A eucommia ulmoides particle for treating osteoporosis and a preparation method thereof

Abstract

The application discloses a eucommia ulmoides oliver particle for treating osteopenia, which is prepared from the following raw materials in a weight ratio: eucommia ulmoides oliver 25-35 parts, rehmannia 20-30 parts, yam 18-22 parts, rhizoma discontinuorum 20-30 parts, myrrh 18-22 parts, chuanxiong 20-30 parts, panax notoginseng 15-25 parts, safflower 18-22 parts, white atractylodes 20-30 parts, poria cocos 20-30 parts, astragalus 25-35 parts, ginseng 20-30 parts, polygonatum 18-22 parts, dendrobium 15-25 parts, notopterygium 18-22 parts, angelica pubescens 20-30 parts, rhizoma cimicifugae 20-30 parts, siler 18-22 parts, which is capable of tonifying liver and kidney, promoting blood circulation, invigorating spleen and stomach, and dispelling wind and dampness, so as to achieve the purpose of treating osteopenia caused by kidney deficiency and blood stasis, and a preparation method thereof.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine research and development technology, and in particular to a Eucommia ulmoides granule for treating osteoporosis and its preparation method. Background Technology

[0002] Osteoarthritis, originating from the "Suwen·Weilun", is a term in Traditional Chinese Medicine. Clinical symptoms include soreness and weakness in the lower back, difficulty in straightening the back, weakness in the lower limbs, dark complexion, and dry, dull teeth. In modern medicine, it is called osteoporosis (OP). According to "Traditional Chinese Medicine Bone Diseases", the main symptoms of osteoarthritis are: pain throughout the body, pain in the lower back, easy cramps, excessive sweating, weakness in both limbs, and inability to bear weight. According to TCM syndrome diagnosis, it can be divided into two types: (1) Kidney deficiency and blood stasis type: The main symptoms are soreness and back, weakness in both knees, severe chest and back pain caused by slight exercise in more severe cases, abdominal distension, loose stools, heaviness and fatigue in the limbs, sallow and thin complexion, thick white tongue coating, and slow and weak pulse. (2) Liver and kidney deficiency type: The main symptoms are soreness and dull pain in the affected area, weakness in the muscles and bones, premature aging, hair loss, loose teeth, forgetfulness, fatigue, sallow and thin complexion, pale tongue, and weak pulse. Among them, the kidney deficiency and blood stasis type is the most common. Summary of the Invention

[0003] The purpose of this invention is to provide Eucommia ulmoides granules for treating osteoporosis, wherein the combination of various drugs in the composition works together to improve the symptoms of osteoporosis caused by kidney deficiency and blood stasis.

[0004] The second objective of this invention is to provide a method for preparing the Eucommia ulmoides granules.

[0005] The third objective of this invention is to provide applications for the Eucommia ulmoides granules.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: a Eucommia ulmoides granule for treating osteoporosis, prepared from the following raw materials in parts by weight: Eucommia ulmoides 25-35 parts, Rehmannia glutinosa 20-30 parts, Dioscorea opposita 18-22 parts, Dipsacus asper 20-30 parts, Commiphora myrrha 18-22 parts, Ligusticum chuanxiong 20-30 parts, Panax notoginseng 15-25 parts, Carthamus tinctorius 18-22 parts, Atractylodes macrocephala 20-30 parts, Poria cocos 20-30 parts, Astragalus membranaceus 25-35 parts, Panax ginseng 20-30 parts, Polygonatum odoratum 18-22 parts, Dendrobium nobile 15-25 parts, Notopterygium incisum 18-22 parts, Angelica pubescens 20-30 parts, Cimicifuga foetida 20-30 parts, Saposhnikovia divaricata 18-22 parts.

[0007] The Eucommia ulmoides granules for treating osteoporosis are prepared from the following raw materials in parts by weight: Eucommia ulmoides 30 parts, Rehmannia glutinosa 25 parts, Dioscorea opposita 20 parts, Dipsacus asper 25 parts, Commiphora myrrha 20 parts, Ligusticum chuanxiong 25 parts, Panax notoginseng 20 parts, Carthamus tinctorius 20 parts, Atractylodes macrocephala 25 parts, Poria cocos 25 parts, Astragalus membranaceus 30 parts, Panax ginseng 25 parts, Polygonatum odoratum 20 parts, Dendrobium nobile 20 parts, Notopterygium incisum 20 parts, Angelica pubescens 25 parts, Cimicifuga foetida 25 parts, and Saposhnikovia divaricata 20 parts.

[0008] The preparation method of the Eucommia ulmoides granules for treating osteoporosis includes the following steps:

[0009] Step 1: Mix and grind Rehmannia glutinosa, Dioscorea opposita, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Dendrobium nobile, and Cimicifuga foetida into a powder of 20 mesh. Add 2-4 times the amount of distilled water and soak for 1-3 hours. Then add 6-8 times the amount of water and decoct 1-3 times, 1-3 hours each time. After filtering the decoction, add ethanol to precipitate it, so that the alcohol content is 75%-90%. Filter again and concentrate the filtrate into extract I for later use.

[0010] Step 2: Mix and crush the remaining Chinese herbal medicine pieces into coarse powder, add 8-12 times the weight of the medicinal materials and 50%-80% ethanol by volume for reflux extraction, extract 2-4 times, 1-4 hours each time, filter, recover the ethanol from the filtrate, concentrate under reduced pressure to extract II, the relative density of extract II at 50℃ is 1.2-1.3, and set aside for later use;

[0011] Step 3: Combine extract I and extract II, dry them, and obtain extract powder;

[0012] Step 4: Add pharmaceutically acceptable excipients to the extract powder to prepare granules.

[0013] The Eucommia ulmoides granules for treating osteoporosis are prepared by following step 1: adding 3 times the amount of distilled water to soak for 2 hours, then adding 7 times the amount of water to decoct twice, 2 hours each time; after filtering the decoction, adding ethanol to precipitate it so that the alcohol content is 85%.

[0014] The Eucommia ulmoides granules for treating osteoporosis are prepared by step 2, adding 10 times the weight of the medicinal material and 60% ethanol for reflux extraction, and extracting 3 times, 3 hours each time.

[0015] The application of Eucommia ulmoides granules for treating osteoporosis in the preparation of drugs for treating osteoporosis.

[0016] The application of Eucommia ulmoides granules for treating osteoporosis in the preparation of drugs for treating osteoporosis, which belongs to the kidney deficiency and blood stasis type.

[0017] All of the above-mentioned drugs meet the standards of the Chinese Pharmacopoeia.

[0018] The main symptoms of kidney deficiency and blood stasis type osteoporosis include lower back pain, weakness in both knees, and in severe cases, severe chest and back pain with slight exertion, abdominal distension, loose stools, heaviness and fatigue in the limbs, sallow complexion, emaciation, thick white tongue coating, and a slow and weak pulse. Traditional Chinese medicine classifies osteoporosis under the category of "osteoporosis" and believes that bones and kidneys are closely related. Once a patient suffers from kidney essence deficiency or severe qi deficiency, it can lead to malnourishment of the bones, resulting in weakness and atrophy. Elderly individuals often experience liver and kidney deficiency and depletion of essence and blood, clinically manifesting as lower back pain, weakness, and loss of appetite.

[0019] Traditional Chinese medicine (TCM) theory holds that the pathological mechanism of osteoporosis is kidney deficiency caused by multiple factors; it belongs to the category of deficiency in the root and excess in the branch, with the root manifestation being insufficient qi and blood in the kidney, liver, and spleen, and the branch manifestation being blood stasis and qi stagnation; the essence and blood of the spleen, stomach, kidney, and other organs are significantly insufficient. Therefore, the main principle of TCM treatment for this condition is "tonifying the kidney and strengthening the Du meridian, nourishing the liver and kidney."

[0020] The *Jingyue Quanshu* (Complete Works of Jingyue) states in its chapter on "Blood Depletion and Amenorrhea": "When kidney water is exhausted, the wood qi fails to flourish, resulting in dryness and weakness of the limbs, hence frequent anger, scorched hair, and atrophy of muscles and bones." It further states, "Blood stasis is the accumulation of blood," and ancient texts describe it as "blood vessels congealing and stagnating." Factors such as internal organ cold and heat, external pathogens, and emotional disturbances can all lead to blood stasis. The *Reading Medical Notes* records, "Yin deficiency inevitably leads to blood stasis," "Yang deficiency inevitably leads to blood stasis," and "Qi deficiency is insufficient to propel blood, therefore blood stasis is inevitable." Internal organ deficiency and qi, blood, yin, and yang deficiencies are the main causes of blood stasis, i.e., deficiency leads to stasis. The *Jingyue Quanshu*, in its chapter on "Hypochondriac Pain," states: "The qi and blood of a person are like a spring; when abundant, they flow smoothly; when deficient, they stagnate. Therefore, if qi and blood are not deficient, there will be no stagnation; if deficient, there will be no stagnation." Therefore, in addition to nourishing the liver and kidneys, it is also necessary to invigorate blood and remove blood stasis.

[0021] The *Suwen* (Plain Questions) chapter on flaccid paralysis states: "The kidneys govern the bone marrow of the body... When the kidney qi is hot, the lower back and spine cannot be lifted, the bones wither and the marrow decreases, resulting in bone flaccidity." Both the spleen and stomach belong to the central earth element. The spleen is the Taiyin damp earth, and the stomach is the Yangming dry earth. The limbs receive qi from the stomach, but the transport of stomach fluids to the limbs requires the spleen's function of ascending clear qi. If the spleen fails to ascend clear qi, the limbs cannot receive nourishment from food and water. Over time, the muscles of the limbs begin to atrophy, the blood vessels become blocked, and ultimately, the muscles and bones become "disused." A healthy spleen and stomach are a prerequisite for sufficient vital energy. The methods for tonifying the spleen and stomach can be summarized as regulating the spleen and stomach, strengthening the spleen and stomach, tonifying the qi of the spleen and stomach, and tonifying the yin of the spleen and stomach.

[0022] Li Dongyuan believed that the cause of osteoporosis was spleen and stomach weakness, leading to insufficient Yang Qi. Therefore, he proposed using pungent and sweet-tasting herbs to nourish stomach Qi and using Yang-raising herbs to restore vital energy. Yang-raising involves guiding the sunken spleen Qi upward through the spring-like Qi of Lesser Yang. The spleen Qi assists Lesser Yang Qi in restoring its ascending function, thereby eliminating dampness trapped in the liver and kidneys. This is the method of Yang-raising and dampness-eliminating. Herbs that conform to the characteristics of spring-like Qi of Lesser Yang are mostly wind-dispelling herbs, and wind can overcome dampness. Commonly used herbs in clinical practice include Notopterygium root, Angelica pubescens root, Bupleurum root, Cimicifuga rhizome, Saposhnikovia root, Pueraria root, Ligusticum chuanxiong rhizome, Atractylodes rhizome, and Acorus tatarinowii rhizome. The *Treatise on the Spleen and Stomach* states, "When the spleen is diseased, it flows downward and attacks the kidneys… then the bones become weak and feeble, which is called bone erosion." Spleen and stomach weakness leads to insufficient Qi to transport and transform, insufficient blood to nourish, and insufficient essence to irrigate muscles and bones, ultimately resulting in malnourishment of the bones.

[0023] Traditional Chinese medicine also believes that the main cause of osteoporosis is "kidney heat," which "lies in the lower body and affects kidney deficiency." This means that excessive kidney qi transforms into heat, damaging essence, while kidney yin deficiency and depletion of kidney essence are the internal causes. External causes are mainly dampness, cold, and heat. Drinking alcohol in the wind, sleeping outdoors in cool conditions, wading through water in the rain, prolonged residence in damp places, and a preference for spicy and strongly flavored foods can all induce wind, cold, and dampness to invade the body, leading to joint pain, bone marrow weakness, and heaviness in the limbs.

[0024] This invention employs Eucommia ulmoides, Rehmannia glutinosa, Dioscorea opposita, and Dipsacus as the principal herbs to tonify the kidneys and strengthen the spleen, as well as nourish the liver and kidneys. Myrrh, Ligusticum chuanxiong, Panax notoginseng, and Carthamus tinctorius are used as the assistant herbs to invigorate blood and remove blood stasis. Atractylodes macrocephala and Poria cocos are used to invigorate qi and strengthen the spleen; Astragalus membranaceus and Panax ginseng are used to tonify the qi of the spleen and stomach; Polygonatum odoratum and Dendrobium nobile are used to tonify the yin of the spleen and stomach. Notopterygium incisum, Angelica pubescens, Cimicifuga foetida, and Saposhnikovia divaricata are used as the guiding herbs to dispel wind and dampness. As stated in the *Treatise on the Spleen and Stomach* (specifically, the chapter on the waxing and waning of the spleen and stomach): "When the spleen is diseased, it flows downward and attacks the kidneys… leading to weakness and fatigue in the bones." "Bone erosion" is caused by spleen and stomach deficiency, which leads to insufficient qi and blood, insufficient blood and essence to nourish muscles and bones, ultimately resulting in malnourishment of the bones. The formula of this invention contains Eucommia ulmoides, Rehmannia glutinosa, Dioscorea opposita, Dipsacus asper, Commiphora myrrha, Ligusticum chuanxiong, Panax notoginseng, Carthamus tinctorius, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Panax ginseng, Polygonatum odoratum, Dendrobium nobile, Notopterygium incisum, Angelica pubescens, Cimicifuga foetida, and Saposhnikovia divaricata. It aims to treat bone atrophy of the kidney deficiency and blood stasis type by nourishing the liver and kidneys, promoting blood circulation and removing blood stasis, strengthening the spleen and stomach, and dispelling wind and dampness. Detailed Implementation

[0025] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0026] Example 1: Take 30g of Eucommia ulmoides, 25g of Rehmannia glutinosa, 20g of Dioscorea opposita, 25g of Dipsacus asper, 20g of Commiphora myrrha, 25g of Ligusticum chuanxiong, 20g of Panax notoginseng, 20g of Carthamus tinctorius, 25g of Atractylodes macrocephala, 25g of Poria cocos, 30g of Astragalus membranaceus, 25g of Panax ginseng, 20g of Polygonatum odoratum, 20g of Dendrobium nobile, 20g of Notopterygium incisum, 25g of Angelica pubescens, 25g of Cimicifuga foetida, and 20g of Saposhnikovia divaricata. The preparation method includes the following steps:

[0027] Step 1: Mix and grind Rehmannia glutinosa, Dioscorea opposita, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Dendrobium nobile, and Cimicifuga foetida into a powder of 20 mesh. Add 3 times the amount of distilled water and soak for 2 hours. Then add 7 times the amount of water and decoct twice, 2 hours each time. After filtering the decoction, add ethanol to precipitate it so that the alcohol content is 85%. Filter the filtrate and concentrate it into extract I for later use.

[0028] Step 2: Mix and crush the remaining Chinese herbal medicine pieces into coarse powder, add 10 times the weight of the medicinal materials and 70% ethanol by volume for reflux extraction, extract 3 times, 2 hours each time, filter, recover the ethanol from the filtrate, concentrate under reduced pressure to extract II, the relative density of extract II at 50℃ is 1.25, and set aside for later use;

[0029] Step 3: Combine extract I and extract II, dry them, and obtain extract powder;

[0030] Step 4: Add pharmaceutically acceptable excipients to the extract powder to prepare granules.

[0031] Example 2: Take 25g of Eucommia ulmoides, 30g of Rehmannia glutinosa, 18g of Dioscorea opposita, 30g of Dipsacus asper, 18g of Commiphora myrrha, 30g of Ligusticum chuanxiong, 15g of Panax notoginseng, 22g of Carthamus tinctorius, 20g of Atractylodes macrocephala, 30g of Poria cocos, 25g of Astragalus membranaceus, 30g of Panax ginseng, 18g of Polygonatum odoratum, 25g of Dendrobium nobile, 18g of Notopterygium incisum, 30g of Angelica pubescens, 20g of Cimicifuga foetida, and 22g of Saposhnikovia divaricata. The preparation method includes the following steps:

[0032] Step 1: Mix and grind Rehmannia glutinosa, Dioscorea opposita, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Dendrobium nobile, and Cimicifuga foetida into a powder of 20 mesh. Add 4 times the amount of distilled water and soak for 1 hour. Then add 8 times the amount of water and decoct once, for 3 hours each time. After filtering the decoction, add ethanol to precipitate it so that the alcohol content is 75%. Filter the filtrate and concentrate it into extract I for later use.

[0033] Step 2: Mix and crush the remaining Chinese herbal medicine pieces into coarse powder, add 12 times the weight of the medicinal materials and 50% ethanol by volume for reflux extraction, extract 4 times, 1 hour each time, filter, recover the ethanol from the filtrate, concentrate under reduced pressure to extract II, the relative density of extract II at 50℃ is 1.3, and set aside for later use.

[0034] Step 3: Combine extract I and extract II, dry them, and obtain extract powder;

[0035] Step 4: Add pharmaceutically acceptable excipients to the extract powder to prepare granules.

[0036] Example 3: Take 35g of Eucommia ulmoides, 20g of Rehmannia glutinosa, 22g of Dioscorea opposita, 20g of Dipsacus asper, 22g of Commiphora myrrha, 20g of Ligusticum chuanxiong, 25g of Panax notoginseng, 18g of Carthamus tinctorius, 30g of Atractylodes macrocephala, 20g of Poria cocos, 35g of Astragalus membranaceus, 20g of Panax ginseng, 22g of Polygonatum odoratum, 15g of Dendrobium nobile, 22g of Notopterygium incisum, 20g of Angelica pubescens, 30g of Cimicifuga foetida, and 18g of Saposhnikovia divaricata. The preparation method includes the following steps:

[0037] Step 1: Mix and grind Rehmannia glutinosa, Dioscorea opposita, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Dendrobium nobile, and Cimicifuga foetida into a powder of 20 mesh. Add twice the amount of distilled water and soak for 3 hours. Then add six times the amount of water and decoct three times, one hour each time. After filtering the decoction, add ethanol to precipitate it so that the alcohol content is 90%. Filter the filtrate and concentrate it into extract I for later use.

[0038] Step 2: Mix and crush the remaining Chinese herbal medicine pieces into coarse powder, add 8 times the weight of the medicinal materials and 80% ethanol by volume for reflux extraction, extract twice, 4 hours each time, filter, recover the ethanol from the filtrate, concentrate under reduced pressure to obtain extract II, the relative density of extract II at 50℃ is 1.2, and set aside for later use.

[0039] Step 3: Combine extract I and extract II, dry them, and obtain extract powder;

[0040] Step 4: Add pharmaceutically acceptable excipients to the extract powder to prepare granules.

[0041] Example 4: Clinical Study

[0042] Eighty patients with kidney deficiency and blood stasis type osteoporosis (senile osteoporosis) who were hospitalized at Jiangsu Provincial Hospital of Traditional Chinese Medicine from September 2021 to September 2022, commissioned by our company, were randomly divided into a control group and a treatment group. The control group consisted of 40 patients (23 males and 17 females, aged 60-79 years). The treatment group consisted of 40 patients (24 males and 16 females, aged 62-83 years). There were no statistically significant differences between the two groups in terms of age, sex, bone mineral density, and pain level (P>0.05), making them comparable.

[0043] Diagnostic criteria: The Western medicine diagnostic criteria refer to the "Guidelines for the Diagnosis and Treatment of Osteoporosis and Bone Mineral Diseases (Discussion Draft) - Guidelines for the Diagnosis and Treatment of Primary Osteoporosis" formulated by the Osteoporosis and Bone Mineral Diseases Branch of the Chinese Medical Association in 2006. Clinical symptoms include: pain; spinal deformity, decreased height, kyphosis; vertebral compression fractures; fragility fractures, etc. Bone mineral density measurement standards: Referring to the standards of the World Health Organization (WHO), based on dual-energy X-ray absorptiometry, and considering the national conditions in my country, the following standards are adopted: Normal: >M-1SD. Osteopenia: ≤M-1SD--2SD. Osteoporosis: <M-2SD or higher. One or more fractures indicate severe osteoporosis. The diagnostic criteria of traditional Chinese medicine were formulated with reference to the "Guiding Principles for Clinical Research on New Chinese Medicine Drugs for the Treatment of Osteoporosis". The main symptoms of osteoporosis of the kidney deficiency and blood stasis type are: lower back pain, weakness in both knees, severe chest and back pain caused by slight exercise in more severe cases, abdominal distension, loose stools, heaviness and fatigue in the limbs, sallow complexion and emaciation, thick white tongue coating, and slow and weak pulse.

[0044] Administration method: The control group received Xianling Gubao Capsules (produced by Sinopharm Tongjitang (Guizhou) Pharmaceutical Co., Ltd., National Medicine Approval Number Z20025337) orally, 3 capsules each time, twice a day, taken with warm water, for 3 consecutive months as one course of treatment. The treatment group received the granules prepared in Example 1 of this invention (daily dosage: Eucommia ulmoides 30g, Rehmannia glutinosa 25g, Dioscorea opposita 20g, Dipsacus asper 25g, Commiphora myrrha 20g, Ligusticum chuanxiong 25g, Panax notoginseng 20g, Carthamus tinctorius 20g, Atractylodes macrocephala 25g, Poria cocos 25g, Astragalus membranaceus 30g, Panax ginseng 25g, Polygonatum odoratum 20g, Dendrobium nobile 20g, Notopterygium incisum 20g, Angelica pubescens 25g, Cimicifuga foetida 25g, Saposhnikovia divaricata 20g), one dose per day, divided into three doses, for 3 consecutive months as one course of treatment. Clinical efficacy was observed after one course of treatment.

[0045] Observation indicators and methods: ① Clinical symptoms and signs: Observed once a month. ② Bone mineral density test: The average bone mineral density of the 2nd-4th lumbar vertebrae was measured using a dual-energy X-ray absorptiometry (DXA) system. Tests were performed before medication and at the end of treatment. ③ Biochemical tests: Serum calcium, phosphorus, and alkaline phosphatase were measured before medication and at the end of treatment.

[0046] Traditional Chinese Medicine (TCM) Syndrome Therapy Evaluation Criteria: Scoring is performed using the nimodipine method, with the reduction rate calculated as [(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score] × 100%. Clinical Cure: Clinical symptoms and signs have essentially disappeared or disappeared, with a reduction rate of over 90%. Significant Effect: Clinical symptoms and signs have significantly improved, with a reduction rate between 70% and 90%. Effective: Clinical symptoms and signs have improved, with a reduction rate between 30% and 70%. Ineffective: Clinical symptoms and signs have not significantly improved, with a reduction rate less than 30%.

[0047] Bone mineral density (BMD) efficacy evaluation criteria: Following current international standards and referring to "Clinical Diagnosis and Treatment of Osteoporotic Fractures," T-scores were measured using a GE dual-energy X-ray absorptiometry (DXA) system. The T-scores before and after treatment were calculated and compared between the two groups. See Table 1.

[0048] Table 1 Comparison of bone mineral density T-scores before and after treatment in the two groups (x±s)

[0049] Group Before treatment After treatment control group -3.6573±0.7531 -0.7834±0.5628 Example 1 Group -3.6934±0.8251 -1.5526±0.9847

[0050] As shown in Table 1, the bone mineral density (BMD) T-values ​​of the two groups before and after treatment were compared. Both groups showed a certain increase in BMD T-values ​​after treatment. Moreover, the increase in BMD T-value in the example group was significantly higher than that in the control group. The difference between the two groups was statistically significant (P < 0.05).

[0051] Table 2 shows the comparison of the therapeutic effects of the two groups of TCM syndromes.

[0052] Table 2 Comparison of therapeutic effects of TCM syndromes between the two groups (%)

[0053] Group Effective efficient invalid Overall efficiency control group 12 25 3 92.5 Example 1 Group 7 19 14 65.0

[0054] Table 2 shows that the total effective rate in Example 1 group was 92.5%, while the total effective rate in the control group was 65.0%. The differences in efficacy between the two groups were statistically significant (P < 0.05). No adverse reactions occurred during the observation period, and the patients' blood pressure, heart rate, pulse, respiration, and body weight were all within the normal range after treatment. Blood routine tests, liver and kidney function indicators were normal before and after treatment. This indicates that the present invention has a good effect on treating bone atrophy of the kidney deficiency and blood stasis type.

[0055] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A Eucommia ulmoides granule for treating senile osteoporosis of the kidney deficiency and blood stasis type, characterized in that, It is prepared from the following raw materials in parts by weight: Eucommia ulmoides 25-35 parts, Rehmannia glutinosa 20-30 parts, Dioscorea opposita 18-22 parts, Dipsacus asper 20-30 parts, Commiphora myrrha 18-22 parts, Ligusticum chuanxiong 20-30 parts, Panax notoginseng 15-25 parts, Carthamus tinctorius 18-22 parts, Atractylodes macrocephala 20-30 parts, Poria cocos 20-30 parts, Astragalus membranaceus 25-35 parts, Panax ginseng 20-30 parts, Polygonatum odoratum 18-22 parts, Dendrobium nobile 15-25 parts, Notopterygium incisum 18-22 parts, Angelica pubescens 20-30 parts, Cimicifuga foetida 20-30 parts, Saposhnikovia divaricata 18-22 parts.

2. The Eucommia ulmoides granules for treating senile osteoporosis of the kidney deficiency and blood stasis type as described in claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: Eucommia ulmoides 30 parts, Rehmannia glutinosa 25 parts, Dioscorea opposita 20 parts, Dipsacus asper 25 parts, Commiphora myrrha 20 parts, Ligusticum chuanxiong 25 parts, Panax notoginseng 20 parts, Carthamus tinctorius 20 parts, Atractylodes macrocephala 25 parts, Poria cocos 25 parts, Astragalus membranaceus 30 parts, Panax ginseng 25 parts, Polygonatum odoratum 20 parts, Dendrobium nobile 20 parts, Notopterygium incisum 20 parts, Angelica pubescens 25 parts, Cimicifuga foetida 25 parts, Saposhnikovia divaricata 20 parts.

3. The Eucommia ulmoides granules for treating senile osteoporosis of the kidney deficiency and blood stasis type as described in claim 1, characterized in that, The preparation method includes the following steps: Step 1: Mix and grind Rehmannia glutinosa, Dioscorea opposita, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Dendrobium nobile, and Cimicifuga foetida into a powder of 20 mesh. Add 2-4 times the amount of distilled water and soak for 1-3 hours. Then add 6-8 times the amount of water and decoct 1-3 times, 1-3 hours each time. After filtering the decoction, add ethanol to precipitate it, so that the alcohol content is 75%-90%. Filter again and concentrate the filtrate into extract I for later use. Step 2: Mix and crush the remaining Chinese herbal medicine pieces into coarse powder, add 8-12 times the weight of the medicinal materials and 50%-80% ethanol by volume for reflux extraction, extract 2-4 times, 1-4 hours each time, filter, recover the ethanol from the filtrate, concentrate under reduced pressure to extract II, the relative density of extract II at 50℃ is 1.2-1.3, and set aside for later use; Step 3: Combine extract I and extract II, dry them, and obtain extract powder; Step 4: Add pharmaceutically acceptable excipients to the extract powder to prepare granules.

4. The Eucommia ulmoides granules for treating senile osteoporosis of the kidney deficiency and blood stasis type according to claim 3, characterized in that, The preparation method is as follows: add 3 times the amount of distilled water to soak for 2 hours, then add 7 times the amount of water to decoct twice, 2 hours each time; after filtering the decoction, add ethanol to precipitate, so that the alcohol content is 85%.

5. The Eucommia ulmoides granules for treating senile osteoporosis of the kidney deficiency and blood stasis type according to claim 3, characterized in that, The preparation method is as follows: add 10 times the weight of the medicinal material and 60% ethanol by volume for reflux extraction, and extract 3 times, 3 hours each time.