A traditional Chinese medicine composition for treating throat diseases, its preparation and preparation process

Abstract

The present invention relates to the field of treating throat diseases, and in particular to a traditional Chinese medicine composition for treating throat diseases, its preparation and preparation process. The traditional Chinese medicine composition is made from the following traditional Chinese medicines: 20 - 150 parts by weight of Scrophulariae Radix, 50 - 140 parts by weight of Isatidis Radix, 30 - 120 parts by weight of Scutellariae Radix, 30 - 120 parts by weight of Gardeniae Fructus, 10 - 50 parts by weight of Coptidis Rhizoma, and 33 - 52 parts by weight of Sterculiae Lychnophorae Semen. The synergistic effect of the active ingredients of the traditional Chinese medicines in the present invention enables the medicinal effect to be fully exerted and maximized in a short time, and can effectively relieve throat discomfort symptoms. Through reasonable compatibility and upgrading of the formula, pharmacological experiments have found that its effect is greater than that of any single ingredient or other compound formulas with different ratios. The preparation process of the mixture prepared from the composition of the present invention has been optimized. It is found in the accelerated test that the effective substances do not change significantly, effectively guaranteeing the quality of the mixture and improving the drug safety.

Description

Technical Field

[0001] The present invention relates to the field of treating throat diseases, and particularly to a traditional Chinese medicine composition for treating throat diseases, its preparation, and preparation process. Background Art

[0002] Throat diseases are common upper respiratory diseases, mostly caused by upper respiratory tract infections, manifested as acute inflammation of the pharyngeal mucosa and submucosal tissue, often involving pharyngeal lymphoid tissue, and can occur alone or secondary to acute and chronic rhinitis, acute and chronic tonsillitis. Current research believes that its main causes include viruses, bacteria, and non-infectious factors, such as mouth breathing, allergic reactions, gastroesophageal reflux, smoking, alcohol, high temperature, dust, smoke, irritating gases, etc. Currently, clinical patients still widely receive antibiotic treatment, with a great risk of over-treatment.

[0003] Currently, the treatment of throat diseases is mainly divided into the following methods:

[0004] Drug treatment is the main method: For acute pharyngitis and tonsillitis, drugs such as antibiotics and anti-inflammatory drugs can be used for treatment. Local treatment methods include: gargling pharyngeal lotion, spraying, etc., which can relieve pharyngeal discomfort symptoms. A more serious situation is surgical treatment: For severe tonsillitis or pharyngeal tumors, surgical treatment may be required, such as tonsillectomy, tumor resection, etc. Adjuvant treatment physical therapy: Such as pharyngeal physiotherapy, vocal cord rehabilitation training, etc., which can help restore throat function. Preventive measures: Pay attention to keeping the indoor air fresh, avoid overusing the voice, and maintain good personal hygiene habits.

[0005] In recent years, major pharmaceutical companies have successively launched throat drug products. Throat disease medications, as one of the mainstream drugs in the domestic TC market, have a very broad market space. Numerous domestic pharmaceutical companies have stepped into this pharmaceutical field. With the rapid development of the domestic throat drug market, market competition has become increasingly fierce. Summary of the Invention

[0006] In summary, it is necessary for the present invention to provide a traditional Chinese medicine composition for treating throat diseases, its preparation, and preparation process, which can effectively relieve throat pain symptoms and have relatively few side effects. In the 15 years of clinical application, no adverse events have occurred.

[0007] Specifically, the technical solution of the present invention is realized as follows:

[0008] A traditional Chinese medicine composition for treating throat diseases is made from the following traditional Chinese medicines: 20 - 150 parts by weight of Scrophulariae Radix, 50 - 140 parts by weight of Isatidis Radix, 30 - 120 parts by weight of Scutellariae Radix, 30 - 120 parts by weight of Gardeniae Fructus, 10 - 50 parts by weight of Coptidis Rhizoma, and 33 - 52 parts by weight of Sterculiae Lychnophorae Semen.

[0009] Further, the traditional Chinese medicine composition is made from the following traditional Chinese medicines: 100 parts by weight of Scrophulariae Radix, 80 parts by weight of Isatidis Radix, 60 parts by weight of Scutellariae Radix, 60 parts by weight of Gardeniae Fructus, 27 parts by weight of Coptidis Rhizoma, and 40 parts by weight of Sterculiae Lychnophorae Semen.

[0010] The second object of the present invention is to provide a pharmaceutical preparation, which can be one of mixture, granule, pill, tablet, capsule, and powder. Preferably, the pharmaceutical preparation is selected from the mixture.

[0011] The third object of the present invention is to provide the preparation process of the mixture as follows:

[0012] A) Put Sterculiae Lychnophorae Semen into a gauze bag, soak it in water for 20 - 40 min, then decoct it for 55 - 65 min, filter, and collect the filtrate to obtain filtrate A;

[0013] B) Take the formula amount of Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Coptidis Rhizoma, and Scrophulariae Radix, soak them in water for 20 - 40 min, then decoct them for 60 - 80 min, filter, and collect the filtrate to obtain filtrate B;

[0014] C) Continue to decoct the filter residue filtered in step B with water for 30 - 50 min, filter, and collect the filtrate to obtain filtrate C;

[0015] D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 950 mL, dissolve 3 - 8 g of the formula amount of sodium benzoate in 50 mL of purified water and add it to filtrate D, then let it stand and filter, collect the filtrate to obtain filtrate E, and fill it into containers to obtain the product.

[0016] In the preferred embodiment of the present invention, especially with 100 parts by weight of Scrophulariae Radix, 80 parts by weight of Isatidis Radix, 60 parts by weight of Scutellariae Radix, 60 parts by weight of Gardeniae Fructus, 27 parts by weight of Coptidis Rhizoma, and 40 parts by weight of Sterculiae Lychnophorae Semen, the therapeutic effect is better. The preparation process of the mixture of this prescription is as follows:

[0017] A) Put Sterculiae Lychnophorae Semen into a gauze bag, soak it in water for 30 min, then decoct it for 60 min, filter, and collect the filtrate to obtain filtrate A;

[0018] B) Take the formula amount of Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Coptidis Rhizoma, and Scrophulariae Radix, soak them in water for 30 min, then decoct them for 70 min, filter, and collect the filtrate to obtain filtrate B;

[0019] C) Continue to decoct the filter residue filtered in step B with water for 40 min, filter, and collect the filtrate to obtain filtrate C;

[0020] D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 950 mL, dissolve 5.5 g of sodium benzoate in the formula amount with 50 mL of purified water and add it to filtrate D, then let it stand and filter, collect the filtrate to obtain filtrate E, and fill it to get the product.

[0021] In steps A, B, C, and D of the above steps, a sieve mesh with a pore size of 100 - 200 meshes is used for filtration, and the filtration effect is better; taking water as a reference, the relative density of the mixture is greater than 1.08.

[0022] Further, in a preferred embodiment of the present invention, the mixture is made from the following raw materials: 20 - 150 parts by weight of Scrophulariae Radix, 50 - 140 parts by weight of Isatidis Radix, 30 - 120 parts by weight of Scutellariae Radix, 30 - 120 parts by weight of Gardeniae Fructus, 10 - 50 parts by weight of Coptidis Rhizoma, 33 - 52 parts by weight of Sterculiae Lychnophorae Semen, and 3 - 8 parts by weight of sodium benzoate.

[0023] Even further, in a preferred embodiment of the present invention, the mixture is made from the following raw materials: 100 parts by weight of Scrophulariae Radix, 80 parts by weight of Isatidis Radix, 60 parts by weight of Scutellariae Radix, 60 parts by weight of Gardeniae Fructus, 27 parts by weight of Coptidis Rhizoma, 40 parts by weight of Sterculiae Lychnophorae Semen, and 5 parts by weight of sodium benzoate.

[0024] Compared with the prior art, the beneficial effects are mainly reflected in:

[0025] For the traditional Chinese medicine composition of the present invention, the synergistic effect of the effective components of each traditional Chinese medicine enables the medicinal effect to be fully exerted and maximized in a short time, and can effectively relieve the symptoms of throat discomfort. The prescription composition and dosage of the present invention have been rationally formulated and upgraded through reasonable compatibility, and are greater than any single - formula or other - ratio compound formula, and can be used for the treatment of acute and chronic pharyngitis.

[0026] During the preparation process of the preparation, the process and the screening of excipients are further optimized. The effective substances of the final product will not change significantly during the accelerated test, effectively ensuring the quality of the mixture and providing medication safety. Description of the Drawings

[0027] Figure 1 : Auricle swelling rate (%) of mice in each example;

[0028] Figure 2 : Change in pain threshold before drug administration in each example group;

[0029] Figure 3 : Change in pain threshold 1 h after drug administration in each example group;

[0030] Figure 4 : Change in pain threshold 1.5 h after drug administration in each example group;

[0031] Figure 5 : Changes in pain threshold of each experimental group 2 hours after drug administration;

[0032] Figure 6 : Experiment on the effect of the examples screened by the present invention on the vocal cord index of rabbits;

[0033] Figure 7 : Statistical analysis of the treatment effects of the treatment group and the observation group;

[0034] Figure 8 : Changes in the total amounts of harpagide and harpagoside in Scrophulariae Radix at 0, 1, 2, 3, and 6 months during the accelerated experiment. Specific Embodiments

[0035] The following combines some specific embodiments to further illustrate in detail the present invention regarding a greengage for treating throat diseases and its preparation method, and the specific examples are not intended to limit the protection scope of the present invention.

[0036] I. Experiment on the effect of the drugs of the examples of the present invention on xylene-induced ear swelling in mice

[0037] 1. Animal grouping and drug administration

[0038] Animals: Kunming mice, weighing 18 - 20 g, 110 in total, with an equal number of males and females. Temperature: 20 - 25 °C; Humidity: 40% - 70%. The animals were adaptively fed for 1 week before the experiment. During this period, the appearance signs, behavioral activities, fecal characteristics, body weight, diet, and other indicators of the animals were observed, and they had free access to food and water.

[0039] Drug administration: The daily human dosage of Examples 1 - 3 and Comparative Examples 1 - 6 is 20 mL. The daily dosage for mice was calculated by body surface area conversion as 20 mL / 60 kg × 12.3 = 4 mL / kg as the experimental dose; Positive control group (prednisone tablets: 6 mg / kg. Model group blank solvent: 20 mL / kg, administration volume: 0.2 mL / 10 g mouse), and the model group was given the same volume of normal saline.

[0040] The mice were randomly divided into 11 groups according to body weight: model group, positive control group, Examples 1 - 3 groups, and Comparative Examples 1 - 6 groups, with 10 mice in each group. Each group was intragastrically administered the test drug at the above doses for 3 days, once a day.

[0041] 2. Induction and measurement of ear swelling

[0042] 1 hour after the last drug administration, xylene was evenly applied to both sides of the right ear of the mice, 10 μL on each side, and the left ear was not treated. The mice in each group were sacrificed 1 hour after applying xylene. The ears were cut off, and ear discs with a diameter of 6 mm were punched out and weighed. The swelling rate was calculated as = (weight of the right ear disc - weight of the left ear disc) × 100% / weight of the left ear disc.

[0043] 3. Data processing

[0044] The experimental data was statistically processed using GraphPad Prism 9.0 biostatistics software: The data was expressed as Mean±SD, and one-way ANOVA was used for comparison between groups.

[0045] 4. Results

[0046] From Figure 1 It can be seen that there were significant differences between Example 1 and Comparative Examples 1-6 (P<0.05), significant differences between Examples 2-3 and Comparative Example 5 (P<0.05), and significant differences between Example 3 and Comparative Example 2 (P<0.05). It can be seen that Example 1 had a better therapeutic effect compared to other examples.

[0047] II. Experiment on the effect of the drug of the embodiment of the present invention on the pain threshold of mice

[0048] 1. Animal grouping and drug administration

[0049] Animals: Kunming mice: 18-20 g, 110 in total, with an equal number of males and females. Temperature and humidity: 20-25°C; humidity: 40%-70%. They were adaptively fed for 1 week before the experiment. During this period, indicators such as the appearance signs, behavioral activities, fecal traits, body weight, and diet of the animals were observed, and they were allowed to eat and drink freely.

[0050] Drug administration: The daily human dosage of Examples 1-3 and Comparative Examples 1-6 was 20 mL. The daily dosage for mice was calculated by body surface area conversion as 20 mL / 60 kg×12.3 = 4 mL / kg as the experimental dose; positive control group (aspirin tablets: 200 mg / kg. Blank solvent: 20 mL / kg, administration volume: 0.2 mL / 10 g mice), and the model group was given the same volume of normal saline.

[0051] The mice were randomly divided into groups according to body weight: model group, positive control group, Examples 1-3 groups, and Comparative Examples 1-6 groups, a total of 11 groups, with 10 mice in each group. Each group was intragastrically administered the test drug at the above doses for 3 days, once a day.

[0052] 2. Experimental method

[0053] Fill the water bath box with water so that the hot plate touches the water surface. When the room temperature is 15 - 20 °C (too high will make the reaction too sensitive, too low will make the reaction slow), adjust the water temperature of the constant temperature water bath box to 55 ± 0.5 °C and preheat the metal plate for 10 minutes. Each time, put a healthy female mouse into the metal plate. Record the time (seconds) from putting it into the metal plate until it starts licking its hind foot, which is used as the pain threshold of the mouse. Discard the mice whose licking hind foot time is less than 5 seconds or those that still do not lick their feet within 30 seconds. Select 110 mice with pain thresholds between 5 - 30 seconds, randomly divide them into 11 groups with 10 mice in each group, and re - measure their normal pain thresholds once. Take the average of the two measurements as the basal pain threshold (pain threshold before drug administration) of the mouse.

[0054] Measure the pain thresholds at 1 h, 1.5 h, and 2 h after the last drug administration. Use the mouse's licking hind foot reaction as the pain threshold index, and exclude the mice that have other reactions. To prevent foot burns, set a cut - off time of 60 seconds. If there is still no pain sensation reaction on the hot plate after 60 seconds, take it out immediately and record its pain threshold as 60 seconds.

[0055] 3. Data processing

[0056] The experimental data were statistically processed by GraphPad Prism 6.0 biostatistics software: The data were expressed as Mean ± SD, and one - way ANOVA was used for inter - group comparison. The percentage increase in pain threshold (%) = (average pain threshold after drug administration - average pain threshold before drug administration) / average pain threshold before drug administration × 100%

[0057] 4. Experimental results

[0058] The experimental results are shown in Tables 1 - 3 and Figures 2 - 5 , from Figure 2 it can be seen that before drug administration, the pain thresholds did not change, indicating that there were no significant differences among the groups of mice (P > 0.05); Figure 3 it can be seen that at 1 h after drug administration, there were significant differences between Example 1 and Comparative Examples 1 - 6 in pain threshold (P < 0.05), and at 1.5 h and 2 h after drug administration, there were significant differences between Example 1 and Comparative Examples 1 - 6 in pain threshold (P < 0.05).

[0059] Table 1 Comparison of the effects of each example and comparative example on hot - plate - induced pain in mice (pain threshold at 1 h after drug administration)

[0060]

[0061] Table 2 Comparison of the effects of each example and comparative example on hot - plate - induced pain in mice (pain threshold at 1.5 h after drug administration)

[0062]

[0063] Table 3 Comparison of the effects of each example and comparative example on heat plate-induced pain in mice (pain threshold 2.0 h after administration)

[0064]

[0065] III. Experimental Example: Effects of the drug on croton oil-induced vocal cord inflammation in rabbits

[0066] 3.1 Test animals and drugs:

[0067] Animals: New Zealand rabbits of ordinary grade, half male and half female, weighing 2 - 2.5 kg, a total of 40 rabbits.

[0068] Experimental drugs: Model group (normal saline), dexamethasone acetate cream (positive control group), the mixture of Example 1, the mixture of Comparative Example 1, and the mixture of Comparative Example 3.

[0069] Dosing dose: The dosing dose of Example 1 is 734 mg / mL, and the dosing volume is 0.2 mL for all; the dosing dose of Comparative Example 1 is 534 mg / mL, and the dosing volume is 0.2 mL for all; and the dosing dose of Comparative Example 3 is 734 mg / mL, and the dosing volume is 0.2 mL for all; Dexamethasone acetate cream group: that is, the positive control group, 0.2 mL; the model group is given 0.2 mL of normal saline.

[0070] 3.2 Establishment and grouping of the inflammation model:

[0071] Grouping: The rabbits to be dosed are randomly divided into a model group, a positive control group, an Example 1 group, a Comparative Example 1 group, and a Comparative Example 3 group, with 8 rabbits in each group, half male and half female.

[0072] Model establishment: The animals were anesthetized with 20% urethane by intravenous injection, and a neck operation was performed to expose the trachea. 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: absolute ethanol: ether: distilled water = 2:20:73:5, V / V) was inserted through the incision with forceps, and the vocal cords were wiped several times and left for 0.5 h to cause inflammation. The normal control group used normal saline instead of the croton oil inflammatory solution. After inflammation, each test drug group was given a cotton ball with the set dose of the drug to wipe the vocal cords, and the dressing was changed every 20 min and the same operation was performed once, for a total of 3 times. During this period, the cotton ball was placed on the vocal cords, and the model group used normal saline instead of the drug. After the last dose, both groups were intravenously injected with 2 mL / kg of 30 g / L Evans blue solution.

[0073] 3.3 Index determination:

[0074] 1 h after injecting the Evans blue solution, the animals were sacrificed, and the two sides of the vocal cords were removed and weighed. The vocal cord index was calculated according to the following formula respectively. Vocal cord index = vocal cord weight / rabbit weight

[0075] 3.4 Results:

[0076] Compared with the model group, the mixture in Example 1, the mixture in Comparative Example 1, the mixture in Comparative Example 3, and the positive control group all had significant inhibitory effects on the vocal cord inflammatory reaction in rabbits caused by croton oil. There were statistically significant differences between the examples and Comparative Example 1 and Comparative Example 3 (P<0.05), as shown in Figure 5 .

[0077] IV. Clinical Efficacy Test of the Mixture in Experimental Example 1

[0078] The traditional Chinese medicine mixture produced according to Example 1 has a 13-year application history in our hospital, and its efficacy and safety have been confirmed by experts. In this experiment, the efficacy of the mixtures prepared in each example in treating chronic pharyngitis was evaluated.

[0079] 4.1 Diagnostic criteria: Refer to "Otolaryngology - Head and Neck Surgery":

[0080] Chronic pharyngitis: Generally, there are no obvious systemic symptoms, such as foreign body sensation in the pharynx, itching, burning sensation, or slight pain. There is often a sticky secretion attached to the posterior pharyngeal wall, causing the patient to have frequent irritating cough in the morning, accompanied by nausea. There is no sputum or only granular-like lotus root starch-like secretion can be coughed out.

[0081] 4.2 Exclusion criteria

[0082] Formulated with reference to "Guiding Principles for Clinical Research of New Traditional Chinese Medicines":

[0083] (1) Those with food or drug allergies;

[0084] (2) Those with pharyngeal symptoms or inflammation caused by certain lesions in the oropharynx, nasopharynx, laryngopharynx, nose, larynx, esophagus, neck, and the whole body confirmed by examination;

[0085] (3) Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, influenza, granulocytopenia, infectious mononucleosis, leukemia, etc.;

[0086] (4) Those under 18 years old or over 55 years old;

[0087] (5) Pregnant or lactating women;

[0088] (6) Serum creatinine > 150 umoL / L, urea > 10 mmol / L, and / or proteinuria > +, and / or erythrocyturia > + (urinary Hb is not used as a judgment criterion). ALT exceeds one time the upper limit of the normal value. Those with severe primary diseases in the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, and psychiatric patients.

[0089] 4.3 Research methods

[0090] Treatment group: Chronic pharyngitis patients were given 20 mL of the drug in Example 1 group, twice a day, once in the morning and once in the evening, 10 mL each time.

[0091] Observation group: Chronic pharyngitis patients were given oral amoxicillin, three times a day, 1 pill (125 mg) each time, and Yinhuang Buccal Tablets were taken sublingually, three times a day, 1 pill each time.

[0092] For the above observation group and treatment group, a 3-day treatment is regarded as one course of treatment, and it lasts for 3 courses.

[0093] 4.4 Efficacy judgment criteria:

[0094] Cured: The symptoms of sore throat, signs and traditional Chinese medicine clinical symptoms (such as dryness, burning, pain, pain on swallowing, congestion and swelling of the pharynx, fever and aversion to cold, headache, general body aches, hyperplasia of lymphoid follicles on the posterior pharyngeal wall, etc.) disappeared, and the total score value decreased by ≥ 95%;

[0095] Markedly effective: The symptoms of sore throat, signs and traditional Chinese medicine clinical symptoms (such as dryness, burning, pain, pain on swallowing, congestion and swelling of the pharynx, fever and aversion to cold, headache, general body aches, hyperplasia of lymphoid follicles on the posterior pharyngeal wall, etc.) were significantly improved, the total score value decreased by ≥ 70% and < 95%;

[0096] Effective: The symptoms of sore throat, signs and traditional Chinese medicine clinical symptoms (such as dryness, burning, pain, pain on swallowing, congestion and swelling of the pharynx, fever and aversion to cold, headache, general body aches, hyperplasia of lymphoid follicles on the posterior pharyngeal wall, etc.) all improved, the total score value decreased by ≥ 30% and < 70%;

[0097] Ineffective: The symptoms of sore throat, signs and traditional Chinese medicine clinical symptoms (such as dryness, burning, pain, pain on swallowing, congestion and swelling of the pharynx, fever and aversion to cold, headache, general body aches, hyperplasia of lymphoid follicles on the posterior pharyngeal wall, etc.) did not improve significantly, or even worsened, and the total score value decreased by < 30%.

[0098] 4.5 Efficacy observation:

[0099] For all cases, detailed outpatient records were made at the initial diagnosis, including detailed medical history, address and telephone number. The efficacy was understood during the follow-up visit. For those who did not return for follow-up visit 3 days later, the treatment effect was followed up by phone. For those who returned for follow-up visit, the efficacy was followed up by phone again 9 days later. The specific results are shown in Figure 7 。

[0100] The drug for clearing heat and detoxifying, relieving sore throat and detumescence described in the present invention has the following specific composition and preparation process:

[0101] Table 4 Composition of the drug in the example

[0102]

[0103]

[0104] Preparation process:

[0105] A) Soak Sterculia lychnophora in gauze for 20 - 40 min with water, then decoct for 55 - 65 min, filter, collect the filtrate to obtain filtrate A;

[0106] B) Take the formula amount of Isatis root, Scutellaria baicalensis, Gardenia jasminoides, Coptis chinensis, and Scrophularia ningpoensis, soak in water for 20 - 40 min, then decoct for 60 - 80 min, filter, collect the filtrate to obtain filtrate B;

[0107] C) Continue to decoct the residue filtered in step B with water for 30 - 50 min, filter, collect the filtrate to obtain filtrate C;

[0108] D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 950 mL, dissolve 3 - 8 g of the formula amount of sodium benzoate in 50 mL of purified water and add it to filtrate D, then let it stand and filter, collect the filtrate to obtain filtrate E, and fill it into containers to obtain the product.

[0109] In steps A, B, C, and D, a sieve mesh with a pore size of 100 - 200 meshes is used for filtration.

[0110] Comparative example 1: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, its composition and preparation process are as follows:

[0111] Dosage (g) Isatis Root 80 Scutellaria Root 60 Gardenia Fruit 60 Phellodendron Bark 27 Sterculia Lychnophora 40

[0112] Preparation process: For the above five flavors (Sterculia lychnophora wrapped in cloth for decoction), soak in water for 30 minutes, decoct twice, the first time for 1.5 hours, the second time for 1 hour, combine the decoction liquids, filter, concentrate the filtrate to 1000 mL, add 3 g of sodium benzoate, stir well, filter, fill it into containers to obtain the product.

[0113] Comparative example 2: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, its composition and preparation process are as follows:

[0114] Composition: Gypsum 335 g, Flos Lonicerae 67 g, Scrophularia ningpoensis 53.5 g, Rehmannia glutinosa 40 g, Gardenia jasminoides 33.5 g, Forsythia suspensa 33.5 g, Viola philippica 33.5 g, Scutellaria baicalensis 33.5 g, Gentiana scabra 33.5 g, Isatis root 33.5 g, Anemarrhena asphodeloides 27 g, Ophiopogon japonicus 27 g, Steviosin 2.5 g, Sodium benzoate 2 g, Ethylparaben 0.5 g, Orange juice essence 4 mL, Lemon essence 1 mL, Grape essence 4 mL, Activated carbon 5 g.

[0115] Preparation process: Soak the above traditional Chinese medicines in water for 30 minutes, decoct twice, the first time for 1.5 hours, the second time for 1 hour, combine the decoction liquids, filter, and concentrate the filtrate to 1000 mL.

[0116] Comparative Example 3: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, and its composition and preparation process are as follows:

[0117] Dosage (g) Scrophularia Root 100 Dandelion 80 Scutellaria Root 60 Gardenia Fruit 60 Coptis Root 27 Sterculia Lychnophora 40

[0118] Comparative Example 4: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, and its composition and preparation process are as follows:

[0119] Dosage (g) Scrophularia Root 100 Herba Violae 80 Forsythia Fruit 60 Gardenia Fruit 60 Coptis Root 27 Sterculia Lychnophora 40

[0120] Comparative Example 5: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, and its composition and preparation process are as follows:

[0121] Dosage (g) Isatis Root 80 Scutellaria Root 60 Gardenia Fruit 60 Coptis Root 27 Sterculia Lychnophora 40

[0122] Comparative Example 6: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, and its composition and preparation process are as follows:

[0123] Dosage (g) Scrophularia Root 170 Isatis Root 40 Scutellaria Root 40 Gardenia Fruit 30 Coptis Root 60 Sterculia Lychnophora 30

[0124] The preparation process is the same as that of Example 1.

[0125] Comparative Example 7: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, and its composition and preparation process are as follows:

[0126] Dosage (g) Scrophularia Root 100 Isatis Root 80 Scutellaria Root 60 Gardenia Fruit 60 Coptis Root 27 Sterculia Lychnophora 40

[0127] Preparation process:

[0128] A) Soak the semen sterculiae lychnopherae in a gauze bag in water for 20 - 40 min, then decoct for 55 - 65 min, filter, and collect the filtrate to obtain filtrate A;

[0129] B) Take the formula amount of radix isatidis, scutellaria baicalensis, gardenia jasminoides, coptis chinensis, and scrophularia ningpoensis, soak in water for 20 - 40 min, then decoct for 60 - 80 min, filter, and collect the filtrate to obtain filtrate B;

[0130] C) Continue to decoct the filter residue filtered in step B with water for 30 - 50 min, filter, and collect the filtrate to obtain filtrate C;

[0131] D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 900 mL, dissolve 5 g of sodium benzoate in the formula amount with 50 mL of purified water, then dissolve 3 g of ethylparaben in the formula amount with 50 mL of 75% ethanol to obtain an ethylparaben alcohol solution, let the sodium benzoate solution and the ethylparaben alcohol solution stand and filter, collect the filtrate, add it to filtrate D, and fill into containers to obtain the product.

[0132] Comparative Example 8: A drug for clearing heat and detoxifying, relieving sore throat and reducing swelling, with its composition and preparation process as follows:

[0133] Dosage (g) Scrophularia Root 100 Isatis Root 80 Scutellaria Root 60 Gardenia Fruit 60 Coptis Root 27 Sterculia Lychnophora 40

[0134] Preparation process:

[0135] A) Soak Sterculia lychnophora in gauze, soak it in water for 20 - 40 min, then decoct it for 55 - 65 min, filter, collect the filtrate to obtain filtrate A;

[0136] B) Take the formula amount of Isatis root, Scutellaria baicalensis, Gardenia jasminoides, Coptis chinensis, and Scrophularia ningpoensis, soak them in water for 20 - 40 min, then decoct them for 60 - 80 min, filter, collect the filtrate to obtain filtrate B;

[0137] C) Continue to decoct the filter residue filtered in step B with water for 30 - 50 min, filter, collect the filtrate to obtain filtrate C;

[0138] D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 950 mL, dissolve 5 g of butylated hydroxyanisole of the formula amount with 50 mL of ethanol and add it to filtrate D, then let it stand, filter, collect the filtrate to obtain filtrate E, and fill it into containers to obtain the product.

[0139]

Content determination

[0140] Chromatographic conditions and system suitability test: Use octadecylsilane chemically bonded silica gel as the filler; use acetonitrile as mobile phase A and 0.03% phosphoric acid solution as mobile phase B, and perform gradient elution according to the regulations in the following table; the detection wavelength is 210 nm.

[0141]

[0142] Preparation of reference substance solution: Take appropriate amounts of harpagide reference substance and harpagoside reference substance, weigh accurately, dissolve them with 30% methanol to make a mixed solution containing 60 μg of harpagide and 20 μg of harpagoside per 1 mL, and you will get it.

[0143] Preparation of test solution: Take 1 mL of the mixture agents of Examples 1 - 3 and Comparative Examples 7 and 8 of the present invention, place it in a stoppered conical flask, accurately add 50 mL of 50% methanol, tightly stopper it, let it cool, make up the lost weight with 50% methanol, shake well, filter, and take the subsequent filtrate, and you will get it.

[0144] Determination method: Accurately pipette 10 μL of the reference substance solution and the test solution respectively, inject them into the liquid chromatograph for determination, and you will get it.

[0145] Accelerated test: Place for 6 months under the conditions of temperature 40°C ± 2°C and relative humidity 75% ± 5%. Detect the total amount of harpagide and harpagoside at the 0th, 1st, 2nd, 3rd, and 6th months respectively. The specific results are shown in Figure 8 .

[0146] For those skilled in the art, various corresponding changes and deformations can be made according to the technical solutions and concepts described above, and all such changes and deformations should fall within the protection scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for clearing heat and detoxifying, relieving sore throat and reducing swelling, characterized in that, The described traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: 20 - 150 parts by weight of Scrophulariae Radix, 50 - 140 parts by weight of Isatidis Radix, 30 - 120 parts by weight of Scutellariae Radix, 30 - 120 parts by weight of Gardeniae Fructus, 10 - 50 parts by weight of Coptidis Rhizoma, 33 - 52 parts by weight of Sterculiae Lychnophorae Semen.

2. The traditional Chinese medicine composition according to claim 1, wherein, The described traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: 100 parts by weight of Scrophulariae Radix, 80 parts by weight of Isatidis Radix, 60 parts by weight of Scutellariae Radix, 60 parts by weight of Gardeniae Fructus, 27 parts by weight of Coptidis Rhizoma, 40 parts by weight of Sterculiae Lychnophorae Semen.

3. A pharmaceutical preparation, characterized in that, The described pharmaceutical preparation is made from the traditional Chinese medicine composition according to any one of claims 1 - 2 and pharmaceutically acceptable excipients.

4. The pharmaceutical preparation according to claim 3, characterized in that, The dosage form of the described pharmaceutical preparation is selected from one of mixture, granule, pill, tablet, capsule, and powder.

5. The pharmaceutical preparation according to claim 4, characterized in that, The dosage form of the described pharmaceutical preparation is mixture.

6. The pharmaceutical preparation according to claim 5, characterized in that, The described mixture is made from the following raw materials: 20 - 150 parts by weight of Scrophulariae Radix, 50 - 140 parts by weight of Isatidis Radix, 30 - 120 parts by weight of Scutellariae Radix, 30 - 120 parts by weight of Gardeniae Fructus, 10 - 50 parts by weight of Coptidis Rhizoma, 33 - 52 parts by weight of Sterculiae Lychnophorae Semen, 3 - 8 parts by weight of sodium benzoate.

7. The pharmaceutical preparation according to claim 5, characterized in that, The described mixture is made from the following raw materials: 100 parts by weight of Scrophulariae Radix, 80 parts by weight of Isatidis Radix, 60 parts by weight of Scutellariae Radix, 60 parts by weight of Gardeniae Fructus, 27 parts by weight of Coptidis Rhizoma, 40 parts by weight of Sterculiae Lychnophorae Semen, 5.5 parts by weight of sodium benzoate.

8. A preparation process for the mixture according to claim 6, characterized in that, The preparation process of the described mixture is as follows: A) Put Sterculiae Lychnophorae Semen into a gauze bag, soak it in water for 20 - 40 min, then decoct it for 55 - 65 min, filter, and collect the filtrate to obtain filtrate A; B) Take the formulated amounts of Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Coptidis Rhizoma, and Scrophulariae Radix, soak them in water for 20 - 40 min, then decoct them for 60 - 80 min, filter, and collect the filtrate to obtain filtrate B; C) Continue to add water to decoct the filter residue from step B for 30 - 50 min, filter, and collect the filtrate to obtain filtrate C; D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 950 mL, dissolve 3 - 8 g of the formulated amount of sodium benzoate in 50 mL of purified water and add it to filtrate D, then let it stand, filter, and collect the filtrate to obtain filtrate E, and fill it into containers to obtain the product.

9. A preparation process for the mixture as claimed in claim 7, characterized in that, The preparation process of the described mixture is as follows: A) Put Sterculiae Lychnophorae Semen into a gauze bag, soak it in water for 30 min, then decoct it for 60 min, filter, and collect the filtrate to obtain filtrate A; B) Take the formulated amounts of Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Coptidis Rhizoma, and Scrophulariae Radix, soak them in water for 30 min, then decoct them for 70 min, filter, and collect the filtrate to obtain filtrate B; C) Continue to add water to decoct the filter residue from step B for 40 min, filter, and collect the filtrate to obtain filtrate C; D) Combine filtrate A, filtrate B, and filtrate C, then heat and concentrate to obtain filtrate D; then concentrate filtrate D to 950 mL, dissolve 5.5 g of the formulated amount of sodium benzoate in 50 mL of purified water and add it to filtrate D, then let it stand, filter, and collect the filtrate to obtain filtrate E, and fill it into containers to obtain the product.

10. The preparation process according to any one of claims 8 or 9, characterized in that, In the preparation process steps A, B, C, and D, a sieve mesh with a pore size of 100 - 200 meshes is used for filtration.

11. The preparation process according to any one of claims 8 or 9, characterized in that, Taking water as a reference, the relative density of the mixture is greater than 1.08.

Images