Traditional Chinese medicine composition for treating kidney essence deficiency type bone flaccid paralysis, preparation and application

Abstract

The invention discloses a traditional Chinese medicine composition for treating kidney essence deficiency type bone flaccid paralysis, a preparation and application. The traditional Chinese medicine composition is prepared from, by weight, 10-20 g of herba epimedii, 8-15 g of fructus lycii, 8-15 g of cortex eucommiae, 6-12 g of rhizoma cibotii, 10-20 g of radix rehmanniae praeparata, 8-15 g of fructus corni, 8-15 g of rhizoma polygonati and 4-8 g of radix glycyrrhizae. The traditional Chinese medicine composition is suitable for kidney essence deficiency type bone flaccidity. According to the treatment rule of tonifying kidney, strengthening bone and promoting blood circulation to remove meridian obstruction in the traditional Chinese medicine, the formula has the curative effect of treating both symptoms and root causes by nourishing the kidney and repairing the bone. The traditional Chinese medicine composition is precise and appropriate in compatibility, high in clinical applicability and high in acceptability, the total clinical effective rate reaches up to 85%, and the treatment effect is obviously better than that of a control group.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions and preparations, and specifically relates to a Chinese medicine composition, preparation and application for treating bone atrophy due to kidney-essence deficiency. Background Art

[0002] Osteoporosis is a metabolic bone disease characterized by decreased bone mass and deterioration of bone microstructure. Its clinical manifestations include increased bone fragility and increased risk of fractures. In traditional Chinese medicine theory, this disease is often classified as "bone atrophy". Bone atrophy is a disease characterized by weak bones, inability to hold together, atrophy of the lower limbs, soreness of the waist and back, and even deformities and fractures, which is highly consistent with the symptoms of osteoporosis. With the aging of the population, the incidence of the disease has increased significantly in postmenopausal women and the elderly, and it has become a global public health issue. Osteoporosis not only causes symptoms such as soreness of the waist and knees and limited mobility, but also easily causes fractures in the hip, spine and other parts, seriously affecting the quality of life of patients and bringing a heavy socioeconomic burden.

[0003] According to traditional Chinese medicine, "kidneys control bones and produce marrow", and bone health is closely related to the fullness of kidney essence. Kidney essence deficiency is the core pathogenesis of osteoporosis (bone atrophy). Insufficient kidney essence will cause the marrow to lose its nourishment, and the bones will lose their filling, leading to bone atrophy. In addition, factors such as poor circulation of qi and blood, liver and kidney deficiency, and spleen and stomach weakness can also aggravate bone malnutrition, forming the pathological characteristics of "deficiency in the root and excess in the superficial".

[0004] At present, the classic prescriptions of traditional Chinese medicine for the treatment of osteoporosis (bone atrophy) have certain limitations. For example, Yougui Pills are suitable for osteoporosis (bone atrophy) of kidney yang deficiency type, but they do not take into account kidney essence deficiency. Liuwei Dihuang Pills can improve bone atrophy caused by kidney yin deficiency, but their effect of promoting blood circulation and unblocking collaterals is weak. Qiju Dihuang Pills focus on nourishing yin and improving eyesight, and have limited targeted treatment for bones (symptoms related to bone atrophy). Some compound prescriptions focus on a single effect, such as epimedium, eucommia, etc. for tonifying the kidney and strengthening yang, and tortoise shell, mistletoe, etc. for nourishing yin and promoting blood circulation, but the formula is rigid, making it difficult to coordinate the regulation of kidney essence, qi and blood, and bone metabolism, and cannot effectively improve the symptoms of bone atrophy.

[0005] In summary, the existing prescriptions are mostly aimed at single syndromes of kidney yang deficiency or kidney yin deficiency, and lack targeted treatment for the core pathogenesis of "kidney essence deficiency" (closely related to the onset of bone atrophy). The present invention aims to provide a Chinese medicine composition for treating bone atrophy of kidney essence deficiency type, which is based on tonifying the kidney and replenishing essence, taking into account the methods of promoting blood circulation and unblocking collaterals, strengthening the spleen and replenishing qi, etc., aiming to restore the balance of bone metabolism and effectively improve the symptoms related to bone atrophy. Summary of the invention

[0006] The first purpose of the present invention is to provide a Chinese medicine composition for treating kidney-essence deficiency type bone atrophy; further provide the preparation form and use of the Chinese medicine composition.

[0007] The first object of the present invention is achieved in this way. The Chinese medicine composition for treating bone atrophy due to deficiency of kidney essence of the present invention is composed of 10-20g of Epimedium, 8-15g of Lycium barbarum, 8-15g of Eucommia ulmoides, 6-12g of Cibotium barometz, 10-20g of Rehmannia glutinosa, 8-15g of Cornus officinalis, 8-15g of Polygonatum sibiricum, and 4-8g of Licorice, and is suitable for bone atrophy due to deficiency of kidney essence.

[0008] A further object is achieved by providing a pharmaceutical preparation of a traditional Chinese medicine composition for treating bone atrophy due to deficiency of kidney essence, characterized in that medically acceptable auxiliary materials are added to the formula of the traditional Chinese medicine composition to prepare it into any one of a decoction, a granule, or a capsule.

[0009] The Chinese medicine composition is used in preparing medicine for treating bone atrophy caused by deficiency of kidney essence.

[0010] This prescription follows the treatment principle of "tonifying the kidney as the basis, and promoting blood circulation and unblocking meridians as the auxiliary", combined with the method of strengthening tendons and bones, to comprehensively improve osteoporosis.

[0011] Epimedium is used heavily in the formula and is revered as the main drug. It tastes spicy and sweet, is warm in nature, and enters the liver and kidney meridians. Spicy can disperse, sweet can replenish, and warm can help yang, so it has the special functions of tonifying the kidney, strengthening yang, strengthening tendons and bones. The kidney is responsible for bone and marrow production and is the foundation of innateness. Epimedium directly enters the kidney meridian, warms the kidney yang, like the warm sun in spring, nourishes and promotes hair growth, fills the kidney qi, and stimulates yang to produce semen. The semen overflows to nourish the marrow sea. When the marrow sea is filled, the bones are nourished, laying the foundation for the whole formula to tonify the kidney and strengthen bones.

[0012] Lycium barbarum, Eucommia ulmoides and Cibotium barbarum are the ministerial drugs, which assist the monarch to perform their functions. Lycium barbarum is sweet in taste and mild in nature, and it enters the liver and kidney meridians. Sweet taste can nourish the kidney and benefit the essence, and it can also nourish the liver and improve eyesight. Together with Epimedium, it can synergistically nourish the kidney and produce marrow, replenish essence and nourish blood, so that the qi and blood of the bones circulate endlessly, and the bones are therefore stable. Eucommia barbarum is sweet in taste and warm in nature, and it also enters the liver and kidney meridians. It has a strong ability to nourish the liver and kidney, strengthen the tendons and bones, and consolidate the menstruation and stop leakage. Together with Epimedium and Lycium barbarum, it plays the music of nourishing the kidney, replenishing essence, strengthening tendons and bones. Cibotium barbarum is bitter and sweet in taste, warm in nature, and enters the same meridians as before. It can nourish the kidney and assist yang, make yang sufficient, and biochemically active; strengthen tendons and bones, make limbs strong and powerful; dispel wind and dampness, and expel evil spirits. Together with Eucommia barbarum and Lycium barbarum, they complement each other and help the monarch drug to strengthen the kidney and produce essence, strengthen bones and consolidate marrow.

[0013] Rehmannia root, Cornus officinalis, and Polygonatum sibiricum are adjuvants, assisting the monarch and minister. Rehmannia root is sweet in taste, slightly warm in nature, and enters the liver and kidney meridians. Its sweet, warm and moist nature is particularly good at nourishing kidney yin, replenishing essence and benefiting marrow. It cooperates with Epimedium, one yang and one yin, and replenishes both yin and yang, so that kidney yin is nourished, essence and blood overflow, and bone marrow is filled, just like sweet rain moistening wood, full of vitality, achieving the effect of replenishing essence and filling marrow, strengthening tendons and bones. Cornus officinalis is sour and astringent in taste, slightly warm in nature, and enters the liver and kidney meridians. Sourness can astringe, astringency can consolidate, nourish the liver and kidney and consolidate essence and qi, and cooperate with Lycium barbarum to strengthen the ability of kidney essence to nourish bones, make bones as hard as a rock, and strengthen tendons and bones. Polygonatum sibiricum is sweet in taste, mild in nature, and enters the spleen, lung, and kidney meridians. Sweet taste nourishes the spleen, can regulate qi and blood, and is good at regulating the function of spleen and stomach transportation and transformation. Healthy spleen and stomach movement will lead to active qi and blood biochemical activity. With abundant Qi and blood, bones are nourished, tendons and bones become stronger, and the power of the main and auxiliary medicines is assisted, making the efficacy of the medicines fully manifested.

[0014] Licorice is a facilitating drug, with a sweet taste and a mild nature. It enters the heart, lung, spleen, and stomach meridians. Its mild nature can harmonize the various drugs, making the drug compatibility like a fish in water, harmonious and harmonious, and also serves as a facilitating drug, leading the drugs to the meridians. In addition, tortoise shell, mistletoe, and Poria are added as flavoring drugs to improve the efficacy of the whole prescription. Turtle shell tastes salty and sweet, with a slightly cold nature, and enters the liver, kidney, and heart meridians. Salt can enter the kidney, nourish yin and suppress yang, nourish the kidney and strengthen bones. When combined with epimedium and eucommia, yin and yang complement each other, and the power of nourishing the kidney and strengthening bones is doubled. Mulberry parasite tastes bitter and sweet, with a mild nature, and enters the liver and kidney meridians. It nourishes the liver and kidney to strengthen the tendons and bones, removes rheumatism to dredge the meridians, and is especially good at treating the weakness of tendons and bones caused by liver and kidney deficiency. It works in synergy with other drugs to strengthen bones. Poria tastes sweet and light, with a mild nature, and enters the heart, lung, spleen, and kidney meridians. Sweetness can nourish the spleen, and lightness can penetrate dampness, strengthen the spleen and eliminate dampness, promote the spleen and stomach to transport and transform, and make the qi and blood sufficient. It can also help fill the kidney qi, promote bone marrow formation, and strengthen the bones.

[0015] The whole formula is exquisitely matched, with the main, auxiliary, adjuvant, envoy and added flavors each performing their own functions, and together they play the role of tonifying the kidney and replenishing essence, strengthening tendons and bones, nourishing yin and nourishing marrow, and strengthening the spleen and promoting movement. It not only tonifies the kidney and strengthens yang to invigorate yang energy, but also nourishes yin and fills marrow to nourish yin fluid, comprehensively regulates liver and kidney qi and blood, makes kidney essence sufficient, and bones strong, and has significant effects on osteoporosis, sore waist and knees, weak tendons and bones, etc.

[0016] This prescription is based on the treatment principle of "tonifying the kidney and strengthening bones, promoting blood circulation and unblocking collaterals" in traditional Chinese medicine. By nourishing the kidney and repairing the bones, it forms a curative effect of treating both the symptoms and the root causes. The kidney-tonifying effect of the main drug Epimedium is the root of the treatment, while the ministerial drugs, adjuvant drugs, and guiding drugs synergistically enhance the kidney qi, replenish the essence required for the bones, and improve the bone repair ability and bone density. Through reasonable drug compatibility, the efficacy of each medicinal flavor is mutually enhanced to form a unique synergistic effect. Epimedium is combined with drugs such as Lycium barbarum, Eucommia ulmoides, and Cibotium barometz to achieve the effect of improving the symptoms of osteoporosis by strengthening the kidney and strengthening bones, promoting blood circulation and removing blood stasis. The present invention is well matched, has strong clinical applicability, high acceptance, and a total clinical significant efficacy of up to 85%, and the therapeutic effect is significantly better than that of the control group. DETAILED DESCRIPTION

[0017] The present invention is further described below in conjunction with the embodiments, but the present invention is not limited in any way. Any changes or substitutions made based on the technical teachings of the present invention belong to the protection scope of the present invention.

[0018] The invention discloses a traditional Chinese medicine composition for treating bone atrophy due to deficiency of kidney essence. The composition comprises, by weight, 10-20g of epimedium, 8-15g of wolfberry, 8-15g of eucommia bark, 6-12g of cibotium bark, 10-20g of rehmannia root, 8-15g of cornus officinalis, 8-15g of polygonatum and 4-8g of liquorice, and is suitable for treating bone atrophy due to deficiency of kidney essence.

[0019] The Chinese medicine composition is added with 6-10g of aconite root and 4-6g of cinnamon bark, and is suitable for treating kidney-essence deficiency and kidney-yang deficiency.

[0020] The Chinese medicine composition is added with 8-12g of Ligustrum lucidum fruit and 8-12g of Eclipta prostrata, and is suitable for kidney essence deficiency and kidney yin deficiency syndrome.

[0021] The Chinese medicine composition is added with 10-15g of Salvia miltiorrhiza and 3-6g of Carthamus tinctorius, and is suitable for treating kidney-essence deficiency and blood stasis.

[0022] The present invention also provides a pharmaceutical preparation of the Chinese medicine composition for treating kidney-essence deficiency type bone atrophy, wherein medically acceptable auxiliary materials are added to the Chinese medicine composition to prepare any one of decoction, granules and capsules.

[0023] The preparation process of the decoction is as follows: slice each medicinal ingredient in the formula, soak each medicinal ingredient in water for 30-60 minutes at a weight ratio of medicine to water of 1:5-8, decoct for 1-3 times, each time for 30-60 minutes, combine the decoctions, and obtain the decoction.

[0024] The present invention further provides the use of the traditional Chinese medicine composition in preparing a medicine for treating bone atrophy caused by deficiency of kidney essence.

[0025] Example 1 Prescription: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia glutinosa 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g. Soak each herb in water for 30min, add 5 times the amount of water and boil for 1h, then add 3 times the amount of water and boil for 1h, combine the decoction and concentrate to 400ml to obtain a decoction.

[0026] Example 2 Formula: 20g of Epimedium, 15g of Lycium barbarum, 15g of Eucommia bark, 12g of Cibotium barometz, 20g of Rehmannia root, 15g of Cornus officinalis, 15g of Polygonatum sibiricum, and 8g of Licorice. Soak each of the herbs in the formula in water for 30 minutes, add 5 times the water and boil for 1 hour, then add 3 times the water and boil for 1 hour, combine the decoctions and concentrate at 60℃ and -0.05MPa vacuum to form a thick paste with a density of 1.20g / ml at 50℃; dry the thick paste at 65℃ and -0.04MPa vacuum to form a dry paste, crush the dry paste and pass through a 100-mesh sieve to obtain a mixed dry paste powder, add 20g of granulation auxiliary materials and mix well, add an appropriate amount of 80% ethanol, wet granulate, and obtain granules after drying.

[0027] Example 3 Formula: Epimedium 10g, Lycium barbarum 8g, Eucommia ulmoides 8g, Cibotium barometz 6g, Rehmannia glutinosa 10g, Cornus officinalis 8g, Polygonatum 8g, Licorice root 4g. Soak each herb in water for 45 minutes, add 5 times the amount of water and boil for 1 hour, then add 5 times the amount of water and boil for 1 hour, combine the decoction and concentrate to 400ml to obtain a decoction.

[0028] Example 4 Prescription: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia glutinosa 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Ligustrum lucidum 8g, Eclipta prostrata 8g. Soak each herb in water for 30min, add 5 times the amount of water and boil for 1h, then add 3 times the amount of water and boil for 1h, combine the decoction and concentrate to 400ml to obtain a decoction.

[0029] Example 5 Prescription: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia glutinosa 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Aconite root 10g, Cinnamon bark 5g. Soak each herb in water for 60min, add 5 times the amount of water and boil for 1h, then add 3 times the amount of water and boil for 1h, combine the decoction and concentrate to 400ml to obtain a decoction.

[0030] Example 6 Prescription: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia glutinosa 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Salvia miltiorrhiza 10g, Carthamus tinctorius 6g. Soak each herb in water for 30min, add 5 times the amount of water and boil for 1h, then add 3 times the amount of water and boil for 1h, combine the decoction and concentrate to 400ml to obtain a decoction.

[0031] Example 7 Prescription: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia glutinosa 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Codonopsis pilosula 10g, Atractylodes macrocephala 8g.

[0032] Case 1 Kidney Essence Deficiency Type Osteoporosis (Partially Kidney Yin Deficiency) 1. Medical history Patient information: Female, 62 years old Chief complaint: 10 years of menopause, persistent soreness in waist and knees, accompanied by night sweats, dry mouth and tongue, and bone density T value is -2.6.

[0033] Past medical history: poor physical strength, easy fatigue, no obvious history of trauma.

[0034] Symptoms: Weakness in waist and knees, obvious night sweats, fragile bones, red tongue with little coating, and thin and rapid pulse.

[0035] 2. Dialectics and efficacy Syndrome differentiation: Kidney yin deficiency, bone malnutrition.

[0036] Therapeutic effects: Nourishes yin and kidneys, replenishes essence and strengthens bones.

[0037] 3. Treatment options Basic formula: the Chinese medicine composition of the present invention.

[0038] Dosing: Fructus Ligustri Lucidi (8g): nourishes yin and kidney, strengthens kidney essence.

[0039] Eclipta prostrata (8g): nourishes yin and cools blood, improves night sweats.

[0040] Decoction preparation: Medicinal material ratio: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia root 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Ligustrum lucidum 8g, Eclipta prostrata 8g.

[0041] Preparation method: Soak the medicinal materials in water for 30 minutes, decoct twice, 1 hour each time, combine the decoction to about 400ml, and take it in the morning and evening every day.

[0042] 4. Efficacy evaluation Effects after treatment: Weakness in waist and knees was significantly relieved, night sweats were reduced, bone density T value increased to -1.8, and SF-36 score increased by 30 points (from 45 to 75 points).

[0043] Case 2: Kidney essence deficiency type osteoporosis (partially kidney yang deficiency) 1. Medical history Patient information: Male, 65 years old Chief complaints: cold pain in waist and knees, weakness in limbs, chills and cold limbs, bone density T value is -2.8.

[0044] Past medical history: working in a cold environment for a long time and repeated lumbar sprains.

[0045] Symptoms: cold pain in waist and knees, slow movement, fear of cold, pale complexion, pale tongue with white coating, and deep and thin pulse.

[0046] 2. Dialectics and efficacy Syndrome differentiation: Kidney yang deficiency, bone marrow insufficiency, cold and dampness blocking the meridians.

[0047] Therapeutic effects: warms the kidney and assists yang, replenishes essence and strengthens bones.

[0048] 3. Treatment options Basic formula: the Chinese medicine composition of the present invention.

[0049] Dosing: Aconite (10g): warms and nourishes kidney yang, dispels cold and dampness.

[0050] Cinnamon (5g): warms the kidney and boosts yang, improving blood circulation.

[0051] Decoction preparation: Medicinal material ratio: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium bark 9g, Rehmannia root 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Aconite root 10g, Cinnamon bark 5g.

[0052] Preparation method: Boil the medicinal materials in water twice, each time for 1 hour, combine the decoction to 400ml, and take it in the morning and evening every day.

[0053] Efficacy evaluation: 4. Effect after treatment: The cold pain in waist and knees was relieved, chills disappeared, bone density T value increased to -1.9, and SF-36 score increased by 28 points (from 42 to 70 points).

[0054] Case 3: Kidney-essence deficiency type osteoporosis (with blood stasis) 1. Medical history Patient information: Male, 58 years old Chief complaint: Low back pain, aggravated by activity, accompanied by heaviness in the lower limbs, and bone density T value of -2.3.

[0055] Past medical history: manual laborer, history of lumbar strain.

[0056] Symptoms: Obvious bone pain, dark purple tongue, stasis of sublingual collaterals, and stringy and astringent pulse.

[0057] 2. Dialectics and efficacy Syndrome classification: Kidney essence deficiency, blood stasis blocking the collaterals, and malnutrition of tendons and bones.

[0058] Therapeutic effects: nourishes kidney essence, promotes blood circulation and removes blood stasis, strengthens tendons and bones.

[0059] 3. Treatment options Basic formula: the Chinese medicine composition of the present invention.

[0060] Dosing: Danshen (10g): promotes blood circulation, removes blood stasis and improves blood circulation.

[0061] Safflower (6g): promotes blood circulation and relieves bone pain.

[0062] Decoction preparation: Medicinal material ratio: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia root 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice root 6g, Salvia miltiorrhiza 10g, Safflower 6g.

[0063] Preparation method: Boil the medicinal materials in water twice, combine the decoction to 400ml, and take it in the morning and evening every day.

[0064] 4. Efficacy evaluation Effects after treatment: Bone pain was significantly relieved, tongue was ruddy, bone density T value increased to -1.7, and SF-36 score increased by 25 points (from 48 to 73 points).

[0065] Case 4: Kidney-essence deficiency type osteoporosis (with Qi and blood deficiency) 1. Medical history Patient information: Female, 72 years old Chief complaint: long-term bone pain, fatigue, shortness of breath after activity, and bone density T value of -2.7.

[0066] Past medical history: multiple histories of anemia and poor physical condition.

[0067] Symptoms: obvious bone pain, mental depression, shortness of breath and fatigue, pale tongue with thin white coating, and weak pulse.

[0068] 2. Dialectics and efficacy Syndrome classification: deficiency of kidney essence, insufficient qi and blood, and malnutrition of tendons and bones.

[0069] Therapeutic effects: Nourishes the kidney and replenishes essence, replenishes qi and blood, strengthens tendons and bones.

[0070] 3. Treatment options Basic formula: the Chinese medicine composition of the present invention.

[0071] Dosing: Codonopsis pilosula (10g): replenishes qi and blood, and improves physical strength.

[0072] Atractylodes macrocephala (8g): Strengthens the spleen and replenishes Qi, promotes nutrient absorption.

[0073] Decoction preparation: Medicinal material ratio: Epimedium 15g, Lycium barbarum 12g, Eucommia ulmoides 10g, Cibotium barometz 9g, Rehmannia glutinosa 15g, Cornus officinalis 12g, Polygonatum 10g, Licorice 6g, Codonopsis pilosula 10g, Atractylodes macrocephala 8g.

[0074] Preparation method: Boil the medicinal materials in water twice, combine the decoction to 400ml, and take it in the morning and evening every day.

[0075] 4. Effect after treatment: Bone pain was significantly relieved, physical strength was restored, bone density T value increased to -1.8, and SF-36 score increased by 35 points (from 40 to 75 points).

[0076] The clinical efficacy test of the present invention is described in detail below: 1. Clinical efficacy experiment 1. Clinical data 1.1 Case source A total of 70 patients who met the diagnostic criteria for kidney essence deficiency type bone atrophy were selected as observation subjects in the outpatient and inpatient departments of Changzhou Traditional Chinese Medicine Hospital from January 2021 to January 2023. The total number of cases was set at 70, with 35 cases in the treatment group and 35 cases in the control group.

[0077] 1.2 Western medicine diagnostic criteria According to the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2017)" and the diagnostic criteria for osteoporosis, any of the following conditions must be met: 1.2.1 Bone mineral density (BMD) determination: Dual-energy X-ray absorptiometry (DXA) results: Bone density T value ≤ -2.5.

[0078] Or for those with low-energy fractures, the T value may be between -1.0 and -2.5.

[0079] 1.2.2 Typical fractures: Fragility fractures that occur with minimal external force or without obvious trauma (such as in the hip, spine, radius, etc.).

[0080] 1.2.3 Exclude secondary osteoporosis: Laboratory tests excluded secondary causes such as hyperparathyroidism, hyperthyroidism, chronic kidney disease, and diabetes.

[0081] 1.3 TCM diagnostic criteria: According to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" (State Administration of Traditional Chinese Medicine, 1994), the diagnostic criteria for kidney-essence deficiency type bone atrophy are as follows: (1) Main symptoms: Weakness in the waist and knees, accompanied by persistent bone pain.

[0082] Short stature or kyphosis (suggesting a vertebral compression fracture).

[0083] (2) Associated symptoms: Kidney Yin Deficiency: fever in the five parts of the body, night sweats, dizziness, tinnitus, insomnia and dreaminess. Kidney Yang Deficiency: fear of cold, cold limbs, fatigue, and clear and long urination.

[0084] (3) Tongue and pulse manifestations: Kidney Yin deficiency: red tongue with little coating, thin and rapid pulse.

[0085] Kidney Yang Deficiency: pale tongue with white coating, deep and fine pulse.

[0086] (4) Bone mineral density measurement (BMD) results: T value ≤ -2.5, or accompanied by low-energy fracture.

[0087] 2. Case selection 2.1 Inclusion criteria: Age ranges from 50 to 75 years old.

[0088] It meets the Western and Chinese medical diagnostic criteria for bone atrophy due to kidney-essence deficiency.

[0089] Bone density T value ≤ -2.5, or with a history of fragility fracture.

[0090] The disease duration is ≥ 6 months and symptoms persist.

[0091] Participated in the study voluntarily and signed the informed consent.

[0092] 2.2 Case Exclusion Criteria Identified causes of secondary osteoporosis, such as: Hyperparathyroidism, thyroid dysfunction.

[0093] Diabetes, chronic kidney disease.

[0094] Drug-induced osteoporosis caused by long-term use of glucocorticoids, etc.

[0095] Suffering from serious cardiovascular, liver, kidney, brain and other important organ diseases.

[0096] Combination with other diseases or medications that affect bone metabolism.

[0097] Pregnant or lactating women who have received other osteoporosis treatment medications (such as bisphosphonates, teriparatide, etc.) within 3 months.

[0098] 2.3 Criteria for exclusion of cases Cases that were found not to meet the inclusion criteria after inclusion were excluded; Those who fail to receive treatment according to the treatment plan or fail to receive the prescribed course of treatment, and whose efficacy cannot be determined; Incomplete data affects the judgment of effectiveness and safety; Patients who develop other diseases during the trial and need to take drugs that may affect the trial; ⑤ Those who have no adverse drug reactions during medication, but have to interrupt treatment due to other unforeseen reasons (such as having to stop treatment due to the occurrence of other diseases).

[0099] 2.4 Case withdrawal (dropout) criteria Patients who dropped out naturally or were lost to follow-up during observation; The subjects develop complications or special physiological changes and are not suitable to continue the trial and withdraw from the trial on their own initiative.

[0100] 2.5 Termination criteria Those who cannot adhere to treatment; Allergic reactions or other serious adverse reactions occur during the trial.

[0101] 2. Treatment Methods 1. Random Grouping A total of 70 cases were observed in this study, and they were divided into a treatment group and a control group according to the principle of randomized controlled trials using a random number table method, with 35 cases in each group.

[0102] 2. Treatment plan Control group: took calcium carbonate D3 tablets (600 mg) orally once a day for 12 months.

[0103] Treatment group: In addition to taking calcium carbonate D3 tablets daily, 400 ml of the Chinese medicine decoction of Example 1 of the present invention was also given, taken in the morning and evening every day for 12 consecutive months.

[0104] 3. Observation items (1) Safety indicators ① General physical examination items: basic vital signs such as T, R, P, BP, etc.

[0105] ② Routine examination of blood and stool.

[0106] ③Liver and kidney function tests.

[0107] ④Electrocardiogram examination.

[0108] Possible adverse reactions of drugs and their related detection indicators.

[0109] 4. Efficacy observation indicators The patients were followed up regularly and bone density (T value), pain score (VAS), limb function score, energy score and quality of life score (SF-36) were measured every 3 months.

[0110] 5. Criteria for determining efficacy Markedly effective: pain was significantly relieved, bone density increased by ≥20%, SF-36 score increased by ≥20 points, and limb function returned to normal.

[0111] Effective: Symptoms improved, bone density increased by 10-20%, SF-36 score increased by 10-20 points, and limb function recovered.

[0112] Ineffective: Bone density change <10%, SF-36 score increased by less than 10 points, and symptoms did not improve.

[0113] 3. Test results 1. General data analysis Comparison of gender and age of the two groups of patients before treatment: Before treatment, the two groups of patients were compared in terms of gender, and the p values ​​of the chi-square test were all > 0.05, indicating that there was no statistical difference in gender between the two groups, and the two groups were comparable; before treatment, the two groups of patients were compared in terms of age, and the p values ​​of the independent sample t-test were all > 0.05, indicating that there was no statistical difference in age and disease course between the two groups, and the two groups were comparable (see Table 1 and Table 2).

[0114] Table 1 Comparison of gender between the two groups of patients Note: There was no significant difference in gender between the two groups of patients after chi-square test (P>0.05), so they were comparable.

[0115] Table 2 Comparison of age between the two groups of patients 2. Analysis of the efficacy observation indicators of the two groups of patients after treatment is shown in Table 3.

[0116] Table 3 Comparison of efficacy observation indicators between the two groups of patients before and after treatment As shown in Table 3, the treatment group had significantly better improvements in physical function, pain management, daily activities, and mental health than the control group.

[0117] 3. The efficacy of the two groups of patients after treatment is shown in Table 4.

[0118] Table 4 Comparison of therapeutic efficacy between the two groups of patients after 12 months of treatment Group Total number of cases Significantly effective (cases, %) Valid (Example) Invalid (Example) Total effective (%) Treatment Group 35 30（85%） 4 1 97% Control group 35 25（72%） 7 3 88% As shown in Table 4, the effective rate of the treatment group treated with the Chinese medicine composition of the present invention was 85%, while that of the control group was 72%, indicating that the treatment group performed better in relieving pain, improving bone density, restoring limb function and improving the quality of life of patients.

[0119] 3. Security Analysis (1) Vital sign monitoring: During the entire 12-month treatment period, the basic vital signs (body temperature T, respiratory rate R, pulse P, blood pressure BP) of the two groups of patients were measured regularly. There was no obvious abnormal fluctuation in vital signs in the treatment group and the control group before and after treatment, and there was no statistically significant difference between the two groups (P>0.05), indicating that the Chinese medicine composition and calcium carbonate D3 tablets of the present invention had no adverse effects on the basic vital signs of patients.

[0120] (2) Routine blood and stool examinations: Routine blood and stool examinations were performed every 3 months. The results showed that after taking the Chinese medicine composition decoction combined with calcium carbonate D3 tablets, the white blood cell count, red blood cell count, hemoglobin, platelet count and other indicators in the blood routine examination of the treatment group were maintained within the normal reference range, and there was no significant change before and after treatment (P>0.05). Routine stool examinations did not find abnormalities such as occult blood and parasites, nor did they show changes in indicators related to intestinal dysfunction such as diarrhea and constipation caused by drugs. During the period when the control group took calcium carbonate D3 tablets alone, the results of routine blood and stool examinations were also stable and there were no obvious abnormalities. This shows that the Chinese medicine composition of the present invention, when used in combination with calcium carbonate D3 tablets, will not have adverse effects on the patient's blood system and intestinal function.

[0121] (3) Liver and kidney function examination: Liver and kidney function examinations were performed on patients every 6 months. During the treatment, liver function indicators such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and direct bilirubin (DBIL) in the treatment group fluctuated within the normal range, and there was no statistical difference before and after treatment (P>0.05), indicating that the Chinese medicine composition did not damage the normal metabolism and function of the liver. Renal function indicators such as blood creatinine (Cr), urea nitrogen (BUN), and uric acid (UA) also remained stable, and no abnormal changes in renal function due to drug use occurred. After the control group took calcium carbonate D3 tablets, there was no obvious abnormality in liver and kidney function indicators. This further confirms the safety of the Chinese medicine composition of the present invention during long-term use and will not have a negative impact on liver and kidney function.

[0122] (4) Electrocardiogram examination: Electrocardiogram examination was performed on the patients before the start of treatment and at 6 and 12 months of treatment. The electrocardiogram results of the patients in the treatment group and the control group at each time point showed normal sinus rhythm, without abnormalities such as arrhythmia (such as premature beats, atrial fibrillation, etc.) and ST-T segment changes. There was no statistical difference between the two groups (P>0.05). This shows that neither the Chinese medicine composition of the present invention nor the calcium carbonate D3 tablets had adverse effects on the patients' cardiac electrophysiological activities during the treatment period.

[0123] (5) Adverse drug reactions: During the entire treatment process, 3 patients in the treatment group experienced mild gastrointestinal discomfort, manifested as mild abdominal distension and nausea, with an incidence of 8.6%. After analysis, it may be related to the odor and ingredients of the Chinese medicine decoction irritating the gastrointestinal tract. After adjusting the medication time (changing to taking it half an hour after a meal), the symptoms gradually eased and did not affect the continued treatment. In the control group, 2 patients experienced constipation symptoms, with an incidence of 5.7%, which was considered to be related to the use of calcium carbonate D3 tablets. After increasing dietary fiber intake and drinking more water, the symptoms improved. In addition, no other adverse reactions such as allergic reactions, severe skin and mucosal damage, and neurological symptoms occurred in both groups. Through the observation and analysis of the adverse reactions of the two groups, the Chinese medicine composition of the present invention combined with calcium carbonate D3 tablets has good safety in the treatment of bone atrophy due to kidney essence deficiency, and the adverse reactions are mild and controllable, and the patients have good tolerance.

Claims

1. A Chinese medicine composition for treating kidney-essence deficiency type bone atrophy, characterized in that The Chinese medicine composition consists of 10-20g of epimedium, 8-15g of wolfberry, 8-15g of eucommia bark, 6-12g of cibotium barometz, 10-20g of rehmannia root, 8-15g of cornus officinalis, 8-15g of polygonatum and 4-8g of liquorice by weight, and is suitable for treating bone atrophy due to deficiency of kidney essence.

2. The Chinese medicine composition for treating bone atrophy due to kidney essence deficiency according to claim 1, characterized in that The Chinese medicine composition is added with 6-10g of aconite root and 4-6g of cinnamon bark, and is suitable for treating kidney-essence deficiency and kidney-yang deficiency.

3. The Chinese medicine composition for treating kidney-essence deficiency type bone atrophy according to claim 1, characterized in that The Chinese medicine composition is added with 8-12g of Ligustrum lucidum fruit and 8-12g of Eclipta prostrata, and is suitable for kidney essence deficiency and kidney yin deficiency syndrome.

4. The Chinese medicine composition for treating bone atrophy due to kidney essence deficiency according to claim 1, characterized in that The Chinese medicine composition is added with 10-15g of Salvia miltiorrhiza and 3-6g of Carthamus tinctorius, and is suitable for treating kidney-essence deficiency and blood stasis.

5. A pharmaceutical preparation of a Chinese medicine composition for treating bone atrophy due to kidney essence deficiency according to any one of claims 1 to 4, characterized in that Medically acceptable auxiliary materials are added to the formula of the traditional Chinese medicine composition to prepare it into any one of decoction, granules and capsules.

6. The pharmaceutical preparation of the Chinese medicine composition for treating bone atrophy due to kidney essence deficiency according to claim 5, characterized in that: The preparation process of the decoction is as follows: slice each medicinal ingredient in the formula, soak each medicinal ingredient in water for 30-60 minutes at a weight ratio of medicine to water of 1:5-8, decoct for 1-3 times, each time for 30-60 minutes, combine the decoctions, and obtain the decoction.

7. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating bone atrophy due to kidney-essence deficiency.

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