CN103330837A - Traditional Chinese medicine composition for curing osteoporosis of menopausal women - Google Patents

Abstract

The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating postmenopausal women's osteoporosis, which has simple formula, simple manufacturing process, less toxic and side effects, convenient administration, easy preparation of medicament, and low cost. The traditional Chinese medicine composition of the present invention is compatible with the theory of traditional Chinese medicine, and the efficacy of each medicine produces a synergistic effect, so that it has the effects of nourishing the liver and kidney, strengthening tendons and strengthening bones, thereby effectively treating postmenopausal osteoporosis. The invention adopts traditional Chinese medicinal materials with different medicinal properties, carries out scientific compatibility, can achieve an ideal therapeutic effect, is safe, has little toxic and side effects, is simple to prepare, can directly reach the cause of the disease, has short healing time and quick prevention and treatment effect.

Description

A traditional Chinese medicine composition for treating postmenopausal women's osteoporosis

technical field

The present invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating postmenopausal women with osteoporosis. the

Background technique

Osteoporosis is a systemic bone disease characterized by decreased bone mass and destruction of bone microstructure, resulting in increased bone fragility and easy fractures. Osteoporosis can be divided into three major categories: primary osteoporosis, secondary osteoporosis, and idiopathic osteoporosis. the

The first type of primary osteoporosis can be further divided into postmenopausal osteoporosis (type I) and senile osteoporosis (type II);

The second category is secondary osteoporosis, which is osteoporosis induced by other diseases (such as kidney failure, excess thyroid hormone or leukemia), or drugs (such as steroids);

The third category is idiopathic osteoporosis, which is more common in adolescents or adults aged 8 to 14. Most of them have a genetic family history, and women are more than men. Osteoporosis that occurs during pregnancy and lactation can also be included in idiopathic osteoporosis. Osteoporosis.

Modern medicine believes that postmenopausal osteoporosis (postmenopausal osteoporosis, POP) refers to the decline of ovarian function and estrogen in postmenopausal women, which is characterized by bone loss and changes in bone tissue structure in the body. The clinical manifestations are bone fragility and fractures. A metabolic disorder in which susceptibility is increased. the

Osteoporosis is a common disease in postmenopausal women. It is a frequently occurring disease and its harm is becoming more and more serious. It is called a "silent epidemic" and has attracted worldwide attention. The clinical manifestations are as follows: back pain at the earliest, followed by vertebral body compression, accompanied by spinal deformity, hunchback becoming shorter, etc., severe cases can cause thoracic deformity and affect lung function

Yes, concurrent fractures, and the risk of fractures increases with age. At present, Western medicine treatment methods for this disease mostly use estrogen supplementation, calcium and vitamins, but long-term use of large amounts of estrogen may cause side effects such as endometrial cancer and breast cancer, and the supplementation of calcium and vitamins is difficult to control in terms of dosage. , and traditional Chinese medicine has made many achievements in the drug treatment of postmenopausal osteoporosis.

Although traditional Chinese medicine does not have a name for postmenopausal osteoporosis, its clinical manifestations and pathogenesis should belong to the categories of "asthenia", "bone atrophy", "gubi" and "bone dryness". 

Traditional Chinese medicine believes that kidney deficiency is the main cause of osteoporosis. Clinically, it can be divided into yin deficiency and yang deficiency according to the rise and fall of yin and yang; The clinical treatment is based on the principle of "kidney storing essence governs the production of bone marrow" and "tonifying the kidney" as the method. the

Contents of the invention

The technical problem to be solved by the present invention is to provide a new drug with simple formula, simple manufacturing process, less toxic and side effects, convenient administration, easy manufacture of medicament, and low cost. The traditional Chinese medicine composition of the present invention is compatible with the theory of traditional Chinese medicine, and the efficacy of each medicine produces a synergistic effect, so that it has the effects of nourishing the liver and kidney, strengthening tendons and strengthening bones, thereby effectively treating postmenopausal osteoporosis. The invention adopts traditional Chinese medicinal materials with different medicinal properties, carries out scientific compatibility, can achieve an ideal therapeutic effect, is safe, has little toxic and side effects, is simple to prepare, can directly reach the cause of the disease, has short healing time and quick prevention and treatment effect. the

In order to solve the above-mentioned technical problems, the invention provides a kind of Chinese medicine composition for the treatment of postmenopausal women's osteoporosis, the weight-number ratio of various crude drugs in the said Chinese medicine composition is:

1-10 parts of loquat taro, 1-10 parts of raspberry, 5-15 parts of dodder, 1-5 parts of chestnut, 5-15 parts of medlar, 0.5-0.9 part of privet fruit, 1-15 parts of sealwort, epimedium 1-15 parts, 0.1-0.8 parts of snow lotus, 0.01-0.09 parts of Morinda officinalis, 0.01-0.09 parts of curculigo, 0.01-0.09 parts of geranium, 1-15 parts of black medicine leaves, 1-10 parts of agarwood, road 1-15 parts of Lutong, 1-5 parts of Gecko, 1-15 parts of Turtle Shell, 0.01-0.09 parts of Siberia chinensis, 1-15 parts of Salvia miltiorrhiza, 1-10 parts of sesame, 0.01-0.09 parts of Hagi chinensis, fairy 0.01-0.09 servings of spleen, 1-10 servings of Phalaenopsis japonica, 1-10 servings of viburnum root, 0.01-0.09 servings of double-strand arrow, 1-15 servings of peach kernel, 1-15 servings of jujube, 1-5 servings of mulberry 10-15 parts of mulberry, 10-15 parts of bee milk, 1-5 parts of Cordyceps sinensis, 1-15 parts of papaya.

The present invention provides a kind of Chinese medicine composition for treating postmenopausal women's osteoporosis, the weight-number ratio of various raw materials in the said Chinese medicine composition is:

2-8 parts of loquat taro, 2-8 parts of raspberry, 6-14 parts of dodder, 2-4 parts of chestnut, 6-14 parts of medlar, 0.6-0.8 part of privet fruit, 2-14 parts of sealwort, epimedium 2-14 parts, 0.2-0.7 parts of snow lotus, 0.02-0.08 parts of Morinda officinalis, 0.02-0.08 parts of curculigo, 0.02-0.08 parts of geranium, 2-14 parts of black medicine leaves, 2-9 parts of agarwood, road 2-14 servings of Lutong, 2-4 servings of Gecko, 2-14 servings of Turtle Shell, 0.02-0.08 servings of Scutellaria, 2-14 servings of Salvia, 2-8 servings of Sesame, 0.02-0.08 servings of Hagi, Faerie 0.02-0.08 servings of spleen, 2-8 servings of Phalaenopsis japonica, 2-8 servings of viburnum root, 0.02-0.08 servings of double-strand arrow, 2-14 servings of peach kernel, 2-14 servings of jujube, 2-4 servings of mulberry 11-14 parts of mulberry, 11-14 parts of bee milk, 2-4 parts of Cordyceps sinensis, 2-14 parts of papaya.

The present invention provides a kind of Chinese medicine composition for treating postmenopausal women's osteoporosis, the weight-number ratio of various raw materials in the said Chinese medicine composition is:

5 parts of loquat taro, 5 parts of raspberry, 10 parts of dodder, 3 parts of chestnut, 10 parts of medlar, 0.7 part of Ligustrum lucidum, 10 parts of sealwort, 10 parts of epimedium, 0.5 part of snow lotus, 0.05 part of Morinda officinalis, 0.05 parts curculigo, 0.05 parts geranium, 10 parts cicatrix, 8 parts agarwood, 10 parts passepartout, 3 parts gecko, 10 parts turtle shell, 0.05 parts scallop grass, 12 parts salvia, 5 parts sesame, 0.05 parts of hagi, 0.05 parts of celestial spirit spleen, 5 parts of centipeda, 5 parts of viburnum root, 0.05 parts of double-strand arrow, 12 parts of peach kernel, 12 parts of jujube, 3 parts of mulberry, 12 parts of mulberry, 12 parts of bee milk, 3 parts of Cordyceps sinensis, 10 parts of papaya.

In order to solve the above-mentioned technical problems, the present invention also provides a preparation method of a Chinese medicine composition for the treatment of postmenopausal women's osteoporosis, the dosage form of the Chinese medicine composition is honey refining pills. The preparation method comprises:

a. Soak the raw materials except bee milk in ethanol, and heat extract once to form an extract, which is component 1;

b. The dregs are extracted twice with water, concentrated and filtered to obtain an extract, which is component 2;

c. Concentrate the above two extracts into a paste, add bee milk and knead into a pill.

In the step a, add 5-10 times the amount of 60-90% ethanol to the raw material medicine except bee milk, soak for 1-2 hours, heat and extract for 1-2 hours, remove the supernatant, continue heating and concentrating the medicine paste to In the form of extract, stand for later use and become component 1. the

In the step b, the dregs can be soaked in water for 1-2 hours, extracted twice, each time for 1-1.5 hours, and the extracts are combined, filtered at 80-120 mesh, and then ultrafiltered with a cut-off molecular weight of 5000-10000 Column ultrafiltration, the ultrafiltrate is concentrated under reduced pressure and the extract with a relative density of 1.36 at 80°C is heated and concentrated for 30 minutes to 45 minutes to extract the active ingredient, and the concentrated solution is left to stand to form an extract, which is used as component 2. the

In order to solve the problems of the technologies described above, the present invention also provides a method for preparing a Chinese medicine composition for the treatment of postmenopausal women's osteoporosis. The dosage form of the Chinese medicine composition is a capsule. The preparation method comprises:

a, putting Salvia miltiorrhiza into ethanol and heating under reflux to extract;

b. Take the remaining raw materials in the above recipe except turtle shells, add water and heat under reflux to extract;

c. Combine the above two extracts, recover the ethanol under reduced pressure, concentrate and suction, filter and absorb to obtain the raw material drug; add the turtle shells ground into fine powder, and pack in cans.

In the step a, put Salvia miltiorrhiza into 10 times the amount of ethanol, heat and reflux for extraction twice, each time for 1-2 hours, extract the active ingredient, combine the two extracts and let stand;

In the step b, the remaining raw materials except turtle shells are put into 10 times the amount of water, heated and refluxed for 3 extractions, each time for 45 minutes to 1 hour, and the 3 extracts are combined and allowed to stand.

In the step c, the above two filtrates can be combined, and the ethanol can be recovered under reduced pressure and concentrated to a concentration of 0.4g crude drug/mL. After suction filtration, the relative density of the filtrate is about 1.06 at 20°C; A macroporous adsorption resin column with a volume of 10 L is first eluted with deionized water or distilled water of 10 times the volume of the resin column, and then eluted with 95% ethanol of 5 times the volume of the resin column, and the ethanol eluate is collected, and the solvent is removed to obtain Raw material medicine powder; then the turtle shell is ground into fine powder, and packed into capsules together with the obtained raw material medicine powder. the

In order to solve the problems of the technologies described above, the present invention also provides a method for preparing a Chinese medicine composition for the treatment of postmenopausal women's osteoporosis, wherein the dosage form of the Chinese medicine composition is a tablet and the preparation method comprises:

Put Salvia miltiorrhiza into 10 times the amount of ethanol, heat and reflux for extraction twice, each time for 1 to 2 hours, extract the active ingredients, combine the two extractions and let stand; then take the remaining raw materials in the above recipe and put them into 10 times the amount of water , heated and refluxed for 3 times, each time for 30 minutes to 1 hour, the three extracts were combined and left standing; the above two extracts were combined, ethanol was recovered under reduced pressure and concentrated until the concentration of the drug solution was 0.5g crude drug/mL, pumped After filtration, the relative density of the filtrate is about 1.08 (20°C); the above-mentioned filtrate passes through a macroporous adsorption resin column with a volume of 10L, and is first eluted with deionized water or distilled water 10 times the volume of the resin column, and then washed with 5 times the volume of the resin column Elute with 95% ethanol by volume, collect the ethanol eluate, remove the solvent to obtain the raw material drug; add starch or dextrin to compress into tablets.

In order to solve the above-mentioned technical problems, the present invention also provides a dosage form of a traditional Chinese medicine composition for treating postmenopausal women's osteoporosis, and the pharmaceutical dosage form can be: sugar-coated tablet, film-coated tablet, enteric-coated tablet, hard capsule, Soft capsules, oral liquids, buccal preparations, granules, granules, honeyed pills, powders, elixirs, injections, suppositories, plasters, syrups, injection powders or sustained-release capsules. the

The present invention relates to the pharmacology and property of medicine of Chinese medicine preparation as follows:

Loquat taro

[nature and flavor] "Shaanxi Chinese Herbal Medicine": "astringent, slightly bitter, warm, slightly poisonous." 

[Functions and Indications] Warming the kidney, reducing swelling and relieving pain. Treatment of abdominal distension, stomach pain, hernia, overworked cough, schistosomiasis. ①"Shaanxi Chinese Herbal Medicine": "Regulate qi and relieve pain, relieve cough and reduce phlegm, relieve swelling and invigorate the stomach. Treat abdominal distension, stomach pain, hernia, and cough due to overwork." ②"Chinese herbal medicine commonly used in Tibet": "Tonify kidney and yang, strengthen muscles and bones. Treat backache and leg pain , impotence."

raspberry:

[nature and flavor] warm; sweet, sour; return kidney, urinary bladder channel.

[Functions and Indications] Tonifying the kidney, strengthening essence, reducing urination. For kidney deficiency enuresis, frequent urination, impotence and premature ejaculation, nocturnal emission and spermatorrhea. the

Cuscuta:

[nature and flavor] Ganxinping, enters liver and kidney channels.

[Functions and Indications] Tonifying the kidney and replenishing essence, nourishing the liver and improving eyesight, preventing miscarriage. For liver and kidney deficiency, waist and knee pain, impotence and nocturnal emission, frequent urination and enuresis, dim eyesight, restless fetal movement and other diseases. the

chestnut:

[meridian distribution of nature and flavor] warm in nature, sweet and flat in taste; enters the spleen, stomach, and kidney channels. the

[Efficacy and Indications] Nourishing the stomach and strengthening the spleen, tonifying the kidney and strengthening the tendons; mainly treating nausea and indigestion, diarrhea and dysentery, vomiting blood, epistaxis, blood in the stool, muscle injury, fracture, bruise, pain, scrofula and other diseases. "Food Materia Medica": "Mainly nourishes qi, thickens the stomach, nourishes kidney qi, and makes people resistant to hunger." 

Wolfberry:

[nature and flavor] sweet, flat, enter liver, stomach two meridians, concurrently enter lung meridian;

[Functions and Indications] Tonifying kidney and essence, nourishing liver and improving eyesight, nourishing blood to calm nerves, promoting body fluid to quench thirst, moistening lung and relieving cough. Indications: Treatment of apoplexy, dizziness, asthenia, various blood syndromes, cough with blood, flaccidity, syncope, contracture, dispelling miasma, dryness, nocturnal emission, red and white turbidity, beriberi, crane knee wind.

Ligustrum:

[meridian distribution of nature and flavor] taste bitter, sweet, neutral in nature, enter the liver and kidney channels;

【Efficacy】Nourishing yin and tonifying kidney.

Polygonatum:

[nature and flavor] sweet, flat; Return lung, spleen, kidney channel.

[Functions and Indications] Nourishes the kidney and moistens the spleen, nourishes the spleen and replenishes qi. Cough due to yin deficiency; lung dryness cough; spleen deficiency and fatigue; lack of food, dry mouth; thirst; kidney deficiency, soreness of the waist and knees; the

Epimedium:

[Taste Meridian Distribution] Pungent, sweet, warm. Return liver, kidney meridian;

【Indications】Invigorating kidney yang, strengthening muscles and bones, dispelling rheumatism.

Epimedium stems and leaves contain icariin and volatile oil. It has been confirmed that Epimedium has a male hormone-like effect, and its efficacy is stronger than that of Gecko and hippocampus. It has been clinically shown that by promoting the secretion of semen, the seminal vesicles are filled with semen, which in turn can stimulate the sensory nerves, thereby stimulating sexual desire and causing penile erection. At the same time, Epimedium can also inhibit the vasomotor center, expand peripheral blood vessels, lower blood pressure, relieve cough, eliminate phlegm, and relieve asthma. effect. the

Epimedium is mainly used clinically to treat reproductive, bone and joint, and respiratory diseases. Epimedium is compatible with rehmannia glutinosa, angelica, Atractylodes macrocephala, wolfberry, Eucommia, curculigo, Morinda officinalis, dogwood, cnidium, leek seeds, cistanche, aconite, cinnamon, called "Zanyu Dan", which can cure impotence and premature ejaculation. Epimedium is compatible with Clematis, Xanthium, and Chuanxiong, which can cure joint pain. Regardless of the amount of Epimedium, decoction and gargle can cure toothache. Taking epimedium plus Aodi tea decoction can cure chronic bronchitis, and its expectorant and antitussive effects are more obvious. Taking Epimedium and decocting with Astragalus, Codonopsis, Aconite, Asarum, Ephedra, etc. can treat sick sinus syndrome and atrioventricular block. the

Snow lotus:

[nature and flavor] Uighur medicine: nature, secondary damp heat. Chinese medicine: slightly bitter, warm. the

[Functions and Indications] Uighur medicine: Tonify kidney and activate blood, strengthen muscles and bones, nourish nerves, regulate abnormal body fluids. For rheumatoid arthritis, joint pain, lung cold cough, kidney and lower abdomen cold pain, excessive leucorrhea, etc. Traditional Chinese Medicine: Warming the kidneys and supporting yang, expelling wind and dampness, promoting menstrual flow and promoting blood circulation. For wind block damp arthralgia, rheumatoid arthritis, lower abdomen pain, irregular menstruation. the

Folks from all over the country use the whole herb of snow lotus as medicine to treat snow blindness, toothache, rheumatoid arthritis, impotence, irregular menstruation, red collapse, leucorrhea and other diseases. Indian folks also use snow lotus to treat many chronic diseases. Such as stomach ulcers, hemorrhoids, bronchitis, heart disease, epistaxis and snake bites. Snow lotus has a long history as a medicine in Tibetan medicine. It is recorded in the Tibetan medical literature "Yuewang Yaozhen" and "Four Medical Codes". It has the functions of dispelling rheumatic arthritis, removing cold and reducing phlegm, strengthening yang and enriching blood, and warming the uterus. Indications snow blindness, toothache, rheumatoid arthritis, impotence, irregular menstruation, red menstrual bleeding, leucorrhea embolism. Indian folks also use snow lotus to treat patients with many chronic diseases. Such as stomach ulcers, hemorrhoids, bronchitis, heart disease, epistaxis and snake bites. Snow lotus has a long history as a medicine in Tibetan medicine. As early as in the Qing Dynasty "Compendium of Materia Medica Supplements", there has been a record of snow lotus, saying that snow lotus is "hot in nature, can nourish lean and benefit yang". According to modern chemical composition analysis, snow lotus herb contains alkaloids, flavonoids, zirconols, volatile oils, raw sugar and 16 kinds of amino acids, etc., and its main functions include dispelling cold and dehumidification, relieving pain, promoting blood circulation and stimulating menstruation, warming the palace and dispelling silt, strengthening Tendons help yang and have special curative effects on treating rheumatic diseases. In addition, it has been proved by clinical pharmacy research that snow lotus flowers and herbs are used as medicines, which have the functions of dredging menstruation and activating blood circulation, warming the uterus and dispelling stasis, dispelling cold and dehumidification, strengthening muscles and yang, stopping bleeding and reducing swelling. For the treatment of pain caused by acute and chronic rheumatoid arthritis, cough due to lung cold, abdominal pain due to cold palace, amenorrhea, retained placenta, impotence and impervious measles. the

Morinda:

[nature and flavor] acrid in the mouth, sweet; Slightly warm in nature; Return kidney, liver meridian.

[Function] Tonify kidney and support yang, dispel wind and dampness, strengthen tendons and bones. Indications Impotence and nocturnal emission, cold uterine infertility, irregular menstruation, cold pain in the lower abdomen, rheumatic arthralgia, muscle and bone flaccidity. the

Curculigo:

[nature and flavor] pungent, warm, poisonous. Go into kidney, Liver Channel. the

[functions and indications] warming kidney yang, strengthening muscles and bones. Treatment of impotence and cold essence, urinary incontinence, metrorrhagia, confidant cold pain, cold arthralgia of waist and feet, carbuncle, scrofula, yang deficiency and cold diarrhea. Impotence and essence-cold, wind-cold waist and knees, muscle and bone flaccidity and numbness embolism. the

Geranium:

[nature and flavor] pungent, bitter, flat. the

[return through] returns liver, kidney, spleen channel. the

[function cures mainly] wind-damp dispelling, meridian dredging, antidiarrheal beneficial. For rheumatic arthralgia, numbness and spasm, muscle and bone pain, diarrhea and dysentery.

Herba Leaf:

[meridian distribution of nature and flavor] pungent and warm enter the lung, spleen and kidney meridians;

[Efficacy and Indications] Warming the middle, regulating qi, relieving pain. Control cold and pain in the abdomen, frequent urination, indigestion, rheumatism and arthralgia.

Compatibility effect of black medicine: black medicine compatibility with agarwood: black medicine warms the kidney and dispels cold, promotes qi and relieves pain; Combination of the two medicines, move the qi, reach the lower burner, have the effect of waking the spleen and dispelling cold, promoting qi and relieving pain. It is used to treat chest tightness, abdominal distension, shortness of breath, fatigue, vomiting and other symptoms of liver depression and spleen deficiency. the

Compatibility of black medicine with angelica Wuyao is pungent and warm, promotes qi and relieves depression, dispels cold and relieves pain, and diverts qi; Angelica pungent dissipates and warms, nourishes blood and activates blood, regulates menstruation and relieves pain, and deviates from blood. The combination of the two plays the effect of promoting qi and blood circulation, dispersing cold and warming the meridian, and relieving pain. It is used to treat dysmenorrhea, postpartum abdominal pain, and cold colic caused by cold condensate, qi stagnation, and blood stasis.

Wuyao is compatible with woody incense. Wuyao promotes qi, relieves pain and dispels cold, and is better than warming and dissipating cold and dampness in the lower burner; woody fragrance promotes qi and relieves pain, and is good at promoting spleen and stomach qi stagnation. The two medicines must be used together, and their effects of dispelling cold, promoting qi, and relieving pain are more pronounced. It is used to treat abdominal distension and pain caused by cold stagnation and stagnation of qi, and gastrointestinal neurosis is caused by stagnation of qi.

Compatibility of Wuyao with Xiebai: Wuyao promotes qi, relieves pain and dispels cold; The combination of the two has the effect of promoting qi and promoting yang, relieving pain and dispelling cold. It is used to treat chest pain caused by stagnation of phlegm and phlegm due to yin and cold.

Wuyao is compatible with Yizhiren: Wuyao warms the kidney and dispels cold; Yizhiren nourishes the kidney and reduces urine. The combination of the two has the effect of warming and nourishing kidney yang, dispelling cold and reducing urination, and is used to treat frequent urination and enuresis due to kidney yang deficiency.

Agarwood:

[meridian distribution of property and flavor] pungent, bitter, warm. Return spleen, stomach, kidney, lung meridians

【Efficacy】Reduces the temperature, warms the kidney and absorbs qi. the

[Indications] Treatment of dyspnea and wheezing, vomiting and hiccups, epigastric distension and pain, cold waist and knees, large intestine deficiency and constipation, stranguria in urination, and coldness in men. ① "Bie Lu": "Treat wind, water, poison and swelling, and remove bad breath." 

Passepartout:

[meridian distribution of property and flavor] bitter, flat. Return liver, kidney channel.

[Functions and Indications] Dispelling wind and activating collaterals, diuresis and dredging menstrual flow. For arthralgia, numbness and spasm, edema and fullness, breast oligomenorrhea. the

gecko:

[meridian distribution of property and flavor] salty, cold. It is slightly poisonous.

[function cures mainly] expelling wind, activating collaterals, dispelling stagnation. For stroke paralysis, rheumatic joint pain, osteomyelitis, lymph node tuberculosis, tumor. the

Turtle shell:

[nature and flavor] salty, cold. the

[Function] Nourishes the kidney and subdues the yang, softens the hard mass and relieves stagnation. the

【Indications】Nourishing yin and suppressing yang, softening hard masses and resolving stagnation, reducing fever and removing steam. For yin deficiency and fever, labor heat bone steaming, internal movement of asthenia wind, amenorrhea, lumps in the abdomen, and chronic malaria malaria. "Bie Lu": treat febrile malaria, blood in the abdomen, lumbago, and children's hypochondrium. "Theory of Medicinal Properties": main food, lumps, obsessive qi, cold lumps, labor and emaciation, lowering qi, removing bone heat, labor heat between joints, firmness and congestion. The cured woman missed the five colors to win the thin one. "Nihuazi Materia Medica": remove blood energy, loose feeling knot, bad blood, abortion, reduce sores and swollen blood, malaria, intestinal carbuncle. "Materia Medica Yanyi Supplement": nourishing yin and nourishing qi. "Introduction to Medicine": mainly labor malaria, old malaria, women's amenorrhea, and children's epilepsy. "Compendium": In addition to the old malaria malaria mother, insidious abdominal pain, fatigue recovery, food recovery, spot pox and dyspnea, woman's dystocia, postpartum vaginal prolapse, husband's vulva sore, stone stranguria; astringe ulcer carbuncle. "Jiangxi Traditional Chinese Medicine": treat rickets.

Wexgrass:

[function] dispelling rheumatism, benefiting joints, detoxification. the

[Indications] For rheumatic arthralgia, weakness of muscles and bones, weakness of waist and knees, paralysis of limbs, hemiplegia, rubella eczema.

Danshen:

[meridian distribution of property and flavor] bitter, slightly cold. GUIXIN, Liver Channel.

[Functions and Indications] Dispelling blood stasis and relieving pain, promoting blood circulation and promoting menstrual flow, clearing away heart-fire and relieving restlessness. Used for irregular menstruation, amenorrhea dysmenorrhea, accumulation of lumps in the abdomen, tingling pain in the chest and abdomen, heat pain, sore swelling and pain, restlessness and insomnia; hepatosplenomegaly, angina pectoris. "Materia Medica Justice": Danshen, "The Classic" called it slightly cold, Tao Hongjing suspected it was wrong, Miao Zhongchun also suspected it, and Zhang Shiwan changed it to lukewarm. "Herbal Classic": main confidant evil spirits, borborygmus faint like running water, accumulation of cold and heat; dispelling symptoms and removing lumps in the abdomen, stopping restlessness and fullness, benefiting qi. "Wu Pu Materia Medica": controls abdominal pain. "Bie Lu": Nourishes blood, removes stagnation of qi, strong waist and spine, and numbness of feet; removes wind and heat and keeps heat, long-term use benefits people. Tao Hongjing: Drink it with soaked wine to treat wind numbness. "Medicine Properties": Treat weak feet, pain and numbness, and control evil in the middle; cure abdominal pain, and make the sound of qi. "Rihuazi Materia Medica": nourish the mind and set the will, and benefit the Guanmai. Treat cold and heat fatigue, joint pain, limb paralysis; expel pus and relieve pain, promote muscle growth; break old blood, replenish new blood; induce birth, stop stillbirth; Evil sores and scabies, galls and swollen poisons, erysipelas; headache, red eyes, fever, temperature, maddening and stuffy. "Southern Yunnan Materia Medica": Replenish the mind and set the mind, soothe the nerves and calm the mind. Treat forgetfulness and palpitations, palpitations and insomnia. "Compendium": promoting blood circulation, Tongxin Envelope. Treat colic. "Yunnan Chinese Herbal Medicine Selection": promoting blood circulation and dispelling blood stasis, sedating and relieving pain. Control irregular menstruation, dysmenorrhea, rheumatic arthralgia, uterine bleeding, vomiting blood, mastitis, carbuncle. the

Sesame:

Medicinal records

"Shen Nong's Materia Medica" says that sesame seeds are mainly used to treat "injury and deficiency, tonify the five internal organs, strengthen energy, grow muscles, and fill the essence."

"Baopuzi": resists rheumatism, nourishes aging.

"Compendium of Materia Medica": Take oil from flax, the white one is the best, and the black one is good for taking. the

"Materia Medica Congxin": Taking flax makes the intestines slippery, and those whose energy is weak should not eat it. the

"Materia Medica Seeking Truth": It is contraindicated for loose stools, impotence, leucorrhea, and leucorrhea due to infirmity in the lower Yuan. the

Tao Hongjing, an ancient health-preserving expert, once said: Among the eight grains, this is the only one that is good. Immortals use it as food bait, and if you break the grain, you will live forever. the

In ancient China, sesame has always been regarded as a food for prolonging life. The great poet Su Dongpo of the Song Dynasty also believed that sesame can strengthen the body and resist aging. Going away from illness is the key to longevity. the

Therapeutic effect

Sesame is sweet in taste and flat in nature, and enters the liver, kidney, lung, and spleen meridians.

It has the effects of nourishing blood and improving eyesight, dispelling wind and moistening intestines, promoting body fluid and unblocking milk, nourishing liver and hair, strengthening the body, and anti-aging. the

It can be used to treat symptoms such as physical weakness, dizziness and tinnitus, high blood pressure, high blood fat, cough, physical weakness, premature graying of hair, anemia and chlorosis, insufficient body fluid, dry stool, less milk, and hematuria. the

[Use] Used for liver and kidney deficiency, insufficient essence and blood, premature graying of beard and hair, dizziness and tinnitus, soreness of waist and knees, weakness of limbs; postpartum blood deficiency, insufficient milk; blood deficiency and fluid loss, intestinal dryness and constipation, etc. the

Hagi One Leaf:

【Efficacy】: Promote blood circulation and relax tendons, invigorate spleen and kidney. the

[meridian distribution of nature and flavor]: hard, warm, poisonous. "Hunan Drug Records" "sweet, slightly pungent, warm." Enters the liver, kidney, spleen three meridians

[Usage and Dosage]: Oral administration: Decoction, 3-5 qian. the

[Drug Compatibility]: with Duhuo, expelling wind and dampness; with Angelica, warm and loose; with Xianling Spleen, tonify kidney and strengthen yang. the

Fairy Spleen:

[nature and flavor] pungent, cold, nontoxic.

[Function] Strengthening yang and promoting blood circulation, expelling wind and dampness. the

[Indications] ① Deficiency of the liver and kidney, unable to warm and nourish, obstructed circulation of qi and blood, and pain in limbs and joints caused by the three evils of wind, cold and dampness. ②Lower pain and lower limb weakness caused by deficiency of kidney yang. ③Limb paralysis and skin numbness in stroke sequelae. the

Horsetail Herb:

[meridian distribution of property and flavor]: pungent, warm. Go into liver, kidney two warps. the

【Efficacy】: Expelling wind and dampness, reducing swelling and relieving pain. the

【Indications】: bruises; muscle spasm; muscle and bone pain; rheumatic joint pain; hypertrophic spondylitis; rheumatoid arthritis.

Heart leaf viburnum root:

[nature and flavor] wet, warm. the

[return through] enters Liver Channel. the

[Functions and Indications] Treat rheumatism numbness, pain in muscles and bones, congealed blood stasis due to falls, flatulence in the waist and flanks. the

[Usage and Dosage] Oral administration: decoction, 5-7 qian; or soak in wine. the

【Prescriptions】Treating rheumatism and pain in the muscles and bones: Viburnum cordifolia with Cortex Wujiapi;

Double Arrow:

[nature and flavor] bitter, slightly pungent, warm. the

[function cures mainly] dispels wind-damp, relaxes tendons and collaterals. Treatment of rheumatism, muscle and bone pain, bruises: double-strand arrow three to five qian, decocted in water, or outsourced to the painful area.

peach kernel:

[meridian distribution of nature and flavor] sweet in nature, bitter in taste, enters the lung, liver, and large intestine meridians;

[Functions and Indications] It has the effects of dispelling blood and promoting blood stasis, moistening dryness and smoothing intestines; treating amenorrhea, dysmenorrhea, lumps in the abdomen, bruises, intestinal dryness and constipation.

Jujube:

[meridian distribution of property and flavor] sweet, warm, return spleen, stomach meridian;

[Functions and Indications] Tonify the middle and replenish qi, nourish blood and calm the nerves. It is used for spleen deficiency, lack of food, fatigue and loose stools, and women are dirty and irritable.

Sang Jisheng:

[nature and flavor] bitter, sweet, flat. the

[return through] returns liver, kidney channel. the

[Functions and Indications] Tonify the liver and kidney, strengthen bones and muscles, dispel rheumatism, and calm the fetus. For rheumatic arthralgia, soreness of the waist and knees, weakness of muscles and bones, metrorrhagia, bleeding during pregnancy, fetal movement; hypertension. the

Mulberry:

[nature and flavor] sweet, slightly cold; GUIXIN, liver, kidney channel.

[Functions and Indications] Treat liver and kidney yin deficiency, constipation, dark eyes, tinnitus, primary ulcer, and joint discomfort. It can improve the blood supply of the skin (including the scalp), nourish the skin, make the skin white and tender, black hair, etc., and can delay aging. Mulberry is a good fruit and good medicine for middle-aged and elderly people's body, beauty, and anti-aging. Regular consumption of mulberries can improve eyesight and relieve the symptoms of eye fatigue and dryness. Mulberry has immune-boosting effect. Mulberry fruit has a weight-increasing effect on the spleen, has a strengthening effect on hemolytic reactions, can prevent human arteriosclerosis, bone and joint sclerosis, and promotes metabolism; mulberry fruit can promote the growth of red blood cells, prevent leukopenia, and treat diabetes, anemia, hypertension , hyperlipidemia, coronary heart disease, neurasthenia and other diseases have auxiliary curative effect. Mulberry has the effects of promoting body fluid to quench thirst, promoting digestion, and helping defecation. Eating in moderation can promote the secretion of gastric juice, stimulate intestinal peristalsis and relieve dryness and heat. Traditional Chinese medicine believes that mulberry is sweet and cold in nature and has the effects of nourishing the liver and kidney, promoting body fluid and moistening the intestines, and blackening the eyes. the

Bee milk:

[nature and flavor] sweet and sour, flat.

[Functions and Indications] Nourishing, strengthening, benefiting the liver and invigorating the spleen. Weakness after treatment, malnutrition in children, frailty in the elderly, infectious hepatitis, hypertension, rheumatoid arthritis, duodenal ulcer. the

Cordyceps:

[nature and flavor] sweet in taste, flat in nature.

[Function] It has the functions of nourishing yin and moistening lung, nourishing kidney and strengthening yang, so it can be used as nourishing food for nourishing lung and kidney, stopping bleeding and resolving phlegm, protecting lung, resolving dysentery, and relieving consumptive cough. Cordyceps contains cordycepic acid. Vitamin B12, fat, protein, etc. Cordyceps is sweet, warm and non-toxic. It is a famous tonic and strong medicine. It is often stewed with meat, which has the effect of tonifying deficiency and strengthening the body. It is suitable for the treatment of hemoptysis or bloody sputum and cough caused by lung qi deficiency, lung and kidney deficiency, tuberculosis, etc. Shortness of breath, night sweats, etc. It also has a good curative effect on kidney deficiency, impotence, waist and knee pain, etc. It is also a good nourishing product for the elderly and infirm. the

pawpaw:

[return through] returns liver, spleen channel.

[Functions and Indications] Pinggan soothes tendons, harmonizes stomach and removes dampness, mainly treats symptoms such as weakness of spleen and stomach, loss of appetite, lack of milk, joint pain, and numbness of limbs. the

Detailed ways:

Embodiment 1, formula:

Loquat taro 1g, raspberry 1g, dodder 5g, chestnut 1g, medlar 5g, privet privet 0.5g, sealwort 1g, epimedium 1g, snow lotus 0.1g, Morinda officinalis 0.01g, curculigo 0.01g, geranium Grass 0.01g, black medicine leaf 1g, agarwood 1g, passepartout 1g, gecko 1g, turtle shell 1g, scutellaria 0.01g, salvia miltiorrhiza 1g, sesame 1g, hagi 0.01g, fairy spleen 0.01g, horsetail daughter Grass 1g, heart leaf viburnum root 1g, double arrow 0.01g, peach kernel 1g, jujube 1g, mulberry 1g, mulberry 10g, bee milk 10g, cordyceps 1g, papaya 1g;

The dosage form of the Chinese medicine composition is that the preparation method of honey refining pill comprises:

a. Soak the raw materials except bee milk in ethanol, and heat extract once to form an extract, which is component 1;

b. The dregs are extracted twice with water, concentrated and filtered to obtain an extract, which is component 2;

c. Concentrate the above two extracts into a paste, add bee milk and knead into a pill.

In the step a, add 5-10 times the amount of 60-90% ethanol to the raw material medicine except bee milk, soak for 1-2 hours, heat and extract for 1-2 hours, remove the supernatant, continue heating and concentrating the medicine paste to In the form of extract, stand for later use and become component 1. the

In the step b, the dregs can be soaked in water for 1-2 hours, extracted twice, each time for 1-1.5 hours, and the extracts are combined, filtered at 80-120 mesh, and then ultrafiltered with a cut-off molecular weight of 5000-10000 Column ultrafiltration, the ultrafiltrate is concentrated under reduced pressure and the extract with a relative density of 1.36 at 80°C is heated and concentrated for 30 minutes to 45 minutes to extract the active ingredient, and the concentrated solution is left to stand to form an extract, which is used as component 2. the

Animal local irritation test:

Guinea pig skin allergy test of tablet of the present invention. The results show that: in skin allergy test, 0.8g (medicine powder)/kg in the high-dose group and 0.1g (medicine powder)/kg in the low-dose group are respectively equivalent to 20 times and 2.5 times the proposed clinical human dosage [0.04g (medicine powder)/kg]. times, through the skin administration, no animals were seen to produce allergic reactions; rectal administration irritation test high dose group 5.0g (medicine powder)/kg, low dose group 3.2g (medicine powder)/kg, respectively equivalent to proposed clinical human dosage 125, 80 times, the rectal mucosa was observed within the specified time without congestion, edema, etc., and there was no significant difference in histopathological examination compared with the blank control group, and no obvious irritating reaction was seen. General condition, body weight, breathing, circulation, central nervous system and limb activities, etc., showed no obvious abnormal reaction.

Acute Toxicity Test

Application of mice to carry out acute toxicity test shows: the tablet of the traditional Chinese medicine composition of the present invention is orally administrated into mice, and under the dose of 488.8g crude drug/kg, after administration, the mice have a slight activity reduction, and return to normal in about 1 hour. Continuously observe 7 days after the medicine, no animal dies, and its general condition, diet, water intake, urination and weight gain are all normal. 488.8g crude drug/kg/d (LD 50 >488.8g crude drug/kg). The daily clinical dosage of the traditional Chinese medicine preparation of the present invention is 0.1 g crude drug/kg/d; in terms of body weight, the tolerated dose of the traditional Chinese medicine preparation of the present invention in mice is 4888 times that of clinical patients. It is suggested that the drug has low acute toxicity and is safe for clinical use.

Typical cases and curative effect:

Qin, female, aged 56 years, often suffers from low back pain and decreased physical strength after menopause. Lumbar disc herniation was diagnosed by CT in 2011, cervical spondylosis by CT in 2012, swelling and pain of both knee joints after exertion in 2013, MRI examination: bone hyperplasia, meniscus injury. The patient reported that sometimes his feet hurt and swelled when he landed on the ground in the morning, and his hands and joints hurt in the morning recently, but it can be slightly relieved after activities. On June 5 this year, I went to the hospital to check the bone density: lumbar spine: L1-2.6, L2-2.3, L3-3.0, L4-3.0. After the patient takes the medicine of the present invention for two courses of treatment, joint pain and swelling are alleviated, and the activity function takes a turn for the better.

Embodiment 2, formula:

Loquat taro 2g, raspberry 2g, dodder 6g, chestnut 2g, medlar 6g, privet privet 0.6g, sealwort 2g, epimedium 2g, snow lotus 0.2g, Morinda officinalis 0.02g, curculigo 0.02g, geranium Grass 0.02g, black herb leaves 2g, agarwood 2g, Passepartout 2g, gecko 2g, turtle shell 2g, scutellaria 0.02g, salvia miltiorrhiza 2g, sesame 2g, Hagi 0.02g, fairy spleen 0.02g, horsetail daughter Grass 2g, heart leaf viburnum root 2g, double-strand arrow 0.02g, peach kernel 2g, jujube 2g, mulberry parasite 2g, mulberry 11g, bee milk 11g, cordyceps sinensis 2g, papaya 2g;

The dosage form of the Chinese medicine composition is that the preparation method of tablet comprises:

Put Salvia miltiorrhiza into 10 times the amount of ethanol, heat and reflux for extraction twice, each time for 1 to 2 hours, extract the active ingredients, combine the two extractions and let stand; then take the remaining raw materials in the above recipe and put them into 10 times the amount of water , heated and refluxed for 3 times, each time for 30 minutes to 1 hour, the three extracts were combined and left standing; the above two extracts were combined, ethanol was recovered under reduced pressure and concentrated until the concentration of the drug solution was 0.5g crude drug/mL, pumped After filtration, the relative density of the filtrate is about 1.08 (20°C); the above-mentioned filtrate passes through a macroporous adsorption resin column with a volume of 10L, and is first eluted with deionized water or distilled water 10 times the volume of the resin column, and then washed with 5 times the volume of the resin column Elute with 95% ethanol by volume, collect the ethanol eluate, remove the solvent to obtain the raw material drug; add starch or dextrin to compress into tablets.

Acute Toxicity Test

Application of mice to carry out acute toxicity test shows: the capsules of the traditional Chinese medicine composition of the present invention are orally administrated into mice, and under the dose of 488.8g crude drug/kg, the mice have a slight activity reduction after administration, and return to normal in about 1 hour. Continuously observe 7 days after the medicine, no animal dies, and its general condition, diet, water intake, urination and weight gain are all normal. 488.8g crude drug/kg/d (LD 50 >488.8g crude drug/kg). The daily clinical dosage of the traditional Chinese medicine preparation of the present invention is 0.1 g crude drug/kg/d; in terms of body weight, the tolerated dose of the traditional Chinese medicine preparation of the present invention in mice is 4888 times that of clinical patients. It is suggested that the drug has low acute toxicity and is safe for clinical use.

Embodiment 3, formula:

Loquat taro 5g, raspberry 5g, dodder 10g, chestnut 3g, medlar 10g, privet privet 0.7g, sealwort 10g, epimedium 10g, snow lotus 0.5g, Morinda officinalis 0.05g, curculigo 0.05g, geranium Grass 0.05g, black herb leaves 10g, agarwood 8g, Passepartout 10g, gecko 3g, turtle shell 10g, scutellaria 0.05g, salvia miltiorrhiza 12g, sesame 5g, Hagi 0.05g, fairy spleen 0.05g, horsetail daughter Grass 5g, heart leaf viburnum root 5g, double arrow 0.05g, peach kernel 12g, jujube 12g, mulberry 3g, mulberry 12g, bee milk 12g, cordyceps 3g, papaya 10g;

The dosage form of the Chinese medicine composition is that the preparation method of tablet comprises:

Put Salvia miltiorrhiza into 10 times the amount of ethanol, heat and reflux for extraction twice, each time for 1 to 2 hours, extract the active ingredients, combine the two extractions and let stand; then take the remaining raw materials in the above recipe and put them into 10 times the amount of water , heated and refluxed for 3 times, each time for 30 minutes to 1 hour, the three extracts were combined and left standing; the above two extracts were combined, ethanol was recovered under reduced pressure and concentrated until the concentration of the drug solution was 0.5g crude drug/mL, pumped After filtration, the relative density of the filtrate is about 1.08 (20°C); the above-mentioned filtrate passes through a macroporous adsorption resin column with a volume of 10L, and is first eluted with deionized water or distilled water 10 times the volume of the resin column, and then washed with 5 times the volume of the resin column Elute with 95% ethanol by volume, collect the ethanol eluate, remove the solvent to obtain the raw material drug; add starch or dextrin to compress into tablets.

Long-term toxicity test:

Select SD rats for use, give different concentrations (18.0, 6.0, 2.0g crude drug/kg) of the Chinese medicine preparation honeyed pills of the present invention, gavage once a day, for 90 consecutive days, kill 1/2 of each group alive 24 hours after the last administration Animals (half male and half female), and the remaining 1/2 animals continued to be observed for 2 weeks before being killed alive. During the test, the appearance, general behavior, food intake and body weight changes of the animals were observed, and hematology (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemistry ( AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology and other indicators inspection. The test results show that: the preparation of the present invention is in high, middle and low dose group animals in good general condition, and there are no abnormal changes in appearance signs, behavioral activities, food intake and body weight growth; Urine biochemical examinations were all within the normal range, and there was no significant difference between the groups; no obvious abnormalities were found in the histopathological examination of major organs in each group. The above indicators did not change after 2 weeks of drug withdrawal. The test dosage is respectively 180, 60, and 20 times of the clinical dosage, and according to the test results, the Chinese medicine preparation of the present invention is administered continuously for 90 days at high, medium and low dosages (18.0, 6.0, 2.0g crude drug/kg). It has no obvious effect on rats, no clear target organs of toxicity and sensitive indicators, and no delayed toxic reaction is observed in the recovery period, suggesting that the dose safety of the clinical application of the traditional Chinese medicine preparation of the present invention is relatively high.

Typical cases and curative effect:

Zhang XX, female, 50-year-old postmenopausal, 54-year-old bone density -2.25, 56-year-old bone density -3.45, joints and waist pain and swelling, no tooth decay but reduced tooth force. After the patient takes the medicine of the present invention for a course of treatment, the symptom disappears, and the bone mineral density of laboratory examination is 0.80, which is cured.

Embodiment 4, formula:

Loquat taro 8g, raspberry 8g, dodder 14g, chestnut 4g, medlar 14g, privet privet 0.8g, sealwort 14g, epimedium 14g, snow lotus 0.7g, Morinda officinalis 0.08g, curculigo 0.08g, geranium Grass 0.08g, black medicine leaves 14g, agarwood 9g, Passepartout 14g, gecko 4g, turtle shell 14g, scutellaria 0.08g, salvia miltiorrhiza 14g, sesame 8g, hagi 0.08g, fairy spleen 0.08g, horsetail daughter Grass 8g, heart leaf viburnum root 8g, double-strand arrow 0.08g, peach kernel 14g, jujube 14g, mulberry 4g, mulberry 14g, bee milk 14g, cordyceps 4g, papaya 14g;

The dosage form of described Chinese medicine composition is that the preparation method of honey refining pill comprises:

Step a, add 5-10 times the amount of 60-90% ethanol to the raw materials except bee milk, soak for 1-2 hours, heat and extract for 1-2 hours, remove the supernatant, and continue heating and concentrating the drug paste until it becomes an extract , let it stand for later use, and become component 1.

In step b, soak the dregs in water for 1-2 hours, extract twice, each time for 1-1.5 hours, combine the extracts, filter with 80-120 mesh, and then ultrafilter through an ultrafiltration column with a cut-off molecular weight of 5000-10000 , the ultrafiltrate is concentrated under reduced pressure to the extract with a relative density of 1.36 at 80°C, heated and concentrated for 30 minutes to 45 minutes to extract the active ingredient, and the concentrated solution is left to stand to form an extract, which is used as component 2. the

Step c: Concentrate the above two extracts into a paste, add bee milk and knead into a pill. the

Long-term toxicity test:

Select SD rats for use, give different concentrations (18.0, 6.0, 2.0g crude drug/kg) of the Chinese medicine preparation honeyed pills of the present invention, gavage once a day, for 90 consecutive days, kill 1/2 of each group alive 24 hours after the last administration Animals (half male and half female), and the remaining 1/2 animals continued to be observed for 2 weeks before being killed alive. During the test, the appearance, general behavior, food intake and body weight changes of the animals were observed, and hematology (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemistry ( AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology and other indicators inspection. The test results show that: the preparation of the present invention is in high, middle and low dose group animals in good general condition, and there are no abnormal changes in appearance signs, behavioral activities, food intake and body weight growth; Urine biochemical examinations were all within the normal range, and there was no significant difference between the groups; no obvious abnormalities were found in the histopathological examination of major organs in each group. The above indicators did not change after 2 weeks of drug withdrawal. The test dosage is respectively 180, 60, and 20 times of the clinical dosage, and according to the test results, the Chinese medicine preparation of the present invention is administered continuously for 90 days at high, medium and low dosages (18.0, 6.0, 2.0g crude drug/kg). It has no obvious effect on rats, no clear target organs of toxicity and sensitive indicators, and no delayed toxic reaction is observed in the recovery period, suggesting that the dose safety of the clinical application of the traditional Chinese medicine preparation of the present invention is relatively high.

Typical cases and curative effect:

Zeng XX, 60 years old, retired, chief complaint: five years of intermittent low back pain, outpatient treatment in March 2012, menopausal age 55 years old, has been menopausal for five years; physical examination: height 165CM, weight 58KG, BMI: 21.3kg/m2, Fracture trauma: On 11-10-27, the right ulna was fractured due to a fall, orthopedic treatment; on 12-1-9, he fell again, and the left wrist was fractured, and orthopedic treatment; on March 5 this year, he went to the hospital for bone density examination: Lumbar spine: L1-2.7, L2-2.2, L3-3.1, L4-3.0. After the patient takes the medicine of the present invention for two courses of treatment, joint pain and swelling are alleviated, and the activity function takes a turn for the better.

Embodiment 5, formula:

Loquat taro 10g, raspberry 10g, dodder 15g, chestnut 5g, medlar 15g, privet fruit 0.9g, sealwort 15g, epimedium 15g, snow lotus 0.8g, Morinda officinalis 0.09g, curculigo 0.09g, geranium Grass 0.09g, black medicine leaves 15g, agarwood 10g, passepartout 15g, gecko 5g, turtle shell 15g, scutellaria 0.09g, salvia miltiorrhiza 15g, sesame 10g, hagi 0.09g, fairy spleen 0.09g, horsetail daughter Grass 10g, heart leaf viburnum root 10g, double arrow 0.09g, peach kernel 15g, jujube 15g, mulberry 5g, mulberry 15g, bee milk 15g, cordyceps 5g, papaya 15g;

The dosage form of described Chinese medicine composition is that the preparation method of honey refining pill comprises:

Step a, add 5-10 times the amount of 60-90% ethanol to the raw materials except bee milk, soak for 1-2 hours, heat and extract for 1-2 hours, remove the supernatant, and continue heating and concentrating the drug paste until it becomes an extract , let it stand for later use, and become component 1.

In step b, soak the dregs in water for 1-2 hours, extract twice, each time for 1-1.5 hours, combine the extracts, filter with 80-120 mesh, and then ultrafilter through an ultrafiltration column with a cut-off molecular weight of 5000-10000 , the ultrafiltrate is concentrated under reduced pressure to the extract with a relative density of 1.36 at 80°C, heated and concentrated for 30 minutes to 45 minutes to extract the active ingredient, and the concentrated solution is left to stand to form an extract, which is used as component 2. the

Step c: Concentrate the above two extracts into a paste, add bee milk and knead into a pill. the

Long-term toxicity test:

Select SD rats for use, give different concentrations (18.0, 6.0, 2.0g crude drug/kg) of the Chinese medicine preparation honeyed pills of the present invention, gavage once a day, for 90 consecutive days, kill 1/2 of each group alive 24 hours after the last administration Animals (half male and half female), and the remaining 1/2 animals continued to be observed for 2 weeks before being killed alive. During the test, the appearance, general behavior, food intake and body weight changes of the animals were observed, and hematology (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemistry ( AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, histopathology and other indicators inspection. The test results show that: the preparation of the present invention is in high, middle and low dose group animals in good general condition, and there are no abnormal changes in appearance signs, behavioral activities, food intake and body weight growth; Urine biochemical examinations were all within the normal range, and there was no significant difference between the groups; no obvious abnormalities were found in the histopathological examination of major organs in each group. The above indicators did not change after 2 weeks of drug withdrawal. The test dosage is respectively 180, 60, and 20 times of the clinical dosage, and according to the test results, the Chinese medicine preparation of the present invention is administered continuously for 90 days at high, medium and low dosages (18.0, 6.0, 2.0g crude drug/kg). It has no obvious effect on rats, no clear target organs of toxicity and sensitive indicators, and no delayed toxic reaction is observed in the recovery period, suggesting that the dose safety of the clinical application of the traditional Chinese medicine preparation of the present invention is relatively high.

Typical cases and curative effect:

Liu XX, female, aged 55 years, due to osteoporosis, hip joint degeneration and hardening, thigh pain after walking too much. After the patient took the medicine of the present invention for two courses of treatment, the thigh pain was relieved, and the activity function took a turn for the better.

"Kidney governs bone", "kidney is the innate foundation", after middle age, the kidney essence gradually fails, the two channels of governor and Ren are damaged, the kidney is deficient, the marrow is empty, the bone is not nourished and becomes thin and weak. The waist is the house of the kidneys, so lumbago; weak muscles and bones, so weakness. When the kidney is deficient, the five internal organs cannot be warmed, the yang energy is weakened, and the yin essence is insufficient, so the deficiency and heat come and go, and the qi is timid and spontaneous sweating. the

According to the theory of "kidney governing bone" in traditional Chinese medicine, "Suwen-Zhizhenyaodalun" says: "Salt enters the kidney first", and long-term use of salty food will cause the corresponding visceral function to be strong. The purpose of preventing and treating osteoporosis can be obtained by mobilizing the potential of the body through the use of medicated diet. Among them, soft-shelled turtle tonifies kidney and nourishes yin, treats weakness of waist and knees; fruit of wolfberry tonifies kidney and nourishes essence. Accompanied by jujube and red sage root to nourish blood and nourish qi, medicine and dietary nutrition have the effect of nourishing kidney and strengthening bones. The kidney in Chinese medicine includes the functions of the genitourinary system, endocrine system and nervous system in Western medicine, as a group of functional units. Kidney deficiency syndrome is a body reaction state characterized by dysfunction of multiple target source systems of the hypothalamus and pituitary gland and hypophysiological dysfunction of the whole body. Kidney deficiency can affect the metabolism of phosphorus and calcium, which is reflected in the bone mineral metabolism. Traditional Chinese medicine mainly nourishes the liver, spleen and kidney. As a kidney-tonifying traditional Chinese medicine (herbal medicine) compound with the characteristics of "multi-components, multi-targets, synergistic promotion and synergy, and moderate compatibility and safety", a large number of basic experiments and clinical application research have been carried out, and remarkable achievements have been made. achievement. Kidney deficiency is the root cause of osteoporosis. Tonifying the kidney can correct the low function of the body's immune system, restore the functional activities of the hypothalamus-pituitary-target gland organs, promote bone calcium deposition, inhibit bone resorption, accelerate bone formation, delay bone loss, and increase bone loss. High bone mineral content and bone density, to achieve the purpose of treating osteoporosis. the

Clinical manifestations:

1. General pain in the bones, mainly in the spine, pelvis and fractures, which is worse when changing body positions or going up and down stairs.

2. Short stature. the

3. Easy to fracture. the

Experimental research of the present invention:

1 Objects and methods 1.1 Objects 200 cases of menopausal osteoporosis women received from January 2012 to June 2013.

Inclusion criteria: ① Female ② Age between 55 and 65 years old ③ Menopausal osteoporosis ④ Abnormal bone mineral density ⑤ Abnormal ALP. the

Exclusion criteria: ①Male ②Age younger than 55 and older than 65 ③Unclear diagnosis ④No abnormality in bone mineral density or ALP ⑤Allergic constitution or allergic to experimental drugs ⑥Suspected or confirmed history of alcohol and drug abuse ⑦Participated within 3 months Other clinical trialists ⑧ researchers think should be excluded. 1.2 Methods 1.2.1 Inclusion criteria ① Menopausal women (aged 55 to 65 years old). ②Patients were included in the diagnosis according to international standards, that is, if the bone mineral density of the lumbar spine measured by dual-energy X-ray absorptiometry is lower than 2.5 standard deviations of the average value of normal young females (bone density < 0.861 g/cm2), the diagnosis of osteoporosis can be made. quality loose. 1.2.2 Exclusion criteria No endocrine metabolism or other chronic diseases affecting calcium and phosphorus metabolism, no history of liver and kidney diseases and taking drugs that affect calcium and phosphorus metabolism Basic osteoporosis therapy, through consultation with the patient, after obtaining the consent of the patient, sign the informed consent and cooperate closely. 1.2.4 120 hospitalized menopausal women with osteoporosis, measured the lumbar cancellous bone density by quantitative computerized tomography (QCT) and measured the lumbar spine by dual-energy X-ray absorptiometry (DEXA) before the Chinese medicine composition of the present invention L2-L4) and femoral neck (Neck) bone mineral density and ALP determination. 1.2.5 While undergoing clinical treatment, take the traditional Chinese medicine of the present invention, each dose is divided into 3 doses, 3 doses/day, 15 days is a course of treatment, and the same method is used to measure bone density and ALP after taking it for 1 month. 1.2.6 SPSS13.0 statistical software was used for data analysis of bone density and ALP. 1.3 Observation indicators Before taking the medicine and after taking the medicine for 1 month, the patients in the two groups were measured by quantitative computed tomography (QCT) to measure the lumbar cancellous bone density, and by dual energy X-ray absorptiometry (DEXA) to measure the lumbar spine (L2-L4). And femoral neck (Neck) bone mineral density and ALP determination. 1.4 Statistical analysis SPSS13.0 statistical software was used for data analysis of bone density and ALP. 2 Results 2.1 General situation Before taking the medicine, quantitative computed tomography (QCT) was used to measure lumbar cancellous bone mineral density, and dual energy X-ray absorptiometry (DEXA) was used to measure lumbar spine (L2-L4) and femoral neck (Neck). Bone density and ALP determination. Not statistically significant. 2.2 Changes in bone mineral density and ALP indexes After taking the medicine for one month, the patients in each group were measured by quantitative computed tomography (QCT) to measure the lumbar cancellous bone density, and by dual energy X-ray absorptiometry (DEXA) to measure the lumbar spine (L2-L4). And femoral neck (Neck) bone mineral density and ALP determination. 2.3 Short-term clinical outcome The 100 patients in the control group had no significant improvement in bone pain and dysfunction; the 100 patients in the medication group had significant improvement in bone pain and functional impairment returned to normal after one month. the

Curative effect evaluation standard

1. Cure: disappear, activity function returns to normal, laboratory examination is normal.

2. Improvement: joint pain and swelling are relieved, and the activity function is improved. the

3. Unhealed: no change in joint pain and swelling. the

The statistics of the treatment results of the medication group:

The cure rate is 78%, the improvement rate is 19%, and the non-healing rate is 3%.

Among them: total effective rate = cure rate + improvement rate

The total effective rate is 97%

Therefore, a Chinese medicinal composition for treating postmenopausal women's osteoporosis is effective.

the

Claims (7)

1. Chinese medicine composition for the treatment of the menopausal women osteoporosis, it is characterized in that: the ratio of weight and number of various crude drug is in the Chinese medicine composition:

Rhizoma Xylanches Himalaicae 1-10 part, Fructus Rubi 1-10 part, Semen Cuscutae 5-15 part, Semen Castaneae 1-5 part, Fructus Lycii 5-15 part, Fructus Ligustri Lucidi 0.5-0.9 part, Rhizoma Polygonati 1-15 part, Herba Epimedii 1-15 part, Herba Saussureae Involueratae 0.1-0.8 part, Radix Morindae Officinalis 0.01-0.09 part, Rhizoma Curculiginis 0.01-0.09 part, Herba Erodii 0.01-0.09 part, Folium Linderae strychnifoliae 1-15 part, Lignum Aquilariae Resinatum 1-10 part, Fructus Liquidambaris 1-15 part, Gekko Swinhonis 1-5 part, Carapax Trionycis 1-15 part Herba Siegesbeckiae 0.01-0.09 part, Radix Salviae Miltiorrhizae 1-15 part, Semen Sesami 1-10 part Cacumen Securinegae Suffruticosae 0.01-0.09 part, Herba Epimedii 0.01-0.09 part, Lycopodium sieboldii Miq. 1-10 part, Radix Viburni Cordifolii 1-10 part, Radix Ainsliaeae Bonatii 0.01-0.09 part, Semen Persicae 1-15 part, Fructus Jujubae 1-15 part, Herba Taxilli 1-5 part, Fructus Mori 10-15 part, Lac regis apis 10-15 part, Cordyceps 1-5 part, Fructus Chaenomelis 1-15 part.

2. a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis according to claim 1, it is characterized in that: the ratio of weight and number of various crude drug is in the Chinese medicine composition:

Rhizoma Xylanches Himalaicae 2-8 part, Fructus Rubi 2-8 part, Semen Cuscutae 6-14 part, Semen Castaneae 2-4 part, Fructus Lycii 6-14 part, Fructus Ligustri Lucidi 0.6-0.8 part, Rhizoma Polygonati 2-14 part, Herba Epimedii 2-14 part, Herba Saussureae Involueratae 0.2-0.7 part, Radix Morindae Officinalis 0.02-0.08 part, Rhizoma Curculiginis 0.02-0.08 part, Herba Erodii 0.02-0.08 part, Folium Linderae strychnifoliae 2-14 part, Lignum Aquilariae Resinatum 2-9 part, Fructus Liquidambaris 2-14 part, Gekko Swinhonis 2-4 part, Carapax Trionycis 2-14 part Herba Siegesbeckiae 0.02-0.08 part, Radix Salviae Miltiorrhizae 2-14 part, Semen Sesami 2-8 part Cacumen Securinegae Suffruticosae 0.02-0.08 part, Herba Epimedii 0.02-0.08 part, Lycopodium sieboldii Miq. 2-8 part, Radix Viburni Cordifolii 2-8 part, Radix Ainsliaeae Bonatii 0.02-0.08 part, Semen Persicae 2-14 part, Fructus Jujubae 2-14 part, Herba Taxilli 2-4 part, Fructus Mori 11-14 part, Lac regis apis 11-14 part, Cordyceps 2-4 part, Fructus Chaenomelis 2-14 part.

3. a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis according to claim 1, it is characterized in that: the ratio of weight and number of various crude drug is in the Chinese medicine composition:

5 parts of Rhizoma Xylanches Himalaicaes, 5 parts of Fructus Rubies, 10 parts of Semen Cuscutae, 3 parts in Semen Castaneae, 10 parts of Fructus Lycii, 0.7 part of Fructus Ligustri Lucidi, 10 parts of Rhizoma Polygonatis, 10 parts of Herba Epimedii, 0.5 part of Herba Saussureae Involueratae, 0.05 part of Radix Morindae Officinalis, 0.05 part of Rhizoma Curculiginis, 0.05 part of Herba Erodii, 10 parts of Folium Linderae strychnifoliaes, 8 parts of Lignum Aquilariae Resinatum, 10 parts of Fructus Liquidambaris, 3 parts of Gekko Swinhonis, 0.05 part of 10 parts of Herba Siegesbeckiae of Carapax Trionycis, 12 parts of Radix Salviae Miltiorrhizaes, 0.05 part of 5 parts of Cacumen Securinegae Suffruticosae of Semen Sesami, 0.05 part of Herba Epimedii, 5 parts of Lycopodium sieboldii Miq.s, 5 parts of Radix Viburni Cordifolii, 0.05 part of Radix Ainsliaeae Bonatii, 12 parts in Semen Persicae, 12 parts in Fructus Jujubae, 3 parts of Herba Taxillis, 12 parts in Fructus Mori, 12 parts of Lac regis apis, 3 parts of Cordyceps, 10 parts of Fructus Chaenomeliss.

4. according to any described a kind of Chinese medicine composition for the treatment of the menopausal women osteoporosis of claim 1-3, it is characterized in that: the dosage form of Chinese medicine composition comprises for the preparation method of honey refining pill:

A, the crude drug except Lac regis apis is put into soak with ethanol, heat is extracted 1 time, becomes the extractum shape, is component 1;

B, medicinal residues extracting in water 2 times, thickening filtration are the extractum shape, are component 2;

C, above-mentioned two kinds of extractum are condensed into pasty state, add Lac regis apis and be twisted into pill.

5. according to any described a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis of claim 1-3, it is characterized in that: the dosage form of Chinese medicine composition is that the preparation method of capsule comprises:

A, Radix Salviae Miltiorrhizae is put into the ethanol heating and refluxing extraction;

B, get surplus stock among the above-mentioned side except Carapax Trionycis again, add the water heating and refluxing extraction;

C, above-mentioned two kinds of extracting solution are merged, decompression recycling ethanol also concentrates sucking filtration absorption, obtains crude drug; Add the finely disintegrated Carapax Trionycis, canned.

6. according to any described a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis of claim 1-3, it is characterized in that: the dosage form of Chinese medicine composition is that the preparation method of tablet comprises:

Radix Salviae Miltiorrhizae is put into 10 times of amount ethanol, heating and refluxing extraction 2 times, each 1～2 hour, extract active ingredient, 2 extracting solution are merged leave standstill; The surplus stock of getting again among the above-mentioned side is put into 10 times of water gagings, and heating and refluxing extraction 3 times each 30 minutes～1 hour, leaves standstill 3 extracting solution merging; Above-mentioned two kinds of extracting solution are merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL, behind the sucking filtration, the relative density of filtrate is about 1.08 (20 ℃); Above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, earlier with deionized water or the distilled water eluting of 10 times of resin column volumes, uses 95% ethanol elution of 5 times of resin column volumes again, collects ethanol elution, removes solvent, obtains crude drug; Add starch or dextrin tabletting.

7. according to any described a kind of preparation method for the treatment of the Chinese medicine composition of menopausal women osteoporosis of claim 1-3, it is characterized in that: pharmaceutical dosage form can for: sugar coated tablet, film coated tablet, enteric coated tablet, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, honey pill agent, powder, sublimed preparation, injection, suppository, plaster, syrup, pin powder or slow releasing capsule.