CN108888659B - Traditional Chinese medicine composition and pill for treating femoral head necrosis blood stasis and qi stagnation syndrome and preparation method thereof - Google Patents

Traditional Chinese medicine composition and pill for treating femoral head necrosis blood stasis and qi stagnation syndrome and preparation method thereof Download PDF

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CN108888659B
CN108888659B CN201810973563.7A CN201810973563A CN108888659B CN 108888659 B CN108888659 B CN 108888659B CN 201810973563 A CN201810973563 A CN 201810973563A CN 108888659 B CN108888659 B CN 108888659B
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femoral head
pill
blood stasis
stagnation
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CN108888659A (en
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曹玉举
张大鹏
郭永昌
张鑫杰
陈喜凤
王俊发
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ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
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Abstract

The invention discloses a traditional Chinese medicine composition and a pill for treating femoral head necrosis blood stasis and qi stagnation and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 197-229 parts of corydalis tuber, 127-155 parts of fennel, 64-82 parts of artemisia anomala, 86-104 parts of white peony root, 84-102 parts of herba lycopi, 86-104 parts of red peony root, 84-102 parts of angelica, 64-82 parts of rhizoma drynariae, 64-82 parts of epimedium and 37-53 parts of tribulus terrestris. The traditional Chinese medicine composition disclosed by the invention takes corydalis tuber and fennel as monarch drugs, artemisia anomala, white paeony root, red paeony root, herba lycopi and Chinese angelica as ministerial drugs, rhizoma drynariae and epimedium as adjuvant drugs and tribulus terrestris as a conductant drug, so that the traditional Chinese medicine composition has the effects of activating blood circulation to remove stasis, promoting qi circulation to relieve pain, soothing liver and relieving depression, also has the effects of treating wound to continue fracture, strengthening tendons and bones and tonifying qi and blood, performs both reinforcing and purging, treats both principal and secondary aspects of diseases, and has a remarkable curative effect on the femoral head necrosis, blood stasis and qi stagnation syndrome.

Description

Traditional Chinese medicine composition and pill for treating femoral head necrosis blood stasis and qi stagnation 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, blood stasis and qi stagnation 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 femoral head necrosis can be divided into traumatic osteonecrosis and non-traumatic osteonecrosis, the traumatic osteonecrosis refers to hip fracture caused by various reasons, and the main inducers of the non-traumatic femoral head necrosis are drinking and a large amount of hormone. If the treatment is improper, about 80% of patients can develop femoral head collapse within 1-4 years, and then develop serious hip osteoarthritis, and hip joint replacement has to be adopted. Femoral head necrosis occurs in young and strong years of 20-50 years old, and the average age is 36 years old, which brings inconvenience to life of patients and seriously harms the health of young and strong years.
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. Modern medical research has proved that intravascular coagulation is an important cause of the onset of femoral head necrosis, and at least one abnormality in coagulation or fibrinolysis accounts for 82.2% of osteonecrosis patients. The pathological histological research of the osteonecrosis shows that hematopoietic cells of the necrotic and bone marrow cavity are reduced, necrotic degeneration is observed, and the necrotic degeneration is scattered in calcific foci and fibrous connective tissue is regenerated.
In the existing traditional Chinese medicine research, the syndrome differentiation and the type classification of the femoral head necrosis are mostly classified into blood stasis syndrome and kidney deficiency syndrome, and also the syndrome differentiation is classified into phlegm stasis syndrome and qi and blood deficiency, but the research report on the blood stasis and qi stagnation syndrome is not much. According to the theory of traditional Chinese medicine, qi is the commander of blood, blood is the mother of qi, and qi and blood influence each other, so that qi stagnation can cause blood stasis and can also cause qi stagnation, and clinically, the aim should be fulfilled for blood stasis and qi stagnation at the same time. The causes and pathogenesis of the femoral head necrosis, blood stasis and qi stagnation in traditional Chinese medicine can be summarized as follows: bone fracture and muscle injury after trauma, blood stasis and qi stagnation; or abnormal emotion, such as blood stasis due to qi stagnation, such as liver injury caused by anger and spleen injury; or pathogenic factors affecting the channels and collaterals to cause blood stasis and qi stagnation; or improper diet and improper medication can lead to blood stasis and qi stagnation, obstructed qi and blood circulation, stagnant vein and bone malnutrition. The syndrome of blood stasis and qi stagnation is usually seen in ischemic necrosis of traumatic femoral head and ischemic necrosis of non-traumatic femoral head in early and middle stages. Bone fracture and muscle injury after trauma, blood stasis and stagnation; people with emotional distress, liver-qi stagnation and anxiety damaging the spleen are most likely to cause blood stasis; blood stasis can also be caused by the attack of exogenous pathogenic factors blocking the meridians; improper diet can damage qi and blood and block meridians; people with blood stasis tend to block the circulation of qi, resulting in blood stasis and qi stagnation. Due to blood stasis and qi stagnation, meridians and collaterals are obstructed, so lameness, difficult movement, stabbing pain and distending pain of the hip are seen, and the pain is mild and severe; stagnant blood can cause local pain and even pain at night; mental depression, irritability, distending pain in the chest and hypochondrium, and frequent sighing are symptoms of qi stagnation; dark purple tongue or petechia, thin and white coating, wiry and unsmooth pulse are all the symptoms of blood stasis and qi stagnation.
The clinical manifestations of the femoral head necrosis with blood stasis and qi stagnation are: lameness, difficulty in lower limb movement, hip pain, groin pain, mild or severe pain, distending pain or stabbing pain, or mental depression, irritability, distending pain in chest and hypochondrium, frequent sighing, dark purple tongue or petechia, thin and white tongue coating, and wiry and unsmooth pulse.
A large number of patients with femoral head necrosis caused by blood stasis and qi stagnation are observed in clinic, and the patients with femoral head necrosis caused by blood stasis and qi stagnation suffer great pain and also cause heavy burden to society.
Disclosure of Invention
In view of the above, the traditional Chinese medicine composition for treating the syndrome of femoral head necrosis, blood stasis and qi stagnation 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, blood stasis and qi stagnation selects pure natural traditional Chinese medicine raw materials, corydalis tuber and fennel are taken as monarch drugs, artemisia anomala, white paeony root, red paeony root, herba lycopi and angelica are taken as ministerial drugs, rhizoma drynariae and epimedium are taken as adjuvant drugs, tribulus terrestris is taken as a conductant drug, the action advantages and the mutual synergistic action of the raw materials of the traditional Chinese medicines are comprehensively utilized, the traditional Chinese medicine composition not only has the effects of activating blood circulation, removing stasis, promoting qi, relieving pain, soothing liver and resolving depression, but also has the effects of healing wound, continuing to break, strengthening tendons and bones and nourishing qi and blood, and tonifying qi and nourishing, and the local part of femoral head and qi stagnation is taken into consideration by liver channel guidance drugs, has obvious curative effect on the femoral head necrosis with blood stasis and qi stagnation and is convenient to use.
A traditional Chinese medicine composition for treating femoral head necrosis blood stasis and qi stagnation comprises the following raw materials in parts by weight: 197-229 parts of corydalis tuber, 127-155 parts of fennel, 64-82 parts of artemisia anomala, 86-104 parts of white peony root, 84-102 parts of herba lycopi, 86-104 parts of red peony root, 84-102 parts of angelica, 64-82 parts of rhizoma drynariae, 64-82 parts of epimedium and 37-53 parts of tribulus terrestris.
Further, 201-225 parts of corydalis tuber; 131-151 parts of fennel.
Furthermore, 68-78 parts of diverse wormwood herb; 90-100 parts of white paeony root; 88-98 parts of herba lycopi; 90-100 parts of red paeony root; the weight is 88-98 parts.
Further, 68-78 parts of rhizoma drynariae; 68-78 parts of epimedium; 41-49 parts of tribulus terrestris.
Further, the corydalis tuber is 213 parts; 141 parts of fennel; 73 parts of artemisia anomala; the white paeony root is 95 parts; 93 parts of herba lycopi; the red paeony root is 95 parts; the angelica is 93 parts; 73 parts of rhizoma drynariae; 73 parts of epimedium; 45 parts of tribulus terrestris.
The invention also provides a pill for treating the femoral head necrosis blood stasis and qi stagnation syndrome, which comprises the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis and qi stagnation syndrome.
Furthermore, 2.5-3.5 parts of starch is added into each 100 parts of the traditional Chinese medicine composition.
The invention also provides a preparation method of the pill for treating femoral head necrosis blood stasis and qi stagnation, which comprises the following steps: the pill comprises the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis qi stagnation syndrome; 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, 2.5-3.5 parts of starch and 28-42 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 below 5wt% to obtain plain pills, coating the plain pills with activated carbon, and polishing with talcum powder, wherein 0.45-0.55 part of activated carbon and 0.45-0.55 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 femoral head necrosis blood stasis qi stagnation syndrome and the preparation method thereof have the beneficial effects that:
the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis and qi stagnation syndrome selects pure natural traditional Chinese medicine raw materials, uses corydalis tuber and fennel as monarch drugs, uses artemisia anomala, white paeony root, red paeony root, hiraute shiny bugleweed herb and Chinese angelica as ministerial drugs, uses rhizoma drynariae and epimedium as adjuvant drugs and tribulus terrestris as conductant drugs, comprehensively utilizes the action advantages and the mutual synergistic action of the traditional Chinese medicine raw materials, has the effects of activating blood circulation, removing blood stasis, promoting qi circulation, relieving pain, soothing liver, relieving depression, treating fracture, strengthening tendons and bones and tonifying qi and blood, performs both reinforcing and purging, treats both principal and secondary aspects, aims at the whole manifestation of the femoral head blood stasis and qi stagnation syndrome, takes liver channel drugs and channel-inducing drugs directly to focus, takes care of local femoral head necrosis, has obvious curative effect on the femoral head necrosis blood stasis and qi stagnation syndrome, and is convenient to use. In addition, the pill for treating the femoral head necrosis blood stasis and qi stagnation syndrome 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 blood stasis and qi stagnation comprises the following raw materials in parts by weight:
197-229 parts of corydalis tuber such as 197 parts, 199 parts, 201 parts, 205 parts, 209 parts, 213 parts, 215 parts, 219 parts, 221 parts, 225 parts, 227 parts or 229 parts;
127-155 parts of fennel such as 127 parts, 129 parts, 131 parts, 135 parts, 139 parts, 141 parts, 143 parts, 145 parts, 148 parts, 151 parts, 153 parts or 155 parts;
64-82 parts of diverse wormwood herb, such as 64 parts, 66 parts, 68 parts, 70 parts, 73 parts, 75 parts, 78 parts, 80 parts or 82 parts;
86-104 parts of white peony root such as 86 parts, 88 parts, 90 parts, 92 parts, 95 parts, 98 parts, 100 parts, 102 parts or 104 parts and the like;
84-102 parts of herba lycopi, such as 84 parts, 86 parts, 88 parts, 90 parts, 93 parts, 95 parts, 98 parts, 100 parts or 102 parts;
86-104 parts of red peony root such as 86 parts, 88 parts, 90 parts, 92 parts, 95 parts, 98 parts, 100 parts, 102 parts or 104 parts and the like;
84-102 parts of angelica, such as 84 parts, 86 parts, 88 parts, 90 parts, 93 parts, 95 parts, 98 parts, 100 parts or 102 parts;
64-82 parts of rhizoma drynariae, such as 64 parts, 66 parts, 68 parts, 70 parts, 73 parts, 75 parts, 78 parts, 80 parts or 82 parts;
64-82 parts of epimedium herb such as 64 parts, 66 parts, 68 parts, 70 parts, 73 parts, 75 parts, 78 parts, 80 parts or 82 parts and the like;
37-53 parts of tribulus terrestris, such as 37 parts, 39 parts, 41 parts, 43 parts, 45 parts, 47 parts, 49 parts, 51 parts or 53 parts and the like.
Wherein the rhizoma corydalis is dried tuber of corydalis tuber of Papaveraceae; it is pungent, bitter and warm in flavor; it enters liver and spleen meridians. Rhizoma corydalis has the effects of promoting blood circulation, promoting qi circulation and relieving pain, has good effect on various pains, is particularly suitable for treating arthralgia and myalgia, enters liver channel and has good effect on hernia pain. Pharmacological research proves that the corydalis tuber has good analgesic effect, the analgesic mechanism of the corydalis tuber is related to the central nervous system, and the analgesic effect is weaker than morphine but has no addiction; it also has sedative effect, and has certain dilating effect on femoral artery, and the dilating effect on blood vessel may be one of the reasons for relieving pain. In addition, rhizoma corydalis also has muscle relaxation effect.
Fructus Foeniculi, which is dried mature fruit of Foeniculum vulgare of Umbelliferae; it is pungent and warm in flavor; it enters liver, kidney, spleen and stomach meridians. Fructus Foeniculi has effects of dispelling cold, relieving pain, regulating qi-flowing and regulating stomach; it is mainly used for treating cold hernia with abdominal pain, testis tenesmus, dysmenorrhea, lower abdomen psychroalgia, and abdominal distention and pain. It enters liver meridian, and also warms kidney, dispels cold and relieves pain, so it is suitable for hernia pain.
Herba Artemisiae Anomalae (whole plant of Artemisia Selengensis (L.) Spreng of Compositae); it is pungent, slightly bitter and warm in nature; it enters heart, liver and spleen meridians. Herba Artemisiae Anomalae has effects of removing blood stasis, dredging channels, stopping bleeding, and relieving swelling; it is mainly used for abdominal pain due to blood stasis, abdominal mass, traumatic injury, incised wound hemorrhage, rheumatic arthralgia, carbuncle, sore, toxic swelling, and abdominal pain due to food stagnation. The herbal Zhenzhen: liu Xin is bitter in taste and slightly warm in nature, and can break blood stasis and dredge meridians, remove swelling due to symptoms, and stop bleeding of incised wound, hematochezia and stool, and noxious injury due to fire in decoction. Blood-related factors in the human body are expensive and activate, and stagnation of blood can lead to failure of circulation, which can lead to blood stagnation and even abdominal mass and fullness; when the patient does not move, the blood is retained but not collected, so the blood is good for the patient, and Dan Nu is always the product of breaking blood, so it can break and get through the patient with constipation, and break and get through the patient. Pharmacological studies show that it has the efficacy of relieving smooth muscle spasm.
Radix Paeoniae alba (dry root of Paeonia lactiflora pall. of Ranunculaceae); it is bitter, sour, slightly cold in taste; it enters liver and spleen meridians. Radix Paeoniae alba has effects of nourishing blood, regulating menstruation, astringing yin, arresting sweating, softening liver, relieving pain, and suppressing liver yang; it can be used for treating blood deficiency, sallow complexion, hypochondriac pain, abdominal pain, limb spasm pain, headache, vertigo, etc. Pharmacological research shows that the white peony root has obvious analgesic effect, sedative effect, smooth muscle spasmolytic effect, blood vessel expansion effect, organ blood flow increasing effect, platelet aggregation resistance and anemia improving effect.
Herba Lycopi is dry aerial part of Pachyrhizus Erosi seedling of Labiatae; it is bitter and pungent in flavor and slightly warm in taste; it enters liver and spleen meridians. Herba Lycopi has effects of promoting blood circulation, regulating menstruation, dredging joint and tendons, removing blood stasis, resolving carbuncle, and inducing diuresis to alleviate edema. It is mainly used for treating abdominal pain due to blood stasis, muscle and bone trauma, skin ulcer, carbuncle, toxic swelling, edema and ascites. Pharmacological studies show that the herba lycopi has the effects of improving circulation, reducing blood viscosity and the like.
Radix Paeoniae Rubra (dried root of Paeonia lactiflora pall. or Paeonia veitchii pall. of Ranunculaceae); it is bitter and slightly cold in taste; it enters liver meridian. Radix Paeoniae Rubra has effects of clearing heat, cooling blood, removing blood stasis and relieving pain; it is mainly used for treating nutrient-blood, warm-toxin macula, hematemesis and epistaxis, conjunctival congestion and swelling and pain, liver depression and hypochondriac pain, abdominal mass, traumatic injury, carbuncle, swelling, sore and ulcer. Pharmacological research shows that the red peony root has the functions of resisting thrombosis, resisting platelet aggregation, reducing blood fat, resisting arteriosclerosis and the like.
Radix Angelicae sinensis, which is the dried root of Angelica sinensis (oliv.) Diels of Umbelliferae; it is sweet, pungent and warm in flavor; it enters liver, heart and spleen meridians. The angelica has the effects of enriching blood and activating blood, regulating menstruation and relieving pain, benefiting bones and muscles, treating spasm and the like; it is mainly used for treating blood deficiency, sallow complexion, giddiness, palpitation, asthenia cold, abdominal pain, rheumatalgia, traumatic injury, superficial infection, pyocutaneous disease, etc. The wine-processed radix Angelicae sinensis has effects of promoting blood circulation and dredging channels. Pharmacological research proves that the angelica has the effects of reducing blood fat, resisting atherosclerosis, inhibiting platelet aggregation, promoting the generation of hemoglobin and erythrocyte, relieving pain, resisting inflammation and the like.
Rhizoma Drynariae, which is dried rhizome of Drynariae rhizoma of Polypodiaceae; it is bitter in taste and warm; it enters liver and kidney meridians. Rhizoma Drynariae has effects of healing wound, relieving pain, reuniting bone, invigorating kidney and strengthening bone; can be used for treating traumatic injury, sprain, fracture, lumbago due to kidney deficiency, atrophy-flaccidity of tendons and bones, tinnitus, deafness, and odontoseisis. Pharmacological research shows that the medicine has the effects of promoting the healing of rat bone injury, stimulating compensatory hyperplasia of bone articular chondrocyte, improving degenerative lesion of articular cartilage and the like.
Herba Epimedii is dry leaf of Epimedium brevicornum Maxim, Epimedium sagittatum Maxim, Epimedium pubescens Maxim or Epimedium koreanum nakai of berberidaceae; it is pungent, sweet and warm in flavor; it enters liver and kidney meridians. Herba Epimedii has effects of invigorating kidney yang, strengthening tendons and bones, and dispelling pathogenic wind and dampness; it is mainly used for kidney yang deficiency, flaccidity of bones and muscles, arthralgia due to wind-dampness, numbness and spasm. Pharmacological research shows that epimedium has the functions of reducing blood pressure, reducing blood fat, resisting inflammation, strengthening immunity, etc.
Fructus Tribuli is fruit of Tribulus terrestris of Tribulus family; it is bitter and pungent in flavor and warm in nature; enter liver and lung meridians. Fructus Tribuli has effects of calming liver wind, dispelling liver fire, dispelling pathogenic wind, descending qi, and promoting blood circulation; it is mainly used for treating headache, fullness in chest, cough, mass, carbuncle, etc. The book Ben Cao Hui Yan (treatise on materia Medica): tribulus terrestris, the herb for dispelling wind and descending qi and promoting hydration. It is effective in promoting defecation, promoting circulation, and activating liver and spleen to arrest qi, and can be taken for a long time to remove stagnation. Pharmacological research shows that tribulus terrestris has the effects of resisting arteriosclerosis and platelet aggregation.
The invention adopts treatment methods of promoting blood circulation, removing blood stasis, promoting qi circulation, relieving pain, soothing liver, relieving depression, healing wound, strengthening tendons and bones, tonifying qi and blood and the like aiming at the characteristics of the femoral head necrosis, blood stasis and qi stagnation.
In the raw materials of the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis and qi stagnation syndrome, the corydalis tuber has the effects of promoting blood circulation, promoting qi circulation and relieving pain and can promote qi stagnation in blood; the fructus Foeniculi has effects of dispelling cold, relieving pain and regulating qi-flowing. The two medicines are combined together, have the effects of promoting blood circulation, removing blood stasis, promoting qi circulation, relieving pain, soothing liver and relieving qi stagnation, can treat hernia pain by means of both moving liver meridian, are the same as the pain in the middle point of inguinal region caused by femoral head necrosis, are especially suitable for the syndrome of femoral head necrosis with blood stasis and qi stagnation, and are monarch medicines together.
Herba Artemisiae Anomalae has effects of removing blood stasis, dredging channels, healing wound, promoting blood circulation, relieving pain, and eliminating swelling and stagnation; radix Paeoniae alba has effects of nourishing blood, astringing yin, arresting sweating, promoting blood circulation, removing blood stasis, relieving spasm, softening liver and relieving pain; herba Lycopi has effects in promoting blood circulation, dispelling blood stasis, healing wound, inducing diuresis, relieving swelling, dredging long-term stagnation, benefiting tendons and vessels, nourishing blood and qi, eliminating abdominal mass, promoting granulation, and promoting granulation; radix Paeoniae Rubra has effects of dispersing stagnated liver qi for relieving qi stagnation, clearing heat, cooling blood, removing blood stasis and relieving pain; radix Angelicae sinensis has effects of replenishing blood, promoting blood circulation, regulating menstruation, relieving pain, healing wound, benefiting tendons and bones, and treating spasm. The above medicines are ministerial medicines, and have effects of removing blood stasis, removing stagnation, healing wound, softening liver, promoting qi circulation, relieving pain, invigorating qi and blood, promoting granulation, and dredging joint and tendons.
Rhizoma Drynariae has effects of healing wound, relieving pain, reuniting bone, invigorating kidney and strengthening bone; herba Epimedii has effects of invigorating kidney yang, strengthening tendons and bones, relieving arthralgia, and relieving spasm. The two medicines are used together as adjuvant medicines, and have effects of strengthening tendons and bones, healing wound, removing arthralgia, and relieving pain.
Tribulus terrestris has the functions of purging liver fire, dispelling wind and descending qi, promoting blood circulation and removing stagnation, and removing wind and activating blood circulation, can enhance the effect of monarch drugs, and can lead various drugs to directly reach the focus as guiding drugs.
It should be noted that pain at the femoral head part often occurs during the femoral head necrosis repair process, and physical examination shows pain at the midpoint of the groin. The position of the liver meridian is the same as the position of inguinal hernia pain according to the meridian theory of traditional Chinese medicine. In the invention, the corydalis tuber, the fennel, the tribulus terrestris and the like all enter liver channels and can guide medicaments to directly reach focus, so that the traditional Chinese medicine composition can quickly relieve pain in groin and take effect.
In conclusion, the Chinese medicinal composition for treating the symptoms of femoral head necrosis, blood stasis and qi stagnation selects pure natural Chinese medicinal raw materials, uses the corydalis tuber and the fennel as monarch medicaments, uses the diverse wormwood herb, the white paeony root, the red paeony root, the hiraute shiny bugleweed herb and the Chinese angelica as ministerial medicaments, uses the fortune's drynaria rhizome and the epimedium herb as adjuvant medicaments, uses the tribulus terrestris as a conductant medicament, comprehensively utilizes the action advantages and the mutual synergistic action of the Chinese medicinal raw materials, promotes blood circulation, removes blood stasis, soothes liver, promotes qi, regulates qi and blood, and not only removes blood stasis, but also removes qi stasis and stagnation; removing blood stasis and nourishing blood are applied together, so that the blood circulation is promoted without the worry of blood consumption, and the qi is promoted without the defect of yin impairment; the traditional Chinese medicine composition has the effects of promoting blood circulation, removing blood stasis, promoting qi circulation, relieving pain, soothing liver, relieving depression, healing wound, strengthening tendons and bones, tonifying qi and blood, tonifying and purging, and treating both principal and secondary aspects of diseases; the traditional Chinese medicine composition is used for treating the local femoral head necrosis by aiming at the overall manifestation of the femoral head blood stasis and qi stagnation syndrome and directly reaching the focus with liver meridian medicines and meridian guiding medicines, has obvious curative effect on the femoral head necrosis blood stasis and qi stagnation syndrome and is convenient to use.
Preferably, the corydalis tuber is 201-225 parts; 131-151 parts of fennel.
Preferably, 68-78 parts of diverse wormwood herb; 90-100 parts of white paeony root; 88-98 parts of herba lycopi; 90-100 parts of red paeony root; the weight is 88-98 parts.
Preferably, the rhizoma drynariae accounts for 68-78 parts; 68-78 parts of epimedium; 41-49 parts of tribulus terrestris.
More preferably, the corydalis tuber is 213 parts; 141 parts of fennel; 73 parts of artemisia anomala; the white paeony root is 95 parts; 93 parts of herba lycopi; the red paeony root is 95 parts; the angelica is 93 parts; 73 parts of rhizoma drynariae; 73 parts of epimedium; 45 parts of tribulus terrestris.
The invention also provides a pill for treating the femoral head necrosis blood stasis and qi stagnation syndrome, which comprises the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis and qi stagnation syndrome.
Preferably, 2.5-3.5 parts of starch, such as 2.5 parts, 2.8 parts, 3 parts, 3.2 parts or 3.5 parts, is also added into each 100 parts of the traditional Chinese medicine composition. Preferably, 2 parts of starch and 15 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 femoral head necrosis blood stasis and qi stagnation, which comprises the following steps: the pill comprises the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis qi stagnation syndrome; the preparation method comprises the following steps: and crushing the raw materials and uniformly mixing to obtain powder.
The preparation method also comprises the step of mixing and stirring 100 parts of the powder, 2.5-3.5 parts of starch and 28-42 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 0.45 to 0.55 parts such as 0.45, 0.48, 0.5, 0.52 or 0.55 parts of activated carbon and 0.45 to 0.55 parts such as 0.45, 0.48, 0.5, 0.52 or 0.55 parts 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: 197 parts of corydalis tuber, 155 parts of fennel, 64 parts of artemisia anomala, 86 parts of white paeony root, 84 parts of herba lycopi, 104 parts of red paeony root, 102 parts of angelica, 64 parts of rhizoma drynariae, 82 parts of epimedium and 37 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 2.5 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 28 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 2
(1) Weighing the following traditional Chinese medicine raw materials: 199 parts of corydalis tuber, 153 parts of fennel, 66 parts of artemisia anomala, 88 parts of white paeony root, 86 parts of herba lycopi, 102 parts of red paeony root, 100 parts of angelica, 66 parts of rhizoma drynariae, 80 parts of epimedium herb and 39 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 2.8 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 30 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 0.48 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 3
(1) Weighing the following traditional Chinese medicine raw materials: 201 parts of corydalis tuber, 151 parts of fennel, 68 parts of artemisia anomala, 90 parts of white paeony root, 88 parts of herba lycopi, 100 parts of red paeony root, 98 parts of angelica, 68 parts of rhizoma drynariae, 78 parts of epimedium herb and 41 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 3 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 35 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 0.52 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 4
(1) Weighing the following traditional Chinese medicine raw materials: 205 parts of corydalis tuber, 145 parts of fennel, 70 parts of diverse wormwood herb, 92 parts of white paeony root, 90 parts of hiraute shiny bugleweed herb, 98 parts of red paeony root, 93 parts of Chinese angelica, 70 parts of fortune's drynaria rhizome and 75 parts of epimedium herb, 43 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 3 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 40 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 0.52 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 5
(1) Weighing the following traditional Chinese medicine raw materials: 213 parts of corydalis tuber, 141 parts of fennel, 73 parts of artemisia anomala, 95 parts of white paeony root, 93 parts of herba lycopi, 95 parts of red paeony root, 93 parts of angelica, 73 parts of rhizoma drynariae, 73 parts of epimedium herb and 45 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 3.5 parts of starch is added firstly, the mixture is stirred and mixed for 15min, 35 parts of pure water is added, and the mixture is stirred for about 25min 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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 0.52 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 6
(1) Weighing the following traditional Chinese medicine raw materials: 219 parts of corydalis tuber, 135 parts of fennel, 75 parts of artemisia anomala, 98 parts of white paeony root, 95 parts of herba lycopi, 92 parts of red paeony root, 90 parts of angelica, 75 parts of rhizoma drynariae, 70 parts of epimedium and 47 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 3.2 parts of starch is added firstly, the mixture is stirred and mixed for 15min, 42 parts of pure water is added, and the mixture is stirred for about 25min 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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 7
(1) Weighing the following traditional Chinese medicine raw materials: 225 parts of corydalis tuber, 131 parts of fennel, 78 parts of artemisia anomala, 100 parts of white paeony root, 98 parts of herba lycopi, 90 parts of red paeony root, 88 parts of angelica, 78 parts of rhizoma drynariae, 68 parts of epimedium herb and 49 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 3 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 35 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 8
(1) Weighing the following traditional Chinese medicine raw materials: 227 parts of corydalis tuber, 129 parts of fennel, 80 parts of artemisia anomala, 102 parts of white paeony root, 100 parts of herba lycopi, 88 parts of red paeony root, 86 parts of angelica, 80 parts of rhizoma drynariae, 66 parts of epimedium herb and 51 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 2.8 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 30 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 0.48 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Example 9
(1) Weighing the following traditional Chinese medicine raw materials: 229 parts of corydalis tuber, 127 parts of fennel, 82 parts of artemisia anomala, 104 parts of white paeony root, 102 parts of herba lycopi, 86 parts of red paeony root, 84 parts of angelica, 82 parts of rhizoma drynariae, 64 parts of epimedium herb and 53 parts of tribulus terrestris.
(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 groove mixer (produced by science and technology limited of Tianshuihua Yuan pharmaceutical equipment, Gansu), 3 parts of starch is added firstly, the mixture is stirred and mixed for 15min, and 35 parts of pure water is added and stirred for about 25min, so that a soft material is obtained.
(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) Placing the wet pill in HWL15-1 microwave drying and sterilizing box (produced by Gansu Tianshuihua David pharmaceutical equipment science and technology Co., Ltd.) at 45 deg.C hot air and 90 deg.C in the box, and drying for 60 min to obtain pill with dry water content below 5%.
(6) Placing the above vegetarian pills in a 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 0.52 part of activated carbon and pulvis Talci can be added into each 100 parts of vegetarian pills to obtain the pill.
Comparative example 1
Except for the difference from the example 5, the corydalis tuber is used in 190 parts, the fennel is used in 170 parts, and other components and preparation methods are the same as the example 5.
Comparative example 2
Different from the example 5, the dosage of the diverse wormwood herb is 50 parts, and the dosage of the white paeony root is 120 parts, and other components and the preparation method are the same as the example 5.
Comparative example 3
Different from the embodiment 5, the dosage of the eupatorium japonicum is 80 parts, the dosage of the red paeony root is 120 parts, and other components and the preparation method are the same as the embodiment 5.
Comparative example 4
Different from the example 5, the amount of the angelica is 70 parts, the amount of the rhizoma drynariae is 90 parts, and other components and the preparation method are the same as the example 5.
Comparative example 5
Different from the embodiment 5, the dosage of the epimedium is 58 parts, the dosage of the tribulus terrestris is 60 parts, and other components and preparation methods are the same as the embodiment 5.
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 6g at a time, 3 times a day; 10 days is a treatment course, after continuously using the traditional Chinese medicine composition of the invention for 3 treatment courses, the statistical results are as follows:
TABLE 1
Figure BDA0001776840790000201
Figure BDA0001776840790000211
As can be seen from the above table 1, the Chinese medicinal composition has good effect after treatment, the effective rate is over 84%, and the cure rate is over 70%, so that the pill has good effect on treating the femoral head necrosis, blood stasis and qi stagnation. 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 treats 8 groups of patients (10 patients with femoral head necrosis in each group, age 18-65 years) with the pills prepared in comparative examples 1-5, and the treatment effect is not good or poor (the effective rate is not more than 50%).
Clinical case 1: liu somewhere, male, 24 years old, Anhui province Li Xin county. The patient suffered from right hip pain within 2 months in 2014, had limited activity, and was diagnosed in Zhongshan Hospital in Xiamenmen City, after examination, the patient was diagnosed with right femur head necrosis, and was orally administered with anti-inflammatory, analgesic, blood circulation promoting, and blood stasis removing drugs, and the patient was not significantly improved, and the patient had intermittent pain and increased activity in the posterior hip, and was subjected to comprehensive hospitalization in Guizhong city in Zhengzhou city in 2016, specifically, and the patient had intermittent pain and limited activity in the posterior hip. The Chinese traditional medicine is admitted to our hospital in 2017, 10 and 27 days, and admission symptoms are shown as follows: limping, limited squat, aching pain in the right hip, pain in the right knee, limited mobility, mental clarity, spiritual movement, dark purple tongue with thin and white coating, wiry and unsmooth pulse.
Special examination: the double lower limbs are not swollen, the skin temperature is normal, the midpoint tenderness of the groin on the right side is pressed, the percussion pain at the greater trochanter on the right side is high, the force of the double lower limbs is positive in a 4-shaped test, the stress of the double lower limbs is negative, and the mobility of the double hips is high: the left side abducts 40 degrees, adducts 20 degrees, flexes 140 degrees, rotates 20 degrees, rotates 30 degrees, the right side abducts 20 degrees, adducts 15 degrees, flexes 80 degrees and rotates 5 degrees. Length of both lower limbs: left 90cm, right 91cm, 10cm circumference on patella: the left side 43cm and the right side 41 cm.
Auxiliary inspection: positive pelvic axis, positive right knee lateral DR (2017.10.27068873): the right femoral head becomes 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 density increasing image can be seen, hyperosteogeny can be seen at the periphery of the femoral head at the right side, the gap between the right hip joint becomes narrow slightly, and no obvious abnormality is seen in the left hip joint. The right knee joint clearance is slightly narrowed, and the patella joint clearance is still enough. Double hip MRI (2017.10.2711835) shows: 1. ischemic necrosis of the right femoral head; 2. effusion in the double hip joint cavity; 3. abnormal signals of the left femoral greater trochanter muscle attachment are considered, and inflammation is considered; 4. right femoral head hyperosteogeny.
And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, blood stasis and qi stagnation; and (3) Western diagnosis: 1. right femoral head necrosis (ARCO staging: stage IV) 2. osteoarthritis of the hip joint.
The pill prepared in the embodiment 1 of the invention is taken orally, 3 times a day and 6g each time. The pain of the hip of the patient is relieved after one week, the function is not obviously improved, the pain of the patient is relieved before 2 weeks, the functional activity is improved before, the vital signs are stable, and the patient requires discharge. After discharge, the pill prepared in example 1 of the present invention is continuously taken, exercise is performed with caution, and the liver and kidney function is periodically reviewed. After three months of reexamination, the pain is basically avoided, the function and the activity are good, and the life can be normal.
Clinical case 2: liu Yi in a certain age, male, 10 years old, Han nationality, Puyang county, Henan province. The patient has no obvious induction of right knee paroxysmal pain and lameness in 2015 9 months, and the pain is not relieved after taking the medicine orally (not detailed) for 4 days, considering the normal growth performance by MRI examination in local hospitals. And the pain is relieved after the treatment of half a year by using a abduction bracket for right femoral head epiphysis necrosis in a Luoyang bone-setting hospital. The patient is admitted to our hospital on the 10 th and 12 th days in 2017. Admission symptoms are as follows: lameness, frequent squatting, right hip pain, clear mind, mental retardation, sleep with sleep, normal stool, dark tongue with petechia, thin and white coating, wiry and unsmooth pulse.
Special examination: squatting can, the right inguinal region, gluteus medius muscle do not have the tenderness, the thighbone greater trochanter does not have the percussion pain, two low limbs are isometric, two low limbs muscle power: right grade iii, left normal. Maximum distance between the ankles is 110cm, and the peripatellar diameter is 10 cm: both sides are 31 cm. Mobility of the double hip joints: right-side flexion is 130 degrees, internal rotation is 5 degrees, external rotation is 10 degrees, abduction and adduction are normal, and left-side mobility is optional. The left negative right positive of the "4" test, the whole castle: positive left, negative right, thomas sign, ehies sign.
Auxiliary examination, pelvis positive axial position sheet (2017.10.12062523): the bone density of the right femoral head is not uniform in epiphysis, the trabecular bone is fuzzy, and a cystoid low-density image can be seen; the epiphyseal morphology of the femoral head on the right side becomes flat, and the hip joint clearance is good; the left hip was not significantly abnormal.
And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, blood stasis and qi stagnation; and (3) Western diagnosis: epiphysis necrosis of the right femoral head (type ii).
After admission, the pills prepared in the example 2 of the invention are taken orally 3 times a day, 6g each time. After taking the pill prepared in the embodiment 2 of the invention for 2 weeks, the patient complains about the pain of the right hip and obviously relieves the pain, the hip joint function is improved earlier, the general condition is good, the overall condition is improved, and the patient requires to be discharged, and is approved by the superior physician to be discharged. After discharge, the patient should continue to take the pill prepared in the embodiment 2 of the invention, and lean on walking with double crutches, so that the patient does not tired, prevents trauma and exercises properly. After three months of reexamination, the hip basically has no pain, the function and the activity are good, the daily life can be satisfied, and the function of the liver and the kidney is not abnormal.
Clinical case 3: high certain, sex male, age 42, national Han nationality, current address: henan province and Pian city county. Patients had lameness with pain in the right hip joint and persistent stabbing pain when walking in 2015 12 months, and the pain could be relieved after rest without treatment. The pain was aggravated in 2016 (1 month), and the patients were diagnosed in local hospitals, and the right femur head necrosis and right hip hydrarthrosis were diagnosed after MRI examination, which was not good after oral administration. Then the patient should be admitted to our hospital in 2016 at 3/11. Admission symptoms are as follows: lameness, right hip pain, limited squat, limited functional activity, prolonged walking, aggravation after fatigue, good sleep, easy conditioning, dark purple tongue, thin and white coating, wiry and unsmooth pulse.
Special examination: tenderness in the groin on the right side, percussion pain on the greater trochanter on the right side, grade IV right lower limb muscle strength, positive right-side Tomas sign, "4" test positive, positive Ailis sign, and negative all-Triburg sign.
Auxiliary inspection: pelvic positive axis DR (2016.3.11062470): the right side of the femoral head becomes flat, the 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, the right hip gap is clear, and the left hip is not abnormal. Double hip MRI (2016.2.1161551): 1. ischemic necrosis of the right femoral head; 2. effusion of the right hip joint; 3. edema of the upper bone marrow of the right femur.
And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, blood stasis and qi stagnation; and (3) Western diagnosis: right femoral head necrosis (stage iii).
After the patient is admitted, various examinations are completed, treatment is carried out according to syndrome differentiation of traditional Chinese medicine, and the pill prepared in the embodiment 3 of the invention is taken orally 3 times a day, and 6g is taken each time. In 2016, 24 months, 3 years, the patient generally has good condition, the pain of the right hip is obviously relieved, the movement function of the hip joint is improved, the patient requires discharge, and the patient is approved by a superior physician to be discharged. After the patient is discharged from hospital, the pill prepared in the embodiment 3 of the invention is taken for oral treatment, the liver function and the kidney function are reviewed regularly, the patient keeps leaning on the double-crutch walking, exercises with proper functions, does not fatigue, prevents trauma, and uses hormones with caution. 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: some qiqi, women, age 50 years old, national Han nationality, Anhui province, wen xi county. The patient has no obvious reasons to cause the discomfort of the double hip pain and the hypodynamia with the limited function in 2007 and is not treated. The posterior double hip is interrupted and pain is aggravated due to limited movement, the femoral head necrosis at two sides is diagnosed by MRI examination from 2017 to a local hospital in 4 months, hip joint replacement is recommended, and patients refuse. The pain of the posterior double hips is aggravated and the functional movement is limited. The patient is admitted into the hospital after the treatment, and the admission symptoms are as follows: lameness, difficulty in squatting down, soreness and limitation of the hips, mental clarity, mental capacity, sleep reception, normal stool, dark red tongue with petechia, thin and white coating, wiry and unsmooth pulse.
Special examination: mobility of the double hip joints: right side: flexion is 400 °, backward extension is 5 °, adduction is 5 °, abduction is 5 °, internal rotation is 0 °, external rotation is 0 °, left side: flexion is 30 degrees, extension backward is 5 degrees, adduction is 5 degrees, abduction is 5 degrees, internal rotation is 0 degree, and external rotation is 0 degree. Tenderness in groin on both sides II grade, positive test of "4" on both sides, thomson sign positive, ellis sign positive, muscle strength of both lower limbs: left stage iv, right stage iv.
Auxiliary inspection: pelvic alignment sheet (2017.11.19069107) shows: the bilateral femoral heads become flat, uneven bone density is shown in the acetabulum, the trabecula is fuzzy, a sac-like low-density image and a patch-like high-density image can be seen, hyperosteogeny images can be seen at the peripheries of the bilateral femoral heads and the acetabulum, the gap between the two hip joints becomes narrow, and no abnormality is found. Double hip MRI (2017.11.1912586) show: 1. ischemic necrosis of bilateral femoral head and acetabulum; 2. bilateral hip joint femoral arthritis; 3. uterine abnormalities, myomas.
And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, blood stasis and qi stagnation; and (3) Western diagnosis: 1. bilateral femoral head necrosis (left and right ARCO IV phase) 2. double hip osteoarthritis.
After the patient is admitted, various examinations are perfected, and treatment is carried out according to syndrome differentiation of traditional Chinese medicine, and the pill prepared by the embodiment 4 of the invention is orally taken 3 times a day, and 6g is taken each time. 12 months and 1 day in 2017, the general condition of the patient is good, the hip pain is obviously relieved compared with that of the patient in hospital, the functional activity is improved earlier, the disease condition is improved integrally, and the patient requires to be discharged from the hospital. After discharge, people can keep leaning on the double crutches for walking, exercise moderate functions, avoid fatigue and trauma, use hormones with caution, continue to take the medicine for oral treatment, and periodically review the liver function and the kidney function. After three months of reexamination, the pain of the hip is light, the function activity is good, the daily life is not affected basically, and the function of the liver and the kidney is not abnormal.
Clinical case 5: tian Yi, Man, 47 years old, national Han nationality, Changfeng county, Anhui province. The patient had no obvious cause of left hip pain in 2012 and was left untreated. The diagnosis is made in many places after the year of the year, and the patient is diagnosed as femoral head necrosis in hospital liberty military 105 in 2013 without treatment. The patient is admitted to the hospital in 2017 within 20 months at 6, and admission symptoms are shown as follows: lameness, intermittent pain in the left hip, limited function, difficulty in squatting, mental clarity, sleep accommodation, easy adjustment, normal defecation, dark red tongue, thin and white tongue coating, and wiry and unsmooth pulse.
Special examination: the point tenderness in the groin on the left side is obvious, no tenderness and percussion pain are generated at the greater trochanter on both sides, the gluteus medius tenderness on the left side is negative in the tests of the '4' characters on both sides, Thomas sign negative, Elis sign negative, Tribeberg sign positive on the left side and negative on the right side, the III-grade right side on the left side of the muscle strength of both lower limbs is normal, the muscle circumference of 10cm on the patella of both lower limbs is 42cm, the maximum interval of both ankles is 129cm, and the activity of both hips is as follows: left side: flexion is 130 degrees, external rotation is 20 degrees, internal rotation is 25 degrees, abduction and adduction are normal, and right hip joint mobility is normal.
Auxiliary inspection: pelvic alignment sheet (2017.6.20049893) shows: the medial aspect of the femoral head on both sides shows uneven bone density, a cystoid low-density shadow can be seen, the shape of the femoral head on the left side becomes flat, the edge of the femoral head is technically like a hyperosteogeny shadow, and the gap between the hip joints on both sides can be seen. Double hip MRI (2017.6.20) show: 1. ischemic necrosis of bilateral femoral head; 2. a small amount of liquid is accumulated in the cavity of the double hip joint.
And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, blood stasis and qi stagnation; and (3) Western diagnosis: bilateral femoral head necrosis (left stage III and right stage II of ARCO).
After the patient is admitted, various examinations are completed, treatment is carried out according to syndrome differentiation of traditional Chinese medicine, and the pill prepared by adopting the embodiment 5 of the invention is taken orally 3 times a day, and 6g is taken each time. After taking the medicine for 6 days, the tenderness of the midpoint of the groin on the left side and the tenderness of the gluteus medius on the left side of the patient are both relieved, the left hip joint bends 135 degrees and rotates 25 degrees outwards, the function is improved compared with the prior, and the patient is required to be discharged. After discharge, people can keep leaning on the double crutches for walking, exercise moderate functions, avoid fatigue and trauma, use hormones with caution, continue to take the medicine for oral treatment, and periodically review the liver function and the kidney function. 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.
It should be noted that the pills for treating the femoral head necrosis blood stasis qi stagnation syndrome prepared in embodiments 1 to 5 of the present invention are replaced with the traditional Chinese medicine pills for treating the femoral head necrosis blood stasis qi stagnation syndrome prepared in embodiments 6 to 9 of the present invention, so as to achieve the same experimental effects as described above.
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 (7)

1. A pill for treating femoral head necrosis blood stasis and qi stagnation is characterized in that: the pill comprises a traditional Chinese medicine composition for treating femoral head necrosis blood stasis and qi stagnation; the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 197-229 parts of corydalis tuber, 127-155 parts of fennel, 64-82 parts of artemisia anomala, 86-104 parts of white peony root, 84-102 parts of herba lycopi, 86-104 parts of red peony root, 84-102 parts of angelica, 64-82 parts of rhizoma drynariae, 64-82 parts of epimedium and 37-53 parts of tribulus terrestris;
2.5-3.5 parts of starch is also added into each 100 parts of the traditional Chinese medicine composition.
2. The pill for treating the syndrome of femoral head necrosis with blood stasis and qi stagnation according to claim 1, which is characterized in that: 201-225 parts of corydalis tuber; 131-151 parts of fennel.
3. The pill for treating the syndrome of femoral head necrosis with blood stasis and qi stagnation according to claim 1, which is characterized in that: 68-78 parts of diverse wormwood herb; 90-100 parts of white paeony root; 88-98 parts of herba lycopi; 90-100 parts of red paeony root; the weight is 88-98 parts.
4. The pill for treating the syndrome of femoral head necrosis with blood stasis and qi stagnation according to claim 1, which is characterized in that: 68-78 parts of rhizoma drynariae; 68-78 parts of epimedium; 41-49 parts of tribulus terrestris.
5. The pill for treating the syndrome of femoral head necrosis with blood stasis and qi stagnation according to claim 1, which is characterized in that: 213 parts of corydalis tuber; 141 parts of fennel; 73 parts of artemisia anomala; the white paeony root is 95 parts; 93 parts of herba lycopi; the red paeony root is 95 parts; the angelica is 93 parts; 73 parts of rhizoma drynariae; 73 parts of epimedium; 45 parts of tribulus terrestris.
6. A method for preparing a pill for treating femoral head necrosis with blood stasis and qi stagnation syndrome comprises: the method is characterized in that: the pill is used for treating the symptoms of femoral head necrosis, blood stasis and qi stagnation according to any one of claims 1 to 5; the preparation method comprises the following steps:
crushing the raw materials of the traditional Chinese medicine composition for treating the femoral head necrosis blood stasis qi stagnation syndrome and uniformly mixing to obtain powder;
mixing and stirring 100 parts of the powder, 2.5-3.5 parts of starch and 28-40 parts of pure water, and then preparing into wet pills.
7. The preparation method of the pill for treating femoral head necrosis blood stasis and qi stagnation according to claim 6, wherein the pill comprises: drying the wet pills until the moisture content is below 5wt% to obtain plain pills, coating the plain pills with activated carbon, and polishing with talcum powder, wherein 0.45-0.55 part of activated carbon and 0.45-0.55 part of talcum powder are used for each 100 parts of plain pills.
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