A traditional Chinese medicine composition for improving the quality of life of patients in the rehabilitation period after bone fracture

Abstract

The present application relates to a kind of traditional Chinese medicine composition for improving the quality of life of patient in rehabilitation period after fracture, which can significantly improve the quality of life of patient in rehabilitation period after fracture.The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: eucommia ulmoides, cistanche, sea horse, pilose antler, cordyceps sinensis, ginseng, American ginseng, prepared rehmannia, panax notoginseng, medlar, rhubarb.The improvement of the quality of life of patient in rehabilitation period after fracture refers to promoting fracture healing, while improving immunity, enhancing physical fitness, relieving fatigue, regulating sleep, delaying aging and / or strengthening, reducing the occurrence of complications or secondary symptoms.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for improving the quality of life of patients in the post-fracture rehabilitation period and its preparation method, as well as the application of the traditional Chinese medicine composition in the preparation of drugs for improving the quality of life of patients in the post-fracture rehabilitation period, and the pharmaceutical use of the traditional Chinese medicine composition in promoting fracture healing, improving the body's immunity, strengthening the body, relieving fatigue, regulating sleep, delaying aging and strengthening the body, and reducing the occurrence of complications or secondary diseases. Background Technology

[0002] Fractures are a common surgical condition, primarily caused by external forces disrupting the continuity and integrity of bone, leading to bleeding at the fracture site and resulting in local swelling, pain, and limited mobility. Because fractures impair the bone's weight-bearing capacity, patients undergoing surgical procedures such as reduction and fixation require medication to promote fracture and wound healing, as well as anti-infection treatments. Routine care typically includes bed rest, reduced activity, and avoidance of stress.

[0003] From the perspective of traditional Chinese medicine, during or after the recovery period of a fracture, prolonged bed rest often leads to symptoms of weakness such as qi and blood deficiency and liver and kidney deficiency. Furthermore, due to the blood stasis caused by the fracture, symptoms such as pain, spleen and stomach weakness, poor appetite, insomnia, and premature aging may also occur. Overall, the quality of life of patients in the recovery period after a fracture is reduced.

[0004] In recent years, Western medicine has also increasingly recognized the declining quality of life among patients recovering from fractures, in line with traditional Chinese medicine. For example, research by Li Hedan et al. found that decreased bone density, mineral loss, and reduced muscle protective capacity in the elderly make them more prone to fractures. Hip fractures are a serious health concern for the elderly. Studies have shown that hip fracture patients experience a significant reduction in quality of life, primarily leading to malnutrition, functional impairment, and even disability, as well as shortened lifespan. Many elderly individuals exhibit negative emotions such as anxiety, depression, frustration, and despair (see "A Study on the Impact of Hip Fractures on the Quality of Life of Elderly Patients," Li Hedan et al., Department of Orthopedics, Southern Medical University Southern Hospital, Journal of Practical Orthopedics, Vol. 24, No. 9). Patients in the recovery period after fractures typically experience weakened immunity, insomnia, fatigue, weakness, accelerated aging, and psychological problems.

[0005] However, there are currently no effective medications to treat the reduced quality of life during the recovery period after fractures. For example, although it is noted that hip fractures can lead to very serious consequences and a low quality of life during the recovery period in elderly patients, the general advice is usually only to actively seek surgical treatment and encourage patients to start functional exercises as early as possible to reduce complications, without considering the use of medication. While traditional Chinese medicine emphasizes the use of medications that strengthen tendons and bones and nourish the liver and kidneys for patients in the later stages of fracture recovery, the purpose of these medications is only to accelerate the recovery of the fracture itself, without paying attention to using appropriate medications to improve the patient's quality of life.

[0006] The existing technology, "Effect of Postoperative Fracture Treatment Combined with Three-Stage Syndrome Differentiation Therapy of Traditional Chinese Medicine" (Chen Li, Clinical Medical Research and Practice, 2018, Vol. 3, No. 26), discloses that the focus in the later stage of fracture is to promote rehabilitation, and that a muscle-strengthening and blood-nourishing decoction is given. The formula consists of 12g each of Dipsacus asper and Rehmannia glutinosa, 6g each of Eucommia ulmoides, Paeonia lactiflora, and Ligusticum chuanxiong, and 9g each of Achyranthes bidentata, Paeonia suffruticosa, and Carthamus tinctorius. However, the purpose of the above prescription is still mainly to restore bone injury, and does not pay attention to the patient's quality of life.

[0007] The existing technology, "Traditional Chinese Medicine Treatment in the Perioperative Period of Fractures" (Yang Wei, World's Latest Medical Information Digest, 2019, Vol. 19, No. 12), discloses that Traditional Chinese Medicine (TCM) treatment of bone injuries has a broader scope than Western orthopedic medicine. In addition to the Western medical emphasis on treating the fracture itself and post-fracture muscle and soft tissue rehabilitation, it also pays attention to the healing of the body's Qi, blood, internal organs, and meridians. The perioperative period of fractures is extremely important for patients; mistreatment or delayed treatment can easily lead to various complications such as fat embolism syndrome, disseminated intravascular coagulation, delayed fracture healing, or even nonunion, and is increasingly valued by doctors and patients in clinical practice. However, as can be seen from the above, it still focuses on fracture-related healing issues and does not consider the patient's weakened immune system, insomnia, and other quality-of-life problems.

[0008] The prior art CN106138698A (20161123) discloses a medicine for internal and external use in orthopedic fracture treatment, which is prepared from the following raw materials in parts by weight: 8-15 parts pregnant mare urine, 10-20 parts astragalus, 10-20 parts ophiopogon japonicus, 10-20 parts prepared rehmannia root, 10-20 parts ginseng, 10-20 parts poria cocos, 5-8 parts licorice, 5-8 parts white peony root, 5-8 parts polygala tenuifolia, 5-8 parts red peony root, 5-8 parts cinnamon bark, 10-20 parts matsutake mushroom, 10-20 parts truffle, 10-18 parts honeysuckle, 10-18 parts forsythia, and 10-18 parts angelica sinensis. The prepared medicine, applicable both internally and externally, is used in orthopedic fracture treatment. Composed of pregnant mare urine and other traditional Chinese medicine ingredients, it can relieve pain in patients with fractures and cracks in a short time, promoting faster bone healing, especially for osteoporotic compression fractures in the elderly. This significantly shortens the treatment time, reducing patient suffering. It also has a rapid conditioning effect on fracture rehabilitation, improves the immune system of the elderly, and serves as a health maintenance medicine. However, its use of raw materials such as pregnant mare urine, matsutake mushrooms, and truffles makes it difficult to align with traditional Chinese medicine theory, hindering industrial production and presenting significant challenges in market commercialization.

[0009] It is evident that there is a lack of effective traditional Chinese medicine compositions in the existing technology for improving the quality of life of patients in the post-fracture rehabilitation period. Through years of exploration in clinical practice, the inventors of this application have focused on the problems faced by the aforementioned patients and found a suitable solution, providing an effective product for improving the quality of life of patients in the post-fracture rehabilitation period. Summary of the Invention

[0010] The purpose of this invention is to provide a traditional Chinese medicine composition for improving the quality of life of patients in the post-fracture rehabilitation period, which can significantly improve the quality of life of these patients. In particular, it can significantly improve the quality of life of elderly patients with hip fractures in the post-fracture rehabilitation period and reduce related complications or secondary diseases.

[0011] Specifically, improving the quality of life for patients in the post-fracture rehabilitation period means reducing complications or secondary illnesses. More specifically, the traditional Chinese medicine composition reduces complications or secondary illnesses while being beneficial to fracture rehabilitation; "beneficial" means promoting or at least not producing adverse effects.

[0012] Furthermore, the complications or secondary illnesses of patients in the recovery period include, but are not limited to, weakened immunity, insomnia, fatigue, weakness, accelerated aging, and psychological problems. Furthermore, the improvement in quality of life includes, but is not limited to, enhancing immunity, strengthening the body, relieving fatigue, regulating sleep, delaying aging, and improving overall health.

[0013] Furthermore, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition.

[0014] Furthermore, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for improving the quality of life of patients in the post-fracture rehabilitation period. Further, the invention also provides the use of the traditional Chinese medicine composition in the preparation of a medicament for improving immunity, strengthening the body, relieving fatigue, regulating sleep, delaying aging, and / or strengthening the body.

[0015] To achieve the above objectives, the first aspect of the present invention provides a traditional Chinese medicine composition for improving the quality of life of patients in the post-fracture rehabilitation period, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: Eucommia ulmoides, Cistanche deserticola, seahorse, deer antler, Cordyceps sinensis, ginseng, American ginseng, Rehmannia glutinosa, Panax notoginseng, Lycium barbarum, and rhubarb.

[0016] Furthermore, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the indicated weight ratios: 15-25 parts of Eucommia ulmoides, 7-13 parts of Cistanche deserticola, 3-7 parts of Hippocampus, 3-7 parts of Deer Antler, 1-5 parts of Cordyceps sinensis, 15-25 parts of Ginseng, 3-7 parts of American Ginseng, 9-15 parts of Rehmannia glutinosa, 3-7 parts of Panax notoginseng, 10-20 parts of Lycium barbarum, and 2-6 parts of Rheum palmatum.

[0017] Furthermore, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the indicated weight ratios: 16-24 parts Eucommia ulmoides, 8-12 parts Cistanche deserticola, 4-7 parts Hippocampus, 4-7 parts Deer antler, 2-5 parts Cordyceps sinensis, 16-24 parts Ginseng, 4-7 parts American ginseng, 10-14 parts Rehmannia glutinosa, 4-7 parts Panax notoginseng, 11-19 parts Lycium barbarum, and 3-6 parts Rheum palmatum.

[0018] Furthermore, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the indicated weight ratios: 18-22 parts of Eucommia ulmoides, 9-11 parts of Cistanche deserticola, 4-6 parts of Hippocampus, 4-6 parts of Deer Antler, 2-4 parts of Cordyceps sinensis, 18-22 parts of Ginseng, 4-6 parts of American Ginseng, 11-13 parts of Rehmannia glutinosa, 4-6 parts of Panax notoginseng, 13-17 parts of Lycium barbarum, and 3-5 parts of Rheum palmatum.

[0019] Furthermore, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the indicated weight ratios: 20 parts Eucommia ulmoides, 10 parts Cistanche deserticola, 5 parts seahorse, 5 parts deer antler, 3 parts Cordyceps sinensis, 20 parts ginseng, 5 parts American ginseng, 12 parts Rehmannia glutinosa, 5 parts Panax notoginseng, 15 parts Lycium barbarum, and 4 parts processed rhubarb.

[0020] The Chinese herbal raw materials described in this invention have a significant effect on improving the quality of life of patients in the post-fracture rehabilitation period, and the reason is as follows:

[0021] Eucommia ulmoides: Sweet and warm in nature, it enters the liver and kidney meridians, tonifies the liver and kidneys, strengthens tendons and bones, and relieves pain. It is used for lower back and knee pain and weakness in the lower limbs due to kidney deficiency and weak tendons and bones.

[0022] Pharmacological effects: Contains Eucommia gum, Eucommiplatin, Eucommiol, phenols, organic acids, flavonoids, various free amino acids, various trace elements, trace alkaloids, and a certain amount of vitamin C. It can enhance the body's immune function, has a biphasic regulatory effect on cellular immunity, relaxes vascular smooth muscle, and lowers blood pressure.

[0023] Prepared rhubarb: Used in small, light doses to have a gentle laxative effect. It is combined with herbs that tonify qi, nourish blood, replenish yin, and generate fluids to support the body's resistance and eliminate pathogens.

[0024] Pharmacological effects: It has effects on the cardiovascular system such as lowering blood pressure, improving microcirculation, reducing blood lipids and serum total cholesterol; and on the urinary system such as promoting diuresis, promoting the excretion of urea and creatinine, and improving renal function.

[0025] Seahorse: Tonifies the kidneys and strengthens yang, replenishes kidney essence, when combined with deer antler, cistanche, etc.

[0026] Pharmacological effects: This product contains protein, fat, carbohydrates, various vitamins and trace elements. Seahorse extract exhibits androgen-like effects and has anti-aging properties.

[0027] Panax notoginseng: In addition to stopping bleeding, removing blood stasis and relieving pain, it also has a good tonic and strengthening effect, accelerates the elimination of exercise-induced fatigue, enhances physical fitness, antagonizes memory impairment caused by camphor and willow alkaloids and improves memory consolidation impairment caused by sodium nitrite, and increases brainpower and memory.

[0028] Ginseng: Greatly replenishes vital energy, invigorates the spleen, lungs, heart, and kidneys, promotes the production of body fluids, calms the mind, and improves intelligence. It is an essential medicine for tonifying the lungs. By tonifying lung qi, it can improve symptoms of lung qi deficiency such as shortness of breath, wheezing, and weak voice. For those with deficiency of both lung and kidney, and kidney failure to receive qi, this herb can also tonify kidney qi.

[0029] This product is also an important medicine for tonifying the spleen. By tonifying the spleen, it can improve symptoms of spleen deficiency such as fatigue, weakness, poor appetite, and loose stools.

[0030] This product can also replenish heart qi, improve symptoms of heart qi deficiency such as palpitations, chest tightness, shortness of breath, and weak pulse, and can also calm the mind and improve intelligence, treating insomnia, excessive dreaming, and forgetfulness. It is effective when used alone. Its kidney-tonifying effect can be used not only for shortness of breath and wheezing due to kidney failure to receive qi, but also for impotence caused by kidney qi deficiency. It is effective when used alone. If there is also kidney yang deficiency and kidney essence depletion, it should be combined with kidney-yang-tonifying and kidney-essence-benefiting products such as deer antler.

[0031] Pharmacological effects: This product contains various ginsenosides, volatile oils, amino acids, trace elements, organic acids, sugars, vitamins, and other components. It can significantly increase cardiac amplitude and heart rate, with a more pronounced cardiotonic effect in cases of heart failure; it can stimulate the pituitary-adrenal cortex system, enhancing stress response; it enhances both the excitation and inhibition processes of higher nervous activity; it can improve the flexibility of nervous activity processes and improve mental work function; it has anti-fatigue effects, promotes the synthesis of proteins, RNA, and DNA, promotes hematopoietic system function, and regulates cholesterol metabolism; it can enhance the body's immune function; it can enhance gonadal function, exhibiting gonadotropin-like effects; and it can lower blood sugar. The pharmacological activity of ginseng often exhibits a bidirectional effect depending on the body's functional state.

[0032] American ginseng: Nourishes vital energy, replenishes the qi and yin of the heart, spleen, lungs, and kidneys, clears heat and generates fluids. Used for deficiency of both lung, heart, kidney, and spleen qi and yin. This herb replenishes lung qi, nourishes lung yin, and clears lung heat. It is suitable for shortness of breath, wheezing, cough with little sputum, or blood-streaked sputum caused by heat depleting the qi and yin of the lungs.

[0033] It can also replenish heart qi and nourish heart yin, and is suitable for palpitations, heart pain, insomnia and dreaminess caused by deficiency of both qi and yin. It can also replenish kidney qi and nourish kidney yin, and is suitable for soreness and weakness of the waist and knees, seminal emission and spermatorrhea caused by deficiency of both kidney qi and kidney yin. For those with deficiency of both kidney yin and yang, it can be used together with deer antler, which replenishes kidney yang.

[0034] It can also replenish spleen qi and nourish spleen yin, making it suitable for those with poor appetite and food stagnation due to deficiency of both spleen qi and yin. This product contains various ginsenosides, volatile components, resins, starch, sugars, amino acids, and inorganic salts. American ginseng has a calming effect on the brain and a moderate excitatory effect on the vital centers; it also has anti-hypoxia, anti-myocardial ischemia, anti-myocardial oxidation, increased myocardial contractility, anti-arrhythmia, anti-fatigue, anti-stress, and anticonvulsant effects. In addition, total saponins of American ginseng can lower blood sugar and affect lipid and protein metabolism, but these effects are weaker than those of ginseng.

[0035] Deer antler: Tonifies kidney yang, replenishes essence, nourishes blood, and strengthens tendons and bones. This product strongly tonifies primordial yang, addressing several symptoms caused by kidney yang deficiency, including weak tendons and bones. It also strengthens tendons and bones, and for those with essence and blood deficiency, it replenishes essence and blood, addressing both the root cause and the symptoms. This product contains various amino acids, estrogen, androgens, prostaglandins, and various trace elements. Deer antler extract is an alcoholic extract of deer antler. Deer antler has a tonic effect, improving the body's working capacity, reducing fatigue, improving sleep, promoting appetite, and improving the pathological changes of low energy metabolism in a yang deficiency state; it enhances the body's adaptability to hot and cold stimuli; it enhances the body's immune function; it has sex hormone-like effects; it enhances gastrointestinal motility and secretion; it increases renal diuretic function and has anti-aging effects; it enhances the regeneration process, promoting wound and fracture healing; it enhances the regeneration of red blood cells, hemoglobin, and reticulocytes, increases white blood cell count, and improves tolerance to hypoxia.

[0036] Cordyceps sinensis: tonifies kidney yang and replenishes kidney essence. It is used for impotence, premature ejaculation, and thin semen caused by kidney deficiency. This herb can tonify both kidney yang and kidney essence. It has a certain effect in strengthening yang, relieving impotence, and replenishing essence for impotence, premature ejaculation, and thin semen caused by insufficient kidney yang and deficiency of kidney essence. It can be used alone by soaking in wine and taken together with other kidney-tonifying, essence-replenishing, and yang-strengthening herbs such as deer antler.

[0037] In addition, it has the effect of replenishing deficiencies and strengthening the body, and promoting the recovery of bodily functions.

[0038] This product contains protein, various amino acids, sugars, alcohols, nucleosides, vitamins, organic acids, and trace elements. In addition, it contains cholesterol palmitic acid, ergosterol peroxide, ergosterol, alkaloids, eicosane, and β-sitosterol. Cordyceps sinensis has anti-asthmatic effects and certain antitussive and expectorant effects; it has antibacterial, antiviral, anti-inflammatory, sedative, and anticonvulsant effects; it has certain androgen-like and anti-estrogen-like effects, and can help restore sexual function; it can enhance the synthesis and secretion of adrenal cortex hormones; it can significantly improve renal function in patients with renal failure and enhance cellular immune function; it can slow heart rate, lower blood pressure, resist experimental arrhythmias, resist myocardial ischemia and thrombosis, and lower cholesterol and triglycerides; it also has occasional anaphylactic, anti-aging, and anti-cancer effects.

[0039] Cistanche deserticola: tonifies kidney yang, benefits kidney essence, moistens the intestines and promotes bowel movements. It regulates endocrine function, promotes metabolism and strengthens the body, has certain anti-aging effects, and enhances immunity.

[0040] Goji berries: Nourish liver and kidney yin, benefit essence, replenish blood, and improve eyesight.

[0041] This product is used for liver and kidney yin deficiency syndrome. It can nourish the yin of the liver and kidneys and is suitable for treating liver and kidney yin deficiency syndrome. Ancient prescriptions often use this product to nourish the liver and kidneys, treating symptoms such as decreased vision, blurred vision due to internal cataracts, dizziness, weakness of the lower back and knees, seminal emission, hypochondriac pain, deafness, loose teeth, insomnia, night sweats, and thirst caused by liver and kidney yin deficiency. If there is also deficiency of essence and blood, this product can also benefit essence and replenish blood. Because it can also improve eyesight, it is used for symptoms such as premature graying of hair, decreased vision, weakness of the lower back and knees, and seminal emission caused by deficiency of essence and blood.

[0042] This formula replenishes essence and blood, and is suitable for various symptoms of premature aging caused by deficiency of essence and blood. It can be used alone or in combination with herbs that tonify the liver and kidneys, and replenish essence and blood.

[0043] This product contains betaine, polysaccharides, crude fat, crude protein, thiamine, riboflavin, niacin, carotene, ascorbic acid, nicotinic acid, β-sitosterol, linoleic acid, trace elements, and amino acids. Goji berries promote various immune responses and have immunomodulatory effects; they can increase blood testosterone levels to a certain extent, thus having a tonic effect; they promote hematopoietic function; they also significantly increase white blood cell count in normal healthy individuals; they can reverse some objective indicators of bodily function towards a more youthful state, thus having an anti-aging effect; they also have anti-mutagenic, anti-tumor, lipid-lowering, liver-protective, and anti-fatty liver effects.

[0044] Blood sugar and blood pressure.

[0045] Rehmannia glutinosa (processed): Nourishes blood and yin, replenishes essence and marrow. Used for various symptoms caused by deficiency of essence and blood or insufficient yin fluid (such as soreness and weakness of the lower back and knees, dizziness and blurred vision, premature graying of hair, tinnitus, etc.).

[0046] After years of clinical research, the inventors screened numerous combinations and weight ratios of raw materials, and based on traditional Chinese medicine theory, developed a rationally formulated and effective traditional Chinese medicine composition for treating quality-of-life issues in patients recovering from fractures. The aforementioned raw materials, through a reasonable combination of principal, assistant, and adjuvant herbs, exert their effects of nourishing the liver and kidneys, strengthening tendons and bones, and replenishing qi and blood. A detailed analysis of the formulation is as follows:

[0047] This syndrome is due to deficiency of liver and kidney, resulting in insufficient liver blood, inadequate nourishment of tendons and vessels, insufficient kidney essence, weakness of tendons and bones, fatigue, lethargy of limbs, and insufficient fire to warm the earth due to deficiency of essence and blood, leading to poor appetite. In patients in the later stage of fracture, the tendons and bones are not yet fully healed, resulting in soreness, weakness, and difficulty in joint movement. The liver governs the tendons and stores blood, while the kidneys govern the bones and produce marrow. The liver and kidneys share a common origin and are connected to the tendons and bones. The liver stores blood, supplying the tendons, bones, and joints with the necessary fluids and blood for movement. When kidney essence is abundant, bone marrow is plentiful, providing nourishment to the bones and making them strong. When the kidneys are robust, the bones are full of vitality. Therefore, the treatment should focus on tonifying the liver and kidneys, strengthening tendons and bones, replenishing qi, nourishing blood, and nourishing yin. In this formula, Cistanche deserticola, Eucommia ulmoides, and Hippocampus tonify the liver and kidneys, strengthen tendons and bones, and replenish essence and blood, serving as the principal herbs. Deer antler and Cordyceps sinensis warm the kidney yang and replenish kidney essence. Ginseng, American ginseng, Rehmannia glutinosa, Lycium barbarum, and Panax notoginseng replenish qi, nourish blood, nourish yin, generate fluids, strengthen the spleen and stomach, and achieve the goal of consolidating qi and blood and nourishing the mind, serving as the assistant herbs. Zhang Zhongjing said, "Those who are good at tonifying yang must seek yang within yin, so that yang can be assisted by yin and generate endless transformations." Prepared rhubarb, used in small, light doses, has a slow-acting effect when combined with a large amount of qi-tonifying, blood-nourishing, yin-nourishing, and fluid-generating herbs to support the body's resistance and eliminate pathogens. Once the pathogens are eliminated, the tonifying herbs become effective, and the tonification is not stagnant, serving as the adjuvant herbs. When used together, these herbs tonify the liver and kidneys, replenish essence and marrow, consolidate the original yin and true yang, harmonize yin and yang, and nourish and warm the five internal organs, six bowels, four limbs, bones, muscles, skin, and hair. Together, they have the effects of warming and tonifying the liver and kidneys, strengthening tendons and bones, and replenishing qi and blood.

[0048] The herbal composition of this invention exhibits a sophisticated compatibility, derived from the inventor's creative conception and extensive clinical practice. Clinical practice revealed that Cistanche deserticola, Eucommia ulmoides, and Hippocampus are indispensable principal herbs. The absence of Eucommia ulmoides significantly impacts the recovery speed of fracture patients, hindering healing. Furthermore, the inventor unexpectedly discovered that the addition of Eucommia ulmoides significantly enhances the composition's effects on fatigue, weakness, and weakened immunity, thereby significantly improving the quality of life for fracture patients. The absence of Cistanche deserticola significantly reduces its effects on weakened immunity, sleep disturbances, and fatigue. The absence of Hippocampus negatively impacts weakened immunity and aging. Simultaneously, although Rheum palmatum is an adjuvant herb in the above prescription, it has an unexpected effect on the overall effect. The addition of Rheum palmatum enhances the effects on alleviating weakened immunity, insomnia, fatigue, weakness, accelerated aging, and psychological complications, particularly showing significant improvement in weakened immunity and psychological problems.

[0049] The "strengthening tendons and bones" effect of the traditional Chinese medicine composition described in this invention is beneficial for fracture rehabilitation. It can promote fracture healing, enhance muscle strength, and enable fracture patients to recover quickly. Simultaneously, its effects of "warming and tonifying the liver and kidneys, replenishing qi and blood" are beneficial for improving quality of life, helping to alleviate complications such as low immunity, insomnia, fatigue, weakness, accelerated aging, and psychological issues. Moreover, since fractures are a contributing factor to these complications, the "strengthening tendons and bones" effect also plays a role in improving these complications to a certain extent.

[0050] The traditional Chinese medicine composition is taken orally, for example, prepared as a wine, decoction, powder, granule, oral liquid, tablet, pill, or other dosage form suitable for patients in the fracture recovery period. Of course, those skilled in the art can also develop other superior dosage forms based on this.

[0051] Preferably, it was unexpectedly discovered that when the traditional Chinese medicine composition is prepared as a medicinal wine, its therapeutic effect is more efficient. Clinical trials have shown that compared with dosage forms such as powders, granules, decoctions, and pills, medicinal wine is more convenient to use, has a faster onset of efficacy, and is more acceptable to patients.

[0052] In another aspect of the present invention, the present invention also provides a method for preparing a traditional Chinese medicine composition for improving the quality of life of patients in the rehabilitation period after fracture, characterized in that: the raw materials are weighed by weight, crushed and mixed, 5-100 times the weight of the raw materials are added to white wine, soaked for 1-100 days, and filtered to obtain the final product.

[0053] Furthermore, the preparation method is characterized by: weighing the raw material by weight, pulverizing it into 10-80 mesh particles, mixing it evenly, adding 10-50 times the weight of the raw material in white wine, soaking it for 10-30 days, filtering it, and then obtaining the product.

[0054] Furthermore, the preparation method is characterized by: weighing the raw material by weight, pulverizing it into 20-40 mesh particles, mixing it evenly, adding 10-30 times the weight of the raw material in white wine, soaking it for 20-30 days, filtering it, and then obtaining the product.

[0055] Preferably, the preparation method is characterized by: weighing the raw material by weight, crushing it into 20-mesh particles, mixing it evenly, adding 20 times the weight of the raw material in white wine, soaking for 30 days, and filtering to obtain the final product.

[0056] Through extensive experimentation, the inventors discovered that pulverizing the raw medicinal material to 20 mesh requires less sophisticated pulverizing equipment, results in high pulverization efficiency, and saves preparation time and energy. Furthermore, 20-mesh raw material offers both good soaking and extraction effects, ensuring therapeutic efficacy, and prevents excessive impurities from dissolving in the medicinal wine due to overly small particles, as well as making the medicinal wine difficult to filter due to excessively fine particles. Simultaneously, the experimental research also found that 20 times the amount of liquor and 30 days of soaking are the optimal amounts of liquor and soaking time, resulting in high extraction efficiency.

[0057] The liquor can be liquor with an alcohol content of 15%-90%, preferably 30%-60%, and most preferably 40%-56%.

[0058] Furthermore, the medicinal wine may contain excipients commonly used in traditional Chinese medicine preparations, such as flavoring agents, preservatives, and suspending agents. Flavoring agents include, but are not limited to, sucrose, aspartame, and xylitol. Preservatives include, but are not limited to, sodium benzoate and ethylparaben. Suspending agents include, but are not limited to, glycerin and polyethylene glycol.

[0059] In another aspect of the present invention, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for improving the quality of life of patients in the post-fracture rehabilitation period.

[0060] Furthermore, improving the quality of life for patients in the post-fracture rehabilitation period is to promote fracture healing.

[0061] Furthermore, improving the quality of life for patients in the post-fracture recovery period involves enhancing their immunity, strengthening their constitution, relieving fatigue, regulating sleep, delaying aging, and / or strengthening their bodies.

[0062] Furthermore, improving the quality of life for patients in the post-fracture rehabilitation period involves promoting fracture healing while simultaneously enhancing the body's immunity, strengthening the body, relieving fatigue, regulating sleep, delaying aging, and / or strengthening the body.

[0063] The beneficial effects of this invention are:

[0064] 1. This invention unexpectedly addresses the following technical problem for the first time: by using a traditional Chinese medicine composition, in the recovery period of fracture patients, it is necessary to not only focus on the treatment of the fracture itself, but also on other symptoms affecting the quality of life of fracture patients, such as low immunity, insomnia, fatigue, weakness, accelerated aging, and psychological complications or secondary problems. Furthermore, it creatively develops a traditional Chinese medicine composition that can promote fracture healing while simultaneously improving the body's immunity, strengthening the body, relieving fatigue, regulating sleep, delaying aging, and / or strengthening the body.

[0065] 2. By combining traditional Chinese medicine theory with clinical practice, the formula was optimized by selecting Cistanche deserticola, Eucommia ulmoides, and seahorse as the principal herbs, deer antler and Cordyceps sinensis as the assistant herbs, and rhubarb as the adjuvant herb. This allows the traditional Chinese medicine composition of the present invention to exert the most effective therapeutic effect, namely, to improve the quality of life of patients in the recovery period after fracture, especially to promote fracture healing, improve the body's immunity, enhance physical fitness, relieve fatigue, regulate sleep, delay aging and / or strengthen the body.

[0066] 3. By combining traditional Chinese medicine theory with clinical practice to optimize the prescription, the optimal weight ratio of the prescription was unexpectedly discovered. Under this weight ratio, the prescription as a whole can achieve the best effect. Detailed Implementation

[0067] Example 1:

[0068] A traditional Chinese medicine composition for improving the quality of life of patients in the post-fracture rehabilitation period, characterized in that the composition is prepared from the following raw materials in the indicated weight ratios: 20 parts Eucommia ulmoides, 10 parts Cistanche deserticola, 5 parts Hippocampus, 5 parts Deer antler, 3 parts Cordyceps sinensis, 20 parts Ginseng, 5 parts American ginseng, 12 parts Rehmannia glutinosa, 5 parts Panax notoginseng, 15 parts Lycium barbarum, and 4 parts Rheum palmatum (processed).

[0069] Weigh the raw materials according to their weight, crush them into 20-mesh particles, mix them evenly, add 20 times the weight of the raw materials in 40% white wine, soak for 30 days, filter, and the product is ready.

[0070] Example 2

[0071] A traditional Chinese medicine composition for improving the quality of life of patients in the recovery period after fracture, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the following weight ratio: 25 parts of Eucommia ulmoides, 13 parts of Cistanche deserticola, 7 parts of seahorse, 7 parts of deer antler, 5 parts of Cordyceps sinensis, 25 parts of ginseng, 7 parts of American ginseng, 15 parts of Rehmannia glutinosa, 7 parts of Panax notoginseng, 20 parts of Lycium barbarum, and 2 parts of processed rhubarb.

[0072] Weigh the raw materials according to their weight, crush them into 10-mesh particles, mix them evenly, add 30% white wine at 50 times the weight of the raw materials, soak for 100 days, filter, and the product is obtained.

[0073] Example 3

[0074] A traditional Chinese medicine composition for improving the quality of life of patients in the recovery period after fracture, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the following weight ratio: 15 parts of Eucommia ulmoides, 7 parts of Cistanche deserticola, 3 parts of seahorse, 3 parts of deer antler, 1 part of Cordyceps sinensis, 15 parts of ginseng, 3 parts of American ginseng, 9 parts of Rehmannia glutinosa, 3 parts of Panax notoginseng, 10 parts of Lycium barbarum, and 6 parts of processed rhubarb.

[0075] Weigh the raw materials according to their weight, crush them into 80-mesh particles, mix them evenly, add 50% white wine (10 times the weight of the raw materials), soak for 10 days, filter, and the product is ready.

[0076] Example 4

[0077] A traditional Chinese medicine composition for improving the quality of life of patients in the recovery period after fracture, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the following weight ratio: 24 parts of Eucommia ulmoides, 12 parts of Cistanche deserticola, 7 parts of seahorse, 7 parts of deer antler, 5 parts of Cordyceps sinensis, 24 parts of ginseng, 4 parts of American ginseng, 10 parts of Rehmannia glutinosa, 4 parts of Panax notoginseng, 11 parts of Lycium barbarum, and 3 parts of processed rhubarb.

[0078] Weigh the raw materials according to their weight, crush them into 5-mesh particles, mix them evenly, add 70% white wine at 100 times the weight of the raw materials, soak for 20 days, filter, and the product is ready.

[0079] Example 5

[0080] A traditional Chinese medicine composition for improving the quality of life of patients in the recovery period after fracture, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the following weight ratio: 16 parts of Eucommia ulmoides, 8 parts of Cistanche deserticola, 4 parts of seahorse, 4 parts of deer antler, 2 parts of Cordyceps sinensis, 16 parts of ginseng, 7 parts of American ginseng, 14 parts of Rehmannia glutinosa, 7 parts of Panax notoginseng, 19 parts of Lycium barbarum, and 6 parts of processed rhubarb.

[0081] Weigh the raw materials according to their weight, crush them into 100-mesh particles, mix them evenly, add 60% white wine (5 times the weight of the raw materials), soak for 1 day, filter, and the product is ready.

[0082] Example 6

[0083] A traditional Chinese medicine composition for improving the quality of life of patients in the recovery period after fracture, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the following weight ratio: 22 parts of Eucommia ulmoides, 11 parts of Cistanche deserticola, 6 parts of seahorse, 6 parts of deer antler, 4 parts of Cordyceps sinensis, 22 parts of ginseng, 6 parts of American ginseng, 13 parts of Rehmannia glutinosa, 4 parts of Panax notoginseng, 13 parts of Lycium barbarum, and 3 parts of processed rhubarb.

[0084] Weigh the raw materials according to their weight, crush them into 40-mesh particles, mix them evenly, add 30 times the weight of the raw materials in 15% white wine, soak for 50 days, filter, and the product is ready.

[0085] Example 7

[0086] A traditional Chinese medicine composition for improving the quality of life of patients in the post-fracture rehabilitation period, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in the following weight ratio: 18 parts of Eucommia ulmoides, 9 parts of Cistanche deserticola, 4 parts of seahorse, 4 parts of deer antler, 2 parts of Cordyceps sinensis, 18 parts of ginseng, 4 parts of American ginseng, 11 parts of Rehmannia glutinosa, 6 parts of Panax notoginseng, 17 parts of Lycium barbarum, and 5 parts of processed rhubarb.

[0087] Weigh the raw materials according to their weight, crush them into 60-mesh particles, mix them evenly, add 40 times the weight of the raw materials in 90% white wine, soak for 70 days, filter, and the product is ready.

[0088] Preliminary clinical studies:

[0089] To preliminarily verify the efficacy of the traditional Chinese medicine composition of this application, a preliminary clinical study was conducted on 30 elderly patients (aged 60-72 years) with hip fractures, with the consent of the patients, in order to evaluate the efficacy of the traditional Chinese medicine composition of this invention.

[0090] Patients were randomly divided into two groups: a drug group and a control group, with 15 patients in each group. The age and condition of the patients in the two groups were basically the same.

[0091] In the case of standard surgical treatment and fracture treatment drugs, the drug group took the medicinal wine of the present invention (i.e., the medicinal wine of Example 1) twice a day, 20 mL each time, for 3 consecutive months. The control group took the placebo medicinal wine twice a day, 20 mL each time, for 3 consecutive months.

[0092] The study involved clinical examination of patients' fracture recovery, taking medical history, and completing questionnaires. To ensure patient compliance, invasive clinical testing methods, such as blood draws, were not used in the initial clinical trial.

[0093] 1. Average time for fracture healing

[0094] The criteria for complete fracture healing are: X-ray examination shows the disappearance of the fracture wound at the hip fracture site, and the hip bone has returned to normal. The time from the day of fracture to complete healing is recorded. Results show:

[0095] Average time to heal a fracture 76 days 88 days

[0096] It is evident that the drug group showed superior fracture healing compared to the control group, with an average healing time of 76 days in the drug group and 88 days in the control group. The fracture healing criteria were defined as the disappearance of the fracture wound at the hip fracture site and the restoration of the hip bone to normal.

[0097] 2. Improvement in sleep

[0098] Statistical analysis was conducted using a scoring system, with 0 points indicating no insomnia; 1 point indicating occasional insomnia (less than 2 hours per day); 2 points indicating frequent insomnia (2-4 hours per night); and 3 points indicating complete sleeplessness. Sleep patterns in the drug group and control group were statistically analyzed at 30, 60, and 90 days, with the following results:

[0099] 30 days 1.67 1.93 60 days 1.53 2.53 90 days 0.73 2.73

[0100] It is evident that the drug group significantly improved sleep, showing a marked improvement over the control group. In particular, after 3 months of treatment, the patients' insomnia symptoms were greatly improved, while the insomnia symptoms in the control group progressively worsened.

[0101] 3. Improvement in fatigue

[0102] A scoring system was used for statistical analysis, with 0 points indicating no fatigue; 1 point indicating fatigue lasting less than 4 hours per day; 2 points indicating fatigue lasting an average of 4-8 hours per day (inclusive); 3 points indicating fatigue lasting an average of 8-16 hours per day (inclusive); and 4 points indicating fatigue lasting an average of 16-24 hours per day (inclusive). The fatigue levels in the drug group and the control group were statistically analyzed at 30, 60, and 90 days. The results are as follows:

[0103] 30 days 1.47 2.80 60 days 1.13 3.47 90 days 0.53 3.80

[0104] It is evident that the drug group significantly improved patients' fatigue, showing a marked improvement over the control group. In particular, after 3 months of treatment, patients' fatigue symptoms were greatly improved, while the fatigue symptoms in the control group progressively worsened.

[0105] Pharmacodynamic experiments

[0106] To comprehensively understand the effects of the compositions of this invention and to provide a pharmacological basis for larger-scale clinical studies, the pharmacodynamics of the traditional Chinese medicine compositions were also conducted on animals. Simultaneously, during the pharmacodynamic studies, the optimal composition and weight ratio of the raw materials in the clinical trials of this invention were also verified, proving that the raw material composition and weight ratio obtained from clinical observations are indeed the preferred technical solutions.

[0107] Experimental Example 1: Effects on the phagocytic function of mouse peritoneal macrophages

[0108] Seventy male mice, weighing 22±2g, were randomly divided into seven groups of ten each. The mice were administered the drug via gavage at a dose equivalent to 1g of raw drug / kg of medicinal wine, twice daily for 10 consecutive days. The control group received the same dose of physiological saline.

[0109] Example 1 Group: Drug Administration Example 1 Medicated Wine

[0110] Example 2 Group: Drug Administration Example 2 Medicated Wine

[0111] Group without Eucommia: Prepared according to the formula and method of Example 1, but without Eucommia, and further increased with an equal weight of Cistanche deserticola.

[0112] Hippocampus-free group: prepared according to the formulation and method of Example 1, but without using seahorse, and with an additional amount of Eucommia ulmoides in equal weight to seahorse.

[0113] The group without Cistanche deserticola: prepared according to the formula and method of Example 1, but without Cistanche deserticola, and with the addition of seahorse of equal weight to Cistanche deserticola.

[0114] Group without rhubarb: prepared according to the formula and method of Example 1, but without rhubarb, and with an additional amount of Cistanche deserticola in equal weight to rhubarb.

[0115] Concurrently with the last administration, each mouse was intraperitoneally injected with 1.5 ml of 0.5% hydrolyzed protein. Twenty-four hours later, each mouse was intraperitoneally injected with 0.1 ml of 5% chicken erythrocyte suspension. The time was set, and the mice were sacrificed after 40 minutes. The peritoneal cavity was flushed with physiological saline, yielding approximately 2 ml of solution, which was incubated for 0.5 hours and centrifuged at 3000 rpm for 10 minutes. The precipitate was smeared, stained, and the percentage of chicken erythrocytes phagocytosed by macrophages was observed under an oil immersion microscope.

[0116] Table: Effects on phagocytic function of mouse peritoneal macrophages

[0117] control group 10 13.5±2.4 Example 1 Group 10 30.9±3.1 Example 2 group 10 29.8±3.3 No Eucommia ulmoides group 10 23.3±3.0 Cistanche deserticola group 10 22.7±2.5 No hippocampus group 10 20.4±2.7 rhubarb-free group 10 25.6±2.9

[0118] The results above show that the principal herb composition of Eucommia ulmoides, Cistanche deserticola, and seahorse in this invention has a significant synergistic effect; reducing any one of them reduces the overall efficacy of the prescription to some extent. Furthermore, the experimental results show that Example 1 is significantly better than Example 2, making it the optimal example. Meanwhile, rhubarb also has a certain impact on the overall technical effect of the prescription; even adding an equal weight of the laxative Cistanche deserticola cannot compensate for the effect of rhubarb.

[0119] Experimental Example 2: Effects on mouse superoxide dismutase (SOD)

[0120] Free radicals are active genes or molecules widely present in the human body, while SOD is the main enzyme that scavenges free radicals, reducing the damage caused by free radicals to biological membranes, arteries, and the central nervous system. Furthermore, free radicals often cause DNA, RNA, and protein deformation, and are one of the main causes of aging and frailty. Increased SOD activity can, to some extent, reflect the effects of traditional Chinese medicine compositions on aging, physical condition, and frailty.

[0121] Forty-eight male mice, weighing 22±2g, were randomly divided into six groups of eight each. The mice were administered the drug via gavage at a dose equivalent to 1g of raw drug / kg of medicinal wine, twice daily for 10 consecutive days. The control group received the same dose of physiological saline.

[0122] Example 1 Group: Drug Administration Example 1 Medicated Wine

[0123] Example 3 Group: Drug Administration Example 3 Medicated Wine

[0124] Comparative Group 1: The raw materials are the same, but the weight ratio is outside the scope of the claim, specifically: 30 parts of Eucommia ulmoides, 20 parts of Cistanche deserticola, 10 parts of seahorse, 3 parts of deer antler, 10 parts of Cordyceps sinensis, 10 parts of ginseng, 3 parts of American ginseng, 5 parts of Rehmannia glutinosa, 3 parts of Panax notoginseng, 5 parts of Lycium barbarum, and 2 parts of processed rhubarb.

[0125] Comparative Group 2: The raw materials are the same, but the weight ratio is outside the scope of the claim, specifically: 10 parts Eucommia ulmoides, 5 parts Cistanche deserticola, 5 parts Hippocampus, 10 parts Deer antler, 10 parts Cordyceps sinensis, 30 parts Ginseng, 10 parts American ginseng, 5 parts Rehmannia glutinosa, 10 parts Panax notoginseng, 5 parts Lycium barbarum, and 9 parts Rheum palmatum.

[0126] Comparative Group 3: The raw materials are the same, but the weight ratio is outside the scope of the claim, specifically: 30 parts of Eucommia ulmoides, 15 parts of Cistanche deserticola, 3 parts of seahorse, 10 parts of deer antler, 1 part of Cordyceps sinensis, 10 parts of ginseng, 2 parts of American ginseng, 5 parts of Rehmannia glutinosa, 10 parts of Panax notoginseng, 5 parts of Lycium barbarum, and 1 part of processed rhubarb.

[0127] After the last administration to mice, blood was expelled from the eye sockets, anticoagulated with heparin, and the red blood cells were collected by centrifugation after gentle shaking and SOD measurement.

[0128] Table: Effects on superoxide dismutase (SOD) in mice

[0129] control group 8 259.6±13.5 Example 1 Group 8 415.2±19.3 Example 3 Group 8 398.4±18.8 Comparison Group 1 8 326.7±19.8 Comparison Group 2 8 301.2±17.7 Comparison Group 3 8 309.6±18.4

[0130] The results above show that the weight ratio of the active pharmaceutical ingredients in this invention is preferred and significantly superior to other formulation methods, verifying that the formulation is scientifically sound in clinical practice. Furthermore, the experimental results show that Example 1 is significantly better than Example 3 and is the optimal embodiment.

[0131] The above content is an exemplary description of the technical solution of the present invention and does not constitute any limitation on the technical solution.

Claims

1. A traditional Chinese medicine composition for improving the quality of life of patients in the post-fracture rehabilitation period, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials: 15-25 parts of Eucommia ulmoides, 7-13 parts of Cistanche deserticola, 3-7 parts of Hippocampus, 3-7 parts of Deer Antler, 1-5 parts of Cordyceps sinensis, 15-25 parts of Ginseng, 3-7 parts of American Ginseng, 9-15 parts of Rehmannia glutinosa, 3-7 parts of Panax notoginseng, 10-20 parts of Lycium barbarum, and 2-6 parts of Rheum palmatum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios: 16-24 parts Eucommia ulmoides, 8-12 parts Cistanche deserticola, 4-7 parts Hippocampus, 4-7 parts Deer antler, 2-5 parts Cordyceps sinensis, 16-24 parts Ginseng, 4-7 parts American ginseng, 10-14 parts Rehmannia glutinosa, 4-7 parts Panax notoginseng, 11-19 parts Lycium barbarum, and 3-6 parts Rheum palmatum.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios: 18-22 parts of Eucommia ulmoides, 9-11 parts of Cistanche deserticola, 4-6 parts of Hippocampus, 4-6 parts of Deer Antler, 2-4 parts of Cordyceps sinensis, 18-22 parts of Ginseng, 4-6 parts of American Ginseng, 11-13 parts of Rehmannia glutinosa, 4-6 parts of Panax notoginseng, 13-17 parts of Lycium barbarum, and 3-5 parts of Rheum palmatum.

4. The traditional Chinese medicine composition according to claim 3, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in the indicated weight ratios: 20 parts Eucommia ulmoides, 10 parts Cistanche deserticola, 5 parts seahorse, 5 parts deer antler, 3 parts Cordyceps sinensis, 20 parts ginseng, 5 parts American ginseng, 12 parts Rehmannia glutinosa, 5 parts Panax notoginseng, 15 parts Lycium barbarum, and 4 parts processed rhubarb.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The dosage form of the traditional Chinese medicine composition is a medicinal wine.

6. A method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that: Weigh out the Chinese medicinal materials by weight, crush and mix them, add 5-100 times the weight of the Chinese medicinal materials in white wine, soak for 1-100 days, filter, and you will get the product.

7. The preparation method according to claim 6, characterized in that: Weigh out the Chinese medicinal materials by weight, crush them into 20-mesh particles, mix them evenly, add 20 times the weight of the Chinese medicinal materials in white wine, soak for 30 days, filter, and you have the product.

8. The use of a traditional Chinese medicine composition as described in any one of claims 1-4 in the preparation of a medicament for improving the quality of life of patients in the post-fracture rehabilitation period.

9. The application as described in claim 8, characterized in that: Improving the quality of life for patients in the post-fracture recovery period is achieved by promoting fracture healing.

10. The application as described in claim 8, characterized in that: Improving the quality of life for patients in the post-fracture recovery period involves enhancing their immune system, relieving fatigue, and / or regulating sleep.