Traditional Chinese medicine composition for treating chronic suppurative otitis media and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic suppurative otitis media. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 75 to 80 parts of radix astragali seu hedysari, 15 to 20 parts of radix codonopsis, 35 to 40 parts of rhizoma atractylodis macrocephalae (fried), 20 to 25 parts of pericarpium citri reticulatae, 35 to 40 parts of radix angelicae sinensis, 20 to 25 parts of poria cocos, 35 to 40 parts of radix paeoniae alba, 10 to 15 parts of rhizoma chuanxiong, 10 to 15 parts of cortex cinnamomi, 35 to 40 parts of flos lonicerae, 10 to 15 parts of radix platycodonis, 20 to 25 parts of fructus forsythiae, 10 to 15 parts of bulbus fritillariae cirrhosae, 10 to 15 parts of radix angelicae dahuricae, 15 to 20 parts of liquorice root and 10 to 15 parts of rhizoma zingiberis recens. 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 white to yellow powder; 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 follows the compatibility thought of enriching blood, tonifying qi, invigorating spleen, removing dampness, clearing away heat and toxic materials, expelling pus and diminishing swelling, tonifying without stagnation, warming and dredging meridians and collaterals, and the symptoms of chronic suppurative otitis media running water, pus drainage and hearing loss are more effectively improved.

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 chronic suppurative otitis media and a preparation method thereof. Background Art

[0002] Chronic suppurative otitis media is a chronic suppurative inflammation of the middle ear mucosa, periosteum or deep bone. Its main clinical manifestations are intermittent or continuous pus discharge in the ear, tympanic membrane perforation, and hearing loss. The cause is mostly delayed treatment or improper treatment of acute suppurative otitis media, or it is a direct continuation of acute necrotizing otitis media. In severe cases, it can cause intracranial and extracranial complications.

[0003] In modern medicine, chronic suppurative otitis media is mostly treated with topical or intravenous medications, using antibacterial drugs such as lomefloxacin, ceftazidime, or antibiotics to achieve certain therapeutic effects; Western medicine has an immediate improvement effect on chronic suppurative otitis media, but the effect is poor for some patients. However, patients are prone to recurrent attacks due to immune disorders and inflammation, so seeking a treatment method with stable efficacy has become a clinical consensus.

[0004] Chronic suppurative otitis media belongs to the category of "pus ear" in traditional Chinese medicine. The symptoms of "pus ear" are generally divided into: wind-heat exogenous infection (mostly corresponding to acute suppurative otitis media or the early acute attack period of chronic suppurative otitis media), spleen deficiency and dampness, liver and gallbladder damp-heat (yellow pus discharge, bulging of the eardrum but not perforated), kidney deficiency and hyperactivity of fire (little pus discharge, mostly in the shape of bean curd dregs), etc. Common cases of chronic suppurative otitis media are mostly caused by spleen deficiency and dampness, which invade the ear orifices.

[0005] TCM dialectical treatment follows the principle of comprehensively regulating the body from the inside out. Clinically, the combination of oral Chinese medicine and external Western medicine has achieved good results in the treatment of chronic suppurative otitis media. Commonly used Chinese medicines for spleen deficiency and dampness include Shenling Baizhu San, Xingqi Xiaobai Tang, etc. However, the existing treatment ideas for chronic suppurative otitis media are mainly based on invigorating qi and strengthening the spleen, which is less targeted at the symptoms of chronic suppurative otitis media, and the treatment effect of using Chinese medicine alone is average.

[0006] Therefore, it is important to develop a highly targeted formula for treating chronic suppurative otitis media. Summary of the invention

[0007] In view of the problem that the therapeutic effect of traditional Chinese medicine prescriptions for chronic suppurative otitis media in the prior art still needs to be further improved, the present invention provides a traditional Chinese medicine composition for chronic otitis media and a preparation method thereof.

[0008] The technical scheme of the present invention is as follows: A traditional Chinese medicine composition for treating chronic suppurative otitis media comprises, by mass, 75-80 parts of astragalus, 15-20 parts of codonopsis, 35-40 parts of atractylodes (fried), 20-25 parts of tangerine peel, 35-40 parts of angelica, 20-25 parts of poria, 35-40 parts of white peony root, 10-15 parts of chuanxiong, 10-15 parts of cinnamon, 35-40 parts of honeysuckle, 10-15 parts of platycodon, 20-25 parts of forsythia, 10-15 parts of fritillaria, 10-15 parts of angelica, 15-20 parts of licorice, and 10-15 parts of ginger.

[0009] Preferably, the ingredients in parts by mass include: 75.6 parts of Astragalus, 19 parts of Codonopsis, 37.7 parts of Atractylodes (fried), 22.6 parts of Tangerine Peel, 37.7 parts of Angelica, 22.6 parts of Poria, 37.7 parts of White Peony, 11.3 parts of Ligusticum chuanxiong, 11.3 parts of Cinnamon, 37.7 parts of Honeysuckle, 11.3 parts of Platycodon, 22.6 parts of Forsythia, 11.3 parts of Fritillaria cirrhosa, 11.3 parts of Angelica dahurica, 19 parts of Licorice, and 11.3 parts of Ginger.

[0010] Furthermore, the Chinese medicine composition for treating chronic suppurative otitis media can be used in the form of one or more of decoction, capsule, pill, and tablet.

[0011] The present invention also provides a method for preparing a Chinese medicine composition for treating chronic suppurative otitis media, which is used to prepare the Chinese medicine composition for treating chronic suppurative otitis media; the preparation method of the capsule use form is:

[0012] Weigh the above 16 medicinal materials, remove impurities and select them separately. Except for angelica, cinnamon, chuanxiong and angelica dahurica, which are dried at less than 60°C for 8-12h, the remaining 12 medicinal materials are dried at 70-80°C for 6-8h, crushed by a grinder, sieved, and the powder is yellowish white to yellow powder; bitter in taste; the powder is sent to the capsule filling group for filling to obtain the finished capsule preparation.

[0013] The invention has the advantages that: Astragalus and Codonopsis are the main drugs in the prescription, which can invigorate the spleen and replenish qi, replenish qi and generate blood. Atractylodes macrocephala and dried orange peel are used as the assistant drugs to replenish qi and invigorate the spleen, and Chinese angelica is used to replenish blood and promote blood circulation, while Poria is used to invigorate the spleen and nourish the heart, white peony root is used to nourish blood and restrain yin, and Chuanxiong is used to promote blood circulation and promote qi circulation, so as to replenish without stagnation, and cinnamon is used to warm yang and dredge collaterals. Honeysuckle, forsythia, platycodon, Fritillaria cirrhosa, angelica dahurica, liquorice and ginger are used to clear away heat and detoxify, and promote dampness and discharge pus. All the drugs are used together to play the effects of replenishing qi and blood, invigorating the spleen and removing dampness, and reducing swelling and discharging pus.

[0014] The Chinese medicine composition of the present invention follows the compatibility concept of nourishing blood and qi, strengthening the spleen and removing dampness, clearing away heat and detoxifying, and draining pus and reducing swelling, so as to nourish without stagnation, warm and dredge the meridians, and more effectively improve the symptoms of chronic suppurative otitis media with discharge of water, pus and hearing loss. DETAILED DESCRIPTION

[0015] 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.

[0016] The pathogenesis of chronic suppurative otitis media is discussed in "Baoying Cuoyao·Volume 4·Ear Diseases", emphasizing that "pus discharge from the ear" is "weakness" and "insufficient blood and essence"; "Zhubingyuanzhenglun·Ear Diseases·Puer Ear Symptoms" says: "The ear is where the ancestral meridians gather and where the kidney qi flows. The foot Shaoyin is the kidney meridian. When the blood and qi are damaged by fatigue, heat takes advantage of the deficiency and enters the meridian. The evil follows the blood and qi to the ear, and the heat gathers to produce pus, so it is called puer ear.

[0017] The inventors believe that for chronic suppurative otitis media with spleen deficiency and dampness, the treatment strategy, in addition to strengthening the spleen and removing dampness internally, still needs to focus on nourishing blood and replenishing qi, relieving superficial heat, and removing swelling and pus for the improvement of superficial symptoms; therefore, the Chinese medicine composition of the present invention follows the strategy of nourishing blood and replenishing qi, strengthening the spleen and removing dampness, clearing away heat and detoxifying, and removing pus and swelling, so that it can nourish without stagnation, warm and dredge the meridians, and more effectively improve the symptoms of chronic suppurative otitis media with water discharge, pus discharge, and hearing loss.

[0018] Specifically, the traditional Chinese medicine composition for treating chronic suppurative otitis media (hereinafter referred to as "pus-draining and rot-removing composition") includes, by mass: 75-80 parts of Astragalus, 15-20 parts of Codonopsis, 35-40 parts of Atractylodes (fried), 20-25 parts of Tangerine Peel, 35-40 parts of Angelica, 20-25 parts of Poria, 35-40 parts of White Peony, 10-15 parts of Chuanxiong, 10-15 parts of Cinnamon, 35-40 parts of Honeysuckle, 10-15 parts of Platycodon, 20-25 parts of Forsythia, 10-15 parts of Fritillaria, 10-15 parts of Angelica dahurica, 15-20 parts of Licorice, and 10-15 parts of Ginger.

[0019] Among them, Astragalus has the effects of replenishing qi and raising yang, promoting diuresis and reducing swelling, and supporting sores and promoting tissue regeneration; it can help the body replenish qi and blood and enhance the body's yang. It is particularly suitable for symptoms such as poor appetite, loose stools, fatigue and weakness caused by spleen deficiency, as well as cough, wheezing, low voice and weak breath caused by lung deficiency. Astragalus also has a diuretic effect and is suitable for problems such as qi deficiency edema and difficulty urinating. It can strengthen the body's water metabolism capacity by replenishing the spleen and qi to cure the root cause, thereby eliminating edema. When Astragalus is used externally, it can promote the healing of sores.

[0020] Codonopsis has the functions of replenishing the middle qi, nourishing qi and blood, calming the mind and nourishing the heart; it is suitable for symptoms such as physical weakness, fatigue, poor appetite, loose stools, etc. caused by insufficient middle qi. It is also suitable for patients with anemia, and can improve anemia and increase hemoglobin content.

[0021] 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.

[0022] Tangerine peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm, promote qi and relieve pain. It is used to regulate the qi of the spleen and stomach and eliminate moisture in the body.

[0023] Angelica is known as the "number one blood tonic". It 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.

[0024] 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.

[0025] White peony root is sour and cold in nature. It can restrain liver yin to nourish blood and suppress liver yang. It is used to treat sallow complexion, dizziness and palpitations caused by blood deficiency. It has a good effect on relieving symptoms such as chest and flank fullness and pain caused by liver qi stagnation, as well as abdominal pain and diarrhea caused by spleen deficiency and liver hyperactivity.

[0026] 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.

[0027] Cinnamon is pungent and sweet, and is very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the effects of replenishing fire and strengthening yang, guiding fire back to the origin, warming the middle and dispersing cold, relieving pain and stopping diarrhea, and can be used to treat symptoms such as kidney yang deficiency, cold uterus, cold pain in the waist and knees, and asthma due to kidney deficiency. The hot components of cinnamon can warm and replenish the fire of the gate of life and promote the rise of yang energy throughout the body. Cinnamon is pungent, dispersing, warming, and can play a role in promoting qi and blood circulation and unblocking blood vessels; it is helpful for improving the spleen and stomach.

[0028] Honeysuckle is cold in nature and sweet in taste. It has the effects of clearing away heat and detoxifying, cooling blood, and stopping dysentery. It is aromatic and dispersing, and is good at dispersing heat evil in the lung meridian and penetrating heat to the surface.

[0029] Platycodon grandiflorum is pungent and bitter, and can open up the lung qi, eliminate phlegm and promote qi. Platycodon grandiflorum can nourish the spleen and stomach meridians, and has the effect of increasing appetite and promoting digestion for symptoms such as loss of appetite, nausea, vomiting, abdominal pain, and bloating caused by weakness of the spleen and stomach meridians.

[0030] Forsythia can dispel wind-heat, clear away heat and detoxify, and can effectively relieve symptoms such as fever, headache, thirst, red tongue with little coating caused by exogenous wind-heat or the initial stage of febrile disease; the active ingredients in Forsythia, such as forsythia phenol and forsythia glycoside, have significant antibacterial effects, and can inhibit the growth and reproduction of many kinds of bacteria, thereby achieving the effect of clearing heat and detoxifying.

[0031] Fritillaria cirrhosa can moisten the lungs and nourish yin, and has a significant effect in relieving cough and reducing phlegm. It has a significant effect in relieving symptoms such as dry cough and dry throat caused by dry lungs. It has a certain auxiliary effect in treating inflammatory diseases such as pneumonia and bronchitis.

[0032] Angelica dahurica can dispel wind evil and dampness in the body, has the effects of opening the orifices to relieve pain, reducing swelling and discharging pus, promoting the discharge of pus and accelerating wound healing.

[0033] 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.

[0034] Ginger tastes spicy and slightly warm in nature. It can warm the lungs and dispel cold, resolve phlegm and relieve cough. It also has the effects of strengthening the spleen and stomach, refreshing the mind, and anti-inflammatory and analgesic.

[0035] In the prescription, Astragalus and Codonopsis are the main drugs, which can invigorate the spleen and replenish Qi, replenish Qi and generate blood. Atractylodes macrocephala and dried orange peel are used as assistants to replenish Qi and invigorate the spleen, while Chinese angelica is used to replenish blood and harmonize blood. Poria is used to invigorate the spleen and nourish the heart, white peony root is used to nourish blood and restrain Yin, and Chuanxiong is used to promote blood circulation and promote Qi, so as to replenish without stagnation. Cinnamon is used as assistant to warm Yang and dredge the meridians. Honeysuckle, Forsythia, Platycodon grandiflorum, Fritillaria cirrhosa, Angelica dahurica, Licorice and ginger are used to clear away heat and detoxify, and promote dampness and discharge pus. All the drugs are used together to achieve the effects of replenishing Qi and blood, invigorating the spleen and removing dampness, and reducing swelling and discharging pus.

[0036] The above-mentioned Chinese medicine composition for removing pus and rot 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.

[0037] Taking capsule preparation as an example, the preparation process includes: 75.6 parts of Astragalus, 19 parts of Codonopsis, 37.7 parts of Atractylodes (fried), 22.6 parts of Citrus reticulata, 37.7 parts of Angelica sinensis, 22.6 parts of Poria, 37.7 parts of White Peony Root, 11.3 parts of Ligusticum chuanxiong, 11.3 parts of Cinnamon Bark, 37.7 parts of Honeysuckle, 11.3 parts of Platycodon, 22.6 parts of Forsythia, 11.3 parts of Fritillaria cirrhosa, 11.3 parts of Angelica dahurica, 19 parts of Licorice, and 11.3 parts of Ginger.

[0038] Weigh the above 16 medicinal pieces, remove impurities and select them separately, except for angelica, cinnamon, Chuanxiong and Angelica dahurica which are dried at less than 60°C for 8-12h, and the remaining 12 pieces are dried at 70-80°C for 6-8h, crushed by a grinder, passed through a 90-mesh sieve, and the powder is yellowish white to yellow powder; it tastes bitter; it is placed in a covered container and sent to a capsule filling group for filling, with 0.4 portions per grain to obtain a finished capsule preparation.

[0039] The above capsule preparations are identified as follows:

[0040] (1) Take this product and observe it under a microscope: the connected latex ducts are 12-15um in diameter, and the cells in and around the ducts are filled with oil droplets and fine particles. There are many stone cells, scattered individually or in groups, and some are embedded with cork cells. The stone cells are polygonal, square, rectangular or irregular in shape, with a diameter of 24-51um, and sparse pits. There is a lot of inulin. When using a cold water chloral solution device, the inulin clumps are slightly fan-shaped. It is round or semicircular, with radial lines on the surface (Codonopsis pilosula).

[0041] (2) Take this product and observe it under a microscope: the latex ducts are interconnected, with a diameter of 14-25 μm, and contain light yellow oil droplets and granular substances. The ducts have ladder patterns and reticular patterns, with a diameter of 16-72 μm. There are many inulins (dilute glycerol slides), which are fan-shaped or quasi-circular crystals (Planthoceras).

[0042] (3) 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.

[0043] (4) Take the contents of 10 tablets of this product, add 20 ml of ethanol, shake for 5 minutes, filter, evaporate the filtrate, and add 1 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 1 mg per 1 mL, as the reference solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 4u1 of each of the above two solutions and spot them on the same silica gel 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 position of the chromatogram of the reference substance.

[0044] (5) Take the contents of 10 tablets of this product, add 30 ml of methanol, heat in a water bath and reflux for 1 hour, filter, and use the filtrate as the test solution. Take another hesperidin reference substance, add methanol to make a saturated solution, and use it as the reference solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2015 Edition Part IV 0502), take 10ul of the test solution and 5ul of the reference solution, and spot them on the same silica gel G thin layer plate, respectively, and use the lower layer liquid of chloroform-methanol-water (32:17:5) as the developing agent, develop, take out, and dry. Spray 1% aluminum chloride ethanol solution and examine under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the reference substance, a fluorescent spot of the same color appears.

[0045] Clinical research was conducted using the above-mentioned capsule preparation of the pus-discharging and anti-corrosion composite material as an example, and it is mainly used to treat chronic otitis media and tympanic membrane perforation caused by ulceration and long-term non-healing of sores.

[0046] According to the diagnostic criteria of chronic suppurative otitis media (simple) in Western medicine: intermittent pus discharge in the ear, the amount varies, and the pus discharge may occur or increase during upper respiratory tract infection; the pus is mucopurulent, generally not smelly, and the pus discharge stops during the resting period. There is a perforation in the tense part of the tympanic membrane, the size and location of the perforation vary, which is called central perforation. The tympanic mucosa is slightly red or pale, and there is secretion in the tympanic cavity, which is dry during the resting period. Hearing loss is generally not severe and is conductive. Temporal bone CT scan shows that all parts of the middle ear are normal.

[0047] According to the diagnosis criteria of TCM syndrome, refer to "Chinese Medicine Otolaryngology", published by Shanghai Science and Technology Press in December 1999) spleen deficiency and dampness, affecting the ear. Main symptoms: pus discharge in the ear, over the years, sometimes light and sometimes heavy, lingering for a long time, large amount of pus discharge and thin, no obvious odor, local large perforation in the center of the eardrum, a lot of pus in the ear canal, and conductive deafness in the hearing test. Secondary symptoms: dizziness, fatigue, poor appetite, abdominal distension, loose stools, pale complexion, pale lips and tongue, moist white fur, slow and weak pulse. Diagnosis basis: The main symptoms are necessary; 2-3 secondary symptoms are combined.

[0048] Case inclusion criteria:

[0049] ①Conform to Western medical diagnostic standards

[0050] ②Conform to the diagnostic criteria of TCM syndrome

[0051] ③Age 18-68 years old

[0052] ④Sign the informed consent form for entering the study

[0053] Exclusion criteria:

[0054] ① Those with pus discharge with a foul odor in the ear, dizziness and facial nerve paralysis, perforation in the pars flaccida, cholesteatoma-type otitis media, and traumatic perforation.

[0055] ②Patients with neurological tinnitus and deafness.

[0056] ③The course of disease is less than 3 months.

[0057] ④ Those who have used other drugs or treatment methods before treatment.

[0058] ⑤Pregnant or lactating women.

[0059] ⑥ Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and mental illness.

[0060] Dosage: 6 capsules of the pus-discharging and anti-corruption combination capsule preparation, 3 times a day. Take with warm water after meals; Treatment course: 2 weeks for one course.

[0061] General clinical data: A total of 60 cases (84 ears) were observed, including 29 males and 31 females, aged 18-68 years old (average age 52 years old), with a disease course of 1 to 30 years. The symptoms were pus discharge from the ear, which lasted for years, sometimes severe and sometimes mild, and lingered for a long time. The pus discharge was large and thin, with no obvious odor. A large perforation in the center of the tympanic membrane was visible locally. Hearing tests showed conductive deafness, dizziness, heaviness of the head, fatigue, poor appetite, abdominal distension, sallow complexion, pale lips and tongue, and a slow, thready and weak pulse. The clinical Western medical diagnosis was chronic suppurative otitis media (simple).

[0062] Efficacy and safety evaluation criteria:

[0063] The improvement rate was evaluated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines.

[0064] ① Clinically cured, with no secretions, dryness inside the ear, healed perforations, and significantly improved hearing.

[0065] ② Significantly reduced dryness inside the ear, reduced perforation by 2 / 3, and improved hearing.

[0066] ③Effectively dry out the ear, reduce the perforation by 1 / 3, and reduce hearing instability.

[0067] ④ Ineffective symptoms are not improved, or other complications occur.

[0068] Efficacy analysis:

[0069] After one course of treatment, the total effective rate of the pus-discharging and anti-corrosion composition capsule preparation in the treatment of chronic suppurative otitis media was as high as 72% (60 / 84), the significant effective rate was 20% (16 / 84), the effective rate was 52% (44 / 84), and the ineffective rate was 28% (24 / 84).

[0070] TCM Syndrome Efficacy

[0071] Table 1 Comparison of TCM syndrome scores of patients before and after treatment

[0072] Before treatment After treatment T P Experimental Group 10.1+1.84 9.12+1.50 6.224 0.004

[0073] After treatment, the symptom scores of this group of patients were significantly different and decreased significantly compared with those before treatment.

[0074] Security Analysis

[0075] Analysis of test results of safety indicators:

[0076] Table 2 Laboratory safety index test results

[0077]

[0078] 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.

[0079] The results of clinical trials show that after one course of treatment, the capsule preparation of the combination for draining pus and removing rot has the functions and effects of draining pus, reducing swelling, removing rot and promoting new growth. The total effective rate of treatment is 72%. The capsule preparation of the combination for draining pus and removing rot has a clear efficacy and is effective in treating patients with symptoms such as acne ulcers, pus discharge in the ears that does not heal for a long time, long-term hearing loss and the like.

[0080] 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.

[0081] Some typical cases of using the above-mentioned pus-discharging and anti-corrosion composition are recorded as follows:

[0082] Typical medical history 1

[0083] Kang XX, male, 46 years old, from Fengxiang County, Baoji City, came to the hospital on August 21, 2023, and was admitted to the hospital for "right chronic suppurative otitis media with tympanic membrane perforation". The patient had right ear pain and pus discharge after a cold 20 years ago. After that, whenever he was tired, pus discharge recurred after a cold, and his hearing was significantly reduced. The electric audiometry showed: right mixed deafness, temporal bone CT scan: left chronic otitis media and mastoiditis changes, ABR: right ABR I wave was significantly prolonged, and the waveform differentiation of each wave was poor.

[0084] After external application of Qusu Sheng Ji San in our hospital, the patient was able to remove the rot and regenerate the muscles, simmer the pus and grow the flesh, and take the combination capsule of Qupu Qusu internally, which could invigorate the spleen and remove dampness, reduce swelling and discharge pus. After 68 days of tympanic membrane regeneration treatment, the patient was cured of chronic otitis media in the right ear on November 11, 2023, the tympanic membrane perforation healed, and the hearing of the right ear was improved by 20-30db compared with before. After being cured, the patient came to the hospital twice and both were normal. After a follow-up visit 3 months later, the patient said that the hearing of the right ear had basically returned to normal, and there was no recurrence after a follow-up visit 6 months later.

[0085] Typical medical history 2

[0086] Chen XX, female, 65 years old, from Zhao'an Town, Ansai District, Yan'an City, Shaanxi Province, came to the hospital on August 24, 2023, and was admitted to the outpatient department with "right chronic suppurative otitis media with large perforation of the tympanic membrane". The patient had repeated pus discharge from otitis media for more than 30 years. She had been treated many times in major hospitals locally and in Xi'an, but the pus discharge did not heal. With age, her hearing decreased significantly, and she had tinnitus and dizziness. According to the introduction of local patients who were cured in our hospital, she came to our hospital for treatment today. After admission, she used topical capsules for removing rot and regenerating muscles, simmering pus and growing meat, 1 time / day, and took capsules of the combination of pus removal and rot removal to clear away heat and detoxify, reduce swelling and discharge pus, 3 times / day, 3-4 capsules / time. After 80 days of tympanic membrane regeneration treatment, on November 14, 2023, the right chronic otitis media was cured, the tympanic membrane perforation was healed, and the hearing was improved by 15-20db compared with before.

[0087] The right ear was revisited 3 and 6 months after discharge and no recurrence was found.

[0088] Typical medical history 3

[0089] Liu, male, 65 years old, No. 2, Chang'an South Road, Yanta District, Xi'an, was admitted to the hospital on November 10, 2023 for "bilateral chronic suppurative otitis media and mastoiditis". The patient had a perforated tympanic membrane due to chronic otitis media on the left side. He underwent surgical tympanic membrane repair at the First Hospital of Xi'an Jiaotong University one year ago. Six months after the operation, otitis media in the left ear recurred, and pus has been intermittent since then. Hearing loss, tinnitus, dizziness, headache, and multiple treatments in major hospitals have not been effective. The failure of the operation has caused a psychological burden to the patient. Recently, he was introduced to the hospital for treatment by a friend. The method of external use of rot-removing and muscle-generating, simmering pus and growing meat, and oral administration of pus-removing and rot-removing composite capsules is used to replenish qi and blood, strengthen the spleen and eliminate dampness, and reduce swelling and discharge pus. After about 42 days of tympanic membrane regeneration treatment, there was no water or pus in both ears. Re-examination of ear fiber endoscopy: bilateral ear bottoms were dry, tympanic membrane perforation healed, and re-examination of electrical audiometry: bilateral hearing increased by 15-30db, and continued observation and follow-up for 3-6 months without recurrence.

[0090] Typical medical history 4

[0091] Ms. Li XX, 64 years old, from Guanting Administrative Village, Yingwang Township, Yichuan County, Yan'an City, was admitted to the hospital on February 17, 2024 for "left chronic suppurative otitis media with tympanic membrane perforation". The patient had intermittent pus discharge from the left ear for more than 20 years, with repeated pus discharge in summer and winter every year, and a significant decrease in hearing, tinnitus, and dizziness. She received multiple treatments at the local Yanda Hospital, but the results were not satisfactory.

[0092] The patient was referred to our hospital for treatment. External use of Qufu Shengji San can simmer pus and grow flesh; internal use of Paoping Qufu Capsule can strengthen the spleen and eliminate dampness, reduce swelling and discharge pus. After about 2 months of eardrum regeneration treatment, there was no water or pus discharge in the left ear. Re-examination of ear fiber endoscopy showed that the left ear bottom was dry and the eardrum perforation healed. Re-examination of electrical audiometry showed that the left hearing improved by 10-20db. There was no recurrence after 6 months of observation and follow-up.

[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 chronic suppurative otitis media, characterized in that: The ingredients include: 75-80 parts of Astragalus, 15-20 parts of Codonopsis, 35-40 parts of Atractylodes (fried), 20-25 parts of Tangerine Peel, 35-40 parts of Angelica, 20-25 parts of Poria, 35-40 parts of White Peony, 10-15 parts of Ligusticum chuanxiong, 10-15 parts of Cinnamon, 35-40 parts of Honeysuckle, 10-15 parts of Platycodon, 20-25 parts of Forsythia, 10-15 parts of Fritillaria cirrhosa, 10-15 parts of Angelica dahurica, 15-20 parts of Licorice, and 10-15 parts of Ginger.

2. The Chinese medicine composition for treating chronic suppurative otitis media according to claim 1, characterized in that: The ingredients in parts by mass include: 75.6 parts of Astragalus, 19 parts of Codonopsis, 37.7 parts of Atractylodes (fried), 22.6 parts of Citrus reticulata, 37.7 parts of Angelica sinensis, 22.6 parts of Poria, 37.7 parts of White Peony Root, 11.3 parts of Ligusticum chuanxiong, 11.3 parts of Cinnamon Bark, 37.7 parts of Honeysuckle, 11.3 parts of Platycodon, 22.6 parts of Forsythia, 11.3 parts of Fritillaria cirrhosa, 11.3 parts of Angelica dahurica, 19 parts of Licorice, and 11.3 parts of Ginger.

3. The Chinese medicine composition for treating chronic suppurative otitis media according to claim 1 or 2, characterized in that: The Chinese medicine composition for chronic otitis media 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 chronic suppurative otitis media, characterized in that: The Chinese medicine composition for treating chronic suppurative otitis media as claimed in claim 1 or 2, wherein the preparation method of the capsule form is as follows: weigh the above 16 medicinal pieces, remove impurities and select them separately, except for angelica, cinnamon, ligusticum chuanxiong and angelica dahurica which are dried at less than 60°C for 8-12h, dry the remaining 12 pieces at 70-80°C for 6-8h, grind them separately with a grinder, sieve them, collect the powder, which is yellow-white to yellow powder and bitter in taste; send the powder to the capsule filling group for filling to obtain the finished capsule preparation.

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