Traditional Chinese medicine composition for treating swollen sore throat and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to powder for treating throat pain and a preparation method thereof. The traditional Chinese medicine composition consists of calculus bovis factitius, indigo naturalis, borneol, golden cypress, pollen typhae and liquorice. Through reasonable compatibility, the traditional Chinese medicine composition has the effects of clearing away heat and toxic materials and relieving sore throat and pain, has a remarkable effect on treating throat pain, pharyngeal dryness and the like caused by excessive heat in lung and stomach and heat toxin accumulation, and is simple in preparation and suitable for further industrial mass production.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating sore throat and a preparation method thereof. Background Art

[0002] Sore throat is a common clinical symptom, common in acute pharyngitis, and repeated attacks of acute pharyngitis will lead to chronic pharyngitis. At present, Western medicine research believes that the main causes are viruses, bacteria and non-infectious factors (such as mouth breathing, allergic reactions, gastroesophageal reflux, smoking, alcohol, high temperature, dust, smoke, irritating gases, etc.). Sore throat caused by viruses accounts for about 40% to 60%, of which rhinovirus, coronavirus, adenovirus account for 30%, Epstein Barr virus accounts for 1%, influenza and parainfluenza virus account for 4%, and acute pharyngitis caused by bacteria accounts for about 5% to 40%. However, even though sore throat is mostly caused by viruses, about 78% to 98% of acute pharyngitis patients receive antibiotic treatment in clinical practice, which poses a great risk of overtreatment.

[0003] There are a wide variety of drugs, antibiotics, and traditional Chinese medicines for treating sore throats in the Chinese market, including patented traditional Chinese medicine compositions, such as Chinese Patent 201910339927.0. The present invention discloses a drug for treating acute and chronic pharyngitis, and the raw materials for preparing the drug include the following components by weight: 50-150 parts of dandelion, 200-300 parts of rhizoma scutellariae, and 50-150 parts of wild chrysanthemum. At the same time, the present invention also discloses a method for preparing the drug for treating acute and chronic pharyngitis. The drug for treating acute and chronic pharyngitis of the present invention has the advantages of simple ingredients and good efficacy, and the preparation method is simple and easy to operate. It is difficult to discuss the pharmacology of monarch, minister, assistant, and messenger of three medicines.

[0004] Chinese Patent 202110610703.6 The present invention discloses an antiviral oral spray and a preparation method, comprising the following mass components: 13-25 of honeysuckle, 13-25 of scutellaria, 13-25 of forsythia, 12-22 of isatis indigotica, 6-11 of licorice, 5-10 of bupleurum, 5-10 of wild chrysanthemum, 5-10 of isatis root, 0.2-0.8 of menthol, 5-10 of houttuynia cordata, 1.0-2.0 of sucralose, 0.25-0.85 of 95% benzalkonium bromide, 400-600 of ethanol, and pure water supplemented to 1000. It has the function of killing and inhibiting viruses in the oral cavity. The killing rate for Staphylococcus aureus and Pseudomonas aeruginosa reaches 99.999% within 5 minutes. The average killing logarithmic time for Candida albicans is >4.00 minutes, and the killing rate is also >99.99%. It can prevent oral inflammation and respiratory epithelial mucosal damage caused by virus replication, effectively prevent the spread of virus-carrying droplets, and effectively prevent the spread and spread of the new coronavirus. The preparation process designed by the patent is relatively complicated.

[0005] Chinese Patent 201910513108.3 The present invention provides an oral ulcer spray and a preparation method thereof, which belongs to the technical field of treating oral ulcers, and comprises the following components by volume: 75-85 parts of hibiscus alcohol extract, 5-15 parts of stem cell extract, 3-8 parts of deionized water, 2-6 parts of preservatives and 0.1-0.5 parts of vitamin B2; the concentration of exosome protein in the stem cell extract is 25-35 mg / mL; the pH value of the oral ulcer spray is 6.6-7.11. The oral ulcer spray provided by the present invention has good therapeutic effect, feels gentle and comfortable when used, and has no scars after healing. The total effective rate for patients with oral ulcers is 97.22%. It has high technical requirements and is difficult to industrialize and mass produce.

[0006] Chinese Patent 201810737845.7 The present invention provides an oral analgesic spray and a preparation method thereof. The oral analgesic spray is prepared by preparing extracts of Eucommia ulmoides leaves and Kudingcha tea, mixing the extracts to obtain a mixed solution, and adding borneol. It has analgesic, anti-inflammatory, antibacterial, antitussive and expectorant effects, and is suitable for patients with long-term cough, sore throat and itching to spray at any time to relieve the patient's long-term pain and discomfort. It has less medicinal taste and cannot provide long-term relief. Summary of the invention

[0007] In order to overcome the deficiencies of the prior art, the present invention provides a new Chinese medicine composition for treating sore throat, which is composed of the following Chinese medicines: artificial bezoar, indigo, borneol, phellodendron, pollen, and liquorice. It has the effect of significantly treating the symptoms of long-term pain and discomfort in patients, clearing away heat and detoxifying, relieving sore throat and relieving pain, and is mainly used to treat sore throat caused by excessive heat in the lungs and stomach, accumulation of heat and toxicity, dry throat, burning sensation in the throat, swollen and painful gums, oral sores, etc.

[0008] According to traditional Chinese medicine theory, the dosage of a drug needs to be adjusted based on its properties, interactions with other drugs, the patient's constitution and other factors to ensure efficacy and safety. The specific technical solution is as follows:

[0009] A traditional Chinese medicine composition for treating sore throat, which is composed of the following traditional Chinese medicines: 8.3-16.8 parts by weight of artificial bezoar, 168-299 parts by weight of indigo, 14.6-31.2 parts by weight of borneol, 239-419 parts by weight of phellodendron, 239-419 parts by weight of pollen cattail, and 128.7-249.7 parts by weight of liquorice.

[0010] In a preferred embodiment of the present invention, the Chinese medicine composition is composed of the following Chinese medicines: 11.1 parts by weight of artificial bezoar, 222 parts by weight of indigo, 22.2 parts by weight of borneol, 333 parts by weight of phellodendron, 333 parts by weight of pollen, and 188.7 parts by weight of licorice.

[0011] In a preferred embodiment of the present invention, the Chinese medicine composition is composed of the following Chinese medicines: 8.3 weight parts of artificial bezoar, 168 weight parts of indigo, 14.6 weight parts of borneol, 239 weight parts of phellodendron, 239 weight parts of pollen, and 128.7 weight parts of licorice.

[0012] In a preferred embodiment of the present invention, artificial bezoar is 8.3-16.8 parts by weight, indigo is 299 parts by weight, borneol is 31.2 parts by weight, phellodendron is 419 parts by weight, pollen is 419 parts by weight, and liquorice is 249.7 parts by weight.

[0013] Furthermore, the sore throat is caused by excessive heat in the lungs and stomach and accumulation of heat and toxicity.

[0014] Furthermore, the present invention provides a preparation containing the Chinese medicine composition, specifically one of a decoction, a tablet, a granule, a pill, an oral liquid, and a powder, preferably a powder.

[0015] Furthermore, the preparation also contains pharmaceutically acceptable excipients, and the pharmaceutically acceptable excipients include one or a combination of two or more of fillers, disintegrants, lubricants, preservatives, and flavoring agents.

[0016] As for the preparation process, the present invention provides a method for preparing the powder, which specifically comprises the following steps:

[0017] 1) Grind borneol and artificial bezoar into fine powder respectively, pass through 120 mesh sieve, and set aside;

[0018] 2) Dry Indigo Naturalis, Phellodendron Amurense, Pollen Typhae and Licorice at 80°C under normal pressure for 5 hours, grind into finest powder, pass through 120-mesh sieve and set aside;

[0019] 3) Add the finest powder of step 1) into step 2), stir and mix for 30 minutes, pass through a 120-mesh sieve, sterilize by irradiation, and package to obtain.

[0020] Furthermore, the radiation sterilization dose of step (3) is 8 kGy.

[0021] The "monarch, minister, assistant and envoy" in Chinese medicine prescriptions is an important concept in traditional Chinese medicine theory. It refers to the interaction and coordination between different drugs in the prescription to achieve the best therapeutic effect. The core of this theory is to achieve comprehensive conditioning and treatment of diseases through the mutual coordination of drugs.

[0022] In the combination described in the present invention, artificial bezoar is used as the main medicine, which has the function of clearing away heat and detoxifying, and is most critical for the symptoms; Indigo and Borneol are used as the ministerial medicines, which enhance the main medicine's function of clearing away heat and detoxifying, cooling blood and relieving pain; Phellodendron and Pollen Typhae are used as adjuvants, which can clear away real fire and relieve heat and toxicity, and assist the main and ministerial medicines in clearing away heat and detoxifying; Licorice is used as the guiding medicine to harmonize the medicines and ensure the balance and coordination between the medicines. The whole prescription has the effect of clearing away heat and detoxifying, relieving sore throat and relieving pain. Through such a compatibility, the effect of each medicine can be fully exerted to better treat the corresponding diseases. The nature and flavor of the medicine of the present invention are specifically as follows:

[0023] Artificial Bezoar: Nature and flavor: bitter, cold. Efficacy: clearing away heat and detoxifying, cooling blood and calming the mind. In this prescription, artificial bezoar is the main medicine, which has the function of clearing away heat evil, and is used to treat fever, sore throat, mouth sores, carbuncle and furuncle.

[0024] Indigo: Nature and flavor: salty, cold. Efficacy: clearing away heat and detoxifying, cooling blood and reducing swelling. It is mainly used to treat the heat syndrome of febrile diseases. Indigo has strong blood cooling and detoxification effects when applied externally. Modern research shows that Indigo has antibacterial, antiviral and analgesic effects.

[0025] Borneol: Nature and flavor: bitter, slightly cold. Efficacy: clearing away heat and detoxifying, refreshing the mind, reducing swelling and relieving pain. Indigo and borneol as ministerial drugs can help the monarch drug to enhance the function of clearing heat and detoxifying, cooling blood and relieving pain.

[0026] Phellodendron chinense: Nature and flavor: bitter, cold. Efficacy: clearing away heat and dampness, purging fire and detoxifying. Phellodendron chinense is an adjuvant drug and can be used to treat sore throat caused by excessive fire toxins.

[0027] Puhuang: Nature and flavor: sweet, flat. Efficacy: clearing away heat and detoxifying, stopping bleeding and activating blood circulation. Puhuang is an adjuvant drug, which not only assists the main and auxiliary drugs in clearing away heat and detoxifying, but also has the effects of activating blood circulation and stopping bleeding. Therefore, Puhuang can not only activate blood circulation and reduce swelling, but also prevent bleeding symptoms caused by excessive heat and blood movement.

[0028] Licorice: Nature and flavor: sweet, flat. Efficacy: harmonizes various drugs, relieves pain. Licorice is a guiding drug, which has the effect of harmonizing the properties of drugs and relieving the strong properties of drugs.

[0029] Compared with the prior art, the technical effects of the present invention are:

[0030] The Chinese medicine composition of the present invention has reasonable compatibility, and the synergistic effects of the main medicine, the ministerial medicine, the adjuvant medicine and the guiding medicine are appropriate, so that the overall efficacy of the prescription is more significant, and it has a significant effect in treating acute and chronic pharyngitis. It can be seen that different prescriptions have different effects in treating sore throats. Even if similar drugs are combined together, although there are many types, such as comparative example 5, the therapeutic effect of the present invention cannot be exerted in terms of effect. In pharmacological experiments, in order to explore the dosage for verification, the powder prepared by the Chinese medicine composition of the present invention has significant differences in reducing the swelling degree of the auricle and the vocal cord index compared with the prior art, thereby further verifying that the effect of the present invention is definite. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 : Comparison of results of New Zealand rabbits treated in different embodiments

[0032] Figure 2 : Comparison of pain response time of mice in different examples

[0033] Figure 3 : Comparison of the number of writhing times of mice in different examples

[0034] Figure 4 :Comparison of clinical efficacy and treatment results of different embodiments DETAILED DESCRIPTION

[0035] In order to make the purpose and technical solution of the present invention clearer, the present invention is further described below in conjunction with embodiments, but the protection scope of the present invention is not limited to these embodiments, and the embodiments are only used to explain the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the protection scope of the present invention.

[0036] Example 1: A powder for treating sore throat, as follows:

[0037] Artificial bezoar 11.1g, indigo 299g, borneol 31.2g, phellodendron 419g, pollen 419g, and licorice 249.7g.

[0038] The preparation process is as follows:

[0039] 1) Grind borneol and artificial bezoar into fine powder respectively, pass through 120 mesh sieve, and set aside;

[0040] 2) Dry Indigo Naturalis, Phellodendron Amurense, Pollen Typhae and Licorice at 80°C under normal pressure for 5 hours, grind into finest powder, pass through 120-mesh sieve and set aside;

[0041] 3) Add the finest powder from step 1) to step 2), stir and mix for 30 minutes, pass through a 120-mesh sieve, and sterilize by irradiation.

[0042] The irradiation sterilization dose is 8kGy, and it is packaged and ready to use.

[0043] Example 2: A powder for treating sore throat, as follows:

[0044] Artificial bezoar 11.1g, indigo 222g, borneol 22.2g, phellodendron 333g, pollen 333g, and licorice 188.7g.

[0045] The preparation process is the same as that of Example 1.

[0046] Example 3: A powder for treating sore throat, as follows:

[0047] Artificial bezoar 8.3g, indigo 168g, borneol 14.6g, phellodendron 239g, pollen 239g, and licorice 128.7g.

[0048] The preparation process is the same as that of Example 1.

[0049] Comparative Example 1: A powder for treating sore throat, specifically as follows:

[0050] Artificial bezoar 11.1g, indigo 222g, borneol 22.2g, phellodendron 333g and licorice 188.7g.

[0051] The preparation process is the same as that of Example 1.

[0052] Comparative Example 2: A powder for treating sore throat, specifically as follows:

[0053] Artificial bezoar 11.1g, indigo 222g, borneol 22.2g, phellodendron 333g, mint 333g, and licorice 188.7g.

[0054] The preparation process is the same as that of Example 1.

[0055] Comparative Example 3: A powder for treating sore throat, specifically as follows:

[0056] Artificial bezoar 11.1g, mint 222g, borneol 22.2g, phellodendron 333g, pollen 333g, borax 188.7g.

[0057] The preparation process is the same as that of Example 1.

[0058] Comparative Example 4: A powder for treating sore throat, specifically as follows:

[0059] Artificial bezoar 20g, indigo 188g, borneol 40.5g, phellodendron 430g, pollen 212g, and licorice 219.5g.

[0060] The preparation process is the same as that of Example 1.

[0061] Comparative Example 5: A powder for treating sore throat, which is as follows:

[0062] 11.1g alum, 222g mint, 22.2g borneol, 333g coptis root, 333g sodium sulfate, and 188.7g catechu.

[0063] The preparation process is the same as that of Example 1.

[0064] Verification Example 1: Experiment on the effect of croton oil on vocal cord inflammation in New Zealand rabbits

[0065] 1) Experimental animals: Ordinary New Zealand rabbits, half male and half female, weighing 2-2.5 kg, provided by Tianjin University of Traditional Chinese Medicine, license number SYXK(Tianjin)2023-0003.

[0066] 2) Experimental drugs: model group, Example 1, Example 2, Example 3, Comparative Example 4 and positive control group (approval number of Kaihoujian: National Medicine Standard Z20026493, drug standard code: 86905506000113 production unit: Guizhou Sanli Pharmaceutical Co., Ltd.).

[0067] 3) Dosage: Example 1, Example 2, Example 3, Comparative Example 4 and positive control group; wherein, according to the human dosage, the human dosage is 6g per day, and the daily dosage of New Zealand rabbits converted by body surface area is about 6g / 60kg×3.27=327mg / kg: 3 times a day, spray the affected area, once in the morning, noon and evening; Positive control group: Usage and dosage of Kaihoujian: spray the affected area, one lift each time, 3 times a day, once in the morning, noon and evening. Another 8 rabbits were taken as the normal group, and the affected area was sprayed with physiological saline, once in the morning, noon and evening.

[0068] 4) Establishment and grouping of inflammation model: The rabbits were randomly divided into 7 groups, including normal group, model group, Example 1, Example 2, Example 3, Comparative Example 4 and positive control group model group, with 8 rabbits in each group, half male and half female. The animals were anesthetized by intravenous injection of 20% urethane, and the trachea was exposed by neck surgery, and a tracheal cannula was inserted 3 cm below the cricoid cartilage. Then an incision was made at the tracheal cartilage, and a cotton ball containing 0.2 mL of croton oil inflammatory solution (croton oil: anhydrous ethanol: ether: distilled water = 2:20:73:5, V / V) was inserted through the incision with tweezers, and the vocal cords were rubbed several times and placed for 0.5 hours to cause inflammation. The normal control group was replaced with saline instead of croton oil inflammatory solution. After inflammation, each test drug group was given a sprayed vocal cord containing the drug at the set dose under "3) Dosage", and the normal control group and model control group were replaced with saline instead of the drug. After the last administration, both groups were intravenously injected with 2 mL / kg of 30 g / L Evans blue solution.

[0069] 5) Index determination: 1 hour after the injection of Evans blue solution, the animals were killed, the vocal cords on both sides were removed and weighed, and the vocal cord index and vocal cord swelling inhibition rate were calculated according to the following formulas.

[0070] Vocal cord index = vocal cord weight / rabbit weight

[0071] 6) Results:

[0072] Figure 1 Compared with the model control group, the vocal cord weight of the normal group was significantly reduced, and there was a significant difference (P<0.01), indicating that the model was successfully established. In Examples 1-3 and the positive group, croton oil had a significant inhibitory effect on the inflammatory response of the rabbit vocal cords, and compared with the model group, the difference was statistically significant (P<0.05).

[0073] Verification of Example 2: Investigation of the anti-inflammatory effects of the examples and comparative examples

[0074] Xylene, as a chemical inflammatory agent, can cause the release of inflammatory mediators such as histamine, kinins, and plasmin. The release of these mediators can cause an increase in local capillary permeability and infiltration of inflammatory cells, resulting in acute exudative inflammatory edema in the ear. The above-mentioned inflammatory response experiment is often used to evaluate the anti-inflammatory effect of the test drug.

[0075] 1) Experimental animals: SPF Kunming mice, sex: 18-20 g, 60 males. Breeding unit: Experimental Animal Center of Sun Yat-sen University, provided by Tianjin University of Traditional Chinese Medicine, license number SYXK(Jin)2023-0003.

[0076] 2) Experimental drugs: model group, Example 1, Example 2, Example 3, Comparative Example 4 and positive control group (approval number of Longzhu Ointment: National Medicine Standard Z10950017, drug standard code: 86901954000514, manufacturer: Mayinglong Pharmaceutical Group Co., Ltd.).

[0077] 3) Dosage: Example 1, Example 2, Example 3, Comparative Example 4 and negative control group: Calculated according to the human dosage, the human dosage is 6g per day, and the mouse dosage is about 6g / 60kg×12.3=

[0078] 1.23g / kg: once a day, spray on the affected area at 8 am; Positive control group: Usage and dosage of Longzhu Ointment: Apply this product to the affected area with a thickness of 0.01mm, once a day, at 8 am. Take another 10 as the negative control group and do not do any treatment.

[0079] 4) Experimental results and test indicators

[0080] (1) Induction and measurement of ear swelling

[0081] 1 hour after the last administration, xylene was evenly applied to both sides of the right ear of the mouse, 10uL on each side, and the left ear was not treated. 1 hour after the application of xylene, the mice in each group were killed, the ears were cut off, and the ear pieces with a diameter of 6mm were removed with a puncher and weighed to calculate the swelling rate = (right ear piece weight - left ear piece weight) × 100% / left ear piece weight.

[0082] (2) After continuous feeding for 2 weeks, the mice were subjected to hot plate test and writhing test.

[0083] Mouse hot plate method: Place mice one by one in a mouse thermal pain threshold tester at 55°C, and use licking the hind paw as the pain reaction time indicator. Mouse writhing method: Inject 0.7% acetic acid into the abdominal cavity of each group of mice, 0.3 ml / mouse, and observe and record the number of "writhing" of the mice within 10 minutes.

[0084] 5) Data processing

[0085] The experimental data were statistically processed using GraphPad Prism 6.0 biostatistics software: the data were expressed as Mean ± SD, and the inter-group comparisons were performed using one-way analysis of variance combined with Dunnett's multiple comparisons method.

[0086] 6) Experimental results analysis

[0087] Table 1 Inhibitory effect of xylene-induced ear swelling in mice (n=10, )

[0088] Group Swelling degree (mg) Swelling inhibition rate (%) Negative control group 8.91±1.22* / Positive control group 5.77±0.53**# 0.35 Example 1 Group 5.74±0.67*# 0.36 Example 2 Group 6.01±0.59*# 0.33 Example 3 Group 6.15±0.53*# 0.31 Comparative Example 4 7.82±0.88* 0.12

[0089] Note: Compared with the negative control group, *P<0.05; compared with the control group 4, #P<0.05

[0090] As can be seen from Table 1, compared with the positive control group, the swollen weight of the mouse ear in the negative control group was significantly increased, and there was a significant difference (P<0.01), indicating that the model was successful. Furthermore, compared with Comparative Example 4, Examples 1-3 had significant differences (P<0.05), indicating that the dosage range of traditional Chinese medicine is not arbitrarily changed, and the dosage not within the scope of the present invention has a significantly lower therapeutic effect than the present invention.

[0091] Figure 2 and Figure 3The comparison results of the pain reaction time and the number of twisting of mice in different embodiments show that the pain reaction time of the mice in the positive control group is significantly longer than that of the negative control group, and the number of twisting within 10 minutes is significantly less than that of the negative control group, indicating that the model is successful; further, the pain reaction time of the mice in Examples 1-3 is shorter than that in the negative control group and has a significant difference. At the same time, the pain reaction time of the mice in Examples 1-3 is significantly prolonged compared with that in Comparative Example 4, indicating that the composition used in the present invention has analgesic function.

[0092] Verification Example 3: Verification of Clinical Efficacy Results

[0093] This experiment evaluates the efficacy of the powders prepared in the examples and comparative examples in treating chronic pharyngitis.

[0094] 1) Diagnostic criteria: Refer to the ninth edition of "Otorhinolaryngology Head and Neck Surgery": Chronic pharyngitis: caused by repeated attacks of acute pharyngitis; various nasal diseases and chronic inflammation of the respiratory tract, long-term open mouth breathing and repeated stimulation of the pharynx by inflammatory secretions, or the influence of chronic tonsillitis and periodontitis; excessive smoking and drinking, dust, stimulation of harmful gases and spicy food, etc. Symptoms: Generally no obvious systemic symptoms, foreign body sensation, itching, burning or slight pain in the pharynx. There are often sticky secretions attached to the posterior wall of the pharynx, causing patients to have frequent irritating coughs in the morning, accompanied by nausea. No sputum or only granular lotus root powder-like secretions are coughed up.

[0095] 2) Pathology: Chronic simple pharyngitis: congestion of pharyngeal mucosa, hyperplasia of submucosal connective tissue and lymphoid tissue, thickening of squamous epithelium, increase of small blood vessels in the subepithelial layer, surrounding lymphocyte infiltration, hypertrophy of mucous glands, and hypersecretion.

[0096] 3) Inclusion criteria:

[0097] (1) Patients diagnosed with acute pharyngitis or chronic simple pharyngitis;

[0098] (2) Aged between 18 and 55;

[0099] (3) Voluntarily accept treatment and observation;

[0100] (4) Those who have not received other treatments or taken other medications recently.

[0101] 4) Exclusion criteria

[0102] Formulated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines:

[0103] (1) People with food or drug allergies;

[0104] (2) Pharyngeal symptoms or inflammation confirmed by examination to be caused by certain lesions of the oropharynx, nasopharynx, pharynx, nose, larynx, esophagus, neck, or the whole body;

[0105] (3) Pharyngeal symptoms or inflammation caused by measles, scarlet fever, influenza, agranulocytosis, infectious mononucleosis, leukemia, etc.;

[0106] (4) Aged under 18 or over 55;

[0107] (5) Pregnant or lactating women;

[0108] (6) Serum creatinine > 150umol / L, urea > 10mmol / L or / and proteinuria > +, or / and erythrocyte urine > + (urine Hb is not used as a criterion). ALT exceeds the upper limit of normal by more than one times. Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and mental illness;

[0109] (7) Case dropout or exclusion criteria: those who did not take medication according to the prescribed treatment during the observation period, those whose clinical data were incomplete and whose efficacy could not be judged, and those who voluntarily discontinued treatment during the observation period.

[0110] 5) Research plan:

[0111] The powders prepared in Example 1, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 5 are taken 2 to 3 times a day, with 5 days as a course of treatment, and continued for 3 courses of treatment.

[0112] (4) Criteria for determining efficacy:

[0113] Recovery: The symptoms, signs and clinical symptoms of sore throat (dryness, burning sensation, pain in the throat, pain when swallowing, congestion and swelling of the throat, fever and chills, headache, body aches, hyperplasia of lymph follicles on the posterior pharyngeal wall, etc.) disappear, and the total score decreases by ≥95%;

[0114] Markedly effective: The symptoms, signs and TCM clinical symptoms of sore throat (dryness, burning sensation, pain in the throat, pain when swallowing, congestion and swelling of the throat, fever and chills, headache, body aches, and hyperplasia of lymphoid follicles on the posterior pharyngeal wall) were significantly improved, and the total score decreased by ≥70% and <95%;

[0115] Effective: The symptoms, signs and clinical symptoms of sore throat (dryness, burning sensation, pain in the throat, pain when swallowing, congestion and swelling of the throat, fever and chills, headache, body aches, and hyperplasia of lymphoid follicles on the posterior pharyngeal wall) have all improved, and the total score has decreased by ≥30% and <70%;

[0116] Ineffective: There was no significant improvement in the symptoms, signs and TCM clinical symptoms of sore throat (dryness, burning, pain in the throat, pain when swallowing, congestion and swelling of the throat, fever and chills, headache, body aches, hyperplasia of lymph follicles in the posterior pharyngeal wall, etc.), or even aggravation, and the total score decreased by <30%.

[0117] Table 2 Symptom grading and quantification table

[0118]

[0119] 6) The statistical results are shown in the following table

[0120] Table 3 Comparison of efficacy of each group

[0121] Case cure Significant effect efficient invalid P-value Z-value Example 1 Group 100 36 42 20 2 / Comparative Example 1 98 17 35 36 10 0.0156 2.419 Comparative Example 2 96 16 25 45 12 0.0126 2.496 Comparative Example 3 95 15 23 39 18 0.0082 2.643 Comparative Example 5 97 11 21 42 23 0.0001 4.577

[0122] Note: P value and Z value are the comparison results with Example 1

[0123] Depend on Figure 3 It can be seen that the results show that the effective rate of Example 1 in the present invention in treating chronic pharyngitis is significantly higher than that of Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 5 (p < 0.05)

[0124] Figure 4 :Statistical results of the efficacy of treating chronic pharyngitis

[0125] It can be seen that the cure rate of Example 1 group is 36%, the significant efficiency is 42%, the effective rate is 20%, and the ineffective rate is 2%; the cure rate of Comparative Example 1 group is 17.34%, the significant efficiency is 35.71%, the effective rate is 36.73%, and the ineffective rate is 10.20%; the cure rate of Comparative Example 2 group is 16.67%, the significant efficiency is 26.04%, the effective rate is 46.86%, and the ineffective rate is 12.50%; the cure rate of Comparative Example 3 group is 15.79%, the significant efficiency is 24.21%, the effective rate is 41.05%, and the ineffective rate is 18.94%; the cure rate of Comparative Example 5 group is 11.34%, the significant efficiency is 21.65%, the effective rate is 43.30%, and the ineffective rate is 23.71%.

Claims

1. A Chinese medicine composition for treating sore throat, characterized in that: The traditional Chinese medicine composition consists of the following traditional Chinese medicines: 8.3-16.8 weight parts of artificial bezoar, 168-299 weight parts of indigo, 14.6-31.2 weight parts of borneol, 239-419 weight parts of phellodendron, 239-419 weight parts of pollen, and 128.7-249.7 weight parts of liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following traditional Chinese medicines: 11.1 parts by weight of artificial bezoar, 222 parts by weight of indigo, 22.2 parts by weight of borneol, 333 parts by weight of phellodendron, 333 parts by weight of pollen cattail and 188.7 parts by weight of liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition consists of the following traditional Chinese medicines: 8.3 parts by weight of artificial bezoar, 168 parts by weight of indigo, 14.6 parts by weight of borneol, 239 parts by weight of phellodendron, 239 parts by weight of pollen cattail and 128.7 parts by weight of liquorice.

4. The Chinese medicine composition according to claim 1, characterized in that: 11.1 parts by weight of artificial bezoar, 299 parts by weight of indigo, 31.2 parts by weight of borneol, 419 parts by weight of phellodendron, 419 parts by weight of pollen cattail, and 249.7 parts by weight of liquorice.

5. The Chinese medicine composition according to claim 1, characterized in that: The sore throat is caused by excessive heat in the lungs and stomach and accumulation of heat and toxicity.

6. A preparation made from the Chinese medicine composition according to claim 1, characterized in that: The preparation is one of decoction, tablet, granule, pill, oral liquid and powder, preferably powder.

7. The preparation according to claim 6, characterized in that The preparation further comprises pharmaceutically acceptable excipients, which include one or a combination of two or more of fillers, disintegrants, lubricants, preservatives and flavoring agents.

8. A method for preparing the powder according to claim 6, characterized in that: The method comprises the following steps: 1) Grind borneol and artificial bezoar into fine powder respectively, pass through 120 mesh sieve, and set aside; 2) Dry Indigo Naturalis, Phellodendron Amurense, Pollen Typhae and Licorice at 80°C under normal pressure for 5 hours, grind into finest powder, pass through 120-mesh sieve and set aside; 3) Add the finest powder of step 1) into step 2), stir and mix for 30 minutes, pass through a 120-mesh sieve, sterilize by irradiation, and package to obtain.

9. The method of preparing the powder according to claim 6, characterized in that: The radiation sterilization dose in step (3) is 8 kGy.

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