CN108619287B

CN108619287B - Traditional Chinese medicine composition and pill for treating femoral head necrosis and liver deficiency muscle atrophy and preparation method thereof

Info

Publication number: CN108619287B
Application number: CN201810947832.2A
Authority: CN
Inventors: 曹玉举; 张大鹏; 郭永昌; 胡建庚; 宋京博; 张洪赞; 孙宝霞
Original assignee: ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
Current assignee: ZHENGZHOU TRADITIONAL CHINESE HOSPITAL OF ORTHOPAEDICS
Priority date: 2018-08-20
Filing date: 2018-08-20
Publication date: 2021-09-17
Anticipated expiration: 2038-08-20
Also published as: CN108619287A

Abstract

The invention discloses a traditional Chinese medicine composition and a pill for treating femoral head necrosis, liver deficiency, muscle weakness and flaccidity syndrome and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 129-153 parts of prepared fleece-flower root, 129-153 parts of white peony root, 63-83 parts of red peony root, 63-83 parts of angelica, 29-45 parts of Chinese rose flower, 129-153 parts of abrus cantoniensis hance, 63-83 parts of rosewood, 44-60 parts of green tangerine peel, 63-83 parts of parasitic loranthus, 44-60 parts of vinegar tortoise shell, 44-60 parts of lithospermum, 44-60 parts of madder and 44-60 parts of mulberry twig. The traditional Chinese medicine composition takes the prepared fleece-flower root and the white paeony root as monarch drugs, takes the red paeony root, the Chinese angelica, the Chinese rose flower, the abrus cantoniensis hance, the dalbergia wood and the green tangerine peel as ministerial drugs, takes the loranthus parasiticus, the tortoise shell, the lithospermum and the madder as adjuvant drugs, takes both reinforcing and purging effects and treats both principal and secondary aspects of diseases, has the effects of nourishing liver blood, relaxing tendons and activating collaterals, strengthening tendons and bones, relieving spasm and pain and easing joint movement, and has obvious curative effect on the femoral head necrosis, liver deficiency, muscle weakness and flaccidity syndrome.

Description

Traditional Chinese medicine composition and pill for treating femoral head necrosis and liver deficiency muscle atrophy 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, liver deficiency, muscle weakness and flaccidity syndrome and a preparation method thereof.

Background

Femoral head necrosis is a disease that femoral head vein stasis, arterial blood supply damage or interruption leads to partial death and subsequent repair of osteocyte and bone marrow components, and then bone tissue necrosis is caused, which leads to the change and collapse of femoral head structure, and hip joint pain and dysfunction are caused. The 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 femoral head necrosis obtains certain effect on the treatment of early and middle non-traumatic femoral head necrosis by the hip protection therapy which mainly comprises the traditional Chinese medicine treatment in the categories of bone erosion, bone flaccidity, bone rheumatism, hip bone rheumatism and the like in the traditional Chinese medicine, and the hip protection therapy can enable a patient to obtain a hip joint which is relatively painless and has basically normal function through the traditional Chinese medicine hip protection treatment, so that the artificial joint replacement is delayed or avoided. Many scholars differentiate and classify the disease according to the traditional Chinese medicine theory, for example, the disease is classified into qi stagnation and blood stasis, phlegm stasis and obstruction of collaterals, channel obstruction, liver and kidney deficiency and other symptoms, and certain effect is achieved by selecting the formula according to the evidence. However, the existing syndrome differentiation and classification are still incomplete, and cannot cover all disease types. The common patients in clinic are not in the range of syndrome differentiation and classification, and do not accord with the characteristics of the syndrome, and according to the manifestations, the common patients are differentiated into the flaccidity syndrome of the liver-deficiency tendons, and the specific clinical manifestations are as follows: lameness, hip pain, pain in the middle of groin, dull pain, or stabbing pain, spasm and pain of lower limbs, difficulty in moving, dark red tongue with little coating, and thready and weak pulse, we differentiate it as atrophy of the liver and tendons. Therefore, no traditional Chinese medicine treatment method aiming at treating the femoral head necrosis and the flaccidity syndrome of the liver and the tendons is available at present.

Disclosure of Invention

In view of the above, the traditional Chinese medicine composition for treating the femoral head necrosis liver consumptive disease and the pill and the preparation method thereof provided by the invention better overcome the problems and defects of the prior art, the traditional Chinese medicine composition for treating the femoral head necrosis liver consumptive disease and the flaccid tendons and the preparation method thereof select pure natural traditional Chinese medicine raw materials, prepared polygonum multiflorum and radix paeoniae alba are used as monarch drugs, radix paeoniae rubra, angelica sinensis, Chinese rose, abrus cantoniensis hance, lignum dalbergiae odoriferae and pericarpium citri reticulatae viride are used as ministerial drugs, loranthus parasiticus, tortoise shell, lithospermum and madder are used as adjuvant drugs, ramulus mori is used as a conductant drug, the action advantages and the mutual synergistic effect of the traditional Chinese medicine raw materials are comprehensively utilized, the effects of tonifying and purging are combined, the specimens and the effects of nourishing liver blood, relaxing tendons and activating collaterals.

A traditional Chinese medicine composition for treating femoral head necrosis, liver deficiency, muscle atrophy and the like comprises the following raw materials in parts by weight: 129-153 parts of prepared fleece-flower root, 129-153 parts of white peony root, 63-83 parts of red peony root, 63-83 parts of angelica, 29-45 parts of Chinese rose flower, 129-153 parts of abrus cantoniensis hance, 63-83 parts of rosewood, 44-60 parts of green tangerine peel, 63-83 parts of parasitic loranthus, 44-60 parts of vinegar tortoise shell, 44-60 parts of lithospermum, 44-60 parts of madder and 44-60 parts of mulberry twig.

Furthermore, 134-148 parts of prepared fleece flower root and 134-148 parts of white paeony root.

Furthermore, 67-79 parts of red peony root, 67-79 parts of angelica, 33-41 parts of Chinese rose flower, 134-148 parts of abrus cantoniensis hance, 67-79 parts of dalbergia wood and 49-55 parts of green tangerine peel.

The traditional Chinese medicine composition comprises 67-79 parts of mistletoe, 49-55 parts of vinegar tortoise shell, 49-55 parts of lithospermum, 49-55 parts of madder and 49-55 parts of ramulus mori.

Further, 141 parts of prepared fleece-flower root, 141 parts of white peony root, 73 parts of red peony root, 73 parts of angelica sinensis, 37 parts of Chinese rose flower, 141 parts of abrus cantoniensis hance, 73 parts of dalbergia wood, 52 parts of green tangerine peel, 73 parts of parasitic loranthus, 52 parts of vinegar tortoise shell, 52 parts of lithospermum, 52 parts of madder and 52 parts of ramulus mori.

The invention also provides a pill for treating the flaccidity syndrome of femoral head necrosis liver due to deficient tendons, which comprises the traditional Chinese medicine composition for treating the flaccidity syndrome of femoral head necrosis liver due to deficient tendons.

Furthermore, 1-3 parts of starch and 10-20 parts of honey are also added into each 100 parts of the traditional Chinese medicine composition.

The invention also provides a preparation method of the pill for treating the femoral head necrosis and the flaccidity syndrome of the liver and tendons, which comprises the following steps: the pill comprises the traditional Chinese medicine composition for treating the femoral head necrosis, liver deficiency, muscle weakness and flaccidity 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, 1-3 parts of starch, 10-20 parts of honey and 28-40 parts of pure water, and then preparing wet pills.

The invention also provides a method for preparing the wet pills, which comprises the steps of drying the wet pills until the moisture content is 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, liver deficiency and muscle atrophy and the preparation method thereof have the beneficial effects that:

the traditional Chinese medicine composition for treating the femoral head necrosis liver deficiency tendon flaccidity syndrome selects pure natural traditional Chinese medicine raw materials, takes prepared polygonum multiflorum and radix paeoniae alba as monarch drugs, takes radix paeoniae rubra, angelica sinensis, China rose, abrus cantoniensis hance, dalbergia wood and pericarpium citri reticulatae viride as ministerial drugs, takes loranthus parasiticus, tortoise shell, lithospermum and madder as adjuvant drugs and mulberry twig as conductant drugs, comprehensively utilizes the action advantages and mutual synergistic action of the traditional Chinese medicine raw materials, performs both reinforcing and reducing effects and simultaneously gives consideration to both principal and subordinate symptoms, has the effects of nourishing liver blood, relaxing tendons and activating collaterals, strengthening tendons and bones, relieving spasm and alleviating pain and easing joint movement, has obvious curative effect on the femoral head. In addition, the pill for treating the femoral head necrosis and the flaccidity syndrome of the liver-deficiency tendons 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, liver deficiency, muscle atrophy and the like comprises the following raw materials in parts by weight:

129-153 parts of prepared fleece-flower root such as 129 parts, 132 parts, 134 parts, 137 parts, 139 parts, 141 parts, 143 parts, 145 parts, 148 parts, 150 parts or 153 parts;

129-153 parts of white peony root such as 129 parts, 132 parts, 134 parts, 137 parts, 139 parts, 141 parts, 143 parts, 145 parts, 148 parts, 150 parts or 153 parts;

63-83 parts of red peony root, such as 63 parts, 65 parts, 67 parts, 69 parts, 71 parts, 73 parts, 76 parts, 79 parts, 81 parts or 83 parts;

63-83 parts of angelica such as 63 parts, 65 parts, 67 parts, 69 parts, 71 parts, 73 parts, 76 parts, 79 parts, 81 parts or 83 parts and the like;

29-45 parts of China rose such as 29 parts, 31 parts, 33 parts, 35 parts, 37 parts, 39 parts, 41 parts, 43 parts or 45 parts and the like;

129-153 parts of abrus herb, such as 129 parts, 132 parts, 134 parts, 137 parts, 140 parts, 143 parts, 145 parts, 148 parts, 150 parts or 153 parts;

63-83 parts of rosewood such as 63 parts, 65 parts, 67 parts, 69 parts, 71 parts, 73 parts, 76 parts, 79 parts, 81 parts or 83 parts and the like;

44-60 parts of green tangerine peel, such as 44 parts, 46 parts, 49 parts, 50 parts, 52 parts, 53 parts, 55 parts, 58 parts or 60 parts;

63-83 parts of parasitic loranthus such as 63 parts, 65 parts, 67 parts, 69 parts, 71 parts, 73 parts, 76 parts, 79 parts, 81 parts or 83 parts;

44-60 parts of vinegar tortoise shell such as 44 parts, 46 parts, 49 parts, 50 parts, 52 parts, 53 parts, 55 parts, 58 parts or 60 parts;

44-60 parts of lithospermum, such as 44 parts, 46 parts, 49 parts, 50 parts, 52 parts, 53 parts, 55 parts, 58 parts or 60 parts and the like;

44-60 parts of madder such as 44 parts, 46 parts, 49 parts, 50 parts, 52 parts, 53 parts, 55 parts, 58 parts or 60 parts and the like;

44-60 parts of mulberry twig, such as 44 parts, 46 parts, 49 parts, 50 parts, 52 parts, 53 parts, 55 parts, 58 parts or 60 parts.

It should be noted that, radix Polygoni Multiflori Preparata is a processed product of radix Polygoni Multiflori, which is bitter, sweet, astringent and slightly warm in taste; it enters liver, heart and kidney meridians. The prepared radix Polygoni Multiflori has effects of nourishing liver and kidney, replenishing essence and blood, blackening hair and beard, strengthening tendons and bones, eliminating turbid pathogen, and reducing blood lipid; it is mainly used for treating blood deficiency, sallow complexion, giddiness, tinnitus, early white beard and hair, soreness of waist and knees, numbness of limbs, metrorrhagia, leukorrhagia, hyperlipidemia, etc. Pharmacological research proves that the polygonum multiflorum has the effects of reducing blood fat, resisting arteriosclerosis, resisting platelet aggregation and the like; the water decoction and alcohol precipitation solution of the polygonum multiflorum has the function of promoting the growth of progenitor cells of a rat bone marrow lineage; the radix Polygoni Multiflori Preparata is infused with warm immersion liquid to promote hematopoiesis and increase blood erythrocyte count and hemoglobin content. The record of Polygonum multiflorum includes: strengthen tendons and nourish essence, tonify qi, and prolong life. The book of Kaibao Ben Cao: benefiting blood and qi. The book of medical science: nourish liver, astringe blood and nourish yin. It is indicated for soreness of waist and knees, soreness of tendons and bones. Compendium of materia Medica: he shou Wu enters qi system when it is white and enters blood system when it is red. The kidney is mainly closed and stored, the liver is mainly smoothing flow of qi, the medicine has bitter taste and astringent taste, is bitter and tonifying the kidney, warms and tonifies the liver, and can astringe essence and qi, so the medicine can nourish blood and benefit the liver, secure essence and tonify the kidney, strengthen bones and muscles, is a good nourishing medicine, is not cold and dry, and has the functions of being above the medicines of rehmannia root and cochinchnese asparagus root. is indicated for wind deficiency, abscess and scrofula due to excessive harmonization of qi and blood. The book of materia Medica: the shou Wu is specialized in entering liver and kidney to nourish yin, and has a strong and thick flavor, slightly bitter and astringent taste, mild nature, and is fit for the sealing and storing of lower jiao, so it can replenish essence and qi, and has the action of balancing yin and yang, which is not comparable to yin coagulation of Di Huang. Jiangxi herbal medicine: the cooked food has the effects of nourishing liver and kidney, and nourishing essence and blood.

Radix Paeoniae alba, the dry root of Paeonia lactiflora pall of Ranunculaceae, is bitter, sour and 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, and is mainly used for treating blood deficiency, chlorosis, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, limb spasm pain and headache giddiness. Pharmacological research shows that the white peony root has obvious effects of easing pain, calming, relieving spasm of smooth muscle, expanding blood vessel, increasing blood flow of organs, resisting platelet aggregation and improving anemia. The book Jing: remove blood impediment, break hardness accumulation. Bibliography: dredge blood vessels, slow middle energizer, disperse blood stasis, dispel blood stasis. The Yunnan herbal medicine: collect the pain of liver qi, regulate the blood of liver and spleen, relax the meridians, lower qi and alleviate pain.

Radix Paeoniae Rubra, which is the dried root of Paeonia lactiflora pall or Paeonia veitchii Walker of Ranunculaceae, is bitter and slightly cold in taste; it enters liver meridian. Radix Paeoniae Rubra has effects of clearing heat and cooling blood, removing blood stasis and relieving pain, and is mainly used for treating hot blood, epidemic febrile disease, macula, hematemesis and epistaxis, conjunctival congestion, swelling and pain, liver depression, hypochondriac pain, amenorrhea, dysmenorrhea, abdominal mass, abdominal pain, 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.

Angelica sinensis, a dry root of Angelica sinensis of Umbelliferae, which is sweet, pungent and warm in taste; it enters liver, heart and spleen meridians. The angelica has the effects of enriching and activating blood, regulating menstruation, relieving pain, loosening bowel to relieve constipation and the like; is mainly used for treating blood deficiency and sallow complexion, vertigo and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency cold and abdominal pain, rheumatic arthralgia, traumatic injury, superficial infection, pyocutaneous disease and constipation due to intestinal dryness. Pharmacological research proves that the angelica has the effects of reducing blood fat, resisting atherosclerosis, inhibiting platelet aggregation, promoting the generation of hemoglobin and red blood cells, relieving pain, resisting inflammation and the like. The bibliography: warming middle energizer to alleviate pain, removing blood obstruction, tonifying five zang organs, and promoting muscle generation. Rihuazi Bencao: for wind-heat retention, blood-stasis retention, fatigue syndrome, blood-stasis, new blood and mass syndrome. Compendium (compendium): it can be used for treating headache, heart and abdomen pain, moistening intestine, stomach, tendons, bones and skin, and tonifying blood. The book materia Medica is as follows: it can nourish yin and blood, tonify qi and produce essence, calm five internal organs, strengthen body constitution, benefit spirit, and is not suitable for diseases with physical deficiency. Dispel pain, activate tendons and bones, treat spasm, paralysis, dryness and astringency.

Flos Rosae chinensis, which is dried flower of Rosa chinensis of Rosaceae, and has sweet and warm taste; it enters liver meridian. Flos Rosae chinensis has effects of regulating menstruation, dispersing stagnated liver qi, and resolving stagnation, and can be used for treating qi stagnation, blood stasis, menoxenia, dysmenorrhea, amenorrhea, and chest and hypochondrium distending pain.

Herba abri is dried whole plant of Abrus cantoniensis of Leguminosae; it is sweet, slightly bitter and cool; it enters liver and stomach meridians. Herba abri has effects of promoting diuresis, eliminating jaundice, clearing away heat and toxic materials, dispersing stagnated liver qi, and relieving pain, and can be used for treating damp-heat jaundice, hypochondrium discomfort, gastralgia, and mammary abscess with swelling and pain.

Lignum Dalbergiae Odoriferae, which is the dry heartwood of trunk and root of lignum Dalbergiae Odoriferae of Leguminosae, and is pungent and warm in taste; it enters liver and spleen meridians. Lignum Dalbergiae Odoriferae has effects of removing blood stasis, stopping bleeding, regulating qi-flowing and relieving pain; it is mainly used for hematemesis, epistaxis, traumatic hemorrhage, hypochondriac pain due to stagnation of liver-qi, thoracic obstruction, pain due to stabbing pain, traumatic injury, emesis, and abdominal pain. Pharmacological research shows that the dalbergia wood has the effects of reducing blood fat, easing pain, calming and the like.

Pericarpium Citri Reticulatae viride, the peel of dried young or unripe fruit of Citrus reticulata Blanco of Rutaceae and its cultivar; it is bitter, pungent and warm in flavor; it enters liver, gallbladder and stomach meridians. Pericarpium Citri Reticulatae viride has effects of dispersing stagnated liver qi, relieving qi stagnation, and resolving food stagnation; it is mainly used for treating distending pain in chest and hypochondrium, hernia pain, nodules of breast, acute mastitis, food stagnation, qi stagnation, and abdominal pain.

Herba Taxilli, which is dry stem branch with leaves of herba Taxilli of Taxilliaceae; it is bitter, sweet and mild in taste; it enters liver and kidney meridians. Herba Taxilli has effects of dispelling pathogenic wind and removing dampness, nourishing liver and kidney, strengthening tendons and bones, and calming fetus; it is mainly used for treating rheumatalgia, soreness of waist and knees, weakness of tendons and bones, metrorrhagia, metrostaxis, pregnant hemorrhage, threatened abortion, and dizziness.

Carapax et Plastrum Testudinis, the dorsal and ventral concha of Tortoise of the family Testudinidae; it is salty, sweet and slightly cold in taste; it enters liver, kidney and heart meridians. The tortoise shell has the effects of nourishing yin, suppressing yang, tonifying kidney, strengthening bone, nourishing blood, tonifying heart, strengthening channel and relieving metrorrhagia; it is mainly used for treating hectic fever due to yin deficiency, night sweat due to bone steaming, dizziness, endogenous deficient wind, flaccidity of bones and muscles, heart deficiency, amnesia, metrorrhagia, and menorrhagia.

Radix Arnebiae is dry root of arnebia euchroma (Royle) Johnst or arnebia Mongolica (Royle) Johnst of Boraginaceae; it is sweet, salty and cold in flavor; it enters heart and liver meridians. The lithospermum has the effects of clearing heat and cooling blood, promoting blood circulation and removing toxicity, promoting eruption and eliminating spots; it is mainly used for treating blood heat and toxic materials, macula purple black, measles without adequate eruption, pyocutaneous disease, eczema, and scald due to hot water and fire.

Rubia cordifolia, which is the dried root and rhizome of Rubia cordifolia of Rubiaceae; it is bitter and cold in taste; it enters liver meridian. Radix Rubiae has effects of cooling blood, removing blood stasis, stopping bleeding and dredging channels; it is mainly used for hematemesis, epistaxis, metrorrhagia, traumatic hemorrhage, amenorrhea due to blood stasis, arthralgia, and traumatic injury.

Ramulus Mori, dry twig of Morus alba L of Moraceae; it is slightly bitter and flat; it enters liver meridian. Ramulus Mori has effects of dispelling pathogenic wind, removing dampness and benefiting articulation; is mainly used for rheumatism, pain and numbness of shoulder, arm and joint.

The clinical manifestations of the femoral head necrosis and atrophy of liver-qi and tendons are: lameness, hip pain, pain in the groin, dull pain, or stabbing pain, pain in the lower extremities, difficulty in movement, dark red tongue with little coating.

Over a long period of time, the liver stores blood and governs tendons, and the deficiency of liver blood causes the tendons and vessels to be unable to be nourished, so it causes pain due to accumulation of lower limbs and spasm of the tendons and vessels. Malnutrition of the tendons and vessels due to liver blood deficiency can lead to impaired movement of the limbs and loss of muscle mass. Liver blood deficiency with local malnutrition can lead to dull pain and stabbing pain in collaterals in chronic diseases. Liver meridian runs in the lower abdomen, and liver blood is deficient, so the groin is painful. The liver stores blood and the pulse is blood sea, both nourish each other, the liver governs tendons, the pulse is sea of meridians, which governs infiltrating xi gu, combines with yangming in zong, and the zong governs bone and benefits organs. Liver blood deficiency failing to nourish the tendons and vessels and pulse failing to control the organs, which results in the lower limbs moving badly. A dark red coating with scanty coating and a thready and weak pulse are all the symptoms of liver deficiency and atrophy of tendons and muscles.

The invention mainly adopts treatment methods of nourishing liver blood, relaxing tendons and activating collaterals and the like aiming at the symptoms of femoral head necrosis, liver deficiency and muscle weakness.

In the raw materials of the traditional Chinese medicine composition for treating the femoral head necrosis, liver deficiency, muscle weakness and flaccidity syndrome, the prepared polygonum multiflorum has the effects of nourishing liver and kidney, benefiting essence and blood and strengthening bones and muscles, and can tonify liver and blood and strengthen bones and muscles; white peony root has the effects of nourishing blood, astringing yin, softening liver, relieving spasm and alleviating pain, and is particularly suitable for spasm of muscles and vessels; the two medicines are combined to be a monarch medicine, and have the functions of nourishing liver blood, strengthening tendons and bones, nourishing liver, softening tendons and relieving pain.

Radix Paeoniae Rubra has effects of clearing heat, cooling blood, removing blood stasis and relieving pain, and also can dispel stagnation of liver meridian; the angelica has the effects of nourishing blood, enriching blood, removing blood stasis and relieving pain; the flos Rosae chinensis has effects of promoting blood circulation, regulating menstruation, dispersing stagnated liver qi, and relieving qi stagnation; the herba abri has effects of clearing heat, promoting diuresis, dispersing stagnated liver qi, and relieving pain; lignum Dalbergiae Odoriferae has effects of removing blood stasis, stopping bleeding, regulating qi-flowing and relieving pain; pericarpium Citri Reticulatae viride has effects of dispersing stagnated liver qi, relieving qi stagnation, and resolving food stagnation. The six medicines are used as ministerial medicines, and have the functions of nourishing liver blood, soothing liver stagnation, nourishing blood, relaxing muscles and tendons, regulating qi and relieving pain.

Herba Taxilli has effects of nourishing liver and kidney, and strengthening tendons and bones; the carapax et Plastrum Testudinis has effects of nourishing yin, suppressing yang, invigorating kidney, strengthening bone, nourishing blood, and nourishing heart, and can be used for treating tendons and bones flaccid paralysis; the lithospermum has the effects of clearing heat, cooling blood, promoting blood circulation and removing toxicity; rubia cordifolia has effects of cooling blood, removing blood stasis, stopping bleeding and dredging meridians, and is good at treating arthralgia and tendon and vessel obstruction. The four medicines are combined together to be used as adjuvant medicines, so that the yin and blood of the liver can be nourished, the tendons and vessels can be nourished, the blood can be cooled, the blood stasis can be removed, and the liver can be astringed and yin can be transformed.

Ramulus mori has the effects of dredging the channels and collaterals and benefiting the joints, and is good at treating soreness and numbness of the joints of the limbs, and guiding all the medicines to directly reach the disease as a guiding medicine.

The invention comprehensively utilizes the action advantages and mutual synergistic action of the raw materials of the traditional Chinese medicines, performs both reinforcing and reducing, takes both principal and secondary aspects into consideration, nourishes liver blood, soothes liver and astringes liver, uses prepared fleece flower root to nourish essence and blood of liver, uses the Chinese rose flower and the abrus herb which are mild, clear and mild to regulate liver-smoothing strips without damaging the liver yin, and uses the white paeony root which astringes liver to treat and protect liver yin, nourish liver blood, soothe liver depression and protect liver yin. The traditional Chinese medicine composition has the effects of nourishing liver blood to strengthen thoroughfare, strengthening muscles and bones to benefit organs, is particularly suitable for lower limb disadvantageousness, nourishing blood to dredge collaterals, softening liver to relieve pain, and effectively relieving pain, is developed based on liver meridian medicines, mainly uses mulberry twigs to make the medicines directly reach the affected part, has the effects of nourishing liver blood, relaxing tendons and activating collaterals, strengthening muscles and bones, relieving spasm and pain and relaxing joints, has obvious curative effect on femoral head necrosis, liver deficiency and muscle weakness, and is convenient to use.

Preferably, 134-148 parts of prepared fleece flower root and 134-148 parts of white paeony root.

Preferably, the red peony root is 67-79 parts, the angelica is 67-79 parts, the Chinese rose is 33-41 parts, the abrus herb is 134-148 parts, the rosewood is 67-79 parts, and the green tangerine peel is 49-55 parts.

Preferably, 67-79 parts of parasitic loranthus, 49-55 parts of vinegar tortoise shell, 49-55 parts of lithospermum, 49-55 parts of madder and 49-55 parts of ramulus mori.

Preferably, the radix polygoni multiflori preparata is 141 parts, the radix paeoniae alba is 141 parts, the radix paeoniae rubra is 73 parts, the angelica sinensis is 73 parts, the Chinese rose is 37 parts, the abrus herb is 141 parts, the rosewood is 73 parts, the pericarpium citri reticulatae viride is 52 parts, the mistletoe is 73 parts, the vinegar tortoise shell is 52 parts, the lithospermum is 52 parts, the madder is 52 parts, and the ramulus mori is 52 parts.

Preferably, 1-3 parts of 1 part, 1.5 parts, 2 parts, 2.5 parts or 3 parts of starch and 10-20 parts of honey are 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.

Preferably, the preparation method comprises: mixing radix Polygoni Multiflori Preparata, radix Paeoniae alba, radix Paeoniae Rubra, radix Angelicae sinensis, herba abri, lignum Dalbergiae Odoriferae, pericarpium Citri Reticulatae viride, herba Taxilli, carapax et Plastrum Testudinis and ramulus Mori, pulverizing into fine powder, mixing flos Rosae chinensis, radix Arnebiae and radix Rubiae, pulverizing into fine powder, and mixing the two groups of Chinese medicinal fine powders. Therefore, the raw materials with lighter weight, such as the Chinese rose, the lithospermum and the madder, can be fully crushed, so that the finally obtained powder is more uniform.

The preparation method further comprises the step of mixing and stirring 100 parts of the powder, 1-3 parts of starch, 10-20 parts of honey and 28-40 parts of pure water to prepare wet pills.

Preferably, the wet pellets are dried to a moisture content of 5% by weight or less to obtain plain pellets, and the plain pellets are carbon-coated with activated carbon and polished with talc, wherein 0.45 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: 129 parts of prepared fleece-flower root, 153 parts of white paeony root, 63 parts of red paeony root, 63 parts of Chinese angelica, 129 parts of abrus cantoniensis hance, 83 parts of dalbergia wood, 60 parts of green tangerine peel, 63 parts of Chinese taxillus twig, 60 parts of vinegar tortoise shell and 44 parts of mulberry twig are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 29 parts of China rose, 44 parts of lithospermum and 60 parts of madder, and crushing the mixture into fine powder for later use by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory).

(3) The two groups of traditional Chinese medicine fine powder are put into a GH-200 type efficient three-dimensional motion mixer (produced by Harbin pharmaceutical chemical engineering equipment Co., Ltd.) to be uniformly mixed, and then the powder is obtained.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 2 parts of starch and 15 parts of honey are added firstly, stirred and mixed for 10min, and then 34 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

(5) 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.

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

(7) 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 2

(1) Weighing the following traditional Chinese medicine raw materials: 132 parts of prepared fleece-flower root, 150 parts of white paeony root, 65 parts of red paeony root, 65 parts of Chinese angelica, 132 parts of abrus cantoniensis hance, 81 parts of dalbergia wood, 58 parts of green tangerine peel, 65 parts of parasitic loranthus, 58 parts of vinegar tortoise shell and 46 parts of mulberry twig are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 31 parts of China rose, 46 parts of lithospermum and 58 parts of madder, and crushing the mixture into fine powder for later use by using a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory).

(4) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1 part of starch and 12 parts of honey are added firstly, stirred and mixed for 10min, and then 35 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

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

Example 3

(1) Weighing the following traditional Chinese medicine raw materials: 134 parts of prepared fleece-flower root, 148 parts of white paeony root, 67 parts of red paeony root, 67 parts of Chinese angelica, 134 parts of abrus cantoniensis hance, 79 parts of dalbergia wood, 55 parts of green tangerine peel, 67 parts of Chinese taxillus twig, 55 parts of vinegar tortoise shell and 49 parts of mulberry twig are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 33 parts of China rose, 49 parts of lithospermum and 55 parts of madder are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1.5 parts of starch and 15 parts of honey are added firstly, stirred and mixed for 10min, and then 35 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

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

Example 4

(1) Weighing the following traditional Chinese medicine raw materials: 137 parts of prepared radix polygoni multiflori, 145 parts of radix paeoniae alba, 71 parts of radix paeoniae rubra, 69 parts of angelica sinensis, 137 parts of abrus cantoniensis hance, 76 parts of dalbergia wood, 53 parts of pericarpium citri reticulatae viride, 69 parts of parasitic loranthus, 53 parts of vinegar tortoise shell and 50 parts of ramulus mori, and after mixing, the components are crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 35 parts of China rose, 50 parts of lithospermum and 53 parts of madder are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 2 parts of starch and 15 parts of honey are added firstly, stirred and mixed for 10min, and then 35 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

(7) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.48 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 5

(1) Weighing the following traditional Chinese medicine raw materials: 141 parts of prepared fleece-flower root, 141 parts of white paeony root, 73 parts of red paeony root, 73 parts of Chinese angelica, 141 parts of abrus cantoniensis hance, 73 parts of dalbergia wood, 52 parts of green tangerine peel, 73 parts of Chinese taxillus twig, 52 parts of vinegar tortoise shell and 52 parts of mulberry twig are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 37 parts of China rose, 52 parts of lithospermum and 52 parts of madder are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1.5 parts of starch and 18 parts of honey are added firstly, stirred and mixed for 10min, and then 38 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

(7) Placing the above pill in TG-1000 sugar-coating pan (produced by Gansu Tianshuihua Garden pharmaceutical equipment science and technology Co., Ltd.) and polishing with charcoal coating and pulvis Talci, wherein 0.52 parts of activated carbon and pulvis Talci can be added into each 100 parts of pill to obtain pill.

Example 6

(1) Weighing the following traditional Chinese medicine raw materials: 143 parts of prepared fleece-flower root, 139 parts of white paeony root, 76 parts of red paeony root, 76 parts of Chinese angelica, 139 parts of abrus cantoniensis hance, 71 parts of dalbergia wood, 50 parts of green tangerine peel, 76 parts of Chinese taxillus twig, 50 parts of vinegar tortoise shell and 53 parts of mulberry twig are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 39 parts of China rose, 53 parts of lithospermum and 50 parts of madder, and crushing the mixture into fine powder for later use by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory).

(4) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1.5 parts of starch and 12 parts of honey are added firstly, stirred and mixed for 10min, and then 30 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

Example 7

(1) Weighing the following traditional Chinese medicine raw materials: 148 parts of prepared radix polygoni multiflori, 134 parts of radix paeoniae alba, 67 parts of radix paeoniae rubra, 67 parts of angelica sinensis, 134 parts of abrus cantoniensis hance, 79 parts of dalbergia wood, 55 parts of pericarpium citri reticulatae viride, 79 parts of parasitic loranthus, 49 parts of vinegar tortoise shell and 55 parts of ramulus mori, and crushing the mixture into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery).

(2) Weighing the following traditional Chinese medicine raw materials: 41 parts of China rose, 55 parts of lithospermum and 49 parts of madder are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 3 parts of starch and 20 parts of honey are added firstly, stirred and mixed for 10min, then 30 parts of pure water is added, and stirred for about 20min, so that a soft material is obtained.

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

Example 8

(1) Weighing the following traditional Chinese medicine raw materials: 150 parts of prepared fleece-flower root, 132 parts of white paeony root, 81 parts of red paeony root, 81 parts of Chinese angelica, 132 parts of abrus cantoniensis hance, 65 parts of dalbergia wood, 46 parts of green tangerine peel, 81 parts of Chinese taxillus twig, 46 parts of vinegar tortoise shell and 58 parts of mulberry twig are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 43 parts of Chinese rose, 58 parts of lithospermum and 46 parts of madder are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine mechanical factory) for later use.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type trough mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 2.5 parts of starch and 18 parts of honey are added firstly, stirred and mixed for 10min, and then 38 parts of pure water is added, stirred for about 20min, so as to obtain a soft material.

Example 9

(1) Weighing the following traditional Chinese medicine raw materials: 153 parts of prepared fleece-flower root, 129 parts of white peony root, 83 parts of red peony root, 83 parts of angelica, 153 parts of abrus cantoniensis hance, 63 parts of dalbergia wood, 44 parts of green tangerine peel, 83 parts of Chinese taxillus twig, 44 parts of vinegar tortoise shell and 60 parts of mulberry twig, and crushing the mixture into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(2) Weighing the following traditional Chinese medicine raw materials: 45 parts of China rose, 60 parts of lithospermum and 44 parts of madder are mixed and then crushed into fine powder by a TF300B type double-stage crusher (produced by Tianjin Chinese medicine machinery factory) for later use.

(4) 100 parts of the prepared powder is placed in a CHJ-200 type groove mixer (produced by science and technology limited of pharmaceutical equipment in Tianshuihua Yuan, Gansu), 1 part of starch and 10 parts of honey are added firstly, stirred and mixed for 10min, and then 40 parts of pure water is added, stirred for about 20min, so that a soft material is obtained.

Comparative example 1

Different from the example 1, the dosage of the prepared fleece flower root is 100 parts, the dosage of the white paeony root is 160 parts, and other components and preparation methods are the same as the example 1.

Comparative example 2

Different from the embodiment 1, the amount of red peony root is 50 parts, the amount of angelica is 90 parts, other components and the preparation method are the same as the embodiment 1.

Comparative example 3

Different from the example 1, the using amount of the China rose is 20 parts, the using amount of the lithospermum is 40 parts, the using amount of the madder is 70 parts, and other components and the preparation method are the same as the example 1.

Comparative example 4

Different from the embodiment 1, the dosage of the abrus herb is 120 parts, the dosage of the dalbergia wood is 90 parts, and other components and the preparation method are the same as the embodiment 1.

Comparative example 5

Different from the embodiment 1, the using amount of the green tangerine orange peel is 40 parts, the using amount of the parasitic loranthus is 90 parts, and other components and the preparation method are the same as the embodiment 1.

Comparative example 6

Except for example 1, the amount of the vinegar tortoise shell was 70 parts, the amount of the mulberry twig was 40 parts, and other ingredients and preparation methods were the same as example 1.

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

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

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

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

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

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

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

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

Case inclusion and exclusion criteria:

(ii) case selection and inclusion criteria

a. Subject signs an informed consent;

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

c. patients who can self-describe the condition;

d. hospitalized patients.

② elimination criteria of cases

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

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

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

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

e. are attending other clinical experimenters;

f. pregnant or lactating female patients.

And (3) judging the curative effect:

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

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

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

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

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

TABLE 1

Group of	Total number of people	Cure of disease	Is effective	Invalidation	Total effective rate
						Example 1	50	36	7	7	86％
Example 2	50	38	7	5	90％
						Example 3	50	40	6	4	92％
Example 4	50	42	5	3	94％
						Example 5	50	45	4	1	98％
Example 6	50	42	6	2	96％
						Example 7	50	43	4	3	94％
Example 8	50	40	6	4	88％
						Example 9	50	35	8	7	86％

As can be seen from the above table 1, the Chinese medicinal composition has good effect after treatment, the effective rate is over 86%, and the cure rate is over 70%, so that the pill has good effect on treating the femoral head necrosis, liver deficiency and tendon flaccidity syndrome. 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 (8 patients with femoral head necrosis in each group, age 18-65 years) with the pills prepared in comparative examples 1-6, and the treatment effect is not good or poor (the effective rate is not more than 50%).

Clinical case 1: somebody of abalone, male, 37 years old, wuqiu county in southern Henan province. The patient suffered from double hip pain after 5 months of fatigue in 2017, and was relieved after rest without treatment. The post-pain worsened, to hospital admission MRI in zhongning county: bilateral femoral head necrosis was left untreated. Then, the patient comes to our hospital, and the outpatient clinic takes the 'bilateral femoral head necrosis' as a primary diagnosis to be admitted, and the admission symptoms are as follows: lameness, pain of both hips, mild squat, dark red tongue with little coating, and thready and weak pulse.

Through special examination: the tenderness is obvious in the middle point of the bilateral groin, the percussion pain at the greater trochanter on the left side, the left III level of double lower limb force, the right IV level, the positive of the Thomas sign on the left side, the positive of the Triepengorge sign on the left side, the positive of the test of the '4' character on the left side, the negative of the right side, the negative of the Ailis sign, the double hip mobility: the left side abducts 30 degrees, adducts 10 degrees, flexes 120 degrees, rotates internally 15 degrees, rotates externally 20 degrees, the right side abducts 40 degrees, adducts 15 degrees, flexes 130 degrees, rotates internally 20 degrees, and rotates externally 15 degrees.

Auxiliary inspection: the positive axis DR (2017.08.21DR 068337) image of pelvis shows: the left femoral head has a proper shape, the bone density in the femoral head is not uniform, the trabecular bone is fuzzy, a sac-like low-density image and a spot-like high-density image can be seen, and the left hip joint gap is proper; the density of the femoral head on the right side is not uniform, the shape of the femoral head is proper, and the hip joint clearance is proper.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: atrophy of tendons and bones due to liver erosion; and (3) Western diagnosis: bilateral femoral head necrosis (ARCO stage II).

The pill prepared in the embodiment 1 of the invention is taken orally, 3 times a day, and 9g each time. After one week, the symptoms of both hips of the patient improved better. After taking the pill prepared in the embodiment 1 of the invention for 2 weeks, the pain of the patient is relieved earlier, the function is improved earlier, the vital signs are stable, no special discomfort is complained, and the patient is required to be discharged. The patient is advised to continue taking the medicine after discharge, exercise is insisted on, hormone is cautiously taken, and the liver and kidney functions are reviewed regularly. After three months of reexamination, the pain is basically avoided, the joint mobility is better, the life can be normal, and the functions of the liver and the kidney are normal.

Clinical case 2: somebody of horse, woman, 71 years old, Hui nationality, Zhen nationality of Guanhui nationality of Taikang county, Henan province. The patient has no obvious reason to have pain and dull pain at the right hip in 2011, and the pain can be relieved after rest. For many years, the patients who seek diagnosis in many places are treated by sciatica and are orally taken analgesic drugs and external plasters (detailed), and the curative effect is poor. In 2015, the right femur head necrosis was diagnosed in local hospital by taking film, and was not treated. In 11 months in 2017, the doctor came to our hospital and the clinic admitted the hospital with "right femur head necrosis". Admission symptoms are as follows: lameness, right hip pain with limited function, limited squat, clear mind, mental capacity, sleep with normal stools, dark red tongue with little coating, thready and weak pulse.

Special examination: the middle point of the groin on the right side is pressed to pain level 1, the greater trochanter of the femur is knocked to pain, and the test of the shape of the Chinese character '4' on the two sides: left negative, right incomplete. Bilateral ellis sign negative, bilateral tomassian sign positive, bilateral total castle sign positive, double hip joint mobility: right side: 100 degrees of flexion, 15 degrees of retroflexion, 20 degrees of adduction, 25 degrees of abduction, 25 degrees of internal rotation, 20 degrees of external rotation and 30 degrees of abduction. Muscle strength of both lower limbs: the left side is IV grade, the right side is IV grade, the straight leg elevation test is negative, the supine abdomen-raising test is negative, the neck bending test is negative, the tendon reflex of the knee at both sides is normal, and the achilles tendon reflex is not led out.

Auxiliary inspection: double hip MRI (2017.11.01 home 11986) show: 1. right hip osteoarthritis; 2. right femoral head and right acetabular articular surface lower ischemic foci; 3. edema of soft tissue at the bilateral greater trochanter femoral attachments, taking into account inflammation; 4. a small amount of effusion at the left hip joint; 5. uterine fibroids.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: hip arthralgia, atrophy of tendons and bones due to liver deficiency; and (3) Western diagnosis: 1. right hip osteoarthritis; 2. necrosis of the right femoral head.

After the patient is admitted, various examinations are completed, and the patient suffers from the disease for a long time, consumes qi and blood and is deficient in liver blood after six years. The liver governs tendons, and liver blood deficiency causes failure of nourishing tendons and bones, dark red tongue with little coating, and thready and rapid pulse, which are all the syndromes of liver deficiency and atrophy of tendons and bones. The pill prepared in the embodiment 2 of the invention is orally taken 3 times a day by 9g each time, and is used for treating diseases according to syndrome differentiation of traditional Chinese medicine, and the principle of simultaneous treatment of principal and subordinate symptoms is followed, and the pill is used for nourishing liver blood, relaxing tendons and activating collaterals. After taking the pill prepared in the embodiment 2 of the invention for 1 week, the patient complains that the pain of the right hip is not suitable to be relieved compared with the pain at the time of admission, the pill prepared in the embodiment 2 of the invention is continuously taken for oral treatment, and the patient keeps leaning on walking with two crutches and is matched with proper function exercise. The pain of the right hip of the patient is obviously relieved earlier in 2017, 11 and 20 days, the hip joint function is improved earlier, the general condition is good, the overall condition is improved, the patient requires to be discharged, and the patient is approved by a superior doctor to be discharged. Attention is paid after discharge: 1. leaning on two crutches for walking; 2. advocate avoiding wind, cold and dampness, not tired, preventing trauma, and exercising proper functions; 3. the oral treatment of the pill prepared in example 2 of the present invention was continued, and liver function and kidney function were periodically reviewed. After three months of reexamination, the hip basically has no pain, the function and the activity are good, the daily life can be satisfied, and the function of the liver and the kidney is not abnormal.

Clinical case 3: wangzhi, sex male, age 31, national Han nationality, current address: kaifeng county, Henan province. The patient suffered from double hip pain after 11 months of fatigue in 2015, mainly suffered from soreness, and was relieved after rest without treatment. The diagnosis of bilateral femoral head necrosis is carried out on the double hip MRI examination in the civil hospital from 2 months to Kaifeng county in 2016, the operation treatment is carried out (the details are not detailed), the pain is not relieved, and the systematic diagnosis and treatment are not carried out later. The pain is not relieved after the oral medicine (not detailed) is taken by the clinic at intervals and at most for 1 year. In 2017, the patient is admitted to our hospital 11 months. Admission symptoms are as follows: leaning on double crutches for walking, limping, limited squatting, double hip pain with limited function, easy sleep, convenient adjustment, dark red tongue, little coating and thready and weak pulse.

Special examination: lameness, limitation of squatting, bilateral inguinal region, iliotibial band, adductor, gluteus medius tenderness, bilateral greater trochanter tenderness and percussion pain, bilateral gluteus maximus tenderness, double lower limbs are equal in length, double lower limb muscle strength is III level, the maximum interval of double ankles is 86cm, the muscle circumference of 10cm on the patella: the left and right sides are 43cm, the mobility of the double hip joints: 90 degrees on both sides of flexion, 0 degree on both sides of internal and external rotation, 20 degrees on both sides of abduction and 15 degrees on both sides of adduction. The test of the shape of the Chinese character '4' is not completed on both sides, both sides of the Tomasie sign are positive, both sides of the whole Triepen sign are positive, and both sides of the Alice sign are negative.

Auxiliary inspection: positive axis of pelvis (2017.11.28X-068405) shows: the bilateral femoral heads become flat, uneven bone density is shown in the interior, the trabecular bone is fuzzy, a sac-like low-density image and a patch-like high-density image can be seen in the interior, hyperosteogeny images can be seen at the peripheries of the bilateral femoral heads and the acetabulum, the gap between the double hip joints becomes narrow, and the sacrum 1 vertebral arch plates are not combined. Double hip CT (2017.11.28, home hospital) show: 1. ischemic necrosis of femoral head at two sides 2, effusion of double hip joint cavities 3, and degeneration of double hip joints. Double hip MRI (2017.11.28, home hospital) show: 1. ischemic necrosis of femoral head at two sides 2, hydrops of hip joint cavity 3, edema of femoral head at two sides and bone marrow at femoral neck.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, atrophy of liver deficiency tendons and bones; and (3) Western diagnosis: bilateral femoral head necrosis (ARCO IV phase left and right)

After the patient is admitted, various examinations are completed, and the patient is a middle-aged male, has long-term smoking and drinking addiction, has long course of disease, consumes qi and blood, stores blood in the liver, governs tendons in the liver, loses nourishment of muscles and bones due to liver blood deficiency, has bone erosion, dark red tongue and thready and weak pulse, and belongs to the liver deficiency and muscle atrophy syndrome by differentiation. The pill prepared by the embodiment 3 of the invention is orally taken 3 times a day, 9g each time, according to the treatment based on syndrome differentiation of traditional Chinese medicine and the principle of simultaneous treatment of both principal and secondary aspects, and by taking the treatment of nourishing liver blood and relaxing tendons and activating collaterals as the treatment method. In 2017, 12 and 9 months, the patient generally has good condition, the pain of the double hips is relieved, the tenderness of the inguinal region, the iliotibial band, the adductor and the gluteus medius on both sides is relieved, the mobility of the double hip joints is better than before, the function is improved, the patient is required to be discharged, and the patient is approved by a superior doctor to be discharged. Attention is paid after discharge: 1. leaning on the double-crutch to walk and properly exercise the functions; 2. advising not to fatigue, preventing trauma, taking hormones with caution; 3. the medicine is continuously taken for oral treatment, and the liver function and the kidney function are periodically rechecked. After three months of reexamination, the hip is basically free of pain, the function and the activity are good, the daily life is not influenced, and the functions of the liver and the kidney are not abnormal.

Clinical case 4: liu certain, female, age 29 years old, national Han nationality, Shandong province, Laiwu city steel city people. The patient suffered from left hip and knee pain discomfort after fatigue in 2016 (11 months), manifested as persistent dull pain, stabbing pain, aggravated after fatigue or activity, relieved after rest, no fever and night sweat, and was untreated. The pain is aggravated in 2017 in 1 month, a doctor visits a certain local hospital, the femoral head necrosis is diagnosed after taking tablets, and the pain is relieved by oral administration and acupuncture therapy of calcium tablets and Xianlinggubao capsules. Live in my hospital on the day of 10 and 4 in 2017. Admission symptoms are as follows: lameness, left hip and knee pain, aggravation after activity and fatigue, relief after rest, limited left hip activity, mental clarity, spiritual ability, sleep improvement, dark red tongue with little coating, and thready and weak pulse.

Special examination: the point tenderness in the groin on the left side is obvious, the greater trochanter on the left side has the percussion pain, the gluteus medius on the left side tenderness, the quadriceps muscle strength on the two sides is IV grades, V grades on the right side, the test negative is raised to two straight legs on the two sides, the tomassian sign is positive, the full castle sign is positive, the test positive is shown in a left side '4' word, the ellis sign is positive, the activity of the double hip: right side: flexion is 120 °, adduction is 15 °, abduction is 20 °, internal rotation is 15 °, external rotation is 15 °, left side: 100 degrees of flexion, 10 degrees of adduction, 10 degrees of abduction, 5 degrees of internal rotation and 5 degrees of external rotation. The test of bending neck is negative, the test of supine and abdomen is negative, the knee tendon reflex and the achilles tendon reflex are normal, and the babinski sign is negative.

Auxiliary inspection: pelvic alignment plate (2017.10.04 Hospital No. 068691): the left femoral head is slightly flattened in shape, uneven bone density is shown in the femoral head, trabecular bone is fuzzy, a sac-like low-density image and a patch-like density increasing image can be seen, a hyperosteogeny image can be seen at the periphery of the left femoral head, and the left hip joint gap is narrowed; no obvious abnormality is seen in the bone structure, density and hip joint clearance of the right hip joint. Hypertrophy of the left transverse process of the waist 5 and the auricular surface of the sacrum form a false joint, and a lump-shaped high-density image can be seen in the soft tissues at the peripheries of the ilium at the two sides. Double hip MRI (2017.10.04 Hospital No. 11150): 1. left avascular necrosis of the femoral head: 2. left hip joint cavity effusion.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, atrophy of liver deficiency tendons and bones; and (3) Western diagnosis: left femoral head necrosis (ARCO stage IV), left hip osteoarthritis.

The examination is completed after the admission, and the patients are young women, the congenital deficiency and the acquired malnutrition are caused by liver blood deficiency, the liver stores blood and governs tendons, the tendon and the bone marrow are caused by liver blood deficiency, the tongue is dark red, the tongue has little fur, and the thready and weak pulse is the symptoms of liver deficiency and muscle atrophy. The pill prepared by the embodiment 4 of the invention is orally taken 3 times a day, 9g each time, according to the treatment based on syndrome differentiation of traditional Chinese medicine and the principle of simultaneous treatment of principal and subordinate symptoms and by taking the effects of nourishing liver blood and relaxing tendons and activating collaterals as a treatment method. In 2017, day 10 and 17, the patient generally has good condition, the pain of the left hip is relieved compared with that of the patient who is admitted to the hospital, the function is improved, the sleep can be received, the condition is adjusted for two times, the patient is improved integrally, the patient requires to be discharged, and the patient is approved by a superior physician to be discharged. Attention is paid after discharge: 1. leaning on the double-crutch to walk and properly exercise the functions; 2. hormones should be used with cautions for avoiding tiredness and trauma; 3. the medicine is continuously taken for oral treatment, and the liver function and the kidney function are periodically rechecked. After three months of reexamination, the hip is basically painless, the function activity is good, the daily life is not influenced, and the function of the liver and the kidney is not abnormal.

Clinical case 5: guo of a certain species, male, 64 years old, national Han nationality, Zheng Zhou, Henan province. The patient suffers from double hip pain after 04 months of fatigue in 2017, the pain is aggravated after the patient moves, the patient is diagnosed as lumbar intervertebral disc protrusion in Zhengzhou hospital for neck, shoulder, waist and leg pain, the patient is treated in hospital and treated by massage, important hot compress, traction and the like, and the patient is discharged after the discomfort symptom is changed. Discomfort symptoms reappear after 5 months of overwork in 2017, the first people hospital in Zhengzhou city is diagnosed as lumbar intervertebral disc herniation, the patients are hospitalized and treated by safflower injection, massage and the like, the discomfort symptoms are not obviously improved, and the patients are treated in the hospital in 2017 in 6 months. Admission symptoms are as follows: lameness, double hip pain, aggravation after exercise, and inability to relieve after rest. Difficulty in walking and squatting, clear mind, spiritual, no obvious change in body weight, dark red tongue, little coating, and thready and weak pulse.

Special examination: tenderness in the groin on both sides, tenderness in the greater trochanter on both sides, tenderness and percussion pain in the lumbosacral region, flexor muscle force of hip joint of left grade IV and right grade IV; mobility of the double hip: left side: abduction 30 °, adduction 25 °, flexion 110 °, internal rotation 20 °, external rotation 20 °, right side: abduction 25 °, adduction 20 °, flexion 100 °, internal rotation 15 °, external rotation 15 °. The two sides of the instrument are positive in Thomas sign, positive in Triegen sign, positive in the '4' test, obvious in the right side, positive in Ailis sign, weakened in the reflex of achilles tendon and knee tendon, and negative in Pasteur sign. Lumbar mobility: forward bending 70 degrees, backward stretching 15 degrees, and left and right lateral bending 15 degrees.

Auxiliary inspection: double hip positive axis tablet (2017.05.19 Hospital 067203): the shapes of the femoral heads on both sides are proper, the bone density in the femoral heads is uneven, the trabecular bone is fuzzy, a sac-like low-density image and a high-density patch-like high-density image can be seen, the gap between the two hip joints is proper, and the sacrum 1 is hidden spinal fissure.

And (3) preliminary diagnosis: traditional Chinese medicine diagnosis: bone erosion, atrophy of liver deficiency tendons and bones; and (3) Western diagnosis: 1. bilateral femoral head necrosis (ARCO II stage) 2 lumbar disc herniation 3 hypertension.

After admission, various examinations are completed, and the patient age, long-term fatigue, congenital deficiency, acquired malnutrition and qi and blood are combined. The liver stores blood to govern tendons, and the deficiency of liver blood can cause malnutrition of tendons, vessels and bone marrow, dark red tongue with little coating, and thready and weak pulse, which are the symptoms of liver deficiency and atrophy of tendons. The pill prepared in the embodiment 5 of the invention is orally taken 3 times a day, 9g each time, according to the treatment based on syndrome differentiation of traditional Chinese medicine and the principle of simultaneous treatment of both principal and secondary aspects, and by taking the treatment of nourishing liver blood and relaxing tendons and activating collaterals as the treatment method. The hip pain of the patient is obviously relieved in 7 and 11 days in 2017 compared with that of the patient who is admitted, the hip joint function is improved earlier, the general condition is good, the overall disease condition is improved, the patient requires to be discharged, and the patient is allowed to be discharged after the approval of a superior doctor. Attention is paid after discharge: 1. leaning on the double-crutch to walk and properly exercise the functions; 2. hormones should be used with cautions for avoiding tiredness and trauma; 3. the medicine is continuously taken for oral treatment, and the liver function and the kidney function are periodically rechecked. After three months of reexamination, the hip is free from pain, the function and the activity are good, the daily life is not influenced, and the functions of the liver and the kidney are not abnormal.

It should be noted that the pills for treating flaccidity syndrome of liver tendon deficiency caused by femoral head necrosis prepared in embodiments 1 to 5 of the present invention are replaced with the traditional Chinese medicine pills for treating flaccidity syndrome of liver tendon deficiency caused by femoral head necrosis prepared in embodiments 6 to 9 of the present invention, so that the same experimental effects as described above can be achieved.

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

Claims

1. A pill for treating femoral head necrosis, liver deficiency and muscle atrophy is characterized in that: the pill comprises a traditional Chinese medicine composition for treating the femoral head necrosis, liver deficiency, muscle weakness and flaccidity syndrome, and the traditional Chinese medicine composition is composed of the following raw material medicines in parts by weight: 129-153 parts of prepared fleece-flower root, 129-153 parts of white peony root, 63-83 parts of red peony root, 63-83 parts of angelica, 29-45 parts of Chinese rose flower, 129-153 parts of abrus cantoniensis hance, 63-83 parts of rosewood, 44-60 parts of green tangerine peel, 63-83 parts of parasitic loranthus, 44-60 parts of vinegar tortoise shell, 44-60 parts of lithospermum, 44-60 parts of madder and 44-60 parts of mulberry twig;

1-3 parts of starch and 10-20 parts of honey are also added into each 100 parts of the traditional Chinese medicine composition.

2. The pill for treating flaccidity of femoral head necrosis liver and tendons according to claim 1, wherein: 134-148 parts of prepared fleece flower root and 134-148 parts of white paeony root.

3. The pill for treating flaccidity of femoral head necrosis liver and tendons according to claim 1, wherein: 67-79 parts of red peony root, 67-79 parts of angelica, 33-41 parts of Chinese rose flower, 134-148 parts of abrus cantoniensis hance, 67-79 parts of rosewood and 49-55 parts of green tangerine peel.

4. The pill for treating flaccidity of femoral head necrosis liver and tendons according to claim 1, wherein: 67-79 parts of parasitic loranthus, 49-55 parts of vinegar tortoise shell, 49-55 parts of lithospermum, 49-55 parts of madder and 49-55 parts of ramulus mori.

5. The pill for treating flaccidity of femoral head necrosis liver and tendons according to claim 1, wherein: 141 parts of prepared fleece-flower root, 141 parts of white paeony root, 73 parts of red paeony root, 73 parts of angelica, 37 parts of Chinese rose flower, 141 parts of abrus cantoniensis hance, 73 parts of rosewood heart wood, 52 parts of green tangerine peel, 73 parts of loranthus parasiticus, 52 parts of vinegar tortoise shell, 52 parts of lithospermum, 52 parts of madder and 52 parts of ramulus mori.

6. A preparation method of a pill for treating femoral head necrosis and consumptive disease of liver deficiency tendons comprises: the method is characterized in that: the pill is the pill for treating the flaccidity syndrome of the necrotic femoral head and the liver and tendons as defined in any one of claims 1 to 5; the preparation method comprises the following steps:

pulverizing the raw materials and mixing uniformly to obtain powder;

mixing and stirring 100 parts of the powder, 1-3 parts of starch, 10-20 parts of honey and 28-40 parts of pure water, and then preparing wet pills.

7. The preparation method of the pill for treating flaccidity of femoral head necrosis liver due to deficiency of tendons as claimed in claim 6, wherein: 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.