Throat-clearing and throat-soothing composition, its preparation method and application

Abstract

The present application provides a throat-soothing composition, a preparation method thereof, and an application thereof. The throat-soothing composition includes an extraction mixture. The raw material components of the extraction mixture are calculated by weight and include: 15-55 parts by weight of honeysuckle, 60-90 parts by weight of momordica grosvenori, 60-90 parts by weight of platycodon grandiflorum, 3-12 parts by weight of mentha haplocalyx, 70-100 parts by weight of dried tangerine peel, 5-15 parts by weight of dendrobium officinale, and 60-90 parts by weight of citron. The present application uses the raw materials of medicine and food homology, namely honeysuckle, momordica grosvenori, mentha haplocalyx, platycodon grandiflorum, dried tangerine peel, dendrobium officinale, and citron, in synergistic combination. The prepared throat-soothing composition has the effect of relieving throat problems. In addition, after the extraction mixture is reasonably included with an appropriate cyclodextrin, it has a low bitterness value and a good taste, and can be better applied to the development of related products.

Description

Technical Field

[0001] This application relates to the technical field of functional foods, and particularly to a throat-soothing composition, a preparation method thereof, and an application thereof. Background Art

[0002] The throat is an important immune organ of humans. With the increasing health awareness of consumers, there are an endless stream of products with throat-soothing effects on the market. However, most of them have problems such as a strong traditional Chinese medicine taste, too strong irritation, or a heavy taste, which to a certain extent limits the user group. Therefore, there is still a need to develop a throat-soothing composition with a good taste. Summary of the Invention

[0003] The purpose of this application is to provide a throat-soothing composition, a preparation method thereof, and an application thereof. The throat-soothing composition has a significant effect on relieving throat problems, a low bitterness value, and a good taste, and can be better applied to the development of related products. The specific technical solutions are as follows:

[0004] In the first aspect of this application, a throat-soothing composition is provided, wherein the composition includes an extraction mixture. The raw material components of the extraction mixture are calculated by weight and include: 15-55 parts by weight of honeysuckle, 60-90 parts by weight of momordica grosvenori, 60-90 parts by weight of platycodon grandiflorum, 3-12 parts by weight of mint, 70-100 parts by weight of dried tangerine peel, 5-15 parts by weight of dendrobium officinale, and 60-90 parts by weight of citron.

[0005] In some embodiments of this application, the raw material components of the extraction mixture are calculated by weight and include: 25-35 parts by weight of honeysuckle, 70-80 parts by weight of momordica grosvenori, 80-90 parts by weight of platycodon grandiflorum, 3-8 parts by weight of mint, 85-95 parts by weight of dried tangerine peel, 5-10 parts by weight of dendrobium officinale, and 80-90 parts by weight of citron.

[0006] In some embodiments of this application, the composition further includes cyclodextrin, and the mass ratio of the extraction mixture to the cyclodextrin is (20-30):1.

[0007] In some embodiments of this application, the cyclodextrin includes β-cyclodextrin and γ-cyclodextrin; preferably, the mass ratio of the β-cyclodextrin to the γ-cyclodextrin is 10:(4-10).

[0008] In some embodiments of this application, the preparation method of the extraction mixture includes the steps of:

[0009] Mix honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale, and citron and add water for extraction to obtain an extract;

[0010] Concentrate the extract to obtain a concentrated extract;

[0011] Centrifuge the concentrated solution, filter the supernatant, and collect the filtrate.

[0012] Dry the filtrate to obtain the extraction mixture.

[0013] In some embodiments of the present application, in the method for preparing the extraction mixture, the extraction temperature is 90 - 100 °C, the number of extractions is 3 - 4 times, and the time for each extraction is 1 - 3 h.

[0014] The weight of the water is 4 - 8 times the total weight of honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale, and citron.

[0015] In some embodiments of the present application, in the method for preparing the extraction mixture, the relative density of the concentrated solution is 1.05 - 1.15.

[0016] The rotation speed of the centrifugation is 6000 - 8000 rpm, and the centrifugation time is 10 - 15 min.

[0017] The drying is spray drying, the inlet temperature of the spray drying is 130 - 160 °C, and the outlet temperature is 80 - 90 °C.

[0018] In some embodiments of the present application, the composition further comprises at least one of calamondin powder, lemon powder, and sweetener; preferably, the sweetener comprises at least one of sucralose and stevioside.

[0019] The second aspect of the present application provides a method for preparing a throat - soothing composition, which includes the steps of:

[0020] Complex the extraction mixture described in the first aspect of the present application with a saturated aqueous solution of cyclodextrin to obtain the throat - soothing composition.

[0021] In some embodiments of the present application, the complexing temperature is 35 - 55 °C; during the complexing process, continuous stirring is carried out for 1 - 3 h; preferably, after complexing, the steps of filtration and drying are further included.

[0022] The third aspect of the present application provides the use of the throat - soothing composition described in the first aspect of the present application or the throat - soothing composition prepared by the method described in the second aspect of the present application in the preparation of products for improving throat discomfort.

[0023] Advantages of the present application:

[0024] This application uses the raw materials of honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron, which are both medicine and food, and uses them in synergistic combination to prepare a throat-clearing and throat-soothing composition with remarkable efficacy in relieving throat problems. In addition, after appropriately using cyclodextrin to reasonably encapsulate the extraction mixture, it has a low bitterness value and good taste, and can be better applied to the development of related dosage form products. In addition, the preparation method of the throat-clearing and throat-soothing composition provided by this application is simple and controllable, and can be mass-produced.

[0025] Of course, it is not necessary for any product or method implementing this application to achieve all the above-mentioned advantages simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of this application, the following will briefly introduce the drawings required for description in the embodiments. Obviously, the drawings in the following description are only some embodiments of this application, and those of ordinary skill in the art can also obtain other embodiments based on these drawings.

[0027] Figure 1 Graph showing the effect of ammonia stimulation on the cough latency of rats on the third day of modeling;

[0028] Figure 2 Graph showing the effect of ammonia stimulation on the cough frequency of rats on the third day of modeling (compared with the normal control group, )

[0029] Figure 3 Graph showing the effect of ammonia stimulation on the cough latency of rats after seven days of drug administration (compared with the model control group, )

[0030] Figure 4 Graph showing the effect of ammonia stimulation on the cough frequency of rats after seven days of drug administration (compared with the normal control group, ; compared with the model control group, )

[0031] Figure 5a Graph showing the pathological staining results of the lungs of rats in the normal control group after seven days of drug administration;

[0032] Figure 5b Graph showing the pathological staining results of the lungs of rats in the model control group after seven days of drug administration;

[0033] Figure 5c Graph showing the pathological staining results of the lungs of rats in the positive control group after seven days of drug administration;

[0034] Figure 5dThe figure shows the pathological staining results of the lungs of rats in the low-dose group (250 mg / kg) after seven days of administration;

[0035] Figure 5e The figure shows the pathological staining results of the lungs of rats in the medium-dose group (500 mg / kg) after seven days of administration;

[0036] Figure 5f The figure shows the pathological staining results of the lungs of rats in the high-dose group (1000 mg / kg) after seven days of administration. Detailed implementation manners

[0037] Next, the technical solutions in the present application will be clearly and completely described in conjunction with the embodiments of the present application and the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those skilled in the art based on the present application belong to the scope of protection of the present application.

[0038] The first aspect of the present application provides a throat-clearing and throat-soothing composition, wherein the composition includes an extraction mixture. The raw material components of the extraction mixture are as follows by weight: 15-55 parts by weight of honeysuckle, 60-90 parts by weight of monk fruit, 60-90 parts by weight of platycodon root, 3-12 parts by weight of mint, 70-100 parts by weight of dried tangerine peel, 5-15 parts by weight of dendrobium officinale, and 60-90 parts by weight of citron.

[0039] The present application uses the raw materials of medicine and food homology, namely honeysuckle, monk fruit, mint, platycodon root, dried tangerine peel, dendrobium officinale and citron, in synergistic combination, and has a significant effect on relieving throat problems.

[0040] In some embodiments of the present application, the raw material components of the extraction mixture are as follows by weight: 25-35 parts by weight of honeysuckle, 70-80 parts by weight of monk fruit, 80-90 parts by weight of platycodon root, 3-8 parts by weight of mint, 85-95 parts by weight of dried tangerine peel, 5-10 parts by weight of dendrobium officinale, and 80-90 parts by weight of citron.

[0041] In some embodiments of the present application, the composition further includes cyclodextrin, and the mass ratio of the extraction mixture to the cyclodextrin is (20-30):1. In some embodiments of the present application, the mass ratio of the extraction mixture to cyclodextrin can be 20:1, 22:1, 24:1, 26:1, 28:1, 30:1 or a range composed of any two ratios therebetween. By controlling the mass ratio of the extraction mixture to cyclodextrin within the above range, it is beneficial for cyclodextrin to better encapsulate the extraction mixture, greatly reducing the bitterness value of the prepared throat-clearing and throat-soothing composition and improving the taste.

[0042] In some embodiments of the present application, the cyclodextrin includes β-cyclodextrin and γ-cyclodextrin.

[0043] In some embodiments of the present application, the mass ratio of β-cyclodextrin to γ-cyclodextrin is 10:(4 - 10). In some embodiments of the present application, the mass ratio of β-cyclodextrin to γ-cyclodextrin can be 10:4, 10:5, 10:6, 10:7, 10:8, 10:9, 10:10 or any range composed of any two numerical ratios therebetween. By controlling the mass ratio of β-cyclodextrin to γ-cyclodextrin within the above range in the present application, it is beneficial for cyclodextrin to better encapsulate the active ingredients, greatly reducing the bitterness value of the throat-clearing and voice-nourishing composition and improving the taste.

[0044] In some embodiments of the present application, the method for preparing the extraction mixture includes the steps of:

[0045] S1: Mix honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron, and then add water for extraction to obtain an extract;

[0046] S2: Concentrate the extract to obtain a concentrated solution;

[0047] S3: Centrifuge the concentrated solution, take the supernatant and filter it, and collect the filtrate;

[0048] S4: Dry the filtrate to obtain the extraction mixture.

[0049] The present application does not particularly limit the filtering method in step S3, as long as the inventive purpose of the present application can be achieved. For example, filtering can be carried out using gauze to remove solid impurities in the supernatant.

[0050] In some embodiments of the present application, in step S1, the extraction temperature is 90 - 100 °C, the number of extractions is 3 times, the extraction time for each time is 1 - 3 h, and the weight of water is 4 - 8 times the total weight of honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron. In some embodiments of the present application, the extraction temperature can be 90 °C, 91 °C, 92 °C, 93 °C, 94 °C, 95 °C, 96 °C, 97 °C, 98 °C, 99 °C, 100 °C or any range composed of any two numerical values therebetween; the extraction time for each time can be 1 h, 1.5 h, 2 h, 2.5 h, 3 h or any range composed of any two numerical values therebetween; the weight of water can be 4 times, 5 times, 6 times, 7 times, 8 times the total weight of honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron or any range composed of any two numerical values therebetween. By controlling the water dosage, extraction temperature and extraction time for each time within the above range in the present application, it is beneficial to better extract the active ingredients from honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron.

[0051] In some embodiments of the present application, in step S2, the relative density of the concentrated solution is 1.05 - 1.15. The relative density referred to in the present application means the density relative to water, which is measured under room temperature conditions such as 25°C. In some embodiments of the present application, the relative density of the concentrated solution can be 1.05, 1.07, 1.10, 1.12, 1.15 or any range composed of any two values therebetween. Controlling the relative density of the concentrated solution within the above range in the present application is beneficial for better subsequent centrifugal separation and minimizes the loss of active ingredients as much as possible.

[0052] In some embodiments of the present application, in step S4, the rotation speed of the centrifugation is 6000 - 8000 rpm, and the time of the centrifugation is 10 - 15 min. In some embodiments of the present application, the rotation speed of the centrifugation can be 6000 rpm, 6200 rpm, 6400 rpm, 6600 rpm, 6800 rpm, 7000 rpm, 7200 rpm, 7400 rpm, 7600 rpm, 7800 rpm, 8000 rpm or any range composed of any two values therebetween; the time of the centrifugation can be 10 min, 11 min, 12 min, 13 min, 14 min, 15 min or any range composed of any two values therebetween. Controlling the rotation speed and time of the centrifugation within the above range in the present application is beneficial for better subsequent centrifugal separation and minimizes the loss of active ingredients as much as possible.

[0053] In some embodiments of the present application, in step S4, the drying is spray drying, the inlet temperature of the spray drying is 130 - 160°C, and the outlet temperature is 80 - 90°C. In some embodiments of the present application, the inlet temperature of the spray drying can be 130°C, 135°C, 140°C, 145°C, 150°C, 155°C, 160°C or any range composed of any two values therebetween; the outlet temperature of the spray drying can be 80°C, 82°C, 84°C, 86°C, 88°C, 90°C or any range composed of any two values therebetween. Controlling the inlet temperature and outlet temperature of the spray drying within the above range in the present application is beneficial for better drying and minimizes the loss of active ingredients as much as possible.

[0054] In some embodiments of the present application, the composition further comprises at least one of calamansi powder, lemon powder and sweetener.

[0055] In some embodiments of the present application, the sweetener comprises at least one of sucralose and stevioside.

[0056] In some embodiments of the present application, the throat-soothing composition can be formulated into a pharmaceutically acceptable preparation; preferably, the throat-soothing composition is formulated into any one of granule, oral liquid, pill, tablet or capsule.

[0057] In this application, by using the raw materials of honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron which are both medicine and food in synergistic cooperation, and at the same time using appropriate cyclodextrin to reasonably encapsulate the extraction mixture, the pharyngeal and laryngeal clearing composition prepared has a low bitterness value and good taste, and can be better applied to the development of related products.

[0058] The second aspect of this application provides a preparation method of a pharyngeal and laryngeal clearing composition, which includes the steps of:

[0059] Encapsulating the extraction mixture described in the first aspect of this application with a saturated aqueous solution of cyclodextrin to obtain the pharyngeal and laryngeal clearing composition.

[0060] The encapsulation described in this application means mixing the extraction mixture described in the first aspect of this application and the saturated aqueous solution of cyclodextrin, and then continuously stirring to carry out the encapsulation.

[0061] The preparation method of the pharyngeal and laryngeal clearing composition provided by this application is simple and controllable, and can be produced on a large scale; and different dosage forms, such as tablets, oral liquids, etc., can be prepared according to actual needs.

[0062] In some embodiments of this application, in the preparation method of the pharyngeal and laryngeal clearing composition, the temperature of the encapsulation is 35-55°C; and continuously stir for 1-3 hours during the encapsulation process. In some embodiments of this application, the temperature of the encapsulation can be 35°C, 37°C, 40°C, 42°C, 45°C, 47°C, 50°C, 52°C, 55°C or any range composed of any two values therebetween; the time of continuously stirring during the encapsulation process can be 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours or any range composed of any two values therebetween. By controlling the temperature of the encapsulation and the time of continuous stirring within the above ranges in this application, it is beneficial for cyclodextrin to better encapsulate the extraction mixture, greatly reducing the bitterness value of the prepared pharyngeal and laryngeal clearing composition and improving the taste.

[0063] In some embodiments of this application, in the preparation method of the pharyngeal and laryngeal clearing composition, after the encapsulation, it further includes the steps of filtration and drying. According to the dosage form requirements of the pharyngeal and laryngeal clearing composition, drying can be carried out after the encapsulation is completed, and the obtained product can be prepared into dosage forms such as granules, tablets, capsules, etc.

[0064] In some embodiments of this application, when the composition further includes at least one of calamondin powder, lemon powder and sweetener, in the preparation method of the pharyngeal and laryngeal clearing composition, after the encapsulation, it further includes a mixing step, that is, mixing the product obtained by encapsulating the extraction mixture with a saturated aqueous solution of cyclodextrin and at least one of calamondin powder, lemon powder and sweetener. In some embodiments of this application, the mixing step is carried out after drying.

[0065] The third aspect of the present application provides the use of the throat-soothing and throat-clearing composition described in the first aspect of the present application or the throat-soothing and throat-clearing composition prepared by the method described in the second aspect of the present application in the preparation of products for improving throat discomfort.

[0066] The traditional Chinese medicine compound oral liquid prepared by using the throat-soothing and throat-clearing composition of the present application has a good taste and has a very good effect of soothing the throat and clearing the throat. The traditional Chinese medicine compound lozenge prepared by using the throat-soothing and throat-clearing composition of the present application has a good taste, and the effects of relieving sore throat and treating throat diseases are more significant.

[0067] The terms used in the present application, if not clearly stated or defined, have the general meanings known to those skilled in the art.

[0068] Hereinafter, examples and comparative examples are given to more specifically illustrate the embodiments of the present application. Various tests and evaluations are carried out according to the following methods. In addition, unless otherwise specified, "parts" and "%" are based on mass.

[0069] Example 1

[0070] S1: Weigh the following raw material components respectively: 15 g of honeysuckle, 60 g of monk fruit, 60 g of platycodon root, 3 g of mint, 70 g of dried tangerine peel, 5 g of dendrobium officinale, and 60 g of citron. Mix the above raw material components, and then add water for extraction 3 times. The weight of water added each time is 6 times the total weight of honeysuckle, monk fruit, mint, platycodon root, dried tangerine peel, dendrobium officinale, and citron. The extraction time each time is 2 h, and the extraction temperature each time is 90 °C. The extracts obtained 3 times are all filtered, and the filtrates are combined to obtain an extract.

[0071] S2: Concentrate the above extract to obtain a concentrated solution with a relative density of 1.1.

[0072] S3: Centrifuge the above concentrated solution at 6000 rpm for 10 min, take the supernatant and filter it with gauze, and collect the filtrate.

[0073] S4: Spray-dry the above filtrate, with an inlet temperature of 130 °C and an outlet temperature of 80 °C, collect the dried product, and obtain an extraction mixture.

[0074] S5: Include the above extraction mixture with a saturated aqueous solution of cyclodextrin to obtain a throat-soothing and throat-clearing composition; wherein, the mass ratio of the extraction mixture to cyclodextrin is 20:1, and the cyclodextrin is β-cyclodextrin and γ-cyclodextrin with a mass ratio of 10:8; the inclusion temperature is 35 °C, stir for 1 h, filter and remove the filtrate and dry it to obtain a throat-soothing and throat-clearing composition.

[0075] S6: After uniformly mixing 3.77 kg of the above pharynx-clearing and throat-soothing composition, 5.86 kg of isomaltitol, 0.05 kg of silicon dioxide, 0.2 kg of magnesium stearate, and 0.12 kg of citric acid, place them in a tabletting machine for tabletting to obtain pharynx-clearing lozenges with a smooth and complete surface and a tablet weight of 0.6 g.

[0076] Example 2

[0077] S1: Weigh the following raw material components respectively: 30 g of honeysuckle, 75 g of monk fruit, 85 g of platycodon grandiflorum, 5 g of mint, 90 g of tangerine peel, 8 g of dendrobium officinale, and 85 g of citron. Mix the above raw material components, and then add water for extraction 3 times. The weight of water added each time is 10 times the total weight of honeysuckle, monk fruit, mint, platycodon grandiflorum, tangerine peel, dendrobium officinale, and citron. The extraction time each time is 0.5 h, and the extraction temperature each time is 95 °C. The extracts obtained 3 times are all filtered, and the filtrates are combined to obtain an extract.

[0078] S2: Concentrate the above extract to obtain a concentrated solution with a relative density of 1.15.

[0079] S3: Centrifuge the above concentrated solution at 8000 rpm for 15 min, take the supernatant and filter it with gauze, and collect the filtrate.

[0080] S4: Spray-dry the above filtrate, with an inlet temperature of 160 °C and an outlet temperature of 90 °C, collect the dried product to obtain an extraction mixture.

[0081] S5: Inclusion-complex the above extraction mixture with a saturated aqueous solution of cyclodextrin to obtain a pharynx-clearing and throat-soothing composition; wherein, the mass ratio of the extraction mixture to cyclodextrin is 25:1, and the cyclodextrin is β-cyclodextrin and γ-cyclodextrin with a mass ratio of 10:8; the inclusion-complex temperature is 45 °C, stir for 2 h, filter and remove the filtrate and dry to obtain a pharynx-clearing and throat-soothing composition.

[0082] S6: After uniformly mixing 3.77 kg of the above pharynx-clearing and throat-soothing composition, 5.86 kg of isomaltitol, 0.05 kg of silicon dioxide, 0.2 kg of magnesium stearate, and 0.12 kg of citric acid, place them in a tabletting machine for tabletting to obtain pharynx-clearing lozenges with a smooth and complete surface and a tablet weight of 0.6 g.

[0083] Examples 3 - 5

[0084] Except for adjusting the dosages of each raw material component as shown in Table 1, the rest are the same as in Example 2.

[0085] Examples 6 - 15

[0086] Except for adjusting the types and proportions of cyclodextrin as shown in Table 2, the rest are the same as in Example 2.

[0087] Comparative Examples 1-7

[0088] Except for adjusting the dosages of each raw material component as shown in Table 1, the rest was the same as in Example 2.

[0089] Table 1 Raw material components of each example and comparative example

[0090]

[0091] Table 2 Kinds and proportions of cyclodextrins in different examples

[0092]

[0093] The efficacy of the throat lozenges prepared in each example and comparative example of the present application will be illustrated below through efficacy tests.

[0094] 1. Efficacy experiment on rats

[0095] (1) Sample preparation

[0096] Positive control group: Pediatric Cough Syrup, directly used for administration.

[0097] Experimental group 1: Take an appropriate amount of the throat lozenges prepared in Example 2, grind them into powder in a mortar, weigh 2.5 g of the powder, add 50 mL of distilled water, and mix well to prepare a working solution of 50 mg / mL.

[0098] Experimental group 2: Take an appropriate amount of the throat lozenges prepared in Example 2, grind them into powder in a mortar, weigh 5.0 g of the powder, add 50 mL of distilled water, and mix well to prepare a working solution of 100 mg / mL.

[0099] Experimental group 3: Take an appropriate amount of the throat lozenges prepared in Example 2, grind them into powder in a mortar, weigh 10.0 g of the powder, add 50 mL of distilled water, and mix well to prepare a working solution of 200 mg / mL.

[0100] (2) Animal information

[0101] SD rats, weighing 160 - 180 g, half male and half female, a total of 60 rats.

[0102] The experimental animals were provided by Spf (Suzhou) Biotechnology Co., Ltd. (China), certificate of conformity: SCXK (Su) 2022 - 0006.

[0103] (3) Instruments, consumables and reagents

[0104] Micropipette (Eppendorf, Germany); biological safety cabinet (HFsafe-1500LC, HealForce Bio-Medical Technology Holdings Co., Ltd.); RNase bagged pipette tips (EXTRAGENE, USA); rat gavage needle (No. 16, Jinuotai Technology Development Co., Ltd.); inverted fluorescence microscope (ICX41, Sunny Optical Technology (Group) Co., Ltd.); dissection instruments, small animal anesthesia machine (R500IE, Shenzhen Rewod Life Science Co., Ltd.); biological tissue embedding machine (YD-6L, Jinhua Yidi Medical Equipment Co., Ltd.); water-jacketed constant temperature incubator (GNP-9270, Shanghai Jinghong Experimental Equipment Co., Ltd.); rotary microtome (MT1, Dakewei (Shenzhen) Medical Equipment Co., Ltd.); compressed atomizer (NE-C25S, Zhongshan Quankang Medical Technology Co., Ltd.).

[0105] (4)Experimental methods

[0106] a) Establishment of cough model by ammonia stimulation and gavage intervention

[0107] After adaptive feeding, all rats were randomly divided into 6 groups, namely: normal control group, model control group, positive control group, experimental groups (3 doses), with 7 rats in each group.

[0108] After establishing the cough model of SD rats by nebulizing inhalation of 25% ammonia water in the throat for 3 days, the positive control group was given 9 mL / kg of pediatric cough syrup by oral gavage daily, and the experimental groups were given Qingyan Buccal Tablets solution by oral gavage daily (low-dose group: 250 mg / kg, medium-dose group: 500 mg / kg, high-dose group: 1000 mg / kg; the doses were calculated according to 5 times, 10 times, and 20 times of the recommended daily dosage of 6 tablets for a 60-kg human body), the model control group and the normal control group were given 9 mL / kg of normal saline, once a day, for 7 days in total.

[0109] b) Detection of the efficacy of clearing the lung and relieving cough

[0110] Once a day during the modeling period and at a total of 4 time points after the administration was completed, the cough latency (the time required from inhaling ammonia water aerosol to coughing) within 1 min and the number of coughs within 3 min of the rats after ammonia stimulation were detected respectively. The rats were sacrificed 24 h after the last administration, and lung tissue was taken for pathological section analysis.

[0111] (5)Experimental results

[0112] a) Establishment of the cough model by ammonia stimulation

[0113] Under the experimental conditions of this study, the rats in each group had normal diet and water intake and were lively during the modeling period. Figure 1The result graph of the effect of ammonia water stimulation on the cough latency of rats on the third day of model establishment; Figure 2 The result graph of the effect of ammonia water stimulation on the cough times of rats on the third day of model establishment (compared with the normal control group, ). Note: There is no latency in the normal control group.

[0114] From Figures 1 to 2 it can be seen that there is no cough behavior record in the normal control group; compared with the normal control group, the cough times of the model control group are significantly increased, p < 0.001; compared with the model control group, there are no significant differences in the cough times and cough latency of the rats in the positive control group and the experimental group, p > 0.05. The above results indicate that the establishment of the ammonia water-stimulated rat cough model is successful.

[0115] b) Evaluation of the effect of Qingyan Buccal Tablets in clearing the throat and relieving cough

[0116] Under the conditions of this experiment, the diet and drinking water of the rats in each group were normal during the model establishment period, and the mental state was lively. Figure 3 The result graph of the effect of ammonia water stimulation on the cough latency of rats after seven days of drug administration (compared with the model control group, ); Figure 4 The result graph of the effect of ammonia water stimulation on the cough times of rats after seven days of drug administration (compared with the normal control group, ; compared with the model control group, ). Table 3 shows the recorded results of cough times and latency after seven days of ammonia water stimulation.

[0117] Table 3 Record table of cough times and latency after seven days of ammonia water stimulation

[0118]

[0119] Note: Compared with the normal control group, ; compared with the model control group, , ; "-" indicates non-existence.

[0120] From Figures 3 to 4 and Table 2, it can be seen that there is no cough behavior record in the normal control group; compared with the model control group, the cough latency of the rats in experimental group 3 (high-dose group 1000 mg / kg) is significantly improved, , and the cough times are significantly decreased, .

[0121] c) Evaluation of pathological results

[0122] Figure 5a The result graph of the pathological staining of the lungs of rats in the normal control group after seven days of drug administration; Figure 5b The result graph of the pathological staining of the lungs of rats in the model control group after seven days of drug administration;Figure 5c It is the pathological staining result diagram of the lungs of rats in the positive control group after seven days of drug administration; Figure 5d It is the pathological staining result diagram of the lungs of rats in the low-dose group (250 mg / kg) after seven days of drug administration; Figure 5e It is the pathological staining result diagram of the lungs of rats in the medium-dose group (500 mg / kg) after seven days of drug administration; Figure 5f It is the pathological staining result diagram of the lungs of rats in the high-dose group (1000 mg / kg) after seven days of drug administration.

[0123] From Figures 5a to 5f It can be seen that under the experimental conditions, the alveolar interstitium of the lungs of rats in the model control group thickened, the lung tissue structure was unclear, and the capillaries expanded. The lung structures of rats in the positive control group and the high-dose group were significantly improved compared with the model control group. Specifically, the alveolar interstitium became thinner, and compensatory dilation occurred in some alveolar cavities compared with the normal control group.

[0124] 2. Human evaluation test

[0125] Using a random method, experimental groups were set up (22 people in each group, who respectively took the throat-clearing lozenges prepared in Examples 1-5 and Comparative Examples 1-7), taken sublingually every day, with a dosage of 6 tablets, and taken continuously for 7 days.

[0126] (1) Inclusion criteria

[0127] ① People aged 18-65, regardless of gender;

[0128] ② At least meet the following symptoms: sore throat, itchy throat, dry throat, etc.;

[0129] ③ Those who can cooperate and participate in the follow-up time of the experimental study, and can timely report their own health status or any changes in the food, adverse reaction symptoms, and can abide by the research requirements and time arrangements.

[0130] (2) Exclusion criteria

[0131] ① Suffering from important organ diseases such as heart, liver, lung, and kidney, blood diseases, neoplastic diseases, severe diseases such as bronchus and lung, etc.;

[0132] ② Subjects with major mental diseases, who have difficulty controlling their own behaviors and cannot cooperate;

[0133] ③ Those caused by acute exacerbation of chronic pharyngitis, acute pharyngitis, vocal cord nodules, colds or smoking factors;

[0134] ④ Those caused by nasopharyngeal, pharyngeal, laryngeal, nasal, laryngeal, esophageal, neck and tuberculosis, metastatic lung cancer lesions;

[0135] ⑤ Those who have used health foods or drugs related to the tested function within the past 1 month and affect the judgment of the results;

[0136] ⑥ Those who did not take the test sample as required or took other medications during the process, making it impossible to judge the efficacy or with incomplete data;

[0137] ⑦ Those with allergic constitution or allergic to the test products;

[0138] ⑧ Pregnant, planning to be pregnant or lactating women;

[0139] ⑨ Those who participated in or are participating in other clinical trials within the past 3 months;

[0140] ⑩ Those whom the researcher determines are not suitable to participate in this trial or are likely to be lost to follow-up.

[0141] (3) Observation indicators

[0142] Throat symptom score: sore throat (0 points for no symptom, 1 point for mild, 2 points for moderate, 3 points for severe), itchy throat (0 points for no symptom, 1 point for mild, 2 points for moderate, 3 points for severe), dry throat (0 points for no symptom, 1 point for mild, 2 points for moderate, 3 points for severe).

[0143] (4) Result determination

[0144] Each person was scored on the day before the first consumption of the throat-clearing lozenges and the day after the last consumption of the throat-clearing lozenges. The test results (taking the average score of each group) are shown in Table 4 below.

[0145] Table 4 Results of the human evaluation test

[0146]

[0147] 3. Sensory profile evaluation test

[0148] According to GB / 10220 General Principles of Sensory Analysis Methodology, a sensory profile evaluation test was carried out on the throat-clearing lozenges prepared in Example 2 and Examples 6 - 15 and the commercially available throat-clearing dropping pills Products 1 - 5. There were 16 evaluators in total. All evaluators first rinsed their mouths with water, and then tasted them in the order of commercially available throat-clearing dropping pills Products 1 - 5, the throat-clearing lozenges prepared in Example 2, and the throat-clearing lozenges prepared in Examples 6 - 15, and scored them one by one according to the tasting order; after tasting each sample, they rinsed their mouths with water and then tasted the next sample. The number of evaluation rounds was 2 rounds.

[0149] 16 evaluators scored the overall sensory of different samples. The specific scoring criteria are shown in Table 5 below.

[0150] Table 5 Sensory profile scoring table

[0151]

[0152] The scoring results are shown in Table 6 below.

[0153] Table 6 Sensory profile scoring results

[0154]

[0155] Note: " / " indicates non-existence.

[0156] As can be seen from the above results, the use of β-cyclodextrin and γ-cyclodextrin alone in the composition is not very effective in masking bitterness and astringency; while when β-cyclodextrin and γ-cyclodextrin are used in combination at a certain mass ratio, they have good masking effects on both bitterness and astringency.

[0157] The above are only the preferred embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A throat-clearing and throat-soothing composition, wherein, The composition includes an extraction mixture, and the raw material components of the extraction mixture are as follows by weight: 15-55 parts by weight of honeysuckle, 60-90 parts by weight of momordica grosvenori, 60-90 parts by weight of platycodon grandiflorum, 3-12 parts by weight of mint, 70-100 parts by weight of dried tangerine peel, 5-15 parts by weight of dendrobium officinale, 60-90 parts by weight of citron.

2. The throat-clearing and throat-soothing composition according to claim 1, wherein, The raw material components of the extraction mixture are as follows by weight: 25-35 parts by weight of honeysuckle, 70-80 parts by weight of momordica grosvenori, 80-90 parts by weight of platycodon grandiflorum, 3-8 parts by weight of mint, 85-95 parts by weight of dried tangerine peel, 5-10 parts by weight of dendrobium officinale, 80-90 parts by weight of citron.

3. The throat-clearing and throat-soothing composition according to claim 1, wherein, The composition further includes cyclodextrin, and the mass ratio of the extraction mixture to the cyclodextrin is (20-30):

1.

4. The throat-clearing and throat-soothing composition according to claim 3, wherein, The cyclodextrin includes β-cyclodextrin and γ-cyclodextrin.

5. The throat-clearing and throat-soothing composition according to claim 4, wherein, The mass ratio of the β-cyclodextrin to the γ-cyclodextrin is 10:(4-10).

6. The throat-clearing and voice-clearing composition according to claim 1, wherein, The preparation method of the extraction mixture includes the steps: Mix honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron, and then add water for extraction to obtain an extraction solution; Concentrate the extraction solution to obtain a concentrated solution; Centrifuge the concentrated solution, take the supernatant and filter it, and collect the filtrate; Dry the filtrate to obtain the extraction mixture.

7. The throat-soothing composition according to claim 6, wherein, The temperature of the extraction is 90-100°C, the number of extractions is 3-4 times, and the time for each extraction is 1-3 h; The weight of the water is 4-8 times the total weight of honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, dried tangerine peel, dendrobium officinale and citron; The relative density of the concentrated solution is 1.05-1.15; The rotation speed of the centrifugation is 6000-8000 rpm, and the time for the centrifugation is 10-15 min; The drying is spray drying, the inlet temperature of the spray drying is 130-160°C, and the outlet temperature is 80-90°C.

8. The throat-clearing and throat-soothing composition according to any one of claims 1-7, wherein The composition further includes at least one of kumquat powder, lemon powder and sweetener.

9. The throat-clearing and voice-calming composition according to claim 8, wherein, The sweetener includes at least one of sucralose and stevioside.

10. A method for preparing the throat-clearing and throat-soothing composition according to any one of claims 3-7, wherein, Including the steps: Incorporate the extraction mixture with a saturated aqueous solution of cyclodextrin to obtain the throat-soothing composition.

11. The preparation method according to claim 10, wherein, The temperature of the incorporation is 35-55°C; continuous stirring is carried out for 1-3 h during the incorporation process.

12. The preparation method according to claim 10, wherein, After the incorporation, it further includes the steps of filtration and drying.

13. Use of the throat-soothing composition according to any one of claims 1-9 or the throat-soothing composition prepared by the method according to any one of claims 10-12 in the preparation of products for improving throat discomfort.

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