day afterwards, measures serum calcium, phosphorus index.Peel off left and right femur and measure femur weight, and carry out bone densitometry.
3 date processing
SPSS16.0 statistical package is adopted to analyze.Result of calculation represents with x ± s, compares and adopt t inspection between group.
4 results
Chinese medicine composition described in 4.1 is on the impact of rat model Biochemical Indices In Serum
Compared with blank group, model group rats serum calcium, phosphorus content significantly reduce (P<0.05 or P<0.01).Described Chinese medicine composition object height, middle dosage group can significantly improve model group rats serum calcium, phosphorus content, compare have significant difference (P<0.05 or P<0.01) with matched group).The results are shown in Table 1.
Table 1 Chinese medicinal composition capsules on the impact of rat model Biochemical Indices In Serum (
n=10)
Note: compare with model group, * P < 0.05, * * P < 0.01.Table 2-3 is same.
Chinese medicine composition described in 4.2 is on the impact of rat model bone density and femur weight
Compared with blank group, model group rats femur weight, bone density significantly reduce (P<0.01).Described Chinese medicine composition high dose group, middle dosage group can significantly increase model group rats femur weight and bone density, compare have significant difference (P<0.05 or P<0.01) with matched group.Described Chinese medicine composition low dose group significantly can increase model group rats bone density (P<0.05).The results are shown in Table 2.
Table 2 Chinese medicinal composition capsules on the impact of rat model bone density and femur weight (
n=10)
Traditional Chinese medicine composition for treating corticosteroid femur head necrosis pharmacodynamic study described in embodiment 2
1, material
1.1 laboratory animal
Wistar rat neonatal rat.
1.2 medicines and reagent
Prescription: Radix Polygoni Multiflori Preparata 100 parts, Rhizoma Polygonati 100 parts, Radix Rehmanniae Preparata 100 parts, Semen Euryales 100 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 50 parts, the Radix Astragali 100 parts, 100 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 18 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 60 parts, Margarita 3 parts, succinum 8 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 80 parts.Method for making: 1. get recipe quantity Radix Panacis Quinquefolii 70% ethanol 10 times amount and extract 2 times, each 1 hour, merge extractive liquid, filters, and reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii residue dry, pulverize into coarse powder, for subsequent use.2. get recipe quantity Semen Euryales, Margarita, Succinum powder be broken into fine powder.3. recipe quantity Rhizoma Polygonati, Semen Sesami Nigrum, the Radix Astragali, Poria, Radix Asparagi, Radix Ophiopogonis, Placenta Hominis, Os Draconis eight taste is got, 10 times amount that add water decoct 2 times, each 1 hour, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol 2 times amount, leaves standstill 20 hours, leaching supernatant, reclaim ethanol, be condensed into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C), for subsequent use; 4. recipe quantity Radix Rehmanniae Preparata, Semen sojae atricolor, Rhizoma Dioscoreae, Cacumen Platycladi, the Radix Polygoni Multiflori Preparata five tastes are got, by 70% ethanol 10 times amount heating and refluxing extraction 2 times, 4 hours first times, second time 3 hours.Merge extractive liquid, filters, and reclaims ethanol, is concentrated into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C).5. fine drug powder, Radix Panacis Quinquefolii coarse powder and above-mentioned clear paste are mixed, make paste block, dry, add adjuvant, make capsule.Specification: every dress 0.3g.Lot number: NC17006033.Described Chinese medicine composition distilled water is mixed with variable concentrations gavage medicinal liquid.
QIANGGU JIAONANG, 0.25g/ grain, Beijing Qihuang Pharmaceutical Co., Ltd produces, lot number 140513.The medicinal distilled water of described positive control is mixed with for finite concentration gastric infusion medicinal liquid.Prednisone acetate tablets, 5mg/ sheet, Tianjin Pharmaceutical Group Xinzheng Co., Ltd. produces, and lot number 140516, is mixed with finite concentration gavage solution with distilled water.
2, experimental technique
Get Wistar rat neonatal rat, male and female half and half.It is divided into 6 groups at random, often organize 10, be respectively blank group, model group, positive controls (QIANGGU JIAONANG, 1.5g/kg), Chinese medicine composition of the present invention three dosage groups (low dose group 0.8g crude drug in whole/kg, middle dosage group 1.6g crude drug in whole/kg, high dose group 3.2g crude drug in whole/kg).Blank group gavages same volume distilled water, totally 30 days.Femoral head necrosis model matched group is that neonatal rat cut limb after 1.5 months, only gavages prednisolone acetate, does not give other any medicines.Chinese medicine composition of the present invention three dosage groups, while gavaging prednisolone acetate, start to gavage various dose Chinese medicine composition, 1 times/day.Gavage 3 months altogether.Positive drug QIANGGU JIAONANG group starts to gavage while gavaging prednisolone acetate, 1 times/day.Gavage 3 months altogether.1. femoral head blood capillary distribution situation is observed: femur head necrosis is tested each treated animal under pentobarbital sodium anesthesia, inject prepared Chinese ink to side femoral artery and be about 5mL, take off femoral head to put in neutral formalin liquid fixing after, through Gradient elution using ethanol process, embed with methyl methacrylate, polymerization, uses low speed bone saw to make 0.3-0.5mm osteocomma.Observe blood capillary form and distribution.2. fatty deposition conditions in femoral head is observed: taken off by another for above-mentioned animal side femoral head successively by fixing in 700-900ml/L ethanol, row frozen section, Lillie oil red O stain, observes Fat Distribution, and calculates the ratio of the painted chondrocyte of fat, osteocyte.
3 date processing
SPSS16.0 statistical package is adopted to analyze.Result of calculation with
represent, compare between group and adopt t inspection.
4 results
4.1 femoral head blood capillary distributions
Normal rats femoral head blood capillary is scattered in net, has a large amount of blood capillary to lead directly to subchondral layer, distributes in fan-shaped, and have horizontal branch to link up, in the femoral head of femoral head necrosis model animal, blood capillary is obviously sparse, arrangement disorder, and in unit are, blood capillary proportion obviously declines.After gavaging various dose Chinese medicine composition, in femoral head, blood capillary almost recovers normal level, and gather in head blood capillary, arranges also comparatively rule.
In 4.2 femoral head osseous tissues, lipidosis measures
Femoral head necrosis model rat femur head pulp cavity fatty tissue increases, and bone trabecula is sparse, attenuate, in chondrocyte and osteocyte the ratio of fat stains obviously increase.Normal rat has no or rarely seen a small amount of fat drop.The rat taken after various dose Chinese medicine composition has no or rarely seen a small amount of fat drop.More all there were significant differences (P<0.05 or P<0.01) with model group for various dose Chinese medicine composition group fat tinctorial yield, and wherein to reduce fatty tinctorial yield effect the most remarkable for high dose group Chinese medicine composition.Concrete outcome is in table 3.
Table 3 Chinese medicinal composition capsules on the impact of femoral head necrosis model rat bone tissue lipidosis (
n=10)
Traditional Chinese medicine composition for treating osteoporosis clinical research described in embodiment 3
1 data and standard
1.1 physical data: select patients with primary osteoporosis 90 example, 45 ~ 75 years old age, average 61.5 years old.Treatment group 45 example, matched group 45 example.Two groups of patient ages, sex, medicine typing aspect there was no significant differences, have comparability.
1.2 inclusive criterias: 1. the geratic period age >=60 years old, presenium 45 ~ 59 years old.2. doctor trained in Western medicine Criteria of Osteoporosis is met: according to " the Chinese's osteoporosis suggestion diagnostic criteria " within 1999, passed through.3. meet TCM syndrome diagnostic criteria: " the Chinese medical disease Standardization of diagnosis and curative effect " of " the dialectical reference standard of Chinese medicine deficiency-syndrome " formulated with reference to Zhengzhou meeting in 1986 and national health management board issue in 1994 is formulated, belong to deficiency of kidney-QI or caused by liver and kidney deficiency card.
1.3 exclusion standards: the age is person below 45 years old; The person that do not meet diagnosis of osteoporosis; Often take medicine, be addicted to drink, cigarette amateur; Participated in other drug test (comprising Chinese and Western tonic) in three months or once made excessive operator; There are hyperthyroidism, diabetes, rheumatoid arthritis, the secondary osteoporosis patients such as multiple myeloma; The serious organic disease person such as the heart, brain, liver, kidney and endocrine; There is drug allergy person.
1.4 reject standard: do not take medicine by regulation; Cannot conclude that curative effect or data are not congruent to affect the treatment and safety judgement person.
2 Therapeutic Method
The oral described Chinese medicinal composition capsules of 2.1 medication therapy groups, each 3, every day 2 times 3 months is a course for the treatment of (Chinese medicine composition prescription: Radix Polygoni Multiflori Preparata 90 parts, Rhizoma Polygonati 90 parts, Radix Rehmanniae Preparata 90 parts, Semen Euryales 90 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 40 parts, the Radix Astragali 90 parts, 90 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 14 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 40 parts, Margarita 3 parts, succinum 7 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 90 parts.Method for making: 1. get recipe quantity Radix Panacis Quinquefolii 70% ethanol 10 times amount and extract 2 times, each 1 hour, merge extractive liquid, filters, and reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii residue dry, pulverize into coarse powder, for subsequent use.2. get recipe quantity Semen Euryales, Margarita, Succinum powder be broken into fine powder.3. recipe quantity Rhizoma Polygonati, Semen Sesami Nigrum, the Radix Astragali, Poria, Radix Asparagi, Radix Ophiopogonis, Placenta Hominis, Os Draconis eight taste is got, 10 times amount that add water decoct 2 times, each 1 hour, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol 2 times amount, leaves standstill 20 hours, leaching supernatant, reclaim ethanol, be condensed into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C), for subsequent use; 4. recipe quantity Radix Rehmanniae Preparata, Semen sojae atricolor, Rhizoma Dioscoreae, Cacumen Platycladi, the Radix Polygoni Multiflori Preparata five tastes are got, by 70% ethanol 10 times amount heating and refluxing extraction 2 times, 4 hours first times, second time 3 hours.Merge extractive liquid, filters, and reclaims ethanol, is concentrated into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C).5. fine drug powder, Radix Panacis Quinquefolii coarse powder and above-mentioned clear paste are mixed, make paste block, dry, add adjuvant, make capsule.Specification: every dress 0.3g).
Matched group gives XIANLING GUBAO JIAONANG (Guizhou Tongjitang Pharmaceutical Co., Ltd), each 2, and every day 3 times, half an hour is oral after the meal.Within 3 months, be a course for the treatment of, two groups of all cases all follow up a case by regular visits to 3 months.
2.2 observation item
1. safety indexes: general physical examination; Blood, urine, stool routine examination; Liver and kidney function, electrocardiogram.
2. health giving quality index: the observation of two groups of clinical efficacies; The relation of TCM Syndrome Type and curative effect; Bone mineral content, bone density inspection.
2.3 curative effect determinate standard
1. tcm symptom standards of grading: " the dialectical reference standard of Chinese medicine deficiency-syndrome " that " the new Chinese medicine clinical research technological guidance principle " of promulgating in 1993 with reference to Ministry of Public Health bureau of drug administration and Zhengzhou meeting in 1986 are formulated is formulated.
2. tcm syndrome curative effect determinate standard: judge tcm syndrome curative effect according to " senile disease guideline of clinical investigations treated by new drug (Chinese medicine) " relevant Syndrome in TCM integration method.Effective: symptom integral value decline >2/3 after treatment; Effective: after treatment, symptom integral value declines between 2/3 ~ 1/3: invalid: after treatment, symptom integral value declines not as good as 1/3.
3. osteoporosis curative effect determinate standard: as follows with reference to first international bone metabolism academic conference data " osteoporosis " book formulation criterion in 1992: effective: the symptoms such as spinal column ache disappear substantially, pain symptom integration declines>=2/3, and rise after the treatment of bone density inspection display radius (ulna) bone density value 0.059/cm
2; Effective: the symptoms such as spinal column ache are clearly better, pain symptom integration declines 2/3.Bone density inspection has no bone density obviously to be increased or <0.059/cm
2; Invalid: the symptoms such as spinal column ache are without improvement, and pain symptom integration decline≤l/3, bone density checks without changing or continuing to decline.
2.4 statistical methods: dosage information adopts t inspection, and enumeration data adopts χ
2inspection, ranked data adopt Ridit to analyze.
3 therapeutic outcomes
3.1 liang of group Clinical efficacy comparisons
Chinese medicinal composition capsules treatment group total effective rate reaches 84.4%, and difference has significant (P < 0.05) compared with matched group, illustrates that Chinese medicinal composition capsules clinical efficacy is better than matched group.The results are shown in Table 4.
Table 4 liang group Clinical efficacy comparison
Note: compare with matched group, * P < 0.05.
The change of 3.2 liang of group patient Chinese medicine syndrome integral values
The improvement aspect of Chinese medicinal composition capsules treatment group tcm syndrome has a clear superiority in, and total effective rate reaches 84.4%, obvious effective rate 44.4%, has significant difference (P < 0.05) compared with matched group.The results are shown in Table 5.
A table 5 liang group patient Chinese medicine syndrome integral value compares
The comparitive study of 3.3 treatment group TCM Syndrome Type
Chinese medicinal composition capsules treatment group all has good curative effect to deficiency of kidney-QI, caused by liver and kidney deficiency, each typing comparitive study there was no significant difference.The results are shown in Table 6.
Table 6 treatment group TCM Syndrome Type comparitive study
The change of bone mineral content, bone density before and after 3.4 liang of group patient treatments
Through treatment, treatment group patient bone mineral content (BMC) and bone density (BMD) all rise, and compare that there were significant differences (P < 0.01) with before treatment; Matched group bone mineral content is also meaningful rising (P < 0.05), bone density rising significance (P < 0.01); Comparing difference all meaningless (P > 0.05) between treatment group and matched group group.The results are shown in Table 7.
Bone ore deposit mutation analysis before and after table 7 liang group treatment
Note: compare with before medication, * P < 0.05, * * P < 0.01.
Before and after 3.5 treatments, safety indexes is observed
The routine blood test for the treatment of group and matched group patient, routine urinalysis, just routine, Liver and kidney function, electrocardiogram normally, treat rear no abnormality seen before treating, and normally treat the abnormal situation of rear appearance before not having treatment.In process of the test, there is not obvious adverse reaction, think that investigational agent has good safety according to safety evaluatio standard.
Traditional Chinese medicine composition for treating femur head necrosis clinical research described in embodiment 4
1 data and standard
1.1 physical data: 80 routine patients, performance all to some extent has hip pain, walks with difficulty, joint stuffiness, fatigue and weak and soreness of the waist and knees symptom, and time movable, pain increases the weight of.Be divided into treatment group and each 40 examples of matched group at random.Man 28 example in treatment group, female 12 example, 41 ± 10.8 years old mean age; Man 21 example in matched group, female 19 example, 42 ± 10.2 years old mean age.Two groups of patient ages, sex, course of disease aspect there was no significant differences (P > 0.05), have comparability.
1.2 diagnostic criterias: " the Chinese medical disease Standardization of diagnosis and curative effect " issued with reference to State Administration of Traditional Chinese Medicine.
1. without obvious hip joint trauma history.
2. have limping, soreness of waist and knee joint, stiff sense in early days, oxycinesia of living, takes a turn for the better after having a rest.
3. hip limitation of activity is limited swivel the earliest, after relate to flexing, abduction and adduction, suffering limb amyotrophy.
4. the later stage is flexing adduction deformity
5. x-ray takes the photograph the collapse of the femoral head of the visible femoral head density change of sheet and middle and late stage.X-ray film staging scale is according to the staging system standard of international bone circulating research meeting osteonecrosis: I phase x-ray is negative, but bone scanning is positive or MRI is positive.II phase X-ray film is abnormal, shows femoral head Density inhomogeneity or has cystis degeneration, without subsiding.The x-ray display collapse of the femoral head of III phase.IV phase x-ray display femoral head joint space narrows, and hyperosteogeny is formed.
1.3 inclusive criterias:
Age, at 30 ~ 62 years old, meets diagnostic criteria.
1.4 exclusion standards: 1. suffer from bone tuberculosis, bone tumor, transient synovitis, femur skull dirt spondylolisthesis and other bone patient irrelevant with primary disease.2. anemia of pregnant woman, nursing women.3. allergic constitution and psychotic.4. the severe primary disease patients such as serious cardiovascular, cerebrovascular, liver, kidney, hemopoietic system, hormonal system are merged.5. treat or using other drug therapist.6. wound, the femur head necrosis caused of drinking.
2 Therapeutic Method
The oral described Chinese medicinal composition capsules of 2.1 medication therapy groups, each 3, every day 2 times 3 months is a course for the treatment of, and drug withdrawal was checked in one week.Chinese medicine composition prescription: Radix Polygoni Multiflori Preparata 120 parts, Rhizoma Polygonati 120 parts, Radix Rehmanniae Preparata 80 parts, Semen Euryales 80 parts, Placenta Hominis 6 parts, Semen Sesami Nigrum 60 parts, the Radix Astragali 80 parts, 120 parts, Poria, Rhizoma Dioscoreae 50 parts, Radix Panacis Quinquefolii 10 parts, Radix Asparagi 60 parts, Radix Ophiopogonis 40 parts, Margarita 4 parts, succinum 6 parts, Os Draconis 30 parts, Cacumen Platycladi 60 parts, Semen sojae atricolor 110 parts.Method for making: 1. get recipe quantity Radix Panacis Quinquefolii 70% ethanol 10 times amount and extract 2 times, each 1 hour, merge extractive liquid, filters, and reclaim ethanol, be condensed into clear paste, Radix Panacis Quinquefolii residue dry, pulverize into coarse powder, for subsequent use.2. get recipe quantity Semen Euryales, Margarita, Succinum powder be broken into fine powder.3. recipe quantity Rhizoma Polygonati, Semen Sesami Nigrum, the Radix Astragali, Poria, Radix Asparagi, Radix Ophiopogonis, Placenta Hominis, Os Draconis eight taste is got, 10 times amount that add water decoct 2 times, each 1 hour, collecting decoction, filter, filtrate is concentrated in right amount, adds ethanol 2 times amount, leaves standstill 20 hours, leaching supernatant, reclaim ethanol, be condensed into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C), for subsequent use; 4. recipe quantity Radix Rehmanniae Preparata, Semen sojae atricolor, Rhizoma Dioscoreae, Cacumen Platycladi, the Radix Polygoni Multiflori Preparata five tastes are got, by 70% ethanol 10 times amount heating and refluxing extraction 2 times, 4 hours first times, second time 3 hours.Merge extractive liquid, filters, and reclaims ethanol, is concentrated into the clear paste that relative density is 1.10 ~ 1.40 (detected temperatures 60 ~ 98 DEG C).5. fine drug powder, Radix Panacis Quinquefolii coarse powder and above-mentioned clear paste are mixed, make paste block, dry, add adjuvant, make capsule.Specification: every dress 0.3g).
Matched group gives QIANGGU JIAONANG (Beijing Qihuang Pharmaceutical Co., Ltd), uses warm water delivery service after meal.1 time 1,3 times on the one three months is a course for the treatment of.Drug withdrawal was checked in one week.
2.2 observation index: observe the hip arthralgia, joint stuffiness, walk with difficulty, the symptom such as fatigue and weak, soreness of the waist and knees improves situation.The reference of observation index scalar quantization standard " new Chinese medicine guideline of clinical investigations (2002 ".
3 curative effect judging standards: " new Chinese medicine guideline of clinical investigations (2002) " of issuing with reference to State Food and Drug Administration formulate curative effect determinate standard.Adopt nimodipine method to calculate, formula is: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
Clinical recovery: the transference cures such as pain, joint motion is normal, and symptom, somatic feature score reduce >=95%.Effective: the transference cures such as pain, joint motion is not limited, and symptom, somatic feature score reduce >=70%, < 95%.Effective: the symptoms such as pain disappear substantially, joint motion is slightly limited, and symptom, somatic feature score reduce >=30%, < 70%.Invalid: the symptoms such as pain and joint motion are not improved, symptom, somatic feature score reduce < 30%.
4 statistical methods: data acquisition t inspection and rank test, P < 0.05 has significant for difference.Statistical data adopts SPSS16.0 process.
5 therapeutic outcomes
Before and after 5.1 liang of group treatments, clinical symptom remission situation compares
Treatment group and matched group all can be alleviated the hip arthralgia, walk with difficulty, joint stuffiness, fatigue and weak, soreness of the waist and knees clinical symptoms, and treatment group and matched group alleviating the hip arthralgia, joint stuffiness, fatigue and weak, soreness of the waist and knees 4 indexs have significant difference (P < 0.05).The results are shown in Table 8.
A table 8 liang group clinical symptom remission situation compares
Note: compare after treatment with before treatment,
▲p < 0.01; Treatment group compares * P < 0.05 with matched group.
Before and after 5.2 liang of group treatments, clinical indexes compares
Effective 34 examples for the treatment of group, invalid 6 examples, total effective rate is 85.0%; Effective 29 examples of matched group, invalid 11 examples, total effective rate is 72.5%.Two groups are compared total effective rate and have significant difference (P < 0.05).Two groups are showed no obvious adverse reaction.
Model case:
Case 1: Bai, man, 37 years old, have rheumatoid arthritis history, long-term taking meticortelone, recently occur the right hip arthralgia, X sheet shows: cystis degeneration, sclerosis under right Femoral cardlage, joint space is normal.After taking 1 course for the treatment of of Chinese medicine composition of the present invention, right hip pain obviously alleviates, then after continuing to take two courses for the treatment of, pain disappears.Continue to take two the course for the treatment of consolidate curative effect, clinical symptoms disappears completely, follows up a case by regular visits to without recurrence.
Case 2: Xue so-and-so, female, 52 years old.Long-term Hormone causes the one-sided necrosis of femoral head, and take Chinese medicine composition of the present invention the symptom course for the treatment of and obviously alleviate, after two courses for the treatment of, pain disappears, and functional rehabilitation after a year, after taking 2 years, clinical symptoms disappears completely.
Case 3: Shao so-and-so, man 56 years old, chronic alcoholism, right lateral thigh head necrosis, hurt like hell, is difficult to normal work, once doctor trained in Western medicine and acupuncture and moxibustion therapy was adopted, fail to cure, take medicine of the present invention three months pains and disappear, June, function was obviously improved, examination in hospital is removed after 1 year, the basic rehabilitation of necroses, existing freedom of movement, can normally work.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the premise without departing from the principles of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (9)
1. a Chinese medicine composition is for the preparation of the application in the medicine for the treatment of osteoporosis, osteonecrosis or health product, it is characterized in that, Chinese medicine composition comprises: Radix Polygoni Multiflori Preparata, Rhizoma Polygonati, Radix Rehmanniae Preparata, Semen Euryales, Placenta Hominis, Semen Sesami Nigrum, the Radix Astragali, Poria, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Asparagi, Radix Ophiopogonis, Margarita, succinum, Os Draconis, Cacumen Platycladi and Semen sojae atricolor.
2. a kind of Chinese medicine composition according to claim 1 is for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, and it is characterized in that, Chinese medicine composition comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 80 ~ 120 parts, Rhizoma Polygonati 80 ~ 120 parts, Radix Rehmanniae Preparata 80 ~ 120 parts, Semen Euryales 80 ~ 120 parts, Placenta Hominis 6 ~ 12 parts, Semen Sesami Nigrum 30 ~ 60 parts, the Radix Astragali 80 ~ 120 parts, 80 ~ 120 parts, Poria, Rhizoma Dioscoreae 40 ~ 50 parts, Radix Panacis Quinquefolii 10 ~ 20 parts, Radix Asparagi 40 ~ 60 parts, Radix Ophiopogonis 40 ~ 60 parts, Margarita 2 ~ 4 parts, succinum 6 ~ 9 parts, Os Draconis 20 ~ 30 parts, Cacumen Platycladi 40 ~ 60 parts, Semen sojae atricolor 90 ~ 110 parts.
3. a kind of Chinese medicine composition according to claim 1 is for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, and it is characterized in that, Chinese medicine composition comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 90 parts, Rhizoma Polygonati 90 parts, Radix Rehmanniae Preparata 90 parts, Semen Euryales 90 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 40 parts, the Radix Astragali 90 parts, 90 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 14 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 40 parts, Margarita 3 parts, succinum 7 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 90 parts.
4. a kind of Chinese medicine composition according to claim 1 is for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, and it is characterized in that, Chinese medicine composition comprises the raw material of following parts by weight:
Radix Polygoni Multiflori Preparata 100 parts, Rhizoma Polygonati 100 parts, Radix Rehmanniae Preparata 100 parts, Semen Euryales 100 parts, Placenta Hominis 10 parts, Semen Sesami Nigrum 50 parts, the Radix Astragali 100 parts, 100 parts, Poria, Rhizoma Dioscoreae 40 parts, Radix Panacis Quinquefolii 18 parts, Radix Asparagi 40 parts, Radix Ophiopogonis 60 parts, Margarita 3 parts, succinum 8 parts, Os Draconis 26 parts, Cacumen Platycladi 40 parts, Semen sojae atricolor 80 parts.
5. a kind of Chinese medicine composition according to claim 1 is for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, it is characterized in that, Chinese medicine composition comprises the raw material of following parts by weight: Radix Polygoni Multiflori Preparata 120 parts, Rhizoma Polygonati 120 parts, Radix Rehmanniae Preparata 80 parts, Semen Euryales 80 parts, Placenta Hominis 6 parts, Semen Sesami Nigrum 60 parts, the Radix Astragali 80 parts, 120 parts, Poria, Rhizoma Dioscoreae 50 parts, Radix Panacis Quinquefolii 10 parts, Radix Asparagi 60 parts, Radix Ophiopogonis 40 parts, Margarita 4 parts, succinum 6 parts, Os Draconis 30 parts, Cacumen Platycladi 60 parts, Semen sojae atricolor 110 parts.
6. a kind of Chinese medicine composition according to claim 1-5, for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, is characterized in that, Chinese medicine composition is prepared into oral preparations.
7. a kind of Chinese medicine composition according to claim 6 is for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, and it is characterized in that, described oral preparations comprises pill, tablet, capsule, oral liquid and syrup.
8. according to any one of claim 1-7 a kind of Chinese medicine composition for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, it is characterized in that, described osteonecrosis comprises femur head necrosis, knee joint is downright bad, shoulder joint is downright bad, spinal bone is downright bad, humerus is downright bad, navicular bone is downright bad, talus necrosis, metatarsal are downright bad, scaphoid bone is downright bad and the moon osteonecrosis.
9. Chinese medicine composition according to claim 8 is for the preparation of the application in treatment osteoporosis, the medicine of osteonecrosis or health product, it is characterized in that, described osteonecrosis comprises Alcohol Osteonecrosis and hormonal stock is downright bad.
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| CN104758534A (en) * | 2015-04-29 | 2015-07-08 | 赵振荣 | Medicine for treating osteoporosis and preparing method thereof |
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| CN103536757A (en) * | 2013-09-26 | 2014-01-29 | 雷允上药业有限公司 | Traditional Chinese medicine composition having effects of tonifying kidney, replenishing essence, tonifying qi, nourishing blood and consolidating basis, and preparation method and application thereof |
| CN104758534A (en) * | 2015-04-29 | 2015-07-08 | 赵振荣 | Medicine for treating osteoporosis and preparing method thereof |
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Denomination of invention: Application of a traditional Chinese medicine composition in the preparation of drugs or health products for the treatment of osteoporosis and osteonecrosis Effective date of registration: 20221019 Granted publication date: 20171201 Pledgee: Shanghai Bank Co.,Ltd. Suzhou Branch Pledgor: LEIYUNSHANG PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2022320010593 |