CN112206271A

CN112206271A - Medicine formula for treating femoral head necrosis

Info

Publication number: CN112206271A
Application number: CN202011101939.9A
Authority: CN
Inventors: 李金祥
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-10-15
Filing date: 2020-10-15
Publication date: 2021-01-12

Abstract

The invention discloses a medicine formula for treating femoral head necrosis, which comprises the following medicine components: olibanum, Myrrha, Eupolyphaga Seu Steleophaga, Carthami flos, radix Angelicae sinensis, sanguis Draxonis, Pyritum, Pyrolusitum, Notoginseng radix, radix Dipsaci, radix aucklandiae, Eucommiae cortex, Achyranthis radix, rhizoma Drynariae, rhizoma Ligustici Chuanxiong, ramulus Cinnamomi, lignum sappan, Catechu, rhizoma corydalis, and artificial Moschus. The medicament formula of the invention adopts natural traditional Chinese medicine components, is a pure traditional Chinese medicine preparation, and has low cost and no toxic or side effect. The components in the medicine are scientifically compatible and mutually synergistic, so that the effects of tonifying kidney and strengthening bones, promoting blood circulation and removing obstruction in channels, relieving swelling and pain and the like can be realized, the effects of purgation and tonification are simultaneously realized, the evil is dispelled without damaging the body resistance, and the purpose of treating both principal and secondary aspects is achieved.

Description

Medicine formula for treating femoral head necrosis

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a medicine formula for treating femoral head necrosis.

Background

The femoral head necrosis is called aseptic necrosis of femoral head or avascular necrosis of femoral head, it is because different causes, destroy the blood supply of femoral head, lead to bone cell, bone marrow cell, hematopoietic cell and adipocyte of femoral head because of avascular necrosis, the nutrition of bone tissue is interrupted, cause a series of pathological changes such as femoral head density increase or decrease, osteocystic change, fracture of trabecular bone, collapse of femoral head finally, etc., it is a common disease of hip joint, it is a bone injury difficult disease with extremely high disability rate, the operation is still used extensively as the main method of the treatment, but the iatrogenic damage brought by this can't be avoided either.

Ischemic necrosis of femoral head belongs to the categories of 'bone erosion', 'bone bi', 'bone atrophy' and 'thigh Pivot bi' in the traditional Chinese medicine. The traditional Chinese medicine holds that: the five internal organs and six internal organs of the human body, limbs and bones are connected with each other through meridians and collaterals, and the meridians and collaterals can conduct information, convey qi and blood, and maintain the growth, development, repair and normal physiological functions of bone tissues, so that the disease of femoral head necrosis is related to the strength of kidney qi on one hand and the state of collaterals in bones on the other hand.

Under normal conditions, the collaterals in the bones are smooth and unobstructed, and can circulate qi and blood in the bones, thereby playing an important role in the growth, development and repair of the bones. In pathological conditions, the disease has a plurality of etiological factors, and the traditional Chinese medicine considers that the internal factors are the physical weakness of the organism and the low disease resistance, and the pathological changes relate to the liver, the spleen and the kidney. Kidneys are the innate root, governing the bone to produce marrow, and kidney healthy to produce marrow, and marrow full to strengthen bone. On the other hand, the marrow withers and the bone is withered, and the regeneration ability is lost. The liver governs tendons and stores blood which is homologous with kidney, and both of them are good and weak. If the liver is affected and blood is stored abnormally, the blood volume cannot be regulated normally, the blood is not operated well, and nutrition is difficult to be supplemented, which is an important factor for causing femoral head necrosis. The spleen governs transportation and transformation, and fails to transport and transform without qi source, so that muscles, bones and muscles are all grown without qi. Osteoporosis caused by insufficiency of essence and blood of liver, spleen and kidney is a potential cause of ischemic necrosis of femoral head; the external factors include unexpected trauma, chronic strain, invasion of six excesses, seven emotions, food stagnation or taking of the drugs for curing the diseases, which cause the disturbance of qi and blood circulation, the stagnation of qi and blood, the stasis of channels and vessels, the disturbance of blood circulation, the loss of nutrition of limbs and the decline of regeneration and repair ability, thus causing the paralysis pain due to the loss of muscle and bone. For example, in Yun from class syndrome control and discipline arthralgia syndrome: "all arthralgia … … are due to deficiency of ying-wei-qi and interstitial space, and wind-cold-dampness attacking the interior. Healthy qi is obstructed by pathogens and cannot be passed, so stagnation of qi and blood can lead to stagnation of qi and blood, which can lead to arthralgia after a long time.

In summary, the necrosis of the femoral head is caused by the invasion of pathogenic wind-cold-dampness due to the decline of the body, the deficiency of the liver and kidney, the lack of close striae, the weakness of the wei-defense and the marrow, the blockage of the meridians and collaterals and the blockage of the blood vessels to the joints, which causes the disease, the dull pain and dull pain of the hip joints or the peripheral joints, the aggravation after the movement and the further development of the disease can cause the functional disorder of the hip joints.

Disclosure of Invention

Based on the background, the invention summarizes the causes of the femoral head necrosis mostly caused by deficiency, toxicity and stasis on the basis of clinical practice and exploration for more than 10 years, so the invention treats the femoral head necrosis by the foundational theory of tonifying kidney and strengthening bones, promoting blood circulation and removing obstruction in channels and relieving swelling and pain, and provides a medicinal formula for treating the femoral head necrosis, which can achieve simultaneous treatment of principal and subordinate symptoms.

The technical scheme of the invention is as follows:

a medicine formula for treating femoral head necrosis comprises the following medicine components: olibanum, Myrrha, Eupolyphaga Seu Steleophaga, Carthami flos, radix Angelicae sinensis, sanguis Draxonis, Pyritum, Pyrolusitum, Notoginseng radix, radix Dipsaci, radix aucklandiae, Eucommiae cortex, Achyranthis radix, rhizoma Drynariae, rhizoma Ligustici Chuanxiong, ramulus Cinnamomi, lignum sappan, Catechu, rhizoma corydalis, and artificial Moschus.

Preferably, it consists of the following drugs in parts by weight: the traditional Chinese medicine composition comprises the following medicines in parts by weight: 15-35 parts of frankincense, 15-35 parts of myrrh, 12-32 parts of ground beeltle, 6-25 parts of safflower, 9-25 parts of angelica, 10-28 parts of dragon's blood, 12-35 parts of native copper, 12-32 parts of pyrolusite, 10-33 parts of pseudo-ginseng, 15-35 parts of discontinuous, 6-22 parts of costus root, 15-35 parts of eucommia bark, 12-33 parts of achyranthes root, 8-25 parts of drynaria rhizome, 6-24 parts of ligusticum wallichii, 12-33 parts of cassia twig, 8-25 parts of sappan wood, 12-35 parts of catechu, 10-30 parts of rhizoma corydalis and 0.2-3 parts of artificial musk.

Preferably, it consists of the following drugs in grams by weight: it is composed of the following medicines by weight: 15-35 g of frankincense, 15-35 g of myrrh, 12-32 g of ground beetle, 6-25 g of safflower, 9-25 g of angelica, 10-28 g of dragon's blood, 12-35 g of native copper, 12-32 g of pyrolusite, 10-33 g of pseudo-ginseng, 15-35 g of discontinuous, 6-22 g of costus root, 15-35 g of eucommia bark, 12-33 g of achyranthes root, 8-25 g of drynaria rhizome, 6-24 g of chuanxiong rhizome, 12-33 g of cassia twig, 8-25 g of sappan wood, 12-35 g of catechu, 10-30 g of rhizoma corydalis and 0.2-3 g of artificial musk.

Preferably, the frankincense, the myrrh and the rhizoma corydalis are all processed by vinegar, and the native copper is processed by calcination.

Preferably, the pharmaceutical formulation is a capsule.

The pseudo-ginseng, the artificial musk, the dragon's blood, the frankincense and the myrrh in the medicine formula are monarch medicines, and the effects of reuniting the sinew and the bone, promoting blood circulation to remove blood stasis, reducing swelling and relieving pain and the like can be realized under the combined action.

Sanqi is the essential herb for traumatology because it can stop bleeding and activate blood circulation, so it can stop bleeding without retaining stasis. Recorded in Ben Cao gang mu, san Qi is indicated for bleeding stopping, bleeding dispersing, pain relieving, incised wound, traumatic injuries and crutch sore, bleeding stopping; modern pharmacological research proves that the traditional Chinese medicine composition has good hemostatic and hematopoietic effects, and can improve microcirculation and inhibit thrombosis; and it also has anti-inflammatory and analgesic effects.

Musk, pungent and warm in flavor, extremely fragrant in smell, strong in nature of moving, has strong effects of inducing resuscitation and stopping, promoting blood stasis in blood, opening choking of channels and collaterals, and has good effects of activating blood and resolving masses, and relieving swelling and pain. Compendium of materia Medica: "unblock orifices, open meridians and collaterals, penetrate muscle and bone". The musk has the effect of activating channels and collaterals, can exert the potential specific repair function of an organism and promote the repair of the femoral head of necrotic bone.

The dragon's blood enters blood system exclusively, and has the functions of promoting blood circulation, removing blood stasis, relieving pain, astringing, stopping bleeding and promoting granulation. Can be used for treating traumatic injury, pain due to blood stasis due to internal injury, and hemorrhage due to external injury. Modern pharmacological research proves that the traditional Chinese medicine composition also has the effects of resisting inflammation and thrombus and promoting wound healing. The original menstrual period was: the formula for "Xue Jie", which is used together with Ru Xiang and Wu Yao in yang-tonifying herbs, is used to regulate blood and qi without stagnation and toxin accumulation. "

Frankincense, radix seu folium Olibanum, rhizoma Gastrodiae, radix astragali. Blood stasis and blood stasis can relieve pain, spasm and stretching muscles, swelling and sore, growing muscles, so it has the actions of alleviating pain, stretching muscles, relieving swelling and promoting granulation. Modern pharmacology proves that the traditional Chinese medicine composition has obvious effects of resisting inflammation, reducing blood fat and relieving pain.

Myrrha, dissipating blood stasis, alleviating pain, promoting the subsidence of swelling, and promoting granulation. It is pungent and bitter with the actions of dispersing and purging, similar to Ru Xiang, with the actions of dispelling blood stasis and dissipating blood. Modern pharmacology proves that the traditional Chinese medicine composition has obvious effects of resisting inflammation, reducing blood fat and relieving pain. Has obvious detumescence effect on blood stasis and swelling caused by trauma. The composition is used together with frankincense to treat qi and blood, and has the effects of dredging channels and collaterals, promoting blood circulation, removing blood stasis, relieving swelling, alleviating pain, healing sore and promoting granulation.

The eucommia bark, the teasel root, the rhizoma drynariae and the ground beeltle in the medicine formula are ministerial medicines, and the effects of tonifying liver and kidney and strengthening tendons and bones can be realized.

Eucommia bark, cortex Eucommiae tonifies liver and kidney, and strengthens tendons and bones. In Yun Zhong, Du Zhong tonifies liver and kidney, and reaches qi and blood of lower muscles and bones in the book Ben Cao Zhen. The liver governs tendons, the kidney governs bones, the kidney governs tendons, the liver governs tendons, and the tendons are strong and flexible. The record of Shen nong Ben Cao Jing: eucommia bark is used for treating lumbago, strengthening the middle-jiao, benefiting vital essence and strengthening bones and muscles.

Teasel root is pungent and mild in property, has the functions of tonifying liver and kidney, strengthening tendons and bones, treating fracture and breaking powder, has the functions of promoting blood circulation, removing blood stasis, warming and tonifying, strengthening bones and muscles, and has the functions of promoting reunion of fractured bones, treating injury and relieving pain. Modern pharmacology proves that the traditional Chinese medicine composition has the effects of improving osteoporosis, promoting bone injury healing, delaying aging, resisting inflammation, relieving pain and resisting coagulation. The herbal Zhenzhen: xu Duan, the first herb to dredge qi, blood, tendons and bones, is also called xu Duan. The fact that eucommia bark is sweet and warm is good at tonifying and nourishing but not moving. Xu Duan is pungent, bitter and warm in property, good at activating blood and unblocking collaterals and tonifying and moving well. The two medicines are combined to multiply the pharmacology and tonify without stagnation.

The bone fragment can invigorate blood circulation, dissipate blood stasis, relieve swelling and pain, reunion of fractured bones, and is called as the essential drug of the traumatology because it enters kidney to treat bone and can treat bone fracture. Materia Medica Shi Yi: mainly for fracture and bone fracture. "(this Jing Chang Shu": rhizoma Drynariae (Kaibao Ben Cao) has the main actions of breaking blood, stopping bleeding and tonifying wound, so it can not make stagnant blood stagnation and flowing person go recklessly and tonify Juques wound and fold, as it is not tasted to hurt and fold. Modern pharmacology proves that the rhizoma drynariae directly acts on bones, accelerates callus growth, enhances bone metabolism and promotes bone growth. Has effects in promoting bone absorption of calcium, increasing blood calcium and phosphorus levels, and promoting bone calcification and bone formation. Can improve the function of chondrocytes and delay the degenerative change of osteocytes. Has beneficial regulation effect on the expression of related genes such as transforming growth factor, bone morphogenetic protein and the like in the bone healing process.

Ground beetle can break blood and remove stasis, reunion of fractured tendons and bones, is a key herb in traumatology, and can be used for traumatic injury, fracture and pain due to muscle and tendon injury, and can dispel blood stasis, relieve pain and reunion of bones and muscles. The book Ben Cao Jing Shu Yun: for traumatic injury, it has special effect to reunite the muscles and bones, it can enhance the efficacy of promoting blood circulation, removing blood stasis and relieving pain when used together with native copper, frankincense, myrrh, etc., and can promote new bone generation and strengthen tendons and bones when used together with eucommia bark, dipsacus root, drynaria rhizome, etc.

Eucommia bark, teasel root, drynaria rhizome and ground beetle have the functions of tonifying liver and kidney essence and blood, and have strong conditioning effects on development and growth of bones, metabolism, repair and remodeling of fractures on the one hand, and have the functions of warming and strengthening kidney and governing yang qi, and supporting the healthy energy to drive out evil, and yin is filled with yang and is exuberant, so that the evil can be driven out, and the evil can be defended from invading again.

The Chinese angelica, the ligusticum wallichii, the safflower, the sappan wood, the catechu, the native copper and the pyrolusite in the medicine formula are adjuvant medicines, and the effects of promoting blood circulation to remove blood stasis, dredging collaterals and relieving pain can be realized.

Dang Gui Gan Bu Xin san has the action of nourishing blood and promoting blood circulation. The book materia medica justice cloud: dang Gui is sweet and heavy in flavor, so it can tonify blood, and its qi is light and pungent, so it can move blood, tonify middle energizer and tonify middle energizer, and is good for qi in blood and holy herbs in blood. Modern pharmacology proves that the angelica has the function of promoting hematopoiesis and has obvious effect of inhibiting the hematopoiesis function of bone marrow caused by chemical drugs and radioactive rays.

Chuan Xiong is pungent and warm and dry, so it is good at walking and has the actions of activating blood and moving qi. The book materia Medica is as follows: chuan Xiong is good at dispersing and moving liver meridian and blood and qi. Rihuazi Bencao: "treat one stroke, all qi, all strain, all blood, tonify five internal organs, strengthen tendons and bones, regulate the channels of the masses, break mass and old blood, nourish new blood, promote the growth of flesh, … …". Modern pharmacological research can excite the phagocytic function of the central nervous endothelium system and improve the disease resistance, thereby being beneficial to the recovery of arthritis, and the traditional Chinese medicine has the effects of enhancing blood circulation, resisting platelet aggregation, reducing blood viscosity, inhibiting thrombosis, calming, relieving pain and the like. Dang Gui and Chuan Xiong can tonify qi and blood, so they can not treat arthralgia first but nourish qi and blood first for the reason of long-term arthralgia, swelling, pain and deformation of joints and stiffness. The compatibility of Chinese angelica and Szechuan lovage rhizome, promoting blood circulation, nourishing blood and promoting qi circulation, and moistening dryness to supplement each other, the moistening of Chinese angelica can be used for preparing pungent-dryness Chinese ligusticum rhizome, and the pungent-dryness Chinese ligusticum rhizome can prevent the greasiness of Chinese angelica, so that blood stasis can be removed without damaging qi and blood, and the blood can be nourished without causing blood stasis and qi stagnation.

Safflower has the functions of promoting blood circulation, dredging meridian, eliminating blood stasis and relieving pain. Modern pharmacology proves that the safflower has the effects of expanding blood vessels, improving microcirculation, increasing the number of open capillaries, accelerating the blood flow rate of microcirculation, reducing blood fat, resisting blood coagulation, improving the hypoxia tolerance of organisms and improving the local environment of a damaged part.

Caesalpinia sappan, salty in flavor and salty in property and entering blood system, has the effects of activating blood and removing stasis, and relieving swelling and pain, and can be used for treating traumatic injury, fracture and tendon injury, stasis and swelling pain, and the like. It is a commonly used herb in traumatology's department in treatment of … … bleeding, and is used in combination with native copper, dragon's blood, frankincense, myrrh, drynaria rhizome, teasel root, etc. to strengthen the actions of activating blood circulation, dissipating blood stasis, relieving pain, tonifying kidney, setting bone and healing wound.

Catechu, bitter and astringent in flavor and cool in nature, has the effects of promoting blood circulation, removing blood stasis, astringing, stopping bleeding, promoting granulation, and healing sore. Modern pharmacology proves that the medicine has the effects of resisting platelet aggregation, resisting thrombosis, resisting radiation, increasing white blood cells and resisting tumors, and has the effects of protecting liver, benefiting gallbladder, improving the sense and detoxifying.

Innominate abnormal qi entering liver and kidney meridians, it can dispel blood stasis, alleviate pain, activate blood, relieve swelling, stop bleeding and promote tissue regeneration. Article Hui Jing Yao (essence of article): "bone and meat reunion". "," Kaibao Ben Cao ": ' Zhu jin Jiang can break internal injury, alleviate pain and promote muscle growth. "(Ben Cao Jing Shu): the unknown abnormal salty taste can enter blood, sweet taste can enrich blood, and cold property can remove heat, so jin Jiang can break internal injury and alleviate pain and grow muscles. Compendium of materia Medica: "moisture vapor collection". Modern pharmacology proves that the traditional Chinese medicine composition has the effects of promoting the proliferation of fracture repair cells, increasing the activity of osteoblasts, inducing the synthesis of Bone Morphogenetic Protein (BMP) and accelerating fracture healing.

Pyritum is pungent and dispersing in flavor and moves blood system of liver channel, and has the actions of dissipating blood stasis, knitting bone and alleviating pain, so it is good at reuniting bone and is the essential herb for traumatology because it enters liver and kidney channel, and liver governs tendons and kidney governs bones. Modern pharmacology proves that the traditional Chinese medicine composition has a promoting effect on fracture healing, can promote callus growth and improve fracture resistance.

The costustoot, the cassia twig, the achyranthes root and the corydalis tuber in the medicine formula are used as guiding drugs, and the effects of warming channels, activating arthralgia and smoothening qi can be realized.

Mu Xiang is pungent in flavor and bitter in property and warm in nature, and can smooth qi movement and qi circulation to move blood, so it can alleviate pain. Compendium of materia Medica: mu Xiang is a medicine for the triple energizer and qi system and can ascend and descend. The book of medical science: mu Xiang is fragrant in ventilating and combines with five zang organs, and is the essential herb for regulating qi.

Ramulus Cinnamomi warms and unblocks meridians, and has the effects of supporting yang, regulating qi, dispelling wind-cold, dispelling wind and eliminating dampness. The Benjing Shu Zheng (the sparse meridians): gui Zhi can promote joint movement, warm meridians and unblock collaterals, so it is also indicated for its action. Su Wen and Yin Yang corresponding manifestation bibliographic theory says that thick taste induces diarrhea, thick qi induces fever, pungent flavor induces stagnation and sweet flavor induces deficiency. So it is also indicated for it can harmonize the striae, descend qi to dispel adverse flow, alleviate pain and relieve restlessness. The cover has six steps: the Chinese traditional medicine is like harmonizing camp, activating yang, promoting water, descending qi, discharging phlegm and supplementing center. The miscellaneous records of famous physicians: the action of "Xuan Zhi Bai Yao" is combined with the actions of activating blood, moving qi and warming yang to enhance the action of warming yang and promote the growth of qi and blood.

Achyranthes root, radix Achyranthis bidentatae removes blood stasis, promotes menstruation, tonifies liver and kidney, strengthens muscles and bones, and draws blood downward. It is mainly responsible for the lower blood component, prefers to benefit blood and promote blood circulation, and combines with Du Zhong to dominate the lower qi component, which is good at tonifying kidney qi. Modern pharmacology proves that achyranthes can play roles of strengthening bones and resisting osteoporosis by promoting the proliferation of osteoblasts.

Corydalis tuber has the functions of promoting blood circulation, promoting qi circulation and relieving pain. Yan Hu Suo is a miraculous one in compendium of materia Medica, which is specially used for treating pain of upper and lower parts of the body because Yan Hu Suo can promote qi stagnation in blood and qi stagnation in qi and blood. It is combined with Tu Biao, Zi ran Tong and mu Xiang to remove blood stasis, alleviate pain, promote qi and blood circulation, promote absorption of dead bone and promote generation of new bone.

By adopting the technical scheme, the beneficial effects are as follows:

the medicament formula of the invention adopts natural traditional Chinese medicine components, is a pure traditional Chinese medicine preparation, and has low cost and no toxic or side effect. The components in the medicine are scientifically compatible and mutually synergistic, so that the effects of tonifying kidney and strengthening bones, promoting blood circulation and removing obstruction in channels, relieving swelling and pain and the like can be realized, the effects of purgation and tonification are simultaneously realized, the evil is dispelled without damaging the body resistance, and the purpose of treating both principal and secondary aspects is achieved.

Detailed Description

Embodiment 1 a pharmaceutical formulation for treating femoral head necrosis, which comprises the following drugs in parts by weight: 15-35 parts of frankincense, 15-35 parts of myrrh, 12-32 parts of ground beeltle, 6-25 parts of safflower, 9-25 parts of angelica, 10-28 parts of dragon's blood, 12-35 parts of native copper, 12-32 parts of pyrolusite, 10-33 parts of pseudo-ginseng, 15-35 parts of discontinuous, 6-22 parts of costus root, 15-35 parts of eucommia bark, 12-33 parts of achyranthes root, 8-25 parts of drynaria rhizome, 6-24 parts of ligusticum wallichii, 12-33 parts of cassia twig, 8-25 parts of sappan wood, 12-35 parts of catechu, 10-30 parts of rhizoma corydalis and 0.2-3 parts of artificial musk.

1. The frankincense, the myrrh and the rhizoma corydalis are all processed by vinegar, and the native copper is calcined and processed. The processing steps are as follows:

1) vinegar milk gum: mixing Olibanum 100kg with vinegar 5kg, stirring, standing, parching in a super-container until the surface is bright, taking out, and cooling.

2) Vinegar myrrh: mixing cleaned Myrrha per 100kg Olibanum with 5kg vinegar, stirring, standing thoroughly, parching in a super-container until the surface is bright, taking out, and cooling.

3) Vinegar rhizoma corydalis: mixing cleaned rhizoma corydalis with Olibanum 20kg per 100kg, stirring, sealing thoroughly, parching in a super-container until the surface is bright, taking out, and cooling.

4) Calcining Pyritum: calcining Pyritum to dark red, immediately penetrating into rice vinegar, quenching with vinegar until the surface is black brown, and the luster disappears and is loose, taking out, drying, and crushing. Per 100kg of native copper, 30kg of vinegar is used.

2. The preparation of the medicine formula is capsules, and the production process flow is as follows:

1) pulverizing precious and fine medicinal materials

Pulverizing Notoginseng radix and sanguis Draxonis into fine powder of 20-40 meshes, and pulverizing into fine powder of 80-100 meshes.

2) Grinding artificial musk in a mortar, and sieving the ground artificial musk through a 100-mesh sieve.

3) Uniformly mixing the powder obtained in the step 2) with the powder obtained by grinding the pseudo-ginseng and the dragon's blood in the step 1) in an equivalent progressive manner, wherein an equivalent progressive method is that when the proportion of the two components is very different, the component with small amount and the other components with equivalent amount are simultaneously placed in a mixer for uniform mixing, and then sequentially amplifying and diluting in an equal time until all the components with large amount are added.

4) Mixing other materials, pulverizing into 20-40 mesh, further pulverizing, and sieving with 80-100 mesh sieve.

5) Mixing the pseudo-ginseng, the dragon's blood and the artificial musk mixed in the step 3) with the sieved medicinal materials in the step 4) by using a mixer, and rotating for 30 minutes.

6) Sterilizing the mixed medicinal materials obtained in the step 5).

7) Filling the sterilized medicinal materials in the step 6) into capsules, then carrying out ionization sealing and bottling.

Years of clinical practice experiments prove that the traditional Chinese medicine composition has a good curative effect on treating femoral head necrosis.

Example 2: toxicity testing of capsules prepared with the pharmaceutical formulations of the present invention

The test is mainly used for observing acute toxic reaction generated after animals orally administer the capsules prepared by the prescription formula of the invention.

The tested animals of the test are Kunming mice of 18-0.7055oz, half of male and female, which are provided by the center of experimental animals in Hebei province. Before the experiment, the mice were left in the experimental environment for 3 days, and during the experiment, the mice were fed with solid feed, free drinking water, laboratory temperature: 20-25 ℃, relative humidity: 40-60 percent.

The test process comprises the following steps: the test drug was orally administered to mice 2 times a day 1 at intervals of 13.3g/kg for each time and 6 hours for each time, and the total dose was 26.7g/kg, and the toxicity, body weight, food intake and death in mouse 14 were observed.

As a result: the mice show normal behavior after oral administration, and death does not occur within 14 days; after the observation period, the mice were sacrificed for necropsy, and no obvious abnormality was observed in each major organ.

And (4) conclusion: the mice do not die after being administered 26.7g/kg of the drug one day, and the drug belongs to a practical nontoxic level.

Example 3: next, 134 experimental cases were introduced to demonstrate the therapeutic effect.

1. Patient data

In the experimental case, the femoral head necrosis patients diagnosed from 2006 to 2019 are screened according to the inclusion standard and the exclusion standard, and 134 femoral head necrosis patients meeting the diagnosis condition are extracted.

1) Inclusion criteria for laboratory patients

(1) The age is 18-65 years old;

(2) the standard of diagnosis basis is met;

(3) accords with the dialectical classification standard of traditional Chinese medicine.

2) Exclusion criteria for laboratory patients

(1) Under 18 years of age or over 65 years of age;

(2) cases not within the scope of drug action;

(3) patients with temporary apathy, femoral head epiphyseal slippage, bone tuberculosis and the like;

(4) a woman in lactating or preparing pregnancy;

(5) allergic constitution or people allergic to various drugs (the medicine);

(6) patients with serious primary diseases such as cardiovascular disease, cerebrovascular disease, liver disease, kidney disease, hemopoietic system, endocrine system, etc. and psychosis;

(7) combined with other treatments;

(8) patients who need hormone therapy due to primary disease during treatment.

3) Patient diagnostic criteria

Reference to the standard of curative effect of diagnosis of traditional Chinese medicine diseases (first edition 10 months 2012, published by Chinese medicine science and technology) issued by the State administration of traditional Chinese medicine

Firstly, obvious history of hip trauma is available; ② there is no history of hip trauma and there are long-term hormone taking, excessive drinking, etc.; ③ hip pain, mainly at the origin of the internal adductor muscle, which can be continuous or intermittent, and can radiate pain downwards to the knee joint; the walking is difficult, lameness is formed, and the progressive aggravation is realized; hip joint dysfunction, mainly limited internal rotation and external expansion, and surrounding tissue cramps of passively moving hip joints; sixthly, the density change of the femoral head and the collapse of the femoral head in the middle and later period can be seen through X-ray radiography examination.

4) Dialectical diagnosis standard of traditional Chinese medicine

Qi stagnation and blood stasis: hip pain, severe pain at night, stabbing pain without moving, and difficulty in flexion and extension of joints. Dark tongue with petechia, wiry or deep and unsmooth pulse.

② liver and kidney deficiency type: dull and continuous hip pain, stiff joints, restlessness, insomnia, thirst, dry throat and flush face. Red tongue with thready and rapid pulse.

5) Standard of pathological stage

Referring to the 'standard of curative effect for diagnosing traditional Chinese medicine symptoms' (first edition of 10 months in 2012, China pharmaceutical science and technology publishing agency) issued by the State administration of traditional Chinese medicine, the ischemic necrosis of the femoral head is divided into 6 stages according to the X-ray representation;

stage I: the hip is asymptomatic, with slightly increased density, or spot-like areas of increased density, in the femoral head of the X-ray film.

And stage II: the hip is asymptomatic, with a significant increase (in whole or in part) in bone density in the X-ray strands, and no collapse.

Stage III: the symptoms are slight, and subchondral fracture or crescent moon signs exist in the femoral load bearing area of the X-ray film.

And IV, period: hip pain, paroxysmal or persistent, lameness and limited function, flattening of the X-ray femoral head or collapse of the dead bone area.

Stage V: the pain of the hip is obvious, the necrotic bone of the X-ray film is broken, the gap of the hip joint is narrow, and the bone density is harder.

Stage VI: the pain of the hip is severe, some pains are relieved in stage V, and the femoral head of the X-ray sheet is hypertrophic and deformed, subluxation, unsmooth acetabulum or even hardened and proliferated.

Through the above standard, 134 patients with femoral head necrosis meeting the diagnosis condition are screened out in total, wherein 105 male patients and 29 female patients are screened out; the age is 18-65 years, and the average age is 45.59 years; 42 cases on one side and 92 cases on both sides; wherein, the hormone is 30 cases, the alcohol is 65 cases, the traumatic type is 12 cases, the mixed type is 18 cases, and the congenital dysplasia is 9 cases; 111 cases of qi stagnation and blood stasis, 23 cases of liver and kidney deficiency, 1 case in stage 2, 2 cases in stage 3, 40 cases in stage 4, 48 cases in stage 5 and 43 cases in stage 6.

2. Patient treatment

The capsules prepared by the oral administration of the pharmaceutical formula are adopted by 134 cases of femoral head necrosis patients selected by the extraction, 7 capsules are taken once, and 3 times a day. During the period of the drug treatment, the patient stops using hormone drugs, avoids drinking, reduces the load of the femoral head on the affected side, and properly cooperates with the load-free function exercise.

The course of treatment is as follows: 3 months is a course of treatment, and the follow-up visit and the observation of the curative effect are carried out after 3 courses of treatment.

3. Treatment of conditions

1) Criteria for efficacy assessment

Refer to the guiding principles of clinical research on new Chinese medicine (Zhengxian Yu, China pharmaceutical science and technology publishing agency (first edition of 2002, 5 months) issued by the State administration of traditional Chinese medicine), and specifically refer to the first table.

Evaluation standard of disease curative effect

The effect is shown: pain is eliminated and joint movement is not limited.

The method has the following advantages: pain was substantially eliminated and joint movement was mildly limited.

And (4) invalidation: the pain and the joint movement are not obviously improved.

② evaluation standard of curative effect by X-ray examination

And (3) healing: the X-ray indicates recovery to normal.

The effect is shown: the X-ray showed a clear improvement, essentially approaching normal.

The method has the following advantages: the X-ray shows an improvement.

And (4) invalidation: the X-ray was unchanged.

Table one: evaluation standard of clinical curative effect of femoral head necrosis

2) According to the above standards, 134 selected femoral head necrosis patients are observed, and according to the pain degree before and after treatment, the hip joint function activity condition, the walking condition, the change of symptoms and physical signs and the change of X-ray representation of bilateral hip joints, the accurate curative effect of the invention in the clinical femoral head ischemic necrosis treatment is summarized.

After treatment, repeated diagnosis and follow-up visit for 3 treatment courses, the evaluation results of 134 patients treated by the method according to the above standards are as follows: 52 cases of obvious effect account for 38.8 percent; 77 effective cases account for 57.5%, and 5 ineffective cases account for 3.7%.

The syndrome differentiation and typing of the traditional Chinese medicine (see the table II): 111 cases of qi stagnation and blood stasis type, 44 cases with obvious effect, 63 cases with effect and 4 cases with no effect; the drug is effective in 23 cases of liver and kidney deficiency type, 8 cases of the drug are effective, 14 cases of the drug are effective, and 1 case of the drug is ineffective.

② etiology classification curative effect statistics (see table III): 30 hormone types, 10 obvious effects, 19 effective cases and 1 ineffective case; 65 cases of alcohol types, 25 cases with obvious effect, 37 cases with effective effect and 3 cases with ineffective effect; 12 cases of traumatic type, 6 cases of obvious effect and 6 cases of effective effect; 18 mixed types, 8 obvious effective cases and 10 effective cases; 9 cases of dysplasia, 3 cases of marked effect, 5 cases of effective effect and 1 case of ineffective effect.

Thirdly, statistics of the pathological typing curative effect (see table four): stage II, 1 case, and 1 case with obvious effect; stage III 2 cases, and obvious effect 2 cases; in the IV period, 40 cases, 24 cases, 15 cases and 1 case are effective; stage V48, 29 cases with obvious effect, 18 cases with effect and 1 case with no effect; VI stage 43, show effect 7, effective 33, ineffective 3.

Table two: statistics of differential classification curative effect of traditional Chinese medicine

Table three: etiology classification curative effect statistics

Table four: statistics of therapeutic effects of pathological typing

Example 4: typical cases

Case 1: zhao, Man, 54 years old, Qin Huang island city Changli county. The patients are mainly diagnosed in 1 year to 11, 12 days in 2014 due to limited activities and lameness of right hip joint pain. The capsule prepared by the medicine formula of the invention is orally taken for about 1 year, the increase shadow of the bone density of the femoral head on the right side is obviously reduced, the bone density on the left side is obviously improved, and the clinical symptoms and the functions of the bilateral hip joint are obviously improved.

Case 2: yi in Yi (some of the Chinese characters), Man in 63 years old, and people in Qian' an city in Tang shan. The left hip joint pain is mainly accompanied by limited activity and lameness, and the diagnosis is given in 9 months and 9 days in 2014. The symptoms gradually worsen, stabbing pain does not move, activity is limited, lameness is caused, and the symptoms worsen after activity. After the capsule prepared by the medicine formula of the invention is orally taken for 15 months, the increase shadow of the bone density of the left femur head is obviously reduced, the bone density is obviously improved, the bone density of the right femur head is uniform, and the clinical symptoms and the functions of the bilateral hip joint are obviously improved.

Case 3: changzhi, women, 46 years old, Qinhuang island city sea and harbor people. The patients mainly suffer from limited activity and lameness in the right hip joint in 6 years and then see the patients in 8-19 months in 2014. It belongs to the dysplasia of bilateral hip joints. The capsules prepared by the medicine formula of the invention are orally taken for about 1 year, and fibrous tissues are filled in the bone density reduction area of the femoral head on the right side. Follow-up examination is respectively carried out after 2 years and 4 years, the low-density area is further filled, the articular surface is smooth, the clinical symptoms and the functions of the right hip joint are obviously improved, and the left side is effectively prevented without reoccurrence.

Case 4: shen some, men, 36 years old, Qian' an city people, whose main reasons are that the left side hip pain is severe, the knee joint pain is gradually aggravated for 2 years, and the patient is diagnosed in a hospital of 2012 8 month and 6 days since the half year of the double-crutch walking difficulty, the upper gastrointestinal bleeding splenectomy caused by the liver cirrhosis of the affected liver 2 years ago, the left side hip pain is severe, the knee joint pain, the double-crutch walking difficulty during the diagnosis, and the function is severely limited. X-ray shows that: the right hip joint clearance exists, the femoral head bone density is uneven, the bone texture is disordered, and the shape is good; the absorption of the left femoral head disappears, the density of the femoral neck bone is uneven, the trabecular bone is broken and is pulled out to the upper part, and the inner side of the femoral head is provided with a 3.0 x 2.0cm bone density increasing area. After the patient takes the capsules prepared by the medicine formula of the invention orally for 1 year and 2 months, the symptoms and hip joint functions are obviously improved. 11/19/2014X-ray review: the bone density and the bone texture of the right femur head are basically normal; the left side is obviously absorbed by the dead bone, the new bone surface part is formed, and the patient does not lean on the double crutches after being treated, and the activity and the symptoms are obviously improved.

The medicine formula and the prepared capsule are pure traditional Chinese medicine preparations, and can achieve the effects of recovering blood circulation of femoral head, regaining nutrition of necrotic femoral head, carrying out metabolism, absorbing necrotic bone cells and growing new bones by promoting blood circulation, strengthening bones and dredging collaterals. The medicines are combined to activate blood and dredge collaterals, tonify kidney and strengthen bones, reduce swelling and relieve pain, treat both principal and secondary aspects of diseases, perform purgation and tonification simultaneously, and eliminate pathogenic factors without damaging vital qi.

The medicine formula and the prepared capsule are established for the patients with qi stagnation, blood stasis and liver and kidney deficiency type ischemic necrosis of femoral head, have no toxic or side effect, and are safe and reliable in clinical application. However, it is contraindicated for patients with bleeding tendency, pregnant women, and lactation period. The capsule has obvious curative effect after being taken for 1 month generally, and has obvious curative effect for users according to the course of treatment. The capsule is generally taken for 3 months as a treatment course, and generally 3 treatment courses are required. The treatment effect can be ensured only by giving up the inducement and not bearing the weight during the administration.

Implementation 5: over the years, many patients who are treated by the invention have femoral head necrosis.

In the patients who are treated by medical treatment, drinking is the most common cause of femoral head necrosis, poor liquor is mostly drunk, and loose white liquor is frequently drunk, and in most of the 30-60-year-old men, the recovery of the illness state is better as long as drinking is abstained; secondly, patients who take glucocorticoid mostly have rheumatism diseases, and in order to relieve limb joint pain, hormone medicines are taken all the year round, and the patients are not self-known and are examined and diagnosed in hospitals when hip pain is discovered. Generally, the curative effect is poor, and long-time administration is needed for treating rheumatic diseases at the same time, so that the patients account for 11.9 percent; the curative effect of the trauma patient is more ideal, and after the capsule is taken for 3-6 months, the fracture healing and the new bone growth of the femoral head can be seen.

Generally, patients taking the capsules for half a year are reexamined, patients in early stage (stage I or stage II) are cured, clinical symptoms disappear, no positive sign exists, and the growth of the femoral head with trabecula bone is confirmed by an X-ray film, and the femoral head does not continuously deform. The middle stage (stage III or V) patients have the advantages that most symptoms are obviously relieved, the lower limb dysfunction is obviously improved, the double crutches can be removed, the necrotic femoral head is filled in a saccular area, new bones grow, and the collapsed femoral head does not continuously collapse. Patients in later stage (stage V or VI) can basically take care of their lives, walk with double crutches, recover the function of lower limbs, and have dead bone absorption and new bone growth on the femoral head as confirmed by X-ray pictures.

After the capsule of the invention is taken for 1 year, the examination is repeated, the early patient basically has no clinical symptoms, and the lower limb function activity is normal. The symptoms of the patients in the middle stage are further improved, the lower limb functions are basically recovered to be normal, and no yang signs exist. The hip joint gap is not narrowed by the X-ray film, the formation of new bone zone is seen, and the bone trabecula grows continuously. The patients in the late stage have stable disease conditions and do not further worsen, the clinical symptoms and physical signs are all improved, and the lower limb functions are obviously improved. The hip joint space is not narrowed by X-ray film, and the femoral head is covered by the new bone belt.

Patients with complications have slow improvement, need to treat the complications actively, and have certain curative effect.

To sum up: the medicine formula and the prepared capsule have the advantages of nourishing liver and kidney, strengthening bones and muscles, relaxing muscles and tendons, promoting blood circulation, promoting qi circulation and removing blood stasis according to traditional Chinese medicine theory, method, formula and medicine formula, are a pure traditional Chinese medicine preparation, and are very suitable for treating liver and kidney deficiency type and qi stagnation and blood stasis type ischemic necrosis of femoral head caused by various reasons. Through years of clinical effect observation, gradually adjusting the prescription, repeatedly screening, optimizing and refining.

The medicine of the invention has definite curative effect for years after clinical application, can control the relapse of diseases, changes the blood supply around the osteonecrosis to a certain extent, stimulates the regeneration function of dead bones, further the kidney is filled with bone and is firm, the tendons and vessels are unobstructed, the bones nourish essence and blood, the osteonecrosis is filled with blood supply, the backflow is unobstructed, the clinical cure is achieved, and the relapse is avoided after the cure.

The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to enable one skilled in the art to make and use various exemplary embodiments of the invention and various alternatives and modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.

Claims

1. The formula of the medicine for treating femoral head necrosis is characterized by comprising the following medicinal components: olibanum, Myrrha, Eupolyphaga Seu Steleophaga, Carthami flos, radix Angelicae sinensis, sanguis Draxonis, Pyritum, Pyrolusitum, Notoginseng radix, radix Dipsaci, radix aucklandiae, Eucommiae cortex, Achyranthis radix, rhizoma Drynariae, rhizoma Ligustici Chuanxiong, ramulus Cinnamomi, lignum sappan, Catechu, rhizoma corydalis, and artificial Moschus.

2. The pharmaceutical formulation for treating femoral head necrosis according to claim 1, which is prepared from the following drugs in parts by weight: 15-35 parts of frankincense, 15-35 parts of myrrh, 12-32 parts of ground beeltle, 6-25 parts of safflower, 9-25 parts of angelica, 10-28 parts of dragon's blood, 12-35 parts of native copper, 12-32 parts of pyrolusite, 10-33 parts of pseudo-ginseng, 15-35 parts of discontinuous, 6-22 parts of costus root, 15-35 parts of eucommia bark, 12-33 parts of achyranthes root, 8-25 parts of drynaria rhizome, 6-24 parts of ligusticum wallichii, 12-33 parts of cassia twig, 8-25 parts of sappan wood, 12-35 parts of catechu, 10-30 parts of rhizoma corydalis and 0.2-3 parts of artificial musk.

3. The pharmaceutical formulation for treating femoral head necrosis according to claim 1, which comprises the following drugs in weight gram: 15-35 g of frankincense, 15-35 g of myrrh, 12-32 g of ground beetle, 6-25 g of safflower, 9-25 g of angelica, 10-28 g of dragon's blood, 12-35 g of native copper, 12-32 g of pyrolusite, 10-33 g of pseudo-ginseng, 15-35 g of discontinuous, 6-22 g of costus root, 15-35 g of eucommia bark, 12-33 g of achyranthes root, 8-25 g of drynaria rhizome, 6-24 g of chuanxiong rhizome, 12-33 g of cassia twig, 8-25 g of sappan wood, 12-35 g of catechu, 10-30 g of rhizoma corydalis and 0.2-3 g of artificial musk.

4. The pharmaceutical formulation for treating femoral head necrosis according to claim 1, wherein the frankincense, the myrrh and the rhizoma corydalis are all processed by vinegar, and the native copper is processed by calcination.

5. The pharmaceutical formulation for treating femoral head necrosis according to claim 1, wherein the pharmaceutical formulation is a capsule.