A traditional Chinese medicine composition and preparation for senile osteoporosis and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition and preparation for senile osteoporosis and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The composition comprises the following components: rhizoma drynariae, eucommia ulmoides, rhizoma curculiginis, angelica sinensis, rhizoma smilacis, radix angelicae pubescentis, acanthopanax, safflower, herba epimedii, taxillus, cistanche deserticola, radix astragali, radix rehmanniae preparata, rhizoma dioscoreae, cornus officinalis, cynomorium, rhizoma anemarrhenae, cornu cervi, herba monochori. The preparation is prepared from the traditional Chinese medicine raw material of the composition, and the preparation method comprises the following steps: mixing the above raw materials, soaking in water, and then decocting; and after decocting, taking medicinal liquid, and the obtained medicinal liquid can be used as a decoction or further processed into other Chinese patent medicine preparations according to a conventional process. The traditional Chinese medicine composition and the preparation thereof can treat senile osteoporosis through multiple targets and multiple pathways, have the characteristics of being simple, cheap and safe, can better reduce the burden of patients, and meet the diagnosis and treatment needs of patients.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for senile osteoporosis, a preparation prepared from the traditional Chinese medicine composition, and a preparation method of the preparation. BACKGROUND

[0002] Senile osteoporosis (OP) is a kind of systemic bone disease which is prone to occur in the elderly, characterized by low bone mass, bone microstructure damage, increased bone fragility, and easy to fracture. Clinically, it mainly manifests as fatigue, waist and back or limb pain, spinal deformity and even fracture. Most patients can reduce or relieve symptoms after active and effective treatment. If the older patients cannot fully recover, the brittle fracture may be accompanied by chronic pain, disability, and even death in severe cases. At present, most scholars at home and abroad believe that the primary measure for senile osteoporosis is to intervene in the lifestyle, such as controlling diet, regular exercise, and changing bad living habits. For patients with diagnosed senile osteoporosis, especially those with obvious joint waist and back pain, osteoporotic fracture and postoperative patients, on the basis of lifestyle intervention, calcium and vitamin D are used as the basic treatment measures. For patients who have not been standardized for osteoporosis treatment, bisphosphonate drugs are the first choice for treatment. Other drugs that can be used to treat senile osteoporosis include calcitonin, selective estrogen receptor modulators, parathyroid analogs, RANKL inhibitors, active vitamin D, romozolimab, strontium salt, vitamin K, and the like. However, the effect of western medicine alone in treating senile osteoporosis is still not satisfactory. According to foreign data, 20% of patients die within 1 year, 25% of patients who survive more than 1 year lose the ability to move, and 21% of patients need to use a walking stick to walk. Therefore, more and more people are seeking the combination of traditional Chinese and western medicine to treat senile osteoporosis. SUMMARY

[0003] The first object of the present application is to provide a traditional Chinese medicine composition for senile osteoporosis. To this end, the present application adopts the following technical solution:

[0004] A traditional Chinese medicine composition for senile osteoporosis, comprising the following components in parts by weight: 10-20 parts of rhizoma drynariae, 10-20 parts of eucommia ulmoides, 10-20 parts of rhizoma curculiginis, 6-12 parts of angelica sinensis, 6-12 parts of rhizoma sinopensis, 3-10 parts of radix angelicae pubescentis, 5-20 parts of cortex acanthopanacis, 3-10 parts of safflower, 10-20 parts of herba epimedii, 9-15 parts of taxilli herba, 6-10 parts of cistanche deserticola, 9-15 parts of radix astragali, 5-15 parts of radix rehmanniae preparata, 10-20 parts of rhizoma dioscoreae, 10-20 parts of fructus corni, 5-15 parts of herba cynomorii, 9-24 parts of vitellicolla, 6-12 parts of rhizoma anemarrhenae, 3-6 parts of cornu cervi, and 6-12 parts of herba lycopi.

[0005] In one or more embodiments, the traditional Chinese medicine composition comprises the following components by weight: rhizoma drynariae 15 parts, eucommia ulmoides oliver 15 parts, rhizoma curculiginis 15 parts, angelica sinensis 10 parts, rhizoma smilacis 10 parts, radix angelicae pubescentis 10 parts, cortex acanthopanacis 15 parts, safflower 10 parts, herba epimedii 15 parts, taxillus 15 parts, cistanche 10 parts, radix astragali 15 parts, radix rehmanniae preparata 10 parts, radix dioscoreae 15 parts, fructus corni 15 parts, herba cynomorii 10 parts, radix anemarrhenae 10 parts, deer antler glue 5 parts, herba agrimoniae 10 parts.

[0006] A second object of the present application is to provide a preparation for senile osteoporosis. To this end, the present application also adopts the following technical solution:

[0007] A preparation for senile osteoporosis is prepared by using the components of the above-mentioned composition as raw materials and by using a conventional process to form a common traditional Chinese medicine preparation.

[0008] In one or more embodiments, the traditional Chinese medicine preparation includes a liquid preparation, a semi-solid preparation, or a solid preparation.

[0009] In one or more embodiments, the dosage form of the traditional Chinese medicine preparation includes a decoction, a decocted paste, a pill, a tablet, a granule, or a capsule.

[0010] A third object of the present application is to provide a preparation method of the above-mentioned preparation. To this end, the present application also adopts the following technical solution:

[0011] A preparation method of the above-mentioned preparation includes: mixing the above-mentioned raw materials, soaking them in water, and then decocting them. After decocting, the obtained medicinal liquid can be used as a decoction, or the obtained medicinal liquid can be further processed into other traditional Chinese medicine preparations by using a conventional process.

[0012] In one or more embodiments, the water added in the soaking process is 5-15 times the total weight of the raw materials.

[0013] In one or more embodiments, the soaking time is 20-60 minutes.

[0014] In one or more embodiments, the decocting process is performed 1-3 times, each time for 1-2 hours. After filtration, the filtrates are combined to obtain the medicinal liquid.

[0015] Compared with the prior art, the present application can achieve the following beneficial effects:

[0016] 1) There are many types of drugs currently used for the treatment of senile osteoporosis, but the clinical treatment effect is not obvious. The present application uses a traditional Chinese medicine prescription with multiple raw material components to treat senile osteoporosis through multiple targets and multiple pathways, which is simple, inexpensive, and safe, can better reduce the burden on patients, and meets the needs of patients for diagnosis and treatment.

[0017] 2) The symptoms of senile osteoporosis patients are severe, the rate of disability is high, the treatment demand is large, and the related drug cost is high and the treatment effect is poor. The application can fully play the advantages of traditional Chinese medicine, maximize the benefits of patients, restore the labor and life ability of patients as soon as possible, reduce the cost and burden of social rehabilitation and life, and benefit the majority of senile osteoporosis patients. DETAILED DESCRIPTION

[0018] The application will be described in detail below with exemplary embodiments. It should be understood that the application can be implemented in various different forms and should not be construed as being limited to the embodiments set forth herein. The embodiments are provided herein to make the disclosure of the application more complete and to fully convey the concept of the application to those skilled in the art.

[0019] In one aspect, the application provides a traditional Chinese medicine composition for senile osteoporosis, comprising the following components by weight: rhizoma drynariae 10-20 parts, eucommia ulmoides 10-20 parts, rhizoma curculiginis 10-20 parts, angelica sinensis 6-12 parts, rhizoma smilacis 6-12 parts, radix angelicae pubescentis 3-10 parts, cortex acanthopanacis 5-20 parts, safflower 3-10 parts, epimedium 10-20 parts, taxillus 9-15 parts, cistanche 6-10 parts, astragalus 9-15 parts, radix rehmanniae preparata 5-15 parts, dioscorea 10-20 parts, cornus 10-20 parts, cynomorium 5-15 parts, vinegar turtle plate 9-24 parts, anemarrhena 6-12 parts, deer horn glue 3-6 parts, and herba potentillae 6-12 parts.

[0020] The above components are conventional traditional Chinese medicine raw materials in the art, and refer to Chinese Pharmacopoeia, etc. Their common sources are as follows: rhizoma drynariae, which is the dry rhizome of the plant Drynaria fortunei of the family Drynariaceae. Eucommia ulmoides, which is the bark of the plant Eucommia ulmoides of the family Eucommiaceae. Rhizoma curculiginis, which is the dry root of the plant Curculigo orchioides of the family Curculiginaceae. Angelica sinensis, which is the dry root of the plant Angelica sinensis of the family Umbelliferae. Rhizoma smilacis, which is the dry whole plant of the plant Smilax riparia of the family Smilacaceae. Radix angelicae pubescentis, which is the dry root of the plant Angelica pubescens of the family Umbelliferae. Cortex acanthopanacis, which is the dry root bark of the plant Acanthopanax gracilistylus of the family Araliaceae. Safflower, which is the dry flower of the plant Carthamus tinctorius of the family Compositae. Epimedium, which is the dry leaf of the plant Epimedium sagittatum, Epimedium koreanum, Epimedium wushanense or Epimedium koreanum of the family Berberidaceae. Taxillus, which is the dry leafy stem of the plant Taxillus delavayi of the family Loranthaceae. Cistanche, which is the dry leafy stem of the plant Cistanche deserticola of the family Orobanchaceae. Astragalus, which is the dry root of the plant Astragalus membranaceus or Astragalus membranaceus of the family Leguminosae. Radix rehmanniae preparata, which is the tuber of the plant Rehmannia glutinosa of the family Scrophulariaceae, also known as Rehmannia glutinosa or Rehmannia glutinosa, which is processed and prepared. Dioscorea, which is the dry rhizome of the plant Dioscorea opposita of the family Dioscoreaceae. Cornus, which is the dry mature fruit pulp of the plant Cornus officinalis of the family Cornaceae. Cynomorium, which is the dry fleshy stem of the plant Cynomorium songaricum of the family Cynomoriaceae. Vinegar turtle plate, also known as vinegar turtle shell, which is the shell of the turtle Chinemys reevesii after being processed with vinegar. Anemarrhena, which is the dry rhizome of the plant Anemarrhena asphodeloides of the family Liliaceae. Deer horn glue, which is the solid glue made by water decocting, concentrating and preparing deer antlers. Herba potentillae, which is the aboveground part of the herbaceous plant Potentilla chinensis of the family Rosaceae.

[0021] The above composition is most commonly made into a decoction. The amount of each ingredient can be adjusted according to the individual patient. Here, the inventor provides a commonly used ratio, i.e., the Chinese medicine composition for senile osteoporosis, by weight, comprises the following components: 15 parts of rhizoma drynariae, 15 parts of eucommia ulmoides, 15 parts of rhizoma curculignis, 10 parts of angelica sinensis, 10 parts of rhizoma sinopennis, 10 parts of radix angelicae pubescentis, 15 parts of cortex acanthopanacis, 10 parts of safflower, 15 parts of herba epimedii, 15 parts of taxilli herba, 10 parts of cistanche deserticola, 15 parts of radix astragali, 10 parts of radix rehmanniae preparatae, 15 parts of rhizoma dioscoreae, 15 parts of fructus corni, 10 parts of herba cynanchi paniculati, 5 parts of cornu cervi, 10 parts of herba lycopodii, 10 parts of rhizoma anemarrhenae, and 10 parts of cornu saigae tataricae.

[0022] The above composition is most commonly made into a decoction. The amount of each ingredient can be adjusted according to the individual patient. Here, the inventor provides a commonly used ratio, i.e., the Chinese medicine composition for senile osteoporosis, by weight, comprises the following components: 15 parts of rhizoma drynariae, 15 parts of eucommia ulmoides, 15 parts of rhizoma curculignis, 10 parts of angelica sinensis, 10 parts of rhizoma sinopennis, 10 parts of radix angelicae pubescentis, 15 parts of cortex acanthopanacis, 10 parts of safflower, 15 parts of herba epimedii, 15 parts of taxilli herba, 10 parts of cistanche deserticola, 15 parts of radix astragali, 10 parts of radix rehmanniae preparatae, 15 parts of rhizoma dioscoreae, 15 parts of fructus corni, 10 parts of herba cynanchi paniculati, 5 parts of cornu cervi, 10 parts of herba lycopodii, 10 parts of rhizoma anemarrhenae, and 10 parts of cornu saigae tataricae.

[0023] In another aspect, the present application also provides a preparation method of the above preparation, comprising: mixing the above raw materials, soaking in water, then decocting, taking the medicinal liquid after decocting, which can be used as a decoction, or further processing the medicinal liquid into other Chinese medicine preparations according to conventional processes. The conventional processes can include concentration, drying, mixing, granulation, tabletting, sterilization, packaging and other common pharmaceutical processes in the art.

[0024] Optionally, the water added in the soaking is 5-15 times the total weight of the raw materials, and the soaking time is 20-60 minutes. Optionally, the decocting is performed 1-3 times, each time for 1-2 hours, and the filtrates are combined after filtration to obtain the medicinal liquid.

[0025] The traditional Chinese medicine composition of the present application has the following components: Gusuibu, Xuexuanshu, Bushen, Gongtang, etc. can be used for treating traumatic injury, muscle and bone injury, and blood stasis and swelling pain. Duzhong and Xuduan can both tonify liver and kidney and strengthen muscles and bones. Duzhong is good at strengthening muscles and bones and is a good product for lumbago and soreness and pain of knees. Xuduan is good at tonifying liver and kidney and connecting muscles and bones, which is a good combination for relieving lumbago and soreness and pain of knees, promoting bone health, and enhancing joint function. The above three drugs are the monarch drugs and have the functions of tonifying liver and kidney, strengthening muscles and bones, and helping the body recover. In addition, it is found in clinical practice that any one of the three drugs is indispensable and will affect the therapeutic effect on senile osteoporosis. Wujiapi, Sangjisheng, and Shanzhu are the ministerial drugs and have the functions of tonifying liver and kidney and strengthening muscles and bones, which assist the monarch drugs. Yinyanghuo can tonify kidney and Yang. Cogonglong can tonify essence and blood and strengthen kidney Yang. Huangqi can tonify Qi and consolidate the exterior. Shudihuang can tonify blood and nourish Yin. Shanyao can benefit Qi and nourish Yin. The combination of the above drugs can tonify Qi, blood, Yin, and Yang and make up for the deficiency of the monarch drugs. Jiaowang, Jiaogu Ban, Zhimu, Lujiaojiao, and Xianhecao are the auxiliary drugs and can assist the monarch and ministerial drugs to exert the pharmacological effects. The combination of the above drugs can tonify liver and kidney, strengthen muscles and bones, and stop pain.

[0026] The above composition and preparation have the effects of strengthening bones, filling marrow, tonifying kidney, and consolidating osteoporosis. It is mainly used for treating obvious joint lumbago and back pain caused by senile osteoporosis, osteoporotic fracture, and postoperative patients.

[0027] In addition, the present application further provides a plurality of specific embodiments for further illustrating the composition and preparation method of the above traditional Chinese medicine preparation for senile osteoporosis, which are as follows.

[0028] Embodiment 1

[0029] 1) The raw medicinal materials are weighed according to the following weight parts: Gusuibu 15 parts, Duzhong 15 parts, Xuduan 15 parts, Danggui 10 parts, Shentongcao 10 parts, Duhuo 10 parts, Wujiapi 15 parts, Honghua 10 parts, Yinyanghuo 15 parts, Sangjisheng 15 parts, Cogonglong 10 parts, Huangqi 15 parts, Shudihuang 10 parts, Shanyao 15 parts, Shanzhu 15 parts, Jiaowang 10 parts, Jiaogu Ban 10 parts, Zhimu 10 parts, Lujiaojiao 5 parts, and Xianhecao 10 parts.

[0030] 2) The above raw medicinal materials are mixed, soaked in 10 times the weight of water of the total weight of the raw medicinal materials for 30 minutes, and then decocted twice, each time for 1.5 hours. The filtrates are combined and used as the decoction.

[0031] Embodiment 2

[0032] 1) The raw medicinal materials are weighed according to the following weight parts: Gusuibu 10 parts, Duzhong 15 parts, Xuduan 20 parts, Danggui 6 parts, Shentongcao 10 parts, Duhuo 10 parts, Wujiapi 5 parts, Honghua 8 parts, Yinyanghuo 20 parts, Sangjisheng 9 parts, Cogonglong 8 parts, Huangqi 15 parts, Shudihuang 5 parts, Shanyao 15 parts, Shanzhu 20 parts, Jiaowang 5 parts, Jiaogu Ban 18 parts, Zhimu 12 parts, Lujiaojiao 3 parts, and Xianhecao 10 parts.

[0033] 2) Mix the above raw medicinal materials, add 5 times the weight of water of the total weight of the raw medicinal materials, soak for 40 minutes, then decoct 3 times, each time for 1 hour, filter and combine the filtrate, concentrate the obtained medicinal liquid into a decoction, add refined honey to concentrate the decoction, and prepare a decoction.

[0034] Example 3

[0035] 1) Take the raw medicinal materials according to the following weight parts: 15 parts of Drynariae Rhizoma, 20 parts of Eucommiae Cortex, 10 parts of Rhizoma Curculiginis, 10 parts of Angelica sinensis, 12 parts of Rhizoma Polygonati, 3 parts of Angelica pubescens, 16 parts of Acanthopanax, 10 parts of Carthamus tinctorius, 10 parts of Epimedium, 12 parts of Taxilli Herba, 10 parts of Cistanche, 9 parts of Astragalus membranaceus, 10 parts of Radix Paeoniae Alba, 20 parts of Dioscoreae Rhizoma, 10 parts of Fructus Corni, 10 parts of Cynomorium songaricum, 6 parts of Anemarrhena asphodeloides, 5 parts of Cornu Cervi Degelatinatum, and 12 parts of Herba Lycopodii.

[0036] 2) Mix the above raw medicinal materials, add 12 times the weight of water of the total weight of the raw medicinal materials, soak for 60 minutes, then decoct 1 time, each time for 1.5 hours, filter, and concentrate, dry, and pulverize the obtained medicinal liquid to prepare a fine powder, add excipients, and press tablets to prepare tablets.

[0037] Example 4

[0038] 1) Take the raw medicinal materials according to the following weight parts: 20 parts of Drynariae Rhizoma, 10 parts of Eucommiae Cortex, 15 parts of Rhizoma Curculiginis, 12 parts of Angelica sinensis, 6 parts of Rhizoma Polygonati, 5 parts of Angelica pubescens, 20 parts of Acanthopanax, 3 parts of Carthamus tinctorius, 15 parts of Epimedium, 15 parts of Taxilli Herba, 6 parts of Cistanche, 12 parts of Astragalus membranaceus, 15 parts of Radix Paeoniae Alba, 10 parts of Dioscoreae Rhizoma, 16 parts of Fructus Corni, 15 parts of Cynomorium songaricum, 9 parts of Anemarrhena asphodeloides, 6 parts of Cornu Cervi Degelatinatum, and 6 parts of Herba Lycopodii.

[0039] 2) Mix the above raw medicinal materials, add 15 times the weight of water of the total weight of the raw medicinal materials, soak for 20 minutes, then decoct 2 times, each time for 2 hours, filter and combine the filtrate, concentrate, dry, and pulverize the obtained medicinal liquid to prepare a fine powder, add excipients, granulate, and package in capsules to prepare capsules.

[0040] In order to illustrate and verify the efficacy of the composition and preparation of the present application, the following experimental examples are also provided:

[0041] Experimental Example 1: Animal Experiment

[0042] 1. Experimental animals

[0043] 8-week-old SAMP6 rats [body weight (180±20) g] were selected, and dexamethasone 5 mg / kg was administered intragastrically once a week for 12 weeks to establish a model of senile osteoporosis in rats according to the changes in bone mass and bone histopathology. The animal experiment has been approved by the Experimental Animal Ethics Committee of Guangxi University of Chinese Medicine and complies with the Guide for the Care and Use of Laboratory Animals.

[0044] 2. Experimental grouping and intervention

[0045] 50 cases of osteoporosis rat models were treated with calcium and vitamin D routine therapy, and were supplemented with complete Qianggu Decoction (A group) in 10 cases, Qianggu Decoction without Sanjiaoshu (B group) in 10 cases, Qianggu Decoction without Duzhong (C group) in 10 cases, and Qianggu Decoction without Xuduan (D group) in 10 cases. The above were the research groups, and 10 cases without additional treatment were the control group.

[0046] 3. Statistical results

[0047] 3.1. Comparison of bone mass and bone histopathology improvement.

[0048] The difference between the research group and the control group was statistically significant (P<0.05); the difference between A group and B, C, and D groups was statistically significant (P<0.05); and the difference between B, C, and D groups was not statistically significant (P>0.05).

[0049] Example 2: Clinical trial

[0050] 1. General information

[0051] From July 2016 to June 2020, 100 cases of elderly patients with osteoporosis in the Spinal Surgery Department of the First Affiliated Hospital of Guangxi University of Chinese Medicine were selected, among which 57 cases were of qi deficiency and blood stasis syndrome, including 34 males and 23 females, aged 65-80 years old, with an average age of (69.37±8.83) years old, and a disease course of 6 months to 3 years, with an average of (20.89±7.98) months. The bone mineral density T value (BMD-T) before treatment was -5 to -2.5, with an average of (-4±0.77). According to whether Qianggu Decoction (a decoction prepared from the traditional Chinese medicine composition in the present application) was taken, all patients were divided into two groups: A group (n=22) was treated with routine calcium and vitamin D bone strengthening and pain relief, and B group (n=35) was treated with Qianggu Decoction on the basis of routine calcium and vitamin D.

[0052] 2. Diagnostic criteria:

[0053] 1.1, OP diagnostic criteria refer to the Chinese Medical Association Osteoporosis and Bone Mineral Disease Branch "Primary Osteoporosis Diagnosis and Treatment Guidelines" (2022 edition), Chinese Gerontology and Geriatrics Society Osteoporosis Branch "Chinese Geriatric Osteoporosis Diagnosis and Treatment Guidelines" (2023 edition), the diagnostic criteria for senile osteoporosis: under the premise of ≥65 years old women and ≥70 years old men, ① based on DXA measurement results: bone mineral density value is lower than that of the same gender, same race healthy adult bone peak 1 standard deviation and within the normal range; decreased by 1-2.5 standard deviations is low bone mass (or low bone mass); equal to and more than 2.5 standard deviations is osteoporosis; the degree of bone mineral density reduction meets the diagnostic criteria for osteoporosis, accompanied by one or more fragile fractures is severe osteoporosis; ② based on the diagnosis of fragile fractures: fragile fracture refers to fracture that occurs immediately after minor trauma or daily activities. When patients have hip or vertebral fragile fractures, they can be diagnosed with osteoporosis clinically without relying on bone mineral density measurement; while patients have fragile fractures in the proximal humerus, pelvis or distal forearm, even if the bone mineral density measurement shows low bone mass (-2.5 < T-value < -1.0), osteoporosis can also be diagnosed.

[0054] 1.2, TCM syndrome differentiation (diagnosis) criteria According to Shi Xiaolin's "Old Age Osteoporosis Diagnosis and Treatment Guidelines", the TCM syndrome types and diagnostic criteria for senile osteoporosis are as follows: ① Liver and kidney deficiency. Main symptoms: limb acid and body pain; secondary symptoms: waist and back bending, limb weakness, dizziness, blurred vision, tinnitus, two sides not comfortable, waist and knees soft, limb numbness; tongue and pulse: tongue red and little saliva, little moss, pulse slow and fine. ② Liver and kidney yin deficiency. Main symptoms: waist and knees pain, weakness; secondary symptoms: humpbacked, lower limbs flaccid or cramp, affected area slightly hot, body weight loss, dry eyes, dizziness and tinnitus, or five heart heat, insomnia and dreaminess; tongue and pulse: tongue red and little moss, pulse thin and rapid. ③ Spleen and kidney yang deficiency. Main symptoms: waist and hip cold pain, waist and knees soft; secondary symptoms: cold limbs, pale face, umbilical cold pain, cold pain relieved by warming, chronic diarrhea, five o'clock diarrhea, undigested food, chronic dysentery, edema and oliguria; tongue and pulse: tongue pale or with tooth marks, moss white and smooth, pulse slow and weak. ④ Kidney deficiency and blood stasis. Main symptoms: waist and spine pain or distending pain, refusal to press, unable to turn over and bend; secondary symptoms: spinal deformity, waist and knees soft, lower limbs flaccid, walking difficult, unable to stand for a long time; tinnitus, deafness, hair loss, tooth shaking, forgetfulness, slow movement, often with a history of trauma or chronic illness; tongue and pulse: tongue purple and dark, with blood stasis points or patches, pulse thin and rapid or stringy. ⑤ Qi deficiency and blood stasis. Main symptoms: local pain in chest, waist, abdomen, etc., fixed and not moving; secondary symptoms: pale face, pale or purple skin, limb numbness, flaccid, body fatigue, weakness, shortness of breath, and lazy speech; tongue and pulse: tongue pale and dark, tongue moss thin and white, pulse thin and weak.

[0055] 2. Case inclusion criteria:

[0056] ① Meet the diagnostic criteria of OP; ② Patients with TCM syndrome types of liver and kidney deficiency, liver and kidney yin deficiency, spleen and kidney yang deficiency, kidney deficiency and blood stasis, and qi deficiency and blood stasis; ③ Postoperative patients who can be followed up.

[0057] 3. Case exclusion criteria:

[0058] ① Patients with severe primary diseases of liver, kidney, endocrine system, hematopoietic system, and mental diseases; ② Patients who take other drugs that can affect the efficacy or evaluation during the observation period; ③ Patients with critical illness who are difficult to make a definite evaluation of the efficacy; ④ Patients who do not meet the inclusion criteria but are included.

[0059] 4. Observation indicators and evaluation criteria

[0060] The visual analogue scale (VAS) pain score and the daily life ability scale were used for scoring. A reduction of 4 points or more in the visual analogue scale (VAS) pain score and an improvement of 20 points or more in the daily life ability scale were considered excellent; a reduction of 2 points or more in the visual analogue scale (VAS) pain score and an improvement of 10 points or more in the daily life ability scale were considered good; a reduction of 1 point or more in the visual analogue scale (VAS) pain score and an improvement of 5 points or more in the daily life ability scale were considered acceptable; no reduction or an increase in the visual analogue scale (VAS) pain score and no improvement or a decrease in the daily life ability scale were considered poor.

[0061] The TCM disease efficacy determination criteria used the efficacy determination criteria for cervical spondylosis in the General Principles for Clinical Research of New Drugs of Traditional Chinese Medicine: a reduction of 95% or more in the scores of symptoms and signs such as pain and fatigue was considered clinical cure, a reduction of 70%-94% was considered significant effect, a reduction of 30%-69% was considered effective, and less than 30% was considered ineffective. The X-ray findings of the cervical spine were not considered.

[0062] The visual analogue scale (VAS) pain score and the daily life ability scale were used for scoring all patients at the 1st, 6th, and 12th months of drug treatment, and the improvement of bone density at the 12th month after treatment was calculated. The efficacy determination criteria for cervical spondylosis in the General Principles for Clinical Research of New Drugs of Traditional Chinese Medicine were used for the efficacy determination of all patients at the 12th month after treatment.

[0063] 5. Treatment method

[0064] According to the DXA measurement results, the appropriate drug treatment method is determined, and the patients who do not standardize the treatment of osteoporosis are given calcium and vitamin D as the basis. The first choice for the treatment of osteoporosis is bisphosphonate drugs. Other drugs that can be used to treat senile osteoporosis include calcitonin, selective estrogen receptor modulators, parathyroid analogues, RANKL inhibitors, active vitamin D, romozolimab, strontium salt, vitamin K, etc. On this basis, the traditional Chinese medicine treatment group takes the traditional Chinese medicine Qianggu Decoction, which contains the following ingredients: Rubus parvifolius 15g, Eucommia ulmoides 15g, Dipsacus asper 15g, Angelica sinensis 10g, Rhizoma Sinodendri 10g, Radix Angelicae Pubescentis 10g, Acanthopanax 15g, Safflower 10g, Herba Epimedii 15g, Taxillus 15g, Cistanche 10g, Radix Astragali 15g, Radix Rehmanniae Preparata 10g, Rhizoma Dioscoreae 15g, Fructus Corni 15g, Herba Cynomorii 10g, Cornu Cervi Degelatinatum 5g, Rhizoma Anemarrhenae 10g, Cornu Cervi 10g. Usage: Soak the above-mentioned medicines in 1000ml of water for 30 minutes, then boil them with a strong fire, and then simmer them with a weak fire until 250ml of liquid is obtained. Pour out the liquid and reserve it for later use. Add 500ml of water and simmer the medicines until 200ml of liquid is obtained. Pour out the liquid and mix it with the previously reserved liquid. Take the mixture in the morning and evening.

[0065] 6. Statistical results:

[0066] 6.1 Comparison of general information. There was no statistically significant difference in age, gender, disease duration, and other general information between the two groups (P>0.05); the baseline was balanced between the groups, and they were comparable.

[0067] 6.2 Comparison of visual analogue scale (VAS) pain score and daily life ability scale score. There was no statistically significant difference in cervical JOA score between the two groups before treatment and at 1 month after treatment (P>0.05). There were statistically significant differences in visual analogue scale (VAS) pain score and daily life ability scale score between the two groups at 6 and 12 months after treatment (P<0.05). There were statistically significant differences in visual analogue scale (VAS) pain score and daily life ability scale score at different time points within the two groups (P<0.05), and there were statistically significant differences between any two time points (P<0.05).

[0068] 6.3 Comparison of the improvement degree of bone density. There was a statistically significant difference in the improvement rate of visual analogue scale (VAS) pain score and daily life ability scale score between the two groups at 12 months after treatment (P<0.05).

[0069] 6.4 Comparison of the efficacy of traditional Chinese medicine. There was a statistically significant difference in the efficacy of traditional Chinese medicine between the two groups at 12 months after treatment (P<0.05).

[0070] 7. Safety

[0071] There were no obvious adverse reactions in the two groups during the treatment.

[0072] 8. Typical cases

[0073] Case 1:

[0074] In July 2018, patient Zhang, female, 78 years old, retired worker, because of falling a day ago to our hospital outpatient service, patient family members complained that the patient began to appear four limbs joint pain, difficulty in movement and height shortening symptoms half a year ago, and appeared a fall a day ago, now left wrist pain, difficulty in movement. Outpatient service is "fracture" into our hospital. Patients with unexplained bone pain and easy bone fracture symptoms, combined with bone mineral density examination after admission shows that the hip and lumbar spine bone mineral density is significantly decreased, and the diagnosis is osteoporosis. Treatment plan: 1. Encourage to increase calcium, vitamin D and protein intake, and select anti-bone resorption drugs and estrogen drugs according to the patient's condition; 2. Actively treat the patient's hypertension and other underlying diseases; 3. Strict observation and regular follow-up to prevent the patient from falling and fracturing. After 6 months of standard drug treatment, the patient complained of unexplained bone pain, so the traditional Chinese medicine prescription "strong bone soup" was added on the basis of the original. After taking for 3 months, the patient complained of pain relief, and the bone mineral density examination showed that the hip and lumbar spine bone mineral density was higher than before taking "strong bone soup".

[0075] Case 2:

[0076] In October 2019, patient Wang, female, 71 years old, because of "lower extremity weakness with difficulty walking for 1 year, and upper limb difficulty for half a year" to the hospital. The patient had no obvious inducement for bilateral lower extremity knee joint pain, weakness and difficulty walking for 1 year, and was treated in the local hospital. Lower extremity X-ray showed: knee joint degeneration, severe osteoporosis, calcium and dietary adjustment were given, and the above symptoms had no obvious relief. In the past half a year, the patient had difficulty raising her arms, she couldn't comb her hair, she had difficulty eating and needed help, the lower extremity weakness symptoms were aggravated, and the walking distance was shortened. Since the onset of the disease, the patient has been in a low mood, appetite decreased, sleep normal, normal urination and defecation, and body weight decreased by 5 kg in 1 year. Our hospital is "osteoporosis" admitted to hospital, and the bone mineral density measured by dual-energy X-ray absorptiometry (DXA) after admission shows that the whole body bone mineral density is significantly lower than normal. Diagnosis of senile osteoporosis. Treatment plan: 1. Routine treatment with calcium and vitamin D; 2. Give supplemental parenteral nutrition, supplement albumin, give adequate vitamins and trace elements. After 4 months of regular drug treatment, there was no improvement, so the traditional Chinese medicine prescription "strong bone soup" was given for treatment. After taking for 3 months, the patient complained of symptom relief, and the whole body bone mineral density was significantly higher than before taking "strong bone soup".

Claims

1. A Chinese medicine composition for senile osteoporosis, characterized in that: The invention comprises the following components in parts by weight: 10-20 parts of drynaria rhizome, 10-20 parts of eucommia bark, 10-20 parts of dipsaci, 6-12 parts of angelica sinensis, 6-12 parts of striata herb, 3-10 parts of angelica pubescens, 5-20 parts of acanthopanax cortex, 3-10 parts of safflower, 10-20 parts of epimedium, 9-15 parts of mistletoe, 6-10 parts of cistanche deserticola, 9-15 parts of astragalus, 5-15 parts of rehmannia root, 10-20 parts of yam, 10-20 parts of cornus officinalis, 5-15 parts of cynomorium songaricum, 9-24 parts of tortoise shell with vinegar, 6-12 parts of anemarrhena asphodeloides, 3-6 parts of antler glue and 6-12 parts of agrimony.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by weight: 15 parts of drynaria rhizome, 15 parts of eucommia bark, 15 parts of dipsacus root, 10 parts of angelica root, 10 parts of striata herb, 10 parts of angelica dahurica, 15 parts of acanthopanax bark, 10 parts of safflower, 15 parts of epimedium, 15 parts of mistletoe, 10 parts of cistanche deserticola, 15 parts of astragalus, 10 parts of rehmannia root, 15 parts of yam, 15 parts of cornus officinalis, 10 parts of cynomorium songaricum, 10 parts of tortoise shell with vinegar, 10 parts of anemarrhena asphodeloides, 5 parts of antler glue and 10 parts of agrimony.

3. A preparation for senile osteoporosis, characterized in that: The components of the composition according to claim 1 or 2 are used as raw materials and prepared into common Chinese patent medicine preparations according to conventional processes.

4. The preparation according to claim 3, characterized in that: The Chinese patent medicine preparation is a liquid preparation, a semisolid preparation or a solid preparation.

5. The preparation according to claim 3, characterized in that: The dosage form of the Chinese patent medicine preparation is decoction, decoction paste, pill, tablet, granule or capsule.

6. A method for preparing the preparation according to claim 3, characterized in that: include: The raw materials are mixed, soaked in water, and then decocted. The medicinal liquid is taken after decocting and used as a decoction, or the medicinal liquid is further processed into other Chinese patent medicine preparations according to conventional processes.

7. The preparation method according to claim 6, characterized in that: The water added during the soaking is 5-15 times the total weight of the raw material medicine.

8. The preparation method according to claim 6, characterized in that: The soaking time is 20-60 minutes.

9. The preparation method according to claim 6, characterized in that: The decoction is performed 1-3 times, each time for 1-2 hours. After filtering, the filtrates are combined to obtain the medicinal solution.