Traditional Chinese medicine composition for treating toxin retention type tinnitus and deafness and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating toxin retention type tinnitus and deafness. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 55 to 60 parts of radix angelicae sinensis, 55 to 60 parts of radix puerariae, 25 to 30 parts of rhizoma acori graminei, 25 to 30 parts of rhizoma chuanxiong, 25 to 30 parts of radix paeoniae rubra, 25 to 30 parts of flos carthami, 10 to 15 parts of semen persicae, 25 to 30 parts of radix salviae miltiorrhizae, 25 to 30 parts of rhizoma atractylodis macrocephalae (fried), 20 to 25 parts of manis pentadactyla, 20 to 25 parts of lumbricus, 20 to 25 parts of stiff silkworm, 20 to 25 parts of rhizoma alismatis, 10 to 15 parts of radix scrophulariae and 5 to 10 parts of liquorice root. 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 yellowish-brown medicinal powder with slight smell, slight sour taste and slight bitter taste; and feeding the medicine powder to a capsule filling group for filling. The traditional Chinese medicine composition has the advantages that besides clearing and activating the channels and collaterals, the compatibility thought of replenishing blood and activating blood, invigorating the spleen and replenishing qi and promoting blood circulation by qi circulation is matched, so that ear orifices are better nourished, and the symptoms of tinnitus and deafness caused by toxin retention 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 tinnitus and deafness caused by retention of evil toxins 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] Drug-induced deafness is mainly caused by certain drugs or human contact with certain chemicals. It manifests as chronic poisoning of the auditory system, mainly deafness and tinnitus. Deafness is usually bilateral and symmetrical, starting with high-frequency hearing loss and gradually extending to low frequencies. In a few people, it will continue to worsen and become completely deaf. Tinnitus often lasts for a long time, aggravating the patient's pain. Ototoxic drugs can also cause systemic damage to the liver, kidneys, hematopoietic, endocrine, and nervous systems.

[0004] In the classification of deafness symptoms in traditional Chinese medicine, the dialectical classification based on the cause can include: retention of evil toxins, blood stasis, liver and kidney yin deficiency, kidney yang deficiency, liver and gallbladder dampness and heat, spleen and stomach weakness, etc. For drug-toxic deafness (patients with a slow course and unclear history of ototoxic drug use are also diagnosed as neurological deafness) or some patients with neurological deafness (mostly caused by trauma, staying up late and drinking, etc.), they mostly correspond to the situation of retention of evil toxins and blood stasis. Compared with patients with other types of deafness and tinnitus, patients with retention of evil toxins and blood stasis often have symptoms of heavy swelling and blockage in the ears, dizziness and stuffiness.

[0005] Existing traditional Chinese medicines for treating Qi and blood stasis mainly focus on promoting blood circulation and activating collaterals, but there is still room for further improvement in treatment ideas and effects. Summary of the invention

[0006] In view of the problem that the treatment effect of tinnitus and deafness symptoms caused by retention of evil toxins in the prior art still needs to be further improved, the present invention provides a traditional Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins and a preparation method thereof.

[0007] The technical scheme of the present invention is as follows: A traditional Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins, comprising, by mass: 55-60 parts of angelica sinensis, 55-60 parts of kudzu root, 25-30 parts of acorus scabra, 25-30 parts of chuanxiong, 25-30 parts of red peony root, 25-30 parts of safflower, 10-15 parts of peach kernel, 25-30 parts of salvia miltiorrhiza, 25-30 parts of atractylodes macrocephala (fried), 20-25 parts of pangolin, 20-25 parts of earthworm, 20-25 parts of bombyx batryticatus, 20-25 parts of oriental rhizome, 10-15 parts of Scrophularia ningpoensis, and 5-10 parts of liquorice.

[0008] Preferably, the ingredients in parts by mass include: 55.2 parts of Angelica sinensis, 55.2 parts of Pueraria lobata, 27.6 parts of Acorus chinensis, 27.6 parts of Ligusticum chuanxiong, 27.6 parts of Paeonia lactiflora, 27.6 parts of Carthamus tinctorius, 13.7 parts of Semen persica, 27.6 parts of Salvia miltiorrhiza, 27.6 parts of Atractylodes macrocephala (fried), 22.1 parts of Pangolin, 22.1 parts of Pheretima, 22.1 parts of Bombyx batryticatus, 22.1 parts of Orientalis, 13.7 parts of Scrophularia ningpoensis, and 8.2 parts of Licorice.

[0009] Furthermore, the Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins may be used in the form of one or more of decoctions, capsules, pills, and tablets.

[0010] The present invention also provides a method for preparing a Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins, which is used to prepare the Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins; the preparation method of the capsule use form thereof is as follows:

[0011] Fifteen kinds of medicinal pieces are weighed, and the impurities are removed and cleaned respectively. Except for angelica, chuanxiong, earthworm and peach kernel which are dried at less than 60°C for 8-12 hours, the remaining 11 pieces are dried at 70-80°C for 6-8 hours, and crushed by a grinder respectively. The powder is sieved and collected. The powder is yellow-brown powder with a slight odor and a slightly sour and bitter taste. The powder is sent to the capsule filling group for filling to obtain the finished capsule preparation.

[0012] The advantages of the present invention are as follows: Angelica sinensis and Pueraria root are used as the main drugs to nourish blood, invigorate blood circulation, promote yang and open the orifices, and promote the menstruation and hearing. Acorus calamus is used as the assistant to awaken the mind, eliminate dampness and open the orifices. Peach kernel, safflower, Chuanxiong, red peony root, and Salvia miltiorrhiza can invigorate blood circulation and remove blood stasis, strengthen the menstruation and activate the collaterals, and stir-fried Atractylodes macrocephala can invigorate the spleen and replenish qi, eliminate dampness and promote diuresis, and stimulate blood circulation. Pangolin, earthworm, bombyx batryticatus, and orientalis can clear away heat and unblock the collaterals, invigorate blood circulation and eliminate symptoms, and promote dampness and dissipate stagnation as the adjuvant drugs. Scrophularia ningpoensis and liquorice are used to invigorate the spleen and replenish qi, detoxify, open the orifices and dissipate stagnation. All the drugs are used together to invigorate blood circulation, remove blood stasis, promote the menstruation and activate the collaterals, and promote the hearing.

[0013] The Chinese medicine composition of the present invention not only promotes blood circulation and activates collaterals, but also nourishes blood, invigorates the spleen and replenishes qi, and uses the idea of ​​qi to drive blood circulation, so that the ears can be better nourished and the symptoms of tinnitus and deafness can be more effectively treated. DETAILED DESCRIPTION

[0014] 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.

[0015] The inventors believe 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 effect on improving this type of tinnitus and deafness; but in addition to dredging the meridians and activating the meridians, the symptoms of pain and stuffy headaches associated with patients with deafness and tinnitus caused by retention of evil toxins and stasis of qi and blood further indicate that insufficient blood supply, poor qi circulation, and deafness caused by blockage of evil toxins in the body.

[0016] Therefore, the Chinese medicine composition of the present invention not only promotes blood circulation and activates collaterals, but also nourishes blood, invigorates the spleen and replenishes qi, and uses qi to drive blood circulation, so that the ears can be better nourished and the symptoms of tinnitus and deafness can be treated more effectively.

[0017] Specifically, the traditional Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins (hereinafter referred to as "the blood-activating and ear-invigorating composition") includes, by mass: 55-60 parts of Angelica sinensis, 55-60 parts of Pueraria root, 25-30 parts of Acorus thunbergii, 25-30 parts of Ligusticum chuanxiong, 25-30 parts of Red Peony Root, 25-30 parts of Carthamus tinctorius, 10-15 parts of Persica kernel, 25-30 parts of Salvia miltiorrhiza, 25-30 parts of Atractylodes macrocephala (fried), 20-25 parts of Pangolin, 20-25 parts of Pheretima, 20-25 parts of Bombyx batryticatus, 20-25 parts of Alismatis orientalis, 10-15 parts of Scrophularia ningpoensis, and 5-10 parts of Licorice.

[0018] Among them, angelica is known as the "number one blood tonic", which can effectively improve various symptoms caused by blood deficiency, and has the effects of promoting blood circulation, removing blood stasis, nourishing the heart and calming the mind. Angelica is often used in combination with other medicinal materials to enhance the efficacy. For example, when used in combination with astragalus and codonopsis, it can treat qi deficiency and blood deficiency; when used in combination with chuanxiong and peach kernel, it can treat blood stasis.

[0019] Pueraria root can stimulate the rise of the yang energy of the spleen and stomach, and has the effect of dredging the meridians and dispersing pathogens; it helps to treat stroke hemiplegia, chest pain, heart pain, dizziness and headache. It also helps to improve symptoms such as stiffness of the head and neck, tinnitus, dizziness, and numbness of the limbs.

[0020] 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.

[0021] Chuanxiong is warm in nature and has the effects of promoting blood circulation, removing blood stasis, dispelling wind and relieving pain, and promoting blood circulation. It can help improve blood circulation, eliminate blood clots, and improve the condition of blocked meridians. It is used to treat pain symptoms such as headaches, toothaches, and rheumatoid arthritis. It is especially good at treating headaches caused by external evils such as wind-cold, wind-heat, and rheumatism, as well as joint pain caused by rheumatoid arthritis.

[0022] Red peony root tastes bitter and is cold in nature. It enters the liver meridian and can clear away liver fire, relieve blood heat, and play a role in cooling blood and stopping bleeding. Red peony root can also promote blood circulation and disperse blood stasis, accelerate the dissipation of blood stasis, and treat pain caused by blood stasis.

[0023] Safflower has the effects of promoting blood circulation and removing blood stasis, unblocking meridians, and reducing swelling and dispersing nodules. It has a good effect on various pains caused by blood stasis; it has a certain effect on reducing swelling and dispersing nodules for swelling and pain caused by trauma, carbuncle, ulcer, etc. It can promote local blood circulation and accelerate the disappearance of swelling.

[0024] Peach kernel can promote blood circulation, eliminate blood stasis, and improve the nutritional supply of local tissues, thereby relieving pain and discomfort; it also has the effects of soothing the liver and relieving depression, lowering lung qi, relieving cough and relieving asthma.

[0025] Salvia miltiorrhiza has the effects of cooling blood, promoting blood circulation and removing blood stasis, and is often used to treat various symptoms of blood stasis. Salvia miltiorrhiza can also nourish the heart and calm the mind, improve heart function, and has a good effect in relieving restlessness, insomnia, and heat pain.

[0026] 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.

[0027] Pangolin has the effects of promoting blood circulation, dispersing nodules, regulating menstruation, reducing lactation, reducing swelling, and eliminating suppuration. It is used to treat rheumatism, joint pain, stroke, hemiplegia, various common sores, carbuncles, poisoning and other symptoms.

[0028] Earthworms have the effects of promoting blood circulation and removing blood stasis, warming the meridians and relieving pain, calming the mind and settling the spirit, promoting diuresis and reducing swelling, unblocking meridians and relieving asthma. They are used to improve diseases caused by blood stasis and blood stasis. They are often used to treat blood stasis pain. Their effect of warming the meridians helps to harmonize Qi and blood and relieve pain. Earthworms can also help calm the mind and improve sleep quality.

[0029] Bombyx batryticatus has the effects of calming wind and stopping convulsions, dispelling wind and unblocking meridians, resolving phlegm and dispersing nodules, nourishing yin and moistening the lungs. It has a good effect on unblocking meridians for facial paralysis, numbness and hemiplegia. At the same time, it can also relieve sore throat, relieve pain and relieve itching. It can be used to treat skin itching, sore throat caused by wind-heat, and dizziness and headache caused by wind-heat.

[0030] 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.

[0031] Scrophularia has the effects of cooling blood and stopping bleeding, nourishing yin and moistening dryness, reducing fire and relieving restlessness, clearing the heart and calming the mind. It is suitable for yin deficiency and hyperactivity of fire, and can remove the heat evil in the body. It is suitable for symptoms such as dry mouth, thirst, and night sweats caused by yin deficiency and hyperactivity of fire. It also has a certain sedative and tranquilizing effect, and can relieve psychological symptoms such as anxiety, insomnia, palpitations, etc.

[0032] 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.

[0033] In the prescription, Angelica and Puerariae Radix are used as the main drugs to nourish blood, invigorate blood circulation, promote yang and open the orifices, and promote the hearing. Acorus calamus is used as the assistant to awaken the mind, eliminate dampness and open the orifices. Peach kernel, safflower, Chuanxiong, red peony root, and Salvia miltiorrhiza can invigorate blood circulation and remove blood stasis, strengthen the circulation of meridians and collaterals, and stir-fry Atractylodes macrocephala can invigorate the spleen and replenish qi, eliminate dampness and promote diuresis, and stimulate blood circulation. Pangolin, earthworm, bombyx batryticatus, and orientalis are used as adjuvant drugs to clear heat and unblock the collaterals, invigorate blood circulation and eliminate symptoms, and promote dampness and dissipate stagnation. Scrophulariae and licorice are used to invigorate the spleen and replenish qi, detoxify, open the orifices and dissipate stagnation. All the drugs are used together to invigorate blood circulation, remove blood stasis, promote the circulation of meridians and collaterals, and promote the hearing.

[0034] The above-mentioned Chinese medicine composition for promoting blood circulation and improving ear function 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.

[0035] Taking capsule preparation as an example, the preparation process includes: 55.2 parts of Angelica sinensis, 55.2 parts of Pueraria lobata, 27.6 parts of Acorus chinensis, 27.6 parts of Ligusticum chuanxiong, 27.6 parts of Paeonia lactiflora, 27.6 parts of Carthamus tinctorius, 13.7 parts of Persica kernel, 27.6 parts of Salvia miltiorrhiza, 27.6 parts of Atractylodes macrocephala (fried), 22.1 parts of Pangolin, 22.1 parts of Pheretima, 22.1 parts of Bombyx batryticatus, 22.1 parts of Alismatis rhizome, 13.7 parts of Scrophularia ningpoensis, and 8.2 parts of Licorice.

[0036] Weigh the above 15 kinds of medicinal pieces, remove impurities and select them separately. Except for angelica, chuanxiong, earthworm and peach kernel which are dried at less than 60℃ for 8-12h, the remaining 11 pieces are dried at 70-80℃ for 6-8h, crushed by a grinder, passed through a 90-mesh sieve, and the powder is collected. The powder is yellow-brown powder with a slight odor and a slightly sour and bitter taste. It is placed in a covered container and sent to the capsule filling group for filling. Each piece is filled with 0.4g to obtain the finished capsule preparation.

[0037] The above capsule preparations are identified as follows:

[0038] (1) Take this product and observe it under a microscope: the phloem thin-walled cells are spindle-shaped, with slightly thick walls and extremely fine oblique interlaced lines on the surface. Sometimes thin transverse septa can be seen. Scalar vessels and reticulate vessels are common, with a diameter of about 80 μm. Sometimes oil chamber fragments (Angelica sinensis) can be seen.

[0039] (2) Take this product and observe it under a microscope: there are many starch granules, single granules are elliptical, oblong, sub-circular, oval or kidney-shaped, with a diameter of 5-16um and a length of about 21um, with umbilical points, long slits or herringbone shapes; occasionally there are compound granules, consisting of 2-4 sub-granules. Calcium oxalate crystals exist in thin-walled cells, in the form of sub-circular masses or clusters, with a diameter of 10-25um. The cork cells are dark yellow-brown, polygonal in surface view, and slightly curved. The oil chambers are mostly broken, and oil chamber fragments can occasionally be seen. The secretory cell walls are thin and contain more oil droplets. The ducts are mainly spiral ducts. There are also reticular and ladder-shaped ducts with a diameter of 14-50um (Chuanxiong).

[0040] (3) Take the contents of 10 tablets of this product, add 20 ml of methanol, let stand for 2 hours, filter, evaporate the filtrate, add 0.5 ml of methanol to dissolve the residue, and use it as the test solution. Take another 0.8 g of Pueraria root reference medicinal material and prepare the reference medicinal material solution in the same way. Take the puerarin reference substance and add methanol to prepare a solution containing 1 mg per 1 ml, which is used as the reference substance solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 10 ul of each of the above three solutions and spot them on the same silica gel G thin layer plate to form strips. Use chloroform-methanol-water (7:2.5:0.25) as the developing agent, 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 and the chromatogram of the reference substance, fluorescent strips of the same color appear.

[0041] (5) Take the contents of 8 tablets of this product, add 10 mL of n-hexane, ultrasonically treat for 15 minutes, filter, evaporate the filtrate at low temperature (below 60°C), dissolve the residue in 1 mL of n-hexane, and use it as the test solution. Take another 0.2 g of Atractylodes macrocephala control medicinal material, add 5 mL of n-hexane, 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 10uL of each of the above two solutions and spot them on the same silica gel G thin layer plate, use petroleum ether (60-90°C)-ethyl acetate (20:1) as the developing solvent, develop, take out, and dry. Spray 5% vanillin sulfuric acid solution and blow with hot air until the spots are clearly colored. In the chromatogram of the test product, the same pink spots appear at the corresponding positions of the chromatogram of the control medicinal material.

[0042] (6) Take the contents of 10 tablets of this product, add 20 ml of ethanol, shake for 5 minutes, filter, evaporate the filtrate, and add 2 ml of ethanol to the residue to dissolve it as the test solution. Take another reference substance of paeoniflorin, add ethanol to make a solution containing 2 mg per 1 ml, as the reference solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 4 u1 of each of the above two solutions and spot them on the same silica gel G thin layer plate, use chloroform-ethyl acetate-methanol-formic acid (40:5:10:0.2) as the developing agent, develop, take out, dry, spray with 5% vanillin sulfuric acid solution, and heat until the spots are clearly colored. In the chromatogram of the test product, the same blue-purple spots appear at the corresponding positions of the chromatogram of the reference substance.

[0043] Clinical research was carried out using the above-mentioned Huoxuecong'er combination capsule preparation as an example, which is mainly used to treat tinnitus and deafness that are not cured for a long time due to the retention of evil toxins and the stagnation of qi and blood, resulting in fullness and blockage in the ear.

[0044] 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.

[0045] According to the diagnostic criteria of TCM syndromes, refer to "Chinese Medicine Otolaryngology", published by Shanghai Science and Technology Press in December 1999), the symptoms of evil toxin retention and blood stasis are as follows: main symptoms: fullness and blockage in the ear, which does not heal over time, or even as if blocked by something, hearing loss, and tinnitus like cicadas; secondary symptoms: dizziness, stuffiness, fatigue, pale purple tongue and sluggish pulse. Diagnosis basis: main symptoms are required; 2-3 secondary symptoms are present.

[0046] Case inclusion criteria:

[0047] ①Conform to Western medical diagnostic standards

[0048] ②Conform to the diagnostic criteria of TCM syndrome

[0049] ③Age 18-70 years old

[0050] ④Sign the informed consent form for entering the study

[0051] Exclusion criteria:

[0052] ①Acute and chronic suppurative otitis media.

[0053] ②Sudden tinnitus and deafness caused by viral reasons.

[0054] ③ Those who have used other drugs or treatment methods before treatment.

[0055] ④Pregnant or lactating women.

[0056] ⑤ Patients with serious primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system, and mental illness

[0057] Dosage: Take 6 capsules of Huoxuecong'er combination capsules 3 times a day. Take with warm water after meals. Treatment course: 1 month for one course.

[0058] General clinical data: A total of 60 cases (100 ears) were observed, including 25 males (9 in one ear and 16 in both ears) and 35 females (11 in one ear and 24 in both ears), aged 18-70 years old, with an average age of 45 years old. Symptoms included fullness and blockage in the ears, as if there was something blocking them, which lasted for a few days or a few years, dizziness, fatigue, pale purple tongue, and sluggish pulse. All were diagnosed by Western medicine as neurological tinnitus and deafness.

[0059] Efficacy and safety evaluation criteria:

[0060] The improvement rate was evaluated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines.

[0061] ① Clinically cured: TCM clinical symptoms and signs disappear or almost disappear, and the syndrome score decreases by ≥95%

[0062] ② Markedly effective: Clinical symptoms and signs of TCM are significantly improved, and the syndrome score is reduced by ≥ 70%

[0063] ③ Effective TCM clinical symptoms and signs have improved significantly, and the syndrome score has decreased by ≥30%

[0064] ④ Ineffective TCM clinical symptoms and signs are significantly improved or even aggravated, and the syndrome score is reduced by less than 30%

[0065] Efficacy analysis:

[0066] After one course of treatment, the total effective rate of the Huoxuecong'er composition capsule preparation in treating tinnitus and deafness caused by retention of evil toxins, blockage of qi and blood stasis, and long-term persistent tinnitus and deafness was as high as 77% (77 / 100), the cure rate was 8% (8 / 100), the marked efficiency was 46% (46 / 100), the effective rate was 23% (23 / 100), and the ineffective rate was 23% (23 / 100).

[0067] TCM Syndrome Efficacy

[0068] Table 1 Comparison of TCM syndrome scores of patients before and after treatment

[0069] Before treatment After treatment T P Experimental Group 9.69+1.59 8.23+1.18 5.147 0.003

[0070] After treatment, the symptom scores of this group of patients were significantly different and decreased significantly compared with those before treatment.

[0071] Security Analysis

[0072] Analysis of test results of safety indicators:

[0073] Table 2 Laboratory safety index test results

[0074]

[0075]

[0076] 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.

[0077] The results of clinical trials show that most of the clinical patients are middle-aged and elderly and have a long course of disease. After one course of treatment, the Huoxue Cong'er Composition Capsule Preparation has a good improvement effect on ear distension, blockage, tinnitus and deafness caused by retention of evil toxins and blood stasis. The total effective rate of treatment is 77%. The Huoxue Cong'er Composition Capsule Preparation has a clear efficacy and is effective in treating symptoms such as ear distension, blockage, tinnitus and deafness caused by retention of evil toxins and blood stasis.

[0078] 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.

[0079] Some typical cases of using the above-mentioned kidney-tonifying and ear-concentrating composition are recorded as follows:

[0080] Typical medical history 1

[0081] Zhang, female, 37 years old, an employee of a company in Xi'an, came to the clinic on December 5, 2023 with 10 days of left tinnitus. She said that the company had been doing year-end inventory in the past month, and she often stayed up late to work overtime. 10 days ago, she had left tinnitus, which was like a pulse, accompanied by left-sided headache, stiffness and discomfort in the cervical spine, and sometimes dizziness. The blood pressure was 135 / 90 mmHg. The patient's ear canal and eardrum were normal. The hearing and transcranial Doppler examinations showed left-sided neurological tinnitus and deafness, and insufficient blood supply to the brain and cervical spine. The patient was busy with work and could not be hospitalized. She was given 20 days' supply of Huoxuecong'er composite capsules, 5 capsules each time, 3 times a day, and vitamin B1 tablets, oryzanol tablets, and betahistine mesylate tablets. She was advised to relax, rest on time, avoid spicy and cold food, and stay away from noise.

[0082] On January 10, 2024, he came to the clinic and reported that his left tinnitus was significantly relieved, his sleep improved, and his blood pressure was 120 / 75 mmHg. He was given Huoxue Cong'er Combination Capsules for half a month, 3 capsules each time, 3 times a day, and the western medicine was the same as before. He was advised to follow the doctor's advice.

[0083] Betahistine mesylate tablets are vasodilators that can dilate blood vessels and improve vertigo symptoms. In this case, they were used together with vitamin tablets as a Western medicine.

[0084] Typical medical history 2

[0085] Liu, male, 45 years old, from Baoji, had tinnitus in the right ear for 7 days. He came to the clinic on May 3, 2024. He said that he stayed up late and drank alcohol for work and social activities a week ago, and then had tinnitus in the right ear, which sounded like heartbeats, headaches and dizziness. He had been treated, but the effect was not good. He came to the clinic today. The blood pressure was checked at 140 / 90mmHg. He had a history of hypertension, hyperlipidemia, cervical spondylosis, and took antihypertensive drugs to control it. He has been busy with work recently and stayed up late for social activities. The patient's ear canal and eardrum were normal. The hearing test showed right-side neurological tinnitus and deafness. He was given 20 days of Huoxuecong ear combination capsules, 5 capsules each time, 3 times a day, with vitamin B1 tablets, oryzanol tablets, and betahistine mesylate tablets. He was advised to rest on time and avoid spicy food, tobacco and alcohol.

[0086] The patient came to the clinic on May 20, 2024 and reported that the tinnitus in the right ear had been alleviated. His blood pressure was measured at 130 / 85 mmHg, and he continued to take the medicine for half a month.

[0087] He came to the clinic on June 15, 2024, and said that the pain in his right ear had been significantly relieved. He was going on a business trip recently. This capsule is effective and very convenient to carry and take. He continued to take the same medication and the doctor's instructions were the same as before.

[0088] Typical medical history 3

[0089] Gao, female, 38 years old, from Fufeng, had right tinnitus and ear pain for half a year, which worsened for 10 days. She went to the hospital for treatment on December 5, 2023. She said that she had been busy with work in the past six months, often staying up late, and was under great pressure. Later, she developed right tinnitus, but did not pay attention to it. The tinnitus gradually worsened and right ear pain reappeared. She was diagnosed and treated locally, and took blood-activating and anti-inflammatory drugs, which relieved her symptoms. 10 days ago, the patient had severe tinnitus in the right ear and worsening ear pain, so he came to our hospital for treatment. Examination of the patient's ear canal and tympanic membrane was normal without redness or swelling. Examination of the patient's blood pressure was 130 / 80 mmHg, accompanied by headache, tinnitus, ear pain, and cervical vertebrae pain. Examination of the right ear canal and tympanic membrane were normal. Hearing, blood routine and transcranial Doppler were checked: the test results showed: normal blood routine, right-side neurological tinnitus and deafness, insufficient blood supply to the cervical spine and brain. The patient was busy with work and was not convenient for hospitalization, so he was given 20 days' supply of Huoxuecong'er combination capsules, 5 capsules each time, 3 times a day, and vitamin B1 tablets, betahistine mesylate tablets, oryzanol tablets, and brain protein hydrolyzate tablets. He was advised to relax, prevent and treat colds, keep a regular schedule, avoid spicy and cold food, and stay away from noise.

[0090] The patient came to the clinic on January 6, 2024 and reported no discomfort after taking the medication, his right ear pain was significantly relieved, his right tinnitus improved, his blood pressure was measured at 120 / 75 mmHg, and he continued to take the medication as before.

[0091] On March 9, 2024, he came to the clinic and said that after taking the medicine, the ear pain disappeared, the tinnitus was very small, and the treatment effect was good. He continued to take Huoxuecong ear combination capsules for half a month, 3 capsules each time, 3 times a day, and the western medicine was the same as before. The latter patient introduced several friends with tinnitus to our hospital for diagnosis and treatment.

[0092] Typical medical history 4

[0093] Sun, male, 58 years old, from Caijiapo, had right tinnitus and dizziness for 7 days. He came to the clinic on May 8, 2024. He said that he had right tinnitus and dizziness 7 days ago. He went to a nearby clinic and took medicine. The effect was not great. He had severe dizziness in the past few days and came to the clinic today. The patient now has persistent tinnitus, severe dizziness, objects do not rotate, no nausea and vomiting, but unstable walking, and blood pressure of 130 / 90mmHg. The patient's ear canal and eardrum were normal, and hearing and transcranial Doppler were checked. The results showed: right-side neural tinnitus, insufficient blood supply to the brain and cervical spine. Give 5 doses of Huoxue Cong'er composite decoction, vitamin B1 tablets, and betahistine mesylate tablets. The patient was advised to relax, stay away from noise, pay attention to rest, avoid eating raw, cold and greasy food, and go to the superior hospital for timely examination and treatment if there is no change in dizziness after taking the medicine.

[0094] On May 14, 2024, he came to the clinic and said that his dizziness and tinnitus were relieved after taking the medicine, and he could walk normally. His blood pressure was normal. He was given 3 bottles of Huoxuecong'er combination capsules, 3 capsules each time, 3 times a day orally, and the western medicine was the same as before. He was asked to follow the doctor's advice.

[0095] 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 tinnitus and deafness caused by retention of evil toxins, characterized in that: The ingredients include 55-60 parts of angelica sinensis, 55-60 parts of kudzu root, 25-30 parts of acorus chinensis, 25-30 parts of ligusticum chuanxiong, 25-30 parts of red peony root, 25-30 parts of safflower, 10-15 parts of peach kernel, 25-30 parts of salvia miltiorrhiza, 25-30 parts of atractylodes macrocephala (fried), 20-25 parts of pangolin, 20-25 parts of earthworm, 20-25 parts of bombyx batryticatus, 20-25 parts of oriental rhizome, 10-15 parts of Scrophularia ningpoensis, and 5-10 parts of liquorice.

2. The Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins according to claim 1, characterized in that: The ingredients by mass include: 55.2 parts of Angelica sinensis, 55.2 parts of Pueraria lobata, 27.6 parts of Acorus chinensis, 27.6 parts of Ligusticum chuanxiong, 27.6 parts of Paeonia lactiflora, 27.6 parts of Carthamus tinctorius, 13.7 parts of Persica kernel, 27.6 parts of Salvia miltiorrhiza, 27.6 parts of Atractylodes macrocephala (fried), 22.1 parts of Pangolin, 22.1 parts of Pheretima, 22.1 parts of Bombyx batryticatus, 22.1 parts of Alismatis rhizome, 13.7 parts of Scrophularia ningpoensis, and 8.2 parts of Licorice.

3. The Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins according to claim 1 or 2, characterized in that: The Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins can be used in the form of one or more of decoctions, capsules, pills and tablets.

4. A method for preparing a Chinese medicine composition for treating tinnitus and deafness caused by retention of evil toxins, characterized in that: The Chinese medicine composition for treating tinnitus and deafness of evil toxin retention type as claimed in claim 1 or 2, wherein the preparation method of the capsule form is: Fifteen kinds of medicinal pieces are weighed, and the impurities are removed and cleaned respectively. Except for angelica, chuanxiong, earthworm and peach kernel which are dried at less than 60°C for 8-12 hours, the remaining 11 pieces are dried at 70-80°C for 6-8 hours, and crushed by a grinder respectively. The powder is sieved and collected. The powder is yellow-brown powder with a slight odor and a slightly sour and bitter taste. The powder is sent to the capsule filling group for filling to obtain the finished capsule preparation.

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