CN117064958A - Traditional Chinese medicine composition for improving life quality of fracture later convalescence patients - Google Patents
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- CN117064958A CN117064958A CN202311228525.6A CN202311228525A CN117064958A CN 117064958 A CN117064958 A CN 117064958A CN 202311228525 A CN202311228525 A CN 202311228525A CN 117064958 A CN117064958 A CN 117064958A
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Abstract
The application relates to a traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence period, which can obviously improve the life quality of the patients in the post-fracture convalescence period. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: eucommia ulmoides, cistanche salsa, hippocampus, cornu Cervi Pantotrichum, cordyceps, ginseng, american ginseng, radix rehmanniae Preparata, pseudo-ginseng, fructus Lycii, and radix et rhizoma Rhei preparata. The improvement of the life quality of the patient in the post-fracture convalescence refers to promotion of fracture healing, improvement of body immunity, physical fitness enhancement, fatigue relief, sleep regulation, aging delay and/or strengthening, and reduction of complications or secondary diseases.
Description
Technical Field
The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for improving the life quality of a patient in the post-fracture convalescence period, a preparation method thereof, application of the traditional Chinese medicine composition in preparing a medicine for improving the life quality of the patient in the post-fracture convalescence period, and pharmaceutical application of the traditional Chinese medicine composition in promoting fracture healing, improving organism immunity, strengthening physique, relieving fatigue, regulating sleep, delaying aging and strengthening, and reducing complications or secondary diseases.
Background
Fractures are common surgical diseases, mainly caused by external forces, which lead to the continuous and integral destruction of bones, thus leading to bleeding at the fracture ends and the occurrence of local swelling, pain and restricted movement. Because the bearing capacity of bones is destroyed after fracture, fracture patients need to receive medicaments for promoting fracture and wound healing and anti-infection symptomatic treatment after being treated in a surgical mode such as reduction and fixation, and generally need to receive routine nursing such as lying in bed, reducing activities, avoiding stress and the like.
According to traditional Chinese medicine analysis, in or after the fracture rehabilitation period of a patient, the patient is usually caused to have weak symptoms such as qi and blood deficiency, liver and kidney deficiency and the like due to long-time bedridden, and symptoms such as pain, spleen and stomach weakness, poor appetite, easy insomnia, aging and the like can also be caused due to qi and blood stasis and blood blocking caused by fracture, and the overall life quality of the patient in the fracture rehabilitation period is reduced.
In recent years, western medicine has also gradually paid attention to the problem of reduced quality of life of patients in post-fracture convalescence, such as Li Hedan, etc., found that old people have reduced bone density, lost minerals, reduced muscle protection ability and are prone to fracture, hip fracture is a serious injury to old people health, and research has shown that the quality of life of hip fracture patients is significantly reduced, mainly resulting in malnutrition, dysfunction, even disability, and shortened life span, and old people mostly show negative moods such as anxiety, depression and frustration, and frustration (see research on influence of hip fracture on old patients' quality of life, li Heshan, etc., southern hospitals in southern medical university orthopedics, journal of practical orthopedics, volume 24, 9). Patients in convalescence after fracture often show hypoimmunity, insomnia, fatigue, weakness, aging acceleration, psychological problems and the like.
However, there is currently a lack of effective therapeutic agents for the reduction of quality of life in post-fracture convalescence. For example, although it is noted that elderly patients with hip fractures have very serious consequences with low quality of life in convalescence, it is also only generally recommended to actively receive surgical treatment and encourage patients to perform functional exercises early to reduce complications, etc., and treatment with drugs is not envisaged. Although the traditional Chinese medicine field emphasizes that the medicines for strengthening tendons and bones and tonifying liver and kidney are suitable for patients in the later period of fracture, the purpose of using the medicines is only to accelerate the rehabilitation of the fracture, and the patients are not careful to use proper medicines to improve the life quality.
The prior art (the effect of three-stage dialectical treatment of traditional Chinese medicine matched after fracture operation) (Chenli, clinical medical research and practice, 2018, volume 3, and stage 26) discloses that the later stage of fracture is heavily promoted to be recovered, and the traditional Chinese medicine is treated by reinforcing the tendons and nourishing the blood decoction, wherein the prescription comprises 12g of radix dipsaci and radix rehmanniae respectively, 6g of eucommia ulmoides, white paeony root and szechuan lovage rhizome respectively, and 9g of achyranthes root, moutan bark and safflower respectively. However, the purpose of the prescription is still mainly to recover bone fracture, and the quality of life of patients is not concerned.
The prior art (Yang Wei, abstract of latest medical information in the world, 2019, volume 19 and 12) discloses that the traditional Chinese medicine bone fracture has wider treatment range than western medicine orthopedics, and the traditional Chinese medicine bone fracture is also used for treating fracture per se, muscle soft tissues and functional exercise after fracture healing after healing, and also paying attention to qi and blood, viscera and channels of a human body. The perioperative period of fracture is extremely important for patients, and the treatment failure and the false treatment are extremely easy to cause various complications such as fat embolism syndrome, disseminated intravascular coagulation, delayed fracture healing and even non-healing, and the like, and the fracture perioperative period is more and more important for doctors and patients clinically. From the above, it is still a concern about fracture-related healing, and the quality of life problems such as hypoimmunity and insomnia of the patient are not noticed.
The prior art CN106138698A (20161123) discloses a medicine which can be taken orally and used externally for treating bone fracture in orthopaedics, and is prepared from the following raw materials in parts by weight: 8-15 parts of pregnant mare urine, 10-20 parts of astragalus membranaceus, 10-20 parts of dwarf lilyturf tuber, 10-20 parts of rehmannia glutinosa, 10-20 parts of ginseng, 10-20 parts of poria cocos, 5-8 parts of liquorice, 5-8 parts of white paeony root, 5-8 parts of polygala tenuifolia, 5-8 parts of red paeony root, 5-8 parts of cinnamomum cassia bark, 10-20 parts of tricholoma matsutake, 10-20 parts of truffle, 10-18 parts of honeysuckle, 10-18 parts of weeping forsythiae capsule and 10-18 parts of Chinese angelica. The prepared medicine for treating bone fracture in orthopaedics can be taken orally and used for two purposes, and can eliminate pain of patients suffering from bone fracture and bone fracture in a short time by combining pregnant mare urine with the rest traditional Chinese medicines, and the healing speed of the injured bone is faster, especially for senile osteoporosis compression fracture, the medicine for treating bone fracture is greatly shortened, so that the pain of the patients is reduced. Has rapid conditioning effect on fracture healing, and can improve the immunity of the elderly, and is a health care medicine. However, the raw materials such as pregnant mare urine, tricholoma matsutake, truffle and the like are difficult to match with the theory of traditional Chinese medicine, industrial production is difficult, and great difficulty is faced in the market transformation.
Therefore, the traditional Chinese medicine composition for improving the life quality of the patient in the convalescence period after fracture is lacking in the prior art, the inventor pays attention to the problems faced by the patient in clinical practice through years of grope, finds a proper solution and provides an effective product for improving the life quality of the patient in the convalescence period after fracture.
Disclosure of Invention
The application aims to provide a traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence, which can obviously improve the life quality of the patients in the post-fracture convalescence. In particular, the hip fracture treatment device can obviously improve the life quality of the patient in the post-fracture rehabilitation period and reduce the complications or secondary symptoms of the related patient aiming at the senile hip fracture patient.
In particular, the improvement of the life quality of the patient in the post-fracture convalescence can reduce complications or secondary symptoms of the patient in the post-fracture convalescence. More specifically, the traditional Chinese medicine composition reduces complications or secondary symptoms under the condition of beneficial fracture rehabilitation, wherein beneficial refers to promotion or at least does not have adverse effects.
Still further, complications or secondary complications of the convalescent patient include, but are not limited to, hypoimmunity, insomnia, fatigue, weakness, accelerated aging, and psychological problems. Further, the improvement of the life quality includes, but is not limited to, improving immunity, strengthening physique, relieving fatigue, regulating sleep, delaying aging, strengthening, etc.
Further, the application also provides a preparation method of the traditional Chinese medicine composition.
Furthermore, the application also provides application of the traditional Chinese medicine composition in preparation of medicines for improving the life quality of patients in the convalescence period after fracture. Further, the Chinese medicinal composition is used for preparing medicaments for improving body immunity, strengthening physique, relieving fatigue, regulating sleep, delaying aging and/or strengthening.
In order to achieve the above purpose, the first aspect of the present application provides a traditional Chinese medicine composition for improving the life quality of a patient in the convalescence period after fracture, which is characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: eucommia ulmoides, cistanche salsa, hippocampus, cornu Cervi Pantotrichum, cordyceps, ginseng, american ginseng, radix rehmanniae Preparata, pseudo-ginseng, fructus Lycii, and radix et rhizoma Rhei.
Further, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of eucommia ulmoides, 7-13 parts of cistanche salsa, 3-7 parts of Hippocampus, 3-7 parts of hairy antler, 1-5 parts of cordyceps sinensis, 15-25 parts of ginseng, 3-7 parts of American ginseng, 9-15 parts of prepared rehmannia root, 3-7 parts of pseudo-ginseng, 10-20 parts of medlar and 2-6 parts of prepared rhubarb.
Further, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 16-24 parts of eucommia ulmoides, 8-12 parts of cistanche salsa, 4-7 parts of sea horse, 4-7 parts of hairy antler, 2-5 parts of cordyceps sinensis, 16-24 parts of ginseng, 4-7 parts of American ginseng, 10-14 parts of prepared rehmannia root, 4-7 parts of pseudo-ginseng, 11-19 parts of medlar and 3-6 parts of prepared rheum officinale.
Further, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 18-22 parts of eucommia ulmoides, 9-11 parts of cistanche salsa, 4-6 parts of sea horse, 4-6 parts of hairy antler, 2-4 parts of cordyceps sinensis, 18-22 parts of ginseng, 4-6 parts of American ginseng, 11-13 parts of prepared rehmannia root, 4-6 parts of pseudo-ginseng, 13-17 parts of medlar and 3-5 parts of prepared rheum officinale.
Further, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 20 parts of eucommia ulmoides, 10 parts of cistanche, 5 parts of hippocampus, 5 parts of hairy antler, 3 parts of cordyceps sinensis, 20 parts of ginseng, 5 parts of American ginseng, 12 parts of prepared rehmannia root, 5 parts of pseudo-ginseng, 15 parts of medlar and 4 parts of prepared rheum officinale.
The traditional Chinese medicine raw material has the effects of particularly and obviously improving the life quality of patients in the convalescence period after fracture, and the reason is that:
eucommia ulmoides: sweet and warm, enter liver and kidney meridians, nourish liver and kidney, strengthen tendons and bones, and relieve pain. Soreness and pain of waist and knees, flaccidity of lower limbs caused by deficiency of kidney and unsmooth tendons and bones.
Pharmacological action: the composition contains gutta-percha, eucommia ulmoides glycoside, eucommia ulmoides alcohol, phenols, organic acid, flavonoid, various free amino acids, various trace elements, trace alkaloids and a certain amount of vitamin C, can enhance the immune function of an organism, has a biphasic regulation effect on cell immunity, and can relax vascular smooth muscle and reduce blood pressure.
Preparing rheum officinale: the small and light weight and slow descending herbs are combined with qi-tonifying, blood-replenishing, yin-nourishing and fluid-producing herbs to strengthen body resistance and eliminate pathogenic factors
Pharmacological action: has effects in lowering blood pressure, improving microcirculation, reducing blood lipid, and reducing serum total cholesterol; has effects in promoting urination of urinary system, promoting excretion of urea and creatinine, and improving renal function;
hippocampus japonicus: kidney-tonifying yang-strengthening kidney-essence-tonifying, and matching with pilose antler, cistanche salsa, etc
Pharmacological action: the product contains proteins, fatty saccharides, vitamins and microelements, and Hippocampus extract has male appearance promoting effect, and antiaging effect
Pseudo-ginseng: besides stopping bleeding, removing stasis and relieving pain, the traditional Chinese medicine composition has better nourishing and strengthening effects, and has the effects of accelerating and eliminating exercise fatigue, enhancing physique, antagonizing memory disorder caused by anisodine, improving memory consolidation disorder caused by sodium nitrite, increasing brain and memory and the like.
Ginseng: greatly reinforcing primordial qi, invigorating spleen, lung, heart and kidney qi, promoting the production of body fluid, tranquillizing and improving intelligence. Is an essential herb for tonifying lung. By tonifying lung qi, it can improve symptoms of deficiency of lung qi such as short breath, dyspnea, lazy speaking, etc. For deficiency of both lung and kidney, kidney can not receive qi, it can tonify kidney qi.
It is also the key herb for tonifying spleen. By invigorating spleen qi, it can improve symptoms of spleen qi deficiency such as listlessness debilitation, anorexia and loose stool.
It also has effects in invigorating heart qi, improving heart qi deficiency symptoms such as palpitation, chest distress, short breath, and weak pulse, tranquilizing mind, improving intelligence, and treating insomnia, dreaminess, and amnesia. The single use is effective. It can be used for treating short qi deficiency with asthma due to kidney qi deficiency, and impotence due to kidney qi deficiency. The single use is effective. For deficiency of kidney yang accompanied by deficiency of kidney essence, it is combined with kidney yang-tonifying and kidney essence-tonifying herbs such as Lu Rong.
Pharmacological action: the product contains various ginsenoside, volatile oil, amino acids, trace elements, organic acids, saccharides, vitamins, etc. The heart beat amplitude and the heart rate can be obviously increased, and the heart strengthening effect is more obvious when the heart fails; can excite pituitary adrenal cortex system and improve stress response capability; has effects in enhancing excitation and inhibition of higher nerve activity; the flexibility of the nerve activity process can be enhanced, and the brain work function can be improved; has antifatigue, protein, RNA, DNA synthesis promoting, hematopoietic system function promoting, cholesterol metabolism regulating, etc.; can enhance immunity; can enhance gonad function and has gonadotrophin-like effect; can reduce blood sugar. The pharmacological activity of ginseng often acts in both directions due to different body functions.
American ginseng: primordial qi, tonifying qi and yin of heart, spleen, lung and kidney, clearing fire and promoting fluid production. It is indicated for shortness of breath, cough with little phlegm or phlegm with blood caused by impairment of lung qi and yin due to heat consumption because it can tonify lung qi, nourish lung yin and clear lung fire,
it can tonify heart qi, nourish heart yin, be suitable for palpitation and heart pain due to deficiency of both qi and yin, insomnia and dreamful sleep, tonify kidney qi, nourish kidney yin, be suitable for soreness and weakness of waist and knees due to deficiency of both kidney qi and kidney yin, spermatorrhea and spermatorrhea, belongs to deficiency of both kidney yin and yang, and can be combined with pilose antler with kidney yang.
It also has effects in invigorating spleen qi, invigorating spleen yin, and is suitable for anorexia due to spleen qi and yin deficiency, and the product contains various ginsenoside, various volatile components, resin, starch, saccharide, amino acid, inorganic salt, etc. American ginseng has sedative effect on brain and has moderate excitation effect on life center; it also has effects in resisting anoxia, myocardial ischemia, myocardial oxidation, myocardial contractility, arrhythmia, fatigue, stress, and convulsion. In addition, american ginseng total saponins can reduce blood sugar and influence lipid and protein metabolism, but are weaker than ginseng.
Velvet antler: tonify kidney yang, replenish essence, enrich blood and strengthen tendons and bones. It has the actions of tonifying primordial yang and kidney yang, and can strengthen tendons and bones, and can nourish essence and blood for people with deficiency of essence and blood, and has the actions of both principal and secondary aspects of diseases, and it contains various amino acids, estrogens, androgens, prostaglandins, various trace elements, etc. Cornu Cervi Pantotrichum extract is ethanol extract of cornu Cervi Pantotrichum. The pilose antler has the effects of strengthening body, improving the working capacity of organisms, relieving fatigue, improving sleep, promoting diet and improving pathological changes of low energy metabolism in yang deficiency state; the adaptability of the body to cold and heat stimulation is improved; can improve the immunity of the organism; sex hormone-like effects; can enhance gastrointestinal motility and secretion function; can increase kidney diuretic function, and has antiaging effect; can enhance regeneration process and promote healing of wound and fracture; can enhance the regeneration of erythrocytes, hemoglobin and reticulocytes, raise leukocytes and improve the hypoxia tolerance.
Cordyceps sinensis: it can tonify kidney yang, tonify kidney essence, and is used for impotence due to kidney deficiency, premature ejaculation and thin sperm combining it, and it can tonify kidney yang as well as kidney essence. For impotence due to deficiency of kidney yang and deficiency of kidney essence, premature ejaculation with thin essence, it is used singly with wine and combined with kidney-tonifying, essence-nourishing and yang-strengthening herbs such as Lu Rong.
In addition, it has the effects of reinforcing deficiency and strengthening weak, and promoting recovery of body functions.
The product contains proteins, various amino acids, saccharides, alcohols, nuclear proteins, vitamins, organic acids, trace wheat, cholesterol palmitic acid, ergosterol peroxide, wheat alcohol, alkaloid, eicosane, sitosterol, etc. Cordyceps sinensis has effects of relieving asthma, relieving cough, and eliminating phlegm; has antibacterial, antiviral, antiinflammatory, tranquilizing, and anticonvulsive effects: has a certain pseudo-androgenic and antiestrogenic effects, and recovery effect on sexual dysfunction: can enhance synthesis and secretion of adrenocortical hormone; can obviously improve the renal function state of patients with renal failure and improve the cellular immunity; has effects in reducing heart rate, lowering blood pressure, resisting experimental arrhythmia and myocardial ischemia, and lowering cholesterol and triglyceride; has effects of resisting aging and cancer
Cistanche deserticola: kidney yang tonifying, kidney essence replenishing, bowel relaxing, and constipation relieving. Regulating endocrine, promoting metabolism and strengthening body, has certain antiaging effect, enhancing immunity,
wolfberry fruit: nourish liver and kidney yin, replenish essence, enrich blood and improve eyesight.
It is indicated for liver and kidney yin deficiency with liver and kidney yin deficiency, and is indicated for liver and kidney yin deficiency with the ancient recipe of treating vision impairment, internal disorder, dizziness, soreness of waist and knees, spermatorrhea, diarrhea, hypochondrium pain, deafness, loose teeth, insomnia, dreaminess, hectic fever, night sweat and diabetes. For deficiency, it can tonify essence and enrich blood. It can also improve eyesight and be used for treating premature graying of beard and hair, hypopsia, soreness and weakness of waist and knees, nocturnal emission and spermatorrhea due to essence deficiency and blood deficiency (this herb can benefit)
Essence and blood are indicated for premature senility due to essence and blood deficiency. It is used singly or combined with liver and kidney tonifying, essence and blood replenishing herbs,
the product contains betaine, polysaccharide, crude fat, crude protein, thiamine, riboflavin, nicotinic acid, carotene, ascorbic acid, nicotinic acid B sitosterol, linoleic acid, microelements, amino acid, etc. The medlar has the promotion effect on various immunity and simultaneously has the immunoregulation effect; the fructus lycii can improve the blood testosterone level to a certain extent and has the strengthening effect; has hematopoietic function promoting effect; has remarkable leukocyte increasing effect on normal healthy people; can reverse some objective indexes reflecting the body function state in blood to the younger direction, and has anti-aging effect; it also has anti-mutation, anti-tumor, blood lipid reducing, liver protecting, fatty liver resisting, and blood lipid lowering effects
Blood sugar and blood pressure are reduced.
Prepared rehmannia root: nourishing blood, nourishing yin, replenishing essence and replenishing marrow. Can be used for treating symptoms caused by essence and blood deficiency or yin fluid deficiency (soreness of waist and knees, dizziness, dim eyesight, premature gray hair, tinnitus, etc.).
Through years of clinical researches, the inventor screens a large number of raw material medicine combinations and weight ratio relations, and based on the theory of traditional Chinese medicine, the traditional Chinese medicine composition which is reasonable in compatibility and effectively treats the life quality problem of a patient in the convalescence after fracture is obtained, and the raw material medicines are reasonably matched through monarch, minister, assistant and guide, so that the effects of nourishing liver and kidney, strengthening tendons and bones and tonifying qi and enriching blood are achieved. The specific formulation analysis is as follows:
the pattern of this recipe is deficiency of the liver and kidney, resulting in deficiency of liver and blood, malnutrition of tendons and vessels, deficiency of kidney essence, weakness of tendons and bones, qi deficiency, listlessness, lassitude of limbs, essence-deficiency and blood-deficiency fire without warming the earth, and poor appetite. In the later stage of fracture, the bones and muscles are connected, the bones and muscles are not firm, the joints are weak and the movement of the joints is strong. Liver and kidney govern blood collection, kidney govern bone marrow generation, liver and kidney homology, bone and muscle connection, liver blood collection, supply the body fluid blood required by the joint movement of the bones and muscles, kidney essence is exuberant, bone marrow is filled, bone nutrition can be provided to enable the bones to be firm, kidney essence is vital energy generation, so liver and kidney tonifying, bone and muscle strengthening, qi supplementing, blood supplementing and yin nourishing, cistanche deserticola, eucommia ulmoides, hippocampus nourishing liver and kidney, bone and muscle strengthening, essence and blood supplementing are principal drugs, hairy antler, cordyceps sinensis warming kidney yang, kidney essence supplementing, ginseng, american ginseng, prepared rhizome of rehmannia, medlar and pseudo-ginseng are vital energy supplementing, blood supplementing, yin supplementing, body fluid generating, spleen and stomach strengthening, qi and blood consolidating, heart spirit nourishing, and being ministerial drugs, and Zhang secondary scenery: for the people who are good at tonifying yang, the yin is needed to nourish yang, and the yang is needed to nourish yin and promote the circulation of qi; preparing rheum officinale: the small amount and light weight with slow descending effect is combined with a large amount of qi-tonifying, blood-enriching, yin-nourishing and fluid-producing herbs to strengthen body resistance and eliminate pathogenic factors, and the pathogenic factors are removed to supplement the herbs and strengthen the body resistance without stagnation, so the Chinese herbal medicine is an adjuvant-guiding herb. The medicines are used together to nourish liver and kidney, fill essence and nourish marrow, strengthen vital essence and yin, coordinate yin and yang, nourish and warm up viscera, limbs and bones, and muscle coat and hair. Has the functions of warming and nourishing liver and kidney, strengthening bones and muscles, tonifying qi and enriching blood.
The traditional Chinese medicine composition disclosed by the application is exquisite in compatibility relation, and is obtained by the inventor through creative conception and a large number of clinical practices. In clinical practice, cistanche, eucommia ulmoides and Hippocampus are found to be indispensable as monarch drugs. If the eucommia ulmoides is absent, the recovery speed of the fracture patient is obviously affected, and the fracture recovery of the patient is not facilitated. On this basis, the inventor also surprisingly found that the addition of eucommia ulmoides can significantly enhance the improvement effect of the traditional Chinese medicine composition on fatigue, weakness and low immunity, and significantly improve the life quality of fracture patients. If cistanche deserticola is absent, the effects on the hypoimmunity, sleep and fatigue of the patient are greatly reduced. In the absence of the hippocampus, patients are severely adversely affected by hypoimmunity and aging effects. Meanwhile, the rheum officinale in the prescription is an adjuvant drug, but has unexpected effect on the effect of the whole prescription, and after the rheum officinale is added, the effects of relieving the complications such as low immunity, insomnia, fatigue, weakness, aging acceleration, psychological complications and the like are enhanced, and particularly the low immunity and psychological problems are obviously improved.
The traditional Chinese medicine composition disclosed by the application has the beneficial effects of strengthening bones and muscles, and can promote healing of fracture, strengthen muscle strength and enable fracture patients to quickly heal. Meanwhile, the effects of warming and nourishing liver and kidney, tonifying qi and enriching blood and the like are beneficial to improving the life quality, are beneficial to relieving the complications such as hypoimmunity, insomnia, fatigue, weakness, aging acceleration, psychological and the like, and the effect of strengthening bones and muscles is exerted to a certain extent because fracture is the cause of the complications.
The traditional Chinese medicine composition is used in an oral way, for example, is prepared into a dosage form suitable for fracture recovery patients, such as wine, decoction, powder, granules, oral liquid, tablets, pills and the like. Of course, those skilled in the art can develop other preferred dosage forms based thereon.
Preferably, it has been unexpectedly found that the traditional Chinese medicine composition can more effectively exert the curative effect when being prepared into medicinal liquor. Clinical verification shows that compared with the dosage forms of powder, granule, decoction, pill, etc., the medicated wine has the advantages of convenient use, rapid drug effect, and high patient acceptance.
In another aspect of the present application, the present application also provides a method for preparing a traditional Chinese medicine composition for improving the quality of life of a patient in the post-fracture convalescence period, which is characterized in that: weighing the raw materials according to the weight, crushing and mixing, adding distilled spirit with the weight 5-100 times of the weight of the raw materials, soaking for 1-100 days, and filtering to obtain the traditional Chinese medicine.
Further, the preparation method is characterized in that: weighing the raw materials according to the weight, pulverizing into particles with the size of 10-80 meshes, uniformly mixing, adding distilled spirit with the weight 10-50 times of the weight of the raw materials, soaking for 10-30 days, and filtering to obtain the traditional Chinese medicine.
Further, the preparation method is characterized in that: weighing the raw materials according to the weight, pulverizing into particles with 20-40 meshes, uniformly mixing, adding distilled spirit with the weight 10-30 times of the weight of the raw materials, soaking for 20-30 days, and filtering to obtain the traditional Chinese medicine.
Preferably, the preparation method is characterized in that: weighing the raw materials according to the weight, pulverizing into particles with 20 meshes, uniformly mixing, adding distilled spirit with the weight being 20 times of that of the raw materials, soaking for 30 days, and filtering to obtain the traditional Chinese medicine.
The inventor finds through a large number of experiments that when the raw material medicines are crushed into 20 meshes, the requirements on crushing equipment are low, the crushing efficiency is high, the preparation time and energy are saved, the raw material medicines with 20 meshes have better soaking and extracting effects, the treatment effect is ensured, excessive impurities in medicinal liquor with too small medicinal powder particles can be prevented, and the medicinal liquor with too fine particles is difficult to filter. Meanwhile, experimental researches also find that 20 times of white spirit and soaking for 30 days are the best white spirit dosage and soaking time, and the extraction efficiency is high.
The white spirit may use white spirit with an alcoholicity of 15% -90%, preferably, the white spirit has an alcoholicity of 30% -60%, and most preferably, the white spirit has an alcoholicity of 40% -56%.
Further, auxiliary materials commonly used in traditional Chinese medicine preparations, such as flavoring agents, preservatives, suspending agents and the like, can be added into the medicinal liquor. Such flavoring agents include, but are not limited to, sucrose, aspartame, xylitol, and the like. Such preservatives include, but are not limited to, sodium benzoate, ethyl paraben, and the like. Such suspending agents include, but are not limited to, glycerin, polyethylene glycol, and the like.
In another aspect of the application, the application also provides application of the traditional Chinese medicine composition in preparation of medicines for improving the life quality of patients in the convalescence period after fracture.
Further, the improvement of the life quality of the patients in the post-fracture convalescence is to promote fracture healing.
Further, the improvement of the life quality of the fracture later convalescence patients is to improve the organism immunity of the fracture later convalescence patients, strengthen physique, relieve fatigue, regulate sleep, delay aging and/or strengthen.
Further, the patient in the post-fracture convalescence improves the life quality, and improves the immunity of the organism, the physique, the fatigue and the sleep, and delays the aging and/or strengthens the body while promoting the fracture healing.
The application has the beneficial effects that:
1. the present application surprisingly provides for the first time the technical problem that by using a traditional Chinese medicine composition, in patients in the post-fracture convalescence period, not only the treatment of the fracture itself, but also other symptoms affecting the life quality of the fracture patient, such as low immunity, insomnia, fatigue, weakness, aging acceleration, psychological complications or secondary symptoms, are required to be concerned. And creatively develops a traditional Chinese medicine composition which can promote fracture healing, improve organism immunity, strengthen physique, relieve fatigue, regulate sleep, delay aging and/or strengthen.
2. The traditional Chinese medicine composition can most effectively exert the treatment effect, namely, can be used for improving the life quality of patients in the convalescence period after fracture, in particular, promoting fracture healing and improving body immunity, strengthening physique, relieving fatigue, regulating sleep, and delaying aging and/or strengthening.
3. The optimal weight ratio relation of the formula is unexpectedly discovered through combining the traditional Chinese medicine theory with clinical practice to optimize the formula, and the formula can exert the optimal effect on the whole body under the weight ratio relation.
Detailed Description
Example 1:
the traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 20 parts of eucommia ulmoides, 10 parts of cistanche salsa, 5 parts of Hippocampus, 5 parts of hairy antler, 3 parts of cordyceps sinensis, 20 parts of ginseng, 5 parts of American ginseng, 12 parts of prepared rehmannia root, 5 parts of pseudo-ginseng, 15 parts of medlar and 4 parts of prepared rheum officinale
Weighing the raw materials according to the weight, pulverizing into particles with 20 meshes, uniformly mixing, adding 40% white spirit with the weight being 20 times of that of the raw materials, soaking for 30 days, and filtering to obtain the traditional Chinese medicine.
Example 2
The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 25 parts of eucommia ulmoides, 13 parts of cistanche, 7 parts of hippocampus, 7 parts of pilose antler, 5 parts of cordyceps sinensis, 25 parts of ginseng, 7 parts of American ginseng, 15 parts of prepared rehmannia root, 7 parts of pseudo-ginseng, 20 parts of medlar and 2 parts of prepared rheum officinale.
Weighing the raw materials according to the weight, crushing into 10-mesh particles, uniformly mixing, adding 30% white spirit which is 50 times of the weight of the raw materials, soaking for 100 days, and filtering to obtain the traditional Chinese medicine.
Example 3
The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 15 parts of eucommia ulmoides, 7 parts of cistanche, 3 parts of hippocampus, 3 parts of pilose antler, 1 part of cordyceps sinensis, 15 parts of ginseng, 3 parts of American ginseng, 9 parts of prepared rehmannia root, 3 parts of pseudo-ginseng, 10 parts of medlar and 6 parts of prepared rheum officinale.
Weighing the raw materials according to the weight, crushing into particles with the particle size of 80 meshes, uniformly mixing, adding 50% white spirit which is 10 times of the weight of the raw materials, soaking for 10 days, and filtering to obtain the traditional Chinese medicine.
Example 4
The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 24 parts of eucommia ulmoides, 12 parts of cistanche salsa, 7 parts of Hippocampus, 7 parts of pilose antler, 5 parts of Cordyceps sinensis, 24 parts of ginseng, 4 parts of American ginseng, 10 parts of prepared rehmannia root, 4 parts of pseudo-ginseng, 11 parts of medlar and 3 parts of prepared rheum officinale.
Weighing the raw materials according to the weight, crushing into 5-mesh particles, uniformly mixing, adding 70% white spirit which is 100 times of the weight of the raw materials, soaking for 20 days, and filtering to obtain the traditional Chinese medicine.
Example 5
The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 16 parts of eucommia ulmoides, 8 parts of cistanche, 4 parts of hippocampus, 4 parts of pilose antler, 2 parts of cordyceps sinensis, 16 parts of ginseng, 7 parts of American ginseng, 14 parts of prepared rehmannia root, 7 parts of pseudo-ginseng, 19 parts of medlar and 6 parts of prepared rheum officinale.
Weighing the raw materials according to the weight, crushing into 100-mesh particles, uniformly mixing, adding 60% white spirit which is 5 times of the weight of the raw materials, soaking for 1 day, and filtering to obtain the traditional Chinese medicine.
Example 6
The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 22 parts of eucommia ulmoides, 11 parts of cistanche salsa, 6 parts of Hippocampus, 6 parts of pilose antler, 4 parts of Cordyceps sinensis, 22 parts of ginseng, 6 parts of American ginseng, 13 parts of prepared rehmannia root, 4 parts of pseudo-ginseng, 13 parts of medlar and 3 parts of prepared rheum officinale.
Weighing the raw materials according to the weight, crushing the raw materials into particles with 40 meshes, uniformly mixing the particles, adding 15% white spirit which is 30 times of the weight of the raw materials, soaking the mixture for 50 days, and filtering the mixture to obtain the traditional Chinese medicine.
Example 7
The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 18 parts of eucommia ulmoides, 9 parts of cistanche, 4 parts of hippocampus, 4 parts of pilose antler, 2 parts of cordyceps sinensis, 18 parts of ginseng, 4 parts of American ginseng, 11 parts of prepared rehmannia root, 6 parts of pseudo-ginseng, 17 parts of medlar and 5 parts of prepared rheum officinale.
Weighing the raw materials according to the weight, crushing the raw materials into particles with 60 meshes, uniformly mixing the particles, adding 90% white spirit which is 40 times of the weight of the raw materials, soaking the mixture for 70 days, and filtering the mixture to obtain the traditional Chinese medicine.
Preliminary clinical study:
in order to preliminarily verify the effect of the Chinese medicinal composition of the present application, preliminary clinical studies were conducted on 30 elderly patients (aged 60-72 years) with hip fracture on the basis of consent of the patients, so as to evaluate the effect of the Chinese medicinal composition of the present application.
Patients were randomized into 2 groups, namely, drug and control groups of 15 patients each, with essentially the same age and condition.
In the case of using standard surgical treatment and fracture treatment medicines, the medicinal group took the medicinal liquor of the present application (i.e., the medicinal liquor of example 1) 2 times a day, 20mL each time, for 3 months continuously. The control group took placebo medicated wine 2 times daily, 20mL each time, for 3 months continuously.
The fracture recovery condition of the patient is clinically checked, and a consultation and a filling scale are carried out. In view of patient compliance, invasive clinical testing, such as blood drawing, is not used for a while during the course of the preliminary clinical study.
1. Average time for fracture healing
The fracture healing criteria were: the fracture gap of the fracture part of the hip is eliminated by X-ray examination, the hip is recovered to be normal, and the time from the current day of fracture to the healing of the patient is counted. The results show that:
| pharmaceutical set | Control group | |
| Average time for fracture healing | For 76 days | 88 days |
As can be seen, the drug group had a preference over the control group in terms of fracture healing, with an average of 76 days for fracture healing, and 88 days for control group. The fracture healing standard is that fracture cracks at the fracture part of the hip disappear and the hip bone returns to normal.
2. Sleep improvement
Statistics were performed using a scoring method, wherein 0 points: no insomnia; 1, the method comprises the following steps: occasionally, insomnia occurs for less than 2 hours per day; 2 minutes, frequent occurrence and insomnia time of 2-4 hours; 3 minutes, the person sleeps at night. Sleep on 30 days, 60 days and 90 days was counted for the drug group and the control group, and the results were as follows:
| average score for insomnia | Pharmaceutical set | Control group |
| For 30 days | 1.67 | 1.93 |
| For 60 days | 1.53 | 2.53 |
| 90 days | 0.73 | 2.73 |
It can be seen that the drug group significantly improves sleep, significantly improves insomnia symptoms of patients, particularly after 3 months of treatment, compared to the control group, which exhibits progressive exacerbation of insomnia symptoms.
3. Fatigue improvement
Statistics were performed using a scoring method, wherein 0 points: no fatigue; 1, the method comprises the following steps: the daily fatigue persists for less than 4 hours; 2 minutes, the average fatigue is 4-8 hours per day, including 4 hours; 3 minutes, the average fatigue feeling is 8-16 hours each day, and the time is 8 hours; 4 minutes, the average fatigue is 16-24 hours per day, containing 16 hours. The fatigue of the drug group, the control group at 30, 60 and 90 days was counted as follows:
| average score for insomnia | Pharmaceutical set | Control group |
| For 30 days | 1.47 | 2.80 |
| For 60 days | 1.13 | 3.47 |
| 90 days | 0.53 | 3.80 |
It can be seen that the pharmaceutical group significantly improved the patient's fatigue, significantly better than the control group, and in particular, the patient's fatigue symptoms improved significantly after 3 months of treatment, whereas the control group showed progressive exacerbation of the fatigue symptoms.
Pharmacodynamic experiments
In order to fully understand the effects of the composition, provide a basis for helping pharmacology for larger-scale clinical research, the application also utilizes animals to conduct pharmacodynamics research of the traditional Chinese medicine composition. Meanwhile, in the pharmacodynamics research process, the optimization of the raw material composition and the weight ratio in the clinical process of the application is verified, and the raw material composition and the weight ratio obtained by clinical summary are proved to be the preferable technical scheme.
Experimental example 1: effects on phagocytic function of mouse peritoneal macrophages
Male mice were selected in 70, 22+ -2 g, and randomly divided into 7 groups of 10 mice each. The medicine is administered by stomach irrigation, the administration dosage is 1g crude drug/kg of medicinal liquor, and the medicine is continuously administered for 10 days twice a day. The control group was given the same dose of physiological saline.
Example 1 group: administration example 1 medicated wine
Example 2 group: administration example 2 medicated wine
Eucommia ulmoides free group: prepared according to the formulation and method of example 1, but without eucommia ulmoides, while further increasing the weight of cistanche deserticola equal to that of eucommia ulmoides.
No hippocampus: prepared according to the formulation and method of example 1, but without the use of Hippocampus, while further increasing the weight of eucommia ulmoides equal to that of the Hippocampus.
Cistanche-free group: prepared according to the formulation and method of example 1, but without cistanche salsa, while further increasing the weight of hippocampus equivalent to cistanche salsa.
Rhubarb-free group: prepared according to the formulation and method of example 1, but without using rhubarb, while further increasing the weight of cistanche deserticola equivalent to that of rhubarb.
At the same time as the last administration, 1.5ml of 0.5% hydrolyzed protein was given to each mouse intraperitoneally. After 24h, 0.1ml of 5% chicken erythrocyte suspension was injected into the abdominal cavity of each mouse again, the time was counted, the abdominal cavity was sacrificed after 40min, the abdominal cavity was flushed with physiological saline, about 2ml of the solution was obtained, and the incubation was performed for 0.5h,3000 rpm/heart was separated for 10 min. The pellet was stained with a smear and the percentage of macrophages that engulfed chicken erythrocytes was observed under an oil microscope.
Table: effects on phagocytic function of mouse peritoneal macrophages
| Group of | Number of animals | Percent phagocytosis (average+ -SD) |
| Control group | 10 | 13.5±2.4 |
| Example 1 group | 10 | 30.9±3.1 |
| Example 2 group | 10 | 29.8±3.3 |
| Eucommia ulmoides free group | 10 | 23.3±3.0 |
| Cistanche-free group | 10 | 22.7±2.5 |
| Hippocampus-free group | 10 | 20.4±2.7 |
| Radix et rhizoma Rhei-free group | 10 | 25.6±2.9 |
From the results, the monarch drug composition of eucommia ulmoides, cistanche and hippocampus has obvious synergistic effect, any one of the monarch drug composition is reduced, and the effect of the whole prescription is reduced to a certain extent. Also, from the experimental results, the results of example 1 are also significantly better than those of example 2, and are the best examples. Meanwhile, the technical effect of the whole prescription of the rheum officinale is also affected to a certain extent, and even if the cistanche deserticola which is an intestine-moistening and bowel-relaxing medicine with the same weight is added, the effect of the rheum officinale cannot be compensated.
Experimental example 2: influence on the superoxide dismutase (SOD) of mice
Free radicals are active genes or molecules widely existing in human bodies, while SOD is a main scavenging enzyme of free radicals, so that damage of the free radicals to biological membranes, arteries and central nervous systems is relieved, and the free radicals also frequently cause deformation of DNA, RNA and proteins, which is one of the main causes of aging and weakness. The SOD activity is improved, and the effects of the traditional Chinese medicine composition on aging, physique and weakness can be reflected to a certain extent.
Male mice were selected in 48, 22+ -2 g body weight, and randomly divided into 6 groups of 8. The medicine is administered by stomach irrigation, the administration dosage is 1g crude drug/kg of medicinal liquor, and the medicine is continuously administered for 10 days twice a day. The control group was given the same dose of physiological saline.
Example 1 group: administration example 1 medicated wine
Example 3 group: administration example 3 medicated wine
Comparative group 1: the raw materials are the same, but the weight ratio is outside the scope of the protection, and the specific steps are as follows: 30 parts of eucommia ulmoides, 20 parts of cistanche, 10 parts of hippocampus, 3 parts of pilose antler, 10 parts of cordyceps sinensis, 10 parts of ginseng, 3 parts of American ginseng, 5 parts of prepared rehmannia root, 3 parts of pseudo-ginseng, 5 parts of medlar and 2 parts of prepared rheum officinale.
Comparative group 2: the raw materials are the same, but the weight ratio is outside the scope of the protection, and the specific steps are as follows: 10 parts of eucommia ulmoides, 5 parts of cistanche, 5 parts of hippocampus, 10 parts of pilose antler, 10 parts of cordyceps sinensis, 30 parts of ginseng, 10 parts of American ginseng, 5 parts of prepared rehmannia root, 10 parts of pseudo-ginseng, 5 parts of medlar and 9 parts of prepared rheum officinale.
Comparative group 3: the raw materials are the same, but the weight ratio is outside the scope of the protection, and the specific steps are as follows: 30 parts of eucommia ulmoides, 15 parts of cistanche, 3 parts of hippocampus, 10 parts of pilose antler, 1 part of cordyceps sinensis, 10 parts of ginseng, 2 parts of American ginseng, 5 parts of prepared rehmannia root, 10 parts of pseudo-ginseng, 5 parts of medlar and 1 part of prepared rheum officinale.
After the last administration of mice, the eyelets were exsanguinated, anticoagulated with heparin, gently shaken, centrifuged to harvest erythrocytes and assayed for SOD.
Table: influence on the superoxide dismutase (SOD) of mice
| Group of | Number of animals | SOD(u/g RBC) |
| Control group | 8 | 259.6±13.5 |
| Example 1 group | 8 | 415.2±19.3 |
| Example 3 group | 8 | 398.4±18.8 |
| Comparative group 1 | 8 | 326.7±19.8 |
| Comparative group 2 | 8 | 301.2±17.7 |
| Comparative group 3 | 8 | 309.6±18.4 |
From the results, the weight ratio of the raw materials is preferable and obviously superior to other compatibility modes except the weight ratio, and the scientific and reasonable formula in clinical practice is verified. Also, from the experimental results, the results of example 1 are also significantly better than those of example 3, and are the best examples.
The above is an exemplary description of the technical solution of the present application and does not constitute any limitation of the technical solution.
Claims (10)
1. The traditional Chinese medicine composition for improving the life quality of patients in the post-fracture convalescence is characterized by being prepared from the following traditional Chinese medicine raw materials: 15-25 parts of eucommia ulmoides, 7-13 parts of cistanche salsa, 3-7 parts of Hippocampus, 3-7 parts of hairy antler, 1-5 parts of cordyceps sinensis, 15-25 parts of ginseng, 3-7 parts of American ginseng, 9-15 parts of prepared rehmannia root, 3-7 parts of pseudo-ginseng, 10-20 parts of medlar and 2-6 parts of prepared rhubarb.
2. The traditional Chinese medicine composition according to claim 1, wherein: the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 16-24 parts of eucommia ulmoides, 8-12 parts of cistanche salsa, 4-7 parts of sea horse, 4-7 parts of hairy antler, 2-5 parts of cordyceps sinensis, 16-24 parts of ginseng, 4-7 parts of American ginseng, 10-14 parts of prepared rehmannia root, 4-7 parts of pseudo-ginseng, 11-19 parts of medlar and 3-6 parts of prepared rheum officinale.
3. The traditional Chinese medicine composition according to claim 2, wherein: the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 18-22 parts of eucommia ulmoides, 9-11 parts of cistanche salsa, 4-6 parts of sea horse, 4-6 parts of hairy antler, 2-4 parts of cordyceps sinensis, 18-22 parts of ginseng, 4-6 parts of American ginseng, 11-13 parts of prepared rehmannia root, 4-6 parts of pseudo-ginseng, 13-17 parts of medlar and 3-5 parts of prepared rheum officinale.
4. A Chinese medicinal composition according to claim 3, wherein: the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 20 parts of eucommia ulmoides, 10 parts of cistanche, 5 parts of hippocampus, 5 parts of hairy antler, 3 parts of cordyceps sinensis, 20 parts of ginseng, 5 parts of American ginseng, 12 parts of prepared rehmannia root, 5 parts of pseudo-ginseng, 15 parts of medlar and 4 parts of prepared rheum officinale.
5. The traditional Chinese medicine composition according to any one of claims 1 to 4, wherein the dosage form of the traditional Chinese medicine composition is medicinal liquor.
6. A method for preparing the traditional Chinese medicine composition according to claim 5, which is characterized in that: weighing the raw materials according to the weight, crushing and mixing, adding distilled spirit with the weight 5-100 times of the weight of the raw materials, soaking for 1-100 days, and filtering to obtain the traditional Chinese medicine.
7. The method of manufacturing according to claim 6, wherein: weighing the raw materials according to the weight, pulverizing into particles with 20 meshes, uniformly mixing, adding distilled spirit with the weight being 20 times of that of the raw materials, soaking for 30 days, and filtering to obtain the traditional Chinese medicine.
8. Use of a Chinese medicinal composition according to any one of claims 1-4 for the manufacture of a medicament for improving the quality of life of a patient in convalescence after fracture.
9. The use according to claim 8, wherein: the improvement of the life quality of the patient in the post-fracture convalescence is to promote fracture healing.
10. The use according to claim 8, wherein: the improvement of the life quality of the fracture later convalescence patients is to improve the organism immunity of the fracture later convalescence patients, strengthen physique, relieve fatigue, regulate sleep, delay aging and/or strengthen.
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