Traditional Chinese medicine composition for oral administration for osteoporosis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for oral administration for osteoporosis and a preparation method thereof, and relates to the technical field of medicines, the traditional Chinese medicine composition for oral administration for osteoporosis comprises salted morinda officinalis, roasted epimedium, scalded rhizoma drynariae, oyster, deer-horn glue, wolfberry and caulis spatholobi. The salted morinda officinalis is used for tonifying kidney yang, strengthening muscles and bones and expelling wind-damp, the roasted herba epimedii is used for treating impotence, stranguria, muscle and bone spasm, hemiplegia, waist and knee weakness, rheumatic arthralgia and limb dysfunction, the scalded rhizoma drynariae is used for promoting blood circulation, relieving pain, diminishing swelling and promoting tissue regeneration, the oyster is used for stopping sweat, arresting seminal emission, reducing phlegm and softening hard mass, and the deer-horn glue is used for warming liver, tonifying kidney and nourishing essence and blood. The fructus lycii is used for replenishing vital essence, improving eyesight and nourishing liver and kidney, the caulis spatholobi is used for regulating menstruation, relieving pain, relaxing tendons and activating collaterals, and osteoporosis is relieved by regulating osteogenesis / osteoclast differentiation capacity, improving bone microstructure and reducing bone loss.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a Chinese medicine combination oral medicine for osteoporosis and a preparation method thereof. Background Art

[0002] Osteoarthritis is a common degenerative joint disease in the middle-aged and elderly population. The symptoms such as joint swelling, pain, deformity and movement disorders caused by it seriously affect the quality of life of patients. The prevalence of bone injuries and osteoarticular diseases in people over 60 years old in my country is higher than 50%, and the prevention and treatment of osteoarticular diseases has become an issue that cannot be ignored. Among them, osteoporosis is a representative of high incidence. Osteoporosis is a degenerative disease with an incidence rate of up to 32%. Osteoporosis is a high-incidence and major disease, affecting more than 1.4 million people, and the annual medical expenditure is as high as 10 billion yuan. At the same time, since there is no radical treatment for the disease, conservative treatment can only temporarily relieve the patient's symptoms, and it is easy to relapse, which has become a serious social problem. At present, in the clinical research and treatment of osteoporosis, bone conversion drugs are effective in increasing bone mass, but they are not ideal for relieving the symptoms of OP patients such as sore waist and knees, joint pain, etc.

[0003] At present, modern medicine mainly focuses on anti-osteoporosis drugs for the treatment of osteoporosis. However, we have found in clinical practice that most patients' osteoporosis-related laboratory test indicators have improved, but there are still problems such as poor improvement in patients' clinical symptoms and low patient satisfaction. Therefore, a Chinese medicine combination oral medicine for osteoporosis and a preparation method thereof are provided to alleviate osteoporosis by regulating osteoblast / osteoclast differentiation ability, improving bone microstructure and reducing bone loss. Summary of the invention

[0004] The object of the present invention is to provide a Chinese medicine combination oral medicine for osteoporosis and a preparation method thereof, so as to solve the problems raised in the above background technology.

[0005] In order to solve the above technical problems, the technical solution adopted by the present invention is:

[0006] In a first aspect, the present invention provides a Chinese medicine combination for osteoporosis, wherein the Chinese medicine combination for osteoporosis comprises: salt Morinda officinalis, roasted Epimedium, scalded Drynaria, oyster, antler glue, wolfberry, Millettia reticulata;

[0007] The proportion of raw materials in each formula is as follows: salt-soaked Morinda officinalis 9g, roasted Epimedium 9g, scalded Drynaria fortunei 9g, raw oyster 15g, forged oyster 15g, antler glue 3g, wolfberry 12g, Millettia reticulata 9g. The raw materials are composed into a medicine according to the proportion.

[0008] The further improvement of the technical solution of the present invention is that the method of taking the Chinese medicine combination for osteoporosis is: seven sets of medicinal materials are mixed and boiled according to corresponding dosages, decocted with water to 400 ml, and taken warm after meals in the morning and evening.

[0009] In a second aspect, the present invention further provides a method for preparing a Chinese medicine combination oral medicine for osteoporosis, the method for preparing the Chinese medicine combination oral medicine for osteoporosis comprising the following steps:

[0010] Step 1: Processing of medicinal materials;

[0011] Step 2: Soak the medicinal materials;

[0012] Step 3: Bring to a boil over high heat;

[0013] Step 4: Simmer over low heat;

[0014] Step 5: Filter the drug solution.

[0015] A further improvement of the technical solution of the present invention is that: the step 1, the medicinal material processing specifically includes: before decoction, it is necessary to check whether there are medicines in the medicinal materials that need to be decocted first or added later, and classify and process them according to the needs.

[0016] A further improvement of the technical solution of the present invention is that the step 2, soaking the medicinal materials specifically includes: placing the medicinal materials in a container and soaking them in cold water. Under normal circumstances, the medicinal materials need to be soaked for about 1 hour to ensure that the medicinal materials are completely soaked, which is conducive to the precipitation of effective ingredients. The soaking time for flower, leaf and stem drugs can be slightly shorter, about 15 minutes, and the soaking time for seeds, fruits and tubers is slightly longer. The amount of water added is generally 2-3 cm higher than the medicinal materials after soaking.

[0017] A further improvement of the technical solution of the present invention is that the step three, boiling over high heat, specifically includes: putting the soaked medicinal materials and cold water into a container together, boiling over high heat, stirring appropriately during the boiling process to prevent the medicinal materials from sticking to the pot, and if the medicinal liquid is burned during boiling, it should be discarded and it is strictly forbidden to continue taking it.

[0018] A further improvement of the technical solution of the present invention is that the step 4, slow cooking over low heat specifically includes: after boiling, continue decocting over low heat, the decocting time depends on the type and nature of the medicinal materials, generally, antipyretic drugs should not be boiled for a long time, and can be decocted over low heat for 10-15 minutes, conditioning drugs need to be decocted over low heat for 20-30 minutes, for drugs that need to be decocted first, such as shellfish and mineral drugs, they need to be decocted for 10-20 minutes before adding other drugs, and for drugs that need to be added later, such as aromatic drugs, they should be added when the first decoction is about to end, and then decocted for another 4-5 minutes.

[0019] A further improvement of the technical solution of the present invention is that: the step five, filtering the medicinal liquid specifically includes: after the first decoction is completed, filtering the decoction liquid while it is hot, paying attention to avoid the loss of the decoction liquid, and then adding an appropriate amount of warm water for a second decoction. The second decoction time is usually slightly shorter than the first time, 15-20 minutes. After the two decoctions are mixed, the medicinal liquids are taken in several doses.

[0020] Due to the adoption of the above technical solution, the present invention has the following technical advances compared with the prior art:

[0021] 1. The present invention provides a Chinese medicine combination for osteoporosis and a preparation method thereof. The salt-cured Morinda officinalis is used for tonifying kidney yang, strengthening tendons and bones, and removing rheumatism; the roasted Epimedium is used for treating impotence, dribbling urination, tendon and bone spasm, hemiplegia, weakness of waist and knees, rheumatic pain, and numbness of limbs; the scalded Drynaria is used for promoting blood circulation and relieving pain, reducing swelling and promoting tissue regeneration; the oyster is used for stopping sweating and astringing sperm, resolving phlegm and softening hard masses; the antler glue is used for warming the liver and tonifying the kidney, nourishing sperm and blood; the wolfberry is used for nourishing sperm and improving eyesight, nourishing the liver and kidney; the Millettia reticulata is used for regulating menstruation and relieving pain, relaxing tendons and activating collaterals; and osteoporosis is relieved by regulating the differentiation ability of osteoblasts / osteoclasts, improving bone microstructure and reducing bone loss.

[0022] 2. The present invention provides a Chinese medicine combination for osteoporosis and a preparation method thereof, which is an oral Chinese medicine combination that can be used to improve the clinical symptoms of patients with osteoporosis. It can be directly taken orally according to the usage method of Chinese medicine prescriptions. According to clinical trials, it has definite efficacy and good patient adaptability. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The figure is a schematic diagram of the process for preparing the Chinese medicine combination for oral administration of the present invention. DETAILED DESCRIPTION

[0024] The present invention is further described in detail below in conjunction with embodiments:

[0025] In a first aspect, the present invention provides a Chinese medicine combination for osteoporosis, wherein the Chinese medicine combination for osteoporosis comprises: salt Morinda officinalis, roasted Epimedium, scalded Drynaria, oyster, antler glue, wolfberry, Millettia reticulata;

[0026] The proportion of raw materials in each formula is as follows: salt-soaked Morinda officinalis 9g, roasted Epimedium 9g, scalded Drynaria fortunei 9g, raw oyster 15g, forged oyster 15g, antler glue 3g, wolfberry 12g, Millettia reticulata 9g. The raw materials are composed into a medicine according to the proportion.

[0027] Salt-cooked Morinda officinalis is used to tonify kidney yang, strengthen muscles and bones, and eliminate rheumatism. Roasted Epimedium is used to treat impotence, dribbling urination, muscle and bone spasms, hemiplegia, weakness of the waist and knees, rheumatic pain, and numbness of the limbs. Scalded Drynaria is used to promote blood circulation and relieve pain, reduce swelling and promote tissue regeneration. Oyster is used to stop sweating, astringe semen, resolve phlegm and soften hard masses. Deer antler glue is used to warm the liver and tonify the kidney, nourish the essence and blood. Lycium barbarum is used to benefit the essence and improve eyesight, nourish the liver and kidney. Millettia reticulata is used to regulate menstruation and relieve pain, relax muscles and activate collaterals. Osteoporosis can be relieved by regulating the differentiation ability of osteoblasts / osteoclasts, improving bone microstructure and reducing bone loss.

[0028] The method of taking the Chinese herbal combination oral medicine for osteoporosis is: mix and boil the seven medicinal materials according to corresponding dosages, decoct them with water to 400 ml, and take them warm after meals in the morning and evening.

[0029] An oral Chinese medicine combination that can be used to improve the clinical symptoms of patients with osteoporosis. It can be directly taken orally according to the usage of Chinese medicine prescriptions. According to clinical trials, it has definite efficacy and good patient adaptability.

[0030] In a second aspect, the present invention further provides a method for preparing a Chinese medicine combination oral medicine for osteoporosis, the method for preparing the Chinese medicine combination oral medicine for osteoporosis comprising the following steps:

[0031] Step 1: Processing of medicinal materials;

[0032] Step 2: Soak the medicinal materials;

[0033] Step 3: Bring to a boil over high heat;

[0034] Step 4: Simmer over low heat;

[0035] Step 5: Filter the drug solution.

[0036] The first step, the processing of medicinal materials, specifically includes: before decoction, it is necessary to check whether there are any drugs that need to be decocted first or added later, and classify and process them according to the needs;

[0037] Step 2, soaking the medicinal materials, specifically includes: putting the medicinal materials into a container and soaking them in cold water. Normally, the medicinal materials need to be soaked for about 1 hour to ensure that the medicinal materials are completely soaked, which is conducive to the precipitation of effective ingredients. The soaking time for flowers, leaves, and stems can be slightly shorter, about 15 minutes, while the soaking time for seeds, fruits, and tubers is slightly longer. The amount of water added is generally 2-3 cm higher than the medicinal materials after soaking.

[0038] Step 3, boiling over high heat, specifically includes: putting the soaked herbs and cold water into a container, boiling over high heat, stirring appropriately during the boiling process to prevent the herbs from sticking to the pot, and if the herbs are burned during boiling, discard them and do not continue to take them;

[0039] Step 4, slow cooking over low heat specifically includes: after boiling, continue to cook over low heat, the cooking time depends on the type and nature of the medicinal materials, generally, antipyretic drugs should not be cooked for a long time, and can be cooked over low heat for 10-15 minutes, conditioning drugs need to be cooked over low heat for 20-30 minutes, for drugs that need to be cooked first, such as shellfish and mineral drugs, they need to be cooked for 10-20 minutes before adding other drugs, for drugs that need to be added later, such as aromatic drugs, they should be added at the end of the first cooking, and then cooked for another 4-5 minutes;

[0040] The fifth step, filtering the medicinal liquid, specifically includes: after the first decoction is completed, filter the decoction liquid while it is hot, and pay attention to avoid the loss of the decoction liquid, and then add appropriate amount of warm water for the second decoction. The second decoction time is usually slightly shorter than the first time, 15-20 minutes. After the two decoctions are mixed, take them in several doses.

[0041] Implementation Case 1

[0042] Wang, female, medical record number: XXX479, 67 years old.

[0043] Chief complaint: Pain in both knees with relief from activities for 3 years.

[0044] Current medical history: The patient reported that he had dull pain in both knees after fatigue 3 years ago, accompanied by poor flexion and extension of joints, especially when going up and down stairs, and difficulty squatting. The patient did not pay attention to it at the time, and the symptoms were relieved after resting and physical therapy. In the following 3 years, the patient felt that the symptoms of pain in both knees recurred, and they were aggravated every time he walked for too long and was tired. The patient did not undergo systematic diagnosis and treatment. 2 months ago, the patient felt that the pain in the left knee joint worsened, accompanied by limited joint movement. Today, for further systematic treatment, he came to our hospital for treatment. The outpatient department was diagnosed with "bilateral knee osteoarthritis" and admitted to our department. Admission symptoms: The patient was conscious and lacked spirit; complained of tingling in both knees, pain in a fixed place, severe pain at night, weakness in the waist and spine, and limited joint movement, especially when going up and down stairs and squatting, and it was difficult to walk for a long time with weight; sleep was not good at night, appetite was good, and bowel movements were normal.

[0045] Specialist examination: The morphology of both knee joints was generally normal, with no obvious swelling, tenderness in the medial joint space and patellofemoral joint, and functional range of motion of both knee joints: flexion 120 degrees, extension 0 degrees, rotation 0 degrees; floating patella test (-), patella thrust test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyration squeeze test (+), McBurney sign (+), pivot shift test (-).

[0046] Western medicine diagnosis: osteoarthritis of both knees

[0047] TCM Syndrome Differentiation: Knee Arthritis-Liver and Kidney Deficiency Syndrome

[0048] Treatment: Tonify the liver and kidney, use the drug example 4 of the present invention in combination with traditional Chinese medicine. After one month of treatment, the knee joint pain symptoms were significantly relieved, and no recurrence has been observed in follow-up so far. To ensure the privacy of the patient, the patient's identity is not published here. The patient's identity information and case number are archived in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0049] Implementation Case 2

[0050] Pan, female, medical record number: XXX782, 68 years old.

[0051] Chief complaint: Pain in both knees with activity for 2 years, aggravated for 1 month.

[0052] Current medical history: The patient reported that he had dull pain in both knees after fatigue 3 years ago, accompanied by poor flexion and extension of joints, especially when going up and down stairs, and difficulty squatting. The patient did not pay attention to it at the time, and the symptoms were relieved after resting and physical therapy. In the following 3 years, the patient felt that the symptoms of pain in both knees recurred, and they were aggravated every time he walked for too long and was tired. The patient did not undergo systematic diagnosis and treatment. 2 months ago, the patient felt that the pain in the left knee joint worsened, accompanied by limited joint movement. Today, for further systematic treatment, he came to our hospital for treatment. The outpatient department was diagnosed with "bilateral knee osteoarthritis" and admitted to our department. Admission symptoms: The patient was conscious and lacked spirit; complained of tingling in both knees, pain in a fixed place, severe pain at night, weakness in the waist and spine, and limited joint movement, especially when going up and down stairs and squatting, and it was difficult to walk for a long time with weight; sleep was not good at night, appetite was good, and bowel movements were normal.

[0053] Specialist examination: The morphology of both knee joints was generally normal, with no obvious swelling, tenderness in the medial joint space and patellofemoral joint, and functional range of motion of both knee joints: flexion 120 degrees, extension 0 degrees, rotation 0 degrees; floating patella test (-), patella thrust test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyration squeeze test (+), McBurney sign (+), pivot shift test (-).

[0054] Western medicine diagnosis: osteoarthritis of both knees

[0055] TCM Syndrome Differentiation: Knee Arthritis-Liver and Kidney Deficiency Syndrome

[0056] Treatment: Tonify the liver and kidney, use the drug example 4 of the present invention in combination with traditional Chinese medicine. After one month of treatment, the knee joint pain symptoms were significantly relieved, and no recurrence has been observed in follow-up so far. To ensure the privacy of the patient, the patient's identity is not published here. The patient's identity information and case number are archived in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0057] Implementation Case 3

[0058] Pan, female, medical record number: XXX782, 68 years old.

[0059] Chief complaint: Pain in both knees with relief from activities for 3 years, aggravated in the left knee for 2 months.

[0060] Current medical history: The patient reported that he had dull pain in both knees after fatigue 3 years ago, accompanied by poor flexion and extension of joints, especially when going up and down stairs, and difficulty squatting. The patient did not pay attention to it at the time, and the symptoms were relieved after resting and physical therapy. In the following 3 years, the patient felt that the symptoms of pain in both knees recurred, and they were aggravated every time he walked for too long and was tired. The patient did not undergo systematic diagnosis and treatment. 2 months ago, the patient felt that the pain in the left knee joint worsened, accompanied by limited joint movement. Today, for further systematic treatment, he came to our hospital for treatment. The outpatient department was diagnosed with "bilateral knee osteoarthritis" and admitted to our department. Admission symptoms: The patient was conscious and lacked spirit; complained of tingling in both knees, pain in a fixed place, severe pain at night, weakness in the waist and spine, and limited joint movement, especially when going up and down stairs and squatting, and it was difficult to walk for a long time with weight; sleep was not good at night, appetite was good, and bowel movements were normal.

[0061] Specialist examination: The morphology of both knee joints was generally normal, with no obvious swelling, tenderness in the medial joint space and patellofemoral joint, and functional range of motion of both knee joints: flexion 120 degrees, extension 0 degrees, rotation 0 degrees; floating patella test (-), patella thrust test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyration squeeze test (+), McBurney sign (+), pivot shift test (-).

[0062] Western medicine diagnosis: osteoarthritis of both knees

[0063] TCM Syndrome Differentiation: Knee Arthritis-Liver and Kidney Deficiency Syndrome

[0064] Treatment: Tonify the liver and kidney, use the drug example 4 of the present invention in combination with traditional Chinese medicine. After one month of treatment, the knee joint pain symptoms were significantly relieved, and no recurrence has been observed in follow-up so far. To ensure the privacy of the patient, the patient's identity is not published here. The patient's identity information and case number are archived in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0065] Implementation Case 4

[0066] Pan, female, medical record number: XXX782, 68 years old.

[0067] Chief complaint: Pain in both knees with relief from activities for 3 years, aggravated in the left knee for 2 months.

[0068] Current medical history: The patient reported that he had dull pain in both knees after fatigue 3 years ago, accompanied by poor flexion and extension of joints, especially when going up and down stairs, and difficulty squatting. The patient did not pay attention to it at the time, and the symptoms were relieved after resting and physical therapy. In the following 3 years, the patient felt that the symptoms of pain in both knees recurred, and they were aggravated every time he walked for too long and was tired. The patient did not undergo systematic diagnosis and treatment. 2 months ago, the patient felt that the pain in the left knee joint worsened, accompanied by limited joint movement. Today, for further systematic treatment, he came to our hospital for treatment. The outpatient department was diagnosed with "bilateral knee osteoarthritis" and admitted to our department. Admission symptoms: The patient was conscious and lacked spirit; complained of tingling in both knees, pain in a fixed place, severe pain at night, weakness in the waist and spine, and limited joint movement, especially when going up and down stairs and squatting, and it was difficult to walk for a long time with weight; sleep was not good at night, appetite was good, and bowel movements were normal.

[0069] Specialist examination: The morphology of both knee joints was generally normal, with no obvious swelling, tenderness in the medial joint space and patellofemoral joint, and functional range of motion of both knee joints: flexion 120 degrees, extension 0 degrees, rotation 0 degrees; floating patella test (-), patella thrust test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyration squeeze test (+), McBurney sign (+), pivot shift test (-).

[0070] Western medicine diagnosis: osteoarthritis of both knees

[0071] TCM Syndrome Differentiation: Knee Arthritis-Liver and Kidney Deficiency Syndrome

[0072] Treatment: Tonify the liver and kidney, use the drug example 4 of the present invention in combination with traditional Chinese medicine. After one month of treatment, the knee joint pain symptoms were significantly relieved, and no recurrence has been observed in follow-up so far. To ensure the privacy of the patient, the patient's identity is not published here. The patient's identity information and case number are archived in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0073] Implementation Case 5

[0074] Mai, male, medical record number: XXX946, 52 years old.

[0075] Chief complaint: Bilateral knee pain and discomfort with limited activity for more than 1 year, aggravated for 1 week.

[0076] Current medical history: The patient reported that he had dull pain in both knees after fatigue one year ago, accompanied by poor flexion and extension of joints, especially when going up and down stairs, and difficulty squatting. The patient did not pay attention to it at the time, and the symptoms were relieved after resting and physical therapy. In the following year, the patient felt that the symptoms of pain in both knees recurred, and they worsened every time he walked for too long and was tired. The patient did not undergo systematic diagnosis and treatment. One week later, the patient felt that the pain in both knees worsened, accompanied by limited joint movement. Today, for further systematic treatment, he came to our hospital for treatment. The outpatient department was diagnosed with "bilateral knee osteoarthritis" and admitted to our department. Admission symptoms: The patient was conscious and lacked spirit; complained of tingling in both knees, pain in a fixed place, severe pain at night, weakness in the waist and spine, and limited joint movement, especially when going up and down stairs and squatting, and it was difficult to walk for a long time with weight; sleep was not good at night, appetite was good, and bowel movements were normal.

[0077] Specialist examination: The morphology of both knee joints was generally normal, with no obvious swelling, tenderness in the medial joint space and patellofemoral joint, and functional range of motion of both knee joints: flexion 120 degrees, extension 0 degrees, rotation 0 degrees; floating patella test (-), patella thrust test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyration squeeze test (+), McBurney sign (+), pivot shift test (-).

[0078] Western medicine diagnosis: bilateral knee osteoarthritis

[0079] TCM Syndrome Differentiation: Knee Arthritis-Liver and Kidney Deficiency Syndrome

[0080] Treatment: nourishing the liver and kidney, using the drug example 4 of the present invention in combination with Chinese medicine, after 1 month of treatment, the knee joint pain symptoms were significantly relieved, and no recurrence has been observed in follow-up so far. To ensure the privacy of the patient, the patient's identity is not published here, and the patient's identity information and case number are archived in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0081] Implementation Case 6

[0082] Li, female, medical record number: XXX722, 71 years old.

[0083] Chief complaint: Pain in both knees with poor mobility for 4 years, aggravated by the right knee for 2 months.

[0084] Current medical history: The patient reported that he had dull pain in both knees after fatigue 4 years ago, accompanied by poor flexion and extension of joints, especially when going up and down stairs, and difficulty squatting. The patient did not pay attention to it at the time, and the symptoms were relieved after resting and physical therapy. In the following 4 years, the patient felt that the symptoms of pain in both knees recurred, and they worsened every time he walked for too long and was tired. The patient did not undergo systematic diagnosis and treatment. Two months ago, the patient felt that the pain in the right knee joint worsened, accompanied by limited joint movement. Now he came to our hospital for further systematic treatment. The outpatient department was diagnosed with "bilateral knee osteoarthritis" and admitted to our department. Admission symptoms: The patient was conscious and lacked spirit; he complained of tingling in both knees, pain in a fixed place, severe pain at night, weakness in the waist and spine, and limited joint movement, especially when going up and down stairs and squatting, difficulty in carrying weight for a long time, poor sleep at night, good appetite, and regular bowel movements.

[0085] Specialist examination: The morphology of both knee joints was generally normal, with no obvious swelling, tenderness in the medial joint space and patellofemoral joint, and functional range of motion of both knee joints: flexion 120 degrees, extension 0 degrees, rotation 0 degrees; floating patella test (-), patella thrust test (+), drawer test (-), Lachmann test (-), lateral stress test (-), gyration squeeze test (+), McBurney sign (+), pivot shift test (-).

[0086] Western medicine diagnosis: bilateral knee osteoarthritis

[0087] TCM Syndrome Differentiation: Knee Arthritis-Liver and Kidney Deficiency Syndrome

[0088] Treatment: nourishing the liver and kidney, using the drug example 4 of the present invention in combination with Chinese medicine, after 1 month of treatment, the knee joint pain symptoms were significantly relieved, and no recurrence has been observed in follow-up so far. To ensure the privacy of the patient, the patient's identity is not published here, and the patient's identity information and case number are archived in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0089] Example 7 Clinical trial of the efficacy of the Chinese medicine composition of the present invention

[0090] In order to illustrate that the present invention has the effect of improving the symptoms of osteoporosis, the present invention conducted the following efficacy test.

[0091] 1. Basic Experimental Design

[0092] 82 patients with osteoporosis were observed, including 41 in the treatment group (10 males and 31 females), and 43 in the control group (9 males and 32 females, aged 40-89 years, with a disease course of 1-10 years). The diagnostic criteria refer to the 2022 Chinese Medical Association Guidelines "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2022)", and the efficacy evaluation refers to the 2019 "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". The trial was conducted in the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine (a tertiary A hospital). To ensure patient privacy, the patient's identity is not disclosed here. The patient's identity information and case number are archived in the archives of the Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine and are available for reference.

[0093] 2. Osteoporosis diagnostic criteria and efficacy evaluation criteria

[0094] 2.1 The diagnostic criteria refer to the 2022 Chinese Medical Association Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2022):

[0095] (1): Bone density test shows that the bone density value is ≤ 2.5 standard deviations below the peak bone density of healthy adults of the same gender and race, and the T value is ≤ -2.5.

[0096] (2) Age 40 or above

[0097] 2.2 The efficacy evaluation criteria refer to the 2019 "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes":

[0098] Cured: swelling and pain disappeared, knee joint movement was normal, walking and squatting were painless, and there was no recurrence.

[0099] Improvement: Swelling and pain have been reduced, pain still exists after excessive fatigue, and knee joint movement is basically normal.

[0100] Not healed: Swelling recurs and knee pain does not ease.

[0101] 3. Treatment options

[0102] Treatment group: 1 set of medicine was composed of 9g salt-cured Morinda officinalis, 9g roasted Epimedium, 9g scalded Drynaria, 15g raw oyster, 3g antler glue, 12g wolfberry and 9g Millettia reticulata, and a total of 7 sets were taken.

[0103] Control group: 1 set was composed of 9g salt-cured Morinda officinalis, 9g roasted Epimedium, 9g scalded Drynaria, 15g oyster, 15g dragon bone, 3g antler glue, 12g wolfberry, and 9g Millettia reticulata, and a total of 7 sets were taken.

[0104] 4. Statistical methods:

[0105] SPSS 26.0 was used for data processing and statistical analysis. The chi-square test was used for count data, and the normality test was used to test whether the measurement data was normally distributed. If the data between groups were normally distributed, two independent sample t tests were used to analyze the statistical significance based on whether the probability P value was less than 0.05.

[0106] 5. Results

[0107] 5.1 General Information

[0108] According to the proposed research plan, there were 41 people in the treatment group, including 10 males and 31 females, and 32 people in the control group, including 9 males and 32 females. After statistical processing and analysis, the chi-square test result was: 0.069, indicating that there was no statistically significant difference in gender between the treatment group and the control group. The age was tested by two independent sample t tests, t = 1.725, corresponding to P = 0.088, indicating that there was no statistically significant difference in age between the treatment group and the control group; see Table 1.

[0109] Table 1 Comparison of human experience baseline data between the treatment group and the control group

[0110]

[0111] 5.2 Improvement of clinical symptoms before and after taking Gusong Bawei Yin

[0112] After taking Gusong Bawei Drink, 41 patients showed improvements in their back pain, weakness in waist and knees, convulsions in lower limbs, difficulty walking, and difficulty holding weight compared to before taking the medicine. Except for difficulty walking, other symptoms showed statistical differences, as shown in Tables 2 and 3.

[0113] Table 2 Improvement of clinical symptoms in the treatment group

[0114]

[0115] Table 3 Improvement of clinical symptoms in the control group

[0116]

[0117] In summary, there was a significant difference in improving the symptoms of difficulty walking between the treatment group and the control group.

[0118] Therefore, the effects of the present invention are as follows: salt Morinda officinalis is used to tonify kidney yang, strengthen tendons and bones, and eliminate rheumatism; roasted Epimedium is used to treat impotence, dribbling urination, tendon and bone spasm, hemiplegia, weakness of waist and knees, rheumatic pain, and numbness of limbs; scalded Drynaria is used to promote blood circulation and relieve pain, reduce swelling and promote tissue regeneration; oyster is used to stop sweating and astringe sperm, resolve phlegm and soften hard masses; antler glue is used to warm the liver and tonify the kidney, nourish the sperm and blood; wolfberry is used to benefit sperm and improve eyesight, nourish the liver and kidney; Millettia reticulata is used to regulate menstruation and relieve pain, relax tendons and activate collaterals; osteoporosis is alleviated by regulating the differentiation ability of osteoblasts / osteoclasts, improving bone microstructure and reducing bone loss. The oral Chinese medicine combination can be used to improve the clinical symptoms of patients with osteoporosis. It can be directly orally taken according to the method of use of the Chinese medicine prescription. According to clinical trials, it has a definite therapeutic effect and good patient adaptability.

[0119] The above generally describes the present invention in detail, but it is obvious to a person skilled in the art that some modifications or improvements can be made to the present invention. Therefore, modifications or improvements that do not depart from the spirit of the present invention are within the scope of protection of the present invention.

Claims

1. A Chinese medicine combination for internal use for osteoporosis, characterized in that: The Chinese medicine combination internal medicine formula for osteoporosis includes: salt Morinda officinalis, roasted Epimedium, scalded Drynaria, oyster, antler glue, wolfberry, Millettia reticulata; The proportion of raw materials in each formula is as follows: salt-soaked Morinda officinalis 9g, roasted Epimedium 9g, scalded Drynaria fortunei 9g, raw oyster 15g, forged oyster 15g, antler glue 3g, wolfberry 12g, Millettia reticulata 9g. The raw materials are composed into a medicine according to the proportion.

2. The Chinese medicine combination for osteoporosis according to claim 1, characterized in that: The method of taking the Chinese medicine combination for osteoporosis is: seven sets of medicine raw materials are mixed and boiled according to corresponding dosages, decocted with water to 400 ml, and taken warm in the morning and evening after meals.

3. A method for preparing a Chinese medicine combination for internal use for osteoporosis, for preparing a Chinese medicine combination for internal use for osteoporosis according to any one of claims 1 to 2, characterized in that: The preparation method of the Chinese medicine combination oral medicine for osteoporosis comprises the following steps: Step 1: Processing of medicinal materials; Step 2: Soak the medicinal materials; Step 3: Bring to a boil over high heat; Step 4: Simmer over low heat; Step 5: Filter the drug solution.

4. The method for preparing a Chinese medicine combination oral medicine for osteoporosis according to claim 3, characterized in that: The step 1, processing of medicinal materials specifically includes: before decoction, it is necessary to check whether there are any medicines that need to be decocted first or added later in the medicinal materials, and classify and process them according to the needs.

5. The method for preparing a Chinese medicine combination oral medicine for osteoporosis according to claim 3, characterized in that: The step 2, soaking the medicinal materials specifically includes: putting the medicinal materials into a container and soaking them in cold water. Normally, the medicinal materials need to be soaked for about 1 hour to ensure that the medicinal materials are completely soaked, which is conducive to the precipitation of effective ingredients. The soaking time for flowers, leaves, and stems can be slightly shorter, about 15 minutes, and the soaking time for seeds, fruits, and tubers is slightly longer. The amount of water added is generally 2-3 cm higher than the medicinal materials after soaking.

6. The method for preparing a Chinese medicine combination oral medicine for osteoporosis according to claim 3, characterized in that: The step three, boiling over high heat, specifically includes: putting the soaked medicinal materials and cold water into a container, and boiling over high heat. During the boiling process, the medicinal materials can be stirred appropriately to prevent the medicinal materials from sticking to the pot. If the medicinal liquid burns during boiling, it must be discarded and it is strictly forbidden to continue taking it.

7. The method for preparing a Chinese medicine combination for osteoporosis according to claim 3, characterized in that: The step 4, slow cooking on low heat specifically includes: after boiling, continue decocting on low heat, the decocting time depends on the type and nature of the medicinal materials, generally, antipyretic drugs should not be boiled for a long time, and can be decocted on low heat for 10-15 minutes, conditioning drugs need to be decocted on low heat for 20-30 minutes, for drugs that need to be decocted first, such as shellfish and mineral drugs, they need to be decocted for 10-20 minutes before adding other drugs, and for drugs that need to be added later, such as aromatic drugs, they should be added when the first decoction is about to end, and then decocted for another 4-5 minutes.

8. The method for preparing a Chinese medicine combination for osteoporosis according to claim 3, characterized in that: The step 5, filtering the medicinal liquid specifically includes: after the first decoction is completed, filtering the decoction liquid while it is hot, paying attention to avoid the loss of the decoction liquid, and then adding an appropriate amount of warm water for a second decoction. The second decoction time is usually slightly shorter than the first time, 15-20 minutes. After the two decoctions are mixed, the medicinal liquids are taken in several doses.

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