Traditional Chinese medicine composition with kidney tonifying effect and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition with a kidney tonifying effect. The traditional Chinese medicine composition is prepared from the following medicinal materials in parts by mass: 40-500 parts of lychee seeds, 160 parts of prepared rehmannia roots, 80 parts of wine-prepared fructus corni, 80 parts of Chinese yams, 60 parts of rhizoma alismatis, 60 parts of moutan barks, 60 parts of poria cocos and 1-200 parts of tea oil. The lychee seed capable of warming and invigorating kidney yang and the tea oil capable of regulating yin and yang are introduced on the basis of the Liuwei Dihuang pill, so that the traditional Chinese medicine composition can effectively regulate and treat kidney yin deficiency, kidney yang deficiency and kidney yin and yang deficiency syndromes, and meanwhile, through the effects of promoting qi circulation and removing stasis and eliminating cold to stop pain of the lychee seed and the effect of lubricating the intestinal tract of the tea oil, the traditional Chinese medicine composition can effectively treat kidney yin deficiency, kidney yang deficiency and kidney yin and yang deficiency syndromes. Adverse reactions such as abdominal distension, nausea, vomiting, stomachache, gastrointestinal discomfort, inappetence and constipation caused by long-term administration of six medicines can be effectively relieved.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with kidney-tonifying effect and application thereof. Background Art

[0002] Liuwei Dihuang Pills is a traditional Chinese medicine prescription, which is composed of six Chinese medicinal materials: cooked rehmannia root, wine cornus fruit, yam, oriental water plantain, poria and peony bark. The prescription is mainly used to tonify kidney yin deficiency syndrome, and has no significant therapeutic effect on kidney yang deficiency, and may aggravate the symptoms of kidney yang deficiency (kidney yang deficiency is manifested as weak yang and hyperactive yin. If yin-tonifying prescriptions are used, it will further promote yin, making yang weaker and aggravating the condition). In 2021, the State Food and Drug Administration issued an announcement on the revision of the instructions for Liuwei Dihuang preparations. The revised announcement mentioned: Monitoring data show that Liuwei Dihuang preparations can cause a series of adverse reactions, including diarrhea, abdominal pain, abdominal distension, nausea, vomiting, gastrointestinal discomfort, loss of appetite, constipation, itching, rash, headache, palpitations and allergies. The release of this announcement challenges the public's widely held belief in the applicability of Liuwei Dihuang Pills, emphasizing that it is not suitable for all people.

[0003] The rapid development of society has brought about great changes in life. Long-term heavy physical or mental labor consumes too much energy, the body cannot get enough rest, and the burden on the kidneys increases, which in turn causes kidney yin deficiency or kidney yang deficiency. Traditional Chinese medicine believes that the kidneys store essence, which generates kidney yin and kidney yang, nourishes and warms the internal organs, maintains the balance of yin and yang, and imbalance leads to kidney yin deficiency or kidney yang deficiency. Kidney yang deficiency usually manifests as insufficient yang energy, leading to coldness in the body. The main symptoms include soreness of the waist and knees, cold pain in the waist and back, and sexual dysfunction. The treatment principle is to warm and tonify the kidney yang. Kidney yin deficiency is due to insufficient kidney yin fluid, which leads to internal heat and hyperactivity of yang. The main symptoms are insomnia and dreaminess, soreness of the waist and knees, irregular menstruation in women, and spermatorrhea in men. The treatment should focus on nourishing the kidney yin. When kidney yin deficiency is severe, it will affect kidney yang, resulting in deficiency of both yin and yang, which is called "yin damage to yang"; when kidney yang deficiency is severe, it will also affect kidney yin, which is called "yang damage to yin", also resulting in deficiency of both yin and yang, and its main manifestations are: fear of both cold and heat (especially afraid of cold in winter and heat in summer). When treating, it is advisable to adopt methods such as tonifying both yin and yang, nourishing yin and strengthening yang. Summary of the invention

[0004] The invention aims to provide a Chinese medicine composition with kidney-tonifying effect, which is used to improve the symptoms of yin deficiency and hyperactivity of fire, sexual dysfunction caused by kidney yin deficiency and soreness of waist and knees, sexual dysfunction caused by kidney yang deficiency.

[0005] The objective of the present invention is achieved through the following technical solutions:

[0006] A Chinese medicine composition with kidney-tonifying effect is prepared from the following medicinal materials in parts by mass: 40-500 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe, and 1-200 parts of tea oil; or prepared from the following medicinal materials in parts by mass: 40-500 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe; or prepared from the following medicinal materials in parts by mass: 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe, and 1-200 parts of tea oil.

[0007] Furthermore, the Chinese medicine composition with kidney-tonifying effect is made of medicinal materials including the following mass parts: 160 parts of litchi seeds, 160 parts of Rehmannia root, 80 parts of cornus fruit with wine, 80 parts of Chinese yam, 60 parts of Alisma orientalis, 60 parts of peony bark, 60 parts of Poria, and 40-60 parts of tea oil; or is made of medicinal materials including the following mass parts: 160 parts of litchi seeds, 160 parts of Rehmannia root, 80 parts of cornus fruit with wine, 80 parts of Chinese yam, 60 parts of Alisma orientalis, 60 parts of peony bark, 60 parts of Poria; or is made of medicinal materials including the following mass parts: 160 parts of Rehmannia root, 80 parts of cornus fruit with wine, 80 parts of Chinese yam, 60 parts of Alisma orientalis, 60 parts of peony bark, 60 parts of Poria, and 40-60 parts of tea oil.

[0008] Furthermore, the Chinese medicine composition with kidney-tonifying effect is made of medicinal materials including the following parts by mass: 160 parts of litchi kernel, 160 parts of Rehmannia root, 80 parts of Cornus officinalis, 80 parts of yam, 60 parts of Alisma orientalis, 60 parts of Paeonia suffruticosa, 60 parts of Poria cocos, and 60 parts of tea oil.

[0009] Another object of the present invention is to provide the use of the Chinese medicine composition with kidney-tonifying effect in preparing medicine for treating kidney deficiency.

[0010] Furthermore, the application is the application of the Chinese medicine composition with kidney-tonifying effect in the preparation of medicines for treating kidney yin deficiency and / or kidney yang deficiency.

[0011] Furthermore, the application is the application of the Chinese medicine composition with kidney-tonifying effect in the preparation of a drug for treating kidney deficiency by exerting at least one of the following effects: promoting recovery from sports fatigue, increasing the levels of testosterone and estradiol in serum, and improving insomnia symptoms.

[0012] Furthermore, the application is the use of the Chinese medicine composition with kidney-tonifying effect in the preparation of a medicine for treating kidney yin deficiency by exerting at least one of the following effects: improving mood swings, soreness of the waist and knees, sexual dysfunction, or hyperactivity of false fire and yang, insomnia, dreaminess and irregular menstruation in women caused by kidney yin deficiency. The application is the use of the Chinese medicine composition with kidney-tonifying effect in the preparation of a medicine for treating kidney yin deficiency by exerting at least one of the following effects: improving symptoms caused by kidney yang deficiency including decreased vitality, cold pain in the waist and limbs, fatigue and decreased libido.

[0013] Furthermore, the dosage form of the drug is a gastrointestinal dosage form and a parenteral dosage form; the gastrointestinal dosage form is selected from powders, tablets, granules, pills, capsules, soft capsules, solutions, emulsions, and suspensions. The parenteral dosage form is selected from injections, sprays, aerosols, external solutions, liniments, ointments, pastes, and suppositories.

[0014] Furthermore, the pills are large honey pills or water-honey pills.

[0015] The Chinese medicine composition of the present invention improves physical fitness, enhances exercise ability, accelerates recovery from fatigue after exercise, and increases the levels of testosterone and estradiol in serum, thereby improving insomnia symptoms.

[0016] Another object of the present invention is to provide the use of the Chinese medicine composition with kidney-tonifying effect in preparing health products that help improve sleep and relieve physical fatigue.

[0017] Furthermore, the health care products are selected from tea, wine, bee products, drinks, soups, fresh juices, and medicinal foods.

[0018] Another object of the present invention is to provide a method for preparing the Chinese medicine composition with kidney-tonifying effect, wherein the Chinese medicine composition contains tea oil and the dosage form of the Chinese medicine composition is a large honey pill, comprising: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; then crushing the medicinal materials, sieving, and mixing them uniformly; mixing the uniformly mixed medicinal powder with tea oil and refined honey to form a soft material; dividing the soft material into small pieces and using a pill-making machine to make pills; packaging the pills;

[0019] When the Chinese medicine composition does not contain tea oil and the dosage form of the Chinese medicine composition is a large honey pill, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; crushing the medicinal materials, sieving, and mixing them uniformly; mixing the uniformly mixed medicinal powder with refined honey to form a soft material; dividing the soft material into small pieces and making pills using a pill-making machine; and packaging the pills;

[0020] When the Chinese medicine composition contains tea oil and the dosage form of the Chinese medicine composition is water-honey pills, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; then crushing the medicinal materials separately, sieving, and mixing them evenly; mixing the evenly mixed medicinal powder with tea oil and refined honey evenly, then making pills with an appropriate amount of water, and drying; packaging the pills;

[0021] When the Chinese medicine composition does not contain tea oil and the dosage form of the Chinese medicine composition is water-honey pills, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; then crushing the medicinal materials separately, sieving, and mixing them uniformly; making pills with the uniformly mixed medicinal powder, refined honey, and an appropriate amount of water, and drying; and packaging the pills.

[0022] The sieving standard is: all powders pass through an 80-mesh sieve, and no less than 95% of the powders pass through a 100-mesh sieve.

[0023] The mass ratio of the medicinal powder to refined honey is 1:0.6 to 1:1.5, preferably 1:0.6 to 1:0.8.

[0024] Specifically, the Chinese medicine composition is a large honey pill made from the following medicinal materials in parts by weight: Radix Rehmanniae Preparata, Fructus Corni with Wine, Rhizoma Dioscoreae, Rhizoma Alismatis, Cortex Moutan, Poria, and Camellia Oil; the preparation method is:

[0025] Step (1), pretreatment of medicinal materials: washing Radix Rehmanniae Preparata, Fructus Corni with wine, Rhizoma Dioscoreae, Rhizoma Alismatis, Poria and Cortex Moutan with ultrapure water, slicing and drying;

[0026] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0027] Step (3), preparing a soft material: mixing the evenly mixed medicinal powder in step (2) with tea oil and refined honey to form a soft material;

[0028] Step (4), pill making: Divide the soft material into small pieces and use an automatic pill making machine to make pills to obtain large honey pills.

[0029] The Chinese medicine composition is a large honey pill made from the following medicinal materials in parts by weight: litchi kernel, Rehmannia root, cornus fruit, yam, orientalis, peony bark, and Poria; the preparation method is:

[0030] Step (1), pretreatment of medicinal materials: washing litchi seeds, Rehmannia root, cornus officinalis, yam, oriental water rhizome, Poria cocos and peony bark with ultrapure water, slicing and drying;

[0031] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0032] Step (3), preparing a soft material: mixing the evenly mixed medicinal powder in step (2) with refined honey to form a soft material;

[0033] Step (4), pill making: the mixed soft material is divided into small pieces, and an automatic pill making machine is used to make pills to obtain large honey pills.

[0034] The Chinese medicine composition is a large honey pill made from the following medicinal materials in parts by weight: litchi kernel, Rehmannia root, wine-boiled cornus fruit, Chinese yam, oriental water plantain, peony bark, Poria cocos, and tea oil; the preparation method is:

[0035] Step (1), pretreatment of medicinal materials: washing litchi seeds, Rehmannia root, cornus officinalis, yam, oriental water rhizome, Poria cocos and peony bark with ultrapure water, slicing and drying;

[0036] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0037] Step (3), preparing a soft material: mixing the evenly mixed medicinal powder in step (2) with tea oil and refined honey to form a soft material;

[0038] Step (4), pill making: the mixed soft material is divided into small pieces, and an automatic pill making machine is used to make pills to obtain large honey pills.

[0039] The Chinese medicine composition is a water-honeyed pill made from the following medicinal materials in parts by weight: Radix Rehmanniae Preparata, Fructus Corni with wine, Rhizoma Dioscoreae, Rhizoma Alismatis, Cortex Moutan, Poria, and Camellia Oil; the preparation method is as follows:

[0040] Step (1), pretreatment of medicinal materials: washing Radix Rehmanniae Preparata, Fructus Corni with wine, Rhizoma Dioscoreae, Rhizoma Alismatis, Poria and Cortex Moutan with ultrapure water, slicing and drying;

[0041] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0042] Step (3), making pills: adding tea oil and refined honey to the evenly mixed medicinal powder in step (2), then making pills with an appropriate amount of water, and drying to obtain water-honey pills.

[0043] The Chinese medicine composition is a water-honeyed pill made from the following medicinal materials in parts by weight: litchi kernel, Rehmannia root, wine-boiled cornus fruit, Chinese yam, oriental water plantain, peony bark, and Poria; the preparation method is:

[0044] Step (1), pretreatment of medicinal materials: washing litchi seeds, Rehmannia root, cornus officinalis, yam, oriental water rhizome, Poria cocos and peony bark with ultrapure water, slicing and drying;

[0045] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0046] Step (3), making pills: adding refined honey to the evenly mixed medicinal powder in step (2), then making pills with an appropriate amount of water, and drying to obtain water-honey pills.

[0047] The Chinese medicine composition is a water-honeyed pill made from the following medicinal materials in parts by weight: litchi kernel, rehmannia root, cornus officinalis, yam, orientalis, peony bark, tuckahoe, and tea oil; the preparation method is:

[0048] Step (1), pretreatment of medicinal materials: washing litchi seeds, Rehmannia root, cornus officinalis, yam, oriental water rhizome, Poria cocos and peony bark with ultrapure water, slicing and drying;

[0049] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0050] Step (3), making pills: adding tea oil and refined honey to the evenly mixed medicinal powder in step (2), then making pills with an appropriate amount of water, and drying to obtain water-honey pills.

[0051] Furthermore, when the Chinese medicine composition is in the form of large honey pills, heat-sealed pills are packaged in a quantity of 9 g per pill; and when the Chinese medicine composition is in the form of water-honey pills, heat-sealed pills are packaged in a quantity of 6 g per pill.

[0052] According to traditional Chinese medicine theory, litchi seeds are warm in nature, bitter in taste, and belong to the liver, kidney, and bladder meridians. They have the effects of nourishing the kidney and astringing essence, promoting qi and dispersing stagnation, and dispelling cold and relieving pain. They are used to treat symptoms such as cold hernia abdominal pain, testicular swelling and pain, and dysmenorrhea. Tea oil, due to its unique sweet, cool, and bitter properties, occupies an important position in the field of traditional Chinese medicine. The sweetness of tea oil enables it to lubricate the intestines and effectively treat constipation; its coolness helps to remove heat and toxins from the body and plays a role in harmonizing yin and yang. The core of the present invention is that on the basis of Liuwei Dihuang Pill (prepared rehmannia root, oriental water chestnut, yam, wine-soaked cornus fruit, tuckahoe, peony bark), litchi kernel for warming and nourishing kidney yang and tea oil for harmonizing yin and yang are introduced, which not only inherits the therapeutic effect of Liuwei on kidney yin deficiency, but also has a therapeutic effect on kidney yang deficiency, so that the traditional Chinese medicine composition can effectively regulate and treat kidney yin deficiency, kidney yang deficiency and kidney yin and yang deficiency syndromes, and can play a role in the different pathological characteristics of kidney yin deficiency and kidney yang deficiency by improving physical fitness, accelerating fatigue recovery, improving insomnia and regulating testosterone and estradiol levels: on the one hand, it nourishes yin and blood, nourishes yin fluid, and improves symptoms such as fatigue and insomnia caused by kidney yin deficiency; on the other hand, it warms yang, assists yang, invigorates yang energy, and alleviates problems such as fatigue and slow recovery from fatigue caused by kidney yang deficiency. At the same time, its yin and yang-tonifying properties help restore the balance of yin and yang, and comprehensively improve the symptoms related to kidney deficiency. It has a significant effect on improving the symptoms caused by kidney yin deficiency, such as mood swings, soreness of waist and knees, hyperactivity of fire and yang, insomnia and dreaminess, and irregular menstruation in women. It can also effectively improve the symptoms of kidney yang deficiency, including decreased vitality, cold pain in the waist and limbs, fatigue, and decreased libido. At the same time, through the qi-promoting, stagnation-dispersing, cold-dispersing and analgesic effects of litchi kernels, combined with the intestinal lubrication effect of tea oil, it can effectively reduce the adverse reactions caused by long-term use of Liuwei, such as abdominal distension, nausea, vomiting, abdominal pain, gastrointestinal discomfort, loss of appetite, and constipation. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 The figure is a curve of body weight changes in rats after hydrocortisone administration.

[0054] Figure 2 The figures are weight gain curves of rats after drug administration; wherein A is the weight gain curve of rats with kidney yin deficiency after drug administration, and B is the weight gain curve of rats with kidney yang deficiency after drug administration.

[0055] Figure 3 The effect of drug administration on the swimming exhaustion time of rats with kidney yin deficiency, n = 5; compared with the normal group, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0056] Figure 4 The effect of drug administration on the swimming exhaustion time of rats with kidney yang deficiency, n = 5; compared with the normal group, ## P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0057] Figure 5 The effect of drug administration on the fatigue recovery time of rats with kidney yin deficiency, n = 5; compared with the normal group, # P<0.05; compared with the model group, *P<0.05, **P<0.01.

[0058] Figure 6 The effect of drug administration on the fatigue recovery time of rats with kidney yang deficiency, n = 5; compared with the normal group, # P<0.05; compared with the model group, *P<0.05, **P<0.01.

[0059] Figure 7 The effect of drug administration on testosterone level in male rats with kidney yin deficiency, n = 5; compared with the normal group, # P<0.05; **P<0.01 compared with the model group.

[0060] Figure 8 The effect of drug administration on testosterone level in male rats with kidney yang deficiency, n = 5; compared with the normal group, # P<0.05; compared with the model group, *P<0.05, **P<0.01.

[0061] Fig. 9 The effect of drug administration on estradiol levels in female rats with kidney yin deficiency, n=5; compared with the model group, *P<0.05, **P<0.01.

[0062] Fig.10 The effect of drug administration on estradiol levels in female rats with kidney-yang deficiency, n=5; compared with the model group, *P<0.05, **P<0.01. Specific implementation plan

[0063] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described in combination with the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0064] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0065] Example 1

[0066] Liuwei + tea oil pills are prepared from the following prescription: 160 parts by weight of Rehmannia root, 80 parts by weight of wine-boiled Cornus officinalis, 80 parts by weight of Chinese yam, 60 parts by weight of Alisma orientalis, 60 parts by weight of Paeonia suffruticosa, 60 parts by weight of Poria cocos, and 60 parts by weight of tea oil. The preparation method is as follows:

[0067] Step (1), pretreatment of raw medicinal materials: washing Radix Rehmanniae, Fructus Corni with wine, Rhizoma Dioscoreae, Rhizoma Alismatis, Poria and Cortex Moutan with ultrapure water, slicing and drying;

[0068] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0069] Step (3), preparing a soft material: mixing the medicinal powder uniformly mixed in step (2) with tea oil and refined honey to form a soft material; wherein the mass ratio of the medicinal powder to the refined honey is 1:0.8;

[0070] Step (4), pelleting: the soft material is divided into small pieces and pellets are made using an automatic pelletizing machine;

[0071] Step (5), packaging: heat-seal the pellets according to the packaging requirements with a packaging amount of 9 g per pellet.

[0072] Liuwei + Litchi Hexene Pills are prepared from the following prescription: 160 parts by weight of litchi hexene, 160 parts by weight of Rehmannia glutinosa, 80 parts by weight of wine-soaked cornus fruit, 80 parts by weight of Chinese yam, 60 parts by weight of oriental rhizome, 60 parts by weight of peony bark, and 60 parts by weight of Poria cocos. The preparation method is as follows:

[0073] Step (1), pretreatment of raw medicinal materials: washing litchi kernel, Rehmannia root, cornus officinalis, yam, oriental water rhizome, Poria cocos and peony bark with ultrapure water, slicing and drying;

[0074] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0075] Step (3), preparing a soft material: mixing the evenly mixed medicinal powder in step (2) with refined honey in a mass ratio of 1:0.8 to form a soft material;

[0076] Step (4), pill making: the mixed soft material is divided into small pieces and made into pellets using an automatic pill making machine;

[0077] Step (5), packaging: heat-seal the pellets according to the packaging requirements with a packaging amount of 9 g per pellet.

[0078] Liuwei+tea oil+litchi kernel pills are prepared from the following prescription: 160 parts by weight of litchi kernel, 160 parts by weight of Rehmannia root, 80 parts by weight of wine-soaked cornus fruit, 80 parts by weight of Chinese yam, 60 parts by weight of oriental rhizome, 60 parts by weight of peony bark, 60 parts by weight of Poria cocos, and 60 parts by weight of tea oil. The preparation method is as follows:

[0079] Step (1), pretreatment of raw medicinal materials: washing litchi seeds, Rehmannia root, cornus officinalis, yam, oriental water chestnuts, Poria cocos and peony bark with ultrapure water, slicing and drying;

[0080] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain a medicinal powder;

[0081] Step (3), preparing a soft material: mixing the medicinal powder uniformly mixed in step (2) with tea oil and refined honey to form a soft material; wherein the mass ratio of the medicinal powder to the refined honey is 1:0.8;

[0082] Step (4), pelleting: the soft material is divided into small pieces and pellets are made using an automatic pelletizing machine;

[0083] Step (5), packaging: heat-seal the pellets according to the packaging requirements with a packaging amount of 9 g per pellet.

[0084] Liuwei+tea oil+litchi kernel water-honeyed pills are prepared from the following prescription: 160 parts by weight of litchi kernel, 160 parts by weight of Rehmannia root, 80 parts by weight of wine-boiled cornus fruit, 80 parts by weight of Chinese yam, 60 parts by weight of oriental rhizome, 60 parts by weight of peony bark, 60 parts by weight of Poria cocos, and 60 parts by weight of tea oil. The preparation method is as follows:

[0085] Step (1), pretreatment of raw medicinal materials: litchi kernel, Rehmannia root, cornus officinalis, yam, oriental water chestnut, Poria cocos and peony bark are washed with ultrapure water, sliced ​​and dried respectively;

[0086] Step (2), batching, crushing, and mixing: accurately weigh the pre-treated medicinal materials according to the prescription, crush and sieve them separately, so that all of them pass through an 80-mesh sieve, and the powder that can pass through a 100-mesh sieve is not less than 95%, and then mix them evenly to obtain medicinal powder;

[0087] Step (3), making pills: adding tea oil and refined honey to the evenly mixed medicinal powder in step (2), making pills with an appropriate amount of water, and drying; wherein the mass ratio of medicinal powder to refined honey is 1:0.6;

[0088] Step (4), packaging: packaging the pills and heat-sealing them in a packaging volume of 6 g per pill.

[0089] Example 2

[0090] 1. Construction of animal models of kidney-yin deficiency and kidney-yang deficiency

[0091] 1 Experimental plan

[0092] Animals: SD rats, half male and half female, 4 weeks old.

[0093] Groups: normal group, kidney yin deficiency group, kidney yang deficiency group.

[0094] Modeling method: After 7 days of adaptive feeding, SD rats were randomly divided into a normal group and a model group (kidney yin deficiency group and kidney yang deficiency group).

[0095] ① Normal group: given an equal volume of normal saline every day for 10 consecutive days.

[0096] ② Kidney Yin deficiency group: Rats were gavaged with a large dose of hydrocortisone solution (50 mg / kg) at a fixed time point every day, once a day, with free access to water and food for 10 consecutive days.

[0097] ③ Kidney Yang Deficiency Group: Rats were intraperitoneally injected with hydrocortisone solution (25 mg / kg) at a fixed time point every day, once a day, with free access to water and food for 10 consecutive days.

[0098] Model evaluation: ① Before and after modeling, the rats in each group were weighed daily to observe the changes in their weight. ② Before and after modeling, the activity, mental state, hair gloss, eating, defecation, and death of the rats were observed daily.

[0099] 2 Modeling results

[0100] ① Changes in rat body weight

[0101] like Figure 1 As shown in the figure, during the experiment, the weight of the rats in the normal group increased steadily. Compared with the normal group, the rats in the kidney yin deficiency group lost weight and their weight gain rate gradually slowed down; the rats in the kidney yang deficiency group also lost weight and their weight gain was slow.

[0102] ② Impact on the living conditions of rats

[0103] During the experiment, the rats in the normal group gained weight steadily, moved freely, had moist hair, and had yellow-brown stools that were neither dry nor watery. Compared with the normal group, the rats in the kidney yin deficiency group had dry stools, were easily startled and irritated, and had dry and dull hair, which were basically consistent with the state of kidney yin deficiency, indicating that the kidney yin deficiency rat model was successfully replicated; the rats in the kidney yang deficiency group had loose stools, fear of cold, arched backs, slow movements, and erect hair, which were basically consistent with the state of kidney yang deficiency, indicating that the kidney yang deficiency rat model was successfully replicated.

[0104] 2. Investigating the effect of Chinese medicine combination on improving the rat model of kidney yin deficiency and kidney yang deficiency

[0105] 1 Experimental plan

[0106] Grouping:

[0107] ① Randomly grab 5 female and 5 male rats from the normal group as the normal group with kidney yin deficiency, and randomly grab 5 female and 5 male rats from the normal group as the normal group with kidney yang deficiency; the rats in the two normal groups were not treated in any way and were raised normally.

[0108] ② Randomly grab 5 female and 5 male rats with kidney yin deficiency model as the kidney yin deficiency model group, without any treatment, and feed normally.

[0109] ③ Randomly grab 5 female and 5 male rats with kidney yin deficiency model as the kidney yin deficiency positive drug group and give them Liuwei Dihuang Pills. The administration method is: disperse Liuwei Dihuang Pills in distilled water and then gavage, the dosage is 371.5 mg / kg, once a day, for 20 consecutive days.

[0110] ④ Randomly grab 15 female and male rats of kidney yin deficiency model and divide them into Liuwei + tea oil group, Liuwei + litchi kernel group, Liuwei + tea oil + litchi kernel group, 10 rats in each group, half of which are female and half are male, and give them the corresponding Chinese medicine composition respectively, the administration method: Liuwei + tea oil pills (Example 1), Liuwei + litchi kernel pills (Example 1), Liuwei + tea oil + litchi kernel pills (Example 1) are dispersed in distilled water and then gavage, the dosage is 371.5 mg / kg, once a day, for 20 consecutive days.

[0111] ⑤ Randomly grab 5 female and 5 male rats with kidney yang deficiency model as the kidney yang deficiency model group, without any treatment, and feed normally.

[0112] ⑥ Randomly grab 5 female and 5 male rats of kidney yang deficiency model as the kidney yang deficiency positive drug group and give them Jinkui Shenqi Pills. The administration method is: disperse Jinkui Shenqi Pills in distilled water and then gavage, the dosage is 185.8 mg / kg, once a day, for 20 consecutive days.

[0113] ⑦ Fifteen female and male rats of kidney yang deficiency model were randomly selected and divided into six-flavor + tea oil group, six-flavor + litchi kernel group, and six-flavor + tea oil + litchi kernel group, with 10 rats in each group, half of which were male and half were female. They were given the corresponding Chinese medicine composition, and the administration method was: six-flavor + tea oil pills (Example 1), six-flavor + litchi kernel pills (Example 1), and six-flavor + tea oil + litchi kernel pills (Example 1) were dispersed in distilled water and then gavage, the dosage was 371.5 mg / kg, once a day, for 20 consecutive days.

[0114] Experimental methods:

[0115] ① During the administration process, the rats' activity, mental state, hair gloss, eating, defecation, and death were observed daily.

[0116] ② During the administration process, the rats were weighed using an electronic weighing scale at fixed time points, the weight changes of the rats in each group were recorded, and the weight changes of the rats in each group were observed.

[0117] ③ 22h after the last administration, fast for 2h, tie a lead block of 10% of the rat's body weight to the base of the rat's tail, place the rats in each group in (25±2)℃ water and swim until exhaustion, and record the exhaustion time. Exhaustion judgment criteria: The rat sinks in the water for more than 10s and cannot complete the righting reaction when placed on a flat surface. The rat loses coordinated movement and runs around in the water without direction, which is considered exhaustion even if it does not reach 10s. Take out the rat, put it in a cage for observation, and record the time from the end of weight-bearing swimming to the complete recovery of appetite and mental state (fatigue recovery time).

[0118] 2 Experimental results

[0119] ① Effect of Chinese herbal medicine combination on the living conditions of rats

[0120] During the drug administration, the rats in the normal group gained weight steadily, had sensitive reactions, had moist hair, and had yellow-brown stools that were neither dry nor watery. Compared with the normal group, the rats in the kidney yin deficiency model group gained weight slowly, were irritable, had arched backs, had dry hair, had increased food intake and water intake, and had dry and hard stools with a foul odor. Compared with the kidney yin deficiency model group, the above symptoms in each drug administration group were improved to a certain extent, with rats gaining weight rapidly, being more docile, having shiny hair, having no dry and hard stools, and having less arched backs.

[0121] Compared with the normal group, rats in the kidney yang deficiency model group had slow weight gain, reduced activity, slow reaction, curled back, fear of cold, dry and dull hair, and loose stools. Compared with the kidney yang deficiency model group, the above symptoms in each drug-treated group were improved to a certain extent, and the rats had rapid weight gain, increased activity, quick reaction, warm limbs, and smooth and shiny hair.

[0122] The experimental results show that whether adding tea oil and litchi kernels together to Liuwei or adding tea oil or litchi kernels alone to Liuwei can effectively improve the symptoms of rats with kidney yin deficiency and kidney yang deficiency.

[0123] ②Effect of Chinese medicine combination on body weight of rats

[0124] Figure 2 A is the weight gain curve of kidney yin deficiency rats after administration. Figure 2A shows that in rats with kidney yin deficiency, on the second day of administration, the weight of rats in all drug groups increased rapidly; on the fourth day of administration, the weight growth rate of all drug groups returned to a normal and gentle state; on the 12th day of administration, the weight of rats in all drug groups increased rapidly. During the drug administration process, the weight growth rate of all drug groups was higher than that of the model group. At the end of the experiment, the overall weight of rats in the kidney yin deficiency positive drug group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group was higher than that of rats in the kidney yin deficiency model group, and was basically close to the average weight of the normal group.

[0125] Figure 2 B is the weight gain curve of kidney yang deficiency rats after administration. Figure 2 B shows that in rats with kidney yang deficiency, the weight of rats in all drug groups increased rapidly on the second day of drug administration. The weight growth rate of all drug groups during the drug administration process was higher than that of the model group. At the end of the experiment, the overall weight of rats in the kidney yang deficiency positive drug group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group was higher than that of rats in the kidney yang deficiency model group, and was basically close to the average weight of the normal group.

[0126] The experimental results show that whether adding tea oil and litchi kernels to Liuwei together, or adding tea oil or litchi kernels alone to Liuwei, can increase the weight gain rate of rats with kidney yin deficiency and kidney yang deficiency.

[0127] ③ The Chinese medicine combination prolongs the time of rats swimming to exhaustion

[0128] Figure 3 The effect of drug administration on the swimming exhaustion time of rats with kidney yin deficiency was investigated by Figure 3 It can be seen that in rats with kidney yin deficiency, the model group had a shorter swimming time to exhaustion than the normal group. Compared with the kidney yin deficiency model group, the positive drug group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group were able to significantly prolong the time of rats swimming to exhaustion, and the Liuwei + tea oil + litchi kernel group had the most significant effect in prolonging the time of rats swimming to exhaustion, which was better than the other drug groups.

[0129] Figure 4 To investigate the effect of drug administration on the swimming exhaustion time of rats with kidney yang deficiency. Figure 4 It can be seen that in rats with kidney yang deficiency, the model group had a shorter swimming time to exhaustion than the normal group. Compared with the kidney yang deficiency model group, the kidney yang deficiency positive drug group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group were able to significantly prolong the time of rats swimming to exhaustion, and the Liuwei + tea oil + litchi kernel group had the most significant effect in prolonging the time of rats swimming to exhaustion, which was better than the other drug groups.

[0130] The experimental results show that adding litchi kernel and tea oil to Liuwei Digest can effectively prolong the time that rats can swim to exhaustion, suggesting that adding litchi kernel and tea oil to Liuwei Digest can improve the physical fitness and exercise endurance of rats, and the effect of improving the physical fitness of rats is better than adding tea oil or litchi kernel alone to Liuwei Digest.

[0131] ④ The Chinese medicine combination shortens the fatigue recovery time of rats

[0132] Figure 5 To investigate the effect of drug administration on the fatigue recovery time of rats with kidney yin deficiency. Figure 5 It can be seen that in the rats with kidney yin deficiency, the model group rats took longer to recover from fatigue than the normal group. Compared with the kidney yin deficiency model group, the kidney yin deficiency positive medicine group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group were able to shorten the fatigue recovery time of rats.

[0133] Figure 6 The effect of drug administration on the fatigue recovery time of rats with kidney yang deficiency was analyzed. Among rats with kidney yang deficiency, the model group took longer to recover from fatigue than the normal group. Compared with the model group with kidney yang deficiency, the positive drug group with kidney yang deficiency, the Liuwei + tea oil group, the Liuwei + litchi kernel group, and the Liuwei + tea oil + litchi kernel group were able to shorten the fatigue recovery time of rats.

[0134] The above results show that adding litchi kernel and tea oil to Liuwei can effectively shorten the time required for rats to recover from fatigue, suggesting that adding litchi kernel and tea oil to Liuwei can promote recovery from sports fatigue and produce anti-fatigue effect, and the anti-fatigue effect is better than adding tea oil or litchi kernel alone to Liuwei.

[0135] 3. Test the effect of the Chinese medicine composition on the testosterone level of male SD rats

[0136] 1 Experimental plan

[0137] Grouping:

[0138] ① Randomly grab 5 normal male rats as the normal group, without any treatment, and feed normally.

[0139] ② Randomly grab 5 male rats with kidney yin deficiency model as the kidney yin deficiency model group, without any treatment, and feed normally.

[0140] ③ Randomly grab 5 male rats with kidney yin deficiency model as the kidney yin deficiency positive drug group and give them Liuwei Dihuang Pills. The administration method is: disperse Liuwei Dihuang Pills in distilled water and then gavage. The dosage is 371.5 mg / kg, once a day, for 20 consecutive days.

[0141] ④ 15 male rats with kidney yin deficiency model were randomly selected and divided into six flavors + tea oil group, six flavors + litchi kernel group, six flavors + tea oil + litchi kernel group, 5 rats in each group, and given corresponding Chinese medicine compositions, respectively. The administration method was: six flavors + tea oil pills (Example 1), six flavors + litchi kernel pills (Example 1), six flavors + tea oil + litchi kernel pills (Example 1) were dispersed in distilled water and then gavage, the dosage was 371.5 mg / kg, once a day, for 20 consecutive days.

[0142] ⑤ Randomly grab 5 male rats with kidney yang deficiency model as the kidney yang deficiency model group, without any treatment, and feed normally.

[0143] ⑥ Randomly grab 5 male rats with kidney yang deficiency model as the kidney yang deficiency positive drug group and give them Jinkui Shenqi Pills. The dosage is as follows: disperse Jinkui Shenqi Pills in distilled water and then gavage. The dosage is 185.8 mg / kg, once a day, for 20 consecutive days.

[0144] ⑦ Fifteen male rats with kidney yang deficiency model were randomly selected and divided into six flavors + tea oil group, six flavors + litchi kernel group, and six flavors + tea oil + litchi kernel group, with 5 rats in each group, and given the corresponding Chinese medicine composition, respectively. The administration method was: six flavors + tea oil pills (Example 1), six flavors + litchi kernel pills (Example 1), and six flavors + tea oil + litchi kernel pills (Example 1) were dispersed in distilled water and then gavage), the dosage was 371.5 mg / kg, once a day, for 20 consecutive days.

[0145] Experimental method: 12 hours after the last administration, blood was collected from the eyeballs and centrifuged to obtain serum, and the testosterone content in the serum of male rats was determined.

[0146] 2 Experimental results

[0147] Testosterone is the most important male sex hormone, also known as androgen. It is mainly secreted by the male testicles. At the same time, the female ovaries and adrenal glands can also secrete a small amount of testosterone. Testosterone levels can be used to determine whether there are abnormalities in testicular function, penile erectile function, sexual desire and sexual function, muscle mass and strength, semen quality, etc.

[0148] Figure 7 , Figure 8 These are the effects of drug administration on the testosterone levels of male rats with kidney yin deficiency and kidney yang deficiency, respectively.

[0149] Depend on Figure 7 It can be seen that in male rats with kidney yin deficiency, the testosterone level of rats in the kidney yin deficiency model group was lower than that in the normal group. Compared with the rats in the kidney yin deficiency model group, the testosterone levels of rats in the kidney yin deficiency positive medicine group, the six-flavor tea oil group, the six-flavor litchi kernel group, and the six-flavor tea oil + litchi kernel group were all increased, and the testosterone level of rats in the six-flavor tea oil + litchi kernel group increased most significantly.

[0150] Depend on Figure 8 It can be seen that in male rats with kidney yang deficiency, the testosterone level of rats in the kidney yang deficiency model group was lower than that in the normal group. Compared with the rats in the kidney yang deficiency model group, the testosterone levels of rats in the kidney yang deficiency positive medicine group, the six-flavor tea oil group, the six-flavor litchi kernel group, and the six-flavor tea oil + litchi kernel group were all increased, and the testosterone level of rats in the six-flavor tea oil + litchi kernel group increased most significantly.

[0151] The experimental results show that adding litchi kernel and / or tea oil to Liuwei can effectively increase the testosterone level of male rats, and is expected to enhance sexual function, sexual desire, and improve penile erection function, thereby improving the symptoms of kidney deficiency. The effect is better than adding tea oil or litchi kernel alone to Liuwei.

[0152] IV. Testing the effect of the Chinese medicine composition on estradiol levels in female SD rats

[0153] 1 Experimental plan

[0154] Grouping:

[0155] ① Randomly capture 5 female rats from the normal group as the normal group, without any treatment, and feed normally.

[0156] ② Randomly grab 5 female rats with kidney yin deficiency model as the kidney yin deficiency model group, without any treatment, and feed normally.

[0157] ③ Randomly grab 5 female rats with kidney yin deficiency model as the kidney yin deficiency positive drug group and give them Liuwei Dihuang Pills. The administration method is: disperse in distilled water and then gavage. The dosage is 371.5 mg / kg, once a day, for 20 consecutive days.

[0158] ④ Fifteen female rats with kidney yin deficiency model were randomly selected and divided into six flavors + tea oil group, six flavors + litchi kernel group, and six flavors + tea oil + litchi kernel group, with 5 rats in each group, and the corresponding Chinese medicine compositions were given respectively. The administration method was: six flavors + tea oil pills (Example 1), six flavors + litchi kernel pills (Example 1), and six flavors + tea oil + litchi kernel pills (Example 1) were dispersed in distilled water and then gavage, and the dosage was 371.5 mg / kg, once a day, for 20 consecutive days.

[0159] ⑤ Randomly grab 5 female rats with kidney yang deficiency model as the kidney yang deficiency model group, without any treatment, and feed normally.

[0160] ⑥ Randomly grab 5 female rats with kidney yang deficiency model as the kidney yang deficiency positive drug group, and give them Jinkui Shenqi Pills 185.8 mg / kg, dispersed in distilled water and then gavage, once a day for 20 consecutive days.

[0161] ⑦ Fifteen female rats with kidney yang deficiency model were randomly selected and divided into six flavors + tea oil group, six flavors + litchi kernel group, and six flavors + tea oil + litchi kernel group, with 5 rats in each group, and given the corresponding Chinese medicine composition, respectively. The administration method was: six flavors + tea oil pills (Example 1), six flavors + litchi kernel pills (Example 1), and six flavors + tea oil + litchi kernel pills (Example 1) were dispersed in distilled water and then gavage, and the dosage was 371.5 mg / kg, once a day, for 20 consecutive days.

[0162] Experimental method: 12 hours after the last administration, blood was collected by removing the eyeballs, and serum was obtained by centrifugation to measure the estradiol content in the serum of female rats.

[0163] 2 Experimental results

[0164] Estradiol mainly promotes and regulates the normal development of female sexual organs and secondary sexual characteristics in the female body. The level of estradiol can reflect the functional status of the ovaries.

[0165] Fig. 9 The effect of drug administration on the testosterone level of male rats with kidney yin deficiency and kidney yang deficiency; Fig.10 To investigate the effect of drug administration on the estradiol level in female rats with kidney yin deficiency and kidney yang deficiency.

[0166] Depend on Fig. 9 It can be seen that in female rats with kidney yin deficiency, compared with the rats in the kidney yin deficiency model group, the estradiol levels of rats in the kidney yin deficiency positive medicine group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group were all increased, and the estradiol level of rats in the Liuwei + tea oil + litchi kernel group increased most significantly.

[0167] Depend on Fig.10 It can be seen that in female rats with kidney yang deficiency, compared with the rats in the kidney yang deficiency model group, the estradiol levels of rats in the kidney yang deficiency positive medicine group, Liuwei + tea oil group, Liuwei + litchi kernel group, and Liuwei + tea oil + litchi kernel group were all increased, and the estradiol level of rats in the Liuwei + tea oil + litchi kernel group increased most significantly.

[0168] The experimental results show that adding litchi kernel and / or tea oil to Liuwei can effectively increase the estradiol level in female rats, which is expected to improve ovarian function and regulate menstruation, thereby improving the symptoms of kidney deficiency, and the effect is better than adding tea oil or litchi kernel alone to Liuwei.

[0169] Example 3

[0170] Testing the effect of Chinese herbal medicine combination on improving insomnia symptoms

[0171] 1 Experimental plan

[0172] Sample information: 30 patients were selected, aged 18 to 65 years old, with an average age of 28 years. The shortest course of disease was 1 month, the longest was 2 years, and the average course of disease was 1 year.

[0173] Treatment method: Use Liuwei + tea oil + litchi kernel water honey pill (Example 1), take with warm water, 6g / time, 1 day / 2 times, take in the morning and evening, one course of treatment is 4 weeks, observe the efficacy after 3 courses of treatment (during the treatment, it is forbidden to use sleeping aids, avoid consuming strong tea, alcohol, coffee, spicy and stimulating food).

[0174] Experimental methods:

[0175] Criteria for selecting cases: The clinical manifestations of insomnia include difficulty falling asleep, difficulty maintaining sleep, early awakening, poor sleep quality, fatigue, inattention, excessive concern or anxiety about sleep, irritability and emotional instability, headache and physical discomfort, and decreased interest in daily activities. Those with 2-3 of the above symptoms can be used as the criteria for selecting cases of insomnia.

[0176] Efficacy evaluation criteria: ① Cured: the patient's main clinical symptoms (difficulty falling asleep, frequent dreams and easy awakening, chills, etc.) completely disappeared, the sleep time reached more than 6 hours, the sleep quality was high, and the patient felt energetic after waking up; ② Improved: the patient's main clinical symptoms (difficulty falling asleep, frequent dreams and easy awakening, chills, etc.) were alleviated, but the sleep time was less than 6 hours; ③ Ineffective: the patient's insomnia symptoms did not improve significantly before and after treatment or worsened.

[0177] 2 Experimental results

[0178] The results are shown in Table 1.

[0179] Table 1. Treatment results

[0180] Total number of cases get well Improvement invalid Cure rate Total Effectiveness 30 cases 20 cases 8 cases 2 cases 66％ 93％

[0181] After the patients took Liuwei + tea oil + litchi kernel water honey pills for 3 courses of treatment, 20 cases were cured, 8 cases improved, and 2 cases were ineffective, with a cure rate of 66% and a total effective rate of 93%. It can be seen that the Chinese medicine composition of the present invention has a very high cure rate and total effective rate for patients with sleep disorders, indicating that the Chinese medicine composition of the present invention can effectively improve the patients' sleep quality, prolong sleep time, and meet the patients' physiological sleep requirements.

[0182] Typical cases among 30 patients:

[0183] 1. Male, 55 years old, cleaner. The patient reported that he had a heavy mental burden, difficulty falling asleep at night, frequent dreams and easy awakening, poor sleep quality, headache after waking up, and mental fatigue. After taking Liuwei + tea oil + litchi kernel water honey pill for one course of treatment, he reported that the above symptoms basically disappeared, his sleep quality was good, he was energetic after waking up, and there were no adverse reactions. He has recovered.

[0184] 2. Male, 42 years old, engineer. The patient reported that he often suffered from insomnia, back pain, cold back, frequent urination, poor sexual intercourse, and rare sperm. After taking Liuwei + tea oil + litchi kernel honey pill for one course of treatment, he reported that the cold back symptom was alleviated, the back pain symptom disappeared, the symptoms of frequent urination and insomnia were significantly improved, the sperm became thicker, there was no insomnia symptom, no adverse reactions occurred, and he was cured.

[0185] 3. Female, 36 years old, university teacher. The patient reported that she had difficulty falling asleep at night for the past two months, with a chaotic mind and difficulty calming down. She had a shallow sleep and woke up easily. After waking up, she felt mentally exhausted, accompanied by anxiety and irritability. After taking Liuwei + tea oil + litchi kernel water honey pills for two courses of treatment, she reported that the above symptoms completely disappeared, her sleep quality was significantly improved, she was in a good mental state after waking up, she was in a relaxed mood, her sleep returned to normal, and there were no adverse reactions. She has recovered.

[0186] 4. Female, 28 years old, nurse. The patient said that she could only sleep for 3 hours every night due to work pressure one year ago, and she had palpitations, anxiety, irritability, dizziness, sticky stools, and menstrual cycle disorders. After taking Liuwei + tea oil + litchi kernel water honey pills for 3 courses, she said that anxiety, irritability, and dizziness symptoms completely disappeared, her menstrual period returned to normal, she fell asleep easily and slept for more than 6 hours, without any adverse reactions, and she has recovered.

[0187] 5. Female, 22 years old, graduate student. The patient reported that she had insomnia and dreaminess for 2 years, and her sleep time was no more than 4 hours per night, accompanied by dizziness, tinnitus, irritability, sweating, dizziness, and irritability after waking up. After taking Liuwei + tea oil + litchi kernel water honey pills for 3 courses, she reported that the above symptoms have improved, her sleep time exceeded 4 hours, her dreaminess has been alleviated, she is in a good mood, and there are no adverse reactions. She has improved.

[0188] 6. Male, 18 years old, high school student. The patient reported that he had great academic pressure, difficulty falling asleep, and was easily awakened when sleeping lightly, accompanied by anxiety and excessive tension. After taking Liuwei + tea oil + litchi kernel water honey pills for 2 courses, he reported that the above symptoms completely disappeared, his sleep returned to normal, he slept deeply and was not easily awakened, and no adverse reactions occurred. He has recovered.

[0189] Through a large number of component and dosage screening experiments, it was found that on the basis of traditional Liuwei Dihuang Pills, litchi kernels and tea oil were added, introducing Chinese herbal ingredients that can warm the kidney yang and regulate the balance of yin and yang. Both kidney yin deficiency and kidney yang deficiency can be effectively regulated and treated. At the same time, it can effectively reduce abdominal distension, nausea, vomiting, abdominal pain, gastrointestinal discomfort, loss of appetite, constipation and other adverse reactions caused by long-term use of Liuwei Dihuang Pills.

[0190] The inventors observed through experiments that adding litchi kernels and tea oil to Liuwei Dihuang Wan can significantly improve the physical strength and athletic ability of rats, accelerate the recovery of fatigue after exercise, and increase the levels of testosterone and estradiol in serum. These results show that the Chinese medicine composition has obvious improvements in improving the symptoms caused by kidney yin deficiency, such as mood swings, soreness of the waist and knees, hyperactivity of fire and yang, insomnia and dreaminess, and irregular menstruation in women. At the same time, it can also effectively improve the symptoms of kidney yang deficiency, including decreased vitality, cold pain in the waist and limbs, fatigue, and loss of libido. In addition, experimental data also show that compared with adding tea oil or litchi kernel alone, this composite addition method is more superior in therapeutic effect.

[0191] Those skilled in the art should understand that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, and these changes and improvements fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A Chinese medicine composition having kidney-tonifying effect, characterized in that: The Chinese medicine composition is prepared from the following medicinal materials in parts by mass: 40-500 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe, and 1-200 parts of tea oil; or prepared from the following medicinal materials in parts by mass: 40-500 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe; or prepared from the following medicinal materials in parts by mass: 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe, and 1-200 parts of tea oil.

2. The Chinese medicine composition according to claim 1 is characterized in that: The Chinese medicine composition is prepared from the following medicinal materials in parts by mass: 160 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe, and 40-60 parts of tea oil; or prepared from the following medicinal materials in parts by mass: 160 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe; or prepared from the following medicinal materials in parts by mass: 160 parts of rehmannia root, 80 parts of cornus fruit with wine, 80 parts of yam, 60 parts of oriental rhizome, 60 parts of peony bark, 60 parts of tuckahoe, and 40-60 parts of tea oil.

3. The Chinese medicine composition according to claim 2 is characterized in that: The traditional Chinese medicine composition is prepared from the following medicinal materials in parts by weight: 160 parts of litchi seeds, 160 parts of rehmannia root, 80 parts of cornus fruit, 80 parts of yam, 60 parts of oriental water chestnuts, 60 parts of peony bark, 60 parts of tuckahoe, and 60 parts of tea oil.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating kidney deficiency; preferably, use of the Chinese medicine composition in the preparation of a medicament for treating kidney yin deficiency and / or kidney yang deficiency; more preferably, use of the Chinese medicine composition in the preparation of a medicament for treating kidney deficiency by exerting at least one of the following effects: promoting recovery from sports fatigue, increasing serum testosterone and estradiol levels, and improving insomnia symptoms.

5. The use according to claim 4, characterized in that: The dosage form of the drug is a gastrointestinal dosage form and a parenteral dosage form; the gastrointestinal dosage form is selected from powders, tablets, granules, pills, capsules, soft capsules, solutions, emulsions, and suspensions; the parenteral dosage form is selected from injections, sprays, aerosols, external solutions, liniments, ointments, pastes, and suppositories.

6. The use according to claim 5, characterized in that: The pills are large honey pills and water-honey pills.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of health products that help improve sleep and relieve physical fatigue.

8. The use according to claim 7, characterized in that: The health care products are selected from tea, wine, bee products, drinks, soups, fresh juices and medicinal foods.

9. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: When the Chinese medicine composition contains tea oil and the dosage form of the Chinese medicine composition is a large honey pill, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; crushing the medicinal materials, sieving, and mixing them uniformly; mixing the uniformly mixed medicinal powder with tea oil and refined honey to form a soft material; dividing the soft material into small pieces and making pills using a pill-making machine; and packaging the pills; When the Chinese medicine composition does not contain tea oil and the dosage form of the Chinese medicine composition is a large honey pill, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; crushing the medicinal materials, sieving, and mixing them uniformly; mixing the uniformly mixed medicinal powder with refined honey to form a soft material; dividing the soft material into small pieces and making pills using a pill-making machine; and packaging the pills; When the Chinese medicine composition contains tea oil and the dosage form of the Chinese medicine composition is water-honey pills, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; then crushing the medicinal materials separately, sieving, and mixing them evenly; mixing the evenly mixed medicinal powder with tea oil and refined honey evenly, then making pills with an appropriate amount of water, and drying; packaging the pills; When the Chinese medicine composition does not contain tea oil and the dosage form of the Chinese medicine composition is water-honey pills, the method comprises: washing the medicinal materials with ultrapure water to remove impurities, slicing, and drying; then crushing the medicinal materials separately, sieving, and mixing them uniformly; making pills with the uniformly mixed medicinal powder, refined honey, and an appropriate amount of water, and drying; and packaging the pills.

10. The method for preparing the Chinese medicine composition according to claim 9, characterized in that: The screening standard is: all powders can pass through an 80-mesh sieve, and no less than 95% of the powders can pass through a 100-mesh sieve; the mass ratio of the medicinal powder to the refined honey is 1:0.6 to 1:1.5, preferably 1:0.6 to 1:0.8.

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