CN108714173B

CN108714173B - Traditional Chinese medicine composition and pill for treating femoral head necrosis damp-heat stasis syndrome and preparation method thereof

Info

Publication number: CN108714173B
Application number: CN201810829647.3A
Authority: CN
Inventors: 曹玉举; 张大鹏; 郭永昌; 宫顺国; 宜娟娟; 石文忠
Original assignee: ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
Current assignee: ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
Priority date: 2018-07-25
Filing date: 2018-07-25
Publication date: 2021-09-17
Anticipated expiration: 2038-07-25
Also published as: CN108714173A

Abstract

The invention discloses a Chinese medicinal composition for treating femoral head necrosis damp-heat stasis, a pill and a preparation method thereof, wherein the Chinese medicinal composition comprises the following components: 411 to 447 parts of flower of abelmoschus manihot, 197 to 229 parts of giant knotweed, 93 to 121 parts of rhubarb, 42 to 60 parts of amur corktree bark, 44 to 62 parts of cape jasmine fruit, 44 to 62 parts of peach kernel, 22 to 35 parts of catechu and 22 to 35 parts of cassia bark. The traditional Chinese medicine composition for treating the syndrome of dampness and heat stasis of femoral head necrosis disclosed by the invention takes abelmoschus manihot and polygonum cuspidatum as monarch drugs, rheum officinale, phellodendron amurense and gardenia jasminoides as ministerial drugs, peach kernels and catechu as adjuvant drugs and cinnamon as conductant drugs, comprehensively utilizes the action advantages and mutual synergistic action of the raw materials of the traditional Chinese medicines, has the effects of clearing heat, promoting diuresis, removing blood stasis, dredging collaterals, matching cold and temperature, reinforcing and purging, taking both symptoms and root causes into consideration, has the effects of clearing heat, promoting diuresis, reducing swelling, removing toxicity, promoting blood circulation, dredging collaterals, promoting tissue regeneration and promoting local repair of femoral head necrosis, and has a remarkable curative effect on the syndrome of dampness and heat stasis of femoral head necrosis.

Description

Traditional Chinese medicine composition and pill for treating femoral head necrosis damp-heat stasis syndrome and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine compounds, and in particular relates to a traditional Chinese medicine composition and a traditional Chinese medicine pill for treating femoral head necrosis damp-heat stasis syndrome and a preparation method thereof.

Background

Femoral head necrosis is a disease that femoral head vein stasis, arterial blood supply damage or interruption leads to partial death and subsequent repair of osteocyte and bone marrow components, and then bone tissue necrosis is caused, which leads to the change and collapse of femoral head structure, and hip joint pain and dysfunction are caused. The main symptoms of femoral head necrosis are hip joint immobilization pain, joint movement function limitation, claudication, lower limb muscular atrophy and the like, the femoral head necrosis is better in young and strong years of 20-50 years old, the average age is 36 years old, more than 70% of patients on both sides are suffered, inconvenience is brought to life of the patients, and health of young and strong years is seriously damaged.

At present, the means for treating femoral head necrosis comprise operation treatment and traditional Chinese medicine treatment, and the operation treatment comprises core decompression, vascular bundle implantation, bone grafting, osteotomy, hip arthroplasty, porous tantalum rod treatment, bone marrow mesenchymal stem cell treatment and the like. But the operation treatment has great harm to human body and the curative effect is not ensured; the operation treatment has certain risks and is easy to relapse after the operation.

The hip protection therapy mainly based on the traditional Chinese medicine treatment achieves a certain effect on the treatment of early and middle non-traumatic femoral head necrosis, and the hip protection treatment through the traditional Chinese medicine can enable a patient to obtain a hip joint which is relatively painless and basically normal in function, so that the artificial joint replacement is delayed or avoided. The traditional Chinese medicine for treating femoral head necrosis has the advantages of no wound, no pain, less side effect, simple method, no influence on artificial joint replacement after failure and the like, and is the most accepted treatment method by patients in China and the most common method. In the existing traditional Chinese medicine research, the syndrome differentiation and the type classification of the femoral head necrosis are mostly divided into blood stasis syndrome and kidney deficiency syndrome, and also the syndrome differentiation is phlegm stasis syndrome and qi and blood deficiency, but no research report on damp-heat stasis syndrome is found. Aiming at the clinical manifestations of damp-heat stasis syndrome, such as claudication, difficult lower limb movement, hip pain, groin pain, distending pain or stabbing pain, heavy and weak lower limbs, fever and sweating or body heat not rising, thirst not desire to drink, red tongue, dark purple or with ecchymosis, yellow and thick tongue coating and wiry and smooth pulse, we distinguish the syndrome of damp-heat stasis. A large number of patients suffering from femoral head necrosis caused by damp-heat stasis are observed in clinic, and the patients suffering from the femoral head necrosis caused by the damp-heat stasis also have a heavy burden on the society.

Disclosure of Invention

In view of the above, the traditional Chinese medicine composition for treating the syndrome of femoral head necrosis damp-heat stasis and the pill and the preparation method thereof provided by the invention better overcome the problems and defects in the prior art, the traditional Chinese medicine composition for treating the syndrome of femoral head necrosis damp-heat stasis selects pure natural traditional Chinese medicine raw materials, takes abelmoschus manihot and polygonum cuspidatum as monarch drugs, rheum officinale, phellodendron and gardenia as ministerial drugs, peach kernels and catechu as adjuvant drugs and cinnamon as conductant drugs, comprehensively utilizes the action advantages and mutual synergistic action of the traditional Chinese medicine raw materials, has the functions of clearing heat, promoting diuresis, removing blood stasis, dredging collaterals, matching cold and temperature, reinforcing and purging, and taking both principal and secondary aspects into consideration, has the effects of clearing heat, promoting diuresis, detoxifying, reducing swelling, activating blood circulation, dredging collaterals, removing blood stasis, promoting tissue regeneration and promoting repair of the local femoral head necrosis, and has obvious curative effect and is convenient to use.

A traditional Chinese medicine composition for treating femoral head necrosis damp-heat stasis comprises the following raw materials in parts by weight: 411 to 447 parts of flower of abelmoschus manihot, 197 to 229 parts of giant knotweed, 93 to 121 parts of rhubarb, 42 to 60 parts of amur corktree bark, 44 to 62 parts of cape jasmine fruit, 44 to 62 parts of peach kernel, 22 to 35 parts of catechu and 22 to 35 parts of cassia bark.

Further, 417-441 parts of abelmoschus manihot; 203-223 parts of giant knotweed.

Further, 99-115 parts of rheum officinale; 48-54 parts of phellodendron; 50-56 parts of gardenia.

Further, 50-56 parts of peach kernels; 25-32 parts of catechu; the cinnamon accounts for 25-32 parts.

Further, 429 parts of abelmoschus manihot flower; 213 parts of giant knotweed; 107 parts of rhubarb; 51 parts of phellodendron; 53 parts of gardenia; 53 parts of peach kernel; the catechu is 29 parts; 29 parts of cinnamon.

The invention also provides a pill for treating the syndrome of dampness-heat and blood stasis of femoral head necrosis, which comprises the traditional Chinese medicine composition for treating the syndrome of dampness-heat and blood stasis of femoral head necrosis.

Furthermore, 0.5-3 parts of starch and 8-20 parts of honey are also added into each 100 parts of the traditional Chinese medicine composition.

The invention also provides a preparation method of the pill for treating the syndrome of femoral head necrosis and dampness-heat stasis, which comprises the following steps: the pill comprises the traditional Chinese medicine composition for treating the syndrome of femoral head necrosis, dampness and heat and blood stasis; the preparation method comprises the following steps: and crushing the raw materials and uniformly mixing to obtain powder.

The preparation method further comprises the following steps: mixing and stirring 100 parts of the powder, 0.5-3 parts of starch, 8-20 parts of honey and 25-40 parts of pure water, and then preparing wet pills.

The invention also provides a method for preparing the wet pills, which comprises the steps of drying the wet pills until the moisture content is less than 5 wt% to obtain plain pills, coating the plain pills with activated carbon, and polishing with talcum powder, wherein 0.35-0.55 part of activated carbon and 0.35-0.55 part of talcum powder are used for each 100 parts of plain pills.

Compared with the prior art, the traditional Chinese medicine composition and the pill for treating the syndrome of the necrosis of the femoral head due to damp-heat and blood stasis and the preparation method thereof have the beneficial effects that:

the traditional Chinese medicine composition for treating the syndrome of dampness-heat and blood stasis of femoral head necrosis selects pure natural traditional Chinese medicine raw materials, takes abelmoschus manihot and polygonum cuspidatum as monarch drugs, takes rheum officinale, phellodendron amurense and gardenia jasminoides as ministerial drugs, takes peach kernels and catechu as adjuvant drugs and cinnamon as conductant drugs, comprehensively utilizes the action advantages and mutual synergistic action of the traditional Chinese medicine raw materials, has the effects of clearing heat, promoting diuresis, removing blood stasis and dredging collaterals, matching cold and temperature, reinforcing and purging, and treating both principal and secondary aspects of diseases, has the effects of clearing heat, promoting diuresis, reducing swelling, detoxifying, promoting blood circulation, dredging collaterals, removing blood stasis, promoting tissue regeneration and promoting the local repair of femoral head necrosis, and has obvious curative effect and convenient use on the syndrome of dampness-heat and blood stasis of femoral head necrosis. In addition, the pill for treating the syndrome of femoral head necrosis, dampness and heat stasis has the advantages of simple preparation method, low preparation cost, safe use, no pain and no toxic or side effect.

In order to make the aforementioned and other objects, features and advantages of the invention more comprehensible, preferred embodiments accompanied with figures are described in detail below.

Detailed Description

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention.

This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

A traditional Chinese medicine composition for treating femoral head necrosis damp-heat stasis comprises the following raw materials in parts by weight:

411 to 447 parts of sunset abelmoschus flowers such as 411 parts, 415 parts, 417 parts, 420 parts, 425 parts, 428 parts, 430 parts, 435 parts, 438 parts, 441 parts, 445 parts or 447 parts;

197-229 parts of giant knotweed such as 197 parts, 199 parts, 203 parts, 205 parts, 210 parts, 215 parts, 218 parts, 220 parts, 223 parts, 225 parts or 229 parts;

93-121 parts of rhubarb, such as 93 parts, 95 parts, 99 parts, 102 parts, 105 parts, 107 parts, 110 parts, 115 parts, 118 parts or 121 parts;

42-60 parts of phellodendron amurense, such as 42 parts, 45 parts, 48 parts, 51 parts, 52 parts, 54 parts, 58 parts or 60 parts;

44-62 parts of gardenia such as 44 parts, 47 parts, 50 parts, 52 parts, 53 parts, 54 parts, 56 parts, 59 parts or 62 parts and the like;

44-62 parts of peach kernel such as 44 parts, 47 parts, 50 parts, 52 parts, 54 parts, 56 parts, 59 parts or 62 parts and the like;

22-35 parts of catechu, such as 22 parts, 23 parts, 25 parts, 27 parts, 29 parts, 30 parts, 32 parts, 34 parts, 35 parts and the like;

and 22-35 parts of cinnamon, such as 22 parts, 23 parts, 25 parts, 28 parts, 30 parts, 32 parts, 34 parts, 35 parts and the like.

The abelmoschus manihot flower is a dry crown of abelmoschus manihot in malvaceae, and is sweet and cold in nature; it enters kidney and bladder meridians. Flos Abelmoschi Manihot has effects of clearing heat, promoting diuresis, relieving swelling and removing toxic substances, and can be used for treating damp-heat stagnation and stranguria with turbid urine and edema; it is indicated for abscess, deep-rooted carbuncle, swelling and toxin, scald due to hot water or fire. Abelmoschus manihot is recorded in Jiayou materia Medica, compendium of materia Medica: the flowers have sweet, cold, smooth and nontoxic smell, are mainly used for treating urinary stranguria and hastening the growth of the patients, are used for treating patients with malignant sores and pus for a long time and are healed after being applied for powder, are the main medicines for sores, eliminate gangrene swelling, soak oil and spread soup for fire injury and the like. The heat clearing, dampness removing, blood circulation promoting and blood stasis removing effects of abelmoschus manihot are identical with the clinical pathology of the femoral head necrosis dampness-heat stasis syndrome, and modern pharmacological studies prove that the abelmoschus manihot total flavone in the abelmoschus manihot can reduce the inflammation level of damaged tissues at the whole level, can reduce the expression of tumor necrosis factor alpha, and can improve the proportion of regulatory T cell subsets to play the roles of inhibiting inflammation and protecting the damaged tissues. The sunset abelmoschus flower total flavone can protect endothelial progenitor cells from apoptosis caused by oxidative stress in vitro. The flos Abelmoschi Manihot total flavone can effectively protect injury level of hindlimb ischemic rat, promote angiogenesis, and inhibit apoptosis of injury part. The sunset abelmoschus flower total flavone can reduce the oxidative stress level of a reperfusion position in a myocardial ischemia reperfusion model, inhibit the activation of an inflammasome NLRP3 in an ischemia reperfusion state and further play a protective role. In addition, flos Abelmoschi Manihot has effects in protecting cerebral ischemia and myocardial ischemia, eliminating sodium retention, relieving inflammation, resisting platelet aggregation, scavenging oxygen free radicals, resisting endothelin, dilating renal capillary, increasing renal perfusion and glomerular filtration rate, relieving tubulointerstitial lesion, and improving renal function. The total flavonoids of abelmoschus manihot can promote the angiogenesis of chick chorioallantoic membrane, and the angiogenesis promoting effect of the total flavonoids of abelmoschus manihot in vivo is prompted. The sunset abelmoschus flower total flavone has the function of obviously promoting the endothelial cells of umbilical vein vessels of human beings to form new vessels.

Rhizoma Polygoni Cuspidati is dried rhizome and root of Polygonum cuspidatum of Polygonaceae. Slightly bitter and cold, entering liver, gallbladder and lung meridians. Rhizoma Polygoni Cuspidati has effects of promoting diuresis, eliminating jaundice, clearing away heat and toxic materials, dispelling blood stasis, relieving pain, relieving cough, and eliminating phlegm; can be used for treating jaundice due to damp-heat pathogen, stranguria with turbid urine, leukorrhagia, rheumatalgia, carbuncle, suppurative sore, scald due to hot water and fire, amenorrhea, abdominal mass, traumatic injury, and cough due to lung heat. Experimental study of Traditional Chinese Medicine (TCM): huzhu is indicated for toothache due to excess fire, damp sores and rotten legs, and damp and rotten toes. "(the description of the materia Medica): hu Zhang is indicated for blood circulation similar to Tian Ming Jing and wind-wind similar to Wang Huo Shi, the first philosophy mostly means relieving summer-heat toxin, which is to remove heat from blood generated source, so blood organs of hand Jueyin and wind organs of foot Jueyin are treated as Ju Ying Floating. "

Radix et rhizoma Rhei (dry root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. Ex Balf. or Rheum officinale Baill. of Polygonaceae) is bitter and cold in taste; it enters spleen, stomach, large intestine, liver and pericardium channel. Radix et rhizoma Rhei has effects of purging pathogenic accumulation, clearing heat-fire, cooling blood, removing toxic substance, removing blood stasis, dredging channels, promoting diuresis and eliminating jaundice; pharmacological studies show that rhubarb also has the effects of spasmolysis, antibiosis and reduction of serum cholesterol. Radix et rhizoma Rhei can be used for treating constipation due to excessive heat accumulation, hematemesis, epistaxis, conjunctival congestion, pharyngeal swelling, carbuncle, furuncle, intestinal carbuncle, abdominal pain, blood stasis, amenorrhea, puerperal blood stasis, traumatic injury, damp-heat dysentery, jaundice, dark urine, stranguria and edema; it can be used for external treatment of burn and scald. The wine rhubarb is good at clearing heat-toxin in the upper energizer blood system and is used for treating conjunctival congestion, swollen throat and gum swelling and pain. The cooked rhubarb has the functions of relieving the purgative force, purging fire and removing toxicity, and is used for treating fire-toxin sores and ulcers. Rhubarb charcoal has the effects of cooling blood, removing blood stasis and stopping bleeding, and is used for treating blood heat with blood stasis and hemorrhage.

Cortex Phellodendri is the dried bark of phellodendron amurense belonging to Rutaceae. Bitter and cold. It enters kidney and bladder meridians. Cortex Phellodendri has effects of clearing heat, eliminating dampness, clearing pathogenic fire, removing steam, removing toxic substance, and treating sore; can be used for treating dysentery due to damp-heat, jaundice, dark urine, leukorrhagia, pudendal pruritus, pyretic stranguria, odynuria, tinea pedis, , bone-steaming, overstrain, night sweat, spermatorrhea, pyocutaneous disease, toxic swelling, eczema, and eczema. Salted phellodendron bark, cortex Phellodendri, is used for nourishing yin and lowering fire, and can be used for treating hyperactivity of fire due to yin deficiency and night sweat and steaming bone. Pharmacological research shows that the phellodendron also has the effects of resisting bacteria, resisting ulcer, reducing blood pressure, promoting urination, regulating immunity and the like.

Fructus Gardeniae is dried mature fruit of Gardenia jasminoides Ellis of Juncaceae. Bitter and cold in flavor, entering heart, lung and triple energizer meridians. Fructus Gardeniae has effects in purging pathogenic fire, relieving restlessness, clearing away heat, promoting diuresis, relieving swelling and pain, cooling blood, and removing toxic materials; it is applied externally. Gardenia jasminoides ellis is used for treating pyretic vexation, damp-heat jaundice, stranguria, hematemesis, epistaxis, conjunctival congestion, swelling and pain, and pyocutaneous disease due to fire toxin; it can be used for treating sprain, contusion and pain.

Peach kernel, a dry mature seed of Prunus persica Batsch belonging to Rosaceae family, which is bitter, sweet and mild in taste; it enters heart, liver and large intestine meridians. Semen Persicae has effects of promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, relieving cough and asthma; can be used for treating amenorrhea, dysmenorrhea, abdominal mass, pulmonary abscess, intestinal abscess, traumatic injury, constipation due to intestinal dryness, cough, and asthma. The method of medication administration: tao ren is used for blood coagulation because it is bitter to purge stagnant blood and sweet to promote blood generation. Also remove heat in blood. "(Ben Cao Jing Shu): "fu blood is also yin; in the case of both tangible and peri-affluent patients, stagnation of blood may be manifested as abdominal mass, blood stasis, or obstruction of menstrual flow, or impaired blood accumulation due to attack of blood stasis, or persistent blood and pain in the heart, which are all affected by the liver meridian and blood-storing viscera. The actions of Tan He ren are bitter and can purge stagnation, pungent and disperse accumulation, and sweet and warm passing through to relieve liver, so it is also indicated for the first-class syndrome. When the heart-blood goes to the lower part of the body, the qi goes downward and the cough goes to the end. It is bitter and pungent in flavor, so it can kill both parasites and parasites. The peach kernel is good in breaking blood, dispersing but not collecting, purging but not tonifying, used too much, and it can make blood flow stop and damage true yin. "meaning of pharmacy": peach kernel, semen Persicae, bitter in flavor, can purge blood heat, moisten body and nourish intestinal dryness. If the connective tissue is smashed into pieces for multiple purposes, it can break and store blood, dispel water in the moon, and cause general pain, numbness of limbs, hemiplegia and even pain of the left foot, it can be used to remove the skin, activate blood, promote blood circulation, remove blood stasis and promote tissue regeneration, and if it is peeled and smashed, it is used in large intestine to treat dry blood, constipation, dry blood and difficult defecation, so it has the actions of moistening, cooling blood, activating blood, resolving masses and relieving stagnation. "(original source of the menstrual cycle): tao ren is a specialized herb for blood stasis and blood block. Bitter taste can purge blood stagnation, while sweet taste can promote blood generation. After all, the blood breaking action is mostly known from the book Jing. Zhongjing peach pit can take action of relieving qi and acting as decoction to break blood. It is also indicated for blood stasis in blood chamber, mass, amenorrhea, malaria, abdominal pain, constipation of large intestine, and blood stagnation dispersing in liver meridian. For hernia pain and itching, it is also known as Qian jin from Qian jin. "pharmacological studies show that: peach kernel has the function of removing blood stasis: the product can be decocted with water and precipitated with ethanol to increase blood flow of ear vein of rabbit in vitro, and has vasodilating effect. The product also has blood coagulation inhibiting, hemolytic, antiinflammatory, and antiallergic effects.

Catechu, which is dry decocted extract of peeled branch and dried Catechu of Leguminosae, and has bitter, astringent and slightly cold taste; it enters lung and heart meridians. Catechu has effects of promoting blood circulation, relieving pain, stopping bleeding, promoting granulation, eliminating dampness, healing sore, clearing lung, and eliminating phlegm; it can be used for treating traumatic injury, traumatic hemorrhage, hematemesis, cerebral hemorrhage, unhealed pyocutaneous disease, eczema, and cough due to lung heat. Catechu extract has effects of protecting liver, promoting gallbladder function, promoting immunity, resisting blood platelet aggregation, and resisting thrombosis. The infantile tea has effects of inhibiting intestinal tract movement and relieving diarrhea. The tea infusion can inhibit common pathogenic dermatophytes and bacteria in test tubes. Catechu also has cancer cell inhibiting effect. The tea tannin has effects of improving capillary vessel resistance and resisting histamine, and has antiinflammatory effect, and can inhibit formation of experimental vesical calculus.

Cinnamon, the dry bark of cinnamon belonging to the family Lauraceae, is pungent, sweet and hot in flavor. It enters kidney, spleen, heart and liver meridians. Cortex Cinnamomi has effects of nourishing fire, supporting yang, guiding fire, expelling cold, relieving pain, and warming and dredging channels and collaterals; it can be used for treating sexual impotence, cold womb, lumbago, gonalgia, asthma due to kidney deficiency, floating of deficient yang, vertigo, conjunctival congestion, cold pain of heart and abdomen, vomiting and diarrhea due to deficiency cold, cold hernia, abdominal pain, dysmenorrhea, and amenorrhea. Pharmacological research shows that the catechu has the functions of resisting platelet aggregation, resisting coagulation, resisting bacteria, promoting urination, etc.

The causes and pathogenesis of the femoral head necrosis with damp-heat stasis can be summarized as follows: pinsu is drunk, is overeating with fat and sweet, or is taking hormone for a long time, and is in body damp-heat accumulation, or is suffered from damp-heat caused by pathogenic factors of damp-heat or internal accumulation, or is in cold-damp stagnation for long time to transform heat, so that damp evil blocks qi movement, and the meridians and collaterals are unsmooth in qi and blood, and the veins are stagnant; or excessive heat consuming yin and burning fluid, viscous blood, and obstructed blood flow in the veins; exuberant heat moves blood, which urges blood to flow recklessly and the blood leaving meridians stays locally; long-term damp-heat can cause heat-stasis. Stagnation of collaterals and malnutrition of tendons and bones can cause this disease. Or heat in the kidney, internally depressing kidney essence, consuming essence and marrow, and failing to nourish the bones.

The clinical manifestations of the femoral head necrosis with damp-heat stasis syndrome are: lameness, difficulty in lower limb movement, hip pain, groin pain, distending pain or stabbing pain, heaviness and weakness of lower limbs, fever with sweating or lingering fever, thirst with no desire for drinking, red tongue with purple dark or ecchymosis, yellow, thick and greasy coating, and wiry, smooth and rapid pulse.

Dampness-heat attacks the body and dampness is a turbid, sticky and greasy property, so it is manifested as heaviness of the muscles of joints, pain, distending pain and difficulty in flexion and extension. Heat is the pathogenic factor of yang, and fever and sweating can be seen as the pathogenic factor of heat. Damp-heat refers to the condition of a poor fever and a desire to drink. Heat and blood stasis are combined, so hot pain and stabbing pain of joints of limbs are seen. The red, dark or ecchymosis tongue with yellow, thick and greasy coating and wiry, smooth and rapid pulse are the symptoms of heat and blood stasis.

The invention adopts treatment methods of clearing heat and promoting diuresis, reducing swelling and detoxifying, activating blood and dredging collaterals, removing blood stasis and promoting tissue regeneration and the like aiming at the characteristics of the femoral head necrosis dampness-heat stasis syndrome.

In the raw materials of the traditional Chinese medicine composition for treating the syndrome of femoral head necrosis, the abelmoschus manihot clears heat and promotes diuresis, reduces swelling and detoxifies, and activates blood and removes blood stasis; giant knotweed rhizome, rhizoma Polygoni Cuspidati has the effects of promoting diuresis and removing jaundice, clearing heat and removing toxicity, and removing blood stasis and relieving pain, and the two medicines can clear dampness and heat, activate blood and remove blood stasis when used together, and are monarch medicines together. Radix et rhizoma Rhei has effects in clearing away heat, promoting diuresis, removing blood stasis, dredging channels, regulating blood circulation, and benefiting articulation; phellodendron bark, cortex Phellodendri, radix Angelicae sinensis, radix rehmanniae Preparata, and cortex Phellodendri can clear heat, eliminate dampness and treat flaccidity of lower limbs; the gardenia has the effects of clearing heat and promoting diuresis, cooling blood and removing toxicity, and relieving swelling and pain, the three medicines are combined to serve as ministerial medicines, and the effects of clearing heat and promoting diuresis, relieving swelling and pain of monarch medicines are assisted, and the rhubarb has the functions of promoting blood circulation and removing blood stasis and stimulating the menstrual flow, and can assist the monarch medicines in promoting blood circulation and removing blood stasis and dredging collaterals. Peach kernel, semen Persicae has the effects of promoting blood circulation, removing blood stasis, and removing abdominal mass and blood stasis; catechu has effects of promoting blood circulation, relieving pain, stopping bleeding, promoting granulation, removing blood stasis, promoting tissue regeneration, and promoting local repair of femoral head necrosis. Cinnamon warms and unblocks meridians, strengthens joints and unblocks blood vessels, and can guide meridians to enable the drug effect to directly reach the focus; the medicine can be matched with the coldness and the warmness of the phellodendron bark and the like, and the bitter coldness and the dampness eliminating are combined with the warming and the dampness eliminating to help the gasification of the bladder, eliminate the dampness and the heat and make the dampness and the heat isolated so as to better dispel the dampness and the heat; it can warm yang qi without generating pathogenic heat, and enter blood system to warm and dredge blood vessels, and is used as a guiding drug in combination with heat-clearing and dampness-drying herbs such as Da Huang, Huang Bai and Zhi Zi to remove the bitter and cold. The composition has the effects of clearing heat, promoting diuresis, removing blood stasis, dredging collaterals, matching cold and temperature, reinforcing and purging, treating both manifestation and root cause of disease, clearing heat, promoting diuresis, reducing swelling, removing toxic substances, promoting blood circulation, dredging collaterals, removing blood stasis, promoting tissue regeneration and promoting repair of local femoral head necrosis, and has obvious curative effect on the femoral head necrosis, dampness and heat stasis syndrome and convenient use.

The invention embodies the principle of removing blood stasis and promoting tissue regeneration, promoting blood circulation and removing meridian obstruction without damaging vital qi, and the abelmoschus manihot flower medicine for removing blood stasis and removing meridian obstruction can treat carbuncle, deep-rooted carbuncle and malignant boil without closing up and scald caused by water and fire; the giant knotweed rhizome can dissipate blood stasis and relieve pain, and can treat damp sores and leg rot; rhubarb, radix et rhizoma Rhei dispels blood stasis and promotes menstruation, and can be used for treating scald caused by hot water or fire; the catechu can activate blood and relieve pain, and can treat unhealing sores and ulcers, and the product for activating blood, dissolving stasis and dredging collaterals used by the invention has the effects of promoting tissue regeneration and promoting tissue regeneration, does not damage vital qi, can promote the body repair, and is similar to the repair process of femoral head necrosis. The invention embodies three methods of 'dispersing upward', 'smoothing middle' and 'seeping downward' for promoting diuresis, namely cape jasmine fruit is used for dredging qi activity, permeating damp evil and dispersing and gasifying dampness to be more upper-jiao; uses phellodendron bark, rhubarb and giant knotweed rhizome, etc. to reduce dampness and eliminate damp-heat pathogen in the middle energizer; cinnamon is used to promote the transformation of bladder and remove damp-heat to expel damp-pathogen from urine.

The traditional Chinese medicine composition provided by the invention conforms to the femoral head necrosis repair mechanism. In the process of repairing femoral head necrosis, a reactive fibrous tissue repair area with clear boundary is formed by hyperplastic tissue, dense fibrous tissue contains abundant neovascularization, and an immunohistochemical method is used for marking CD34, so that the neovascularization is densely distributed in the fibrous tissue in a net shape and extends into a new bone trabecula surrounded by the fibrotissue. The active ingredient of the flower of abelmoschus manihot in the traditional Chinese medicine composition can effectively protect the injury level of a hindlimb ischemic rat, promote angiogenesis and inhibit apoptosis of the injured part at the whole level; can promote the angiogenesis of chick chorioallantoic membrane, and prompt that the chick chorioallantoic membrane has the function of promoting angiogenesis in vivo; has the function of obviously promoting the endothelial cells of the umbilical vein of the human to form new vessels. The flos Abelmoschi Manihot has effect in promoting angiogenesis and can be used for repairing femoral head necrosis.

Preferably, the flower of abelmoschus manihot is 417-441 parts; 203-223 parts of giant knotweed.

Preferably, 99-115 parts of rheum officinale; 48-54 parts of phellodendron; 50-56 parts of gardenia.

Preferably, 50-56 parts of peach kernels; 25-32 parts of catechu; the cinnamon accounts for 25-32 parts.

Preferably, the flower of abelmoschus manihot is 429 parts; 213 parts of giant knotweed; 107 parts of rhubarb; 51 parts of phellodendron; 53 parts of gardenia; 53 parts of peach kernel; the catechu is 29 parts; 29 parts of cinnamon.

Preferably, 0.5-3 parts of starch and 8-20 parts of honey are also added into 100 parts of the traditional Chinese medicine composition, such as 0.5 part, 1 part, 1.5 parts, 2 parts, 2.5 parts or 3 parts of starch and 8-20 parts of honey, such as 8 parts, 10 parts, 12 parts, 15 parts, 18 parts or 20 parts. Preferably, 1 part of starch and 10 parts of honey are also added into each 100 parts of the traditional Chinese medicine composition.

The preparation method further comprises the step of mixing and stirring 100 parts of the powder, 0.5-3 parts of starch, 8-20 parts of honey and 25-40 parts of pure water to prepare wet pills.

Preferably, the wet pellets are dried to a moisture content of 5% by weight or less to obtain plain pellets, and the plain pellets are carbon-coated with activated carbon and polished with talc, wherein 0.35 to 0.55 parts such as 0.35 part, 0.4 part, 0.45 part, 0.48 part, 0.5 part, 0.52 part, or 0.55 part of activated carbon and 0.35 to 0.55 parts such as 0.35 part, 0.4 part, 0.45 part, 0.48 part, 0.5 part, 0.52 part, or 0.55 part of talc are used per 100 parts of the plain pellets.

The traditional Chinese medicine composition and the pill thereof are safe to use and have no toxic or side effect. The pill is simple to prepare, easy to take and convenient to carry, does not need or needs few auxiliary materials during preparation, is low in cost and suitable for mass production, and therefore the dosage form is preferably the pill. Of course, other formulations such as tablets, capsules, granules and the like may be prepared as required.

In order to facilitate understanding of the present invention, the technical solutions of the present invention will be further described below with reference to examples and specific cases.

Example 1

(1) Weighing the following traditional Chinese medicine raw materials: 411 parts of abelmoschus manihot, 229 parts of giant knotweed, 93 parts of rhubarb, 60 parts of phellodendron, 44 parts of gardenia, 44 parts of peach kernel, 35 parts of catechu and 22 parts of cinnamon.

(2) Pulverizing the above Chinese medicinal materials into fine powder with TF300B type double-stage pulverizer (manufactured by Tianjin Chinese medicinal machinery factory), and mixing in GH-200 type high-efficiency three-dimensional motion mixer (manufactured by Harbin pharmaceutical chemical engineering equipment, Inc.) to obtain powder.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology Limited of pharmaceutical Equipment in Tianshuihua Yuan, Gansu), 0.8 part of starch and 10 parts of honey are added firstly, stirred and mixed for 10min, and then 25 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

(4) The soft material is placed in an YUJ-17B type intelligent high-efficiency full-automatic pill making machine (produced by Gansu Tianshuihua pharmaceutical equipment science and technology Limited) to be pulled into strips and rubbed into pills, so that round and uniform wet pills with consistent appearance are obtained, and the diameter is 4.0-4.3 mm.

(5) The prepared wet pills are placed in an HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua pharmaceutical equipment science and technology Co., Ltd.) and dried for 50-60 minutes under the conditions of hot air at 50 ℃ and the box temperature of 80 ℃ to obtain the vegetarian pills with the dry moisture of less than 5 percent.

(6) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.35 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 2

(1) Weighing the following traditional Chinese medicine raw materials: 415 parts of flower of abelmoschus manihot, 225 parts of giant knotweed, 95 parts of rhubarb, 58 parts of phellodendron, 47 parts of gardenia, 47 parts of peach kernel, 34 parts of catechu and 23 parts of cinnamon.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1 part of starch and 12 parts of honey are added firstly, stirred and mixed for 10min, and then 35 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

(6) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.4 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 3

(1) Weighing the following traditional Chinese medicine raw materials: 417 parts of flower of abelmoschus manihot, 223 parts of giant knotweed, 99 parts of rhubarb, 54 parts of amur corktree bark, 50 parts of cape jasmine fruit, 50 parts of peach seed, 32 parts of catechu and 25 parts of cassia bark.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1.5 parts of starch and 15 parts of honey are added firstly, stirred and mixed for 10min, and then 35 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

(6) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.5 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 4

(1) Weighing the following traditional Chinese medicine raw materials: 425 parts of flower of abelmoschus manihot, 218 parts of giant knotweed, 105 parts of rhubarb, 52 parts of amur corktree bark, 52 parts of cape jasmine fruit, 52 parts of peach seed, 30 parts of catechu and 28 parts of cassia bark.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 2 parts of starch and 15 parts of honey are added firstly, stirred and mixed for 10min, and then 35 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

(6) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.45 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 5

(1) Weighing the following traditional Chinese medicine raw materials: 429 parts of abelmoschus manihot, 213 parts of giant knotweed, 107 parts of rhubarb, 51 parts of phellodendron, 53 parts of gardenia, 53 parts of peach kernel, 29 parts of catechu and 29 parts of cinnamon.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1.5 parts of starch and 15 parts of honey are added firstly, stirred and mixed for 10min, then 38 parts of pure water is added, and stirred for about 20min, so that a soft material is obtained.

Example 6

(1) Weighing the following traditional Chinese medicine raw materials: 445 parts of flower of abelmoschus manihot, 199 parts of giant knotweed, 118 parts of rhubarb, 45 parts of amur corktree bark, 59 parts of cape jasmine fruit, 59 parts of peach seed, 23 parts of catechu and 34 parts of cassia bark.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1 part of starch and 12 parts of honey are added firstly, stirred and mixed for 10min, then 30 parts of pure water is added, and stirred for about 20min, so that a soft material is obtained.

(6) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.3 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 7

(1) Weighing the following traditional Chinese medicine raw materials: 441 parts of abelmoschus manihot, 203 parts of giant knotweed, 115 parts of rhubarb, 48 parts of amur corktree bark, 56 parts of cape jasmine fruit, 56 parts of peach seed, 25 parts of catechu and 32 parts of cassia bark.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1 part of starch and 10 parts of honey are added firstly, stirred and mixed for 10min, then 30 parts of pure water is added, and stirred for about 20min, so that a soft material is obtained.

Example 8

(3) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 2.5 parts of starch and 18 parts of honey are added firstly, stirred and mixed for 10min, and then 38 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

Example 9

(1) Weighing the following traditional Chinese medicine raw materials: 447 parts of flower of abelmoschus manihot, 197 parts of giant knotweed, 121 parts of rhubarb, 42 parts of amur corktree bark, 62 parts of cape jasmine fruit, 62 parts of peach seed, 22 parts of catechu and 35 parts of cassia bark.

(3) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology Limited of pharmaceutical Equipment in Tianshuihua Yuan, Gansu), 0.8 part of starch and 8 parts of honey are added firstly, stirred and mixed for 10min, and then 40 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

(6) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.55 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Comparative example 1

Different from the example 1, the amount of the flower of abelmoschus manihot is 400 parts, and other components and the preparation method are the same as the example 1.

Comparative example 2

Except for the difference from example 1, the dosage of the giant knotweed rhizome is 240 parts, and other components and the preparation method are the same as example 1.

Comparative example 3

Except for example 1, the amount of rhubarb used is 85 parts, and other ingredients and preparation method are the same as example 1.

Comparative example 4

Except for example 1, 70 parts of phellodendron bark was used, and the other components and preparation method were the same as example 1.

Comparative example 5

Except for example 1, the amount of gardenia was 40 parts, and other ingredients and preparation method were the same as example 1.

Comparative example 6

Except for example 1, the amount of peach kernel was 37 parts, and other ingredients and preparation method were the same as example 1.

Comparative example 7

Except for example 1, the amount of catechu is 45 parts, and other ingredients and preparation method are the same as example 1.

Comparative example 8

Except for example 1, cinnamon was used in an amount of 18 parts, and other ingredients and preparation methods were the same as example 1.

The effect of the pill for treating femoral head necrosis is verified as follows:

450 patients with femoral head necrosis, 18-65 years old, were randomly divided into 9 groups and treated with the Chinese medicinal composition of the present invention in examples 1-9 according to the above-mentioned application method.

The 450 patients with femoral head necrosis are judged according to the following diagnosis standards:

refer to the standard for diagnosing femoral head necrosis in 2015, "standard for clinical diagnosis and treatment of femoral head necrosis-Lizi Rong".

a. There are a long history of a lot of alcohol abuse, glucocorticoid application and hip trauma.

b. The symptoms are mainly hip joint pain, the function is normal in the early stage or only the abduction and adduction are slightly limited, the test of the shape of a Chinese character '4' is positive, the abduction and the anteflexion of the hip joint are carried out along with the disease, and the internal and external rotation can be obviously limited until the function of the hip joint is completely lost.

c.X thread piece: the necrotic foci are surrounded by sclerotic bands, segmental collapse, crescentic features, collapse of the femoral head but maintenance of the joint space.

MRI: gold standard for diagnosis of femoral head necrosis. T1WI banding low signal surrounding fat (medium high signal) or necrotic bone (medium signal), a typical image of femoral head necrosis. T2W 1: two-line characterization, T2W1 liposuction: bone marrow edema of the femoral head, neck except focal zone and T1WI banding low signal.

Case inclusion and exclusion criteria:

(ii) case selection and inclusion criteria

a. Subject signs an informed consent;

b. the diagnosis is carried out by western medicine for femoral head necrosis, and the ARCO is divided into stages I, II and III-a;

c. patients who can self-describe the condition;

d. hospitalized patients.

② elimination criteria of cases

a. Patients with severe osteoporosis, severe hypertension and severe cardiovascular and cerebrovascular diseases, tumor, etc. or mental patients;

b. hip joint dysfunction caused by osteomyelitis, bone tumor, bone tuberculosis and other reasons;

c. patients with unstable joints, non-union fractures, joint swelling, post-artificial joint replacement, excessive pain, and increased joint mobility;

d. poor patient compliance or rejection of patients participating in the study;

e. are attending other clinical experimenters;

f. pregnant or lactating female patients.

And (3) judging the curative effect:

and (4) making a curative effect evaluation standard by referring to a Harris scoring table, a hip VAS score, an X-ray-based femoral head necrosis hip-protecting curative effect evaluation method research and the like. Harris score symptom reduction calculation method: degree of improvement ═ (post-treatment-pre-treatment)/pre-treatment × 100%. The VAS score improvement degree calculation method comprises the following steps: degree of improvement ═ (pre-treatment-post-treatment)/pre-treatment × 100%.

And (3) curing: symptoms and signs basically disappear, and the Harris and VAS scores are improved to 51-100%.

The method has the following advantages: symptom signs were relieved, and the improvement of Harris and VAS scores was 26% -50%.

And (4) invalidation: symptoms and signs were not improved before treatment, and the Harris and VAS scores were improved to less than 25%.

The using method comprises the following steps: orally administered at a dose of 9g, 3 times a day; 10 days is a treatment course, and after the traditional Chinese medicine composition is continuously used for 3 treatment courses, the statistical result is as follows:

group of	Total number of people	Cure of disease	Is effective	Invalidation	Total effective rate
						Example 1	50	37	7	6	88％
Example 2	50	39	6	5	90％
						Example 3	50	41	6	3	94％
Example 4	50	42	6	2	96％
						Example 5	50	45	4	1	98％
Example 6	50	43	5	2	96％
						Example 7	50	41	5	4	92％
Example 8	50	40	6	4	90％
						Example 9	50	37	8	5	90％

The above table shows that the traditional Chinese medicine composition has good effect after treatment, the effective rate is more than 88%, and the cure rate is more than 74%, so that the pill has good effect on treating the femoral head necrosis dampness-heat stasis. In addition, the therapeutic effect of example 5 is the best in terms of the combination of cure rate and efficacy.

In addition, the inventor also treated 8 groups of patients (5 patients with femoral head necrosis in each group, age 18-65 years) with the pills prepared in comparative examples 1-8, and all the patients had no treatment effect or had poor treatment effect (the effective rate is not more than 50%).

Clinical case 1: one in Chaiyu, male, 61 years old, Henan province \37154, Ling county Peng shop county. The patients have intermittent pain in the hips in 2017 in 3 months, have no radiating pain in the lower limbs, are aggravated when suffering from heat or after moving, and are relieved after rest, which has not been paid attention. Toukong 37154; (Zhenyu MRI presentation of institute of TCM in Ling county): bilateral femoral head necrosis without treatment; then the traditional Chinese medicine and the plaster are orally taken and externally applied for 1 month in local clinics; the pain symptoms are reduced; the pain of the hip part worsened before 5 days after fatigue, and the pain of the hip part worsened before the right side. The patients are admitted into the hospital, and the admission symptoms are as follows: claudication, pain of both hips, weakness and heaviness of the lower limbs, a red tongue with a yellow, thick and greasy coating, and a wiry, slippery and rapid pulse.

Through special examination: tenderness in the groin at both sides, percussion pain of greater trochanter at both sides, left III level of force of both lower limbs, right IV level, positive tomassian sign at both sides, positive tomasburg sign at both sides, positive test of the left side in the shape of a '4', incomplete test of the right side in the shape of a '4', negative allesis, and double hip mobility: the left side abducts 30 degrees, adducts 15 degrees, flexes 130 degrees, rotates 15 degrees, abducts 10 degrees, adducts 5 degrees, flexes 45 degrees and rotates 5 degrees. The neck bending test is negative, the supine abdomen raising test is negative, and the straight leg raising test is negative. The knee tendon reflex and the achilles tendon reflex were normal, and the Barnski sign was negative.

Auxiliary inspection: the positive axis DR of pelvis (2017.08.14DR-068276) is shown in image: the right femur head is slightly flat in shape, uneven bone density is shown in the femoral head, trabecular bone is fuzzy, a sac-like low-density image and a spot-like high-density image can be seen, and the right hip joint clearance can be maintained; the left femoral head has the proper shape, the bone density in the femoral head is not uniform, the trabecular bone is fuzzy, and the left hip joint gap is proper. Double hip MRI (2017.08.14MR-09517 Hospital) show: 1. ischemic necrosis of bilateral femoral head; 2. effusion in the double hip joint cavity; 3. bone marrow edema of the right femoral head, neck and trochanter; 4. abnormal signals at the attachments of bilateral femoral greater trochanter muscles are considered, and inflammation is considered; 5. edema of right iliac, gluteus minimus, and medial femoral muscles.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, dampness, heat and blood stasis; and (3) Western diagnosis: bilateral femoral head necrosis (ARCO staging: left II right III).

The pill prepared in the embodiment 1 of the invention is taken orally, 3 times a day, 9g each time. One week after taking the pill prepared in example 1 of the present invention, the patient was returned from a laboratory examination: blood is generally normal, liver function, kidney function and electrolyte are generally normal, blood coagulation is four, immunity is five, and blood fat and blood sugar are normal. Five items of hepatitis B: positive and negative hepatitis B surface antibody, prompting the patient to take hepatitis B of three positive and small positive, and recommending to review regularly; the four items of rheumatism are: blood sedimentation: 32 mm/h; c-reactive protein: 13.2mg/L, considering coxitis. And (3) electrocardiogram displaying: sinus bradycardia, roughly normal electrocardiogram. The calcified focus in the liver is indicated by ultrasound and is checked regularly. After 2 weeks of taking the pill prepared in the embodiment 1 of the invention, the pain of the patient is relieved earlier, the function is improved earlier, and the vital signs are stable; patients do not complain of special discomfort, insist on exercise, use hormone with cautions, and regularly review liver and kidney functions. After three months, the product has no pain basically and can be used for normal life.

Clinical case 2: somebody of wen, man, 30 years old, han nationality, shannan province, puyang county town. After 2 months early fatigue of 2016, patients feel uncomfortable right hip pain, go to Puyang county people hospital for treatment, are given related medicaments (specific medicaments are not good) for oral administration, the effect is poor, the Puyang county people hospital is subjected to repeated diagnosis, the femoral head necrosis is diagnosed through MRI examination, surgical treatment is recommended, and the patients refuse. The second subsidiary hospital from 3 months to Zhengzhou university in 2016 is diagnosed and orally taken with Chinese medicine decoction, and the curative effect is general. After 8 and 7 days in 2017, the hospital is admitted to the hospital: lameness, aching and uncomfortable right hip, prolonged walking, aggravated after fatigue, relieved after rest, difficulty in squatting, clear mind, good spirit, sleep with a sleep, normal stool, red tongue with yellow, thick and greasy coating, and smooth and rapid pulse.

Special examination: soreness and pain of the hips, tenderness in the groin on both sides, percussive pain of greater trochanter of femur, negative results of pelvic separation and extrusion tests, and tests in the shape of a double-side '4': and (4) positive. Mobility of the double hip joints: right side: flexion is 80 degrees, extension is 15 degrees, adduction is 20 degrees, abduction is 25 degrees, internal rotation is 20 degrees, and external rotation is 25 degrees, and abduction is 30 degrees. Relative length of both lower limbs: 94cm on the left side, 94cm on the right side, and the circumference at the position of 10cm on the patella of the two lower limbs: left 43cm, right 42cm, both lower limb muscle strength: left stage iv, right stage iv, full castle: and (4) negativity. Thomasgy characteristics: negative, negative for ehrlich; dafeng sign: left negative, right positive.

Auxiliary examination of pelvic Positive axial position (2017.08.07 Hospital 068207): uneven bone density and fuzzy trabecula are shown in the femoral heads on both sides, and a sac-like low-density image is seen in the right side; the right femoral head becomes flat in shape and the left is proper, the bone structures of the right femoral head and the periphery of the acetabulum become sharp, the clearance of the right hip joint becomes narrow and the left is proper. Double hip MRI (2017.08.07 home 09302) show: 1. ischemic necrosis of bilateral femoral head; 2. bone marrow edema between the femoral head, neck and trochanter on the right side; 3. the right hip joint cavity is filled with liquid.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, dampness-heat stasis; and (3) Western diagnosis: bilateral femoral head necrosis (ARCO II phase)

After the pill is admitted, various examinations are perfected, the treatment is carried out according to syndrome differentiation of traditional Chinese medicine and the principle of simultaneous treatment of principal and subordinate symptoms according to the conditions of long-term drinking, endogenous dampness and heat and obstruction of collaterals by a patient, and the treatment method comprises the steps of clearing heat and promoting diuresis, promoting blood circulation and removing meridian obstruction and removing blood stasis and promoting tissue regeneration. After 1 week of taking the pill prepared in example 2 of the present invention, the patient complained that the right hip pain was not suitable to be relieved, the hip joint function was improved, and the pain and discomfort were still felt during the functional exercise, and the oral treatment was continued by taking the pill prepared in example 2 of the present invention. The user can walk with double crutches while keeping leaning on the body and can do proper functional exercises by pulling the skin of the lower limbs. The pain of the right hip of the patient is obviously relieved earlier in 2017, 8 and 21 days, the hip joint function is improved earlier, the general condition is good, the overall condition is improved, and the patient requires to be discharged from the hospital and is approved by a superior doctor to be discharged from the hospital. Attention is paid after discharge: 1. walking with double crutches, and performing bedside traction with double lower limbs for 30 minutes and 3 times a day; 2. advocate avoiding wind, cold and dampness, not tired, preventing trauma, and exercising proper functions; 3. the oral treatment of the pill prepared in example 1 of the present invention was continued, and liver function and kidney function were periodically reviewed. After three months of reexamination, the hip basically has no pain, the function and the activity are good, the daily life and the work can be satisfied, and the function of the liver and the kidney is not abnormal.

Clinical case 3: wuyi, sex male, age 52, national Han nationality, current address: the Henan province, yellow county, high Dioxian village. The patients suffered from pain in the left knee joint in 2017 in 5 months, were diagnosed with hyperosteogeny in the high dike and country health institute for double knee joint DR, and were applied with plaster (not detailed) for 5 months (during the period of pain in the right knee joint in 2017 in 7 months), without pain in the knee joint being relieved. 20 days before the pain of the double hip joints, the MRI, DR and the DR of the double hip joints are performed in the first subsidiary hospital of Zhengzhou university 10 and 18 days in 2017, the bilateral femoral head necrosis and the degenerative change of the double knee joints are diagnosed without treatment, and the vascular dredging operation is performed in a certain hospital in Zhengzhou city later, so that the pain is not relieved. In 2017, 11, 8 days later, the hospital is admitted: lameness, pain in the hips and knees with limited hip function, prolonged walking, aggravation after fatigue, severe pain at night, frequent squatting, easy sleep, easy conditioning, red tongue with yellow and greasy coating, and smooth and rapid pulse.

Special examination: the knee joint walking pain is negative on the left and right of the Mains disease, the knee joint grinding test is negative on the left and right of the lateral test, the knee joint grinding test is negative on the left and right of the knee joint, the knee joint moves normally, the midpoint tenderness in the groin on two sides, no tenderness and percussion pain on the greater trochanter on two sides, the tenderness of the gluteus medius on two sides, the tenderness of the starting point of the iliotibial band on two sides, the negative of the pelvic squeezing and separating test, the left and right of the sign of '4' are positive, the left and right of the sign of Tomasie is positive, the sign of Ailisse is positive, and the left and right of the sign of the whole castle is positive. The muscle strength of the two lower limbs is III level, the left side of the perimeter of the 10cm muscle of the two lower limbs is 50cm, the right side of the perimeter is 52cm, the maximum distance between two ankles is 92cm, the relative length of the two lower limbs is 98cm, and the mobility of the two hip joints is as follows: the left side is bent for 110 degrees, the right side is bent for 95 degrees, the outer left side is rotated for 20 degrees, the right side is rotated for 15 degrees, the inner left side is rotated for 20 degrees, the right side is rotated for 15 degrees, the left side is extended and the right side is retracted for 30 degrees, and the user squats.

Auxiliary examination of the double hip and knee joints DR examination (2017.10.18 first subsidiary Hospital of Zhengzhou university): ischemic changes in the bilateral femoral head, bilateral sacroiliac arthritis? Degenerative changes in the knee joints. Double hip MRI (2017.10.18 zhengzhou university first subsidiary hospital) shows: 1. bilateral femoral head necrosis, and edema of femoral neck, intertrochanteric and greater and lesser trochanteric bone marrow on both sides. 2. A little bone marrow edema 3 in right acetabulum and a little effusion in bilateral marrow joints. Left knee MRI (2017.11.09 at home): l, left knee femoral external condyle bone infarction, 2, left knee femoral internal ankle and tibia near-end local bone ischemia stove, 3, left patellar chondromalacia, 4, a small amount of effusion in left knee joint cavity and patellar upper capsule, 5, left knee inboard meniscus posterior horn tear, 6, left knee patellar anterior subcutaneous soft tissue edema, 7, left knee degenerative osteoarthritis. Double hip CT (2017.11.09 at Hospital) show: 1. ischemic necrosis of femoral head at two sides 2, effusion of double hip joint cavity. Bone densitometry (2017.11.09 at the Hospital) shows: t value (left hip): -0.7, normal bone mass.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, dampness-heat stasis; and (3) Western diagnosis: bilateral femoral head necrosis (left and right ARCO III phase)

After hospitalization, various examinations are perfected, and combined with that the patient is middle-aged male, the patient is good for long-term smoking and drinking, the diet is fat, sweet, thick and greasy, damp and heat is generated in the interior, and the blood are blocked in the pulse channel, so that the circulation of qi and blood is not smooth, the circulation and transformation are not enough, the liver and the kidney are injured for a long time, the liver and the liver control tendons, the kidney controls bones, the liver and the kidney are damaged, the muscles and bones are not nourished, the bone is dead and the marrow is reduced, the bone erosion is caused, the tongue is red, the tongue coating is yellow and greasy, the pulse is rapid, and the syndrome is identified as damp-heat stasis. The pill prepared in the embodiment 3 of the invention is orally taken 3 times a day, 9g each time, and is taken according to the treatment based on syndrome differentiation of traditional Chinese medicine, the principle of simultaneous treatment of principal and subordinate symptoms is followed, and the treatment methods are heat clearing, dampness removing, blood circulation promoting, collateral dredging and blood stasis removing and tissue regeneration promoting. In 2017, day 11 and day 22, the general condition of the patient is good, walking pain of double knee joints, pressing pain of midpoints of femurs at two sides, pressing pain of gluteus medius at two sides and pressing pain of starting points and stopping points of iliotibial bands at two sides are all relieved, and the mobility of the double hip joints is as follows: the left side l15 degrees is flexed, the right side is 100 degrees, the left side is rotated to 25 degrees, the right side is rotated to 20 degrees, the left and right sides of abduction and adduction are 35 degrees, the operation is better, the function is improved, the patient requires discharge, and the patient is approved by a superior physician to be discharged. Attention is paid after discharge: 1. leaning on the double-crutch to walk and properly exercise the functions; 2. advising not to fatigue, preventing trauma, taking hormones with caution; 3. the medicine is continuously taken for oral treatment, and the liver function and the kidney function are periodically rechecked. After three months of reexamination, the hip is basically free of pain, the function and the activity are good, the daily life is not influenced, and the functions of the liver and the kidney are not abnormal.

Clinical case 4: wang a certain, male, age 51 years old, national Han nationality, Henan province, Baoyeng county, Zhao Zhuang village people. The patient has no obvious reason to cause left hip pain and discomfort in 2017, 2, 5 and visits a certain local clinic, is diagnosed as lumbar disc herniation and is caused by pressing sciatic nerve, and is not improved after being orally taken for 3 months by related traditional Chinese medicines (detailed medicines) which are not shown in detail. Then, the patient goes to the national hospital in Baofeng county and is confirmed to be 'lumbar disc interrogation prominent' through lumbar MRI and is not treated. Then, the patient goes to a Jinboda hospital to see a doctor, and the left femoral head necrosis is diagnosed and is not treated. The patient is diagnosed in 11 days 7 and 7 months in 2017 in a national hospital of Baofeng county, and the patient is confirmed to be 'avascular necrosis of the femoral head on the left' through hip joint MRI and is not treated. Then the patient is in the hospital. Admission symptoms are as follows: lameness, soreness and discomfort of the left hip, prolonged walking, aggravation after fatigue, relief after rest, mental clarity, spiritual and sleep, normal stools, red tongue with yellow and greasy coating, and wiry and slippery pulse.

Special examination: left hip soreness, pain in the left groin, bilateral "4" trials: positive on the left and negative on the right. Mobility of the double hip joints: right side: flexion is 120 °, backward extension is 15 °, adduction is 25 °, abduction is 30 °, internal rotation is 15 °, external rotation is 25 °, left side: flexion is 120 degrees, extension backward is 15 degrees, adduction is 25 degrees, abduction is 30 degrees, internal rotation is 10 degrees, and external rotation is 25 degrees. Relative length of both lower limbs: 96cm on the left side, 95.5cm on the right side, and the circumference of the patella of the two lower limbs at the position of 10 cm: left 47cm, right 49cm, lower limb muscle strength: left grade III, right grade iv, full denburg: and (4) positive. Thomasgy characteristics: negative, positive for ehrlich.

Auxiliary examination of pelvic Positive axial position sheet (2017.11.09 Hospital No. 067973): the left femoral head has a proper shape, the bone density in the femoral head is not uniform, the trabecular bone is fuzzy, a sac-like low-density image and a spot-like high-density image can be seen, and the left hip joint gap is proper; no obvious abnormality is seen in the bone structure, density and hip joint clearance of the right hip joint. Hip MRI (2017.11.09 hospital No. 12277) show: 1. left avascular necrosis of the femoral head: 2. abnormal signals in the femoral head on the right side are considered synovium hernia 3. effusion in the double hip joint cavity (left side is great) 4. hydroncus of the femoral head on the left side, femoral neck, intertrochanteric and femoral shaft upper segment bone marrow: 5. abnormal signals at bilateral greater trochanter femoral muscle attachments, considering inflammation: 6. bilateral ischial internal abnormal signals, synovial hernia is considered; 7. the abnormal signal of right sacroiliac articular surface, consider right sacroiliac arthritis, please combine clinical and other relevant examinations. Bone density (2017.11.09 Hospital): 1-4, the average bone density T value of the lumbar vertebra is-0.2, the bone mass is normal, osteoporosis is not seen, and the regular reexamination is recommended.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, dampness-heat stasis; and (3) Western diagnosis: left femoral head necrosis (ARCO stage II)

After the patient is hospitalized, various examinations are perfected, and the patient is easy to generate internal dampness, stagnates for a long time and generates heat, and blocks the veins, blood circulation is not smooth, muscles and bones are not nourished, the tongue is red, the tongue coating is yellow and greasy, and the pulse is wiry and smooth and is the symptom of damp-heat and blood stasis. According to the treatment based on syndrome differentiation of the traditional Chinese medicine, the principle of simultaneous treatment of principal and subordinate symptoms is followed, the treatment method is that heat clearing and dampness removing, blood circulation promoting and vein relaxing and blood stasis removing and tissue regeneration promoting are adopted, and the pill prepared by the embodiment 4 of the invention is orally taken 3 times a day, 9g each time. In 2017, day 11 and day 21, the patient generally has good condition, the pain of the left hip is relieved compared with that of the patient who is admitted, the function is improved, the sleep can be received, the condition is adjusted for two times, the patient is improved integrally, the patient requires to be discharged, and the patient is approved by a superior physician to be discharged. Attention is paid after discharge: 1. leaning on the double-crutch to walk and properly exercise the functions; 2. hormones should be used with cautions for avoiding tiredness and trauma; 3. the medicine is continuously taken for oral treatment, and the liver function and the kidney function are periodically rechecked. After three months of reexamination, the hip is basically painless, the function activity is good, the daily life is not influenced, and the function of the liver and the kidney is not abnormal.

Clinical case 5: jiang a certain person, male, 46 years old, national Han nationality, Guangxi province, county, dragon and town. The patient has no obvious reason to cause right hip joint pain in 10 months in 2014, and then the patient can seek treatment in national hospitals in county of the whole state. The femoral head necrosis is confirmed and suggested to be treated by the operation, and the patient does not receive the treatment. The patient came to my hospital, and admission symptoms were as follows: lameness, right hip joint pain, difficulty in squatting, aggravation after long-term fatigue, relief after rest, mental clarity, spiritual ability, sleep improvement, easy conditioning, normal stool, red tongue with yellow and greasy coating, and wiry and slippery pulse.

Special examination: the tenderness in the groin on the right side is obvious, the percussion pain is generated at the greater trochanter on the right side, the muscle strength of the double lower limbs is right IV grade and left V grade, the Thomas sign is positive, the right side is positive in the whole castle sign, the right side 4-shaped test is not completed, the left side 4-shaped test is positive, the Ailis sign is positive, the right lower limb has the buckling deformity, and the mobility of the double hip is as follows: left side: abduction 20 °, adduction 10 °, flexion 110 °, internal rotation 10 °, external rotation 10 °, right side: abduction 5 °, adduction 0 °, flexion 100 °, internal rotation 0 °, external rotation 0 °.

Auxiliary examination, double hip positive axial position sheet (2017-10-11 Hospital 068760): the right femoral head becomes flat in shape, the volume is obviously smaller than that of the left femoral head, the bone density in the right femoral head and the acetabulum is uneven, a sac-like low-density image and a spot-like high-density image can be seen, the right hip joint gap is narrowed, the periphery of the acetabulum and the femoral head can be seen with hyperosteogeny, and the bone structure, density and hip joint gap of the left hip joint are not obviously abnormal. Double hip CT (No. 119956, 2017-10-11 in Hospital) shows: 1. ischemic necrosis of right femoral head and acetabulum; 2. right hip osteoarthritis; 3. effusion in the cavity of the double hip joint.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, dampness-heat stasis; and (3) Western diagnosis: right femoral head necrosis (ARCO IV phase)

After the patient is hospitalized, various examinations are perfected, and the patients are combined with the ages and complaints of the patients, the patients are addicted to diet for a long time, the patients are fattened, sweet and thick, the spleen and the stomach are damaged, the water dampness is transported and dissolved to be disregulated, the patients are easy to generate internal dampness, the dampness blocks the qi activity, the obstruction causes pain, the dampness is heavy and turbid, the lower limbs are sunken and trapped, the damp evil is stagnated to be transformed into heat for a long time, the vein is blocked, the blood circulation is not smooth, the tendons and the bones and the marrow are not nourished, the tongue is red, the tongue is yellow and greasy, and the pulse is wiry and slippery. According to the treatment based on syndrome differentiation of the traditional Chinese medicine, the principle of simultaneous treatment of principal and subordinate symptoms is followed, the treatment method is that heat clearing and dampness removing, blood circulation promoting and vein relaxing and blood stasis removing and tissue regeneration promoting are adopted, and the pill prepared by the embodiment 5 of the invention is orally taken 3 times a day, 9g each time. After the medicine is taken for 5 days, the pain of the right hip and the knee joint of a patient is obviously relieved compared with the pain of the right hip and the knee joint, the function of the hip joint is improved, and the patient rarely suffers from pain and discomfort during functional exercise, and the medicine is continuously taken. The pain of the right hip of the patient is obviously relieved in 2017, 10 and 18 days, compared with the pain of the patient when the patient is admitted, the hip joint function is improved earlier, the general condition is good, the overall disease condition is improved, the patient requires to be discharged, and the patient is allowed to be discharged after the approval of a superior doctor. Attention is paid after discharge: 1. leaning on the double-crutch to walk and properly exercise the functions; 2. hormones should be used with cautions for avoiding tiredness and trauma; 3. the medicine is continuously taken for oral treatment, and the liver function and the kidney function are periodically rechecked. After three months of reexamination, the hip is free from pain, the function and the activity are good, the daily life is not influenced, and the functions of the liver and the kidney are not abnormal.

It should be noted that the pills for treating the syndrome of dampness-heat and blood stasis due to femoral head necrosis prepared in embodiments 1 to 5 of the present invention are replaced with the traditional Chinese medicine pills for treating the syndrome of dampness-heat and blood stasis due to femoral head necrosis prepared in embodiments 6 to 9 of the present invention, so that the same experimental effects as described above can be achieved.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and it will be apparent to those skilled in the art that various modifications and variations can be made in the formulation and preparation process of the present invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A pill for treating femoral head necrosis damp-heat stasis syndrome is characterized in that: the pill comprises a traditional Chinese medicine composition for treating the syndrome of dampness-heat and blood stasis of femoral head necrosis, and the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 411 to 447 parts of flower of abelmoschus manihot, 197 to 229 parts of giant knotweed, 93 to 121 parts of rhubarb, 42 to 60 parts of amur corktree bark, 44 to 62 parts of cape jasmine fruit, 44 to 62 parts of peach kernel, 22 to 35 parts of catechu and 22 to 35 parts of cassia bark;

0.5-3 parts of starch and 8-20 parts of honey are also added into each 100 parts of the traditional Chinese medicine composition.

2. The pill for treating the syndrome of femoral head necrosis with damp-heat stasis according to claim 1, wherein: 417-441 parts of abelmoschus manihot; 203-223 parts of giant knotweed.

3. The pill for treating the syndrome of femoral head necrosis with damp-heat stasis according to claim 1, wherein: 99-115 parts of rheum officinale; 48-54 parts of phellodendron; 50-56 parts of gardenia.

4. The pill for treating the syndrome of femoral head necrosis with damp-heat stasis according to claim 1, wherein: 50-56 parts of peach kernels; 25-32 parts of catechu; the cinnamon accounts for 25-32 parts.

5. The pill for treating the syndrome of femoral head necrosis with damp-heat stasis according to claim 1, wherein: 429 parts of abelmoschus manihot; 213 parts of giant knotweed; 107 parts of rhubarb; 51 parts of phellodendron; 53 parts of gardenia; 53 parts of peach kernel; the catechu is 29 parts; 29 parts of cinnamon.

6. A preparation method of pill for treating femoral head necrosis with syndrome of damp-heat and blood stasis comprises: the method is characterized in that: the pill for treating the femoral head necrosis damp-heat stasis syndrome is prepared according to any one of claims 1 to 5; the preparation method comprises the following steps:

pulverizing the raw materials and mixing uniformly to obtain powder;

mixing and stirring 100 parts of the powder, 0.5-3 parts of starch, 8-20 parts of honey and 25-40 parts of pure water, and then preparing wet pills.

7. The preparation method of the pill for treating femoral head necrosis damp-heat stasis as claimed in claim 6, wherein: drying the wet pills until the moisture content is below 5 wt% to obtain plain pills, coating the plain pills with activated carbon, and polishing with talcum powder, wherein 0.35-0.55 part of activated carbon and 0.35-0.55 part of talcum powder are used for each 100 parts of plain pills.