Traditional Chinese medicine composition for treating pharyngitis and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating pharyngitis and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions.The preparation method comprises the following steps that 1, hosta plantaginea flowers and tabasheer are extracted with alcohol, and medicine residues 1 and alcohol extract are obtained; (2) performing water extraction on clove, liquorice, radix aucklandiae and fructus chebulae to obtain medicine residues 2 and a water extract; (3) adding water into the medicine residue 1 and the medicine residue 2, mixing and performing enzymolysis to obtain enzymatic hydrolysate; and (4) mixing the alcohol extract, the water extract and the enzymatic hydrolysate, drying, adding borneol, and crushing. Enzymes adopted in the enzymolysis in the step (3) are pectinase, lactase and fig protease; the mass ratio of the pectinase to the lactase to the ficin protease is (0.5-0.8): (0.3-0.5): 1. The traditional Chinese medicine composition can further exert the anti-inflammatory effect of the Mongolian prescription, and experiments prove that compared with the prior art, the traditional Chinese medicine composition has a better treatment effect on acute pharyngitis and also has a treatment effect on chronic pharyngitis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions. Specifically, it relates to a traditional Chinese medicine composition for treating pharyngitis, its preparation method and application. Background Art

[0002] Pharyngolaryngitis is a disease caused by bacteria, which is divided into acute pharyngolaryngitis and chronic pharyngolaryngitis. Among them, acute pharyngitis is a common disease of acute inflammation of the pharyngeal mucosa, often invading the submucosa and lymphoid tissue. Chronic pharyngitis is a chronic inflammation of the pharyngeal mucosa, submucosa and lymphoid tissue, which is relatively common in clinical practice and has the characteristics of long course and easy recurrence of symptoms.

[0003] CN102225168A discloses a Mongolian medicine for treating pharyngolaryngitis, which is made from the following raw materials by weight: 5 - 9 parts of cloves, 2 - 3 parts of shisandra fruit, 8 - 12 parts of licorice, 8 - 12 parts of costus root, 8 - 12 parts of terminalia chebula, 8 - 12 parts of fragrant plantain lily flower, and 0.3 - 0.7 parts of borneol. The medicine of this invention mainly uses fragrant plantain lily flower, terminalia chebula and licorice with the effects of clearing heat and detoxifying, reducing fire and relieving sore throat, relieving cough and resolving phlegm to treat sore throat, regulating microcirculation of the affected area, antibacterial, antiviral and enhancing the body's immunity. It is supplemented with cool medicines such as shisandra fruit and borneol with the effects of clearing heat and resolving phlegm, detumescence and pain relief to enhance its detumescence and pain relief effect. In addition, warm medicines such as cloves and costus root with the effects of warming the middle - energizer, promoting qi and relieving pain are added to neutralize the cold medicines in this formula and eliminate their side effects. In addition, licorice in this formula can also coordinate the properties of various medicines. The prescription of this invention is scientifically formulated and rationally compatible, and has a good therapeutic effect on pharyngolaryngitis.

[0004] In order to further develop the medicinal effect of this Mongolian medicine, CN118021750A discloses a preparation method of a throat - clearing and throat - soothing capsule. The preparation method includes the following steps: (1) crushing shisandra fruit to obtain shisandra fruit powder, mixing and crushing part of the shisandra fruit powder with borneol to obtain powder; (2) mixing cloves and costus root, extracting to obtain volatile oil; (3) mixing licorice and terminalia chebula, decocting with water, filtering, combining the filtrates and concentrating to obtain thick paste A; (4) heating and refluxing to extract fragrant plantain lily flower, filtering, combining the filtrates and concentrating to obtain thick paste B; (5) combining thick paste A and thick paste B, drying, crushing and mixing evenly to obtain extract powder; (6) adding the volatile oil obtained in step (2) to the remaining shisandra fruit powder, mixing evenly, then adding the powder obtained in step (1) and the extract powder obtained in step (5), mixing evenly, and filling into hollow capsules to obtain the product. By optimizing the extraction methods of different medicinal materials, this invention fully extracts the effective components of each medicinal material. Through the synergistic cooperation between the effective components after extraction, it helps to fully exert the therapeutic effect of the capsule, and the effect is particularly remarkable in the treatment of acute pharyngitis.

[0005] How to further develop its medicinal effect and maximize the medicinal value of the above - mentioned Mongolian medicine is of great significance. Summary of the Invention

[0006] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating pharyngitis, its preparation method and application. The traditional Chinese medicine composition is prepared by using water extraction and enzymatic hydrolysis processes. The preparation method is simple and has remarkable effects in the treatment of acute and chronic pharyngitis.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions: In the first aspect, the present invention provides a preparation method of a traditional Chinese medicine composition for treating pharyngitis, comprising the following steps: (1) Extract the hosta flower and concretio silicea bambusae with alcohol, perform solid-liquid separation to obtain residue 1 and alcohol extract; (2) Extract cloves, licorice, costus root and myrobalan with water, perform solid-liquid separation to obtain residue 2 and water extract; (3) Mix residue 1 and residue 2 with water and perform enzymatic hydrolysis, then perform solid-liquid separation to obtain enzymatic hydrolysate; (4) Combine the alcohol extract, water extract and enzymatic hydrolysate, dry them, add borneol and pulverize to obtain the product.

[0008] In some embodiments, the enzymes used in the enzymatic hydrolysis in step (3) are pectinase, lactase and ficin; preferably, the mass ratio of pectinase, lactase and ficin is 0.5-0.8:0.3-0.5:1; more preferably 0.6:0.3-0.5:1; even more preferably 0.6:0.4:1.

[0009] In some embodiments, the amount of water used in step (3) is 5-10 times the total weight of hosta flower, concretio silicea bambusae, cloves, licorice, costus root and myrobalan; preferably 6-8 times; more preferably 7 times.

[0010] In some embodiments, the addition amount of the enzyme in step (3) is 0.05%-1.2% of the mass of water; preferably 0.06%-1.0%; more preferably 0.08%.

[0011] In some embodiments, the conditions of the enzymatic hydrolysis in step (3) are: enzymatic hydrolysis at 25°C - 35°C for 3h - 6h; preferably enzymatic hydrolysis at 28°C - 32°C for 4h - 6h; more preferably enzymatic hydrolysis at 30°C for 4h.

[0012] In some embodiments, the alcohol extraction in step (1) is reflux extraction with ethanol.

[0013] Preferably, the mass fraction of the ethanol is 70%-85%; optionally, the mass fraction of the ethanol is any value among 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85% or the range composed of any two endpoints.

[0014] In some embodiments, the conditions for the extraction in step (1) are as follows: the amount of ethanol (solution) used is 6-12 times the total weight of Hosta plantaginea Aschers. and Concretio Silicea Bambusae, the extraction is carried out 1-3 times, and the time for each extraction is 0.5h-1.5h. Preferably, the extraction is carried out 2 times, and the time for each extraction is 0.5h-1.5h; more preferably, the extraction is carried out 2 times, and the time for each extraction is 1h.

[0015] In some embodiments, the water extraction in step (2) is carried out by decocting with water. Preferably, the conditions for the water extraction are as follows: the amount of water added is 8-15 times the total weight of Flos Caryophylli, Radix Glycyrrhizae, Radix Aucklandiae and Fructus Chebulae, more preferably 11-13 times; even more preferably 12 times; the number of extraction times is 1-3 times, more preferably 2 times, and the time for each extraction is 0.5h-2h, more preferably 1h-2h; even more preferably 1h.

[0016] In some embodiments, the drying in step (4) is carried out until the water content is lower than 10%. Preferably, the drying is spray drying, vacuum drying or freeze drying.

[0017] The traditional Chinese medicine composition described in the present invention, by weight, comprises 160-240 parts of Hosta plantaginea Aschers., 100-180 parts of Flos Caryophylli, 160-240 parts of Radix Glycyrrhizae, 40-60 parts of Concretio Silicea Bambusae, 160-240 parts of Radix Aucklandiae, 160-240 parts of Fructus Chebulae and 6-14 parts of Borneolum Syntheticum.

[0018] Preferably, it is 190-210 parts of Hosta plantaginea Aschers., 133-147 parts of Flos Caryophylli, 190-210 parts of Radix Glycyrrhizae, 47.5-52.5 parts of Concretio Silicea Bambusae, 190-210 parts of Radix Aucklandiae, 190-210 parts of Fructus Chebulae and 9.5-10.5 parts of Borneolum Syntheticum; More preferably, it is 200 parts of Hosta plantaginea Aschers., 140 parts of Flos Caryophylli, 200 parts of Radix Glycyrrhizae, 50 parts of Concretio Silicea Bambusae, 200 parts of Radix Aucklandiae, 200 parts of Fructus Chebulae and 10 parts of Borneolum Syntheticum.

[0019] The solid-liquid separation involved in the present invention is a conventional technical means for separating solid and liquid phases in the art, such as filtration, centrifugation or pressure filtration.

[0020] In the second aspect, the present invention provides the traditional Chinese medicine composition prepared by the above preparation method.

[0021] In the third aspect, the present invention provides the application of the above traditional Chinese medicine composition in the preparation of a drug for treating pharyngitis.

[0022] Preferably, the pharyngitis includes chronic pharyngitis and acute pharyngitis.

[0023] Through the improvement of the preparation method, the traditional Chinese medicine composition of the present invention further exerts the anti-inflammatory effect of the Mongolian prescription, has a good regulatory effect on inflammatory factors, especially interleukin-1β (IL-1β) and interleukin-6 (IL-6).

[0024] Fourthly, the present invention provides an application of the above traditional Chinese medicine composition in the preparation of an IL-1β blocker.

[0025] Fifthly, the present invention also provides a pharmaceutical preparation, which includes the aforementioned traditional Chinese medicine composition.

[0026] In some embodiments, the traditional Chinese medicine composition of the present invention can also be used as a raw material and mixed with pharmaceutically acceptable excipients to prepare corresponding pharmaceutical preparations.

[0027] Preferably, the pharmaceutical preparation is a powder, tablet, capsule, granule, pill or liquid preparation.

[0028] The beneficial effects of the present invention are as follows: (1) The traditional Chinese medicine composition of the present invention is prepared by improving the preparation method. Among them, ethanol extraction is used for Hosta plantaginea and Concretio Silicea Bambusae, water extraction is used for Flos Caryophylli, Glycyrrhiza uralensis Fisch., Aucklandia lappa Decne. and Fructus Chebulae, and the residues after ethanol extraction and water extraction are enzymolyzed. The optimization of processes can effectively extract the active ingredients in each medicinal material. By the synergistic compounding of the active ingredients in the ethanol extract, water extract and enzymolysis solution, the anti-inflammatory effect of the Mongolian prescription can be further exerted, so as to achieve the therapeutic effect on acute and chronic pharyngitis.

[0029] (2) It has been proved by experiments that compared with the prior art, the traditional Chinese medicine composition prepared by the present invention has a better therapeutic effect on acute pharyngitis and also has a therapeutic effect on chronic pharyngitis.

[0030] (3) The preparation method of the traditional Chinese medicine composition of the present invention has a simple process, high production efficiency, less enzyme dosage, low cost, is green and environmentally friendly, and meets the requirements of large-scale production. Detailed implementation manners

[0031] The following specific examples illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0032] Before further describing the specific embodiments of the present invention, it should be understood that the protection scope of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the embodiments of the present invention are for describing specific embodiments and not for limiting the protection scope of the present invention.

[0033] When an embodiment gives a numerical range, it should be understood that unless otherwise specified in the present invention, both endpoints of each numerical range and any value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0034] All numerical values or expressions related to component amounts, process conditions, etc. used in the present invention should be understood to be modified by "about" in all cases. When the term "about" refers to a quantity or a numerical range, it means that the quantity or numerical range indicated is an approximation within the experimental variability (or within the statistical experimental error). In the present invention, the term "about" should have the meaning within 10% of the specified value or range, preferably within 5%.

[0035] The "pharmaceutical preparation" described in the present invention includes a traditional Chinese medicine composition and pharmaceutically acceptable excipients. In specific embodiments, the traditional Chinese medicine composition described in the present invention is provided in the composition in an effective amount (for example, a therapeutically effective amount).

[0036] The "acceptable" components used in the present invention are substances that are suitable for humans and / or animals without excessive adverse side effects (such as toxicity, irritation, and allergic reactions), that is, substances with a reasonable benefit / risk ratio. The "pharmaceutically acceptable excipients" include inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants and / or oils. Excipients (such as cocoa butter and suppository wax), colorants, coating agents, sweeteners and flavoring agents may also be present in the composition.

[0037] The "pharmaceutical preparation" described in the present invention can be prepared by any method known in pharmacy. Generally, these preparation methods include associating the traditional Chinese medicine composition (hereinafter referred to as the active ingredient) with a carrier or excipient and / or one or more other auxiliary components, and then, if necessary and / or desired, shaping and / or packaging the product into a desired single-dose or multi-dose unit.

[0038] The "pharmaceutical preparation" of the present invention can be prepared according to known methods, such as those described in the general rules of preparation in the Chinese Pharmacopoeia 2020 Edition, the 16th Edition of the Japanese Pharmacopoeia, the United States Pharmacopoeia, and the 9th Edition of the European Pharmacopoeia. The specific preparation method depends on the dosage form.

[0039] In the "traditional Chinese medicine preparation" described in the present invention, the active ingredients and pharmaceutically acceptable excipients will vary according to the identity, body size, and / or condition of the subject being treated and further according to the route of administration of the active ingredient. The pharmaceutical composition may contain between 0.1% and 100% (w / w) of the active ingredient.

[0040] As used in the present invention, unless otherwise indicated, the term "treatment" means reversing, alleviating the disease or disorder to which the term applies or one or more symptoms of such a disease or disorder, inhibiting the progression of the disease or disorder or one or more of its symptoms, or preventing the disease or disorder or one or more of its symptoms. The term "treatment" as used in the invention refers to a treatment act as "treatment" was just defined above.

[0041] Unless otherwise specified, the raw materials used are ordinary commercially available products, so their sources are not specifically limited. Unless otherwise specified, all operations are carried out at room temperature, where room temperature is 20 - 25 °C. Unless otherwise specified, all percentages are mass percentages and the solvent is water. Exemplarily, the pectinase, CAS No. 9032 - 75 - 1, enzyme activity 30,000 U / g, the lactase, CAS No. 9031 - 11 - 2, enzyme activity 500 U / mg, the ficin, CAS No. 9001 - 33 - 6, enzyme activity 10 U / g.

[0042] [Traditional Chinese Medicine Composition and Its Preparation Method] Example 1 The traditional Chinese medicine composition is composed of the following raw materials by weight: 200 parts of Hosta plantaginea Aschers, 140 parts of Syzygium aromaticum, 200 parts of Glycyrrhiza uralensis Fisch, 50 parts of Concretio Silicea Bambusae, 200 parts of Aucklandia lappa Decne, 200 parts of Terminalia chebula Retz, and 10 parts of Borneol. The preparation method is as follows: (1) Reflux extract Hosta plantaginea Aschers and Concretio Silicea Bambusae with 80% ethanol solution twice, each time for 1 h, and the amount of ethanol solution used each time is 8 times the total weight of Hosta plantaginea Aschers and Concretio Silicea Bambusae. Filter and combine the filtrates to obtain residue 1 and the ethanol extract. (2) Decoct Syzygium aromaticum, Glycyrrhiza uralensis Fisch, Aucklandia lappa Decne, and Terminalia chebula Retz twice with water, each time for 1 h, and the amount of water used each time is 10 times the total weight of Syzygium aromaticum, Glycyrrhiza uralensis Fisch, Aucklandia lappa Decne, and Terminalia chebula Retz. Filter and combine the filtrates to obtain residue 2 and the water extract. (3) Mix residue 1 and residue 2 with water, enzymatically hydrolyze at 30 °C for 4 h, and filter to obtain the enzymatic hydrolysate; Among them, the amount of water used is 7 times the total weight of hosta flower, concretio silicea bambusae, clove, liquorice, costus root and myrobalan fruit; the addition amount of the enzyme is 0.08% of the mass of water; the enzyme is pectinase, lactase and ficin with a mass ratio of 0.6:0.4:1; (4) Combine the ethanol extract, water extract and enzymatic hydrolysate, concentrate and dry at 50 °C, add borneol and crush, and pass through an 80-mesh sieve.

[0043] Example 2 The traditional Chinese medicine composition is composed of the following raw materials by weight: 160 parts of hosta flower, 100 parts of clove, 160 parts of liquorice, 40 parts of concretio silicea bambusae, 160 parts of costus root, 160 parts of myrobalan fruit and 6 parts of borneol; The preparation method is as follows: (1) Reflux and extract hosta flower and concretio silicea bambusae with 70% ethanol for 3 times, 0.5 h each time, and the amount of ethanol used each time is 6 times the total weight of hosta flower and concretio silicea bambusae, filter, combine the filtrates to obtain residue 1 and ethanol extract; (2) Decoct clove, liquorice, costus root and myrobalan fruit with water for 1 time, 2 h each time, and the amount of water used each time is 15 times the total weight of clove, liquorice, costus root and myrobalan fruit, filter, combine the filtrates to obtain residue 2 and water extract; (3) Mix residue 1 and residue 2 with water, enzymatically hydrolyze at 25 °C for 6 h, and filter to obtain the enzymatic hydrolysate; Among them, the amount of water used is 10 times the total weight of hosta flower, concretio silicea bambusae, clove, liquorice, costus root and myrobalan fruit; the addition amount of the enzyme is 1.2% of the mass of water; the enzyme is pectinase, lactase and ficin with a mass ratio of 0.5:0.3:1; (4) Combine the ethanol extract, water extract and enzymatic hydrolysate, concentrate and dry at 50 °C, add borneol and crush, and pass through an 80-mesh sieve.

[0044] Example 3 The traditional Chinese medicine composition is composed of the following raw materials by weight: 240 parts of hosta flower, 180 parts of clove, 240 parts of liquorice, 60 parts of concretio silicea bambusae, 240 parts of costus root, 240 parts of myrobalan fruit and 14 parts of borneol; The preparation method is as follows: (1) Reflux and extract hosta flower and concretio silicea bambusae with 85% ethanol for 1 time, 1.5 h each time, and the amount of ethanol used each time is 12 times the total weight of hosta flower and concretio silicea bambusae, filter, combine the filtrates to obtain residue 1 and ethanol extract; (2) Decoct cloves, licorice, costusroot and myrobalan fruit with water three times, each time for 0.5 h, and the amount of water used each time is 8 times the total weight of cloves, licorice, costusroot and myrobalan fruit. Filter and combine the filtrates to obtain medicinal residues 2 and aqueous extract. (3) Mix medicinal residues 1 and medicinal residues 2 with water and enzymatically hydrolyze at 35 °C for 3 h. Filter to obtain enzymolysis solution. Among them, the amount of water used is 5 times the total weight of hosta flower, concretio silicea bambusae, cloves, licorice, costusroot and myrobalan fruit; the addition amount of the enzyme is 0.05% of the water quality; the enzyme is pectinase, lactase and ficin with a mass ratio of 0.8:0.5:1. (4) Combine the ethanol extract, aqueous extract and enzymolysis solution, concentrate and dry at 50 °C, add borneol and pulverize, and pass through an 80-mesh sieve.

[0045] Comparative Example 1 The difference between this comparative example and Example 1 lies in: different compositions of the enzyme.

[0046] Specifically, the enzyme is pectinase, lactase and ficin with a mass ratio of 1:0.2:0.5.

[0047] The preparation method is basically the same as that of Example 1.

[0048] Comparative Example 2 The difference between this comparative example and Example 1 lies in: different preparations of the enzyme.

[0049] Specifically, the enzyme is pectinase, lactase and ficin with a mass ratio of 0.2:0.8:1.5.

[0050] The preparation method is basically the same as that of Example 1.

[0051] Comparative Example 3 The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 200 parts of hosta flower, 140 parts of cloves, 200 parts of licorice, 50 parts of concretio silicea bambusae, 200 parts of costusroot, 200 parts of myrobalan fruit and 10 parts of borneol; The difference between the preparation method and Example 1 lies in: hosta flower and concretio silicea bambusae are not subjected to ethanol extraction.

[0052] The steps are as follows: (1) Decoct hosta flower, concretio silicea bambusae, cloves, licorice, costusroot and myrobalan fruit with water twice, each time for 1.5 h, and the amount of water used each time is 8 times the total weight of hosta flower, concretio silicea bambusae, cloves, licorice, costusroot and myrobalan fruit. Filter and combine the filtrates to obtain medicinal residues and aqueous extract. (2) Mix the medicinal residues with water and enzymatically hydrolyze at 30 °C for 4 h. Filter to obtain enzymolysis solution. Among them, the dosage of water is 7 times the total weight of hosta flower, bamboo sap, clove, licorice, costus root and myrobalan; the addition amount of the enzyme is 0.08% of the mass of water; the enzyme is pectinase, lactase and ficin with a mass ratio of 0.6:0.4:1; (3)Merge the water extract and the enzymolysis solution, concentrate and dry at 50 °C, add borneol and crush, and pass through an 80-mesh sieve to obtain the product.

[0053] Comparative Example 4 A traditional Chinese medicine composition was prepared according to the preparation method of Example 1 of CN118021750A.

[0054] The specific preparation method is as follows: (1)Crush 50 parts of bamboo sap to obtain bamboo sap powder, mix 10 parts of bamboo sap powder with 10 parts of borneol and crush to obtain powder; (2)After mixing 140 parts of cloves and 200 parts of costus root, extract by the co-distillation method with water. Specifically, add 8 times the total weight of cloves and costus root of water, soak for 12 h, and extract for 16 h to obtain volatile oil; (3)After mixing 200 parts of licorice and 200 parts of myrobalan, decoct with water. The number of decoctions is 3 times, and the time for each time is 1.5 h. The amount of water added for the first decoction is 10 times the total weight of licorice and myrobalan, and the amount of water added for the second and third decoctions is 8 times the total weight of licorice and myrobalan. Filter after each decoction to obtain filtrate. Merge the filtrates of each decoction and concentrate to obtain a thick paste A with a relative density of 1.30 - 1.35 (60 °C); (4)Reflux and extract 200 parts of hosta flower in a water bath at 90 °C. The number of reflux extractions is 3 times, and the time for each time is 1 h. Carry out in ethanol with a mass fraction of 80%. The dosage of ethanol is 8 times that of hosta flower. Filter after each reflux extraction to obtain filtrate. Merge the filtrates of each reflux extraction and concentrate to obtain a thick paste B with a relative density of 1.30 - 1.35 (60 °C); (5)Merge thick paste A and thick paste B, dry under vacuum at 70 °C, crush and mix evenly to obtain extract powder; (6)Add the volatile oil obtained in step (2) to the remaining 40 parts of bamboo sap powder, mix evenly, and then add the powder obtained in step (1) and the extract powder obtained in step (5), and mix evenly to obtain the product.

[0055] [Evaluation of the effect in treating acute pharyngitis and chronic pharyngitis] I. Evaluation of the effect in treating acute pharyngitis 1. Test samples The traditional Chinese medicine compositions provided by Examples 1 - 3 and Comparative Example 4.

[0056] 2. Test methods SD rats (weighing 180 - 220 g, male, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd.) were randomly divided into a normal group, a model group, and a medicated group according to body weight. Except for the normal group, rats in the other groups were sprayed with 5% ammonia water (0.3 mL / kg·d) into the pharynx, twice a day for 7 consecutive days. Rats in the normal group were sprayed with an equal volume of normal saline. On the 8th day, the spraying was stopped. Rats in the medicated group were intragastrically administered the traditional Chinese medicine composition of the corresponding example or comparative example, with a dosage of 0.2 g of crude drug / kg, once a day. Rats in the normal group and the model group were intragastrically administered an equal volume of normal saline, and intragastric administration was continued for 4 days.

[0057] 1 h after the last intragastric administration, blood was taken from the abdominal artery of the rats, and the levels of 1L-1β and IL-6 in the serum were measured according to the kit. The results are shown in Table 1.

[0058] Table 1 Contents of 1L-1β and IL-6 in serum (mean ± standard deviation)

[0059] Note: Compared with the normal group, *P < 0.01, *P < 0.05; compared with the model group, #P < 0.05; compared with Example 1 group, ◇P < 0.05.

[0060] The results showed that: compared with the normal group, the levels of 1L-1β and IL-6 in the serum of rats in the model group increased significantly (P < 0.01 or P < 0.05). Compared with the model group, the levels of 1L-1β and IL-6 in the serum of rats in each group decreased significantly (P < 0.05), indicating that the traditional Chinese medicine compositions prepared in Examples 1 - 3 and Comparative Example 4 all have the efficacy of treating acute pharyngitis.

[0061] Compared with the Example 1 group, the level of 1L-1β in the serum of rats in the Comparative Example 4 group decreased significantly (P < 0.05), indicating that the traditional Chinese medicine composition prepared by the present invention has a better efficacy in treating acute pharyngitis than the prior art.

[0062] II. Evaluation of the effect on treating chronic pharyngitis 1. Test samples The traditional Chinese medicine compositions provided in Examples 1 - 3 and Comparative Examples 1 - 4.

[0063] 2. Test method SD rats (weighing 180 - 220 g, male, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd.) were randomly divided into a normal group, a model group, and a medicated group according to their body weights. Except for the normal group, chronic pharyngitis models were established in other groups by stimulating with a mixture of pepper water and ammonia water (see: Ji Meina, et al. Study on the effects of different parts of Dendrobium officinale on rats with chronic pharyngitis induced by the stimulation of a mixture of pepper water and ammonia water [J]. China Journal of Chinese Materia Medica, 2022, 47(9), 2525 - 2532). Each day, a mixed solution of 0.01 ml of liquor - pepper solution per gram of body weight was intragastrically administered (liquor with 40% alcohol content, pepper solution concentration 1.2 g / ml, volume ratio 1:1), and at the same time, 2.5 wt% ammonia water was sprayed (twice a day, 3 seconds each time). The normal group was intragastrically administered an equal volume of normal saline, and an equal volume of normal saline was sprayed at the same time. After 21 days of modeling, the medicated group was intragastrically administered the traditional Chinese medicine composition of the corresponding example or comparative example, with a dosage of 0.2 g of crude drug per kg of body weight. The normal group and the model group were intragastrically administered an equal volume of normal saline, and continuous intragastric administration was carried out for 14 days.

[0064] After the last administration, all rats were fasted for 4 h, anesthetized using a respiratory anesthesia machine, the changes in the pharyngeal appearance were observed, and scoring was carried out according to Table 2.

[0065] Table 2 Pharyngeal appearance score

[0066] After the experiment, blood was taken from the abdominal artery of the rats, and kits were used to measure the contents of 1L - 1β and IL - 6 in the serum.

[0067] The results are shown in Tables 3 and 4.

[0068] Table 3 Pathological scores of pharyngeal tissues of rats in each group (n = 8)

[0069] Table 4 Levels of 1L - 1β and IL - 6 in the serum of rats in each group (mean ± standard deviation)

[0070] Note: Compared with the normal group, **P < 0.01; compared with the model group, #P < 0.05.

[0071] The results showed that: compared with the normal group, the pathological scores of the pharyngeal tissues of the rats in the model group were significantly increased, and the levels of 1L - 1β and IL - 6 in the serum were significantly increased (P < 0.01). At the same time, compared with the model group, the pathological scores of the pharyngeal tissues of the rats in Example 1 - 3 groups were significantly decreased, and the levels of 1L - 1β and IL - 6 in the serum were significantly decreased (P < 0.05), indicating that the traditional Chinese medicine compositions prepared in Examples 1 - 3 of the present invention can effectively inhibit the inflammatory response caused by the stimulation of a mixture of pepper water and ammonia water, and improve the pathological changes of pharyngeal tissues, thereby achieving the treatment of chronic pharyngitis.

[0072] Although Comparative Examples 1-4 can, to a certain extent, improve the pathological changes of pharyngeal tissues, their anti-inflammatory effects are weak and cannot achieve the therapeutic effect on chronic pharyngitis.

[0073] The above is a further description of the present invention in combination with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation to the scope of the present invention. Those skilled in the art should understand that the details and forms of the technical solutions of the present invention can be modified or replaced without departing from the spirit and scope of the present invention, but such modifications and replacements all fall within the protection scope of the present invention.

Claims

1. A method for preparing a Chinese medicine composition for treating pharyngitis, characterized in that: The steps include: (1) extracting Hosta odorata and Rhizoma Cibotii with alcohol, separating the solid from the liquid, and obtaining a residue 1 and an alcohol extract; (2) extracting clove, liquorice, costusroot and terminalia chebula with water, separating the solid and liquid, and obtaining a residue 2 and a water extract; (3) Adding water to the residue 1 and the residue 2, mixing them for enzymatic hydrolysis, and separating the solid and the liquid to obtain an enzymatic hydrolyzate; (4) Combine the alcohol extract, water extract and enzymatic hydrolyzate, dry them, add borneol and crush them; The enzymes used for the enzymatic hydrolysis in step (3) are pectinase, lactase and ficin; the mass ratio of pectinase, lactase and ficin is 0.5-0.8:0.3-0.5:

1.

2. The preparation method according to claim 1, characterized in that: The amount of the enzyme added is 0.05-1.2% of the water mass; And / or the conditions of the enzymatic hydrolysis are: enzymatic hydrolysis at 25°C-35°C for 3h-6h.

3. The preparation method according to claim 1, characterized in that: The alcohol extraction in step (1) is reflux extraction with ethanol; the mass fraction of the alcohol is 70%-85%.

4. The preparation method according to claim 3, characterized in that: The alcohol extraction conditions are: heating reflux extraction 1-3 times, each time for 0.5h-1.5h.

5. The preparation method according to claim 1, characterized in that: The water extraction in step (2) is to boil water for 1-3 times, each time for 0.5h-2h.

6. The preparation method according to claim 1, characterized in that The traditional Chinese medicine composition comprises, by weight, 160-240 parts of hosta flower, 100-180 parts of cloves, 160-240 parts of liquorice, 40-60 parts of dahlia, 160-240 parts of costusroot, 160-240 parts of terminalia chebula and 6-14 parts of borneol.

7. The preparation method according to any one of claims 1 to 6, characterized in that: The traditional Chinese medicine composition comprises, by weight, 200 parts of hosta flowers, 140 parts of cloves, 200 parts of liquorice, 50 parts of dahliae, 200 parts of costusroot, 200 parts of terminalia chebula and 10 parts of borneol.

8. A Chinese medicine composition prepared by the preparation method according to any one of claims 1 to 7.

9. Use of the Chinese medicine composition according to claim 8 in preparing a drug for treating pharyngitis or in preparing an IL-1β blocker, wherein the pharyngitis includes at least one of acute pharyngitis and chronic pharyngitis.

10. A pharmaceutical preparation, characterized in that The Chinese medicine composition according to claim 8 and pharmaceutically acceptable excipients are included, and the pharmaceutical preparation is a powder, tablet, capsule, granule, pill or liquid preparation.

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