Traditional Chinese medicine composition for treating exogenous damp-heat, preparation, preparation method and application

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating exogenous damp-heat, a preparation, a preparation method and application. The traditional Chinese medicine composition comprises the following components in parts by weight: 12-24 parts of artemisia rupestris, 12-24 parts of artemisia annua, 6-20 parts of scutellaria baicalensis, 10-20 parts of schizonepeta, 10-20 parts of radix saposhnikoviae, 6-20 parts of platycodon grandiflorum, 10-24 parts of burdock, 6-20 parts of pogostemon cablin, 6-20 parts of eupatorium fortunei and 4-20 parts of liquorice. Aiming at the pathogenesis characteristics of exogenous damp-heat and unsolved exterior evil, the traditional Chinese medicines with the effects of clearing away heat and toxic materials, resolving dampness and regulating the middle warmer, relieving exterior syndrome and eliminating evil and the like are screened out, and through scientific compatibility and preparation process research, the traditional Chinese medicine is used for treating fever with aversion to cold, clear nasal discharge, throat disadvantage, body pain, hypodynamia, anorexia, regurgitation, nausea, vomiting and the like caused by exogenous damp-heat, so that a new choice is expected to be provided for clinic.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition, a preparation, a preparation method and an application for treating damp-heat exogenous syndrome. Background Art

[0002] A cold is a common exogenous disease that is caused by being affected by wind-evil or epidemic toxin, resulting in the disorder of the lung-defense function. Its main clinical features include nasal congestion, runny nose, sneezing, cough, headache, aversion to cold, fever, general discomfort, and floating pulse. This disease can occur throughout the four seasons, especially in winter and spring. The qi of the four seasons, or "the qi of an inappropriate season", such as spring should be warm but is instead cold, summer should be hot but is instead cool, autumn should be cool but is instead hot, and winter should be cold but is instead warm, can all become pathogenic factors invading the human body. In relatively humid and hot areas in China, such as the Sichuan Basin, the situation is relatively complex. Different from common wind-cold, wind-heat, and summer-damp exogenous syndromes, damp-heat exogenous syndrome is accompanied by exterior cold, or the exterior cold has not been resolved in the initial stage and transforms into heat inside, forming a situation of intermingled cold and heat.

[0003] Damp-heat exogenous syndrome is different from summer-damp cold, wind-cold cold, and wind-heat cold. Summer-damp cold only occurs in summer, and its etiology is summer-heat pathogen combined with dampness, which is likely to consume qi and injure body fluid, with high fever and profuse sweating that does not stop after sweating. It is suitable to clear summer-heat and resolve dampness. Wind-cold cold is more common in autumn and winter, and its etiology is wind-cold attacking the exterior and the defensive yang being checked. It is suitable to relieve the exterior with pungent-warm herbs. Wind-heat cold is more common in spring and autumn, and its etiology is wind-heat attacking externally and the defensive exterior being disharmonious. It is suitable to relieve the exterior with cool herbs. While damp-heat exogenous syndrome can occur throughout the four seasons, and its etiology is the combined invasion of damp pathogen and heat pathogen (especially in relatively humid seasons or environments), which is likely to be lingering and difficult to cure. It is suitable to relieve both the exterior and interior, and at the same time disperse cold, clear heat, and remove dampness.

[0004] Currently, for the treatment of damp-heat exogenous syndrome, Western medicine mostly adopts symptomatic treatments such as antiviral, antipyretic and analgesic, and antidiarrheal, but there are problems such as limited efficacy and large side effects. Traditional Chinese medicine has a long history in the treatment of damp-heat exogenous syndrome and has accumulated rich experience. Commonly used prescriptions such as Huoxiang Zhengqi Powder, Sanren Decoction, and Ganlu Xiaodu Dan, etc. However, existing prescriptions mostly have deficiencies such as complex formula, single efficacy, and slow onset of action. Summary of the Invention

[0005] In order to solve the defects existing in the prior art, the present invention provides a traditional Chinese medicine composition, a preparation, a preparation method and an application for treating damp-heat exogenous syndrome. The inventors of the present application, based on traditional Chinese medicine theory and combined with modern pharmacological research, in view of the pathogenesis characteristics of damp-heat exogenous syndrome with unresolved exterior pathogen, screened traditional Chinese medicines with the effects of clearing heat and detoxifying, promoting digestion and regulating the middle-jiao, and relieving the exterior and dispersing pathogen. Through scientific compatibility and preparation process research, it is used for symptoms such as fever and aversion to cold, clear nasal discharge, discomfort in the throat, body pain, fatigue, loss of appetite, nausea, vomiting, etc. caused by damp-heat exogenous syndrome, in order to provide a new choice for clinical practice.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating damp-heat exogenous diseases. Calculated by weight parts, the components of the traditional Chinese medicine composition include: 12 - 24 parts of Artemisia rupestris, 12 - 24 parts of Artemisia annua, 6 - 20 parts of Scutellaria baicalensis, 10 - 20 parts of Schizonepeta tenuifolia, 10 - 20 parts of Saposhnikovia divaricata, 6 - 20 parts of Platycodon grandiflorum, 10 - 24 parts of Arctium lappa, 6 - 20 parts of Pogostemon cablin, 6 - 20 parts of Eupatorium fortunei, and 4 - 20 parts of Glycyrrhiza uralensis.

[0008] Preferably, the components of the traditional Chinese medicine composition are: 18 parts of Artemisia rupestris, 15 parts of Artemisia annua, 12 parts of Scutellaria baicalensis, 12 parts of Schizonepeta tenuifolia, 12 parts of Saposhnikovia divaricata, 12 parts of Platycodon grandiflorum, 12 parts of Arctium lappa, 12 parts of Pogostemon cablin, 12 parts of Eupatorium fortunei, and 6 parts of Glycyrrhiza uralensis.

[0009] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating damp-heat exogenous diseases, which is prepared from the above traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0010] Preferably, the dosage form of the traditional Chinese medicine preparation is any one of granule, decoction, powder, pill, solution, and capsule.

[0011] Preferably, the preparation method of the granule comprises the following steps: mixing the components of the above traditional Chinese medicine composition, decocting with water, combining the decoction liquids, filtering, concentrating into an extract, drying and pulverizing, and adding excipients to obtain the granule.

[0012] Preferably, during the water decocting process, 6 - 10 times the amount of water is added, the decocting time is 15 - 45 min, and the number of decocting times is 1 - 3 times.

[0013] Preferably, the decocting is divided into two times. The amount of added water is 10 times the amount of water. The first decocting is for 45 min, and the second decocting is for 30 min.

[0014] In a third aspect, the present invention provides a preparation method of a traditional Chinese medicine composition for treating damp-heat exogenous diseases, which comprises mixing the components of the above traditional Chinese medicine composition to obtain the composition.

[0015] Preferably, the preparation method comprises the following steps: mixing the components of the above traditional Chinese medicine composition, decocting with water, combining the decoction liquids, filtering, concentrating into an extract, drying and pulverizing, and adding excipients to obtain the composition.

[0016] Preferably, during the water decocting process, 6 - 10 times the amount of water is added, the decocting time is 15 - 45 min, and the number of decocting times is 1 - 3 times.

[0017] Preferably, the decocting is divided into two times. The amount of added water is 10 times the amount of water. The first decocting is for 45 min, and the second decocting is for 30 min.

[0018] Preferably, the relative density of the extract at 60 °C is 1.20 - 1.30.

[0019] Fourthly, the present invention provides an application of the above traditional Chinese medicine composition in the preparation of a product for treating damp-heat exogenous syndrome.

[0020] Preferably, the treatment of damp-heat exogenous syndrome is clearing heat and detoxifying, relieving exterior syndrome and resolving dampness.

[0021] The beneficial effects of the present invention are as follows:

[0022] In the traditional Chinese medicine composition of the present invention, Artemisia rupestris is used to clear heat and detoxify, Artemisia annua (sweet wormwood) is used to clear heat and cool blood, and Scutellaria baicalensis is used to clear heat and dry dampness, purge fire and detoxify. The three herbs work synergistically to dispel the pathogenic factors of dampness and heat, and are the monarch herbs. Schizonepeta tenuifolia and Saposhnikovia divaricata are used to induce sweating and relieve exterior syndrome, open the pores of the skin, so that the pathogenic factors of dampness and heat are discharged with sweat. At the same time, Saposhnikovia divaricata can restrain the cold nature of Artemisia annua and prevent the coolness from checking the damp pathogen, and they are both ministerial herbs. Arctium lappa is good at dispersing wind-heat, promoting the dispersing function of the lung-qi, Platycodon grandiflorum is good at dispersing the lung-qi, relieving sore throat and promoting voice production, resolving phlegm and relieving cough. And damp-heat exogenous syndrome is often associated with damp pathogen. Pogostemon cablin is combined with Eupatorium fortunei, and the two herbs are used together in a mutually reinforcing manner, which can resolve dampness and relieve exterior syndrome, harmonize the stomach and arrest vomiting. The four herbs work synergistically to take into account the dampness obstruction in the upper and middle jiao, relieve sore throat and resolve dampness, and regulate qi movement, and are all assistant herbs. Glycyrrhiza uralensis is sweet and neutral, which can harmonize all the herbs, regulate the spleen and stomach and transform and transport the pathogenic factors of dampness and water, and is the guiding herb. The combination of all the herbs can achieve the effects of clearing heat and detoxifying, relieving exterior syndrome and resolving dampness. Detailed implementation manners

[0023] In order to enable those skilled in the art to better understand the technical solutions of the invention, the present invention will be further described in detail below in conjunction with specific implementation manners.

[0024] Artemisia rupestris: It is the dried whole herb of Artemisia rupestris L., a plant of the Compositae family. In the present invention, it has a significant effect of clearing heat and detoxifying, relieving symptoms of exogenous heat-toxin; has the effect of resolving dampness, improving dampness symptoms, and helping to relieve body pain; has a broad-spectrum antibacterial effect, improving inflammatory reactions; has the effect of relieving exterior syndrome, relieving exterior syndrome symptoms, and helping to expel exogenous pathogens.

[0025] Artemisia annua: This product is the dried aerial part of Artemisia annua L., a plant of the Compositae family. It is harvested when the flowers are in full bloom in autumn, the old stems are removed, and it is dried in the shade. It has the effects of clearing away deficiency-heat, removing bone-steaming, relieving summer heat, arresting malaria, and subsiding jaundice. In the present invention, it has the effect of clearing heat and detoxifying, which can relieve symptoms of exogenous heat-toxin; has the effect of resolving dampness, improving dampness symptoms; has a broad-spectrum antibacterial effect, improving inflammatory reactions; has the effect of relieving summer heat, relieving summer heat symptoms.

[0026] Scutellaria baicalensis Georgi: This product is the dried root of the plant Scutellaria baicalensis Georgi of the Lamiaceae family. It is harvested in spring and autumn, the fibrous roots and sediment are removed, it is dried in the sun and then the rough bark is knocked off and dried again. It has the functions of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. In the present invention, it has a significant heat-clearing effect, can relieve internal heat symptoms, and improve damp-heat syndromes; it has a fire-purging effect, can relieve fire symptoms, and improve heat-toxin syndromes; it has a broad-spectrum antibacterial effect and can improve inflammatory reactions; it has a blood-cooling effect and can improve blood-heat syndromes.

[0027] Schizonepeta tenuifolia Briq.: This product is the dried aerial part of the plant Schizonepeta tenuifolia Briq. of the Lamiaceae family. It is harvested in summer and autumn when the flowers reach the top and the spikes are green, impurities are removed, and it is dried in the sun. It has the functions of inducing sweating to disperse wind, promoting eruption, and resolving carbuncles. In the present invention, it has a significant sweating-inducing effect, can relieve exterior syndrome symptoms, and helps to expel exogenous pathogenic factors; it has a wind-dispelling effect, can improve wind pathogen symptoms, and helps to relieve body pain; it has a broad-spectrum antibacterial effect and can improve inflammatory reactions.

[0028] Saposhnikovia divaricata (Turcz.) Schischk.: This product is the dried root of the plant Saposhnikovia divaricata (Turcz.) Schischk. of the Umbelliferae family. The roots of the plants without flowering stems are harvested in spring and autumn, the fibrous roots and sediment are removed, and it is dried in the sun. It has the functions of expelling wind and relieving exterior syndrome, eliminating dampness and relieving pain, and stopping convulsions. In the present invention, it has a wind-dispelling effect, can relieve wind pathogen symptoms; it has a dampness-eliminating effect, can improve damp pathogen symptoms; it has a broad-spectrum antibacterial effect and can improve inflammatory reactions.

[0029] Platycodon grandiflorum (Jacq.) A.DC.: This product is the dried root of the plant Platycodon grandiflorum (Jacq.) A.DC. of the Campanulaceae family. It is harvested in spring and autumn, washed, the fibrous roots are removed, and it is dried while still fresh by peeling off the outer skin or without peeling off the outer skin. It has the functions of dispersing lung qi, relieving sore throat, resolving phlegm, and discharging pus. In the present invention, it has a significant lung qi-dispersing effect, can relieve the symptoms of unsmooth lung qi, and helps to improve throat discomfort; it has a phlegm-resolving effect, can improve phlegm-dampness symptoms; it has a heat-clearing and detoxifying effect, can relieve heat-toxin symptoms; it has a broad-spectrum antibacterial effect and can improve inflammatory reactions.

[0030] Arctium lappa L.: This product is the dried ripe fruit of the plant Arctium lappa L. of the Compositae family. When the fruits are ripe in autumn, the inflorescence is harvested, dried in the sun, the fruits are beaten off, impurities are removed, and then it is dried again. It has the functions of dispersing wind-heat, dispersing lung qi and promoting eruption, and detoxifying and relieving sore throat. In the present invention, it has a significant wind-heat dispersing effect, can relieve wind-heat symptoms; it has a lung qi-dispersing effect, can improve unsmooth lung qi; it has a detoxifying effect, can relieve heat-toxin symptoms; it has a broad-spectrum antibacterial effect and can improve inflammatory reactions.

[0031] Patchouli: This product is the dried aerial part of the plant Pogostemon cablin (Blanco) Benth. of the Lamiaceae family. It is harvested when the branches and leaves are lush, exposed to the sun during the day and covered at night, and repeated until dry. It has the effects of aromatic turbidity resolution, regulating the middle-jiao to stop vomiting, and relieving exterior syndrome and dissipating summer heat. In the present invention, it has a significant dampness-resolving effect, can relieve dampness pathogen symptoms; has a middle-jiao regulating effect, improves the functions of the spleen and stomach; has an exterior-relieving effect, relieves exterior syndrome symptoms, and helps to expel exogenous pathogens; has a broad-spectrum antibacterial effect, and improves the inflammatory response.

[0032] Eupatorium fortunei: This product is the dried aerial part of the plant Eupatorium fortunei Turcz. of the Asteraceae family. It is harvested in two times in summer and autumn, impurities are removed, and it is dried in the sun. It has the effects of aromatic dampness resolution, awakening the spleen and promoting appetite, and relieving exterior syndrome and dissipating summer heat. In the present invention, it has a significant dampness-resolving effect, can relieve dampness pathogen symptoms; has a middle-jiao regulating effect, improves the functions of the spleen and stomach; has an exterior-relieving effect, relieves exterior syndrome symptoms, and helps to expel exogenous pathogens; has a broad-spectrum antibacterial effect, and improves the inflammatory response.

[0033] Licorice: This product is the dried root and rhizome of the plant Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. of the Leguminosae family. It is dug in spring and autumn, the fibrous roots are removed, and it is dried in the sun. It has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and coordinating various medicinal herbs. In the present invention, it has the effect of coordinating various medicinal herbs, relieves the side effects of medicines, and enhances the curative effects of other medicines.

[0034] In the present invention, the above-mentioned traditional Chinese medicine components are differentiated and treated, and rationally combined to clear heat and detoxify, relieve exterior syndrome and resolve dampness, so as to achieve the effect of treating damp-heat exterior syndrome symptoms, with stable curative effect and good safety.

[0035] In the embodiments of the present invention, the parts are in grams.

[0036] Example 1

[0037] This example provides a traditional Chinese medicine composition for treating damp-heat exterior syndrome. In parts by weight, the components of the traditional Chinese medicine composition are: 18 parts of Artemisia rupestris, 15 parts of Artemisia annua, 12 parts of Scutellaria baicalensis, 12 parts of Schizonepeta tenuifolia, 12 parts of Saposhnikovia divaricata, 12 parts of Platycodon grandiflorum, 12 parts of Arctium lappa, 12 parts of Pogostemon cablin, 12 parts of Eupatorium fortunei, and 6 parts of Glycyrrhiza uralensis.

[0038] Example 2

[0039] This example provides a traditional Chinese medicine composition for treating damp-heat exterior syndrome. In parts by weight, the components of the traditional Chinese medicine composition are: 24 parts of Artemisia rupestris, 24 parts of Artemisia annua, 20 parts of Scutellaria baicalensis, 20 parts of Schizonepeta tenuifolia, 20 parts of Saposhnikovia divaricata, 20 parts of Platycodon grandiflorum, 24 parts of Arctium lappa, 20 parts of Pogostemon cablin, 20 parts of Eupatorium fortunei, and 20 parts of Glycyrrhiza uralensis.

[0040] Example 3

[0041] This example provides a traditional Chinese medicine composition for treating damp-heat exogenous diseases. Calculated by weight, the components of the traditional Chinese medicine composition are: 12 parts of Artemisia rupestris, 12 parts of Artemisia annua, 6 parts of Scutellaria baicalensis, 10 parts of Schizonepeta tenuifolia, 10 parts of Saposhnikovia divaricata, 6 parts of Platycodon grandiflorum, 10 parts of Arctium lappa, 6 parts of Pogostemon cablin, 6 parts of Eupatorium fortunei, and 4 parts of Glycyrrhiza uralensis.

[0042] Example 4

[0043] Traditional Chinese medicine granule preparation

[0044] The preparation method of the granule preparation is as follows: Mix the compositions described in any one of Examples 1 to 3, decoct with water, combine the decoction liquids, filter, concentrate the filtrate to an extract with a relative density of 1.20 - 1.30 (around 60 °C), dry, pulverize into dry extract powder, add an appropriate amount of dextrin, stevioside, water and a small amount of ethanol, mix evenly, make into granules, and dry.

[0045] Taking the composition of Example 1 as an example, an orthogonal test analysis is carried out on the preparation parameters of the granule preparation, as follows:

[0046] 1. Header design

[0047] Table 1. Orthogonal test factor levels

[0048]

[0049] 2. Results of the orthogonal experiment for water extraction

[0050] Table 2. Results of the orthogonal experiment for water extraction

[0051]

[0052] Note: 1. The flavonoid content is the proportion of the flavonoids contained in the extract in the total amount of the medicinal materials. 2. Comprehensive weighted scoring formula: Comprehensive score = 40% × (dry extract rate / maximum dry extract rate) + 60% × (total flavonoid content / maximum total flavonoid content). (Scoring range 0 - 100, dry extract rate min = 14.16%, max = 27.31%; total flavonoid min = 0.32%, max = 1.82%). 3. Ki represents the sum of the comprehensive scores at the corresponding levels of the corresponding factors.

[0053] 3. Result analysis

[0054] (1) Sum of squares and degrees of freedom analysis, see Table 3.

[0055] Table 3. Analysis results of sum of squares and degrees of freedom

[0056]

[0057] (2) Analysis of variance, see Table 4

[0058] Table 4. Results of analysis of variance

[0059]

[0060] Conclusion: It can be seen from the intuitive analysis in Table 2 that the order of the influence of each factor on the result is C > B > A, and the different levels of each factor are in turn A 3 > A 2 > A 1 , B 3 > B 2 > B 1 , C 3 > C 2 > C 1 , and the optimal factor combination is A 3 B 3 C 3 . In summary, the paste yield and total flavonoid content are the highest when the combination is A 3 B 3 C 3 , that is, the water addition is 10 times, decoction for 45 min, and decoction 3 times.

[0061] It can be seen from the results of the orthogonal experiment that the water addition amount, decoction time and decoction times have no significant influence. Considering the nature and efficacy of the preparation prescription, it is not suitable for long-term decoction, and decocting once industrially fails to effectively extract the active ingredients of the drug, and decocting 3 times takes a long time and has a high cost. Therefore, the decoction time and times can be optimized to 2 times, decocting for 45 min for the first time and 30 min for the second time.

[0062] Example 5

[0063] Traditional Chinese medicine decoction

[0064] The preparation method of the traditional Chinese medicine preparation includes: taking the traditional Chinese medicine composition described in Examples 1 to 3, decocting with water respectively, and filtering to obtain the traditional Chinese medicine decoction.

[0065] Example 6

[0066] Traditional Chinese medicine powder

[0067] The preparation method of the traditional Chinese medicine preparation includes: taking the components of the traditional Chinese medicine composition in Examples 1 to 3, pulverizing and mixing to obtain the traditional Chinese medicine powder.

[0068] Example 7

[0069] Traditional Chinese medicine pills

[0070] The preparation method of the traditional Chinese medicine preparation includes: taking the components of the traditional Chinese medicine composition in Examples 1 to 3, pulverizing, adding a binder to make spherical pills to obtain the traditional Chinese medicine pills; the binder is water.

[0071] Example 8

[0072] Traditional Chinese medicine oral liquid

[0073] The traditional Chinese medicine oral liquid is prepared from the traditional Chinese medicine composition components of Examples 1 to 3 and pharmaceutically acceptable excipients.

[0074] Example 9

[0075] Traditional Chinese medicine concentrated oral liquid

[0076] The traditional Chinese medicine concentrated oral liquid is prepared from the traditional Chinese medicine composition components of Examples 1 to 3 and pharmaceutically acceptable excipients.

[0077] Example 10

[0078] Traditional Chinese medicine capsules

[0079] The traditional Chinese medicine capsules are prepared from the traditional Chinese medicine composition components of Examples 1 to 3 and pharmaceutically acceptable excipients.

[0080] Comparative Example 1

[0081] This example provides a traditional Chinese medicine composition. In parts by weight, the components of the traditional Chinese medicine composition are: 15 parts of Artemisia annua, 12 parts of Scutellaria baicalensis, 12 parts of Schizonepeta tenuifolia, 12 parts of Saposhnikovia divaricata, 12 parts of Platycodon grandiflorum, 12 parts of Arctium lappa, 12 parts of Pogostemon cablin, and 6 parts of Glycyrrhiza uralensis.

[0082] Comparative Example 2

[0083] This example provides a traditional Chinese medicine composition. In parts by weight, the components of the traditional Chinese medicine composition are: 10 parts of Artemisia rupestris, 10 parts of Artemisia annua, 5 parts of Scutellaria baicalensis, 12 parts of Schizonepeta tenuifolia, 12 parts of Saposhnikovia divaricata, 12 parts of Platycodon grandiflorum, 12 parts of Arctium lappa, 12 parts of Pogostemon cablin, 12 parts of Eupatorium fortunei, and 6 parts of Glycyrrhiza uralensis.

[0084] Effect Example 1

[0085] The therapeutic effect of the traditional Chinese medicine composition of the present invention will be illustrated below through clinical data.

[0086] I. Inclusion of research subjects

[0087] 1. Case inclusion criteria

[0088] Traditional Chinese medicine syndrome differentiation: Damp-heat exogenous syndrome (main symptoms: fever and aversion to cold, body pain and fatigue; secondary symptoms: clear nasal discharge, discomfort in the throat, anorexia and nausea; tongue and pulse: red tongue with thin yellow and greasy coating, floating, slippery and rapid pulse).

[0089] 2. Exclusion criteria

[0090] ① Those with wind-cold cold;

[0091] ② Those with spleen-stomach deficiency-cold;

[0092] ③ Pregnant women and lactating women;

[0093] ④ Postpartum blood deficiency;

[0094] ⑤ Those with severe psychological or emotional disorders or those determined by other doctors to be unsuitable for participating in this study.

[0095] 3. Shedding standard

[0096] ① Patients with poor compliance or who actively request to withdraw from this clinical trial.

[0097] ② Those who have serious adverse events and should withdraw from the clinical trial according to the doctor's judgment.

[0098] ③ Failure to use medication as prescribed, insufficient course of treatment or incomplete case report.

[0099] 4. Elimination criteria

[0100] ① Those who fail to complete clinical trials, affecting the judgment of efficacy and safety.

[0101] ② During the medication process, the patient participates in other clinical trials or combined medications and treatments not within the prescribed scope, especially those that have a significant impact on the test results and affect the judgment of efficacy and safety.

[0102] According to the above standards, an observational study design was conducted. All samples were from patients visiting Zhongjiang County Traditional Chinese Medicine Hospital. In principle, the number of samples in each group was not less than 25. Considering the dropout rate of 10%, a total of 100 patient samples that met the diagnostic criteria were included and randomly divided into three groups: experimental group, control group A, and control group B. The specific case details are shown in the table below:

[0103] Group Number of cases Gender (male / female) Age (years, X±S) Disease course (days, X±S) Experimental group 34 12 / 22 35.2±10.5 2.1±0.8 Control group A 33 11 / 22 36.5±9.8 2.3±1.0 Control group B 33 13 / 20 34.8±11.2 2.0±0.7

[0104] After analysis and comparison, there was no statistical difference in gender, age and disease course among the three groups (P>0.05).

[0105] 2. Dosage regimen

[0106] The compositions of Example 1, Comparative Example 1 and Comparative Example 2 were selected for administration, wherein Example 1 was administered to the test group, Comparative Example 1 was administered to the control group A, and Comparative Example 2 was administered to the control group B. All three groups were decocted in water, each dose was decocted for 2 days, and administered 3 times a day for 1 week.

[0107] III. Efficacy evaluation criteria

[0108] 1. Observation indicators and judgment criteria

[0109] Total effective rate: Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" to determine marked effect, effective, and ineffective. Among them, marked effect: After treatment, the overall symptoms of damp-heat exogenous syndrome are controlled and cured after 1 week of medication; effective: Some symptoms of damp-heat exogenous syndrome are controlled and significantly improved after 1 week of medication; ineffective: The symptoms of damp-heat exogenous syndrome are aggravated. Total effective rate = (number of cases with marked effect + number of effective cases) / total number of tested cases.

[0110] Antipyretic time: The time required for the body temperature to drop below 37.3°C.

[0111] Time for dampness elimination: The time for the improvement and disappearance of nausea, heaviness of the body, and greasy tongue coating.

[0112] Traditional Chinese medicine syndrome score: Fever, aversion to cold, body pain, loss of appetite, nausea and vomiting (each item is scored from 0 to 3 points, and the total score is from 0 to 15 points).

[0113] 2. Statistical methods

[0114] Measurement data: For normal distribution, paired t-test (mean ± standard deviation) is used, and for non-normal distribution, Wilcoxon signed-rank sum test (median [M(QL~QU)]) is used.

[0115] Count data: Paired chi-square test (number of cases, percentage).

[0116] Significance level: α = 0.05 (SPSS 22.0).

[0117] IV. Test results

[0118] 1. Comparison of total effective rates

[0119]

[0120] 2. Antipyretic time and time for dampness elimination

[0121]

[0122] 3. Changes in traditional Chinese medicine syndrome scores

[0123]

[0124] From the above test results, it can be seen that the total effective rate of the experimental group is 91.2%, and the time for reducing fever and removing dampness is significantly shorter than that of the control group. This is because in the compatibility of the embodiments of the present invention, Artemisia rupestris, Artemisia annua, and Scutellaria baicalensis are the monarch drugs, and their synergistic effect enhances the effect of clearing away damp-heat; Schizonepeta tenuifolia and Saposhnikovia divaricata are the ministerial drugs, which can induce sweating to relieve the exterior syndrome, open the pores of the skin, and enable the pathogenic factors of damp-heat to be eliminated with sweat. At the same time, Saposhnikovia divaricata can check the cold nature of Artemisia annua and prevent the coolness from checking the damp pathogenic factors; Arctium lappa can disperse wind-heat, promote the dispersing function of the lung-qi and soothe the throat, Platycodon grandiflorum can promote the dispersing function of the lung-qi, soothe the throat and promote voice production, resolve phlegm and relieve cough, Pogostemon cablin combined with Eupatorium fortunei can remove dampness and relieve the exterior syndrome, harmonize the middle-jiao and stop vomiting. The four drugs act synergistically as the assistant drugs, which can take into account the dampness obstruction in the upper and middle jiao, soothe the throat and resolve dampness, and regulate qi movement; finally, Glycyrrhiza uralensis is added, which is sweet and flat, can harmonize all the drugs, regulate the spleen and stomach, and transform and transport the pathogenic factors of dampness and water. In contrast, Group A lacks Artemisia rupestris and Eupatorium fortunei, with weak dampness-removing power and poor antipyretic effect. In Group B, the dosages of Artemisia rupestris, Artemisia annua, and Scutellaria baicalensis are insufficient, which affects the key compatibility and results in slightly inferior curative effects.

[0125] Effect Example 2

[0126] The traditional Chinese medicine composition for treating damp-heat exogenous syndrome obtained in Example 1 was made into a decoction. Each dose was decocted for 2 days, administered 3 times a day, and taken continuously for 1 week (1 course of treatment).

[0127] 84 patients who met the diagnostic criteria (main symptoms: fever and aversion to cold, body pain and fatigue; secondary symptoms: clear nasal discharge, discomfort in the throat, poor appetite and nausea; tongue and pulse: red tongue with thin yellow and greasy coating, floating, slippery and rapid pulse) and visited Zhongjiang County Traditional Chinese Medicine Hospital during 2024 were screened for clinical observation. It was found that after the composition of the present invention was used, the symptoms of damp-heat exogenous syndrome were improved within 2 days, and the effective rate reached 83.79%, without other adverse reactions.

[0128] Typical Cases

[0129] Patient 1: Ms. Li, 71 years old, symptoms: aversion to cold, clear nasal discharge, accompanied by fatigue and poor appetite, occasional nausea, diagnosed as damp-heat exogenous syndrome; took the medicine of the composition in Example 1. After taking the medicine for 2 days, the symptoms of aversion to cold and clear nasal discharge disappeared, and the fatigue and nausea improved. After continuing to take the medicine for 4 days to consolidate the curative effect, she was cured.

[0130] Patient 2: Mr. Zhang, 29 years old, symptoms: fever that did not subside for 2 days, accompanied by discomfort in the throat, poor appetite and nausea, diagnosed as damp-heat exogenous syndrome; took the medicine of the composition in Example 1. After taking the medicine for 1 day, the fever subsided, and after continuing to take the medicine for 3 days, he was cured.

[0131] Patient 3: Ms. Sun, 32 years old, symptoms: low fever accompanied by expectoration and nausea. She reported that her condition had persisted for several days and the effect of using the cold-induced common cold granules was not good. She was diagnosed as damp-heat exogenous syndrome. After taking the medicine of the composition in Example 1 for 2 days, the fever subsided, and the expectoration and nausea improved. After continuing to take the medicine for 4 days, she was cured.

[0132] The above are only the preferred embodiments of the present invention. It should be noted that the above preferred embodiments should not be construed as limiting the present invention, and the protection scope of the present invention should be defined by the scope of the claims. For those of ordinary skill in the art, several improvements and modifications can be made without departing from the spirit and scope of the present invention, and these improvements and modifications should also be regarded as within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating damp-heat exogenous syndrome, characterized in that: In parts by weight, the components of the traditional Chinese medicine composition include: 12-24 parts of Artemisia annua, 12-24 parts of Artemisia annua, 6-20 parts of Scutellaria baicalensis, 10-20 parts of Nephrolepis truncatum, 10-20 parts of Saposhnikovia divaricata, 6-20 parts of Platycodon grandiflorum, 10-24 parts of Arctium lappa, 6-20 parts of Patchouli, 6-20 parts of Cymbidium orbiculare cymbopogon, and 4-20 parts of Licorice.

2. The Chinese medicine composition for treating exogenous damp-heat according to claim 1, characterized in that: The components of the traditional Chinese medicine composition are: 18 parts of Artemisia annua, 15 parts of Artemisia annua, 12 parts of Scutellaria baicalensis, 12 parts of Nephrolepis truncatum, 12 parts of Saposhnikovia divaricata, 12 parts of Platycodon grandiflorum, 12 parts of Arctium lappa, 12 parts of Patchouli, 12 parts of Cyperus rotundus and 6 parts of Licorice.

3. A Chinese medicine preparation for treating damp-heat exogenous syndrome, characterized in that: The traditional Chinese medicine preparation is made from the traditional Chinese medicine composition according to claim 1 or 2 and pharmaceutically acceptable excipients.

4. The Chinese medicine preparation according to claim 3, characterized in that: The dosage form of the traditional Chinese medicine preparation is any one of granules, decoctions, powders, pills, solutions and capsules.

5. A method for preparing a Chinese medicine composition for treating damp-heat exogenous syndrome, characterized in that: The method comprises mixing the components of the Chinese medicine composition according to claim 1 or 2.

6. The preparation method according to claim 5, characterized in that: The preparation method comprises the following steps: mixing the components of the traditional Chinese medicine composition, boiling with water, combining the decoctions, filtering, concentrating into an extract, drying and crushing, and adding auxiliary materials to obtain the extract.

7. The preparation method according to claim 6, characterized in that: During the decoction process, 6 to 10 times of water is added, the decoction time is 15 to 45 minutes, and the decoction times are 1 to 3 times.

8. The preparation method according to claim 6, characterized in that: The relative density of the extract at 60° C. is 1.20-1.

30.

9. Use of the traditional Chinese medicine composition according to claim 1 or 2 in preparing a product for treating exogenous damp-heat syndrome.

10. The use according to claim 9, characterized in that: The treatment of exogenous damp-heat is to clear away heat, detoxify, and resolve exterior symptoms and dampness.

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