Traditional Chinese medicine composition for treating nervous tinnitus due to deficiency of kidney yang and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating nervous tinnitus caused by deficiency of kidney yang. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 10-15 parts of radix aconiti carmichaeli (prepared), 15-20 parts of cortex cinnamomi, 40-50 parts of radix rehmanniae praeparata, 15-20 parts of fructus corni, 20-30 parts of fructus lycii, 20-30 parts of rhizoma dioscoreae, 20-30 parts of semen cuscutae, 20-30 parts of cortex eucommiae, 45-60 parts of rhizoma alismatis, 35-40 parts of magnetite, 20-30 parts of rhizoma chuanxiong, 25-30 parts of radix achyranthis bidentatae, 25-30 parts of poria cocos, 15-20 parts of liquorice root and 20-30 parts of rhizoma atractylodis macrocephalae. The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: classifying and drying the medicinal decoction pieces, crushing, sieving, and mixing to obtain grey brown powder which is slightly sour and sweet in taste; and feeding the medicine powder to a capsule filling group for filling. The traditional Chinese medicine composition has the advantages that the traditional Chinese medicine composition is based on warming and strengthening kidney yang and is combined with the compatibility thought of nourishing liver and kidney, invigorating spleen and replenishing qi, promoting blood circulation to remove blood stasis and opening orifices, so that the traditional Chinese medicine composition can be used for opening ear orifices and treating tinnitus, 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 neurological tinnitus due to kidney-yang 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 perspective of improving the overall function of the human body; therefore, based on different populations, for those who also show symptoms of continuous or intermittent tinnitus, the dialectical classification according to the cause may include: kidney yang deficiency, retention of evil toxins, blood stasis, liver and kidney yin deficiency, liver and gallbladder dampness and heat, spleen and stomach weakness, etc. The treatment ideas of traditional Chinese medicine for different dialectical classifications are also quite different, especially neurological tinnitus and deafness are mostly chronic diseases, and the course of the patient's illness can be as short as a few days or as long as several years. The longer the disease lasts, the worse the treatment effect; among them, the symptoms of neurological deafness belonging to deficiency syndrome are mostly in the middle-aged and elderly, and the treatment is difficult and the effect is poor; for the tinnitus symptoms caused by the deficiency of kidney yang, there is also a lack of effective symptomatic prescriptions in the existing Chinese medicine preparations. Summary of the invention

[0005] Aiming at the problem that the prior art has poor therapeutic effect on tinnitus symptoms caused by kidney yang deficiency and lacks effective symptomatic prescriptions, the present invention provides a Chinese medicine composition for treating neurological tinnitus caused by kidney yang deficiency and a preparation method thereof.

[0006] The technical scheme of the present invention is as follows: A Chinese medicine composition for treating neurological tinnitus due to deficiency of kidney yang, comprising, by mass: 10-15 parts of aconite (processed), 15-20 parts of cinnamon bark, 40-50 parts of rehmannia root, 15-20 parts of cornus officinalis, 20-30 parts of wolfberry, 20-30 parts of yam, 20-30 parts of dodder seeds, 20-30 parts of eucommia bark, 45-60 parts of orientalis, 35-40 parts of magnetite, 20-30 parts of chuanxiong, 25-30 parts of achyranthes bidentata, 25-30 parts of poria, 15-20 parts of liquorice, and 20-30 parts of atractylodes macrocephala.

[0007] Preferably, the ingredients in parts by mass include: 12.5 parts of processed aconite, 15 parts of cinnamon, 50 parts of prepared rehmannia, 20 parts of cornus, 25 parts of wolfberry, 25 parts of yam, 25 parts of dodder seeds, 25 parts of eucommia, 50 parts of oriental water chestnuts, 37.5 parts of magnetite, 25 parts of chuanxiong, 25 parts of achyranthes bidentata, 25 parts of poria, 15 parts of liquorice, and 25 parts of atractylodes.

[0008] Furthermore, the Chinese medicine composition for treating neurological tinnitus due to kidney-yang deficiency can be used in the form of one or more of decoctions, capsules, pills, and tablets.

[0009] A method for preparing a Chinese medicine composition for treating neurological tinnitus due to deficiency of kidney yang, which is used for preparing the Chinese medicine composition for treating neurological tinnitus due to deficiency of kidney yang; the preparation method of the Chinese medicine composition for use in capsule form is as follows: 15 medicinal materials are weighed by mass, and the impurities are removed and cleaned respectively; 3 medicinal materials, namely cinnamon bark, wolfberry fruit and chuanxiong, are dried at 60°C for 8-12h, and the remaining 11 medicinal materials except magnetite are dried at 70-80°C for 6-8h, and are respectively crushed by a pulverizer and sieved; then the magnetite is removed of impurities and smashed, the sieved medicinal powder is collected and mixed with the smashed magnetite, and placed in a container with a cover, the mixed medicinal powder is gray-brown powder with a slightly sour and sweet taste; the medicinal powder is sent to a capsule filling group for filling, and a finished capsule preparation is obtained.

[0010] The advantages of the present invention are: using aconite and cinnamon bark to warm and strengthen kidney yang as the main medicine; Rehmannia root, Cornus officinalis, Lycium barbarum, and Chinese yam are used to nourish yin and kidney, replenish essence and marrow, and nourish the liver and spleen, and are all ministerial medicines. Cuscuta chinensis and Eucommia bark are used to nourish the liver and kidney and strengthen the waist and knees; Alisma orientalis is used to promote diuresis and eliminate dampness, Achyranthes bidentata, Chuanxiong, Magnetite, remove blood stasis and promote menstruation, nourish the liver and kidney, strengthen tendons and bones, and Poria, Atractylodes macrocephala, and Licorice are used to invigorate qi, invigorate the spleen and calm the mind. All the medicines are used together to warm the kidney and invigorate the spleen, and open the orifices and improve hearing. The Chinese medicine composition of the present invention is based on warming and strengthening kidney yang, combined with the idea of ​​compatibility of nourishing the liver and kidney, invigorating the spleen and invigorating qi, promoting blood circulation, eliminating fatigue and opening the orifices, so that the drug efficacy can open the ear orifices and control tinnitus, and achieve more effective treatment of tinnitus and deafness symptoms. DETAILED DESCRIPTION

[0011] 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.

[0012] According to traditional Chinese medicine, the kidney governs water, and the normal distribution of body fluids depends on the transpiration and gasification of Yang Qi. Kidney Yang, also known as Yuan Yang, is the root of Yang Qi in the body. If kidney Yang is insufficient, gasification will be weak, the distribution of body fluids will be abnormal, and the ears will not be nourished, resulting in tinnitus. If Yuan Yang is deficient, the ears will not be warmed by kidney Yang, which will also cause tinnitus. "Jingyue Complete Works, Volume 27" states: "If kidney Qi is sufficient, the ears and eyes will be sharp... "Yi" says: Kan is the ear, because Kan's Yang is in the middle, and the ear's hearing is inside, which is why they correspond. Nowadays, many elderly people's ears are not sharp inside, but hear sounds outside. This is a sign that the kidney Yuan is not solid and Yang Qi is gradually weakening." This is a description of tinnitus caused by kidney Yang deficiency.

[0013] Although there is no shortage of prescriptions for treating kidney yang deficiency in existing prescription preparations, most of them are based on the idea of ​​promoting defecation and are mainly used for symptoms such as soreness of waist and knees, dizziness, spontaneous sweating, and frequent urination at night. Therefore, directly using prescriptions for treating kidney yang deficiency has limited effect on improving tinnitus and deafness. The inventor believes that "the ear is where the main meridians gather", and tinnitus and deafness are closely related to the functional status of the internal organs and meridians throughout the body; deafness is caused by lack of nourishment to the ear, so dredging the blocked meridians has a direct improvement effect on tinnitus and deafness, which is also the treatment idea of ​​modern medicine; the ear is the orifice of the kidney, so for patients with tinnitus and deafness with symptoms of kidney yang deficiency, warming and strengthening the kidney yang is the fundamental method; but the liver and kidney are of the same origin, and the liver is responsible for the regulation of qi, and the smoothness of the whole body's qi depends on the regulation function of the liver, so patients with deafness and tinnitus also need to nourish the liver and kidney at the same time; the spleen is the source of qi and blood production, and only when qi flows can the essence of water and grain be carried up to nourish the ear orifices, so patients with deafness and tinnitus also need to strengthen the spleen and replenish qi and remove dampness.

[0014] Therefore, the Chinese medicine composition of the present invention is based on warming and strengthening kidney yang, combined with the idea of ​​nourishing the liver and kidney, strengthening the spleen and replenishing qi, promoting blood circulation, eliminating fatigue and opening the orifices, so that the drug efficacy can open the ear orifices, achieving more effective treatment of tinnitus and deafness symptoms.

[0015] Specifically, the Chinese medicine composition for treating neurological tinnitus due to deficiency of kidney yang (hereinafter referred to as "kidney-tonifying and ear-improving composition") includes, by mass: 10-15 parts of processed aconite, 15-20 parts of cinnamon, 40-50 parts of prepared rehmannia, 15-20 parts of cornus, 20-30 parts of wolfberry, 20-30 parts of yam, 20-30 parts of dodder seeds, 20-30 parts of eucommia, 45-60 parts of orientalis, 35-40 parts of magnetite, 20-30 parts of chuanxiong, 25-30 parts of Achyranthes bidentata, 25-30 parts of Poria, 15-20 parts of liquorice, and 20-30 parts of Atractylodes macrocephala.

[0016] Among them, Fuzi (controlled) has a strong warming property and can treat diseases caused by yang deficiency and play a role in restoring yang and rescuing adverse conditions. It can help the heart yang, warm the spleen yang, and replenish the kidney yang. It is often used to treat long-term illness, physical weakness, yang deficiency, yin and cold, or yang deficiency caused by sweating, vomiting, and diarrhea.

[0017] Cinnamon can warm the body and dispel coldness. It is often used to treat symptoms such as kidney yang deficiency, fear of cold and cold limbs, spleen yang deficiency, cold pain in the abdomen, poor appetite and loose stools. In addition, cinnamon can invigorate spleen yang and promote blood circulation. It is often used for symptoms such as long-term illness, weak body, and insufficient qi and blood.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] Cuscuta can replenish kidney yang and kidney yin, and has a good effect on alleviating symptoms such as impotence, spermatorrhea, and soreness of waist and knees caused by kidney deficiency. Cuscuta also has the effect of nourishing the liver and improving eyesight, and can improve symptoms such as tinnitus, dizziness, and decreased vision caused by liver and kidney yin deficiency and insufficient essence and blood.

[0023] Eucommia can nourish the liver and kidneys, and has a good therapeutic effect on symptoms such as soreness of waist and knees, dizziness, tinnitus, impotence and spermatorrhea caused by liver and kidney deficiency. It can enhance the function of the liver and kidneys and improve related symptoms.

[0024] 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.

[0025] Magnet is cold in nature and can clear away heat, which can suppress hyperactive liver yang and is suitable for patients with hyperactive liver yang and dizziness. It can calm the liver and suppress yang, and benefit kidney yin, and is used to treat symptoms of hyperactivity and dizziness. Magnet can nourish yin and kidney, improve hearing and eyesight, and is suitable for the treatment of liver and kidney yin deficiency, tinnitus, deafness, decreased vision and other symptoms. Magnet enters the kidney meridian, and its heavy quality settles, which makes the kidney help the lung to keep breathing, and has the effect of benefiting the kidney, absorbing qi and calming asthma.

[0026] Chuanxiong can promote blood circulation and dissipate blood stasis. Its active ingredients can dilate blood vessels, improve microcirculation, and thus enhance blood flow. Chuanxiong can regulate Qi and relieve muscle tension, and has a certain effect on pain caused by Qi stagnation and blood stasis.

[0027] Achyranthes bidentata has significant therapeutic effects on symptoms such as amenorrhea, dysmenorrhea, abdominal pain during menstruation, retained placenta, and pain from falls caused by blood stasis. Achyranthes bidentata can also nourish the liver and kidneys, enhance liver and kidney function, and has a good therapeutic effect on symptoms such as soreness and weakness of the waist and knees, physical fatigue, etc. caused by liver and kidney deficiency.

[0028] 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.

[0029] Licorice is sweet and neutral in nature. It enters the heart, lung, stomach and other meridians, and has a good effect of replenishing qi and restoring pulses. Licorice enters the middle jiao, and has the effects of strengthening the spleen and stomach, relieving acute pain. Licorice has a moderate medicinal property and is often used to adjust the cold and hot bias and strong properties of drugs, which helps to alleviate the toxicity of drugs and enhance the efficacy of drugs.

[0030] Atractylodes can be widely used in the treatment of spleen and stomach qi deficiency syndrome, and has the effects of drying dampness and promoting diuresis; it is "the first important medicine for replenishing qi and strengthening the spleen", and also has the effects of replenishing qi and nourishing blood, promoting blood circulation and relieving pain, promoting dampness and stopping diarrhea, and calming the nerves and stabilizing the mind.

[0031] In the formula, aconite and cinnamon bark are used as the main drugs to warm and strengthen the kidney yang; Rehmannia root, Cornus officinalis, Lycium barbarum, and Chinese yam are used as the assistant drugs to nourish yin and benefit the kidney, replenish essence and marrow, and nourish the liver and spleen. Cuscuta chinensis and Eucommia bark are used to nourish the liver and kidney and strengthen the waist and knees; Alisma orientalis is used to promote diuresis and eliminate dampness; Achyranthes bidentata, Chuanxiong, Magnetite, remove blood stasis and promote menstruation, nourish the liver and kidney, strengthen tendons and bones; Poria, Atractylodes macrocephala, and Licorice are used to invigorate qi, strengthen the spleen, and calm the mind. All the drugs are used together to warm the kidney and strengthen the spleen, and open the orifices and improve hearing.

[0032] The above-mentioned kidney-tonifying and ear-enhancing 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.

[0033] Taking capsule preparation as an example, the preparation process includes: according to 12.5 parts of processed aconite, 15 parts of cinnamon bark, 50 parts of prepared rehmannia root, 20 parts of cornus officinalis, 25 parts of wolfberry, 25 parts of yam, 25 parts of dodder seed, 25 parts of eucommia bark, 50 parts of oriental arisaema, 37.5 parts of magnetite, 25 parts of chuanxiong, 25 parts of achyranthes bidentata, 25 parts of poria, 15 parts of liquorice, 25 parts of atractylodes macrocephala, weigh the above 15 kinds of medicinal materials, remove impurities and select them respectively, and remove cinnamon bark and wolfberry bark. The three medicinal materials of wolfberry and chuanxiong are dried at 60℃ for 8-12h, and the other 11 medicinal materials except magnetite are dried at 70-80℃ for 6-8h, and then crushed by a grinder and passed through a 90-mesh sieve; the magnetite is then crushed to remove impurities, the sieved medicinal powder is collected and mixed with the crushed magnetite, and placed in a covered container. The mixed medicinal powder is gray-brown powder with a slightly sour and sweet taste; the medicinal powder is sent to a capsule filling group for filling, and each capsule is filled with 0.4g to obtain a finished capsule preparation.

[0034] The above capsule preparations are identified as follows:

[0035] (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 11-13μm. 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 20-92μm, and the vessel molecules are shorter, 80-150μm long. There are a few small square crystals of calcium oxalate with a diameter of about 5μm (Rehmannia glutinosa).

[0036] (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).

[0037] (3) Take 0.4 g of this product, add 5 ml of dilute hydrochloric acid, stir thoroughly, heat and boil for 1-2 minutes, filter, and the filtrate shows the identification reaction of iron salt (Chinese Pharmacopoeia 2015 Edition Part IV 0807).

[0038] (4) Take the contents of 10 tablets of this product, add 40mL of ether and reflux extract for 1 hour, filter, evaporate the filtrate and dissolve the residue in 1ml of ethyl acetate to prepare the test solution. Take 1g of Atractylodes macrocephala as the control medicinal material and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 3uL of each of the two newly prepared solutions and spot them on the same silica gel G thin layer plate, use petroleum ether (60-90℃)-ethyl acetate (50:1) as the developing solvent, develop, take out, dry, spray with 5% vanillin sulfur liquid solution, blow with hot air until the spots of the same color are clear, and in the chromatogram of the test product, at the corresponding position of the chromatogram of the control medicinal material, there are spots.

[0039] (5) Take the contents of 10 tablets of this product, add 20 ml of ethyl acetate, ultrasonically treat for 30 minutes, filter, add the filtrate to an alumina column (200-300 mesh, 5 g, inner diameter 1 cm, dry column), elute with 10 ml of ethyl acetate, collect the eluate, evaporate to dryness, add 1 ml of ethyl acetate to the residue to dissolve it, and use it as the test solution. Take another 23-acetyl alismatol B reference substance, add ethyl acetate to make a solution containing 2 mg per 1 ml, and use it as the reference solution. Test according to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 5 μl of each of the above two solutions and spot them on the same silica gel H thin layer plate, use cyclohexane-ethyl acetate (1:1) as the developing solvent, develop, take out, beak dry, spray with 5% silicotungstic acid ethanol solution, and heat until the spots are clearly colored. In the chromatogram of the test product, spots of the same color appear at the corresponding positions of the chromatogram of the reference substance.

[0040] (6) Take the contents of 10 tablets of this product, add 50 ml of ether, ultrasonically treat for 10 minutes, filter, evaporate the filtrate, and add 1 ml of methanol to the residue to dissolve it as the test solution. Take 1 g of Poria Root as a control medicinal material and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 2 ul of each of the above two solutions and spot them on the same silica gel G thin layer plate, use toluene-ethyl acetate-formic acid (20:5:05) as the developing solvent, develop, take out, dry, spray with 2% vanillin sulfuric acid solution-ethanol (4:1) mixed solution, and heat at 105°C until the spots are clearly colored. In the chromatogram of the test product, a main spot of the same color appears at the corresponding position of the chromatogram of the control medicinal material.

[0041] Clinical research was carried out using the above-mentioned capsule preparation of the Bushencong'er combination as an example, which is mainly used to treat symptoms such as cold body and limbs, dizziness, tinnitus and deafness caused by insufficient kidney yang.

[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 diagnostic criteria of TCM syndromes, refer to "Chinese Medicine Otolaryngology", published by Shanghai Science and Technology Press in December 1999) Kidney Yang Deficiency Symptoms: Main Symptoms: Cicadas are often heard, day and night, worse at night; Secondary Symptoms: Dizziness, soreness of waist and knees, coldness of lower limbs, impotence, pale tongue, white fur, weak pulse. Diagnosis basis: 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 heart, cerebrovascular, liver, kidney and hematopoietic system, and mental illness

[0055] Dosage: Take 6 capsules of Bushen Conger Composition 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 (96 ears) were observed, including 33 males (15 in one ear and 18 in both ears) and 27 females (11 in one ear and 16 in both ears), aged 18-65 years old, with an average age of 51 years old. The symptoms were tinnitus and deafness, with a course of several years in some cases, sometimes mild and sometimes severe, dizziness, soreness of waist and knees, coldness of lower limbs, impotence, pale tongue, and weak pulse. 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, physical signs disappeared or almost disappeared, symptom score reduced 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 Bushencong'er composition capsule preparation in treating cold limbs, dizziness, tinnitus and deafness caused by kidney yang deficiency was as high as 72% (69 / 96), the cure rate was 4% (4 / 96), the marked efficiency was 23% (22 / 96), the effective rate was 45% (43 / 96), and the ineffective rate was 28% (27 / 96).

[0065] TCM Syndrome Efficacy

[0066] Table 1 Comparison of TCM syndrome scores of patients before and after treatment (000)

[0067] Before treatment After treatment T P Experimental Group 11.3+2.0 9.12+1.8 2.890 0.027

[0068] Table 1 shows that after treatment, the symptom scores of this group of patients were statistically different, and compared with before treatment, the symptom scores decreased significantly.

[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 most of the clinical patients are middle-aged and elderly with a long course of disease. After one course of treatment, the Bushen Cong'er Composition Capsules have a good improvement effect on many patients with long-term tinnitus and deafness symptoms, with a total effective rate of 72%. The Bushen Cong'er Composition Capsules have a clear efficacy and are effective in treating patients with symptoms such as cold limbs, dizziness, tinnitus, deafness, etc. due to kidney yang 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 using the above-mentioned kidney-tonifying and ear-concentrating composition are recorded as follows:

[0077] Typical medical history 1

[0078] Zhang, male, 10 years old, from Xi'an, had a hearing loss in his left ear for 3 years and aggravated for 7 days. He came to the clinic on April 16, 2018. His father said that the child had a poor physical condition when he was young and often caught a cold. He couldn't keep up with his studies after going to school 3 years ago. After carefully questioning the patient, he found that his left ear had poor hearing. Later, he was treated in Xi'an Children's Hospital but the effect was not obvious. He went to other large hospitals in Xi'an and was told that it could not be cured. Later, the patient's father was transferred to our hospital through a friend's introduction. In the past week, the patient's hearing has obviously decreased. His father brought him to the clinic today. The patient's external auditory canal was normal, the patient's tongue coating was white, and there were tooth marks on the edge of the tongue. The child was in poor spirits, forgetful, and picky about food; the hearing test showed: moderate sensorineural hearing loss on the left side. Give 10 doses of half the amount of Bushen Cong'er Composition Decoction, combined with multi-dimensional element tablets and adenosine disodium triphosphate tablets. Ask the patient's parents to strengthen the nutrition of the child, take medicine on time, and prevent and treat colds.

[0079] Adenosine triphosphate disodium participates in the metabolism of fat, protein, sugar, nucleic acid and nucleotide in the body. It can also improve the stability and reconstruction ability of nerve cell membrane structure and promote the regrowth of nerve processes. In this case, it is used together with multi-dimensional element tablets as a nutritional supplement.

[0080] The child came to the clinic on May 6, 2018. His family said that after taking the medicine, the child ate better than before and his hearing improved a little, so he continued to take the same medicine as before.

[0081] The child came to the clinic on June 3, 2018. He was in good spirits. After questioning, he said that his hearing had improved and his studies were better. Because the patient had a lot of homework and his parents were busy with work, the parents asked him to take 20 doses of medicine and the nutritional supplements were the same as before.

[0082] On August 6, 2018, the patient came for a follow-up visit, and the hearing was improved by 20db. The patient was given the Bushen Cong'er Composition Capsule Preparation for one and a half months, 3 capsules each time, twice a day, and nutritional supplements were taken as before.

[0083] In June 2024, the patient came to the clinic with his father. He said that his hearing improved after the treatment six years ago, and the hearing in his left ear was only slightly poor. This year he is a second year of high school and has a heavy workload. Today he came to get some medicine to regulate his body. The patient's father said that his child is doing well in school now, so he was given one and a half months' supply of Bushencong'er combination capsules, vitamin B1 and brain protein hydrolyzate tablets, and was asked to follow the doctor's orders.

[0084] Typical medical history 2

[0085] Yu, male, 75 years old, from Qishan County, has had hearing loss in both ears for 6 years, which has worsened for more than 1 month. He went to the hospital for treatment on April 20, 2024. He said that he had hearing loss in both ears 6 years ago and went to Xi'an and Baoji hospitals for treatment, but the effect was not great. He was equipped with hearing aids later, but he still couldn't hear clearly. The symptoms have been severe in the past month, and he came to the hospital today. The examination showed that the patient's external auditory canal and eardrum were normal. The hearing test results showed bilateral moderate sensorineural hearing loss and blood pressure of 100 / 60mmHg. Fatigue, backache, fear of cold, wanting to sleep, forgetfulness, 8 doses of Bushen Cong'er combination decoction, vitamin B1 tablets, and brain protein hydrolyzate tablets were given. Advise him to stay away from noise and avoid eating raw, cold, smoking and drinking.

[0086] On May 6, 2024, the patient reported that he felt better after taking the medicine, and his hearing improved slightly. He continued to take the Bushen Cong'er Composition Decoction for half a month. On June 10, 2024, the patient reported that his hearing improved significantly, and he was given Bushen Cong'er Composition Capsule Preparation for one and a half months, 3 capsules each time, twice a day, and nutritional supplements as before. Follow the doctor's advice.

[0087] Typical medical history 3

[0088] Liu, female, 30 years old, from Baoji, had hearing loss in both ears and tinnitus for 2 years and aggravated for half a month. She was treated on March 16, 2024. She reported that she had heavy bleeding when she gave birth to a child 2 years ago. After the child was born, she had little milk, could not eat by herself, felt dizzy and weak, and did not want to move. Later, her hearing decreased, accompanied by low-pitched tinnitus. She had been treated locally, but the effect was not obvious. In the past half month, her hearing decreased severely and she could not hear clearly. The external auditory canal tympanic membrane was normal, and a hearing test and a routine blood test were performed. After the examination, it was shown that she had mild anemia, bilateral sensorineural deafness and tinnitus, and a blood pressure of 95 / 60 mmHg. Because she had to take care of the children, she could not be hospitalized. She was given 10 doses of the Bushen Cong'er combination decoction, and multi-dimensional element tablets and brain protein hydrolyzate tablets. She was advised to relax, stay away from noise, strengthen nutrition, and not to work hard.

[0089] On April 8, 2024, the patient reported that he wanted to eat, was in better spirits, and had better hearing after taking the medicine. He continued to take the medicine for 15 days. On May 3, 2024, the patient reported that his hearing had improved significantly, his tinnitus was very small, and his memory had improved. He was given a month's supply of Bushen Cong'er combination capsules, 3 capsules each time, 3 times a day, and the nutritional supplements were the same as before. The doctor's instructions were the same as before.

[0090] Typical medical history 4

[0091] Hao, female, 48 years old, from Xianyang, has bilateral hearing loss and tinnitus for 3 years, which has worsened for 7 days. She came to the clinic on April 15, 2024. She said that she had heavy work and irregular life 3 years ago, and bilateral hearing loss and tinnitus. After local treatment, it was slightly relieved. Later, due to the aggravation of staying up late, she went to Xianyang General Hospital for diagnosis and treatment, but the effect was not good. Now she has severe hearing loss, constant tinnitus, irritability, poor work, forgetfulness, fear of cold, frequent night sleep, clear and long urine, small menstrual volume, light color, waist fatigue and weakness. Examination of the external auditory canal eardrum was normal, blood pressure was 100 / 60mmHg, and hearing test showed: bilateral neurological deafness and tinnitus. Due to heavy work, she could not be hospitalized for treatment. She was given 15 doses of Bushen Cong'er combination decoction, multi-dimensional element tablets, and brain protein hydrolyzate tablets. Advise patients to relax, stay away from noise, keep a regular schedule, avoid eating raw, cold, spicy food, and avoid overwork.

[0092] On May 19, 2024, the patient came to the clinic with a stable mood, reported that tinnitus was reduced, hearing improved, and blood pressure was 115 / 70 mmHg. The medication was the same as before, and the doctor's advice was followed. On June 17, 2024, the patient reported that his hearing was significantly improved and the tinnitus was very small. He was in good spirits, had a stable sleep, and was able to work well. He was given a one-month supply of the Bushen Cong'er compound capsule preparation, 3 capsules each time, 3 times a day, and the western medicine was the same as before. Follow the doctor's advice as before.

[0093] The above is only a preferred embodiment of the present invention, and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment 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 embodiments 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 neurological tinnitus due to kidney yang deficiency, characterized in that: The ingredients include: 10-15 parts of processed aconite, 15-20 parts of cinnamon bark, 40-50 parts of rehmannia root, 15-20 parts of cornus officinalis, 20-30 parts of wolfberry, 20-30 parts of yam, 20-30 parts of dodder seeds, 20-30 parts of eucommia bark, 45-60 parts of oriental arisaema, 35-40 parts of magnetite, 20-30 parts of ligusticum chuanxiong, 25-30 parts of achyranthes bidentata, 25-30 parts of poria, 15-20 parts of liquorice, and 20-30 parts of atractylodes macrocephala.

2. The Chinese medicine composition for treating neurological tinnitus due to kidney yang deficiency according to claim 1, characterized in that: The ingredients in parts by mass include: 12.5 parts of processed aconite, 15 parts of cinnamon bark, 50 parts of prepared rehmannia root, 20 parts of cornus officinalis, 25 parts of wolfberry fruit, 25 parts of yam, 25 parts of dodder seed, 25 parts of eucommia bark, 50 parts of oriental arisaema, 37.5 parts of magnetite, 25 parts of ligusticum chuanxiong, 25 parts of achyranthes bidentata, 25 parts of poria, 15 parts of liquorice, and 25 parts of atractylodes macrocephala.

3. The Chinese medicine composition for treating neurological tinnitus due to kidney yang deficiency according to claim 1 or 2, characterized in that: The Chinese medicine composition for treating neurological tinnitus due to kidney yang 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 neurological tinnitus due to kidney yang deficiency, characterized in that: For preparing the Chinese medicine composition for treating neurological tinnitus caused by kidney yang deficiency as claimed in claim 1 or 2, the preparation method of the capsule use form is: Fifteen kinds of medicinal materials are weighed by mass, and impurities are removed and cleaned respectively. Among them, cinnamon bark, wolfberry fruit and chuanxiong are dried at 60°C for 8-12 hours, and the remaining 11 kinds of medicinal materials except magnetite are dried at 70-80°C for 6-8 hours, and then ground with a grinder and sieved respectively; then the magnetite is removed of impurities and crushed, and the sieved powder is collected and mixed with the crushed magnetite, and placed in a covered container. The mixed powder is gray-brown powder with a slightly sour and sweet taste; the powder is sent to a capsule filling group for filling to obtain a finished capsule preparation.

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