Traditional Chinese medicine composition for treating liver-kidney yin deficiency nervous tinnitus and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating liver-kidney yin deficiency nervous tinnitus. The traditional Chinese medicine composition is prepared from, by mass, 40-50 parts of prepared rehmannia roots, 20-25 parts of fructus lycii, 25-30 parts of fructus corni, 25-30 parts of rhizoma dioscoreae, 25-30 parts of rhizoma alismatis, 20-25 parts of cortex moutan, 20-25 parts of poria cocos, 25-30 parts of radix polygoni multiflori preparata, 20-25 parts of rhizoma acori graminei, 25-30 parts of radix polygalae, 15-20 parts of rhizoma anemarrhenae, 15-20 parts of cortex phellodendri, 25-30 parts of fructus schisandrae chinensis, 25-30 parts of radix ophiopogonis, 15-20 parts of periostracum cicadae and 10-15 parts of fructus xanthii. The invention further provides a preparation method of the traditional Chinese medicine composition. The preparation method comprises the following steps: weighing decoction pieces of sixteen medicinal materials in parts by mass, classifying, removing impurities, cleaning, drying, crushing and sieving; collecting medicinal powder which is brown yellow or earthy yellow powder and is sour and slightly bitter in taste; the tool cover is arranged in the container; and feeding to a capsule filling group for filling to obtain a capsule preparation finished product. The traditional Chinese medicine composition has the advantages that the traditional Chinese medicine composition can nourish yin, lessen fire and inhibit tinnitus by taking yin nourishing, liver and kidney nourishing as the basis and combining the compatibility thought of calming the heart, soothing the nerves, invigorating the spleen, replenishing qi, dredging collaterals and inducing resuscitation, and the symptoms of tinnitus and deafness are more effectively treated.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating neurotic tinnitus due to liver-kidney yin deficiency and a preparation method thereof. Background Art

[0002] According to modern medicine, neurological tinnitus and hearing loss is a disease caused by lesions in the auditory nerve of the inner ear and the auditory center of the brain, which leads to hearing loss or even hearing loss. Neurological hearing loss is a common and highly prevalent disease, and its occurrence is accompanied by tinnitus and a stuffy feeling in the ears. About half of the patients also experience symptoms of dizziness, nausea and vomiting.

[0003] In the diagnosis of Western medicine, referring to the book Otorhinolaryngology edited by Kong Weijia, People's Medical Publishing House, 1st edition in February 2002, the diagnostic criteria for the symptoms of neurological tinnitus and deafness are: intermittent or continuous tinnitus, aggravated by fatigue and insomnia, especially at night. Tinnitus is like cicada chirping, electric current sound, and buzzing sound; the early hearing loss is mainly high-frequency. With the passage of tinnitus, the hearing of high, medium and low frequencies all decreases; the external auditory canal is unobstructed, the tympanic membrane is intact, and the Eustachian tube is unobstructed; the temporal bone CT scan shows that the structure of the middle ear and inner ear is normal. The treatment principle of modern medicine for neurological deafness is to improve the microcirculation of the inner ear, and a variety of treatment measures such as detoxification, desensitization, vasodilator drugs, neurotrophic drugs, hyperbaric oxygen, and external counterpulsation are adopted to achieve certain therapeutic effects.

[0004] The diagnosis of traditional Chinese medicine does not only stop at the analysis of external symptoms, but also emphasizes the ability to fight diseases from the improvement of the body's overall function. In traditional Chinese medicine, for patients with persistent or intermittent tinnitus symptoms, the dialectical classification according to the cause can include: liver and kidney yin deficiency, retention of evil toxins, qi and blood stasis, liver and kidney yin deficiency, liver and gallbladder damp heat, spleen and stomach weakness, etc.

[0005] Among them, patients with tinnitus due to liver-kidney yin deficiency often present symptoms of gradually becoming severe, accompanied by dry mouth, insomnia and other symptoms. Among the existing traditional Chinese medicine treatment methods, acupuncture therapy, or Liuwei Dihuang Pills or decoctions are mostly used to improve the deafness and tinnitus caused by liver-kidney yin deficiency, and good therapeutic effects have been achieved; but for patients who are not convenient to come for regular medical treatment, it is difficult to cooperate with continuous acupuncture therapy, and they can only use prescription preparations for treatment. Therefore, it is particularly necessary to develop a prescription medicine with strong pertinence and good efficacy for the symptoms of tinnitus and deafness caused by liver-kidney yin deficiency. Summary of the invention

[0006] Aiming at the problem that there are few prescriptions for treating tinnitus induced by liver-kidney yin deficiency in the prior art, but the efficacy of the prescriptions is slightly low, the present invention provides a Chinese medicine composition for treating neurotic tinnitus induced by liver-kidney yin deficiency and a preparation method thereof.

[0007] The technical scheme of the present invention is as follows: A Chinese medicine composition for treating neurological tinnitus due to liver-kidney yin deficiency, comprising, by mass: 40-50 parts of Rehmannia root, 20-25 parts of Lycium barbarum, 25-30 parts of Cornus officinalis, 25-30 parts of Dioscorea opposita, 25-30 parts of Alisma orientalis, 20-25 parts of Paeonia suffruticosa, 20-25 parts of Poria cocos, 25-30 parts of processed Polygonum multiflorum, 20-25 parts of Acorus calamus, 25-30 parts of Polygala tenuifolia, 15-20 parts of Anemarrhena asphodeloides, 15-20 parts of Phellodendron chinense, 25-30 parts of Schisandra chinensis, 25-30 parts of Ophiopogon japonicus, 15-20 parts of Periostracum cicadae, and 10-15 parts of Xanthium sibiricum.

[0008] Preferably, the ingredients in parts by mass include: 45.6 parts of Rehmannia glutinosa, 22.9 parts of Lycium barbarum, 28.6 parts of Cornus officinalis, 28.6 parts of Dioscorea opposita, 28.6 parts of Alisma orientalis, 22.9 parts of Paeonia suffruticosa, 22.9 parts of Poria, 28.6 parts of processed Polygonum multiflorum, 22.9 parts of Acorus calamus, 28.6 parts of Polygala tenuifolia, 17.1 parts of Anemarrhena asphodeloides, 17.1 parts of Phellodendron chinense, 28.6 parts of Schisandra chinensis, 28.6 parts of Ophiopogon japonicus, 17.1 parts of Periostracum cicadae, and 11.3 parts of Xanthium sibiricum.

[0009] Furthermore, the Chinese medicine composition for treating neurological tinnitus due to liver-kidney yin deficiency can be used in the form of one or more of decoctions, capsules, pills, and tablets.

[0010] A method for preparing a Chinese medicine composition for treating neurotic tinnitus due to liver-kidney yin deficiency, which is used for preparing the above-mentioned Chinese medicine composition for treating neurotic tinnitus due to liver-kidney yin deficiency; the preparation method of the capsule use form thereof is as follows: weigh 16 medicinal materials by mass, remove impurities and select them separately, except for two medicinal materials, peony bark and wolfberry, which are dried at 60°C for 8-12h, and the remaining 14 medicinal materials are dried at 70-80°C for 6-8h, and are respectively crushed by a grinder and sieved; the medicinal powder is collected, placed in a container with a cover, and sent to a capsule filling group for filling, so as to obtain a finished capsule preparation; the mixed medicinal powder is brown or khaki powder, and tastes sour and slightly bitter.

[0011] The advantages of the present invention are: Radix Rehmanniae and Fructus Lycii are the main drugs in the prescription, which can replenish essence and marrow, and nourish yin essence. Fructus Corni is used as the minister to nourish the liver and kidney, and Rhizoma Dioscoreae is used to nourish the spleen and replenish qi. Rhizoma Alismatis is used to eliminate dampness and purge turbidity, Cortex Moutan is used to clear and purge the fire, Poria is used to strengthen the spleen and penetrate dampness, Radix Polygoni Multiflori is used to nourish the liver and kidney, and to benefit essence and blood, Acorus calamus is used to open the mind and wake up the spirit, remove dampness and stimulate the appetite, Polygala tenuifolia is used to resolve phlegm and calm the mind, Rhizoma Anemarrhenae and Cortex Phellodendri are used to nourish yin and reduce fire, calm the mind and calm the mind, Fructus Schisandrae Chinensis and Fructus Ophiopogonis are used to replenish qi and produce body fluid, and nourish the kidney and calm the mind. Periostracum Cicadae and Fructus Xanthium are used to dredge the meridians and relieve sore throat, and to benefit the nose and ears. All the drugs are used together to nourish yin and tonify the kidney, strengthen the spleen and calm the mind, and control tinnitus and ears. The Chinese medicine composition of the present invention is based on nourishing yin and tonifying the liver and kidney, combined with the parallel compatibility ideas of calming the mind and calming the mind, strengthening the spleen and replenishing qi, and dredge the meridians and open the mind, so that the drugs can nourish yin and reduce fire, and inhibit tinnitus, and achieve more effective treatment of tinnitus and deafness symptoms. DETAILED DESCRIPTION

[0012] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. 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.

[0013] Traditional Chinese medicine believes that the liver stores blood and the kidney stores essence, and that essence and blood have the same origin, so there is also a saying that "the liver and kidney have the same origin". Essence can produce blood, and blood can transform into essence. The ears can hear when they are nourished by essence and blood. Therefore, when the liver and kidney are yin deficient, the ears are not nourished and can cause tinnitus. When the yin is deficient and the fire is strong, the virtual fire can also cause tinnitus. For example, "Suwen·Five Zang Organs Formation" says: "Indulging in blindness will cause blindness and deafness. The lower part is full and the upper part is empty. The problem is in the foot Shaoyang and Jueyin, and in severe cases, it will enter the liver." "Medical Biography·Volume 5" says: "If they have unrestrained desires, overwork, or after middle age, after a serious illness, the kidney water will dry up and the yin fire will rise, so the ears will itch and tinnitus will occur every day."

[0014] The inventors believe that compared with other symptomatic types, patients with tinnitus and deafness of liver-kidney yin deficiency type have tinnitus as the main symptom, but patients with liver-kidney yin deficiency type are often accompanied by virtual fire and inflammation such as insomnia, restlessness, dry mouth and internal heat; in particular, tinnitus and deafness are closely related to the functional status of the internal organs and meridians of the whole body, and patients with tinnitus and deafness of liver-kidney yin deficiency type are closely related to multiple organs such as kidney, liver, heart and spleen. The treatment of tinnitus and deafness symptoms should be based on nourishing yin and tonifying the liver and kidney, combined with the idea of ​​​​compatibility of calming the mind and tranquilizing the nerves, strengthening the spleen and replenishing qi, and unblocking the meridians and opening the orifices, so that the drug efficacy can reach the ear orifices, nourish yin and reduce fire, and suppress tinnitus, so as to achieve a more effective treatment of tinnitus and deafness symptoms.

[0015] Specifically, the Chinese medicine composition for treating neurological tinnitus due to liver-kidney yin deficiency (hereinafter referred to as "yin-nourishing and ear-invigorating composition") includes, by mass: 40-50 parts of Rehmannia root, 20-25 parts of Lycium barbarum, 25-30 parts of Cornus officinalis, 25-30 parts of Dioscorea opposita, 25-30 parts of Alisma orientalis, 20-25 parts of Paeonia suffruticosa, 20-25 parts of Poria, 25-30 parts of processed Polygonum multiflorum, 20-25 parts of Acorus calamus, 25-30 parts of Polygala tenuifolia, 15-20 parts of Anemarrhena asphodeloides, 15-20 parts of Phellodendron chinense, 25-30 parts of Schisandra chinensis, 25-30 parts of Ophiopogon japonicus, 15-20 parts of Periostracum cicadae, and 10-15 parts of Xanthium sibiricum.

[0016] Rehmannia root is often used to treat symptoms such as yin deficiency and blood deficiency, weakness of waist and knees, fatigue cough and bone steaming, spermatorrhea, metrorrhagia, and irregular menstruation. It helps to strengthen kidney function and improve a series of symptoms caused by kidney yin deficiency, such as weakness of waist and knees, spermatorrhea, and frequent urination at night. At the same time, it also helps to protect the liver and relieve symptoms of patients with liver disease. Rehmannia root can nourish the spleen and stomach, promote appetite and digestion, and improve physical strength. It can be used to treat weak symptoms such as fatigue, tiredness, and indigestion. Rehmannia root is also used to nourish the heart and calm the mind in some traditional Chinese medicine prescriptions, which helps to regulate the nervous system, relieve symptoms such as anxiety, insomnia, and emotional instability, thereby improving mental state.

[0017] Lycium barbarum is sweet and mild in nature, can nourish the yin of liver and kidney, and is a medicine that nourishes kidney essence, liver and blood. It can nourish liver and kidney, replenish qi and blood, and help improve symptoms such as soreness of waist and knees, dizziness, tinnitus, spermatorrhea, and infertility caused by deficiency of liver and kidney essence and blood.

[0018] Cornus officinalis can nourish the liver and kidneys, enhance liver and kidney function, and has a good effect on dizziness, tinnitus, soreness of waist and knees and other symptoms caused by liver and kidney deficiency. In addition, Cornus officinalis has the effects of strengthening the spleen and appetite, calming the mind, anti-oxidation and anti-aging, and improving blood circulation. It can promote the secretion of digestive juices, increase appetite, and improve problems such as loss of appetite and indigestion caused by weak spleen and stomach; at the same time, it can also relieve anxiety, insomnia, palpitations and other symptoms, and has a certain calming effect on people with unstable emotions, irritability, and dreaminess.

[0019] Yam is sweet in taste, beneficial to the digestion and absorption function of the spleen and stomach, can replenish qi, replenish yin, strengthen the spleen and stomach, and nourish the acquired spleen and stomach qi. Yam can also effectively relieve symptoms such as reduced food intake and diarrhea caused by weak spleen and stomach. Yam enters the lung meridian and kidney meridian, and can replenish lung qi and kidney qi. It can produce fluid and benefit the lungs, replenish the kidneys and consolidate essence, and has an improvement effect on symptoms such as insufficient kidney yin, sore waist and knees, dizziness and tinnitus, spermatorrhea, excessive leucorrhea, and frequent urination.

[0020] Alisma has the effect of dispelling dampness, which can help eliminate moisture from the body and improve symptoms of dampness and heat; Alisma also has a certain function of regulating qi and blood, which can promote blood circulation and improve symptoms caused by qi stagnation and blood stasis.

[0021] Peony bark is slightly cold in nature, pungent and bitter in taste, and enters the heart, liver, and kidney meridians. It can clear away heat and cool blood, dissipate blood stasis and eliminate spots. In addition, peony bark also has significant therapeutic effects on symptoms such as febrile diseases damaging yin, yin deficiency fever, night heat and morning coolness, and no sweating and bone steaming. Peony bark also has significant blood circulation and blood stasis effects, and is used to treat hypertension, fundus hemorrhage, liver stagnation, heat stasis and blood stasis.

[0022] Poria cocos can promote diuresis and eliminate moisture, enhance the spleen and stomach's ability to transport and transform, and promote the excretion of moisture in the body. Poria cocos also has a calming and soothing effect, helps regulate the nervous system, and improves sleep quality.

[0023] Prepared Polygonum multiflorum enters the liver and kidney meridians; it can nourish the liver and kidneys, and has obvious therapeutic effects on dizziness, tinnitus, soreness of waist and knees and other symptoms caused by liver and kidney deficiency. In addition, prepared Polygonum multiflorum also has the effects of nourishing essence and blood, nourishing the heart and calming the mind, and can be used to treat symptoms such as blood deficiency, palpitations and insomnia, and physical weakness caused by long-term malaria.

[0024] Acorus calamus tastes pungent and bitter, is warm in nature, and enters the heart and stomach meridians. It has the effect of opening up the orifices and refreshing the mind. Acorus calamus also has the effects of promoting qi and blood circulation, resolving phlegm and calming the mind. It can calm the mind, improve intelligence, and improve hearing and eyesight.

[0025] Polygala is slightly warm in nature, pungent and bitter in taste, and enters the heart, lung, and kidney meridians. It has the effect of calming the mind and settling the spirit. It is often used to treat insomnia, forgetfulness, epilepsy, trance and other symptoms, and can help patients calm their minds and improve sleep quality.

[0026] Zhimu tastes bitter and cold, can clear away heat and purge fire; it has the effect of nourishing yin and moistening dryness, and is suitable for symptoms such as yin deficiency and hyperactivity of fire, dry mouth and tongue. It can nourish lung yin, moisten dryness and relieve cough, and is often used together with yin-nourishing herbs such as Adenophora and Ophiopogon japonicus to relieve symptoms such as bone steaming and hot flashes, night sweats and spermatorrhea caused by yin deficiency.

[0027] Huangbai is cold in nature and bitter in taste. It enters the kidney and bladder meridians, clears away heat and dries dampness. Huangbai can nourish yin and reduce fire, replenish yin fluid in the body, and thus relieve various symptoms caused by yin deficiency, such as night sweats, spermatorrhea, bone steaming and hot flashes.

[0028] Schisandra chinensis is sour and warm in nature. It has the effects of astringency and firmness. It can replenish qi and produce body fluids. It is suitable for patients with thirst, shortness of breath and weak pulse due to loss of body fluids. Schisandra chinensis can also dilate peripheral blood vessels, has certain effects of tonifying the kidney, strengthening the heart and calming the mind, and is used to treat palpitations and insomnia.

[0029] Ophiopogon japonicus is cold in nature and enters the heart meridian. It can clear the heart and eliminate restlessness, calm the mind and stabilize the spirit. It is effective for treating symptoms of restlessness caused by various reasons, especially in treating insomnia due to deficiency. It can nourish yin fluid, promote the production of body fluid and quench thirst, and is used to treat symptoms such as damage to body fluid by fever, restlessness, thirst, and dry throat.

[0030] Cicada shell is cold in nature and sweet in taste. It enters the liver meridian and can disperse wind-heat in the lung meridian. It also has the effect of relieving sore throat and opening the voice. It has a therapeutic effect on symptoms such as red, swollen and painful eyes, and cataracts covering the eyes caused by wind-heat or liver fire.

[0031] Xanthium sibiricum is pungent in taste and can disperse qi, bitter in nature and can dry out dampness, and warm in nature and can dispel cold. Xanthium sibiricum is mild and can clear the nasal passages to eliminate nasal congestion and stop swelling of the forehead and nose.

[0032] In the formula, Radix Rehmanniae and Fructus Lycii are the main drugs, which replenish essence and marrow, and nourish yin essence. Fructus Corni nourishes the liver and kidney, and Rhizoma Dioscoreae nourishes the spleen and replenishes qi. Alisma orientalis removes dampness and turbidity, Peony bark clears and drains the fire of the phase, Poria strengthens the spleen and drains dampness, and processed Polygonum multiflorum nourishes the liver and kidney, and replenishes essence and blood. Acorus calamus opens the mind and wakes the spirit, removes dampness and stimulates appetite, Polygala tenuifolia removes phlegm and calms the mind, Anemarrhena asphodeloides and Phellodendron amurense nourish yin and reduce fire, calm the mind and soothe the nerves, Schisandra chinensis and Ophiopogon japonicus replenish qi and produce body fluid, nourish the kidney and calm the mind. Periostracum Cicadae and Fructus Xanthium sibiricum unblock the meridians and relieve sore throat, and benefit the nose and ears. All the drugs are used together to nourish yin and tonify the kidney, strengthen the spleen and calm the mind, and treat tinnitus and ears.

[0033] The above-mentioned Yin-nourishing and ear-nourishing composition can be made into various forms such as decoctions, capsules, pills, tablets, etc. and can be combined with the required pharmaceutical excipients: flavoring agents, preservatives, stabilizers, diluents, adhesives, wetting agents, disintegrants, lubricants, etc.

[0034] Taking the capsule preparation as an example, the preparation process includes: 45.6 parts of Radix Rehmanniae Preparata, 22.9 parts of Fructus Lycii, 28.6 parts of Fructus Corni, 28.6 parts of Rhizoma Dioscoreae, 28.6 parts of Rhizoma Alismatis, 22.9 parts of Cortex Moutan, 22.9 parts of Poria, 28.6 parts of Radix Polygoni Multiflori Processed, 22.9 parts of Acorus Tatarinowii, 28.6 parts of Radix Polygalae, 17.1 parts of Rhizoma Anemarrhenae, 17.1 parts of Cortex Phellodendri, 28.6 parts of Fructus Schisandrae Chinensis, 28.6 parts of Radix Ophiopogonis, 17.1 parts of cicada slough and 11.3 parts of Xanthium sibiricum are weighed, and the above 16 medicinal materials are removed and cleaned respectively. Except for the two medicinal materials of peony bark and wolfberry, which are dried at 60℃ for 8-12h, the remaining 14 medicinal materials are dried at 70-80℃ for 6-8h, and crushed by a grinder respectively, and passed through a 90-mesh sieve; the powder is collected, placed in a container with a cover, and sent to the capsule filling group for filling, and each particle is filled with 0.4g, and the finished capsule preparation is obtained. The mixed powder is brown or khaki powder, and tastes sour and slightly bitter.

[0035] The above capsule preparations are identified as follows:

[0036] (1) Take the powder of this product and observe it under a microscope: there are many thin-walled cell fragments, light gray-brown or dark brown, the cells are polygonal, wrinkled, and irregular in shape, and contain gray-brown nuclei with a diameter of 11-13um. The secretory cells contain orange-yellow or orange-red oil droplets and secretions (using chloral hydrate solution, without heating), and the secretory cells are clearly visible in the thin-walled tissue. There are marginal pits and reticular vessels with a diameter of 20-92um, and the vessel molecules are shorter, 80-150um long. There are a few small square crystals of calcium oxalate with a diameter of about 5um (Rehmannia glutinosa).

[0037] (2) Take the powder of this product and observe it under a microscope: the epidermal cells of the fruit peel are orange-yellow, polygonal or rectangular in appearance, with a diameter of 16-30um, the antipodal wall is thickened in a beaded manner, the outer flat wall is granular and keratinous, and the cell cavity contains light orange-yellow substances. The mesocarp cells are orange-yellow and mostly wrinkled. There are a few calcium oxalate clusters with a diameter of 12-32um. The cells are square, oval or rectangular, with obvious pits and a large cell cavity (Cornus officinalis).

[0038] (3) Take the contents of 8 tablets of this product, add 20 mL of methanol, heat and reflux in a water bath for 20 minutes, filter, evaporate the filtrate, and dissolve the residue in 2 mL of methanol as the test solution. Take another 0.1 g of Phellodendron chinense as the reference medicinal material. Add 10 mL of methanol and prepare the reference medicinal material solution in the same way. Take berberine hydrochloride and add methanol to prepare a solution containing 0.5 mg per 1 mL. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 10 ul of the test solution, 5 ul of the reference medicinal material and the reference substance solution, and spot them on the same silica gel G thin layer plate. Use n-butanol-glacial acetic acid-water (7:1:2) as the developing solvent, develop, take out, dry, and examine under ultraviolet light (365 nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the reference medicinal material, a fluorescent spot of the same color appears.

[0039] (4) Take the contents of 8 tablets of this product, add 30 ml of ether, reflux at low temperature for 30 minutes, filter, evaporate the ether from the filtrate, and dissolve the residue in 1 ml of acetone as the test solution. Take another reference substance of paeonol, add acetone to make a solution containing 1 mg per 1 ml, and test it according to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502). Take 10 ul of each of the above two solutions and spot them on the same silica gel G thin layer plate, use cyclohexane-ethyl acetate (3:1) as the developing agent, develop, take out, dry, spray hydrochloric acid acid 5% ferric chloride solution, and blow with hot air until the spots are clearly colored. In the chromatogram of the test product, the same blue-brown spots appear at the corresponding positions of the chromatogram of the reference substance.

[0040] (5) Take the contents of 8 tablets of this product, add 30 ml of chloroform, heat and reflux for 30 minutes, filter, evaporate the filtrate, and add 2 ml of chloroform to dissolve the residue to prepare the test solution. Take 1 g of Schisandra chinensis reference medicinal material and prepare the reference medicinal material solution in the same way. Take Schisandra chinensis reference substance and add chloroform to prepare a solution containing 1 mg per 1 ml as the reference substance solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 2 μl of each of the above three solutions and spot them on the same silica gel GF thin layer plate, use the upper layer solution of petroleum ether (30-60℃)-ethyl formate-formic acid (15:5:1) as the developing solvent, develop, take out, dry, and examine under ultraviolet light (254nm). In the chromatogram of the test product, spots of the same color appear at the corresponding positions of the chromatogram of the reference medicinal material and the chromatogram of the reference substance.

[0041] Clinical research was carried out using the above-mentioned Zhiyin Conger Composition Capsule Preparation as an example, which is mainly used to treat dizziness, tinnitus, deafness, etc. caused by liver and kidney deficiency.

[0042] According to the diagnostic criteria of Western medicine, tinnitus is intermittent or continuous, and worsens when tired or insomniac, especially at night. Tinnitus is like cicada chirping, electric current sound, and buzzing sound. In the early stage of hearing loss, high frequency is the main one. As tinnitus lasts for a long time, hearing of high, medium and low frequencies all decrease. Electrical audiometry shows unilateral or bilateral sensorineural hearing loss, with unobstructed external auditory canal, intact tympanic membrane and unobstructed Eustachian tube. Temporal bone CT scan shows normal structure of middle ear and inner ear.

[0043] According to the diagnosis standard of TCM syndrome, refer to "Chinese Medicine Otolaryngology", published by Shanghai Science and Technology Press in December 1999), the main symptoms are tinnitus and deafness, which may last for a few days or a few years, and may be mild or severe at times; the secondary symptoms are dizziness, soreness of waist and knees, red cheeks and dry mouth, hot hands and feet, insomnia and dreaminess, red tongue with little coating, and weak pulse. Diagnosis basis: the main symptoms are required; 2-3 secondary symptoms are present.

[0044] Case inclusion criteria:

[0045] ①Conform to Western medical diagnostic standards

[0046] ②Conform to the diagnostic criteria of TCM syndrome

[0047] ③Age 18-65

[0048] ④Sign the informed consent form for entering the study

[0049] Exclusion criteria:

[0050] ①Acute and chronic suppurative otitis media.

[0051] ②Tinnitus and deafness caused by trauma and drug toxicity.

[0052] ③ Those who have used other drugs or treatment methods before treatment.

[0053] ④Pregnant or lactating women.

[0054] ⑤ Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and mental illness.

[0055] Dosage: Take 6 capsules of Ziyin Conger combination capsules 3 times a day. Take with warm water after meals. Treatment course: 1 month for one course.

[0056] General clinical data: A total of 60 cases (98 ears) were observed, including 29 males (12 in one ear and 17 in both ears) and 31 females (10 in one ear and 21 in both ears), aged 18-70 years old, with an average age of 56 years old. The symptoms were intermittent or continuous tinnitus in one or both ears, which worsened when tired, in a bad mood, or insomnia, especially at night. Tinnitus was like cicada chirping, electric current, and buzzing. Dizziness, sore waist and knees, red cheeks and dry mouth, hot hands and feet, insomnia and dreams, red tongue with little coating, and thin pulse. The external auditory canal was unobstructed, the tympanic membrane was intact, and the Eustachian tube was unobstructed. The early hearing loss was mainly high-frequency. As the tinnitus lasted for a long time, the hearing of high, medium and low frequencies all decreased. The clinical diagnosis of Western medicine was neurological tinnitus and deafness.

[0057] Efficacy and safety evaluation criteria:

[0058] The improvement rate was evaluated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines.

[0059] ① Clinically cured: TCM clinical symptoms and signs disappear or almost disappear, and the syndrome score decreases by ≥95%

[0060] ② Markedly effective: Clinical symptoms and signs of TCM are significantly improved, and the syndrome score is reduced by ≥ 70%

[0061] ③ Effective TCM clinical symptoms and signs have improved significantly, and the syndrome score has decreased by ≥30%

[0062] ④ Ineffective TCM clinical symptoms and signs are significantly improved or even aggravated, and the syndrome score is reduced by less than 30%

[0063] Efficacy analysis:

[0064] After one course of treatment, the total effective rate of the Zhiyin Conger Composition Capsule Preparation in the treatment of neurological tinnitus and deafness was as high as 76.4% (74 / 98), the cure rate was 10.2% (10 / 98), the marked effective rate was 22.4% (22 / 98), the effective rate was 43.8% (42 / 98), and the ineffective rate was 24.4% (24 / 98).

[0065] TCM Syndrome Efficacy

[0066] Table 1 Comparison of TCM syndrome scores of patients before and after treatment

[0067] Before treatment After treatment T P Experimental Group 10.2+1.68 8.20 4.236 0.001

[0068] After treatment, the symptom scores of this group of patients were significantly different and decreased significantly compared with those before treatment.

[0069] Security Analysis

[0070] Analysis of test results of safety indicators:

[0071] Table 2 Laboratory safety index test results

[0072]

[0073] In the experimental group, no indicators that were normal before treatment but abnormal after treatment, or abnormal before treatment but aggravated after treatment were found, and no obvious adverse reactions occurred.

[0074] The results of clinical trials show that after one course of treatment, the Ziyin Cong'er combination capsule preparation has a good improvement effect on patients with tinnitus and deafness caused by liver and kidney yin deficiency, with a total effective rate of 76.4%. The Ziyin Cong'er combination capsule preparation has a clear efficacy and is effective in treating patients with symptoms such as dizziness, tinnitus, deafness, etc. caused by liver and kidney deficiency.

[0075] During the clinical trial, all patients underwent routine tests of heart, liver, and kidney function, and blood and urine before and after treatment. Those who were normal before treatment showed no abnormalities after treatment. No obvious adverse reactions were observed during the withdrawal period and after discontinuation, indicating that the Chinese medicine is safe and reliable.

[0076] Some typical cases of applying the above-mentioned Yin-nourishing and ear-concentrating composition are recorded as follows:

[0077] Typical medical history 1

[0078] Kang Moumou, female, 56 years old, came to the clinic on September 30, 2024, with the main complaint: left tinnitus accompanied by hearing loss for 4 years and aggravated right tinnitus for 6 months. She had a history of "hypertension, diabetes, and cervical spondylosis", all of which were controlled by medication. Four years ago, she was in another place and had sudden tinnitus and deafness in her left ear. Because she was not hospitalized under any conditions, she could only receive infusion treatment at a nearby clinic, but the effect was not good. In the past six months, she had tinnitus in her right ear again. After treatment, the tinnitus did not change much. Now she has tinnitus in both ears, hearing loss, and severe left ear. She has discomfort in the head, fatigue, irritability, and difficulty falling asleep. The blood pressure was checked at 110 / 70 mmHg. Antihypertensive drugs were taken in the morning. A hearing test was given in the outpatient clinic, and the results showed bilateral neurological tinnitus and deafness. Because she was serving her old mother at home, she was hospitalized under no conditions. She was given 15 pairs of decoctions of the Zhiyin Cong'er combination to be taken back for self-decoction, one dose a day, warm in the morning and evening, and vitamin B1 tablets and brain protein hydrolyzate tablets as nutritional supplements after meals. Advise patients to relax, prevent colds, avoid spicy, cold, and greasy food, stay away from noise, avoid overwork, take medication on time, and have follow-up visits in time.

[0079] On October 16, 2024, the patient returned for a follow-up visit and said that he had just finished taking the Chinese medicine and had no discomfort. His tinnitus was relieved, his mind was relaxed, his spirits improved, his hearing also improved, and his sleep improved slightly. The blood pressure was checked at 120 / 70 mmHg. He continued to be given 15 doses of Conger Composition Decoction (with Chinese date seeds added to nourish the heart and calm the mind), the same Western nutritional supplements as before, and the doctor's instructions were the same as before. He continued to be observed.

[0080] Typical medical history 2

[0081] Yang, male, 67 years old, from Long County, Baoji, is now taking care of his grandson in Caijiapo Town. He came to our specialist hospital for treatment on December 20, 2023. He said that he had bilateral tinnitus for 10 days and was treated in Caijiapo Hospital, but the effect was not good. Today he came to our specialist hospital for treatment. The patient reported severe tinnitus in both ears and irritability. He was given a hearing test, and the result was bilateral neurological tinnitus and deafness. He had a history of hypertension, which was controlled by medication. The blood pressure was tested at 130 / 80 mmHg. The patient was unable to receive hospitalization, so he was given Ziyin Cong'er Composition Capsules for one and a half months, 3 capsules each time, orally 3 times a day, and vitamin B1 and citicoline sodium tablets.

[0082] Citicoline Sodium Tablets are a cerebrovascular nutrition drug, mainly used to treat neurological sequelae caused by craniocerebral injury or cerebrovascular accident. It can reduce cerebrovascular resistance, increase cerebral blood flow, promote brain substance metabolism, and thus improve brain microcirculation.

[0083] The patient was re-examined on March 5, 2024. He said that the last medication was effective and the tinnitus was significantly reduced. He may have gotten angry in recent days and the tinnitus has worsened. Examination showed no abnormalities in both external ears and blood pressure was 120 / 70 mmHg. The medication was the same as before, and he was advised to eat less spicy food and stay away from noisy environments.

[0084] I had a follow-up visit on September 20, 2024, and he asked for the Ziyin Cong'er combination capsules. I didn't want any more western medicine as I felt that it was not very effective. I had taken the capsules from our hospital before, and it was very effective, but later the tinnitus worsened. I bought the western medicine I had taken, but it didn't work. Recently, my tinnitus has slightly worsened. Today I came here specifically to buy the Ziyin Cong'er combination capsules to consolidate my effects.

[0085] Typical medical history 3

[0086] Liu, female, 45 years old, from Yongshou County, Xianyang City, had bilateral tinnitus and hearing loss for 5 years, which worsened for 10 days. She came to our department for treatment on September 15, 2023. Examination showed that the tympanic membranes of both external auditory canals were normal, and the blood pressure was 110 / 80mmhg. Hearing and electrocardiogram tests were performed, and the results showed bilateral neurological tinnitus and deafness, and no abnormalities in the electrocardiogram.

[0087] Due to the long course of the disease and the conditions for hospitalization for comprehensive treatment, the patient was given Ginkgo Leaf Extract Injection, Methylcobalamin Injection, Piracetam Injection Infusion, and oral vitamin B1 tablets and Guweiso tablets. The patient was given a decoction of Ziyin Cong'er Composition, one dose per day, warm in the morning and evening, combined with electroacupuncture, acupoint injection, Chinese medicine fumigation, and tinnitus rehabilitation treatment. After 15 days of treatment, the patient's tinnitus was alleviated and hearing improved. The patient was given capsules of Ziyin Ear Composition, vitamin B1 tablets, and brain protein hydrolyzate tablets. The patient was advised to stay away from noise, avoid spicy and cold food, avoid overwork, take medicine on time, and return for follow-up in time.

[0088] On May 18, 2024, the patient was contacted by phone and was told that the last treatment was effective, but her tinnitus had recently become noticeably louder. Because her husband was ill and bedridden, she could not come for treatment. I inquired about her condition in detail over the phone and the medicine was mailed to her, and she took the medicine with her when she was discharged from the hospital.

[0089] On September 16, 2024, the patient expressed gratitude over the phone, saying that his symptoms were relieved after taking the medicine and requested that the medicine be mailed again to consolidate the therapeutic effect.

[0090] Typical medical history 4

[0091] Zhang, female, 50 years old, from Baoji, had bilateral tinnitus and hearing loss for 5 years, which worsened for 2 weeks. She came to the clinic on April 19, 2023. She said that she had bilateral tinnitus 5 years ago, suspected of working night shifts for a long time. Because of the many affairs, she did not receive treatment, and the tinnitus became more severe and the hearing also slowly decreased. Later, she went to several large hospitals in Baoji for treatment, but the effect was not obvious. In the past half month, the tinnitus was severe, affecting sleep, and she was irritable. The blood pressure was 110 / 60mmHg, and the patient's external auditory canal and eardrum were normal. The hearing test showed bilateral neurological tinnitus, deafness, and cervical spondylosis.

[0092] Because it was inconvenient to take leave from work and there were school-age children to take care of at home, he could not be hospitalized. He was given Ziyin Cong'er Decoction with Vitamin B1 Tablets, Citicoline Sodium Tablets, Betahistine Mesylate Tablets, and Oryzanol Tablets, and was advised to relax, avoid spicy food, use protective earplugs, take medicine on time, and return to the hospital in time. On May 8, 23, he returned to the hospital and said that his sleep improved after taking the medicine, but the tinnitus was still loud, and his blood pressure was normal. He continued to take the previous medicine for half a month.

[0093] On June 3, 2023, the patient reported that the tinnitus had been alleviated, and the patient was given the previous medication for half a month and was advised to persist in the treatment.

[0094] The patient came to the clinic on July 10, 2023, and thanked the doctor repeatedly, saying that the tinnitus was greatly relieved and he could sleep normally at night. This tinnitus was too stubborn, and it made me feel uneasy and almost crazy. Thank you doctor for saving me. The patient was given a one-month supply of Ziyin Cong'er combination capsules, vitamin B1 tablets, and citicoline sodium tablets to consolidate the therapeutic effect. He was advised to follow the doctor's advice, relax, and follow up if he felt unwell.

[0095] The above description is only a preferred implementation case of the present invention, and does not constitute any form of limitation to the present invention. Although the present invention has been disclosed as a preferred implementation case as above, it is not used to limit the present invention. Any technician familiar with this patent can make some changes or modify the technical contents suggested above into equivalent implementation cases without departing from the scope of the technical solution of the present invention. However, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the solution of the present invention.

Claims

1. A Chinese medicine composition for treating neurotic tinnitus due to liver-kidney yin deficiency, characterized in that: The ingredients include 40-50 parts of Rehmannia root, 20-25 parts of Lycium barbarum, 25-30 parts of Cornus officinalis, 25-30 parts of Dioscorea opposita, 25-30 parts of Alisma orientalis, 20-25 parts of Paeonia suffruticosa, 20-25 parts of Poria cocos, 25-30 parts of processed Polygonum multiflorum, 20-25 parts of Acorus calamus, 25-30 parts of Polygala tenuifolia, 15-20 parts of Anemarrhena asphodeloides, 15-20 parts of Phellodendron chinense, 25-30 parts of Schisandra chinensis, 25-30 parts of Ophiopogon japonicus, 15-20 parts of Periostracum cicadae, and 10-15 parts of Xanthium sibiricum.

2. The Chinese medicine composition for treating neurological tinnitus due to liver-kidney yin deficiency according to claim 1, characterized in that: The ingredients in parts by mass include: 45.6 parts of Rehmannia root, 22.9 parts of Lycium barbarum, 28.6 parts of Cornus officinalis, 28.6 parts of Dioscorea opposita, 28.6 parts of Alisma orientalis, 22.9 parts of Paeonia suffruticosa, 22.9 parts of Poria, 28.6 parts of processed Polygonum multiflorum, 22.9 parts of Acorus calamus, 28.6 parts of Polygala tenuifolia, 17.1 parts of Anemarrhena asphodeloides, 17.1 parts of Phellodendron chinense, 28.6 parts of Schisandra chinensis, 28.6 parts of Ophiopogon japonicus, 17.1 parts of Periostracum cicadae, and 11.3 parts of Xanthium sibiricum.

3. The Chinese medicine composition for treating neurological tinnitus due to liver-kidney yin deficiency according to claim 1 or 2, characterized in that: The Chinese medicine composition for treating neurological tinnitus due to liver-kidney yin deficiency can be used in the form of one or more of decoction, capsule, pill and tablet.

4. A method for preparing a Chinese medicine composition for treating neurotic tinnitus due to liver-kidney yin deficiency, characterized in that: For preparing the Chinese medicine composition for treating neurotic tinnitus caused by liver-kidney yin deficiency as claimed in claim 1 or 2, the preparation method of the capsule use form is: Weigh 16 kinds of decoction pieces of medicinal materials by mass, remove impurities and select them separately, except for the two kinds of medicinal materials, peony bark and wolfberry, which are dried at 60°C for 8-12 hours, and the remaining 14 kinds of medicinal materials are dried at 70-80°C for 6-8 hours, and then pulverized by a pulverizer and sieved; collect the medicinal powders, put them in a container with a cover, and send them to a capsule filling group for filling, so as to obtain the finished capsule preparation; the mixed medicinal powders are brown or khaki powders, and taste sour and slightly bitter.

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