A Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and its preparation method

Abstract

The invention discloses a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and a preparation method thereof, which comprehensively utilizes the advantages of the functions and mutual synergistic effects of various Chinese medicine raw materials, activates blood circulation and promotes qi, tonifies the kidney and calms the liver, so that qi and blood can flow freely; the liver is the sea of ​​blood, and the kidney is the root of qi, so the kidney is tonified and bone is strengthened, blood circulation and qi are promoted to treat the root, and the liver is calmed and yang is suppressed, and collaterals are unblocked to relieve pain to treat the symptoms. Both the symptoms and the root are taken into account, so that qi can be rooted and blood can flow vigorously; for the overall performance of osteoporosis syndrome of kidney deficiency and blood stasis, the efficacy of osteoporosis syndrome of kidney deficiency and blood stasis is significant, and it is convenient to use; it promotes gastrointestinal function recovery; relieves back pain; promotes tendon and bone healing; improves bone density; shortens bed rest time, restores functional activities as soon as possible, reduces complications, and prevents brittle fractures. The present invention has obvious effects in treating patients with osteoporosis of kidney deficiency and blood stasis type, and the therapeutic effect reaches 86%, which can greatly improve osteoporosis of kidney deficiency and blood stasis type.

Description

Technical Field

[0001] The invention belongs to the technical field of treating diseases with traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and a preparation method thereof. Background Art

[0002] Osteoporosis is a chronic metabolic disease of bone degeneration caused by multiple causes, characterized by decreased bone mass, degeneration of bone tissue microstructure, increased bone brittleness and decreased mechanical properties of bones. This disease can be divided into two categories: primary and secondary. Primary osteoporosis includes postmenopausal osteoporosis (type I), senile osteoporosis (type II) and idiopathic osteoporosis (juvenile type). Postmenopausal osteoporosis generally occurs in women within 5 to 10 years after menopause; senile osteoporosis generally refers to osteoporosis occurring after the age of 70; idiopathic osteoporosis mainly occurs in adolescents, and the cause is still unknown. Secondary osteoporosis refers to osteoporosis caused by diseases or drugs that affect bone metabolism or other clear causes. Most osteoporosis patients do not have obvious clinical symptoms. With the loss of bone mass, destruction of bone microstructure, decreased bone mechanical properties and the occurrence of microfractures, patients may experience low back pain, severe cases may develop spinal deformities, and even serious consequences such as osteoporotic fractures.

[0003] In TCM, osteoporosis belongs to the category of "bone atrophy" and "bone arthritis". TCM theory believes that "kidneys control bone and produce marrow", "kidneys store essence, essence produces marrow, and marrow nourishes bones". If kidney qi is sufficient and kidney essence is abundant, bone marrow biochemistry is active, bones are firm, strong and powerful; if kidney qi is insufficient and kidney essence is deficient, bone marrow biochemistry is deficient, bones are malnourished, fragile and weak. Osteoporosis has a relatively slow onset, with back pain and spinal deformity. TCM believes that this disease is mostly caused by kidney essence deficiency first, Governor Vessel emptiness, and malnourished tendons and bones. This is the pathological basis of osteoporosis. Spleen and stomach deficiency is an important pathogenesis. Blood stasis is a factor that aggravates osteoporosis.

[0004] The existing treatment measures for osteoporosis mainly include drug therapy and non-drug therapy. Non-drug treatment includes: quitting smoking and drinking, regular exercise, balanced diet, etc. Drug treatment refers to taking anti-osteoporosis drugs, generally including: bisphosphonates that inhibit bone absorption, parathyroid hormone analogs that promote bone formation, some special drugs (estrogen, active vitamin D and its analogs, etc.) and Chinese patent medicine (osteoporosis total flavonoids preparations, etc.). Drug treatment causes continuous and cumulative damage to the human body, and there is a certain degree of dependence and resistance to drugs, which brings continuous life burden and mental pressure to patients and their families. Summary of the invention

[0005] In order to solve the above technical problems, the present invention discloses a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type, which is composed of 10-20 parts of Agkistrodon acutus, 10-20 parts of walnut meat, 10-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-18 parts of Psoralea corylifolia, 10-20 parts of Drynaria fortunei, 10-20 parts of calcined dragon bones, 10-20 parts of calcined oyster shells, 10-18 parts of natural copper, 15-25 parts of Epimedium, 10-20 parts of Eucommia bark, 15-25 parts of Cibotium bark, 10-20 parts of Dipsacus asper, 10-20 parts of Cyathula officinalis, 15-25 parts of Chinese yam, 5-15 parts of Asarum, 10-15 parts of Corydalis yanhusuo, 5-15 parts of Scorpio, 2-8 parts of Scolopendra subspinipes, 5-15 parts of Panax notoginseng, 15-25 parts of Salvia miltiorrhiza, and 25-35 parts of Astragalus.

[0006] Further, a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type is composed, by mass, of 10-15 parts of Agkistrodon acutus, 10-15 parts of walnut meat, 10-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-15 parts of Psoralea corylifolia, 10-20 parts of Drynaria fortunei, 10-20 parts of calcined dragon bones, 10-20 parts of calcined oyster shells, 12-18 parts of natural copper, 15-20 parts of Epimedium, 10-18 parts of Eucommia bark, 15-20 parts of Cibotium bark, 10-15 parts of Dipsacus asper, 10-18 parts of Cyathula officinalis, 15-20 parts of Chinese yam, 5-10 parts of Asarum, 10-15 parts of Corydalis yanhusuo, 5-12 parts of Scorpio, 2-5 parts of Scolopendra subspinipes, 5-10 parts of Panax notoginseng, 15-20 parts of Salvia miltiorrhiza, and 20-35 parts of Astragalus.

[0007] Further, a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type is composed, by mass, of 12-15 parts of Agkistrodon acutus, 12-15 parts of walnut meat, 12-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-15 parts of Psoralea corylifolia, 10-15 parts of Drynaria fortunei, 10-15 parts of calcined dragon bones, 10-15 parts of calcined oyster shells, 12-15 parts of natural copper, 15-20 parts of Epimedium, 10-15 parts of Eucommia ulmoides, 15-20 parts of Cibotium barometz, 10-15 parts of Dipsacus asper, 10-15 parts of Cyathula officinalis, 15-20 parts of Chinese yam, 8-10 parts of Asarum, 10-12 parts of Corydalis yanhusuo, 5-10 parts of Scorpio, 2-3 parts of Scolopendra subspinipes, 5-10 parts of Panax notoginseng, 15-20 parts of Salvia miltiorrhiza, and 20-30 parts of Astragalus.

[0008] Further, a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type is divided by mass, consisting of 15g of Agkistrodon acutus, 15g of walnut meat, 15g of Rehmannia glutinosa, 15g of Cornus officinalis, 15g of Psoralea corylifolia, 15g of Drynaria fortunei, 15g of calcined dragon bone, 15g of calcined oyster, 15g of natural copper, 20g of Epimedium, 15g of Eucommia ulmoides, 20g of Cibotium barometz, 15g of Dipsacus asper, 15g of Cyathula officinalis, 20g of Chinese yam, 10g of Asarum, 12g of Corydalis yanhusuo, 10g of Scorpio, 2 centipedes, 10g of Panax notoginseng, 20g of Salvia miltiorrhiza, and 30g of Astragalus;

[0009] Agkistrodon acutus, nature and flavor, meridians: liver meridian, sweet, salty, warm; poisonous; functions and indications: dispelling rheumatism, penetrating tendons and bones, calming convulsions. Treat rheumatic paralysis, joint pain, leprosy, scabies, infantile convulsions, tetanus, bayberry sore, scrofula and malignant ulcers.

[0010] Walnut meat, nature and flavor and meridians: sweet, warm; enters the lung and kidney meridians; functions and indications: tonifies the kidney, strengthens the waist and knees, astringes the lungs and calms asthma, moistens the intestines and promotes bowel movements;

[0011] Rehmannia root, sweet in nature and slightly warm in flavor; enters the liver and kidney meridians; functions and indications: nourishes blood and yin, replenishes essence and fills marrow;

[0012] Cornus officinalis, sour, astringent, slightly warm; enters the liver and kidney meridians; functions and indications: nourishes the liver and kidneys, astringes and consolidates;

[0013] Psoralea corylifolia, pungent and warm, enters the kidney and spleen meridians; Functions and indications: tonifies the kidney and strengthens yang, consolidates semen and reduces urination, warms the spleen and stops diarrhea, promotes qi and relieves asthma;

[0014] Drynaria fortunei, bitter, warm, enters the kidney and liver meridians; Functions and indications: tonifies the kidney and strengthens bones, heals injuries and relieves pain;

[0015] Calcined dragon bone, sweet, astringent, slightly cold, enters the heart and liver meridians; Functions and indications: calms the nerves, soothes the liver and suppresses yang, astringes and consolidates;

[0016] Calcined oyster, salty, slightly cold; enters the liver, gallbladder, and kidney meridians; functions and indications: soothes the liver and suppresses yang, calms the nerves, softens and disperses lumps, and astringes and consolidates;

[0017] Natural copper, pungent, slightly warm, enters the liver meridian; Functions and indications: dispersing blood stasis, relieving pain, setting bones and healing injuries;

[0018] Epimedium, pungent, sweet, warm, enters the liver and kidney meridians; Functions and indications: replenish kidney yang, strengthen tendons and bones, and eliminate rheumatism;

[0019] Eucommia ulmoides, sweet, slightly pungent, warm, enters the liver and kidney meridians; Functions and indications: nourishes the liver and kidneys, strengthens the tendons and bones, and stabilizes pregnancy;

[0020] Dog spine, bitter, sweet, warm, enters the liver and kidney meridians; Functions and indications: nourishes the liver and kidneys, strengthens the tendons and bones, and eliminates rheumatism;

[0021] Sichuan Dipsacus root, bitter, pungent, slightly warm, enters the liver and kidney meridians; Functions and indications: nourishing the liver and kidneys, strengthening tendons and bones, regulating blood vessels, and repairing tendons and bones

[0022] Rhizoma Cynanchum, bitter, sour, neutral, enters the liver and kidney meridians; Functions and indications: activate blood circulation and menstruation, remove rheumatism, benefit joints, guide fire (blood) downward;

[0023] Chinese yam, sweet, flat, enters the spleen, lung, and kidney meridians; Functions and indications: nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, nourishes the kidneys and astringes semen;

[0024] Asarum, pungent, warm, enters the lung, kidney, and heart meridians; Functions and indications: dispel wind and cold, open the orifices, relieve pain, warm the lungs and transform fluid;

[0025] Yuanhu, pungent, bitter, warm, enters the heart, liver, lung, spleen meridians; functions and indications: activate blood circulation, promote qi circulation, relieve pain;

[0026] Scorpion, pungent, neutral, enters the liver meridian; Functions and indications: calming wind and stopping spasms, attacking toxins and dispersing stagnation, unblocking meridians and relieving pain;

[0027] Centipede, pungent, warm, enters the liver meridian; Functions and indications: calming wind and stopping spasms, attacking toxins and dispersing stagnation, unblocking meridians and relieving pain;

[0028] Panax notoginseng, sweet, slightly bitter, warm, enters the liver and stomach meridians; Functions and indications: dissipating blood stasis and stopping bleeding, promoting blood circulation and relieving pain;

[0029] Danshen, bitter, slightly cold, enters the heart and liver meridians; Functions and indications: promoting blood circulation and removing blood stasis, dredges menstruation and relieves pain, clears the heart and relieves restlessness, cools blood and eliminates carbuncle;

[0030] Astragalus is sweet and slightly warm, and enters the lung and spleen meridians. Its functions and indications: tonifies Qi and raises Yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, relieves stagnation and arthritis, expels toxins and discharges pus, and heals sores and promotes tissue regeneration.

[0031] Explanation of the prescription: Osteoporosis is mainly caused by liver and kidney deficiency, which cannot produce marrow and nourish bones. This prescription uses Rehmannia glutinosa and Cornus officinalis as the main ingredients, which belong to the liver and kidney meridians and nourish the liver and kidneys. They are warm in nature and are matched with Psoralea corylifolia and bone-crushing to nourish the kidneys and strengthen bones; Epimedium for pain relief, stir-fried Eucommia ulmoides, stir-fried Dipsacus asper, stewed Longmu, and natural copper to nourish the liver and kidneys, strengthen tendons and bones, and relieve pain; Lycium barbarum takes into account the deficiency of liver and kidney yin; Polygonum multiflorum enters the liver and kidney meridians to disperse blood stasis and eliminate carbuncle; it nourishes the kidney without forgetting the kidney qi; Chinese yam belongs to the spleen, lung, and kidney meridians. It nourishes the spleen and nourishes the stomach, produces fluid and benefits the lungs, nourishes the kidney and astringes the essence, and takes the meaning of nourishing the mother and giving birth to the child; Corydalis yanhusuo activates blood circulation, promotes qi, and relieves pain; Salvia miltiorrhiza activates blood circulation and regulates menstruation, removes blood stasis and relieves pain, cools blood and eliminates carbuncle; Peach kernel breaks blood circulation and removes blood stasis, moisturizes dryness and lubricates the intestines, and the three medicines are used together to lead the medicine into the blood. Astragalus membranaceus belongs to the lung, spleen, liver, and kidney meridians. It replenishes qi and makes qi flow and blood flow. Asarum, Agkistrodon acutus, whole worm, centipede can relax tendons and activate collaterals, dispel wind and cold, make the medicine enter the collaterals, play the role of running through the bones and collaterals, and are collectively the guiding medicine. The whole prescription can nourish the liver and kidney, strengthen tendons and bones, replenish essence, invigorate qi and activate blood circulation, combine nourishment and movement, make the medicine reach tendons and bones, and start strengthening bones and tendons.

[0032] On the other hand, the present invention discloses a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and a preparation method thereof. The preparation method of the granules comprises the following steps:

[0033] S1: decoction: add water to each medicinal ingredient in the formula at a weight ratio of 1:12 and decoct for 1 to 3 times, each time for 60 to 90 minutes, and combine the decoctions;

[0034] S2: Concentration: The decoction is concentrated into a thick paste at 85-95°C and MPa vacuum, with a density of 4-5 g / ml;

[0035] S3: Drying: Dry the thick paste at 60-80°C and MPa vacuum to form a dry paste for later use;

[0036] S4: Weigh the dry paste according to the weight in the formula, and crush it through a 100-mesh sieve to obtain dry paste powder, add 20-40g of granulation auxiliary materials and mix well, add an appropriate amount of 40-50% ethanol, wet granulate, and obtain granules after drying.

[0037] In a third aspect, the present invention discloses a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and a preparation method thereof. The preparation method of the decoction comprises the following steps:

[0038] Add water to the above formula and boil each medicinal ingredient for 1 to 3 times at a weight ratio of 1:12, each time for 15 to 20 minutes, and combine the decoctions to obtain a decoction;

[0039] In a fourth aspect, the present invention discloses a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and a preparation method thereof. The preparation method of the pill comprises the following steps:

[0040] S1.1: Decoction: weigh each medicinal ingredient in the formula according to the formula amount, add water at a weight ratio of 1:12, and decoct for 1 to 3 times, each time for 60 to 90 minutes, and combine the decoctions;

[0041] S2.1: Concentration: The decoction is concentrated into a thick paste at 85-95°C and MPa vacuum, with a density of 5 g / ml;

[0042] S3.1: Drying: Dry the thick paste at 60-80°C and MPa (specifically how many MPa) vacuum to form a dry paste for later use;

[0043] S4.1: Weigh the dry paste according to the weight in the formula, and grind it through a 100-mesh sieve to obtain dry paste powder. Make pills with water or 40-50% or less concentration of ethanol, add 60-80g of pill-making excipients and mix well to obtain pills.

[0044] Furthermore, the granulation and pelleting auxiliary materials are one or a combination of more than one of starch, dextrin or powdered sugar.

[0045] The beneficial effects of the present invention are:

[0046] The present invention comprehensively utilizes the advantages and mutual synergistic effects of various Chinese medicine raw materials, activates blood circulation and promotes qi, tonifies the kidney and calms the liver, so that qi and blood can flow freely; the liver is the sea of ​​blood, and the kidney is the root of qi, so the kidney is strengthened and bones are invigorated, blood circulation and qi are promoted to treat the root, and the liver is calmed and yang is suppressed, and collaterals are unblocked to relieve pain to treat the symptoms. Both the symptoms and the root are taken into account, so that qi can be rooted and blood can flow effectively; for the overall performance of osteoporosis with kidney deficiency and blood stasis syndrome, it has significant curative effect on osteoporosis with kidney deficiency and blood stasis syndrome, and is easy to use; it promotes gastrointestinal function recovery; relieves back pain; promotes tendon and bone healing; improves bone density; shortens bed rest time, resumes functional activities as soon as possible, reduces complications, and prevents brittle fractures. The present invention has obvious effects in treating patients with kidney deficiency and blood stasis type osteoporosis, and the therapeutic effect reaches 86%, which can greatly improve kidney deficiency and blood stasis type osteoporosis. DETAILED DESCRIPTION

[0047] Example 1

[0048] The invention discloses a Chinese medicine composition for treating osteoporosis of kidney deficiency and blood stasis type and a preparation method thereof. The Chinese medicine composition comprises: by weight, 10-20 parts of Agkistrodon acutus, 10-20 parts of walnut meat, 10-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-18 parts of Psoralea corylifolia, 10-20 parts of Drynaria fortunei, 10-20 parts of calcined dragon bones, 10-20 parts of calcined oyster shells, 10-18 parts of natural copper, 15-25 parts of Epimedium, 10-20 parts of Eucommia bark, 15-25 parts of Cibotium bark, 10-20 parts of Dipsacus asper, 10-20 parts of Cyathula officinalis, 15-25 parts of Chinese yam, 5-15 parts of Asarum, 10-15 parts of Corydalis yanhusuo, 5-15 parts of Scorpio, 2-8 parts of Scolopendra subspinipes, 5-15 parts of Panax notoginseng, 15-25 parts of Salvia miltiorrhiza and 25-35 parts of Astragalus.

[0049] Specifically, it is composed of 15g of Agkistrodon acutus, 15g of walnut meat, 15g of Rehmannia root, 15g of Cornus officinalis, 15g of Psoralea corylifolia, 15g of Drynaria fortunei, 15g of calcined dragon bone, 15g of calcined oyster, 15g of natural copper, 20g of Epimedium, 15g of Eucommia bark, 20g of Cibotium bark, 15g of Dipsacus asper, 15g of Rhizoma Cynoglossi, 20g of Dioscorea opposita, 10g of Asarum, 12g of Rhizoma Corydalis, 10g of Scorpio, 2 centipedes, 10g of Panax notoginseng, 20g of Salvia miltiorrhiza, and 30g of Astragalus.

[0050] Take the above Chinese medicine composition, add water to each medicine in the formula according to the weight ratio of medicine to water of 1:12, boil twice, each time for 80 minutes, combine the decoctions, and obtain a decoction.

[0051] Take the above-mentioned Chinese medicine composition, add water to each medicinal ingredient in the formula according to the weight ratio of medicine to water of 1:12, and boil for 2 times, each time for 80 minutes, and combine the decoctions; concentrate the obtained decoctions at 90°C, MPa (specifically how many MPa) vacuum to form a thick paste, and the density of the thick paste is 4-5g / ml; (3) Drying: Dry the thick paste at 75°C, MPa vacuum to form a dry paste for later use; weigh the dry paste according to the weight in the formula, and crush it through a 100-mesh sieve to obtain a dry paste powder, add 35g of granulation auxiliary materials and mix well, add an appropriate amount of 45% ethanol, wet granulate, and obtain granules after drying.

[0052] Weigh each medicinal ingredient except Panax notoginseng according to the formula amount, add water at a weight ratio of 1:12, and boil twice for 80 minutes each time. Combine the decoctions; concentrate the resulting decoction at 90°C and MPa vacuum to form a thick paste with a density of 4-5 g / ml; (3) Drying: Dry the thick paste at 75°C and MPa vacuum to form a dry paste for later use; weigh the dry paste according to the weight in the formula, crush it through a 100-mesh sieve to obtain a dry paste powder, add 75 g of pill-making excipients and mix well, add an appropriate amount of 45% ethanol to make pills, and then obtain pills.

[0053] Example 2

[0054] In this example, in order to further verify the efficacy of the pharmaceutical composition in this application, the decoction, granules and pills prepared by the prescription and preparation method adopted in Example 1 are clinically tested on typical clinical cases, as follows:

[0055] Typical Case 1

[0056] Tang Moumou, female, 59 years old, from Yunnan. The patient had chest and back pain without obvious cause one year ago, and there was no activity restriction at that time. Thoracic MRI showed: T8 vertebral fracture and bone marrow edema, and bone density results showed: severe osteoporosis, diagnosed as "severe osteoporosis". After treatment in our hospital, she was discharged from the hospital after improvement, and there was no obvious discomfort afterwards; a week ago, the patient's chest and back pain symptoms worsened after fatigue, so she came to our hospital for treatment on August 2, 2023, and was admitted to the hospital with the diagnosis of "severe osteoporosis" in the outpatient clinic. Admission certificate: chest and back pain, stabbing pain, difficulty turning over in supine position, difficulty walking, dizziness and tinnitus, poor appetite and sleep, normal urination and defecation, slightly purple tongue, white fur, and stringy pulse.

[0057] Specialist examination: The physiological curvature of the spine has become straight, the local muscles of the thoracic and lumbar spine are stiff, there is tenderness between the spinous processes of T8 and T9 and on both sides of the spinous processes, and there is percussion pain. Femoral nerve traction test: left (-), right (-), neck flexion test is negative, pelvic compression and separation test is negative, straight leg raising test is left (-), right (-), strengthening test is left (-), right (-), Achilles knee tendon reflex is left (elicited), right (elicited), big toe dorsiflexion: left (normal), right (normal), big toe plantar flexion: left (normal), right (normal). Floating patella test: left (-), right (-), patellar pressure test: left (-), right (-), patellar friction test: left (-), right (-), medial collateral ligament compression test: left (-), right (-), lateral ligament compression test: left (-), right (-), McBurney sign is negative, drawer test: left (-), right (-), Babinski sign is negative. The visual analog scale (VAS) for low back pain was 6 points.

[0058] Auxiliary examinations: The bone density results of the physical examination report showed: severe osteoporosis; the results of blood routine, blood sugar, urine routine, nine liver function tests, three kidney function tests, four blood lipids, erythrocyte sedimentation rate, three thyroid function tests, four infectious diseases, six coagulation tests, and electrolytes showed no abnormalities; the electrocardiogram results showed: sinus arrhythmia.

[0059] Initial diagnosis:

[0060] TCM diagnosis: Osteoporosis, kidney deficiency and blood stasis syndrome

[0061] Western medicine diagnosis: severe osteoporosis

[0062] After taking the decoction prepared in Example 1 of the present invention, the patient took it orally, twice a day, 200ML each time. After two weeks, the patient's thoracolumbar pain was relieved, the functional activity was improved compared with before, the symptoms of dizziness and tinnitus disappeared, and the patient could sleep well. The tenderness between the spinous processes of thoracic 8-thoracic 9 and on both sides of the spinous processes, and the percussion pain was relieved. The visual analog scale (VAS) score for low back pain was 2 points.

[0063] Typical Case 2

[0064] Zhao Moumou, female, 67 years old, from Luxi County, Honghe Prefecture, Yunnan Province. The patient reported that she had low back pain without obvious cause two years ago. She had a bone density test and it showed severe osteoporosis. After treatment, the symptoms improved. For further examination and treatment, she came to our hospital again on June 23, 2023. She was admitted to the hospital with the diagnosis of "severe osteoporosis" in the outpatient department. Admission symptoms: low back pain, worse at night, sore waist and knees, tinnitus, aggravated low back pain when exposed to cold and wind, good appetite and sleep, regular bowel movements, slightly dark tongue, white fur, and stringy pulse.

[0065] Specialist examination: no obvious scoliosis deformity of lumbar spine, tenderness in bilateral lumbar muscles and paraspinal processes, spinous process deviation, tenderness and percussion pain, lumbar range of motion: flexion (30°), extension (15°), lateral flexion: left (15°), right (15°), rotation: left (20°), right (20°). Neck flexion test was negative, pelvic separation and compression test were negative, straight leg raising test: left (-), right (-), straight leg raising strengthening test: left (-), right (-), Achilles knee tendon reflex: left (elicited), right (elicited), big toe dorsiflexion: left (normal), right (normal), big toe plantar flexion: left (normal), right (normal). Floating patella test: left (-), right (-), patellar pressure test: left (-), right (-), patellar friction test: left (-), right (-), medial collateral ligament compression test: left (-), right (-), lateral ligament compression test: left (-), right (-), McBurney sign negative, drawer test: left (-), right (-). The visual analog scale (VAS) for low back pain was 5 points.

[0066] Auxiliary examination: Bone density measurement T-score (2023.6.23, this hospital) showed: T<2.5.

[0067] Initial diagnosis:

[0068] TCM diagnosis: Osteoporosis, kidney deficiency and blood stasis syndrome

[0069] Western medicine diagnosis: severe osteoporosis

[0070] After taking the decoction prepared by Example 1 of the present invention, take orally, twice a day, 200ML each time. After two weeks, the patient's thoracolumbar pain was relieved, the functional activity was improved compared with before, the tinnitus symptoms disappeared, the lumbar spinous process and the tenderness on both sides of the spinous process were relieved, and the percussion pain was relieved. The visual analog scale (VAS) score for low back pain was 2 points. After discharge, continue to take the present invention, and advise it: 1. Avoid wind and cold, smooth emotions, be careful about daily life, ban smoking and drinking, and use hormones with caution; 2. Take medicine according to doctor's advice outside the hospital, regularly review liver and kidney function, and follow up for discomfort; 3. Come to the hospital for review after three months.

[0071] Typical Case 3

[0072] Lv Moumou, female, 64 years old, from Huize, Qujing City, Yunnan Province. Half a month ago, due to fatigue, the back pain worsened. Today, in order to seek further systematic diagnosis and treatment, she came to our hospital for treatment on April 15, 2023. After physical examination and combined with the current symptoms, the outpatient clinic was diagnosed with "1. Severe osteoporosis 2. Asthma 3. Hypertension" and admitted to the hospital. Current symptoms: clear consciousness, good spirits, low back pain with limited activity, soreness and pain in both knee joints, soreness in the waist and knees, dizziness and tinnitus, improved after rest, accompanied by mild limitation of activity, good appetite and sleep, regular bowel movements, slightly dark tongue, white fur, and stringy pulse.

[0073] Specialist examination: Neck flexion test negative, tenderness in L4 / 5, L5-S1 interspinous space, no radiating pain in lower limbs, negative supine abdominal lift test, negative straight leg raising test, normal Achilles knee tendon reflex, negative Babinski sign, floating patella test: left (-), right (-), patellar pressure test: left (-), right (-), patellar friction test: left (-), right (-), medial collateral ligament compression test: left (-), right (-), lateral ligament compression test: left (-), right (-), McBurney sign negative, drawer test: left (-), right (-). The visual analog scale (VAS) for low back pain was 7 points.

[0074] Auxiliary examination: Bone density measurement T-score (2023.4.17, this hospital) showed: T<2.5.

[0075] Initial diagnosis:

[0076] TCM diagnosis: 1. Osteoporosis, kidney deficiency and blood stasis syndrome

[0077] Western medicine diagnosis: 1. Severe osteoporosis

[0078] After taking the decoction prepared by the embodiment of the present invention, it was taken orally, twice a day, 200ML each time. After two weeks, the patient's thoracolumbar pain was relieved, the functional activity was improved compared with before, the tinnitus symptoms disappeared, the tenderness between the lumbar spinous processes and on both sides of the spinous processes, and the percussion pain was relieved. The visual analog scale (VAS) score for low back pain was 3 points. Advise him: 1. Continue to take the present invention after discharge; 2. It is recommended to rest and prevent falls; eat more calcium supplements; 4. Regularly review liver and kidney function, and seek medical treatment in time if you feel unwell.

[0079] Example 3

[0080] In this embodiment, the clinical efficacy test of the drug (clinically named "Bu Shen Huo Xue Fang", the same below) prepared by the prescription of the present invention and different dosage forms is specifically introduced:

[0081] First, according to the existing diagnostic criteria of traditional Chinese medicine and Western medicine, 72 patients with osteoporosis who were treated in the orthopedics outpatient clinic and ward of Yunnan Provincial Hospital of Traditional Chinese Medicine from January 2023 to June 2024 were selected.

[0082] The 72 postmenopausal osteoporosis patients selected after screening were randomly divided into two groups according to the random number table method, with 36 cases in the control group and 36 cases in the treatment group. The relevant data were processed and analyzed using SPSS25.0 software. The count data were tested using the x2 test. The measurement data were expressed as mean ± standard deviation (X ± S). If the data were in accordance with the normal distribution and the variance was equal, the independent t test was used for the inter-group comparison, and the paired t test was used for the intra-group comparison. The measurement data and rank data that did not conform to the normal distribution were tested using the rank sum test. P was a two-sided test, P < 0.05 was considered statistically significant, and P < 0.01 was considered statistically significant.

[0083] Refer to the OP-related efficacy evaluation standards in the "Guidelines for Clinical Research of New Chinese Medicines" and combine clinical experience to formulate:

[0084] (1) Significantly effective: The patient's pain is greatly improved, clinical symptoms basically disappear or significantly improve, bone density increases compared to before treatment, and the TCM symptom efficacy index is ≥70%;

[0085] (2) Effective: The patient's pain was improved, clinical symptoms were improved, bone density was slightly increased compared with before treatment, and the TCM symptom efficacy index was ≥30% but <70%;

[0086] (3) Ineffective: The patient's pain did not improve or even worsened, the clinical symptoms did not improve or even worsened, the bone density value did not change or decreased, and the TCM symptom efficacy index was less than 30%;

[0087] (4) TCM syndrome efficacy index = [(score before treatment - score after treatment) / score before treatment] × 100%.

[0088] 2. Assessment of pain efficacy

[0089] According to the VAS scoring standard, 0 points: no pain; 3 points or less: slight pain, tolerable; 4 points-6 points: the patient's pain is obvious, affecting sleep, but this degree of pain can still be tolerated; 7 points-10 points: the patient's pain is very strong and has reached an unbearable level. Compare the pain scores before treatment, 2 weeks after treatment, and 4 weeks after treatment as secondary observation indicators;

[0090] Specifically, (1) both the control group and the treatment group were advised to adjust their diet, increase sunlight exposure and exercise moderately, and were given basic treatment: oral calcium carbonate D3 1 tablet, qn; vitamin D drops 1 tablet, qd;

[0091] (2) Control group: 1 vial of denosumab injection, once every six months;

[0092] (3) Treatment group: The Bu Shen Huo Xue prescription was added to the control group, and the dosage was adjusted according to clinical symptoms.

[0093] The treatment group adopted the decoction prepared in Example 1, and the specific composition prescription was: Acuta 15g, Walnut meat 15g, Rehmannia glutinosa 15g, Cornus officinalis 15g, Psoralea corylifolia 15g, Drynariae rhizoma 15g, calcined dragon bone 15g, calcined oyster 15g, natural copper 15g, Epimedium 20g, Eucommia 15g, Cibotium barometz 20g, Dipsacus asper 15g, Achyranthes bidentata 15g, Chinese yam 20g, Asarum 10g, Rhizoma Corydalis 12g, Scorpio 10g, Scolopendra 2, Panax notoginseng 10g, Salvia miltiorrhiza 20g, Astragalus 30g; the method of use was 3 bags per dose, each bag was 150ml, 1 month was a course of treatment, 3 courses of treatment were observed, and each course was 1 month apart;

[0094] The comparison results after use are shown in Table 1 and Table 2 below:

[0095] Table 1 Comparison of the efficacy of TCM symptoms before and after treatment (%)

[0096]

[0097] Table 2 Comparison of VAS between the two groups before and after treatment

[0098]

[0099] From the results in Table 1, it can be seen that the therapeutic efficiency of the composition for treating osteoporosis obtained by using the present prescription and the preparation method of the present prescription is 86.11% relative to the control group, which is 13.89% higher than the control group; the results show that the present prescription has a very good effect on osteoporosis and can relieve the patient's back pain;

[0100] In addition, as shown in Table 2, the Chinese medicine composition disclosed in the present invention is superior to the control group in terms of pain relief, P<0.05, and the difference is statistically significant. The above control test results show that the Bushen Huoxue prescription can relieve the patient's back pain, improve the patient's quality of life, and effectively prevent and treat osteoporosis.

[0101] The preferred embodiments of the present invention disclosed above are only used to help explain the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to only the specific implementation methods described.

Claims

1. A Chinese medicine composition for treating osteoporosis due to kidney deficiency and blood stasis, characterized in that: The invention comprises 10-20 parts of Agkistrodon acutus, 10-20 parts of walnut meat, 10-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-18 parts of Psoralea corylifolia, 10-20 parts of Drynaria fortunei, 10-20 parts of calcined dragon bones, 10-20 parts of calcined oyster shells, 10-18 parts of natural copper, 15-25 parts of Epimedium, 10-20 parts of Eucommia bark, 15-25 parts of Cibotium bark, 10-20 parts of Dipsacus asper, 10-20 parts of Cyathula officinalis, 15-25 parts of Chinese yam, 5-15 parts of Asarum, 10-15 parts of Corydalis yanhusuo, 5-15 parts of Scorpio, 2-8 parts of Scolopendra subspinipes, 5-15 parts of Panax notoginseng, 15-25 parts of Salvia miltiorrhiza and 25-35 parts of Astragalus.

2. A Chinese medicine composition for treating osteoporosis due to kidney deficiency and blood stasis according to claim 1, characterized in that: The invention comprises 10-15 parts of Agkistrodon acutus, 10-15 parts of walnut meat, 10-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-18 parts of Psoralea corylifolia, 10-20 parts of Drynaria fortunei, 10-20 parts of calcined dragon bones, 10-20 parts of calcined oyster shells, 12-18 parts of natural copper, 15-20 parts of Epimedium, 10-18 parts of Eucommia bark, 15-20 parts of Cibotium bark, 10-15 parts of Dipsacus asper, 10-18 parts of Rhizoma Cynoglossi, 15-20 parts of Dipsacus asper, 15-20 parts of Rhizoma Dioscoreae, 5-10 parts of Asarum, 10-15 parts of Rhizoma Corydalis, 5-12 parts of Scorpio, 2-5 parts of Scolopendra subspinipes, 5-10 parts of Panax notoginseng, 15-20 parts of Salvia miltiorrhiza and 20-35 parts of Astragalus.

3. A Chinese medicine composition for treating osteoporosis due to kidney deficiency and blood stasis according to claim 1, characterized in that: The invention comprises 12-15 parts of Agkistrodon acutus, 12-15 parts of walnut meat, 12-15 parts of Rehmannia root, 10-15 parts of Cornus officinalis, 10-15 parts of Psoralea corylifolia, 10-15 parts of Drynaria fortunei, 10-15 parts of calcined dragon bones, 10-15 parts of calcined oyster shells, 12-15 parts of natural copper, 15-20 parts of Epimedium, 10-15 parts of Eucommia ulmoides, 15-20 parts of Cibotium barometz, 10-15 parts of Dipsacus asper, 10-15 parts of Cyathula capitata, 15-20 parts of Chinese yam, 8-10 parts of Asarum, 10-12 parts of Corydalis yanhusuo, 5-10 parts of scorpion, 2-3 parts of Scolopendra subspinipes, 5-10 parts of Panax notoginseng, 15-20 parts of Salvia miltiorrhiza and 20-30 parts of Astragalus.

4. A Chinese medicine composition for treating osteoporosis due to kidney deficiency and blood stasis according to claim 1, characterized in that: By mass, it consists of 15g of Acuta, 15g of walnut meat, 15g of Rehmannia root, 15g of Cornus officinalis, 15g of Psoralea corylifolia, 15g of Drynaria fortunei, 15g of calcined dragon bone, 15g of calcined oyster, 15g of natural copper, 20g of Epimedium, 15g of Eucommia bark, 20g of Cibotium bark, 15g of Dipsacus asper, 15g of Achyranthes bidentata, 20g of Chinese yam, 10g of Asarum, 12g of Corydalis yanhusuo, 10g of scorpion, 2 centipedes, 10g of Panax notoginseng, 20g of Salvia miltiorrhiza, and 30g of Astragalus.

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