A traditional Chinese medicine composition for treating osteoporosis, an oral liquid, and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating osteoporosis, an oral liquid and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 8-17 parts of radix bupleuri, 10-21 parts of fructus psoraleae, 5-9 parts of rhizoma drynariae, 10-21 parts of herba epimedii, 10-21 parts of angelica sinensis, 10-21 parts of radix curculignis, 10-21 parts of radix rehmanniae preparatae, 5-14 parts of radix codonopsis, and 5-10 parts of radix bupleuri. The traditional Chinese medicine composition and the oral liquid for treating osteoporosis not only have the effect of treating osteoporosis, but also can improve the clinical manifestations of patients, such as cold, joint pain, limb flaccidity and fatigue, so as to achieve the effects of warming and tonifying the spleen and kidney, benefiting qi and nourishing blood, regulating viscera qi and regulating viscera qi.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, oral liquid, preparation method, and application for the treatment of fractures or osteoporosis. Background Technology

[0002] Osteoporosis is a common systemic bone disease among middle-aged and elderly patients. Currently, the main affected groups are postmenopausal women and the elderly. With the increasing aging of the population, changes in bone metabolism, coupled with unhealthy dietary habits, have led to a rise in the incidence and fracture rate of osteoporosis. Joint pain and vertebral compression fractures caused by osteoporosis significantly impact the daily lives of elderly patients, especially those who are unable to move independently due to fractures. Prolonged bed rest severely reduces their quality of life and increases the medical burden.

[0003] Osteoporosis falls under the categories of "bone atrophy" or "bone decay" in Traditional Chinese Medicine (TCM). The kidneys are closely related to the occurrence of bone atrophy. The kidneys govern bones and produce marrow; insufficient kidney essence leads to functional disorders, resulting in reduced marrow and atrophy. In addition, the occurrence of osteoporosis is also closely related to the spleen, liver, lungs, and gallbladder. The spleen and stomach are the foundation of acquired constitution and the source of qi and blood production. A healthy spleen ensures sufficient qi and blood, nourishing the innate kidney qi, thus resulting in healthy bones. The *Suwen* (Plain Questions) states, "When the lungs are hot and the leaves are withered, the skin and hair become weak and thin, eventually leading to atrophy and paralysis." Zhang Jingyue said, "When the gallbladder is diseased, it loses its strength, thus affecting the bones; those who are frightened and injure the gallbladder will inevitably have soft bones." Therefore, osteoporosis is closely related to the spleen, kidneys, lungs, and gallbladder. Clinically, there are many TCM prescriptions for treating osteoporosis or promoting fracture healing, but prescriptions that combine both, address spleen and kidney yang deficiency, and regulate qi are relatively rare. Summary of the Invention

[0004] The technical problem this invention aims to solve is to overcome the deficiency in existing technologies where there is a lack of formulas that combine the treatment of osteoporosis or the promotion of fracture healing with the treatment of spleen and kidney yang deficiency and the regulation of qi. This invention provides a traditional Chinese medicine composition, an oral liquid, its preparation method, and its application. The traditional Chinese medicine composition and oral liquid of this invention not only have the effects of treating osteoporosis and promoting fracture healing, but also improve clinical manifestations such as cold intolerance, joint pain, limb weakness, and fatigue, achieving the effects of warming and tonifying the spleen and kidneys, replenishing qi and nourishing blood, and regulating the qi of the internal organs.

[0005] The present invention solves the above-mentioned technical problems through the following technical solution:

[0006] This invention provides a traditional Chinese medicine composition comprising the following components in parts by weight: 8-17 parts of Dipsacus asperoides, 10-21 parts of Psoralea corylifolia, 5-9 parts of Drynaria fortunei, 10-21 parts of Curculigo orchioides, 10-21 parts of Angelica sinensis, 10-21 parts of Epimedium brevicornu, 10-21 parts of Rehmannia glutinosa, 5-14 parts of Codonopsis pilosula, and 5-10 parts of Bupleurum chinense.

[0007] In the present invention, the Dipsacus asperoides, Curculigo orchioides, Epimedium brevicornu, and Psoralea corylifolia are monarch drugs, with large dosages and specific effects, having the effects of strengthening the liver and kidney tonification and warming the kidney to promote yang. All four monarch drugs have warm and dry properties, which are likely to consume qi and damage yin. Therefore, prepared rehmannia root is used to nourish blood and yin, replenish essence and marrow. On the one hand, it restricts the warm and dry properties of the monarch drugs with the effect of nourishing yin, and on the other hand, it seeks yang from yin and binds yang to yin. Bones and marrow growing together can better promote the healing of fractures.

[0008] In the present invention, Drynaria fortunei can treat injuries, activate blood circulation to relieve pain, and strengthen bones and kidneys. It has various pharmacological effects such as anti-bone injury and anti-osteoporosis, and can promote the absorption of calcium by bones and the healing of fractures. Angelica sinensis is sweet and can tonify and moisten, pungent, warm, and dispersing. It is good at nourishing blood, promoting blood circulation, regulating menstruation and relieving pain, and can dispel cold. It is suitable for all syndromes of blood deficiency, blood stasis with cold.

[0009] In the present invention, the Dipsacus asperoides not only tonifies the liver and kidney, but also promotes blood circulation in the meridians and continues the tendons and bones. It is an important drug for treating fractures in orthopedics and has various pharmacological effects such as hemostasis, analgesia, promoting tissue regeneration, and promoting the healing of bone injuries. Psoralea corylifolia can tonify the kidney and strengthen yang, consolidate essence and reduce urination, and receive qi to relieve asthma. It treats kidney deficiency impotence and kidney deficiency asthma. Using the two together in the present invention can achieve pharmacological effects such as enhancing immunity and promoting the proliferation of osteoblasts.

[0010] In the present invention, Curculigo orchioides is good at warming the kidney and strengthening yang, strengthening muscles and bones, dispelling cold and dampness, and treating long-term arthralgia due to cold and dampness. Epimedium brevicornu is pungent, dispersing, sweet, tonifying, warm and dry. It enters the liver and kidney meridians and has a strong effect. It not only tonifies kidney yang and strengthens muscles and bones, but also dispels wind-dampness and relieves arthralgia pain. It is commonly used for kidney deficiency impotence and rheumatic arthralgia. Using the two together in the present invention can exert the effect of dispelling wind-cold-dampness pathogens.

[0011] Preferably, the Dipsacus asperoides is 10 - 1份, more preferably 15 - 17份, such as 17份.

[0012] Preferably, the Psoralea corylifolia is 15 - 21份, more preferably 18 - 21份, such as 21份.

[0013] Preferably, the Drynaria fortunei is 6 - 9份, more preferably 8 - 9份, such as 9份.

[0014] Preferably, the Curculigo orchioides is 15 - 21份, more preferably 18 - 21份, such as 21份.

[0015] Preferably, the Angelica sinensis is 15 - 21份, more preferably 18 - 21份, such as 21份. <s

[0016] Preferably, the Epimedium brevicornu is 15 - 21份, more preferably 18 - 21份, such as 21份.

[0017] Preferably, the prepared rehmannia root is 15 - 21份, more preferably 18 - 21份, such as 21份. [[ID=三十二]]

[0018] Preferably, the Codonopsis pilosula is 10 - 14份, such as 14份.

[0019] Preferably, the amount of Bupleurum is 10 parts.

[0020] Preferably, the traditional Chinese medicine composition further includes 10-21 parts of Poria cocos, more preferably 18-21 parts, for example 21 parts.

[0021] Preferably, the traditional Chinese medicine composition further includes 5-14 parts of Atractylodes macrocephala, more preferably 10-14 parts, for example 14 parts.

[0022] Preferably, the traditional Chinese medicine composition also includes 5-10 parts of green tangerine peel, for example, 5 parts or 10 parts.

[0023] Preferably, the traditional Chinese medicine composition also includes 5-10 parts of dried tangerine peel, for example, 5 parts or 10 parts.

[0024] Preferably, the traditional Chinese medicine composition also includes 2-5 parts of licorice, for example, 2 or 5 parts.

[0025] In this invention, Atractylodes macrocephala, Poria cocos, and Codonopsis pilosula are added to invigorate the spleen and replenish qi, promoting the generation of qi and blood. Codonopsis pilosula is sweet and nourishing, while also generating fluids and nourishing blood. Atractylodes macrocephala is sweet and nourishing, while also bitter, warm, and drying, effectively invigorating qi, strengthening the spleen, drying dampness, and promoting urination, thus treating spleen and stomach qi deficiency. Poria cocos eliminates dampness and promotes urination, while also strengthening the spleen and promoting the transformation and transportation of water and dampness. Atractylodes macrocephala, Poria cocos, and Codonopsis pilosula are suitable for treating dampness and phlegm retention, regardless of whether it is due to cold or heat, or whether there is spleen deficiency. When used in combination with other herbs, they invigorate the spleen and replenish qi, eliminate internally generated phlegm and dampness, regulate qi, and assist the principal herbs in promoting the circulation of qi and blood.

[0026] In this invention, if the patient has liver and kidney deficiency and spleen deficiency, excessive tonifying drugs may hinder the function of the spleen and stomach. Therefore, green tangerine peel, dried tangerine peel, and bupleurum are used as adjuvant drugs. They are pungent and aromatic, dispersing and dispersing, bitter and drying, warming and transforming. Bupleurum governs the ascending and descending of qi and blood, and unblocks the upper, middle and lower parts of the body. It can relieve stagnation, resolve blood stasis and dissipate nodules, so that qi and blood can be invigorated.

[0027] In some preferred embodiments of the present invention, the traditional Chinese medicine composition comprises the following components: by weight, 10-17 parts of Dipsacus asperoides, 15-21 parts of Psoralea corylifolia, 6-9 parts of Drynaria fortunei, 10-21 parts of Poria cocos, 5-14 parts of Atractylodes macrocephala, 15-21 parts of Curculigo orchioides, 15-21 parts of Angelica sinensis, 15-21 parts of Epimedium brevicornu, 15-21 parts of Rehmannia glutinosa, 5-10 parts of Citrus reticulata peel, 10-14 parts of Codonopsis pilosula, 5-10 parts of Citrus reticulata peel, and 5-10 parts of Bupleurum chinense.

[0028] In some preferred embodiments of the present invention, the traditional Chinese medicine composition comprises the following components by weight: 10-17 parts of Dipsacus asperoides, 15-21 parts of Psoralea corylifolia, 6-9 parts of Drynaria fortunei, 10-21 parts of Poria cocos, 5-14 parts of Atractylodes macrocephala, 15-21 parts of Curculigo orchioides, 15-21 parts of Angelica sinensis, 15-21 parts of Epimedium brevicornu, 15-21 parts of Rehmannia glutinosa, 5-10 parts of Citrus reticulata peel, 10-14 parts of Codonopsis pilosula, 5-10 parts of Citrus reticulata peel, 5-10 parts of Bupleurum chinense, and 2-5 parts of Glycyrrhiza uralensis.

[0029] In a specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 21 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 21 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 5 parts of Glycyrrhiza uralensis.

[0030] This invention also provides a method for preparing an oral liquid, which uses the above-mentioned traditional Chinese medicine composition as raw material and includes the following steps:

[0031] S1. The aforementioned traditional Chinese medicine composition is decocted with water to obtain a concentrated solution;

[0032] S2. Mix the primary concentrate with an aqueous ethanol solution and concentrate under reduced pressure to obtain a secondary concentrate;

[0033] In step S1, the decoction process can be conventional in the art. Preferably, the decoction is performed twice, each time for 2 hours, and the filtrates are combined to obtain the first concentrated liquid.

[0034] Preferably, in step S2, the volume fraction of ethanol in the aqueous ethanol solution is 50% to 80%, for example, 65%.

[0035] Preferably, in step S2, the ethanol-water solution is prepared using 95% ethanol.

[0036] Preferably, in step S2, the volume ratio of the primary concentrate to the ethanol-water solution is 1:(5~20), for example, 1:10.

[0037] Preferably, in step S2, the primary concentrate is placed at room temperature before being mixed with the ethanol-water solution.

[0038] Preferably, in step S2, after mixing the primary concentrate with the ethanol-water solution, the process further includes a standing and refrigeration step; wherein the refrigeration temperature is preferably 2-10°C; and wherein the refrigeration time is preferably 48 hours.

[0039] Preferably, after step S2, step S3 is also included, wherein step S3 is to mix the secondary concentrate with distilled water, filter, and collect the filtrate.

[0040] When step S2 is followed by step S3, preferably, after mixing the secondary concentrate with distilled water, a refrigeration step is also included, wherein the refrigeration temperature is preferably 2-10°C and the refrigeration time is preferably 48 hours.

[0041] When step S2 is followed by step S3, preferably, after the step of collecting the filtrate, a sterilization step is also included, and the sterilization method is preferably boiling.

[0042] When step S2 is followed by step S3, preferably, after the step of collecting the filtrate, auxiliary materials and / or water are added to the filtrate for filtration.

[0043] The excipients are sweeteners and / or preservatives, preferably white sugar, and the amount of sweetener used is preferably 15-30 parts, for example 30 parts; the preservative is preferably sodium benzoate, and the amount of preservative used is preferably 1-3 parts, for example 2.5 parts; the water is preferably purified water. Purified water is added to adjust the volume, for example, to 1000 mL.

[0044] In this invention, the vacuum concentration can be carried out using conventional methods in the art, until the concentrate contains no ethanol.

[0045] In this invention, the filtering, mixing, and boiling processes can all be performed using conventional methods in the art.

[0046] In this invention, the ambient temperature refers to conventional conditions in the field, such as 15-40°C.

[0047] The present invention also provides an oral liquid prepared by the above-described method for preparing oral liquids.

[0048] In this invention, the oral liquid can be in the form of 10mL / vial.

[0049] The present invention also provides the use of the pharmaceutical composition or the oral liquid in a medicament for treating fractures or osteoporosis.

[0050] Based on common knowledge in the field, the above-mentioned preferred conditions can be combined arbitrarily to obtain various preferred embodiments of the present invention.

[0051] The reagents and raw materials used in this invention are all commercially available.

[0052] The positive and progressive effects of this invention are as follows:

[0053] (1) The Chinese medicine composition and oral liquid of the present invention can not only effectively treat osteoporosis and promote fracture healing, but also improve the clinical manifestations of patients such as fear of cold, joint pain, limb weakness, and fatigue, and achieve the effects of warming and tonifying the spleen and kidneys, replenishing qi and nourishing blood, and regulating the qi mechanism of the internal organs.

[0054] (2) The traditional Chinese medicine composition and oral liquid of the present invention have a total effective, significant and curative rate of 90% in treating osteoporosis and fractures, and can significantly improve osteoporosis and fractures.

[0055] (3) Animal experiments were conducted on the treatment of osteoporosis and fractures with traditional Chinese medicine composition of the present invention. The results showed that the traditional Chinese medicine composition and oral liquid of the present invention could significantly reduce the BGP and TRAP content in rats (P<0.05) and increase the femoral bone density in rats (P<0.05). Detailed Implementation

[0056] The present invention is further illustrated below by way of embodiments, but the invention is not limited to the scope of the embodiments described herein. Experimental methods in the following embodiments that do not specify specific conditions were performed according to conventional methods and conditions, or as selected according to the product instructions.

[0057] Example 1

[0058] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 21 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 21 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 5 parts of Glycyrrhiza uralensis.

[0059] Using this traditional Chinese medicine composition as raw material, an oral liquid for treating fractures or osteoporosis is prepared, specifically including the following steps:

[0060] The herbal composition is decocted twice with water, 2 hours each time. The filtrates are combined to obtain a first concentrated solution. The first concentrated solution is placed at room temperature and 65% ethanol is prepared using 95% ethanol. The ethanol solution is added to the first concentrated solution and refrigerated at 2-10℃ for 48 hours. The solution is then concentrated under reduced pressure until it is free of ethanol to obtain a second concentrated solution. Distilled water is added to the second concentrated solution, and the solution is refrigerated at 2-10℃ for 48 hours after water precipitation. The solution is filtered, and 30 parts of white sugar and 2.5 parts of sodium benzoate are added, along with purified water to a final volume of 1000 ml. The solution is stirred, filtered, and boiled for sterilization to obtain an oral liquid for treating fractures or osteoporosis.

[0061] Example 2

[0062] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 18 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 18 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 18 parts of Epimedium brevicornu, 18 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 5 parts of Glycyrrhiza uralensis.

[0063] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0064] Example 3

[0065] The traditional Chinese medicine composition comprises the following components by weight: 10 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 10 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 10 parts of Epimedium brevicornu, 18 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 5 parts of Glycyrrhiza uralensis.

[0066] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0067] Example 4

[0068] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 18 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 15 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 15 parts of Epimedium brevicornu, 18 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 5 parts of Glycyrrhiza uralensis.

[0069] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0070] Example 5

[0071] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 21 parts of Curculigo orchioides, 18 parts of Angelica sinensis, 21 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 5 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 5 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0072] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0073] Example 6

[0074] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 10 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 10 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 5 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 5 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0075] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0076] Example 7

[0077] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 10 parts of Curculigo orchioides, 18 parts of Angelica sinensis, 15 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 5 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0078] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0079] Example 8

[0080] The traditional Chinese medicine composition comprises the following components by weight: 15 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 18 parts of Poria cocos, 8 parts of Atractylodes macrocephala, 21 parts of Curculigo orchioides, 15 parts of Angelica sinensis, 21 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 10 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0081] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0082] Example 9

[0083] The traditional Chinese medicine composition comprises the following components by weight: 17 parts of Dipsacus asperoides, 18 parts of Psoralea corylifolia, 8 parts of Drynaria fortunei, 18 parts of Poria cocos, 10 parts of Atractylodes macrocephala, 18 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 18 parts of Epimedium brevicornu, 18 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 5 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0084] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0085] Example 10

[0086] The traditional Chinese medicine composition comprises the following components by weight: 15 parts of Dipsacus asperoides, 18 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 15 parts of Poria cocos, 10 parts of Atractylodes macrocephala, 15 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 15 parts of Epimedium brevicornu, 15 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 10 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0087] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0088] Example 11

[0089] The traditional Chinese medicine composition comprises the following components by weight: 10 parts of Dipsacus asperoides, 15 parts of Psoralea corylifolia, 6 parts of Drynaria fortunei, 10 parts of Poria cocos, 10 parts of Atractylodes macrocephala, 15 parts of Curculigo orchioides, 15 parts of Angelica sinensis, 15 parts of Epimedium brevicornu, 15 parts of Rehmannia glutinosa, 5 parts of Citrus reticulata peel, 5 parts of Codonopsis pilosula, 5 parts of Citrus reticulata peel, 5 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0090] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0091] Example 12

[0092] The traditional Chinese medicine composition comprises the following components by weight: 8 parts of Dipsacus asperoides, 10 parts of Psoralea corylifolia, 5 parts of Drynaria fortunei, 5 parts of Poria cocos, 5 parts of Atractylodes macrocephala, 10 parts of Curculigo orchioides, 10 parts of Angelica sinensis, 10 parts of Epimedium brevicornu, 10 parts of Rehmannia glutinosa, 5 parts of Citrus reticulata peel, 5 parts of Codonopsis pilosula, 5 parts of Citrus reticulata peel, 5 parts of Bupleurum chinense, and 2 parts of Glycyrrhiza uralensis.

[0093] Using this traditional Chinese medicine composition as raw material, an oral liquid was prepared, and the preparation method was the same as in Example 1.

[0094] Example 1

[0095] (1) Clinical trials

[0096] ① Clinical manifestation score:

[0097] One hundred patients with osteoporosis and spleen and kidney yang deficiency were included in the outpatient clinic. According to the above example, pain level was scored: based on VAS score (the higher the score, the more pain), cold intolerance, fatigue and osteoporosis status are shown in Table 1.

[0098] Table 1 Clinical Performance Scores

[0099] Fraction Afraid of the cold Osteoporosis fatigue 0 points Almost none Almost none Almost none 1 point Slightly sensitive to cold Mild Slightly 2 points Moderate intensity, many people wear jackets moderate medium intensity 3 points I'm very sensitive to the cold and wear more sweaters than others. Severe Extremely tired

[0100] ②Therapeutic effect:

[0101] The effectiveness rate is calculated based on the clinical manifestation score: effectiveness rate = (pain score before treatment - pain score after treatment) / (pain score before treatment) * 100%. The calculated effectiveness rate corresponds to the therapeutic effect, with an effectiveness rate ≤ 25% considered ineffective, > 25% effectiveness rate < 50% considered effective, ≥ 50% effectiveness rate < 75% considered significantly effective, and an effectiveness rate ≥ 75% considered cured.

[0102] Table 2. Treatment efficacy

[0103] therapeutic effect Number of people invalid 10 efficient 16 Effective 54 get well 20

[0104] ③ Typical Case:

[0105] Case 1: Female, 85 years old, with a compression fracture of the T12 vertebral body, experiencing severe lower back pain, slight fatigue, and moderate sensitivity to cold. She was given the decoction prepared in Example 1 orally, one dose daily, twice a day (morning and evening). After 4 weeks, the pain lessened, and she no longer experienced sensitivity to cold or fatigue. After 6 weeks, she was able to engage in moderate activity.

[0106] Case 2, male, 56 years old. He suffered from pain due to a fracture of the right olecranon process. Two weeks after fixation, he experienced local pain and bruising, and was slightly sensitive to cold. He took the decoction prepared in Example 2 orally, one dose per day, twice a day, morning and evening. After two weeks, the pain lessened, the bruising subsided, and he was basically free of cold sensitivity. After four weeks, the affected area was basically healed.

[0107] Case 3, male, 71 years old. He experienced fatigue, lower back pain, and no significant sensitivity to cold. He took the decoction prepared in Example 3 orally, one dose per day, twice a day, morning and evening. After 3 weeks, the pain was significantly reduced, and the fatigue was no longer significant.

[0108] Case 4, female, 58 years old. Postmenopausal osteoporosis, lower back pain, slight cold intolerance, and fatigue. She took the decoction prepared in Example 4 orally, one dose per day, twice a day, morning and evening. After 2 weeks, the pain was relieved, and the fatigue and cold intolerance disappeared.

[0109] Case 5, male, 66 years old. Fracture of the 3rd to 5th ribs on the left side, pain in the left chest and back, usually very sensitive to cold and fatigued. He took the decoction prepared in Example 5 orally, one dose per day, twice a day, morning and evening. The pain was relieved after one week, and the affected area was basically healed after three weeks, and he could move around moderately.

[0110] Case 6, female, 48 years old. Fracture of the first metatarsal bone of the left foot, with slow healing. She took the decoction prepared in Example 6 orally, one dose per day, twice a day, morning and evening. After 2 weeks, the affected area was basically healed and she was able to try walking.

[0111] Case 7, female, 78 years old. Severe osteoporosis, with soreness in the lower back and left lower limb, and mild weakness. She took the decoction prepared in Example 7 orally, one dose per day, twice a day, morning and evening. The pain lessened after 2 weeks and improved significantly after 4 weeks.

[0112] Case 8, male, 75 years old. He suffered from lower back pain, severe osteoporosis, and was very sensitive to cold. He took one dose of the oral liquid prepared in Example 8 twice a day, morning and evening. After 4 weeks, his pain was relieved, and he was only slightly sensitive to cold, so he wore an extra light jacket than usual.

[0113] Case 9, male, 54 years old. He presented with fractures of the 6th and 7th ribs on the right side, pain in the right chest and back, and fatigue. He was given the decoction prepared in Example 9 orally, one dose daily, twice a day (morning and evening). After two weeks, the pain lessened, with only slight fatigue remaining. After three weeks, the affected area had essentially healed.

[0114] Case 10, male, 68 years old. He had a compression fracture of L1, with pain, but no weakness or cold intolerance. He took the decoction prepared in Example 10 orally, one dose per day, twice a day, morning and evening. After 4 weeks, the pain was relieved and he was able to move around slightly.

[0115] Case 11, female, 64 years old. She had weakness in both lower limbs, mild cold intolerance, mild osteoporosis, and joint pain when exerted. She took one dose of the decoction prepared in Example 11, twice a day, morning and evening. After 3 weeks, she no longer had obvious joint pain when exerted, her weakness in walking both lower limbs was significantly improved, and she no longer felt cold.

[0116] Case 12, male, 63 years old. He had soreness in his right tibia, moderate osteoporosis, slight sensitivity to cold, and slight fatigue. He took the decoction prepared in Example 12 orally, one dose per day, twice a day, morning and evening. After 4 weeks, the pain was significantly reduced, and he no longer had significant sensitivity to cold or fatigue.

[0117] (2) Animal experiments

[0118] Healthy female SD rats aged 3 months were housed in an indoor animal room maintained at a temperature of 22-26℃ with consistent light and humidity. After one week of acclimatization, 24 SD rats were randomly assigned to three groups using a random number table: a normal control group, a model group, and a drug-treated group.

[0119] This experiment used dexamethasone intervention to establish a rat model. The method involved subcutaneous injection of dexamethasone 0.75 mg / kg twice a week for 12 consecutive weeks into the model group and the drug group.

[0120] After successful modeling, rats in the drug group were administered the oral solution of Example 1 of this invention by gavage at a concentration of 20g crude drug / kg, at a dose of 10mL / kg, once daily for 6 weeks. Rats in the model group and the normal control group were administered 1mL / rat of physiological saline by gavage once daily for 6 weeks.

[0121] Rats were anesthetized and placed under dual-energy X-ray absorptiometry (DXA) to measure femoral bone mineral density. Blood was also drawn from the abdominal aorta to measure serum osteocalcin (BGP) and tartrate-resistant acid phosphatase (TRAP) levels. All data obtained in this study were processed using SPSS 21.0 statistical software. Quantitative data are expressed as mean ± standard deviation (x̄ ± s). One-way ANOVA was used for comparisons among multiple groups, with P < 0.05 considered statistically significant.

[0122] As shown in Table 3, the results showed that compared with the normal group and the drug group, the BGP and TRAP contents of rats in the model group were significantly increased (P<0.05), and the femoral bone density of rats in the model group was significantly decreased (P<0.05); there was no statistically significant difference between the drug group and the normal group.

[0123] Table 3. Serum bone metabolism-related indicators and bone mineral density in each group of rats.

[0124] Group <![CDATA[BGP(ng·L -1 )]]> <![CDATA[TRAP(pg·ml -1 )]]> <![CDATA[Bone density (g / cm 2 ).]]> normal control group 179.51 ± 11.49 593.77 ± 69.68 0.118 ± 0.003 Model group <![CDATA[209.73 ± 30.75 ▲ ]]> <![CDATA[819.51 ± 76.45 ▲ ]]> <![CDATA[0.092 ± 0.001 ▲ ]]> drug group 187.67 ± 16.82 604.57 ± 43.17 0.107± 0.003

[0125] Note: The superscript ▲ indicates that P < 0.05.

Claims

1. A traditional Chinese medicine composition for treating osteoporosis, characterized in that, It is composed of the following components by weight: 8-17 parts of Dipsacus asperoides, 10-21 parts of Psoralea corylifolia, 5-9 parts of Drynaria fortunei, 10-21 parts of Curculigo orchioides, 10-21 parts of Angelica sinensis, 10-21 parts of Epimedium brevicornu, 10-21 parts of Rehmannia glutinosa, 5-14 parts of Codonopsis pilosula, 5-10 parts of Bupleurum chinense, 10-21 parts of Poria cocos, 5-14 parts of Atractylodes macrocephala, 5-10 parts of Citrus reticulata peel, 5-10 parts of Citrus reticulata peel, and 2-5 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that, The traditional Chinese medicine composition satisfies one or more of the following conditions an: a. The amount of Sichuan pepper is 10-17 parts; b. The amount of Psoralea corylifolia is 15-21 parts; c. The amount of Drynaria fortunei is 6-9 parts; d. The amount of Curculigo orchioides mentioned is 15-21 parts; e. The amount of Angelica sinensis mentioned is 15-21 parts; f. The amount of Epimedium mentioned is 15-21 parts; g. The prepared Rehmannia root is 15-21 parts; h. The amount of Codonopsis pilosula mentioned is 10-14 parts; i. The Bupleurum chinense is in portions of 10; j. The amount of Poria cocos mentioned is 18-21 parts; k. The Atractylodes macrocephala mentioned is 10-14 parts; 1. The green tangerine peel is in portions of 5 or 10 parts; m. The tangerine peel is 5 or 10 parts; n. The licorice is in the form of 2 or 5 parts.

3. The traditional Chinese medicine composition for treating osteoporosis according to claim 2, characterized in that, The traditional Chinese medicine composition satisfies one or more of the following conditions a: a. The amount of Sichuan pepper is 15-17 parts; b. The amount of Psoralea corylifolia is 18-21 parts; c. The amount of Drynaria fortunei is 8-9 parts; d. The amount of Curculigo orchioides mentioned is 18-21 parts; e. The amount of Angelica sinensis mentioned is 18-21 parts; f. The amount of Epimedium mentioned is 18-21 parts; g. The prepared Rehmannia root is 18-21 parts; h. The Codonopsis pilosula mentioned is 14 parts; i. The Poria cocos mentioned is in 21 portions; j. The Atractylodes macrocephala mentioned is 14 parts.

4. The traditional Chinese medicine composition for treating osteoporosis according to claim 2, characterized in that, The traditional Chinese medicine composition meets one or more of the following conditions: a. The amount of Sichuan fracturing mentioned is 17 parts; b. The amount of Psoralea corylifolia is 21 parts; c. The amount of Drynaria fortunei is 9 parts; d. The amount of *Curculigo orchioides* is 21 parts; e. The amount of Angelica sinensis mentioned is 21 parts; f. The amount of Epimedium mentioned is 21 portions; g. The prepared Rehmannia root is 21 parts.

5. The traditional Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components by weight: 10-17 parts of Dipsacus asperoides, 15-21 parts of Psoralea corylifolia, 6-9 parts of Drynaria fortunei, 10-21 parts of Poria cocos, 5-14 parts of Atractylodes macrocephala, 15-21 parts of Curculigo orchioides, 15-21 parts of Angelica sinensis, 15-21 parts of Epimedium brevicornu, 15-21 parts of Rehmannia glutinosa, 5-10 parts of Citrus reticulata peel, 10-14 parts of Codonopsis pilosula, 5-10 parts of Citrus reticulata peel, 5-10 parts of Bupleurum chinense, and 2-5 parts of Glycyrrhiza uralensis.

6. The traditional Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following components by weight: 17 parts of Dipsacus asperoides, 21 parts of Psoralea corylifolia, 9 parts of Drynaria fortunei, 21 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 21 parts of Curculigo orchioides, 21 parts of Angelica sinensis, 21 parts of Epimedium brevicornu, 21 parts of Rehmannia glutinosa, 10 parts of Citrus reticulata peel, 14 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 10 parts of Bupleurum chinense, and 5 parts of Glycyrrhiza uralensis.

7. A method for preparing an oral liquid for treating osteoporosis, characterized in that, It uses the traditional Chinese medicine composition according to any one of claims 1-6 as raw material, and includes the following steps: S1. The aforementioned traditional Chinese medicine composition is decocted with water to obtain a concentrated solution; S2. Mix the primary concentrate with an aqueous ethanol solution and concentrate under reduced pressure to obtain a secondary concentrate.

8. The method for preparing the oral liquid for treating osteoporosis according to claim 7, characterized in that, In step S1, the decoction is performed twice, each time for 2 hours, and the filtrates are combined to obtain the first concentrated liquid; And / or, in step S2, the volume fraction of ethanol in the ethanol-water solution is 50%~80%; And / or, in step S2, the ethanol-water solution is prepared using 95% ethanol; And / or, in step S2, the volume ratio of the primary concentrate to the ethanol-water solution is 1:(5~20). And / or, in step S2, the vacuum concentration continues until the concentrate contains no ethanol.

9. The method for preparing the oral liquid for treating osteoporosis according to claim 8, characterized in that, The volume fraction of ethanol in the aqueous ethanol solution is 65%. And / or, the volume ratio of the primary concentrate to the aqueous ethanol solution is 1:

10.

10. The method for preparing the oral liquid for treating osteoporosis according to claim 7, characterized in that, In step S2, the primary concentrate is left at room temperature before being mixed with the ethanol-water solution. And / or, after mixing the primary concentrate with an aqueous ethanol solution, the process also includes a settling and refrigeration step; And / or, after step S2, step S3 is also included, wherein step S3 is to mix the secondary concentrate with distilled water, filter, and collect the filtrate.

11. The method for preparing the oral liquid for treating osteoporosis according to claim 10, characterized in that, The refrigeration temperature is 2-10℃; And / or, the refrigeration time is 48 hours.

12. The method for preparing the oral liquid for treating osteoporosis according to claim 10, characterized in that, When step S2 is followed by step S3, after mixing the secondary concentrate with distilled water, a refrigeration step is also included. And / or, after the step of collecting the filtrate, a sterilization step is also included; And / or, after the step of collecting the filtrate, an auxiliary material and / or water are added to the filtrate, and then filtered; The excipients are sweeteners and / or preservatives.

13. The method for preparing the oral liquid for treating osteoporosis according to claim 12, characterized in that, The refrigeration temperature is 2-10℃; And / or, the refrigeration time is 48 hours; And / or, the sterilization method is boiling; And / or, the sweetener is white sugar; And / or, the amount of the sweetener used is 15-30 parts; And / or, the preservative is sodium benzoate; And / or, the amount of the preservative used is 1-3 parts; And / or, the water is purified water.

14. The method for preparing the oral liquid for treating osteoporosis according to claim 13, characterized in that, The amount of the sweetener used is 30 parts; And / or, the amount of the preservative used is 2.5 parts.

15. An oral liquid for treating osteoporosis, characterized in that, It is prepared using the method for preparing an oral liquid for treating osteoporosis as described in any one of claims 7-14.

16. The use of a traditional Chinese medicine composition for treating osteoporosis as described in any one of claims 1-6 or an oral liquid for treating osteoporosis as described in claim 15 in the preparation of a medicament for treating osteoporosis.