CN104857440A - Traditional Chinese medicine for treating kidney deficiency and blood stasis type medium and advanced osteonecrosis of femoral head and preparation method of the traditional Chinese medicine - Google Patents

Abstract

The invention belongs to the technical field of medicines and particularly relates to a traditional Chinese medicine for treating kidney deficiency and blood stasis type medium and advanced osteonecrosis of the femoral head. The traditional Chinese medicine is prepared from traditional Chinese medicine raw materials in parts by weight as follows: 4-8 parts of deer-horn glue, 6-14 parts of epimedium herb, 6-14 parts of eucommia bark, 6-14 parts of himalayan teasel roots, 2-4 parts of pseudo-ginseng, 8-16 parts of danshen roots, 4-8 parts of peach seeds, 2-5 parts of safflower, 4-8 parts of twotooth achyranthes roots, 4-8 parts of corydalis tuber, 4-8 parts of turmeric, 4-8 parts of frankincense, 4-8 parts of myrrh, 4-8 parts of common clubmoss herb, 6-14 parts of fortune's drynaria rhizome, 4-8 parts of common burreed rhizome, 2-4 parts of leech, 4-8 parts of pangolin scales and 4-8 parts of liquorice. The traditional Chinese medicine is used for treating kidney deficiency and blood stasis type medium and advanced osteonecrosis of the femoral head and has the advantages of high significant efficiency and short treatment cycle.

Description

A kind ofly treat Chinese medicine of kidney deficiency blood stasis type middle and advanced stage femur head necrosis and preparation method thereof

Technical field

The invention belongs to medical art, be specifically related to a kind of Chinese medicine for the treatment of kidney deficiency blood stasis type middle and advanced stage femur head necrosis.

Background technology

Femur head necrosis (Osteonecrosis of the Femora Head, ONFH) be due to femoral head blood vessel supply discontinuity or impaired, cause the death of osteocyte and bone marrow fraction and the reparation in later stage, cause femoral head structural change further, osseous tissue subsides, and then cause femoral head bone to destroy, pain around hip joint, function of joint go down or the symptom such as forfeiture, are a kind of common refractory diseases.In the last few years, due to hormone abuse class medicine, drink, the reason such as wound, sickness rate in ascendant trend year by year, the number of the infected of China oneself reach more than 700 ten thousand people, annual new cases is also more than 10,000.

Femur head necrosis is a kind of global refractory disease, be apt to occur in the young and the middle aged, be mainly in 20 ~ 60 years old, male is more than women, and state of an illness Progressive symmetric erythrokeratodermia increases the weight of, major part in patient all while there is the hip arthralgia, little by little lose joint motion and walking function, thus lose work and viability, cause life-long disabilities, patient more than half involves bilateral joint, and disability rate is high.When not carrying out effective prevention, in 1 ~ 4 year, 80% conditions of patients there will be Progressive symmetric erythrokeratodermia and increases the weight of, and normal heavy burden can make collapse of the femoral head be out of shape, and causes arthralgia, dysfunction, has a strong impact on quality of life, final disability.Patient mostly final because of collapse of the femoral head, function of joint lose and the artificial joint replacement surgery of Bian of having to is treated, the problem such as there is fixing service life because of artificial joint replacement and complication is more, in addition still unpredictability is strong for the long-term efficacy that joint replacement is postoperative, patient required day by day to improve to quality of life and activity, make this treatment can not meet the demand of patient, therefore retain capital treatment means very necessary.

Conservative treatment: expectant treatment comprises hyperbaric oxygentherapy, strict bed rest, treatment by Chinese herbs, various naturopathy etc., hyperbaric oxygentherapy, strict bed rest, various naturopathy all can only relief of symptoms, fundamentally can not treat femur head necrosis, especially the femur head necrosis of middle and advanced stage.Clinical investigation finds, middle and advanced stage ONFH differential diagnosis in tcm is main for " blood stasis due to renal deficiency ", and treatment is worked as with the kidney invigorating bone strengthening, and blood circulation promoting and blood stasis dispelling, therefore needs to treat with Chinese medicine more.

At present, there is not yet the Chinese medicine being exclusively used in kidney deficiency blood stasis type middle and advanced stage femur head necrosis to come out.

Summary of the invention

Technical problem to be solved by this invention avoids the weak point existing for above-mentioned prior art, provides a kind of Chinese medicine for the treatment of kidney deficiency blood stasis type middle and advanced stage femur head necrosis, and this Chinese medicine has the advantage that cure rate is high, the healing cycle is short.

Another technical problem dosage form being to provide this Chinese medicine composition to be solved by this invention and preparation method thereof.

The present invention is achieved through the following technical solutions:

Treat a Chinese medicine for kidney deficiency blood stasis type middle and advanced stage femur head necrosis, be made up of the raw material of Chinese medicine medicine of following weight portion:

Prescription: Colla cornus cervi 4-8 part, Herba Epimedii 6-14 part, Cortex Eucommiae 6-14 part, Radix Dipsaci 6-14 part, Radix Notoginseng 2-4 part, Radix Salviae Miltiorrhizae 8-16 part, Semen Persicae 4-8 part, Flos Carthami 2-4 part, Radix Achyranthis Bidentatae 4-8 part, Rhizoma Corydalis 4-8 part, Rhizoma Curcumae Longae 4-8 part, Olibanum 4-8 part, Myrrha 4-8 part, Herba Lycopodii 4-8 part, Rhizoma Drynariae 6-14 part, Rhizoma Sparganii 4-8 part, Hirudo 2-4 part, Squama Manis 4-8 part, Radix Glycyrrhizae 4-8 part.

Preferably, the Chinese medicine of above-mentioned treatment kidney deficiency blood stasis type middle and advanced stage femur head necrosis, be made up of the raw material of Chinese medicine medicine of following weight portion:

Colla cornus cervi 5-7 part, Herba Epimedii 8-12 part, Cortex Eucommiae 8-12 part, Radix Dipsaci 8-12 part, Radix Notoginseng 2.5-3.5 part, Radix Salviae Miltiorrhizae 10-14 part, Semen Persicae 5-7 part, Flos Carthami 2.5-3.5 part, Radix Achyranthis Bidentatae 5-7 part, Rhizoma Corydalis 5-7 part, Rhizoma Curcumae Longae 5-7 part, Olibanum 5-7 part, Myrrha 5-7 part, Herba Lycopodii 5-7 part, Rhizoma Drynariae 8-12 part, Rhizoma Sparganii 5-7 part, Hirudo 2.5-3.5 part, Squama Manis 5-7 part, Radix Glycyrrhizae 5-7 part.

Preferred, the Chinese medicine of above-mentioned treatment kidney deficiency blood stasis type middle and advanced stage femur head necrosis, be made up of the raw material of Chinese medicine medicine of following weight portion:

Colla cornus cervi 6 parts, Herba Epimedii 10 parts, the Cortex Eucommiae 10 parts, Radix Dipsaci 10 parts, Radix Notoginseng 3 parts, Radix Salviae Miltiorrhizae 12 parts, 6 parts, Semen Persicae, 3 parts, Flos Carthami, Radix Achyranthis Bidentatae 6 parts, Rhizoma Corydalis 6 parts, 6 parts, Rhizoma Curcumae Longae, Olibanum 6 parts, Myrrha 6 parts, Herba Lycopodii 6 parts, Rhizoma Drynariae l0 part, Rhizoma Sparganii 6 parts, Hirudo 3 parts, Squama Manis 6 parts, 6 parts, Radix Glycyrrhizae.

The ratio of above weight proportion is through that science screening obtains, and for especial patient, as serious symptom or mild, fat or modest patient, can the proportioning of amount of corresponding adjustment composition, and increase or reduce being no more than 100%, drug effect is substantially constant.

The preparation method of the Chinese medicine of above-mentioned treatment kidney deficiency blood stasis type middle and advanced stage femur head necrosis, comprises the steps:

(1) to be broken into fine powder for subsequent use for Radix Notoginseng powder;

(2) Herba Epimedii, the Cortex Eucommiae, Radix Dipsaci, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Rhizoma Corydalis, Rhizoma Curcumae Longae, Olibanum, Myrrha, Herba Lycopodii, Rhizoma Drynariae, Rhizoma Sparganii, Squama Manis part, Radix Glycyrrhizae is got, decoct twice, add the water of medical material volume 5 times amount for the first time, decoct 1.5 hours, filter, add the water of medical material volume 3 times amount for the first time, decoct 1 hour, filter, merge the filtrate of twice, be concentrated into 200-1000ml;

(3) Colla cornus cervi molten;

(4) before taking, the Colla cornus cervi that molten is good is blended in the medicine juice of step (2) gained, together with the Radix Notoginseng fine powder of step (1), takes together.

The weight portion of said medicine, if in units of g, the normally consumption of 1 dose.

The indication of Chinese medicine of the present invention: middle and advanced stage femur head necrosis (kidney deficiency blood stasis type): hipbone pain, becoming severe at night, joint stuffiness, soreness of the waist and knees, complexion is dim or in vain light, deep,thready and forceless pulse, deep-thready pulse or heavy.

The side's of use consumption of Chinese medicine of the present invention: be decocted in water for oral dose, day 1 dose, 1 month was 1 course for the treatment of, took 4 months altogether.

The taboo item of Chinese medicine of the present invention: the fasting for the treatment of period in a medicine is greasy, raw and cold, the smelling of fish or mutton, irritant and stodgy food.

In the Chinese medicine for the treatment of kidney deficiency blood stasis type middle and advanced stage femur head necrosis of the present invention:

Cornu Cervi Pantotrichum: nature and flavor: sweet, salty, warm.Return Liver and kidney warp, effect: invigorating kidney-YANG, benefiting essence-blood, bone and muscle strengthening.Li Shizhen (1518-1593 A.D.) claim in Compendium of Material Medica its " be good at kidney invigorating and YANG supporting, spermatogenesis benefit blood, mend marrow be good for bone ".Record in " Japan hanako materia medica ": " tonify deficiency is thin, strengthening bone and muscle ".

Herba Epimedii: nature and flavor: pungent, sweet, warm.Return liver, kidney channel.Function cures mainly: kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.For impotence and seminal emission, muscles and bones flaccidity is soft, rheumatic arthralgia, numbness contracture; Climacteric hypertension." Elementary Medicine ": " the kidney invigorating is empty, supporing yang." " not Lu ": " hard muscles and bones.Disappear scrofula, red carbuncle.”

The Cortex Eucommiae: nature and flavor: sweet, temperature.Return liver, kidney channel.Function cures mainly: invigorating the liver and kidney, and bone and muscle strengthening is antiabortive.For lumbago due to renal deficiency, muscles and bones is unable, blood leaking in gestation, frequent fetal movement; Hypertension." herbal classic ": " main pain along the spinal column, invigorating middle warmer benefit vital essence, hard muscles and bones, Qiang Zhi, wet except itching under the moon, dribbling urination." " beautiful Chinese catalpa medicine solution ": " liver and kidney tonifying, nourishing muscle and tendon bone go to joint to wet excessive.Control soreness of waist and knee joint, the contracture of lower limb foot." 8. book on Chinese herbal medicine is new again ": " fill biceps, Yang path strenghtening.”

Radix Dipsaci: nature and flavor: bitter, pungent, tepor.Return liver, kidney channel.Function cures mainly: invigorating the liver and kidney, bone and muscle strengthening, continuous injured, only metrorrhagia.For soreness of the waist and knees, rheumatic arthralgia, metrorrhagia, vaginal bleeding during pregnancy, injury from falling down.Prepared RADIX DIPSACI with yellow rice wine is used for rheumatic arthralgia, injury from falling down.Prepared RADIX DIPSACI with salt solution is used for soreness of the waist and knees." herbal classic ": " incised wound, carbuncle and ulcer, folding falls, reuniting the fractured tendons and bones, and married woman's breast is difficult, takes physical strength profiting for a long time for main typhoid fever, tonifying for the deficiency." " the southern regions of the Yunnan Province book on Chinese herbal medicine ": " and meridians are walked in tonifying liver, bone and muscle strengthening, only through in (muscles and bones) ache, antiabortive, control married woman leucorrhea, tissue regeneration promoting blood, removing blood stasis with potent drugs blood, fall dead a word used in place name, and cough-relieving is coughed hemoptysis, controls red white turbid urine.”

Radix Notoginseng: nature and flavor: sweet, micro-hardship, temperature.Return liver, stomach warp.Function cures mainly: dissipating blood stasis stops blooding, subduing swelling and relieving pain.For spitting of blood, spit blood, epistaxis, has blood in stool, metrorrhagia, traumatic hemorrhage, and breast abdomen twinges, tumbling and swelling." detailed outline ": " hemostasis, loose blood, analgesic therapy.Gold sword arrow wound, fall and flutter flogging injury, blood goes out more than person, chews rotten painting, or for mixing it in end, namely its blood stop.Also main haematemesis, epistaxis, hematochezia, dysentery, metrorrhagia, incessant menorrhea, puerperal stagnant blood not under, blood transport, blood pain, Akamu, carbuncle, tiger stings, all diseases of snakebite." " jade seizes medicine solution ": " and with battalion's hemostasis, clots absorbing of promoting blood circulation, clots absorbing blood and hold back fresh blood.All puerperal, menstrual period, traumatic injury, carbuncle, all blood stasis are all broken; Allly tell nosebleed, metrorrhagia, knife injury, arrow penetrate, all fresh blood all stop.”

Radix Salviae Miltiorrhizae: nature and flavor: bitter, be slightly cold.GUIXIN, pericardium, Liver Channel.Function cures mainly: stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, and clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris." choosing of Yunnan Chinese herbal medicine ": " promoting blood circulation to remove blood stasis, sedation-analgesia.Control menoxenia, dysmenorrhea, rheumatic arthralgia, metrorrhagia, spit blood, mastitis, carbuncle." " detailed outline ": " and invigorate blood circulation, logical percardium.Control colic.”

Semen Persicae: nature and flavor: bitter, sweet, flat.GUIXIN, liver, large intestine channel.Function cures mainly: blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation.For amenorrhea, dysmenorrhea ， WEIJIA mass in the abdomen, injury from falling down, dryness of the intestine constipation." herbal classic ": " main blood stasis, blood closes lump in the abdomen, pathogen, kills small worm." " detailed outline ": " and main stasis migratory arthralgia, hectic fever due to YIN-deficiency, liver-malaria cold and heat, puerperal disorders of blood.”

Flos Carthami: nature and flavor: pungent, temperature.GUIXIN, Liver Channel.Function cures mainly: promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.For amenorrhea, dysmenorrhea, lochia, lump in the abdomen mass in the abdomen, injury from falling down, skin infection swells and ache." detailed outline ": " invigorate blood circulation, moisturize, pain relieving, loose swollen, stimulate the menstrual flow.”

Radix Achyranthis Bidentatae: nature and flavor: bitter, sweet, sour, flat.Return liver, kidney channel.Function cures mainly: invigorating the liver and kidney, bone and muscle strengthening, eliminating blood stasis and inducing menstruation, conducting blood to flow downwards.For soreness of waist and knee joint, muscles and bones is unable, amenorrhea lump in the abdomen, dizziness due to hyperactivity of liver-YANG." herbal classic ": " gonalgia can not be bent for main cold-damp flaccidity syndrome and arthralgia syndrome, spasm of the limbs, and by vim and vigour, fire of getting mildewed in warm conditions is rotten, induced abortion." " the southern regions of the Yunnan Province book on Chinese herbal medicine ": " only muscles and bones pain, strong muscle relaxing muscles and tendons, only waist knee joint is tingle, and removing blood stasis with potent drugs is had an abortion, and eliminating stagnation core, attacks scrofula, moves back carbuncle, mange, blood wind, psoriasis, pus nest." essentials of Matea Medica: " wine steams then liver and kidney tonifying, bone and muscle strengthening, controls waist kneecap pain, flaccidity of the lower limbs clonic spasm of the muscle, and impotence is lost and drowned, chronic malaria, dysentery, damaging the spleen and stomach weak breath, and the raw then dispelling malignant blood ， Po Disorder that uses ties, and control all pains of trusted subordinate, drench pain hematuria, amenorrhea is had difficult labour, sore throat toothache, carbuncle malignant boil.”

Rhizoma Corydalis: nature and flavor: pungent, bitter, temperature.Return liver, spleen channel.Function cures mainly: invigorate blood circulation, promoting the circulation of QI, pain relieving.For the breast side of body, epigastric pain, amenorrhea dysmenorrhea, postpartum stagnation, tumbling and swelling." detailed outline ": " invigorate blood circulation, promoting the circulation of QI, pain relieving, diuresis." " Japan hanako materia medica ": " except wind, control gas, warm waist knee joint, broken disease addiction, flutter damage blood stasis, fall tire, and sudden and violent lumbago.”

Rhizoma Curcumae Longae: nature and flavor: pungent, bitter, temperature.Return spleen, Liver Channel.Function cures mainly: removing blood stasis circulation of qi promoting, inducing menstruation to relieve menalgia.Twinge for the breast side of body, amenorrhea ， WEIJIA, rheumatism shoulder arm pain, tumbling and swelling." Japan hanako materia medica ": " control lump in the abdomen clot, carbuncle, logical menstruation, controls to fall and flutter blood stasis, detumescence poison; Only storm wind pain cold air, lower food." " medical center bun is wanted ": " control the anemofrigid-damp arthralgia of extremity."

Olibanum: nature and flavor: pungent, bitter, temperature.Return liver, the heart, spleen channel.Function cures mainly: promoting blood circulation and stopping pain.For all pains of trusted subordinate, the contracture of muscle arteries and veins, traumatic injury, sore, carbuncle and painful swelling; Externally used detumescence granulation promoting." pearl sac ": " fixed all warps pain." " detailed outline ": " all poison of eliminating carbuncle cellulitis, the heart is protected in Tuoli, and analgesic therapy of invigorating blood circulation, stretches muscle, controls married woman's difficult labour, injured.”

Myrrha: nature and flavor: bitter is flat.Return liver, the heart, spleen channel.Function cures mainly: eliminating stasis to stop pain, externally used detumescence granulation promoting.Swell and ache for traumatic injury congestion, ulcer sore pain, all pains of breast abdomen; External is controlled the open sore part and is not restrained for a long time." property of medicine opinion ": " Zhu is Daed E and damaged, and trusted subordinate's blood stasis, Shang Zhe Wei falls, muscles and bones stasis of blood pain, and golden sword damaged, unbearably painful, all with wine throwing drink." " book on Chinese herbal medicine is stated ": " take relaxing muscles and tendons film for a long time, promoting blood circulation, teeth consolidating tooth, long beard and hair.”

Herba Lycopodii: nature and flavor: micro-hardship, pungent, temperature.Return liver,spleen,kidney warp.Function cures mainly: expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral.For joint aches, joint stuffiness." the SHENGCAO property of medicine is standby to be wanted ": " detumescence, except rheumatism.Infusing drugs in wine is drunk, relaxing muscles and tendons and activating QI and blood in the collateral.It effects a radical cure depressed pain, and damage, internal injury caused by metallic tool, removes phlegm and relieving cough." " Zhejiang conventional medical herbs among the people ": " relaxing muscles and tendons, antiinflammatory.Control joint aches, herpes zoster.”

Rhizoma Drynariae: nature and flavor: bitter, temperature.Return kidney, Liver Channel.Function cures mainly: the kidney invigorating bone strengthening, continues and hinders pain relieving.For lumbago due to renal deficiency, Hiccough and deaf, odontoseisis, falling winks frustrates, injured bone; External treatment alopecia areata, vitiligo." Kaibao Bencao ": " main removing blood stasis, hemostasis, benefit is traumaticd fracture." " book on Chinese herbal medicine is just ": " treat bone to be possessed poison, wind heat pain, or diseases caused by exogenous pathogenic factor rheumatism, so that the weak pain of two flaccidity of the lower limbs.”

Rhizoma Sparganii: nature and flavor: pungent, bitter is flat.Return liver, spleen channel.Function cures mainly: removing blood stasis circulation of qi promoting, removing food stagnancy pain relieving.For lump in the abdomen mass in the abdomen, blood stasis amenorrhea, food stagnation distending pain." Japan hanako materia medica ": " control married woman's blood vessels uncomfortable, cardiac and abdominal pain, fall tire, and disappear stagnant blood, mends labor, and logical menstruation, controls flatulence, disappear and flutter damage blood stasis, puerperal abdonimal pain, blood fortune stagnated blood not under.”

Hirudo: nature and flavor: salty, bitter, flat; Slightly poisonous.Return Liver Channel.Function cures mainly: removing blood stasis, and removing blood stasis stimulates the menstrual flow.For lump in the abdomen mass in the abdomen, blood stasis amenorrhea, injury from falling down." herbal classic ": " master closed by stagnant blood, blood stasis, the moon, and removing blood stasis abdominal mass is gathered, loss of fecundity, dredging water passages." amplification on Canon of Materia Medica: " cure the wound folding.”

Squama Manis: nature and flavor: salty, is slightly cold.Return liver, stomach warp.Function cures mainly: stimulating milk secretion of stimulating the menstrual flow, detumescence and apocenosis, expel wind to dredge collateral.For Jing Bi WEIJIA, galactostasis, carbuncle sore tumefacting virus, arthralgia, numbness contracture." the southern regions of the Yunnan Province book on Chinese herbal medicine ": " control mange carbuncle poison, dispelling the stagnated QI promoting the circulation of blood, chest and diaphragm expands against gas, controls bladder hernia pain." " detailed outline ": " and except intermittent fever due to phlegm cold and heat, the tetanic pain of migratory arthralgia, qualcomm meridian, lower milk, subduing inflammation, evacuation of pus blood, sensible parasite killing.”

Radix Glycyrrhizae: nature and flavor: sweet, flat.GUIXIN, lung, spleen, stomach warp.Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.

The medicament composing prescription mechanism of the Chinese medicine for the treatment of kidney deficiency blood stasis type middle and advanced stage femur head necrosis of the present invention is as follows:

Monarch drug: Cornu Cervi Pantotrichum, Herba Epimedii, warm in nature, sweet in the mouth, enter Liver and kidney warp, gets its invigorating the liver and kidney, benefiting essence-blood, effect of bone and muscle strengthening.

Ministerial drug: Radix Notoginseng, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Rhizoma Curcumae Longae, Rhizoma Corydalis, Olibanum, Myrrha, Herba Lycopodii, wherein Radix Notoginseng, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami merit are stimulated the menstrual flow with blood circulation promoting and blood stasis dispelling, Radix Achyranthis Bidentatae has effect of invigorating the liver and kidney, bone and muscle strengthening concurrently, and energy priming is descending, through sick institute; Rhizoma Curcumae Longae, Rhizoma Corydalis, Olibanum, Myrrha, Herba Lycopodii have effect of promoting the circulation of QI to relieve pain and relaxing muscles and tendons and activating QI and blood in the collateral; Each medicine share gas clots absorbing and dispels, blood vessels tonneau, and bone is foster to some extent, and general rule is not bitterly, can alleviate the pain symptom of middle and advanced stage femoral head patient, and energy relaxing muscles and tendons and activating QI and blood in the collateral, make the joint capsule of nervous contracture, fascia and muscle etc. be able to diastole and stretch, thus improve function of joint.

Adjuvant drug: the Cortex Eucommiae, Radix Dipsaci, Rhizoma Drynariae are warm in nature, return Liver and kidney warp, the invigorating the liver and kidney of assistant monarch drug, bone and muscle strengthening; With the passing of time, the stagnant stubbornness of the stasis of blood in blood, Rhizoma Sparganii, Hirudo, Squama Manis, salty in the mouth, hardship, return Liver Channel to the delay of the middle and advanced stage femur head necrosis course of disease, the main blood of liver, and it is stagnant that three medicines share the stasis of blood in removing blood stasis, enhances effect of ministerial drug blood circulation promoting and blood stasis dispelling.

Make medicine: Radix Glycyrrhizae, consonance cold and heat, Heibei provincial opera lifting, coordinating the actions of various ingredients in a prescription, plays the effect of mediation.

Middle and advanced stage femur head necrosis differential diagnosis in tcm is main with " caused by liver and kidney deficiency, qi depression to blood stasis "; Suffer from a deficiency of the kidney and can not main bone, marrow is become homeless foster, deficiency of the liver and can not store blood, and battalion defends imbalance, QI and blood can not warm, moisten nourishing muscle and tendon bone; Caused by liver and kidney deficiency and gas is capable ineffective, the stagnation of QI then hematogenous blockage, blood stasis also can cause that gas is capable to be obstructed, and battalion defends imbalance, closes and obstructed, and bone is become homeless foster, and sends out as primary disease.Treatment is worked as with liver and kidney tonifying, strengthening the tendons and bones, promoting flow of QI and blood blood stasis dispelling.In we, Cornu Cervi Pantotrichum, Herba Epimedii, the Cortex Eucommiae, Rhizoma Drynariae, Radix Dipsaci merit are with invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening, make marrow foster to some extent, enjoy excellent health; Radix Notoginseng, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Rhizoma Curcumae Longae, Rhizoma Corydalis, Olibanum, Myrrha, Herba Lycopodii merit are with promoting flow of QI and blood blood stasis dispelling, relaxing muscles and tendons and activating QI and blood in the collateral pain relieving, be equipped with the obstinate stasis of blood in Rhizoma Sparganii, Hirudo, Squama Manis removing blood stasis stagnant, make blood vessels tonneau, muscles and bones is foster to some extent, and the muscle that withers is unfolded; And with Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, all medicine compatibilities are reasonable, and the pathogenesis of middle and advanced stage femur head necrosis " blood stasis due to renal deficiency " that link closely, therefore achieves good clinical efficacy.。

Detailed description of the invention

Below in conjunction with specific embodiment, the present invention is further described, so that those skilled in the art more understands the present invention, but does not therefore limit the present invention.

Embodiment 1

Prescription: Colla cornus cervi 6g, Herba Epimedii 10g, Cortex Eucommiae 10g, Radix Dipsaci 10g, Radix Notoginseng 3g, Radix Salviae Miltiorrhizae 12g, Semen Persicae 6g, Flos Carthami 3g, Radix Achyranthis Bidentatae 6g, Rhizoma Corydalis 6g, Rhizoma Curcumae Longae 6g, Olibanum 6g, Myrrha 6g, Herba Lycopodii 6g, Rhizoma Drynariae l0g, Rhizoma Sparganii 6g, Hirudo 3g, Squama Manis 6g, Radix Glycyrrhizae 6g.

Preparation method:

(1) to be broken into fine powder for subsequent use for Radix Notoginseng powder;

(2) Herba Epimedii, the Cortex Eucommiae, Radix Dipsaci, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Rhizoma Corydalis, Rhizoma Curcumae Longae, Olibanum, Myrrha, Herba Lycopodii, Rhizoma Drynariae, Rhizoma Sparganii, Squama Manis part, Radix Glycyrrhizae is got, decoct twice, add the water of medical material volume 5 times amount for the first time, decoct 1.5 hours, filter, add the water of medical material volume 3 times amount for the first time, decoct 1 hour, filter, merge the filtrate of twice, be concentrated into 200-1000ml;

(3) Colla cornus cervi molten;

(4) before taking, the Colla cornus cervi that molten is good is blended in the medicine juice of step (2) gained, together with the Radix Notoginseng fine powder of step (1), takes together.

Embodiment 2

Prescription: Colla cornus cervi 5g, Herba Epimedii 8g, Cortex Eucommiae 12g, Radix Dipsaci 8g, Radix Notoginseng 3.5g, Radix Salviae Miltiorrhizae 14g, Semen Persicae 7g, Flos Carthami 2.5g, Radix Achyranthis Bidentatae 5g, Rhizoma Corydalis 7g, Rhizoma Curcumae Longae 5g, Olibanum 7g, Myrrha 5g, Herba Lycopodii 7g, Rhizoma Drynariae 8g, Rhizoma Sparganii 7g, Hirudo 2.5g, Squama Manis 7g, Radix Glycyrrhizae 7g.

Preparation method is with embodiment 1.

Embodiment 3

Prescription: Colla cornus cervi 7g, Herba Epimedii 12g, Cortex Eucommiae 82g, Radix Dipsaci 12g, Radix Notoginseng 2.5g, Radix Salviae Miltiorrhizae 10g, Semen Persicae 5-7g, Flos Carthami 3.5g, Radix Achyranthis Bidentatae 7g, Rhizoma Corydalis 5g, Rhizoma Curcumae Longae 7g, Olibanum 5g, Myrrha 7g, Herba Lycopodii 5g, Rhizoma Drynariae 12g, Rhizoma Sparganii 5g, Hirudo 3.5g, Squama Manis 5g, Radix Glycyrrhizae 5g.

Preparation method is with embodiment 1.

Embodiment 4

Prescription: Colla cornus cervi 4g, Herba Epimedii 14g, Cortex Eucommiae 6g, Radix Dipsaci 14g, Radix Notoginseng 2g, Radix Salviae Miltiorrhizae 16g, Semen Persicae 4g, Flos Carthami 4g, Radix Achyranthis Bidentatae 4g, Rhizoma Corydalis 8g, Rhizoma Curcumae Longae 4g, Olibanum 8g, Myrrha 4g, Herba Lycopodii 8g, Rhizoma Drynariae 6g, Rhizoma Sparganii 8g, Hirudo 2g, Squama Manis 8g, Radix Glycyrrhizae 4g.

Preparation method is with embodiment 1.

Embodiment 5

Prescription: Colla cornus cervi 8g, Herba Epimedii 6g, Cortex Eucommiae 14g, Radix Dipsaci 6g, Radix Notoginseng 4g, Radix Salviae Miltiorrhizae 8g, Semen Persicae 8g, Flos Carthami 2g, Radix Achyranthis Bidentatae 8g, Rhizoma Corydalis 4g, Rhizoma Curcumae Longae 8g, Olibanum 4g, Myrrha 8g, Herba Lycopodii 4g, Rhizoma Drynariae 14g, Rhizoma Sparganii 4g, Hirudo 4g, Squama Manis 4g, Radix Glycyrrhizae 8g.

Preparation method is with embodiment 1.

Carried out clinical pharrnacokinetics test to the Chinese medicine of embodiments of the invention l, Details as Follows:

1. data and method

1.1 object of study

Choose kidney deficiency blood stasis type femur head necrosis 66 example (102 hip) of accepting for medical treatment in April ,-2014 in April, 2013.Wherein male 56 example, women 10 example, 22 ~ 72 years old age, the mean age (45. 67+14. 78) year.ARCO is by stages: II phase 35 hip (34. 3%), III phase 60 hip (58.8%), IV phase 7 hip (6. 9%).

1.2 femur head necrosis diagnosis and staging scale:

1.2.1 Western medicine diagnose standard: the diagnostic criteria proposed with reference to Mont current in the world at present etc., meets wantonly 1 specific index and wantonly 1 non-specificity index simultaneously, and namely ONFH diagnosis sets up.

Specific index

(1) femoral head has subsided but has not had joint space to narrow situation;

(2) there is subchondral fracture, visible x-ray band (i.e. meniscus sign) thoroughly;

(3) there is wedge-like necrotic bone (focus) in capital front outside;

(4) nuclide bone scan (ECT) display: in hot-zone cold-zone (Cold in Hot);

(5) nuclear magnetic resonance image check (MRI): T2WI is shown in, and " two-wire is levied (Double line sign);

(6) osseous tissue biopsy is shown: the empty lacuna of osteocyte is more than 50% and involve contiguous many bone trabecula.

Non-specificity index:

(1) femoral head has subsided and with the narrow situation in joint space;

(2) femoral head internal density is uneven, occurs patchy high and low density shadow;

(3) the visible high-selenium corn signal of ECT;

(4) MRI display: bone marrow edema (pressing down fat as bone marrow region height signal) or fibrosis abnormal signal;

(5) hip joint activity companion pain symptom but X-ray film inspection prompting without exception;

(6) Corticosteroids history or long-term heavy drinking history;

(7) osseous tissue biopsy inspection prompting: non-specific pathological changes, prompting bone Marrow edema or fibrosis.

1.2.2 femur head necrosis staging scale: with reference to the staging scale of international bone circulating research meeting (Association Research Circulation Osseous, ARCO)

0 phase: pathologic finding is pointed out: osteonecrosis, all the other (comprise X-ray film, CT and MRI examines Check) are showed no obvious abnormalities performance.

I phase: ECT or MRI checks and occurs positive change;

Examine Check femoral head lesion area according to MRI to be divided into:

The I a phase: be less than 15%;

The I b phase: be greater than 15%, and be less than 30%;

The I c phase: be greater than 30%.

II phase: the formation of patch shape Density inhomogeneity region, sclerotin Nang Bian district and hardenability band appears in femoral head, and X-ray film and CT do not subside and show, MRI and ECT (+), hip is white without significantly change.

Check femoral head lesion area is examined according to MRI:

The II a phase: be less than 15%;

The II b phase: be greater than 15%, and be less than 30%;

The II e phase: be greater than 30%.

III phase: visible subchondral bone folding (i.e. meniscus sign) on X-ray film, or companion's collapse of the femoral head;

Femoral head lesion area is checked according to MRI:

The III a phase: be less than 15%, the scope of subsiding is less than 2mm;

The III b phase: be greater than 15%, and be less than 30%.The scope of subsiding is less than 4mm and is greater than 2mm;

The III c phase: be greater than 30%, the scope of subsiding is greater than 4mm.

IV phase: X-ray film is pointed out: collapse of the femoral head is out of shape, femoral head form becomes flat, and hip joint space compared with normal is narrow, and acetabular bone occurs osteosclerosis (high density shadow), occurs that sclerotin capsule becomes region and sclerotin lip sample hypertrophy.

1.2.3 Syndrome Types of TCM standard

Three phase four type treatment thinkings of the femur head necrosis proposed in 2003 that weighs with reference to Chen Wei, choose now comparatively common clinically middle and advanced stage kidney deficiency blood stasis type femur head necrosis pattern of syndrome:

Dialectical main points: hipbone pain, becoming severe at night, joint stuffiness, soreness of the waist and knees, complexion is dim or in vain light, deep,thready and forceless pulse, deep-thready pulse or heavy.

1.3 case inclusive criterias:

(1) age is more than 18 years old, male or female;

(2) Mont diagnostic criteria is met;

(3) ARCO is II phase, III phase and IV phase by stages;

(4) Syndrome Types of TCM is kidney deficiency blood stasis type;

1.4 case exclusion standards

(1) other femur head necrosis associated treatment person is accepted;

(2) other severe primary internal disease or the psychotics such as cerebrovascular, cardiovascular, hemopoietic system, hormonal system, liver, kidney are associated with;

(3) hip joint is suffered from existing or once suffered from the infected;

(4) trimester of pregnancy, women breast-feeding their children or preparation gravid woman;

1.5 reject standard:

(1) patient basis or the imperfect person of survey data;

(2) because drug allergy or other reasons drop by the wayside researcher.

1.5 Therapeutic Method

The Chinese medicine of the treatment kidney deficiency blood stasis type middle and advanced stage femur head necrosis of the embodiment of the present invention 1 is adopted to treat.Day 1 dose, 1 month was 1 course for the treatment of, took 4 months altogether.

1.6 observation index and evaluation methodology

1.6.1 imaging evaluation

Stable: before and after treatment, X-ray film performance is roughly the same, is substantially in steady statue; Necrotic area (focal zone) bone density is improved, and sclerotin becomes region area and reduces; Hardenability band is fuzzy; Grade improvement etc. by stages.

Increase the weight of: the appearance collapse of the femoral head of not subsiding before treatment or subsiding of having subsided increase the weight of situation; There is the osteoarthritis performances such as hyperosteogeny; Because of aggravation occur that pain symptom or pain increase the weight of, range of motion extreme difference and then need to accept hip replacement.

1.6.2 hip joint Harris marks

The standard that hip joint Harris marks is the important indicator of evaluation hip joint symptom and the function generally used both at home and abroad at present.Its full marks are 100 points, mainly evaluate from pain (44 points), daily routines (47 points) and locomotor activity (47 points), deformity (4 points) and range of motion (5 points) four hip joints of aspect to patient.

1.6.3 life quality scores (SF-36 scoring)

Quality of life Bian SF-36 general in the world measures table for assessing: (1) somatic function (PF); (2) role limited (RP) that causes of Body health problem; (3) body pain (BP); (4) general health sense (GH); (5) vitality (VT); (6) social functions (SF); (7) role caused by emotional problems limited (RE); (8) mental health (MH), comprises states of psychological depression and Wb content.

1.6.4 evaluation of clinical curative effect

The standard of curative effect evaluation proposed in " Chinese medical disease Standardization of diagnosis and curative effect " that foundation State Administration of Traditional Chinese Medicine issues: clinic control: clinical symptoms, sign disappear, syndrome integral minimizing is greater than 90%; Effective: clinical symptoms, sign are obviously improved, syndrome integral minimizing is greater than 70%; Effective: clinical symptoms, sign all take a favorable turn, syndrome integral minimizing is more than or equal to 30%, is less than 70%; Invalid: clinical symptoms, sign are not improved, even increase the weight of, syndrome integral minimizing is less than 30%;

1.6.5 observing time node: before treatment, treat latter 2 months, treat latter 4 months.

1.7 statistical procedures

Adopt SPSS15.0 version statistics software to process, measurement data represents with percentage rate, and compare between group and adopt t inspection, enumeration data represents with percentage rate, compares employing X 2 test between group, represents that difference has statistical significance with P<0.05.

2. result

2.1 clinical efficacy

(1) treat after 2 months: clinic control 7 example, accounts for 10.61%(7/66); Effective 24 examples, account for 36.36%(24/66); Effective 27 examples, account for 40.91%(27/66); Invalid 8 examples, account for 12.12%(8/66), total effective rate 87.88%(58/66).

(2) treat after 4 months: clinic control 12 example, accounts for 18.18%(12/66); Effective 28 examples, account for 42.42%(28/66); Effective 28 examples, account for 33.33%(22/66); Invalid 4 examples, account for 6.06%(4/66), overall efficiency 93.94%(62/66).

Femur head necrosis iconography ARCO situation of change by stages before and after 2.2 treatments

To the hip joint of 102 hips just, frog position X-ray film evaluation result shows: when (1) treats latter 2 months (comparing with before treatment): stablize 80 hips, coefficient of stabilization 78. 43%, increases the weight of 22 hips, add-on 21.57%.Wherein in II phase 35 hip, stablize 30 hips, coefficient of stabilization 85. 71%, increases the weight of 5 hips, add-on 14.29%; In III phase 60 hip, stablize 45 hips, coefficient of stabilization 75.0%, increase the weight of 15 hips, add-on 25.0%; In IV phase 7 hip, stablize 5 hips, coefficient of stabilization 71. 43%, increases the weight of 2 hips, add-on 28. 57%.(2) (compare with during latter 2 months for the treatment of) when treating latter 4 months: stablize 89 hips, to be 87. 25% (stablize when wherein treating latter 2 months in 80 hips in group and continue to be 77 hips, to increase the weight of 3 hips stable coefficient of stabilization; Add when 2 months in 22 hips in restructuring that to transfer to stable be 12 hips, what continue to increase the weight of is 10 hips.10 newly-increased stable hips are not II phase 5 hip, III phase 6 hip, IV phase 1 hip, increase that to increase the weight of hip be 3 hips newly, are all the II phase), increase the weight of 13 hips, add-on 12. 75%.Wherein in II phase 35 hip, stablize 32 hips, coefficient of stabilization 91. 43%, increases the weight of 3 hips, add-on 8.57%; In III phase 60 hip, stablize 51 hips, coefficient of stabilization 85.0%, increase the weight of 9 hips, in add-on 15.0%, IV phase 7 hip, stablize 6 hips, coefficient of stabilization 85.71%, increase the weight of 1 hip, add-on 14.29%.

Hip joint Harris scoring situation of change before and after 2.3 treatments

Before patient treatment, treat latter 2 months and treat Harris scoring in latter 4 months before treatment, difference has statistical significance (P<0.05), treats latter 2 months and treats latter 4 months Harris scoring comparing differences and have statistical significance (P>0.05); In table 1.

Before table 1 is treated, treat latter 2 months and treat latter 4 months Harris scoring and compare

Case load	Before treatment	Treat latter 2 months	Treat latter 4 months	F value	P value
						66	64.23±1.63	82.65±1.54	86.42±1.62	42.153	0.0001

2.4 treatment Life For The Residents of Three Gorges Reservoir Before SF-36 scoring situations of change

The quality of life SF-36 treating latter 2 months and treat latter 4 months is obviously improvement before marking and all comparatively treating, and difference has statistical significance (P>0.05); Treat latter 2 months and the treatment quality of life SF-36 of latter 4 months scoring comparing difference not statistically significant (P>0.05); In table 2.

Table 2 is treated Life For The Residents of Three Gorges Reservoir Before SF-36 scoring and is compared

Project	Before treatment	Treat latter 2 months	Treat latter 4 months	F value	P value
						PF	4.22±4.23	32.78±4.59	34.13±4.62	26.764	0.0003
RP	21.65±5.43	56.54±5.42	60.03±5.25	0.274	0.6541
						BP	48.35±3.65	71.67±4.34	73.56±4.68	39.496	0.0002
GH	58.56±4.23	72.78±4.37	74.67±4.48	40.264	0.0001
						VT	62.15±4.37	76.75±4.87	77.12±4.90	32.475	0.0005
SF	55.64±4.30	72.26±5.48	75.46±5.94	36.485	0.0004
						RE	56.21±5.48	75.46±5.90	77.45±6.04	27.395	0.0007
HM	65.75±4.68	73.28±5.40	75.35±5.92	33.275	0.0003

Claims (4)

1. treat a Chinese medicine for kidney deficiency blood stasis type middle and advanced stage femur head necrosis, be made up of the raw material of Chinese medicine medicine of following weight portion:

Colla cornus cervi 4-8 part, Herba Epimedii 6-14 part, Cortex Eucommiae 6-14 part, Radix Dipsaci 6-14 part, Radix Notoginseng 2-4 part, Radix Salviae Miltiorrhizae 8-16 part, Semen Persicae 4-8 part, Flos Carthami 2-4 part, Radix Achyranthis Bidentatae 4-8 part, Rhizoma Corydalis 4-8 part, Rhizoma Curcumae Longae 4-8 part, Olibanum 4-8 part, Myrrha 4-8 part, Herba Lycopodii 4-8 part, Rhizoma Drynariae 6-14 part, Rhizoma Sparganii 4-8 part, Hirudo 2-4 part, Squama Manis 4-8 part, Radix Glycyrrhizae 4-8 part.

2. the Chinese medicine for the treatment of kidney deficiency blood stasis type middle and advanced stage femur head necrosis according to claim 1, is characterized in that, be made up of the raw material of Chinese medicine medicine of following weight portion:

Colla cornus cervi 5-7 part, Herba Epimedii 8-12 part, Cortex Eucommiae 8-12 part, Radix Dipsaci 8-12 part, Radix Notoginseng 2.5-3.5 part, Radix Salviae Miltiorrhizae 10-14 part, Semen Persicae 5-7 part, Flos Carthami 2.5-3.5 part, Radix Achyranthis Bidentatae 5-7 part, Rhizoma Corydalis 5-7 part, Rhizoma Curcumae Longae 5-7 part, Olibanum 5-7 part, Myrrha 5-7 part, Herba Lycopodii 5-7 part, Rhizoma Drynariae 8-12 part, Rhizoma Sparganii 5-7 part, Hirudo 2.5-3.5 part, Squama Manis 5-7 part, Radix Glycyrrhizae 5-7 part.

3. the Chinese medicine for the treatment of kidney deficiency blood stasis type middle and advanced stage femur head necrosis according to claim 2, is characterized in that, be made up of the raw material of Chinese medicine medicine of following weight portion:

Colla cornus cervi 6 parts, Herba Epimedii 10 parts, the Cortex Eucommiae 10 parts, Radix Dipsaci 10 parts, Radix Notoginseng 3 parts, Radix Salviae Miltiorrhizae 12 parts, 6 parts, Semen Persicae, 3 parts, Flos Carthami, Radix Achyranthis Bidentatae 6 parts, Rhizoma Corydalis 6 parts, 6 parts, Rhizoma Curcumae Longae, Olibanum 6 parts, Myrrha 6 parts, Herba Lycopodii 6 parts, Rhizoma Drynariae l0 part, Rhizoma Sparganii 6 parts, Hirudo 3 parts, Squama Manis 6 parts, 6 parts, Radix Glycyrrhizae.

4. the preparation method of the Chinese medicine of the treatment kidney deficiency blood stasis type middle and advanced stage femur head necrosis according to claim 1 or 2 or 3, comprises the steps:

(1) to be broken into fine powder for subsequent use for Radix Notoginseng powder;

(2) Herba Epimedii, the Cortex Eucommiae, Radix Dipsaci, Radix Salviae Miltiorrhizae, Semen Persicae, Flos Carthami, Radix Achyranthis Bidentatae, Rhizoma Corydalis, Rhizoma Curcumae Longae, Olibanum, Myrrha, Herba Lycopodii, Rhizoma Drynariae, Rhizoma Sparganii, Squama Manis part, Radix Glycyrrhizae is got, decoct twice, add the water of medical material volume 5 times amount for the first time, decoct 1.5 hours, filter, add the water of medical material volume 3 times amount for the first time, decoct 1 hour, filter, merge the filtrate of twice, be concentrated into 200-500ml;

(3) Colla cornus cervi molten;

(4) before taking, the Colla cornus cervi that molten is good is blended in the medicine juice of step (2) gained, together with the Radix Notoginseng fine powder of step (1), takes together.