CN1778368A - Chinese medicine composition for treating bone disease, its preparation and use thereof - Google Patents

Abstract

A Chinese medicine for treating the osteopathy, such as ischemic femur head necrosis, is prepared from 10 Chinese-medicinal materials including dragon's blood, antler glue, safflower, myrrh, etc. Its preparing process is also disclosed.

Description

Chinese medicine composition of treatment osteopathia and its production and use

Technical field

The present invention relates to Chinese medicine composition, make by Rhizoma Drynariae, Sanguis Draxonis, Radix Dipsaci, Colla cornus cervi, Flos Carthami, Herba speranskiae tuberculatae, Olibanum, Myrrha, Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei, the preparation method, said composition that also relates to said composition in medication preparation purposes and comprise the medicine of said composition as active component, wherein this medicine is used for the treatment of orthopaedic disease.

Background technology

Ischemic necrosis of femoral head is difficult disease, the commonly encountered diseases of orthopedics department, is the frequently-occurring disease of hip joint.Symptoms such as primary disease is clinical to show as mainly that hip joint stationarity pain, function of joint are limited, limping and lower limb muscles atrophy.Its onset is slow, and therapeutic effect is poor, is a kind of locomotor disease that bigger harm is arranged.Ischemic necrosis of femoral head is the dead caused pathological process of active component (osteocyte, medullary cell and adipose cell) of bone.It is generally acknowledged that it is relevant with factors such as hip joint wound, some drugs (as adrenocortical hormone), other diseases.The common pathological manifestations of ischemic necrosis of femoral head is that a variety of causes the femoral head disturbance of blood circulation and the joint stress that cause are not normal.At present, doctor trained in Western medicine to the treatment of ischemic necrosis of femoral head mainly based on operative therapy.But, should not take the still quite a lot of operative treatment because operative treatment has certain indication.And the long-term effect of operation is not fully up to expectations, and the ischemic necrosis of femoral head that particularly young and middle-aged patient brings out because of the life-time service hormone is difficult to solve in treatment especially.The inventor recognizes in secular clinical practice, the generation of ischemic necrosis of femoral head, and it is designated as qi depression to blood stasis, and QI and blood is obstructed, and " stagnation of QI and blood may bring about pain " causes a series of symptoms, signs such as pain, limping, function of joint are limited, the change of femoral head X-ray; At this is deficiency of the liver and kindey.Therefore in treatment with nourishing liver and kidney, fill out the strong bone of marrow, promoting blood circulation and stopping pain is that the rule of treatment is seted forth one's views.Because primary disease has often been fallen ill for many years when going to a doctor, thus in treatment suitable treating both the principal and secondary aspects of a disease, both noted regulating the internal organs allomeric function and effected a permanent cure, look after the local disease of adjustment again and take stopgap measures, be good than the effect of the local promoting flow of QI and blood of simple attention, blood-activating analgetic.

Summary of the invention

The inventor is on the basis of research extensively and profoundly, the medicine that discovery is made by Rhizoma Drynariae, Sanguis Draxonis, Radix Dipsaci, Colla cornus cervi, Flos Carthami, Herba speranskiae tuberculatae, Olibanum, Myrrha, Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei has therapeutic activity to osteopathias such as osteonecrosis, fracture and osteoporosises, to curative effect the best of ischemic necrosis of femoral head.On the basis of this discovery, finished the present invention.

Definite, the invention provides:

1, Chinese medicine composition is made by Rhizoma Drynariae 200-400 weight portion, Sanguis Draxonis 24-48 weight portion, Radix Dipsaci 56-112 weight portion, Colla cornus cervi 48-96 weight portion, Flos Carthami 48-96 weight portion, Herba speranskiae tuberculatae 56-112 weight portion, Olibanum 24-48 weight portion, Myrrha 24-48 weight portion, Endothelium Corneum Gigeriae Galli 8-16 part, Rhizoma Acori Graminei 56-112 weight portion;

2, according to 1 Chinese medicine composition, make by Rhizoma Drynariae 300 weight portions, Sanguis Draxonis 36 weight portions, Radix Dipsaci 84 weight portions, Colla cornus cervi 72 weight portions, Flos Carthami 72 weight portions, Herba speranskiae tuberculatae 84 weight portions, Olibanum 36 weight portions, Myrrha 36 weight portions, 12 parts of Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei 84 weight portions;

3, according to 1 or 2 Chinese medicine composition, wherein Rhizoma Drynariae is a Rhizoma Drynariae (processed), and Olibanum is an Olibanum (processed with vinegar), and Myrrha is a Myrrha (processed with vinegar), and Endothelium Corneum Gigeriae Galli is an Endothelium Corneum Gigeriae Galli (parched), and Herba speranskiae tuberculatae is the iron wire Herba speranskiae tuberculatae;

4, as the preparation method of Chinese medicine composition as described in 1, Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder are broken into fine powder; Rhizoma Acori Graminei is extracted volatile oil with steam distillation, obtain volatile oil, water steaming liquid and medicinal residues; Decoct with water to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, Herba speranskiae tuberculatae, collecting decoction and above-mentioned water steam liquid, filter, and concentrate drying; Add above-mentioned fine powder, granulate, spray into above-mentioned volatile oil;

5, as the purposes of Chinese medicine composition in medication preparation as described in 1, this medicine is used for the treatment of osteonecrosis, fracture, osteoporosis; Function with promoting blood air circulation and building up bone, reinforcing the kidney to strengthen the bone, diffusing impediment and relieving pain;

6, according to 5 purposes, wherein said osteonecrosis is an ischemic necrosis of femoral head;

7, treatment osteonecrosis, fracture, osteoporotic medicine comprise Chinese medicine composition and pharmaceutically acceptable carrier according to 1 or 2;

8, according to 7 medicine, wherein said osteonecrosis is an ischemic necrosis of femoral head;

9, according to 7 or 8 medicine, it is pill, powder, granule, tablet, capsule, lozenge, unguentum, syrup, medicated wine, tincture, suppository.

Chinese medicine composition of the present invention has antiinflammatory, pain relieving, raising immunologic function, to yang deficiency syndrome due to the hormone antagonist with improve osteoporotic effect; Comprise Chinese medicine composition of the present invention and be used for the treatment of ischemic necrosis of femoral head clinically as the medicine of active component, obtained gratifying curative effect, the obvious effective rate of treatment ischemic necrosis of femoral head 203 examples is that 38.92% (matched group is 13.11%, down together), total effective rate is 83.25% (61.48%), X-radiological survey X acceptance rate is 23.15% (11.48%), and statistical analysis has significant difference (p＜0.01).The present invention also has therapeutic activity to osteopathias such as fracture, osteoporosises.

The specific embodiment

Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.

Embodiment 1: the preparation of tablet of the present invention

Get Rhizoma Drynariae (system) 300 grams, Sanguis Draxonis 36 grams, Radix Dipsaci 84 grams, Colla cornus cervi 72 grams, Flos Carthami 72 grams, iron wire Herba speranskiae tuberculatae 84 grams, Olibanum (vinegar system) 36 grams, Myrrha (vinegar system) 36 grams, 12 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 84 grams, Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder are broken into fine powder; Rhizoma Acori Graminei is extracted volatile oil with steam distillation, and the water after the distillation steams liquid device collection in addition; Decoct with water twice to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, iron wire Herba speranskiae tuberculatae, add 12 times of amounts of water at every turn and decocted 1.5 hours, merge decocting liquid and above-mentioned Rhizoma Acori Graminei water and steam liquid, filter, it is 1.05-1.10 that filtrate decompression is concentrated into relative density, and spray drying obtains dry powder; The fine powder and the appropriate amount of starch mixing that add five kinds of Chinese medicine such as above-mentioned Colla cornus cervi.The gained mixture is made granule, and dry below 80 ℃, put coldly, spray adds Rhizoma Acori Graminei volatile oil; Vexed 2 hours, get mixture A; Add a small amount of magnesium stearate, mixing, tabletting, coating, promptly.

Embodiment 2: the preparation of pill of the present invention

Get Rhizoma Drynariae (system) 200 grams, Sanguis Draxonis 24 grams, Radix Dipsaci 56 grams, Colla cornus cervi 48 grams, Flos Carthami 48 grams, Tuberculate Speranskia Herb 56 grams, Olibanum (vinegar system) 24 grams, Myrrha (vinegar system) 24 grams, 8 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 56 grams, Rhizoma Acori Graminei is extracted volatile oil with steam distillation, and the water after the distillation steams liquid device collection in addition; Decoct with water twice to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, iron wire Herba speranskiae tuberculatae, add 10 times of amounts of water at every turn and decocted 1.5 hours, merge decocting liquid and above-mentioned Rhizoma Acori Graminei water and steam liquid, filter, filtrate decompression is concentrated, mix with the fine powder that Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder are broken into again, dry below 80 ℃, put cold, spray adds Rhizoma Acori Graminei volatile oil, pulverizes, and sieves, add the Mel mixing, make pill, or, make pills such as the watered pill concentrated solution and fine powder and auxiliary materials and mixing.

Embodiment 3: the preparation of powder of the present invention

Get Rhizoma Drynariae (system) 400 grams, Sanguis Draxonis 48 grams, Radix Dipsaci 112 grams, Colla cornus cervi 96 grams, Flos Carthami 96 grams, Caulis Impatientis 112 grams, Olibanum (vinegar system) 48 grams, Myrrha (vinegar system) 48 grams, 16 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 112 grams, pulverize separately becomes fine powder, sieve (oral powder should sieve by 5-6 number), carry out mixing by the mixed method that shear, convection current, diffusion etc. combine, reach after dry, loose, mix homogeneously, the color and luster unanimity, divided dose, packing, promptly.

Embodiment 4: the preparation of granule of the present invention

Get Rhizoma Drynariae (system) 200 grams, Sanguis Draxonis 24 grams, Radix Dipsaci 56 grams, Colla cornus cervi 48 grams, Flos Carthami 48 grams, Tuberculate Speranskia Herb 56 grams, Olibanum (vinegar system) 24 grams, Myrrha (vinegar system) 24 grams, 8 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 56 grams, Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, iron wire Herba speranskiae tuberculatae are decocted with water twice, add 8 times of amounts of water decocted 1.5 hours at every turn, filter, it is standby that filtrate decompression is condensed into thick paste; Rhizoma Acori Graminei, Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder are broken into fine powder, with right amount of auxiliary materials mixings such as thick paste and Icing Sugar, make granule again, drying, granulate, packing, promptly.

Embodiment 5: the preparation of capsule of the present invention

Get Rhizoma Drynariae (system) 210 grams, Sanguis Draxonis 30 grams, Radix Dipsaci 62 grams, Colla cornus cervi 53 grams, Flos Carthami 52 grams, iron wire Herba speranskiae tuberculatae 56 grams, Olibanum (vinegar system) 24 grams, Myrrha (vinegar system) 24 grams, 12 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 56 grams, Rhizoma Acori Graminei is extracted volatile oil with steam distillation, and the water after the distillation steams liquid device collection in addition; Decoct with water twice to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, iron wire Herba speranskiae tuberculatae, add 10 times of amounts of water decocted 1.5 hours at every turn, merge decocting liquid and above-mentioned Rhizoma Acori Graminei water and steam liquid, filter, filtrate decompression is concentrated, the fine powder mixing that is broken into Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder again, dry, put coldly, spray adds Rhizoma Acori Graminei volatile oil; Fill, promptly.

Embodiment 6: the preparation of lozenge of the present invention

Get Rhizoma Drynariae (system) 200 grams, Sanguis Draxonis 48 grams, Radix Dipsaci 96 grams, Colla cornus cervi 67 grams, Flos Carthami 48 grams, Tuberculate Speranskia Herb 80 grams, Olibanum (vinegar system) 32 grams, Myrrha (vinegar system) 24 grams, 8 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 68 grams, above 10 flavor medical material pulverize separately are become fine powder, mixing, add an amount of glutinous rice flour and stick with paste, or Mel, kneading becomes agglomerate, molding, trimming, cloudy in after, promptly.

Embodiment 7: the preparation of unguentum of the present invention

Get Rhizoma Drynariae (system) 400 grams, Sanguis Draxonis 24 grams, Radix Dipsaci 56 grams, Colla cornus cervi 48 grams, Flos Carthami 48 grams, Caulis Impatientis 112 grams, Olibanum 24 grams, Myrrha (vinegar system) 24 grams, 16 parts of Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei 56 grams, Olibanum, Myrrha, Rhizoma Acori Graminei pulverize separately are become fine powder, Rhizoma Drynariae, Sanguis Draxonis, Radix Dipsaci, Colla cornus cervi, Flos Carthami, Caulis Impatientis, Endothelium Corneum Gigeriae Galli powder are broken into coarse powder, fried withered with edible vegetable oil 3000 grams with putting in the pot, remove slag, filter, refining is to dripping into pearl.Other gets Plumbum preparatium 900-1100 gram, adds in the oil, stirs evenly, and receives cream, and cream is soaked in the water; Get cream, with slow fire fusing, camphorate, Borneolum Syntheticum and above-mentioned stand-by fine powder, stir evenly, share on animal skin or cloth, promptly.

Embodiment 8: the preparation of syrup of the present invention

Get Rhizoma Drynariae 300 grams, Sanguis Draxonis 48 grams, Radix Dipsaci 112 grams, Colla cornus cervi 75 grams, Flos Carthami 82 grams, Tuberculate Speranskia Herb 56 grams, Olibanum (vinegar system) 24 grams, Myrrha 24 grams, 8 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 56 grams, Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder are broken into fine powder; Rhizoma Acori Graminei is extracted volatile oil with steam distillation, and the water after the distillation steams liquid device collection in addition; Decoct with water twice to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, iron wire Herba speranskiae tuberculatae, add 12 times of amounts of water decocted 1.5 hours at every turn, merge decocting liquid and above-mentioned Rhizoma Acori Graminei water and steam liquid, filter, it is 1.05-1.10 that filtrate decompression is concentrated into relative density, spray drying, obtain dry powder, the fine powder that adds five kinds of Chinese medicine such as above-mentioned Colla cornus cervi, mixing, stand-by; Get sucrose and add water boil, after the dissolving, filter, concentrate and make syrup, add the volatile oil of above-mentioned fine powder, Rhizoma Acori Graminei, mixing adds antiseptic and essence, promptly.

Embodiment 9: the preparation of medicated wine of the present invention

Get Rhizoma Drynariae (system) 340 grams, Sanguis Draxonis 36 grams, Radix Dipsaci 100 grams, Colla cornus cervi 96 grams, Flos Carthami 48 grams, Caulis Impatientis 56 grams, Olibanum (vinegar system) 24 grams, Myrrha (vinegar system) 24 grams, 8 parts of Endothelium Corneum Gigeriae Galli (stir-fry), Rhizoma Acori Graminei 112 grams, put in porcelain altar or other appropriate vessel, add the Chinese liquor of ormal weight, airtight dipping, get supernatant, the squeezing medicinal residues, expressed juice and clear liquid merge, add an amount of sugar or Mel, filtering is left standstill in sealing, fill, promptly.

Embodiment 10: the preparation of tincture of the present invention

Get Rhizoma Drynariae 200 grams, Sanguis Draxonis 24 grams, Radix Dipsaci 56 grams, Colla cornus cervi 48 grams, Flos Carthami 48 grams, iron wire Herba speranskiae tuberculatae 56 grams, Olibanum 32 grams, Myrrha 30 grams, 16 parts of Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei 56 grams, above 10 flavor pulverizing medicinal materials are become coarse powder, the ethanol 1500ml of adding 85% stirs evenly, flood after 24 hours, the ethanol of adding 85%, with the speed of per minute 1-3ml percolation slowly, collect the about 2200m1 of percolate just, device preservation in addition; Continue percolation, treat that the medical material color shoals, when abnormal smells from the patient is thin out, stops percolation.Reclaim ethanol, merge with the liquid of just filtering, and dilute with water, make the medical material effective ingredient all up to specification, leave standstill, after waiting to clarify, filter, promptly.

Embodiment 11: the preparation of suppository of the present invention

Get Rhizoma Drynariae (system) 200 grams, Sanguis Draxonis 24 grams, Radix Dipsaci 86 grams, Colla cornus cervi 58 grams, Flos Carthami 48 grams, iron wire Herba speranskiae tuberculatae 56 grams, Olibanum (vinegar system) 24 grams, Myrrha (vinegar system) 24 grams, 8 parts of Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei 56 grams, Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder are broken into fine powder; Rhizoma Acori Graminei is extracted volatile oil with steam distillation, and the water after the distillation steams liquid device collection in addition; Decoct with water twice to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, iron wire Herba speranskiae tuberculatae, add 8 times of amounts of water at every turn and decocted 1.5 hours, merge decocting liquid and above-mentioned Rhizoma Acori Graminei water and steam liquid, filter, filtrate decompression is become concentrated solution; After adding the fine powder mixing of five kinds of Chinese medicine such as above-mentioned Colla cornus cervi, add the volatile oil of Rhizoma Acori Graminei and glycerol mixing once more, the concentrated solution behind the mixing with an amount of lanoline absorption after, behind the greasing base mix homogeneously, put fusion in the water-bath, impouring scribbles in the bolt mould of remover, cooling is taken out, promptly.

Below set forth the effect of this Chinese medicine composition by test.

Experimental example 1: clinical experiment example

1, ischemic necrosis of femoral head diagnostic criteria: the hormone medicine of use or heavy drinking history are arranged; Gradually or suddenly the hip arthralgia occurs, painful area is common with inguinal region.Pain is obvious during walking, and walking lamely can appear in the later stage, and severe patient need be liied in bed; The pars inguinalis tenderness, the 4 words tests positive or the toma's sign positive, late period hip joint each side limitation of movement, even amyotrophy; The Medical Imaging prover is arranged, as X line and CT examination.

2, differential diagnosis in tcm standard: the stasis of blood of suffering from a deficiency of the kidney resistance card: hip pain, be ache, dull pain or twinge, body is tired weak, soreness of the waist and knees or limping, the joint joint stuffiness is met cold-damp and is increased the weight of, warm then disease is light, light red tongue is dark or ecchymosis is arranged, tongue is white, deep and weak pulse or heavy.

3, include standard in: meet above-mentioned diagnosis and dialectical standard person; Age is 18-65 year person; The femur head necrosis person who causes because of hormone, alcoholism.

4, experimental technique:

(1) lot random packet, controlled trial.

(2) treatment group: 200 examples, the inpatient accounts for more than 1/3.Take the tablet among the embodiment 1, each 12, every day 3 times.1 hour after meal warm water delivery service.

(3) matched group: 100 examples, the inpatient accounts for more than 1/3.Take " walk with vigorous strides to keep fit ball ", each 40, every day 3 times.1 hour after meal warm water delivery service.

(4) 6 months is a course of treatment.The course of treatment, end was followed up a case by regular visits to 6 months.

(5) tried patient in the course of treatment except that being aided with the functional exercise therapy, medicine and method that inactive other treatment should disease, and alcohol prohibition and hormone.

5, observation index:

(1) safety indexes: general physical examination (comprising the untoward reaction performance); Hematuria is just conventional; Electrocardiogram, liver function (ALT), renal function (BUNGr) account for 1/3 of case.

(2) health giving quality index: related symptoms and body card (traditional Chinese medical science sign comprises tongue fur, pulse condition); The judgement of pain relief onset time is the patient who improves with pain relief, by former pain symptom light, in, heavy, serious classification standard reduces time of one (+), is pain relief onset time; The positive bit slice 100% of X skiagram (checking once in per 3 months), the breast-stroke oblique film is no less than 50%.

6, curative effect determinate standard

(1) judges clinical efficacy according to clinical symptoms body card integrated integral

Carry out comprehensive and systematic inspection around the course of treatment, comprise overall health of patients, the integrated integral of clinical symptoms, body card, tongue arteries and veins, by produce effects, effective, invalid three grades of judgement clinical efficacies, standard is as follows:

Produce effects: hip joint function is clearly better, and total mark descends more than 40%, abduction, interior receipts, outward turning, inward turning, anteflexion, after stretch function more than 160 °, pain obviously alleviates, and recovers orthobiosis and work, idol has the ache sense.

Effectively: hip joint function recovers to some extent, and total mark descends 20～39%, abduction, interior receipts, outward turning, inward turning, anteflexion, after stretch function more than 130 °, pain relief can be competent at light work.

Invalid: the contrast of treatment before and after look, symptom, body are not just being seen variation person or are being increased the weight of to some extent.Total mark descends below 19%, and function is improved below 130 °.

(2) judge X line curative effect according to X ray examination curative effect integration

Treatment full half a year of person, with before treating and treat when checking later six months X-ray film relatively, observe X line curative effect from following three aspects: the sequestrum situation of change; The area of new bone growing state; Cryptomere district situation of change.

X line observation of curative effect score standard

Score value

Sequestrum dwindles

The cryptomere district diminishes

The area of new bone growth

0	＞1/2	＞1/2	Increase
				2	＜1/2	＜1/2	Occur
4	Nothing is dwindled	No change	Do not have

Annotating 1:X line efficacy determination keeps the score: excellent 0～2 minute; Good 4～6 minutes; Can 8～10 minutes; Differ from more than 10 minutes.

Annotate 2: a plurality of cryptomeres district, a plurality of sequestrum are all with its area of calculating of maximum.

7, result of the test

(1) clinical efficacy situation:

Group	n	Produce effects (%)	Effectively (%)	Invalid (%)	Total effective rate (%)	R
							The treatment group	203	79(38.92)	90(44.33)	34(16.75)	83.25	0.431
Matched group	122	13(10.66)	62(50.82)	47(38.52)	61.84	0.615

Two groups of clinical efficacies are compared, and Ridit analyzes, U=5.750, and P＜0.01, difference has highly significant, and clinical efficacy treatment group is better than matched group.

(2) pain is improved situation

Group	n	Disappear (%)	Alleviate (%)	Do not alleviate (%)	Increase the weight of (%)	R
							The treatment group	203	14(6.90)	165(81.28)	23(11.33)	1(0.49)	0.438
Matched group	122	4(3.28)	65(53.28)	47(38.52)	6(4.92)	0.603

Two groups of pain improvement are compared, and Ridit analyzes, U=5.156, and P＜0.01, difference has highly significant, and pain is improved the treatment group and is better than matched group.

(3) function is improved situation

Group	n	Normally (%)	Take a turn for the better (%)	Do not take a turn for the better (%)	Increase the weight of (%)	R
							The treatment group	200	12(6.00)	170(85.00)	15(7.50)	3(1.50)	0.440
Matched group	122	2(1.64)	73(59.84)	37(30.33)	10(8.20)	0.599

(4) limping improvement situation

Group

n

Disappear (%)

Take a turn for the better (%)

Do not take a turn for the better (%)

Increase the weight of (%)

R

The treatment group	201	33(16.42)	98(48.76)	66(32.84)	4(1.99)	0.449
							Matched group	121	6(4.96)	46(38.02)	60(49.59)	9(7.44)	0.586

Walk lamely to improve for two groups and compare, Ridit analyzes, U=4.281, and P＜0.01, difference has highly significant, and limping improves the treatment group and is better than matched group.

(5) tcm symptom improves situation

Group	n	Fatigue and weak	Soreness of the waist and knees	The chance cold rnning is heavy	Light red tongue is dark or have ecchymosis, tongue white	Deep and weak pulse or heavy
								Before the treatment	182	177	191	170	164
After the treatment	36	33	52	35	29
						Improvement rate %		80.22	81.36	72.77	79.41	82.32
	Before the treatment	110	105	115	105								107
						After the treatment	48	48	53	37	38
	Improvement rate %	56.36	54.29	53.91	64.76							64.49
							X 2	19.04	23.06	11.33	7.21		11.06
	P	＜0.01	＜0.01	＜0.01	＜0.01							＜0.01

Two groups of tcm symptoms, tongue arteries and veins improve to be compared, and difference has significance, fatigue and weak especially, and soreness of the waist and knees, the improvement of meeting cold rnning heavy prescription face is more remarkable, and the treatment group is better than matched group.

(6) X ray examination curative effect situation

Group	n	Excellent (%)	Very (%)	Can (%)	Difference (%)	Acceptance rate (%)	R
								The treatment group	203	18(8.87)	29(14.29)	111 (54.68)	45(22.17)	23.15	0.444
Matched group	122	2(1.64)	12(9.84)	49(40.16)	59(48.36)	11.48	0.593

Two groups of X ray examination curative effects are compared, and Ridit analyzes, U=4.656, and P＜0.01, difference has highly significant, and X ray examination curative effect treatment group is better than matched group.

(7) the treatment group cause of disease is to the curative effects situation

The cause of disease	n	Produce effects (%)	Effectively (%)	Invalid (%)	Total effective rate (%)	R
							Hormone	93	39(41.94)	42(45.16)	12(12.90)	87.10	0.476
Ethanol	71	28(39.44)	31(43.66)	12(16.90)	83.10	0.498
							Hormone+ethanol	39	12(30.77)	17(43.59)	10(25.64)	74.36	0.561

Ridit analyzes, X2K-1=2.388, and P＞0.05, difference does not have significance, and curative effect is similar between the different causes of disease.

(8) situation (treatment group) is investigated in safety

Project	Before the treatment		After the treatment
						Normal n	Unusual n	Normal n	Unusual n
Routine blood test	203	0	203	0
					Routine urinalysis	203	0	203	0
Just conventional	203	0	203	0
					Liver function (ALT)	170	0	170	0
Renal function (BUN Gr)	170	0	170	0
					Electrocardiogram	170	0	170	0

Claims (10)

1, a kind of Chinese medicine composition, made by following raw materials according: Rhizoma Drynariae 200-400 weight portion, Sanguis Draxonis 24-48 weight portion, Radix Dipsaci 56-112 weight portion, Colla cornus cervi 48-96 weight portion, Flos Carthami 48-96 weight portion, Herba speranskiae tuberculatae 56-112 weight portion, Olibanum 24-48 weight portion, Myrrha 24-48 weight portion, Endothelium Corneum Gigeriae Galli 8-16 part, Rhizoma Acori Graminei 56-112 weight portion are made.

2, Chinese medicine composition as claimed in claim 1 is made by Rhizoma Drynariae 300 weight portions, Sanguis Draxonis 36 weight portions, Radix Dipsaci 84 weight portions, Colla cornus cervi 72 weight portions, Flos Carthami 72 weight portions, Herba speranskiae tuberculatae 84 weight portions, Olibanum 36 weight portions, Myrrha 36 weight portions, 12 parts of Endothelium Corneum Gigeriae Galli, Rhizoma Acori Graminei 84 weight portions.

According to the Chinese medicine composition of claim 1 or 2, it is characterized in that 3, described Rhizoma Drynariae is a Rhizoma Drynariae (processed), Olibanum is an Olibanum (processed with vinegar), and Myrrha is a Myrrha (processed with vinegar), and Endothelium Corneum Gigeriae Galli is an Endothelium Corneum Gigeriae Galli (parched), and Herba speranskiae tuberculatae is the iron wire Herba speranskiae tuberculatae.

4, the preparation method of Chinese medicine composition as claimed in claim 1 is broken into fine powder with Colla cornus cervi, Olibanum, Myrrha, Sanguis Draxonis, Endothelium Corneum Gigeriae Galli powder; Rhizoma Acori Graminei is extracted volatile oil with steam distillation, obtain volatile oil, water steaming liquid and medicinal residues; Decoct with water to medicinal residues and Rhizoma Drynariae, Radix Dipsaci, Flos Carthami, Herba speranskiae tuberculatae, collecting decoction and above-mentioned water steam liquid, filter, and concentrate drying; Add above-mentioned fine powder, granulate, spray into above-mentioned volatile oil, add right amount of auxiliary materials or do not add adjuvant, make required dosage form.

5, the purposes of Chinese medicine composition in medication preparation according to claim 1, this medicine is used for the treatment of osteonecrosis, fracture, osteoporosis.

6, according to the purposes of claim 5, wherein said osteonecrosis is an ischemic necrosis of femoral head.

7, the purposes of Chinese medicine composition in medication preparation according to claim 1, this medicine has the function of promoting blood air circulation and building up bone, reinforcing the kidney to strengthen the bone, diffusing impediment and relieving pain; Be used for the ischemic necrosis of femoral head stasis-eliminating disease of suffering from a deficiency of the kidney, disease is seen hip pain, and the hip joint activity is unfavorable, soreness of the waist and knees or limping.

8, treatment osteonecrosis, fracture, osteoporotic medicine comprise Chinese medicine composition and pharmaceutically acceptable carrier according to claim 1.

9, according to the medicine of claim 7, wherein said osteonecrosis is an ischemic necrosis of femoral head.

10, according to the medicine of claim 7 or 8, it is tablet, capsule, powder, granule, pill, lozenge, unguentum, syrup, medicated wine, tincture, suppository.