Traditional Chinese medicine composition for clearing away lung-heat, dispersing nodules and clearing and nourishing throat and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for clearing away lung-heat, dispersing nodules and clearing and nourishing throat and a preparation method thereof. The traditional Chinese medicine composition is prepared from 15-25 parts of American ginseng, 60-70 parts of bulbus fritillariae cirrhosae, 300-400 parts of loquat, 45-55 parts of platycodon grandiflorum, 25-30 parts of semen armeniacae amarae, 1-5 parts of menthol, 55-60 parts of caragana sinica rehd, 35-40 parts of adina rubella hance roots, 25-35 parts of rhizoma dioscoreae nipponicae, 15-20 parts of rhizoma picrorhizae, 20-30 parts of radix adenophorae, 20-30 parts of rhizoma polygonati and 10-15 parts of rhizoma bletillae. The embodiment of the invention has remarkable treatment advantages in the aspects of clearing away lung-heat, dispersing nodules and clearing and nourishing throat.

Description

Technical Field

[0001] The present invention relates to the technical field of transfer learning, and particularly to a traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx, and a preparation method thereof. Background Art

[0002] In the field of traditional Chinese medicine, with the continuous improvement of people's health awareness, traditional Chinese medicine has been increasingly valued due to its unique curative effects and fewer side effects. As an important part of traditional Chinese medicine, traditional Chinese medicine compositions can play a synergistic role by scientifically combining a variety of Chinese medicinal materials to achieve the purpose of treating or conditioning the body. In recent years, the research and development of traditional Chinese medicine compositions for specific health needs have been increasingly active, especially in the fields of clearing the lungs and dissipating nodules, clearing the throat and moistening the larynx, etc., and the market demand has continued to grow. These traditional Chinese medicine compositions are not only applied to daily health care but also widely used in the treatment of related diseases, such as chronic pharyngitis, bronchitis, etc., and have broad market prospects.

[0003] Chronic pharyngitis is a local or diffuse inflammation of the pharyngeal mucosa, with the main clinical features being dryness, burning, foreign body sensation, itching or slight pain in the pharynx, hoarseness, itching or slight pain, irritating dry cough, and increased and viscous pharyngeal secretions. For those with chronic pharyngitis, the deficiency fire flares up. The internal cause is usually the deficiency of the liver and kidneys and the weak constitution; the external cause is repeated external infections that linger without cure. Repeated attacks of wind-heat pharyngitis, with the wind-heat remaining, cause the depletion of yin fluid, and the deficiency fire flares up, scorching the pharynx and larynx, becoming the deficiency-fire pharyngitis; or the person has a weak constitution, and is additionally stimulated by smoked and spicy foods, consuming body fluids.

[0004] For such chronic diseases, Western medicine lacks effective treatment methods, and traditional Chinese medicine lacks effective ready-made medicines. Therefore, there is an urgent need to develop a traditional Chinese medicine with significant curative effects and no side effects for the treatment of chronic pharyngitis. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx, and a preparation method thereof, aiming to solve at least one problem in the background art.

[0006] In a first aspect, the present invention provides a traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx, which is characterized in that, by mass percentage, it includes:

[0007] 15 - 25 parts of American ginseng, 60 - 70 parts of fritillaria cirrhosa, 300 - 400 parts of loquat, 45 - 55 parts of platycodon grandiflorum, 25 - 30 parts of bitter apricot kernels, 1 - 5 parts of menthol, 55 - 60 parts of sericea lespedeza root, 35 - 40 parts of geum aleppicum root, 25 - 35 parts of dioscorea nipponica, 15 - 20 parts of picrorhiza scrophulariiflora, 20 - 30 parts of adenophora stricta, 20 - 30 parts of polygonatum sibiricum, and 10 - 15 parts of bletilla striata.

[0008] Further, it is characterized in that, by mass percentage, it includes:

[0009] 15 parts of American ginseng, 60 parts of Fritillaria cirrhosa, 300 parts of loquat, 45 parts of Platycodon grandiflorum, 25 parts of bitter apricot kernels, 1 part of menthol, 55 parts of Caragana sinica, 35 parts of Geum aleppicum, 25 parts of Dioscorea nipponica, 15 parts of Picrorhiza scrophulariiflora, 20 parts of Adenophora stricta, 20 parts of Polygonatum sibiricum, 10 parts of Bletilla striata.

[0010] Further, by mass percentage, it includes:

[0011] 25 parts of American ginseng, 70 parts of Fritillaria cirrhosa, 400 parts of loquat, 55 parts of Platycodon grandiflorum, 30 parts of bitter apricot kernels, 5 parts of menthol, 60 parts of Caragana sinica, 40 parts of Geum aleppicum, 35 parts of Dioscorea nipponica, 20 parts of Picrorhiza scrophulariiflora, 30 parts of Adenophora stricta, 30 parts of Polygonatum sibiricum, 15 parts of Bletilla striata.

[0012] Further, by mass percentage, it includes:

[0013] 20 parts of American ginseng, 65 parts of Fritillaria cirrhosa, 350 parts of loquat, 50 parts of Platycodon grandiflorum, 28 parts of bitter apricot kernels, 3 parts of menthol, 58 parts of Caragana sinica, 38 parts of Geum aleppicum, 30 parts of Dioscorea nipponica, 18 parts of Picrorhiza scrophulariiflora, 25 parts of Adenophora stricta, 25 parts of Polygonatum sibiricum, 13 parts of Bletilla striata.

[0014] The pharmacology of each traditional Chinese medicine component in the present invention is as follows:

[0015] I. The monarch drug is:

[0016] 1.1 American ginseng: It is cool in nature, sweet and slightly bitter in taste, and has the effects of replenishing qi and nourishing yin, reducing lung fire, and clearing heat and promoting fluid production. American ginseng acts as the monarch drug in the formula, mainly playing its role of replenishing qi and nourishing yin, clearing heat and promoting fluid production, and targeting symptoms such as qi deficiency and yin deficiency, internal heat and thirst.

[0017] 1.2 Fritillaria cirrhosa: Bitter, sweet, slightly cold, belonging to the lung and heart meridians, and has the effects of clearing heat and moistening the lung, resolving phlegm and relieving cough. Fritillaria cirrhosa, as one of the monarch drugs, mainly treats symptoms such as dry cough due to lung heat and scanty phlegm.

[0018] II. The ministerial drugs:

[0019] 2.1 Loquat: Sweet in nature and sour in taste, entering the lung and spleen meridians, and has the effect of moistening the lung and relieving cough. Loquat can moisten the lungs, relieve cough symptoms, and assist the monarch drug in treating respiratory diseases.

[0020] 2.2 Platycodon grandiflorum: Its root has medicinal value and can treat various diseases. In this formula, it mainly plays its role of dispersing the lung qi, eliminating phlegm, relieving cough, and discharging pus, and assisting the monarch drug to enhance the therapeutic effect.

[0021] 2.3 Bitter apricot kernels: Bitter, slightly warm, belonging to the lung and large intestine meridians, and has the effects of lowering qi and relieving cough, relieving asthma, and moistening the intestines and promoting defecation. Bitter apricot kernels can assist the monarch drug in treating symptoms such as cough and asthma, and also have the function of moistening the intestines and promoting defecation.

[0022] 2.4. Dioscorea nipponica: Slightly warm in nature, bitter in taste, attributing to the liver and kidney meridians, with the effects of dredging collaterals and promoting blood circulation, clearing heat and removing dampness, expelling wind and detoxifying. Dioscorea nipponica can assist the monarch drug in treating symptoms such as rheumatic arthralgia, palpitation and insomnia.

[0023] III. Adjuvant drugs:

[0024] 3.1. Menthol: It has the functions of refreshing and relieving respiratory symptoms, antibacterial and anti-inflammatory. Menthol can soothe respiratory symptoms, relieve discomfort such as cough and sore throat, and has a certain antibacterial effect, assisting the monarch and minister drugs in treating respiratory diseases.

[0025] 3.2. Golden Broom Root: It has the effects of clearing heat and detoxifying, promoting blood circulation to remove blood stasis, inducing diuresis for treating stranguria, clearing the lung and benefiting the spleen. Golden Broom Root can clear heat pathogens in the body, soothe inflammation, and promote blood circulation, assisting the monarch and minister drugs in treating related symptoms.

[0026] 3.3. Geum aleppicum Root: It has the effects of clearing heat and detoxifying, promoting blood circulation to remove blood stasis, promoting diuresis and reducing swelling, expelling wind and relieving pain. Geum aleppicum Root can assist the monarch and minister drugs in clearing heat toxins in the body, improving blood circulation, and relieving discomfort caused by heat toxins.

[0027] 3.4. Picrorhiza scrophulariiflora: It has the effects of clearing heat, detoxifying, antibacterial, and regulating immunity. Picrorhiza scrophulariiflora can enhance the overall medicinal effect and has a certain antibacterial effect, assisting the monarch and minister drugs in treating symptoms such as infections.

[0028] IV. Guiding drug:

[0029] 4.1. Adenophora stricta: Nourishing yin and moistening the lung, promoting the production of body fluid and benefiting the stomach, resolving phlegm and replenishing qi. Adenophora stricta can harmonize the properties of drugs, enabling the drugs to play their roles better, and has a certain effect of nourishing yin and moistening the lung, assisting the monarch and minister drugs in treating respiratory diseases.

[0030] 4.2. Polygonatum sibiricum: Tonifying qi and nourishing yin, strengthening the spleen, moistening the lung, and tonifying the kidney. Polygonatum sibiricum can enhance the overall medicinal effect, improve the constitution, and has a certain effect of moistening the lung, assisting the monarch and minister drugs in treating related symptoms.

[0031] 4.3. Bletilla striata: It has the effects of arresting bleeding with astringents and promoting tissue regeneration and detumescence. Bletilla striata can assist the monarch and minister drugs in treating local symptoms such as hemoptysis and hematemesis, and promoting wound healing.

[0032] In the second aspect, the present invention also provides a preparation method of a traditional Chinese medicine composition for clearing lung nodules and moistening the throat, which is used to prepare the above-mentioned traditional Chinese medicine composition for clearing lung nodules and moistening the throat, and is characterized in that the preparation method includes:

[0033] Step S1. Weigh according to the ratio of each component of the selected traditional Chinese medicine composition to obtain the weight of each component;

[0034] Step S2: Wash the weighed American ginseng, Fritillaria cirrhosa, and menthol, then place them in an extraction tank. Next, pour 20 times the amount of 50% ethanol into the extraction tank and perform reflux extraction for two hours to obtain a first extract. Repeat this extraction process two more times, and then combine the first extracts from the three extractions to obtain an ethanol extract;

[0035] Step S3: Filter and concentrate the ethanol extract under reduced pressure in sequence to obtain a first concentrated solution;

[0036] Step S4: Distill the weighed bitter apricot kernels in a distiller to obtain a distillate;

[0037] Step S5: Grind Platycodon grandiflorum, Caragana rosea, Geum aleppicum, Dioscorea nipponica, Picrorhiza scrophulariiflora, Polygonatum sibiricum, and Bletilla striata into powder, then pour them all into the extraction tank. Add Adenophora polyantha, the residue of American ginseng, the residue of Fritillaria cirrhosa, and the residue of bitter apricot kernels, and boil to obtain a second extract. Repeat this boiling process two more times, and then combine the second extracts from the three extractions to obtain a first combined solution;

[0038] Step S6: Boil, peel, pulp, filter, and concentrate the de-stoned loquat fruits under reduced pressure in sequence to obtain a second concentrated solution;

[0039] Step S7: Combine the first concentrated solution, the distillate, the first combined solution, and the second concentrated solution, add glucose and honey, and stir well to obtain a mixed solution;

[0040] Step S8: Filter, make up the volume, fill, sterilize, perform lamp inspection, and package the mixed solution in sequence to obtain a traditional Chinese medicine oral liquid.

[0041] Further, Step S5 includes:

[0042] Add 8 - 10 times the amount of pure water to the extraction tank before boiling, and boil and extract three times, with each boiling time being 1 - 2 hours.

[0043] Further, Step S3 includes:

[0044] Filter the ethanol extract through a 130 - mesh stainless steel filter screen to obtain a filtrate;

[0045] Under the conditions of a vacuum degree of - 0.05 MPa and a temperature of 65 °C, recover ethanol and concentrate the medicinal liquid until the relative density reaches 1.12 to obtain a first concentrated solution.

[0046] Further, Step S6 includes:

[0047] Boil the de-stoned loquat fruits in 100 °C hot water for 10 minutes until the pulp becomes soft, take them out and peel them, add 2 times the amount of purified water, pulp twice with a pulper, and then extract the loquat raw pulp with a press;

[0048] After filtering through a 130-mesh sieve, the loquat pulp is placed in a vacuum concentration tank and concentrated to a relative density of 1.15 at a vacuum degree of -0.05 MPa and a temperature of 70 °C to obtain the second concentrated liquid.

[0049] Compared with the prior art, the embodiments of the present invention have the following advantages:

[0050] In the traditional Chinese medicine composition proposed in the embodiments of the present invention, components such as the root of Caragana sinica, the root of Geum aleppicum, and Dioscorea nipponica show significant synergistic effects. This synergistic effect significantly improves the overall therapeutic effect. Specifically, the effect of promoting blood circulation and removing blood stasis of the root of Caragana sinica helps to improve blood circulation in the lungs and promote the dissipation of inflammation; the effect of clearing heat and detoxifying of the root of Geum aleppicum can clear lung heat and relieve sore throat; while the effect of dispelling wind and removing dampness of Dioscorea nipponica helps to regulate the respiratory system function and relieve symptoms such as cough. The synergistic effect of these three components in the formula not only enhances their respective pharmacological effects but also significantly improves the overall therapeutic effect. In addition, their synergistic effect also helps to reduce potential adverse reactions and improve the safety of medication. Therefore, the traditional Chinese medicine composition formula of the present invention has significant therapeutic advantages in clearing lung nodules and moistening the throat. Description of the Drawings

[0051] Figure 1 It is a preparation method of a traditional Chinese medicine composition for clearing lung nodules and moistening the throat in an embodiment of the present invention. Detailed Embodiments

[0052] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts belong to the scope of protection of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein shall have the ordinary meaning as understood by those of ordinary skill in the art in the field to which the present invention belongs. The words such as "including" used herein mean that the elements or items appearing before the word cover the elements or items listed after the word and their equivalents, without excluding other elements or items.

[0053] Example 1

[0054] Step S01: Weigh 15 g of American ginseng, 60 g of fritillary bulb, 300 g of loquat, 45 g of platycodon root, 25 g of bitter apricot kernel, 1 g of menthol, 55 g of the root of Caragana sinica, 35 g of the root of Geum aleppicum, 25 g of Dioscorea nipponica, 15 g of picrorhiza rhizome, 20 g of southern sandwort, 20 g of polygonatum, and 10 g of bletilla striata;

[0055] Step S02: Wash the weighed American ginseng, Fritillaria cirrhosa, and menthol, then place them in an extraction tank. Next, inject 20 times the amount of 50% ethanol into the extraction tank and perform reflux extraction for two hours to obtain the first extract. Repeat this extraction process two more times, and then combine the first extracts from the three extractions to obtain the ethanol extract.

[0056] Step S03: Filter the ethanol extract through a 130-mesh stainless steel filter screen to obtain the filtrate. Under the conditions of a vacuum degree of -0.05 MPa and a temperature of 65 °C, recover the ethanol and concentrate the medicinal liquid until the relative density reaches 1.12 to obtain the first concentrated liquid.

[0057] Step S04: Place the weighed bitter apricot kernels in a distiller for distillation to obtain the distillate.

[0058] Step S05: Place the weighed platycodon root, sericea lespedeza root, geum aleppicum root, dioscorea nipponica, picrorhiza scrophulariiflora, adenophora stricta, polygonatum sibiricum, and bletilla striata in an extraction tank, add the residues of American ginseng, Fritillaria cirrhosa, and bitter apricot kernels, and boil to obtain the second extract. Repeat this boiling process two more times, and then combine the second extracts from the three extractions to obtain the first combined liquid.

[0059] Step S06: Blanch the pitted loquat fruits in hot water at 100 °C for 10 minutes until the pulp becomes soft. After taking them out, peel them, add 2 times the amount of purified water, beat them into pulp twice with a pulper, then extract the loquat puree with a press. After filtering through a 130-mesh filter screen, place the loquat pulp in a vacuum concentration tank and concentrate it to a relative density of 1.15 at a vacuum degree of -0.05 MPa and a temperature of 70 °C to obtain the second concentrated liquid.

[0060] Step S07: Combine the first concentrated liquid, the distillate, the first combined liquid, and the second concentrated liquid, add glucose and honey, and stir well to obtain the mixed liquid.

[0061] Step S08: Filter, make up the volume, fill, sterilize, and conduct lamp inspection on the mixed liquid in sequence to obtain the traditional Chinese medicine oral liquid.

[0062] Example 2

[0063] This example is basically the same as Example 1, and the differences are as follows:

[0064] Weigh 25 g of American ginseng, 70 g of Fritillaria cirrhosa, 400 g of loquat, 55 g of platycodon root, 30 g of bitter apricot kernels, 5 g of menthol, 60 g of sericea lespedeza root, 40 g of geum aleppicum root, 35 g of dioscorea nipponica, 20 g of picrorhiza scrophulariiflora, 30 g of adenophora stricta, 30 g of polygonatum sibiricum, and 15 g of bletilla striata.

[0065] Example 3

[0066] This example is basically the same as Example 1, and the differences are as follows:

[0067] Weigh 20 g of American ginseng, 65 g of Fritillaria cirrhosa, 350 g of loquat, 50 g of Platycodon grandiflorum, 28 g of bitter apricot kernels, 3 g of menthol, 58 g of Caragana sinica, 38 g of Geum aleppicum, 30 g of Dioscorea nipponica, 18 g of Picrorhiza scrophulariiflora, 25 g of Adenophora stricta, 25 g of Polygonatum sibiricum, and 13 g of Bletilla striata.

[0068] Comparative Example 1

[0069] This comparative example is basically the same as Example 1, and the difference lies in:

[0070] Weigh 15 g of American ginseng, 60 g of Fritillaria cirrhosa, 300 g of loquat, 45 g of Platycodon grandiflorum, 25 g of bitter apricot kernels, 1 g of menthol, 35 g of Geum aleppicum, 25 g of Dioscorea nipponica, 15 g of Picrorhiza scrophulariiflora, 20 g of Adenophora stricta, 20 g of Polygonatum sibiricum, and 10 g of Bletilla striata; and correspondingly adjust Step S05.

[0071] Comparative Example 2

[0072] This comparative example is basically the same as Example 1, and the difference lies in:

[0073] Weigh 15 g of American ginseng, 60 g of Fritillaria cirrhosa, 300 g of loquat, 45 g of Platycodon grandiflorum, 25 g of bitter apricot kernels, 1 g of menthol, 55 g of Caragana sinica, 25 g of Dioscorea nipponica, 15 g of Picrorhiza scrophulariiflora, 20 g of Adenophora stricta, 20 g of Polygonatum sibiricum, and 10 g of Bletilla striata; and correspondingly adjust Step S05.

[0074] Comparative Example 3

[0075] This comparative example is basically the same as Example 1, and the difference lies in:

[0076] Weigh 15 g of American ginseng, 60 g of Fritillaria cirrhosa, 300 g of loquat, 45 g of Platycodon grandiflorum, 25 g of bitter apricot kernels, 1 g of menthol, 25 g of Dioscorea nipponica, 15 g of Picrorhiza scrophulariiflora, 20 g of Adenophora stricta, 20 g of Polygonatum sibiricum, and 10 g of Bletilla striata; and correspondingly adjust Step S05.

[0077] Comparative Example 4

[0078] This comparative example is basically the same as Example 1, and the difference lies in:

[0079] Weigh 15 g of American ginseng, 60 g of Fritillaria cirrhosa, 300 g of loquat, 45 g of Platycodon grandiflorum, 25 g of bitter apricot kernels, 1 g of menthol, 55 g of Caragana sinica, 35 g of Geum aleppicum, 15 g of Picrorhiza scrophulariiflora, 20 g of Adenophora stricta, 20 g of Polygonatum sibiricum, and 10 g of Bletilla striata; and correspondingly adjust Step S05.

[0080] Comparative Example 5

[0081] This comparative example is basically the same as Example 1, and the difference lies in:

[0082] Weigh 15 g of American ginseng, 60 g of Fritillaria cirrhosa, 300 g of loquat, 45 g of Platycodon grandiflorum, 25 g of bitter apricot kernels, 1 g of menthol, 35 g of Geum aleppicum Jacq. root, 15 g of Picrorhiza scrophulariiflora Pennell, 20 g of Adenophora stricta, 20 g of Polygonatum sibiricum, and 10 g of Bletilla striata; and correspondingly adjust step S05.

[0083] Comparative Example 6

[0084] This comparative example is basically the same as Example 1, and the difference lies in:

[0085] Weigh 15 g of American ginseng, 60 g of Fritillaria cirrhosa, 300 g of loquat, 45 g of Platycodon grandiflorum, 25 g of bitter apricot kernels, 1 g of menthol, 55 g of Caragana rosea Turcz. root, 15 g of Picrorhiza scrophulariiflora Pennell, 20 g of Adenophora stricta, 20 g of Polygonatum sibiricum, and 10 g of Bletilla striata; and correspondingly adjust step S05.

[0086] Test Example 1

[0087] 1. Materials

[0088] 1.1 Test substances: The traditional Chinese medicine oral liquids obtained in Examples 1-3 and Comparative Examples 1-6. The recommended daily oral dose of the traditional Chinese medicine oral liquid for humans is 50 ml per day. Calculated based on an adult body weight of 60 kg, the recommended dose is 50 ml / 60 kg, that is, 0.8333 ml / kgBW. Dilute with pure water to the required concentration for each dose group.

[0089] 1.2 Dose design: Set a dose group of 8.3 ml / kgBW and a pure water control group.

[0090] 1.3 Sample preparation method: Measure 33.3 of the sample according to the designed dose every day, and make up the volume to 80 ml with pure water respectively.

[0091] 1.4 Animals: SPF-grade SD healthy white

[0092] rats provided by the Experimental Animal Center of Southern Medical University, with a body weight of 170.73 ± 12.29 g. The pellet feed is also provided by the Experimental Animal Center of Southern Medical University.

[0093] 1.5 Animal laboratory conditions: The animal laboratory is of SPF grade, with a room temperature of 22 ± 2 °C and a humidity of 60-80%.

[0094] 1.6 Materials: Vernier caliper (precision 0.02 mm), micro syringe (50 uL).

[0095] 1.7 Route of administration of the test substance: Each dose group is given the test substance by gavage once a day at a dose of 2.0 ml / 100 gBW, and the pure water control group is given pure water by gavage with the same volume.

[0096] 2. Methods

[0097] 2.1 Experimental Method

[0098] Rat plantar swelling experiment: The test groups were given the corresponding doses of the test samples, and the blank control group was given pure water. For 30 consecutive days, the test samples were given once again on the day when the experiment ended. One hour later, 0.1 ml of 1% carrageenan was injected subcutaneously into the right hind plantar of each rat. The thickness of the plantar of each rat was measured before and 1, 3, and 6 hours after inflammation induction. The same site was measured three times and the average value was taken. The differences in the plantar thickness of each test group and the blank control group at different time points were compared respectively.

[0099] 2.2 Statistics: All data were statistically analyzed by one-way ANOVA using the SPSS 11.0 software package.

[0100] 3 Test Results

[0101] 3.1 Effects of Examples 1-3 and Comparative Examples 1-6 on the body weight of rats: As can be seen from Table 1, there were no significant differences in the initial weight, middle weight, and final weight indexes of the test groups compared with the pure water control group, indicating that the traditional Chinese medicine oral liquids prepared in both the examples and the comparative examples had no obvious effect on the body weight of rats.

[0102] Table 1 Effects of Traditional Chinese Medicine Oral Liquid on the Body Weight of Rats

[0103] Group Number of animals Initial weight (g) Mid-weight (g) Final weight (g) Control group 12 animals 169.18±7.54 293.13±11.17 336.71±14.77 Example 1 - Dose group 12 animals 173.43±16.15 289.27±21.29 326.47±12.71 Example 2 - Dose group 12 animals 169.71±14.37 285.64±16.43 329.75±11.52 Example 3 - Dose group 12 animals 170.69±10.39 279.05±21.11 323.07±16.35 Comparative Example 1 - Dose group 12 animals 169.13±11.24 278.12±16.51 326.17±17.31 Comparative Example 2 - Dose group 12 animals 168.21±8.63 288.32±13.78 332.54±15.89 Comparative Example 3 - Dose group 12 animals 172.54±17.23 284.98±20.34 324.12±14.67 Comparative Example 4 - Dose group 12 animals 168.97±15.48 281.25±17.65 327.89±12.43 Comparative Example 5 - Dose group 12 animals 171.02±11.45 276.89±22.31 321.56±17.28 Comparative Example 6 - Dose group 12 animals 167.89±12.36 277.45±18.76 324.78±18.12 F value 0.270 1.280 1.780 P value ＞0.05 ＞0.05 ＞0.05

[0104] As can be seen from Table 2, when comparing the test groups of Examples 1-3 with the pure water control group, the differences in the plantar thickness of rats before and after stimulation at each time point decreased. Among them, the difference in the plantar thickness of rats before and after stimulation at the 6-hour time point decreased significantly, indicating that the traditional Chinese medicine oral liquids prepared in Examples 1-3 of the present invention had a significant anti-inflammatory effect, and the difference was significant (P<0.05). At this time point, the difference between the medium-dose group and the pure water control group was very significant (P<0.01), and the test result was positive. In addition, from Examples 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3, it can be seen that the roots of Lespedeza formosa (Vog.) Koehne and Geum aleppicum Jacq. have a synergistic effect in anti-inflammatory; from Examples 1, Comparative Example 1, Comparative Example 4, and Comparative Example 5, it can be seen that the roots of Lespedeza formosa (Vog.) Koehne and Dioscorea nipponica Makino have a synergistic effect in anti-inflammatory; from Examples 1, Comparative Example 2, Comparative Example 4, and Comparative Example 6, it can be seen that the roots of Geum aleppicum Jacq. and Dioscorea nipponica Makino have a synergistic effect in anti-inflammatory.

[0105] Table 2 Effects of Traditional Chinese Medicine Oral Liquid on the Plantar Thickness of Rats

[0106]

[0107] Test Example 2

[0108] 1 Test Subjects: Subjects with chronic pharyngitis aged 18-65 years were selected.

[0109] 1.1、Subject inclusion criteria:

[0110] 1.1.1、Medical history: In the population with chronic pharyngitis, the main symptoms include sore throat, itchy throat, dry throat, dry cough, foreign body sensation, aggravated by excessive talking, etc.

[0111] 1.1.2、Examination: Pharyngeal mucosa edema, mucosal congestion, hyperplasia of lymphoid follicles on the posterior pharyngeal wall, and secretion attachment. Those with the above symptoms and at least one of the examination findings can be included in the observation.

[0112] 1.2、Exclusion criteria:

[0113] 1.2.1、During the acute attack period of chronic pharyngitis, or caused by acute pharyngitis, cold, or smoking factors.

[0114] 1.2.2、Confirmed by examination to be caused by lesions in the nasopharynx, pharynx, nose, larynx, esophagus, neck, etc.

[0115] 1.2.3、Those under 18 years old or over 65 years old, pregnant or lactating women, and those allergic to this product.

[0116] 1.2.4、Those with serious diseases in the cardiovascular, liver, kidney, and hematopoietic systems, etc., and psychiatric patients.

[0117] 1.2.5、Those who have taken items related to the tested function in the short term, have not taken the tested substance as prescribed, cannot judge the efficacy, or have incomplete data, etc., which affect the judgment of efficacy or safety.

[0118] 1.3、Administration method: The test food group takes it 2 times a day, 25 ml each time.

[0119] 1.4、Instruments and reagents: MEK-6318K type blood cell counter (produced in Japan), urine ten-item analyzer (produced by German Baurmann Company), RA1000 fully automatic biochemical analyzer (produced in the United States), and all biochemical reagent kits are provided by Zhong Sheng Company.

[0120] 2、Observation indicators

[0121] Each indicator is tested once at the beginning and end of the experiment.

[0122] 2.1、Safety indicators:

[0123] 2.1.1、General conditions: Spirit, sleep, diet, defecation and urination, heart rate, blood pressure, etc.

[0124] 2.1.2、Routine blood, urine, and stool examinations: Red blood cell count, hemoglobin, white blood cell count and classification; routine urine and stool examinations.

[0125] 2.1.3, Determination of biochemical indicators: blood lipids (total cholesterol TC, triglyceride TG), total serum protein TP, albumin AB, liver function (aspartate aminotransferase AST, alanine aminotransferase ALT, urea UREA, creatinine CR, blood glucose GLU).

[0126] 2.1.4, Abdominal B-ultrasound, electrocardiogram, chest X-ray fluoroscopy.

[0127] 2.1.5, Observation of adverse reactions.

[0128] 2.2, Efficacy indicators:

[0129] 2.2.1, Symptom observation: Ask about the medical history in detail and observe the main symptoms: sore throat, itchy throat, dry cough, dryness in the throat, etc. Count the integral values before and after drinking according to the severity of the symptoms (severe 3 points, moderate 2 points, mild 1 point), and the symptom improvement rate.

[0130] 2.2.2, Pharyngeal examination: Observe the signs such as pharyngeal congestion, follicular hyperplasia on the posterior pharyngeal wall, mucosal edema, and secretions. Classify them as grade 1, 2, and 3 according to mild, moderate, and severe, and check the changes in signs and their improvement rates before and after taking the medicine.

[0131] 3, Data processing and result determination:

[0132] 3.1, Data processing: Use the statistical software STATE6.0 to calculate and analyze the data. For self-control data, paired t-tests are used. For comparing the means of two groups, independent t-tests are used. The latter requires a homogeneity of variance test. For data that is not normally distributed or has unequal variances, appropriate variable transformations are performed. After meeting the requirements of normal distribution and homogeneity of variance, t-tests are performed using the transformed data; if the transformed data (CV>50%) does not meet the requirements of normal distribution and homogeneity of variance, t' tests or rank sum tests are used instead; however, for data with too large a coefficient of variation such as (CV>50%), rank sum tests are applied. Efficacy indicators are tested using the X2 test.

[0133] 4, Results

[0134] 4.1, General information:

[0135] Table 3 Comparison of general conditions before observation (X±SD)

[0136] Grouping Number of cases Age (years) Gender (male) Gender (female) Disease duration (years) Symptom score Example 1 50 44.74±12.48 8 42 7.28±6.78 6.64±2.27 Comparative Example 1 50 46.34±11.76 7 43 43.89±13.21 7.34±2.41 Comparative Example 2 50 43.89±13.21 11 39 44.12±12.09 6.45±2.28 Comparative Example 3 50 44.12±12.09 10 40 45.78±11.56 6.78±2.36

[0137] Table 4 Comparison of heart rates before and after the trial food intake Unit (times / min)

[0138] Grouping Number of cases Before the trial diet After the trial diet Example 1 50 68.12±6.09 68.94±6.77 Comparative Example 1 50 64.23±5.94 65.09±6.31 Comparative Example 2 50 69.12±6.09 69.98±6.47 Comparative Example 3 50 66.78±5.81 67.54±6.19

[0139] Table 5 Changes in blood pressure before and after the trial food intake Unit (mmHg)

[0140]

[0141]

[0142] Table 6 Improvement of Main Symptoms of the Traditional Chinese Medicine Oral Liquid Prepared in Example 1

[0143] Symptoms Number of cases Effective Ineffective Improvement rate (%) Sore throat 33 24 9 72.73 Itchy throat 43 26 17 60.47 Dry cough 43 26 17 60.47 Dryness in the throat 46 30 16 65.22 Pharyngeal congestion 50 31 19 62.00 Follicular hyperplasia on the posterior pharyngeal wall 32 13 19 40.63 Mucosal edema 48 26 22 54.17 Secretions 24 15 9 62.15

[0144] Table 7 Improvement of Main Symptoms of the Traditional Chinese Medicine Oral Liquid Prepared in Comparative Example 1

[0145] Symptoms Number of cases Effective Ineffective Improvement rate (%) Sore throat 34 21 1235 61.76 9 Itchy throat 45 24 2218 53.33 17 Dry cough 41 21 20 51.22 Dryness in the throat 48 28 20 58.33 Pharyngeal congestion 52 27 25 51.92 Follicular hyperplasia on the posterior pharyngeal wall 30 11 19 36.67 Mucosal edema 49 25 24 51.02 Secretions 26 13 13 50.00

[0146] Table 8 Improvement of Main Symptoms of the Traditional Chinese Medicine Oral Liquid Prepared in Comparative Example 2

[0147]

[0148]

[0149] Table 9 Improvement of Main Symptoms of the Traditional Chinese Medicine Oral Liquid Prepared in Comparative Example 3

[0150] Symptoms Number of cases Effective Ineffective Improvement rate (%) Sore throat 35 20 125 57.14 9 Itchy throat 42 20 228 47.62 17 Dry cough 40 20 20 50.00 Dryness in the throat 47 27 20 57.45 Pharyngeal congestion 51 27 24 52.94 Follicular hyperplasia on the posterior pharyngeal wall 31 11 20 35.48 Mucosal edema 42 21 21 50.00 Secretions 24 11 13 45.83

[0151] Table 10 Improvement of Main Symptoms of the Blank Group

[0152] Symptoms Number of cases Effective Ineffective Improvement rate (%) Sore throat 36 15 25 21 41.67 9 Itchy throat 41 14 28 27 34.14 17 Dry cough 39 16 23 41.03 Dryness in the throat 45 19 26 42.22 Pharyngeal congestion 50 21 29 42.00 Follicular hyperplasia on the posterior pharyngeal wall 34 10 24 29.41 Mucosal edema 46 19 27 41.30 Secretions 27 10 17 37.04

[0153] As can be seen from Table 4 and Table 5, the traditional Chinese medicine oral liquid prepared in the examples of the present application has basically no effect on the personnel before and after the trial diet, and their heart rates and blood pressures remain normal, indicating no obvious side effects.

[0154] As can be seen from Table 6 and Table 10, the traditional Chinese medicine oral liquid prepared in the examples of the present application has an obvious improvement effect on the symptoms such as sore throat, itchy throat, dry throat, pharyngeal congestion, follicular hyperplasia on the posterior pharyngeal wall, mucosal edema, and secretions in the chronic pharyngitis trial eaters.

[0155] As can be seen from Table 6, Table 7, Table 8, and Table 9, the base roots and roots of Geum aleppicum in the examples of the present application have slight or significant synergistic effects in treating symptoms such as sore throat, itchy throat, dry throat, pharyngeal congestion, follicular hyperplasia on the posterior pharyngeal wall, mucosal edema, and secretions in the chronic pharyngitis trial eaters.

[0156] Although the embodiments of the present invention have been described in detail above, it is obvious to those skilled in the art that various modifications and changes can be made to these embodiments. However, it should be understood that such modifications and changes are all within the scope and spirit of the present invention described in the claims. Moreover, the present invention described herein can have other embodiments and can be implemented or realized in various ways.

Claims

1. A traditional Chinese medicine composition for clearing the lungs and dissipating nodules and moistening the throat and larynx, characterized in that, By mass percentage, it includes: 15 - 25 parts of American ginseng, 60 - 70 parts of Fritillaria cirrhosa, 300 - 400 parts of loquat, 45 - 55 parts of Platycodon grandiflorum, 25 - 30 parts of bitter apricot kernels, 1 - 5 parts of menthol, 55 - 60 parts of Caragana sinica, 35 - 40 parts of Geum aleppicum, 25 - 35 parts of Dioscorea nipponica, 15 - 20 parts of Picrorhiza scrophulariiflora, 20 - 30 parts of Adenophora stricta, 20 - 30 parts of Polygonatum sibiricum, 10 - 15 parts of Bletilla striata.

2. The traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx according to claim 1, characterized in that, By mass percentage, it includes: 15 parts of American ginseng, 60 parts of Fritillaria cirrhosa, 300 parts of loquat, 45 parts of Platycodon grandiflorum, 25 parts of bitter apricot kernels, 1 part of menthol, 55 parts of Caragana sinica, 35 parts of Geum aleppicum, 25 parts of Dioscorea nipponica, 15 parts of Picrorhiza scrophulariiflora, 20 parts of Adenophora stricta, 20 parts of Polygonatum sibiricum, 10 parts of Bletilla striata.

3. The traditional Chinese medicine composition for clearing the lungs and dissipating nodules and moistening the throat and larynx according to claim 1, characterized in that By mass percentage, it includes: 25 parts of American ginseng, 70 parts of Fritillaria cirrhosa, 400 parts of loquat, 55 parts of Platycodon grandiflorum, 30 parts of bitter apricot kernels, 5 parts of menthol, 60 parts of Caragana sinica, 40 parts of Geum aleppicum, 35 parts of Dioscorea nipponica, 20 parts of Picrorhiza scrophulariiflora, 30 parts of Adenophora stricta, 30 parts of Polygonatum sibiricum, 15 parts of Bletilla striata.

4. The traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx according to claim 1, wherein By mass percentage, it includes: 20 parts of American ginseng, 65 parts of Fritillaria cirrhosa, 350 parts of loquat, 50 parts of Platycodon grandiflorum, 28 parts of bitter apricot kernels, 3 parts of menthol, 58 parts of Caragana sinica, 38 parts of Geum aleppicum, 30 parts of Dioscorea nipponica, 18 parts of Picrorhiza scrophulariiflora, 25 parts of Adenophora stricta, 25 parts of Polygonatum sibiricum, 13 parts of Bletilla striata.

5. A preparation method of a traditional Chinese medicine composition for clearing the lungs and dissipating nodules and moistening the throat and larynx, which is used to prepare the traditional Chinese medicine composition for clearing the lungs and dissipating nodules and moistening the throat and larynx according to any one of claims 1-4, characterized in that, The preparation method includes: Step S1: Weigh according to the ratio of each component of the selected traditional Chinese medicine composition to obtain the weight of each component. Step S2: Wash the weighed American ginseng, Fritillaria cirrhosa and menthol, then place them in an extraction tank, and then inject 20 times the amount of 50% ethanol into the extraction tank for reflux extraction for two hours to obtain the first extraction solution. Repeat this extraction process two more times, and then combine the first extraction solutions of the three times to obtain the ethanol extraction solution. Step S3: Filter and concentrate the ethanol extraction solution under reduced pressure to obtain the first concentrated solution. Step S4: Distill the weighed bitter apricot kernels in a distiller to obtain the distillate. Step S5: Place the weighed Platycodon grandiflorum, Caragana sinica, Geum aleppicum, Dioscorea nipponica, Picrorhiza scrophulariiflora, Adenophora stricta, Polygonatum sibiricum, Bletilla striata in an extraction tank, add the medicinal residues of American ginseng, Fritillaria cirrhosa and bitter apricot kernels, and boil to flow out the second extraction solution. Repeat this boiling process two more times, and then combine the second extraction solutions of the three times to obtain the first combined solution. Step S6: Boil, peel, pulp, filter and concentrate the loquat fruits without kernels under reduced pressure to obtain the second concentrated solution. Step S7: Combine the first concentrated solution, the distillate, the first combined solution and the second concentrated solution, add glucose and honey, and stir well to obtain the mixed solution. Step S8: Filter, make up the volume, fill, sterilize, lamp inspection and package the mixed solution to obtain the traditional Chinese medicine oral liquid.

6. The preparation method of the traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx according to claim 5, characterized in that, Step S5 includes: Add 8 - 10 times the amount of pure water to the extraction tank before boiling, and boil and extract 3 times, with each boiling time being 1 - 2 hours.

7. The preparation method of the traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx according to claim 5, characterized in that, Step S3 includes: Filter the ethanol extraction solution through a stainless steel filter screen with 130 meshes to obtain the filtrate. Under the conditions of a vacuum degree of -0.05 MPa and a temperature of 65 °C, the filtrate is used to recover ethanol and concentrate the medicinal liquid until the relative density reaches 1.12, obtaining the first concentrated liquid.

8. The preparation method of the traditional Chinese medicine composition for clearing the lungs and dissipating nodules and clearing the throat and moistening the larynx according to claim 5, characterized in that, Step S6 includes: The pitted loquat fruits are blanched in hot water at 100 °C for 10 minutes until the pulp becomes soft, then peeled after being taken out, added with 2 times the amount of purified water, beaten twice with a pulper, and then the original loquat pulp is extracted with a press. After being filtered through a 130-mesh sieve, the loquat pulp is placed in a vacuum concentration tank and concentrated to a relative density of 1.15 at a vacuum degree of -0.05 MPa and a temperature of 70 °C, obtaining the second concentrated liquid.

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