A traditional Chinese medicine composition for detoxification and soothing throat, preparation and application thereof

Abstract

The application provides a traditional Chinese medicine composition for relieving toxicity and soothing throat, a preparation and application thereof, and relates to the technical field of medicines.The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of isatis root, 15-25 parts of dandelion and 5-15 parts of momordica grosvenori.The preparation steps are as follows: 1) isatis root, dandelion and momordica grosvenori are decocted with water, filtered to obtain a filtrate;2) the filtrate is concentrated, auxiliary materials are added, and drying is performed to obtain the traditional Chinese medicine composition.The traditional Chinese medicine composition has the characteristics of simple prescription, controllable quality, small dosage and better effect, and is used for treating throat swelling and pain, oral cavity dryness, parotid swelling, acute tonsillitis or parotitis.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medicine, and particularly relates to a traditional Chinese medicine composition for detoxification and soothing throat, a preparation and application thereof. BACKGROUND

[0002] The common treatment methods for inflammation and virus at home and abroad are using antibiotics and antiviral drugs, but antibiotics and antiviral drugs have many disadvantages such as many adverse reactions, great toxic and side effects, and easy drug resistance, and therefore more and more scholars have found that the treatment of inflammation and virus by using traditional Chinese medicine has certain advantages.

[0003] Chinese patent application CN103599249A discloses a traditional Chinese medicine composition for treating pharyngolaryngitis, which is composed of white medicine fruit, Chinese foxglove, grinding disc grass, green vitriol, yellow bamboo, platycodon root, chondrus, winter-plantain herb, black grass, goldfruit magnolia, fat sea, sweetleaf chrysanthemum, monk fruit, butterflybush, forsythia, angelica, bupleurum, honeysuckle, dandelion, isatis root, and licorice, and has the advantages of quick effect, good curative effect, no toxic and side effects, convenient taking, low price, and the like, but the traditional Chinese medicine composition has a complex composition, quality is difficult to control, and a large dose is taken.

[0004] Chinese patent CN102357124B discloses a traditional Chinese medicine composition for detumescence and anti-inflammation and a preparation method thereof, and components and weight fractions of the traditional Chinese medicine composition are as follows: 1.5 parts of radix scutellariae, 4 parts of dandelion, 1 part of bitter ground ivy, and 1.5 parts of isatis root, and the traditional Chinese medicine composition can be used for preparing a medicine with the effects of heat-clearing and detoxification, anti-inflammation, or detumescence, and especially can be used for preparing a medicine for treating parotitis, pharyngitis, tonsillitis, or furuncle, and the like. However, the prescription and extraction process need to be further optimized to improve the effect.

[0005] It is urgent to provide a traditional Chinese medicine composition with the effects of detoxification and soothing throat, which has a simple prescription, controllable quality, small dose, and better effect. SUMMARY

[0006] The present application provides a traditional Chinese medicine composition for detoxification and soothing throat, a preparation and application thereof, which is composed of isatis root, dandelion, and monk fruit, has the characteristics of simple prescription, controllable quality, small dose, and better effect, and is used for treating pharyngolaryngitis, oral and pharyngeal dryness, parotid swelling, acute tonsillitis, or parotitis.

[0007] To achieve the above object, the technical scheme adopted by the present application is as follows.

[0008] The first aspect of the present application is to provide a traditional Chinese medicine composition for detoxifying and soothing throat, which comprises the following traditional Chinese medicine raw materials by weight: 15-25 parts of Banlangen, 15-25 parts of Pugongying and 5-15 parts of Luohan-guo.

[0009] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: 20-25 parts of Banlangen, 20-25 parts of Pugongying and 5-10 parts of Luohan-guo.

[0010] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: 20 parts of Banlangen, 20 parts of Pugongying and 10 parts of Luohan-guo.

[0011] Preferably, the traditional Chinese medicine composition comprises the following preparation steps:

[0012] 1) traditional Chinese medicine raw materials are decocted with water, filtered to obtain a filtrate;

[0013] 2) the filtrate is concentrated, auxiliary materials are added and dried to obtain the product.

[0014] Further preferably, the water added in step 1) is 10-14 times the amount of the traditional Chinese medicine raw materials, and the decoction is performed 1-2 times, each time for 0.5-1.5 h.

[0015] Further preferably, the filtrate is concentrated to a relative density of 1.05-1.10 at 60°C in step 2).

[0016] The second aspect of the present application is to provide a preparation comprising the above-mentioned traditional Chinese medicine composition, which further comprises pharmaceutically acceptable auxiliary materials.

[0017] Preferably, the dosage form of the preparation comprises tablets, capsules, granules, pastes, suppositories, pills, oral liquids, injections, decoctions or suspensions, preferably granules.

[0018] Preferably, the auxiliary materials are selected from at least one of dextrin, maltodextrin, soluble starch and lactose.

[0019] The third aspect of the present application relates to the use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating throat swelling and pain, dryness of the oropharynx, swelling of the parotid gland, acute tonsillitis or parotitis.

[0020] Compared with the prior art, the present application has the following beneficial effects: (1) the medicinal ingredients of the present application are simple, and the indications are clear; the isatis root has the effects of clearing heat and detoxifying, cooling blood and benefiting the throat, and thus is the monarch; the dandelion has the effects of clearing heat and detoxifying, and resolving swelling and removing obstruction, and thus is the minister; the monk fruit has the effects of clearing heat, moistening the lung, benefiting the throat and opening the voice, and moistening the intestines and promoting defecation, and thus is the auxiliary; the three medicinal ingredients are used together, and have the effects of clearing heat and detoxifying, and cooling blood and benefiting the throat; (2) the preparation process of the traditional Chinese medicine composition of the present application is simple, and the medicinal ingredients are less, the dosage is smaller, and the anti-inflammatory effect is better compared with the medicine in CN102357124B. DETAILED DESCRIPTION

[0021] It should be noted that the raw materials used in the present application are all ordinary commercially available products, and their sources are not specifically limited.

[0022] Example 1

[0023] The traditional Chinese medicine raw materials are composed of isatis root 20 parts, dandelion 20 parts, and monk fruit 10 parts by weight.

[0024] Preparation steps:

[0025] The traditional Chinese medicine raw materials in the prescription are weighed, and boiled twice with water; the first time is boiled for 1.0 hour with 14 times the amount of water, and the second time is boiled for 1.0 hour with 11 times the amount of water; the decoction is filtered, the filtrates are combined, and concentrated under reduced pressure to a clear extract with a relative density of 1.05 (60℃); dried, and mixed with an appropriate amount of dextrin to form granules.

[0026] Example 2

[0027] The traditional Chinese medicine raw materials are composed of isatis root 20 parts, dandelion 25 parts, and monk fruit 5 parts by weight.

[0028] The preparation steps are the same as in Example 1.

[0029] Example 3

[0030] The traditional Chinese medicine raw materials are composed of isatis root 25 parts, dandelion 20 parts, and monk fruit 10 parts by weight.

[0031] The preparation steps are the same as in Example 1.

[0032] Example 4

[0033] The traditional Chinese medicine raw materials are composed of isatis root 15 parts, dandelion 25 parts, and monk fruit 5 parts by weight.

[0034] The preparation steps are the same as in Example 1.

[0035] Example 5

[0036] The traditional Chinese medicine raw materials are composed of isatis root 25 parts, dandelion 15 parts, and monk fruit 15 parts by weight.

[0037] The preparation procedure is the same as that of Example 1.

[0038] Comparative Example 1

[0039] In Example 1, replace Momordica grosvenori Schwinn with Herba Scaphium scaphigerum, i.e., the Chinese medicinal material composition is: Radix Isatidis 20 parts, Herba Taraxaci 20 parts, and Herba Scaphium scaphigerum 10 parts.

[0040] The preparation procedure is the same as that of Example 1.

[0041] Comparative Example 2

[0042] In Example 1, add Herba Scaphium scaphigerum to the raw material components, i.e., the Chinese medicinal material composition is: Radix Isatidis 20 parts, Herba Taraxaci 20 parts, Momordica grosvenori Schwinn 10 parts, and Herba Scaphium scaphigerum 10 parts.

[0043] The preparation procedure is the same as that of Example 1.

[0044] Comparative Example 3

[0045] The Chinese medicinal material composition is: Radix Isatidis 20 parts and Herba Taraxaci 30 parts.

[0046] The preparation procedure is the same as that of Example 1.

[0047] Comparative Example 4

[0048] The Chinese medicinal material composition is: Radix Isatidis 20 parts and Momordica grosvenori Schwinn 30 parts.

[0049] The preparation procedure is the same as that of Example 1.

[0050] Comparative Example 5

[0051] The Chinese medicinal composition is prepared according to the document record content of Chinese invention patent CN102357124B. Specifically:

[0052] The Chinese medicinal material composition is: Radix Scophulariae 1.5 parts, Herba Taraxaci 4 parts, and Radix Isatidis 1.5 parts.

[0053] Preparation procedure:

[0054] (1) Herba Taraxaci 40 g, Radix Isatidis 15 g, and Radix Scophulariae 10 g are added to water and decocted twice, each time for 1 hour, the extract is concentrated to an appropriate amount, ethanol is added to make the alcohol content 65%, and after standing, it is filtered, the ethanol is recovered from the filtrate, and concentrated to obtain the water extract and alcohol precipitate;

[0055] (2) Huangqi medicinal material 15 g is extracted twice with 10 times and 8 times of 60% ethanol respectively, the insoluble substances are removed, and the extract is concentrated to an appropriate amount, an appropriate amount of ethanol is added to reach a crude drug concentration of 15 mg / mL, and then the mixture is subjected to HP-20 macroporous resin with a diameter-height ratio of 1:12, impurities are removed with water first, then 12% ethanol solution, and then eluted with 70% ethanol, the eluent is 7 times the column volume, the elution speed is 2 times the column volume, and the eluent is concentrated to obtain Huangqi purified product;

[0056] (3) The water extraction and alcohol precipitation product and the Huangqi purified product are mixed to obtain the product.

[0057] Experimental Example 1 Anti-inflammatory and analgesic effects

[0058] Group administration

[0059] 110 Kunming mice, half male and half female, weighing 18-22 g, were randomly divided into 11 groups according to gender and weight, namely, Example 1-5 groups, Comparative Example 1-5 groups, and a blank control group, 10 mice in each group. The mice in Example 1-5 groups and Comparative Example 1-5 groups were administered with corresponding drugs at an equal volume (0.4 mL / mouse) by gavage, once a day for 3 days, and the dose was 7 g of crude drug per kg. The mice in the blank control group were administered with an equal volume of normal saline by gavage.

[0060] Method

[0061] 1. Anti-inflammatory effect

[0062] 5 mice in each group were taken, 0.5 h after the last administration, xylene was applied to the right ear of the mice, 50 μL / mouse, to cause ear swelling model, and the left ear was used as a control. 0.5 h after modeling, the mice were sacrificed by cervical dislocation, and the two ears were cut along the ear base line, and circular ear pieces were punched out at the same position of the left and right ears with a 7 mm diameter puncher, and weighed. The swelling degree and swelling inhibition rate were calculated according to the following formula:

[0063] Swelling degree = (right ear piece weight - left ear piece weight);

[0064] Swelling inhibition rate = (average swelling degree of the blank control group - average swelling degree of the administration group) / average swelling degree of the blank control group x 100%.

[0065] 2. Analgesic effect

[0066] 5 mice in each group were taken, 0.5 h after the last administration, 0.6% acetic acid 200 μL / mouse was injected intraperitoneally, and the number of writhing times of the mice within 15 min was observed and recorded to calculate the inhibition rate.

[0067] Results

[0068] 1. Anti-inflammatory effect

[0069] The results are shown in Table 1.

[0070] Table 1 Anti-inflammatory effect results

[0071] Group Swelling (mg) Swelling inhibition rate (%) Blank control group 14.67±3.69 - Example 1 group 7.52 ± 1.64 ** ]] 48.6 Example 2 group 8.10 ± 1.75 ** ]] 44.8 Example 3 group 8.04 ± 1.82 ** ]] 45.2 Example 4 group 8.31 ± 1.78 ** ]] 43.4 Example 5 group 8.42 ± 1.56 ** ]] 42.6 Comparative example 1 group 9.46 ± 2.31 * ]] 35.5 Comparative example 2 group 8.69 ± 2.88 ** ]] 40.8 Comparative example 3 group 10.16 ± 3.12 * ]] 30.7 Comparative example 4 group 10.98 ± 2.93 * ]] 25.1 Comparative example 5 group 8.52 ± 2.38 ** ]] 41.9

[0072] Note: compared with the blank control group, * P<0.05, ** P<0.01.

[0073] As shown in Table 1, the drug groups of the present application all have obvious anti-inflammatory effects, and have significant differences compared with the blank control group.

[0074] 2. Analgesic effect

[0075] The results are shown in Table 2.

[0076] Table 2 Effect on acetic acid-induced pain in mice (twisting method)

[0077] Group Number of writhing Inhibition rate (%) Blank control group 31.9±7.9 - Example 1 group 16.1 ± 4.1 ** ]] 49.5 Example 2 group 17.0 ± 4.8 ** ]] 46.7 Example 3 group 16.6 ± 4.7 ** ]] 48.0 Example 4 group 18.1 ± 5.0 ** ]] 43.2 Example 5 group 18.3 ± 5.2 ** ]] 42.6 Comparative example 1 group 21.4 ± 6.4 * ]] 32.9 Comparative example 2 group 20.8 ± 6.5 * ]] 34.7 Comparative example 3 group 26.1 ± 7.2 # ]] 18.2 Comparative example 4 group 28.2 ± 9.6 # ]] 11.6 Comparative example 5 group 23.6 ± 6.7 * ]] 26.1

[0078] Note: compared with the blank control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0079] As shown in Table 2, the drug groups of the present application all have obvious analgesic effects, and have significant differences compared with the blank control group; compared with the Example 1 group, the analgesic effects of Comparative Example 3 group and Comparative Example 4 group are not as good as that of the Example 1 group, and the difference is statistically significant.

[0080] Experimental Example 2 Clinical test

[0081] Basic situation

[0082] 60 patients with acute tonsillitis were randomly divided into two groups. The control group included 14 male and 16 female patients aged 12-20 years old; the research group included 15 male and 15 female patients aged 13-19 years old. The baseline data of the two groups were not statistically different (P>0.05).

[0083] Method

[0084] The control group orally took amoxicillin clavulanate potassium tablets (Lu'nan Bet Pharmaceutical Co., Ltd., State Drug Code H20053424) and the oral liquid prepared from Comparative Example 5, 10 ml each time, three times a day; the research group orally took amoxicillin clavulanate potassium tablets (Lu'nan Bet Pharmaceutical Co., Ltd., State Drug Code H20053424) and the granules prepared from Example 1, 6 g each time, three times a day.

[0085] Observation index

[0086] 1. Clinical efficacy; 2. Fever disappearance time, tonsillar redness disappearance time and sore throat disappearance time of patients.

[0087] Efficacy criteria

[0088] According to the "Diagnosis and Efficacy Criteria of TCM Syndromes", cure: clinical symptoms disappear, tonsils have no hyperemia and edema, no pus or pus points; improvement: clinical symptoms significantly improve, tonsillar redness area, pus or pus points significantly decrease, hyperemia decreases; ineffective: no improvement in clinical symptoms and signs.

[0089] Statistical method

[0090] SPSS19.0 statistical software was used to analyze and process all data.

[0091] Results

[0092] 1) Comparison of clinical efficacy

[0093] The results are shown in Table 3.

[0094] Table 3 Comparison of clinical efficacy results

[0095] Group Number of cases Cured cases Improved cases Ineffective cases Total effective rate (%) Control group 30 16 12 2 93.3 Research group 30 20 10 0 100

[0096] 2) Comparison of clinical symptom disappearance time

[0097] The results are shown in Table 4.

[0098] Table 4 Comparison of clinical symptom disappearance time results

[0099] Group Number of cases Time for disappearance of sore throat (d) Time for disappearance of fever (d) Time for disappearance of tonsillar redness and swelling (d) Research group 30 2.26±0.55 2.11±0.27 2.59±0.36 Control group 30 3.03 ± 1.12 * ]] 2.08±0.45 3.38 ± 0.67 * ]]

[0100] Note: compared with the research group, *P<0.05.

[0101] The present application can significantly shorten the sore throat disappearance time and tonsillar redness disappearance time of patients with tonsillitis (P<0.05).

[0102] Finally, it should be noted that the above content is only used to explain the technical solutions of the present application, and is not a limitation on the protection scope of the present application. Simple modifications or equivalent replacements of the technical solutions of the present application made by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition for detoxifying and soothing the throat, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials by weight parts: 15-25 parts of Banlangen, 15-25 parts of Pugongying, and 5-15 parts of Luohan-guo.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials by weight parts: 20-25 parts of Banlangen, 20-25 parts of Pugongying, and 5-10 parts of Luohan-guo.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials by weight parts: 20 parts of Banlangen, 20 parts of Pugongying, and 10 parts of Luohan-guo.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition comprises the following preparation steps: 1) traditional Chinese medicine raw materials are decocted with water, filtered to obtain a filtrate; 2) the filtrate is concentrated, auxiliary materials are added, and dried to obtain the traditional Chinese medicine composition.

5. The traditional Chinese medicine composition of claim 4, wherein the traditional Chinese medicine composition is prepared by mixing the traditional Chinese medicine extract and the pharmaceutically acceptable carrier. The water added in the decocting of step 1) is 10-14 times the amount of the traditional Chinese medicine raw materials, the decocting is performed 1-2 times, and each decocting is performed for 0.5-1.5 h.

6. The traditional Chinese medicine composition of claim 4, wherein, The filtrate is concentrated to a relative density of 1.05-1.10 at 60°C in step 2).

7. A preparation comprising the traditional Chinese medicine composition according to any one of claims 1-6, characterized in that, The preparation further comprises pharmaceutically acceptable auxiliary materials.

8. The formulation of claim 7, wherein, The auxiliary materials are selected from at least one of dextrin, soluble starch, and lactose.

9. The formulation of claim 8, wherein, The dextrin is malt dextrin.

10. The formulation of claim 7, wherein The dosage form of the preparation is tablet, capsule, granule, paste, suppository, pill, oral liquid, injection, decoction, or suspension.

11. Use of the traditional Chinese medicine composition according to any one of claims 1-6 or the preparation according to any one of claims 7-10 in the preparation of a drug for treating sore throat, dry mouth, and acute tonsillitis.