Throat-clearing composition as well as preparation method and application thereof

Abstract

The invention provides a throat clearing composition and a preparation method and application thereof, the throat clearing composition comprises an extraction mixture, and the extraction mixture comprises the following raw material components in parts by weight, comprising the following components in parts by weight: 15-55 parts of honeysuckle, 60-90 parts of momordica grosvenori, 60-90 parts of platycodon grandiflorum, 3-12 parts of mint, 70-100 parts of pericarpium citri reticulatae, 5-15 parts of dendrobium officinale and 60-90 parts of citron. According to the throat-clearing composition disclosed by the invention, the medicinal and edible raw materials including the honeysuckle flower, the fructus momordicae, the herba menthae, the radix platycodonis, the pericarpium citri reticulatae, the herba dendrodii officinalis and the fructus citri are cooperatively used, so that the prepared throat-clearing composition has the effect of relieving throat diseases; in addition, after proper cyclodextrin is adopted to carry out reasonable inclusion on an extraction mixture, the bitter taste value is low, the taste is good, and the method can be better applied to development of related products.

Description

Technical Field

[0001] The present application relates to the technical field of functional foods, and in particular to a throat clearing and relieving composition and a preparation method and application thereof. Background Art

[0002] The throat is an important immune organ of humans. Many infectious diseases are closely related to the throat. Patients often feel sore throats, accompanied by symptoms such as stiffness, discomfort in the throat, dry throat, or foreign body sensation in the eyes, which belong to the category of "throat paralysis" in traditional Chinese medicine. Throat diseases are often caused by viruses and bacteria. Throat diseases can also be divided into acute and chronic diseases. Common symptoms include throat discomfort, voice changes, coughing and clearing the throat. With the increase of consumers' health awareness, products with relevant effects are emerging in the market, but most of them have problems such as strong taste of traditional Chinese medicine, too strong irritation or heavy taste, which limits the user group to a certain extent. Therefore, it is also necessary to develop a throat clearing and throat relieving composition with good taste. Summary of the invention

[0003] The purpose of the present application is to provide a throat clearing and relieving composition and its preparation method and application. The throat clearing and relieving composition has significant efficacy in relieving throat symptoms, low bitterness value, good taste, and can be better applied to the development of related products. The specific technical solution is as follows:

[0004] The first aspect of the present application provides a throat clearing and relieving composition, wherein the composition comprises an extraction mixture, and the raw material components of the extraction mixture, measured by weight, include: 15-55 weight parts of honeysuckle, 60-90 weight parts of monk fruit, 60-90 weight parts of platycodon, 3-12 weight parts of mint, 70-100 weight parts of tangerine peel, 5-15 weight parts of dendrobium officinale, and 60-90 weight parts of citron.

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

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

[0007] In some embodiments of the present 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 the present application, the method for preparing the extraction mixture comprises the steps of:

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

[0010] Concentrating the extract to obtain a concentrated solution;

[0011] Centrifuging the concentrated solution, filtering the supernatant, and collecting the filtrate;

[0012] The filtrate is dried 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 hours;

[0014] The weight of the water is 4-8 times the total weight of the honeysuckle, momordica grosvenori, mint, platycodon, 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 concentrate is 1.05-1.15;

[0016] The centrifugal speed is 6000-8000rpm, and the centrifugal time is 10-15min;

[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 kumquat powder, lemon powder and a sweetener; preferably, the sweetener comprises at least one of sucralose and steviol glycoside.

[0019] The second aspect of the present application provides a method for preparing a throat clearing and relieving throat composition, which comprises the steps of:

[0020] The extraction mixture described in the first aspect of the present application is included in a saturated aqueous solution of cyclodextrin to obtain the throat clearing and relieving composition.

[0021] In some embodiments of the present application, the inclusion temperature is 35-55°C; stirring is continued for 1-3 hours during the inclusion process; preferably, the inclusion further includes filtering and drying steps.

[0022] The third aspect of the present application provides the use of the throat clearing and relieving composition described in the first aspect of the present application or the throat clearing and relieving composition prepared according to the method described in the second aspect of the present application in the preparation of a product for improving throat discomfort.

[0023] Beneficial effects of this application:

[0024] The present application uses the medicinal and edible raw materials of honeysuckle, monk fruit, mint, platycodon, tangerine peel, dendrobium officinale and citron to prepare a throat-clearing and throat-relief composition that has a significant effect in relieving throat symptoms; in addition, after the extraction mixture is reasonably encapsulated with appropriate cyclodextrin, the bitterness value is low and the taste is good, which can be better applied to the development of related dosage form products. In addition, the preparation method of the throat-clearing and throat-relief composition provided in the present application is simple and controllable, and can be mass-produced.

[0025] Of course, implementing any product or method of the present application does not necessarily require achieving all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application, and a person skilled in the art can also obtain other embodiments based on these drawings.

[0027] Figure 1 This is the result of the effect of ammonia stimulation on the cough latency of rats on the third day of modeling;

[0028] Figure 2 The results of the effect of ammonia stimulation on the number of rat coughs on the third day of modeling (compared with the normal control group, );

[0029] Figure 3 The results of the seven-day ammonia stimulation on the cough latency of rats (compared with the model control group, );

[0030] Figure 4 The results of the seven-day ammonia stimulation on the number of rat coughs (compared with the normal control group, Compared with the model control group, );

[0031] Figure 5a This is the lung pathological staining result of rats in the normal control group that were given the drug for seven days;

[0032] Figure 5b This is the lung pathological staining result of rats in the model control group that were given the drug for seven days;

[0033] Figure 5c This is the lung pathological staining result of rats in the positive control group that were given the drug for seven days;

[0034] Figure 5d This is the lung pathological staining result of rats in the low-dose group (250mL / kg) that were given medicine for seven days;

[0035] Figure 5e This is the lung pathological staining result of rats in the medium-dose group (500mL / kg) that were administered for seven days;

[0036] Figure 5f This is the result of lung pathological staining of rats in the high-dose group (1000mL / kg) that were administered for seven days. DETAILED DESCRIPTION

[0037] The following will be combined with the embodiments of the present application and the accompanying drawings to clearly and completely describe the technical solutions in the present application. Obviously, the described embodiments are only 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 relieving composition, wherein the composition comprises an extraction mixture, and the raw material components of the extraction mixture, measured by weight, include: 15-55 weight parts of honeysuckle, 60-90 weight parts of monk fruit, 60-90 weight parts of platycodon, 3-12 weight parts of mint, 70-100 weight parts of tangerine peel, 5-15 weight parts of dendrobium officinale, and 60-90 weight parts of citron.

[0039] The present application adopts the synergistic use of raw materials of both medicinal and edible origin, namely honeysuckle, monk fruit, mint, platycodon, tangerine peel, dendrobium officinale and citron, which has a significant effect in relieving throat diseases.

[0040] In some embodiments of the present application, the raw material components of the extraction mixture, measured by weight, include: 25-35 parts by weight of honeysuckle, 70-80 parts by weight of monk fruit, 80-90 parts by weight of platycodon, 3-8 parts by weight of mint, 85-95 parts by weight of 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 comprises 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 the cyclodextrin may be 20:1, 22:1, 24:1, 26:1, 28:1, 30:1 or a range consisting of any two ratios therebetween. The present application controls the mass ratio of the extraction mixture to the cyclodextrin within the above range, which is conducive to better inclusion of the extraction mixture by the cyclodextrin, greatly reducing the bitterness value of the prepared throat clearing and throat relieving 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 a range consisting of any two numerical ratios therebetween. The present application controls the mass ratio of β-cyclodextrin to γ-cyclodextrin within the above range, which is conducive to better inclusion of effective ingredients by cyclodextrin, greatly reducing the bitterness value of the throat clearing and throat relieving composition, and improving the taste.

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

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

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

[0047] S3: centrifuging the concentrated solution, filtering the supernatant, and collecting the filtrate;

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

[0049] The present application has no particular limitation on the filtering method in step S3, as long as the purpose of the invention of the present application can be achieved. For example, gauze can be used for filtering 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 time of each extraction is 1-3h, and the weight of the water is 4-8 times the total weight of the honeysuckle, monk fruit, mint, platycodon, 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 a range consisting of any two values ​​therebetween; the time of each extraction can be 1h, 1.5h, 2h, 2.5h, 3h or a range consisting of any two values ​​therebetween; the weight of the water can be 4 times, 5 times, 6 times, 7 times, 8 times the total weight of honeysuckle, monk fruit, mint, platycodon, tangerine peel, dendrobium officinale and citron or a range consisting of any two values ​​therebetween. The present application controls the amount of water, the extraction temperature, and the time of each extraction within the above range, which is conducive to better extracting the effective ingredients in honeysuckle, momordica grosvenori, mint, platycodon, tangerine peel, dendrobium officinale, and citron.

[0051] In some embodiments of the present application, in step S2, the relative density of the concentrate is 1.05-1.15. The relative density described in the present application refers to the density relative to water, which is measured at room temperature, such as 25°C. In some embodiments of the present application, the relative density of the concentrate can be 1.05, 1.07, 1.10, 1.12, 1.15 or a range consisting of any two values ​​therebetween. The present application controls the relative density of the concentrate within the above range, which is conducive to better subsequent centrifugal separation and minimizes the loss of active ingredients.

[0052] In some embodiments of the present application, in step S4, the centrifugal speed is 6000-8000rpm, and the centrifugal time is 10-15min. In some embodiments of the present application, the centrifugal speed can be 6000rpm, 6200rpm, 6400rpm, 6600rpm, 6800rpm, 7000rpm, 7200rpm, 7400rpm, 7600rpm, 7800rpm, 8000rpm or a range consisting of any two values ​​therebetween; the centrifugal time can be 10min, 11min, 12min, 13min, 14min, 15min or a range consisting of any two values ​​therebetween. The present application controls the centrifugal speed and the centrifugal time within the above range, which is conducive to subsequent better centrifugal separation and minimizes the loss of effective ingredients.

[0053] In some embodiments of the present application, in step S4, the drying is spray drying, and 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 a range consisting 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 a range consisting of any two values ​​therebetween. The present application controls the inlet temperature and outlet temperature of the spray drying within the above range, which is conducive to better drying while minimizing the loss of effective ingredients.

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

[0055] In some embodiments of the present application, the sweetener includes at least one of sucralose and steviol glycoside.

[0056] In some embodiments of the present application, the throat clearing and relieving composition can be formulated into a pharmaceutically acceptable preparation; preferably, the throat clearing and relieving composition is formulated into any one of the dosage forms of granules, oral liquids, pills, tablets or capsules.

[0057] The present application adopts the synergistic use of raw materials of both medicinal and edible origin, namely honeysuckle, momordica grosvenori, mint, platycodon, tangerine peel, dendrobium officinale and citron, and adopts appropriate cyclodextrin to reasonably encapsulate the extraction mixture. The prepared throat-clearing and throat-relief composition has low bitterness value and good taste, and can be better applied to the development of related products.

[0058] The second aspect of the present application provides a method for preparing a throat clearing and relieving throat composition, which comprises the steps of:

[0059] The extraction mixture described in the first aspect of the present application is included in a saturated aqueous solution of cyclodextrin to obtain the throat clearing and relieving composition.

[0060] The inclusion described in the present application refers to mixing the extraction mixture described in the first aspect of the present application with a saturated aqueous solution of cyclodextrin, and then continuously stirring to perform inclusion.

[0061] The preparation method of the throat clearing and relieving composition provided in the present 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 the present application, in the preparation method of the throat clearing and throat relieving composition, the inclusion temperature is 35-55°C; the inclusion process is continuously stirred for 1-3h. In some embodiments of the present application, the inclusion temperature can be 35°C, 37°C, 40°C, 42°C, 45°C, 47°C, 50°C, 52°C, 55°C or a range consisting of any two values ​​therebetween; the time of continuous stirring during the inclusion process can be 1h, 1.5h, 2h, 2.5h, 3h or a range consisting of any two values ​​therebetween. The present application controls the inclusion temperature and the continuous stirring time within the above range, which is conducive to better inclusion and extraction of the mixture by cyclodextrin, greatly reducing the bitterness value of the prepared throat clearing and throat relieving composition, and improving the taste.

[0063] In some embodiments of the present application, in the preparation method of the throat clearing and throat relieving composition, the steps of filtering and drying are further included after the inclusion. According to the dosage form requirements of the throat clearing and throat relieving composition, drying can be performed after the inclusion, and the obtained product can be prepared into dosage forms such as granules, tablets, and capsules.

[0064] In some embodiments of the present application, when the composition further includes at least one of green kumquat powder, lemon powder and sweetener, in the preparation method of the throat clearing and throat relieving composition, the inclusion further includes a mixing step, that is, the product after the extraction mixture is included by a saturated aqueous solution of cyclodextrin and at least one of green kumquat powder, lemon powder and sweetener are mixed. In some embodiments of the present application, the mixing step is performed after drying.

[0065] The third aspect of the present application provides the use of the throat clearing and relieving composition described in the first aspect of the present application or the throat clearing and relieving composition prepared according to the method described in the second aspect of the present application in the preparation of a product for improving throat discomfort.

[0066] The Chinese medicine compound oral liquid prepared by using the throat clearing and throat relieving composition of the present application has a good taste and has a good throat clearing and throat relieving effect. The Chinese medicine compound lozenge prepared by using the throat clearing and throat relieving composition of the present application has a good taste and has a more significant effect of relieving throat pain and throat relieving syndrome.

[0067] The terms used in this application, unless otherwise specified or defined, have their general meanings known to those skilled in the art.

[0068] Hereinafter, the embodiments of the present application will be described in more detail with reference to Examples and Comparative Examples. Various tests and evaluations were performed according to the following methods. In addition, unless otherwise specified, "parts" and "%" are by mass.

[0069] Example 1

[0070] S1: Weigh the following raw material components respectively: 15g honeysuckle, 60g monk fruit, 60g platycodon, 3g mint, 70g tangerine peel, 5g dendrobium officinale, 60g citron. Mix the above raw material components, then add water for extraction 3 times, the weight of each water added is 6 times the total weight of honeysuckle, monk fruit, mint, platycodon, tangerine peel, dendrobium officinale and citron, the time of each extraction is 2h, and the temperature of each extraction is 90℃. The extracts obtained 3 times are 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 concentrate at 6000 rpm for 10 min, take the supernatant and filter it with gauze to collect the filtrate.

[0073] S4: spray drying the filtrate at an inlet temperature of 130°C and an outlet temperature of 80°C, collecting the dried product to obtain an extraction mixture.

[0074] S5: The above-mentioned extraction mixture is encapsulated with a saturated aqueous solution of cyclodextrin to obtain a throat-clearing and throat-removing composition; wherein the mass ratio of the extraction mixture to cyclodextrin is 20:1, and the cyclodextrin is β-cyclodextrin and γ-cyclodextrin in a mass ratio of 10:8; the inclusion temperature is 35°C, stirred for 1 hour, filtered, the filtrate is removed and dried to obtain the throat-clearing and throat-removing composition.

[0075] S6: After uniformly mixing 3.77 kg of the above-mentioned throat clearing and relieving composition, 5.86 kg of isomalt, 0.05 kg of silicon dioxide, 0.2 kg of magnesium stearate and 0.12 kg of citric acid, the mixture was placed in a tablet press to obtain a smooth and complete throat clearing lozenge weighing 0.6 g.

[0076] Example 2

[0077] S1: Weigh the following raw material components respectively: 30g honeysuckle, 75g monk fruit, 85g platycodon, 5g mint, 90g tangerine peel, 8g dendrobium officinale, 85g citron. Mix the above raw material components, then add water for extraction 3 times, the weight of each water added is 10 times the total weight of honeysuckle, monk fruit, mint, platycodon, tangerine peel, dendrobium officinale and citron, the time of each extraction is 0.5h, and the temperature of each extraction is 95℃. The extracts obtained 3 times are 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 concentrate at 8000 rpm for 15 min, take the supernatant and filter it with gauze to collect the filtrate.

[0080] S4: spray drying the filtrate with an inlet temperature of 160°C and an outlet temperature of 90°C, collecting the dried product to obtain an extraction mixture.

[0081] S5: The above-mentioned extraction mixture is encapsulated with a saturated aqueous solution of cyclodextrin to obtain a throat clearing and relieving throat composition; wherein the mass ratio of the extraction mixture to cyclodextrin is 25:1, and the cyclodextrin is β-cyclodextrin and γ-cyclodextrin in a mass ratio of 10:8; the inclusion temperature is 45°C, stirred for 2h, filtered, the filtrate is removed and dried to obtain the throat clearing and relieving throat composition.

[0082] S6: After uniformly mixing 3.77 kg of the above-mentioned throat clearing and relieving composition, 5.86 kg of isomalt, 0.05 kg of silicon dioxide, 0.2 kg of magnesium stearate and 0.12 kg of citric acid, the mixture was placed in a tablet press to obtain a smooth and complete throat clearing lozenge weighing 0.6 g.

[0083] Embodiment 3-5

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

[0085] Embodiment 6-15

[0086] Except for adjusting the type and ratio of cyclodextrin as shown in Table 2, the rest is the same as Example 2.

[0087] Comparative Examples 1-7

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

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

[0090] Table 2 Cyclodextrin types and ratios in different embodiments

[0091] The efficacy of the throat-clearing lozenges prepared in the examples and comparative examples of the present application is described below through efficacy tests.

[0092] 1. Efficacy experiment in rats

[0093] (1) Sample preparation

[0094] Positive control group: Children's cough syrup, directly used for medication.

[0095] Experimental group 1: Take an appropriate amount of the Qingyan 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, mix well and prepare a 50 mg / mL working solution.

[0096] Experimental group 2: Take an appropriate amount of the Qingyan 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, mix well and prepare a 100 mg / mL working solution.

[0097] Experimental group 3: Take an appropriate amount of the Qingyan 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 200 mg / mL working solution.

[0098] (2) Animal information

[0099] SD rats, weighing 160-180 g, half male and half female, a total of 60 rats.

[0100] The experimental animals were provided by Sbefor (Suzhou) Biological Co., Ltd. (China), certificate: SCXK (Suzhou) 2022-0006.

[0101] (3) Instruments, consumables and reagents

[0102] Micropipette (Eppendorf, Germany); biological safety cabinet (HFsafe-1500LC, HealForce Likang Biomedical Technology Holdings Co., Ltd.); RNase bagged tips (EXTRAGENE, USA); rat gavage needle (No. 16, Jinuotai Technology Development Co., Ltd.); inverted fluorescence microscope (ICX41, Sunny Optical Technology (Group) Co., Ltd.); dissecting instruments, small animal anesthesia machine (R500IE, Shenzhen Ruiwode Life Science Co., Ltd.); biological tissue embedding machine (YD-6L, Jinhua Yidi Medical Equipment Co., Ltd.); water-proof constant temperature incubator (GNP-9270, Shanghai Jinghong Experimental Equipment Co., Ltd.); rotary slicer (MT1, Dakoway (Shenzhen) Medical Equipment Co., Ltd.); compressed nebulizer (NE-C25S, Zhongshan Quankang Medical Technology Co., Ltd.).

[0103] (4) Experimental methods

[0104] a) Ammonia-induced cough model and intragastric gavage intervention

[0105] After adaptive feeding, all rats were randomly divided into 6 groups: normal control group, model control group, positive control group, and experimental group (3 doses), with 7 rats in each group.

[0106] After the SD rat cough model was established by nebulizing 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 every day, and the experimental group was given clear throat lozenge solution by oral gavage every day (250 mg / kg for low-dose group, 500 mg / kg for medium-dose group, and 1000 mg / kg for high-dose group: the dosage was calculated according to 5 times, 10 times, and 20 times the recommended daily dosage of 6 tablets for 60 kg of human body), respectively. The model control group and the normal control group were given 9 mL / kg of normal saline once a day for 7 days.

[0107] b) Lung-clearing and cough-relieving efficacy test

[0108] The rats were tested for cough latency (the time required for coughing after inhalation of ammonia mist) within 1 minute and the number of coughs within 3 minutes after ammonia stimulation once a day during the modeling period and at 4 time points after the administration. The rats were killed 24 hours after the last administration and the lung tissues were taken for pathological section analysis.

[0109] (5) Experimental results

[0110] a) Construction of ammonia-induced cough model

[0111] Under the conditions of this experiment, rats in each group had normal diet and drinking water during the modeling period and were in an active mental state. Figure 1This is the result of the effect of ammonia stimulation on the cough latency of rats on the third day of modeling; Figure 2 The results of the effect of ammonia stimulation on the number of rat coughs on the third day of modeling (compared with the normal control group, ). Note: There is no incubation period in the normal control group.

[0112] from Figure 1 to Figure 2 It can be seen that there is no record of coughing behavior in the normal control group; compared with the normal control group, the number of coughs in the model control group increased significantly, p<0.001; compared with the model control group, there was no significant difference in the number of coughs and cough latency between the positive control group and the experimental group, p>0.05. The above results show that the ammonia-stimulated rat cough model was established.

[0113] b) Evaluation of the efficacy of Qingyan lozenges in clearing the lungs and relieving cough

[0114] Under the conditions of this experiment, rats in each group had normal diet and drinking water during the modeling period and were in an active mental state. Figure 3 The results of the seven-day ammonia stimulation on the cough latency of rats (compared with the model control group, ); Figure 4 The results of the seven-day ammonia stimulation on the number of rat coughs (compared with the normal control group, Compared with the model control group, Table 3 shows the recorded results of the number of coughs and latency after ammonia stimulation for seven days.

[0115] Table 3 Record of cough frequency and latency after ammonia stimulation for seven days after administration

[0116] Note: Compared with the normal control group, Compared with the model control group, , ; “-” means it does not exist.

[0117] from Figure 3 to Figure 4 As can be seen from Table 2, there was no record of coughing behavior in the normal control group; compared with the model control group, the cough latency of rats in experimental group 3 (high-dose group 1000 mg / kg) was significantly increased. , and the number of coughs decreased significantly, .

[0118] c) Evaluation of pathological results

[0119] Figure 5a This is the lung pathological staining result of rats in the normal control group that were given the drug for seven days; Figure 5b This is the lung pathological staining result of rats in the model control group that were given the drug for seven days; Figure 5cThis is the lung pathological staining result of rats in the positive control group that were given the drug for seven days; Figure 5d This is the lung pathological staining result of rats in the low-dose group (250mL / kg) that were given medicine for seven days; Figure 5e This is the lung pathological staining result of rats in the medium-dose group (500mL / kg) that were administered for seven days; Figure 5f This is the result of lung pathological staining of rats in the high-dose group (1000mL / kg) that were administered for seven days.

[0120] from Figure 5a to Figure 5f It can be seen that under the experimental conditions, the alveolar interstitium of the lungs of rats in the model control group was thickened, the lung tissue structure was unclear, and the capillaries were dilated. The lung structure of rats in the positive control group and high-dose group was significantly improved compared with the model control group, which was specifically manifested in thinning of the alveolar interstitium and compensatory expansion of some alveolar cavities compared with the normal control group.

[0121] 2. Human evaluation test

[0122] The test groups (each group = 22 persons, taking the throat clearing lozenges prepared in Examples 1-5 and Comparative Examples 1-7, respectively) were randomly set up and taken 6 lozenges per day for 7 consecutive days.

[0123] (1) Inclusion criteria

[0124] ① People aged 18-65, regardless of gender;

[0125] ② At least the following symptoms are met: sore throat, itchy throat, dry throat, etc.;

[0126] ③ Those who can cooperate with and participate in the follow-up time of the experimental research, and promptly report any changes in their own health status or food, adverse reaction symptoms, and can comply with the research requirements and time arrangements.

[0127] (2) Exclusion criteria

[0128] ① Suffering from diseases of important organs such as heart, liver, lung, kidney, blood diseases, tumor diseases, bronchial and lung diseases, etc.;

[0129] ② Subjects with serious mental illness who have difficulty controlling their behavior and are unable to cooperate;

[0130] ③ Patients in acute attack stage of chronic pharyngitis or those caused by acute pharyngitis, vocal cord nodules, cold or smoking;

[0131] ④ Those caused by lesions of the nasopharynx, pharynx, larynx, nose, larynx, esophagus, neck, tuberculosis, and metastatic lung cancer;

[0132] ⑤ Those who have used health foods or drugs related to the tested function in the past month, which may affect their judgment of the results;

[0133] ⑥ Those who fail to take the test sample as prescribed or take other drugs during the test, and the efficacy cannot be judged or the data is incomplete;

[0134] ⑦ Those with allergic constitution or allergic to the test product;

[0135] ⑧ Women who are pregnant, planning to become pregnant or breastfeeding;

[0136] ⑨ Participated in or is participating in other clinical trials in the past 3 months;

[0137] ⑩ Those who are judged by the researchers to be unsuitable to participate in this trial or are likely to be lost to follow-up.

[0138] (3) Observation indicators

[0139] Throat symptom scores: pharyngeal pain (0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms), pharyngeal itching (0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms), and dry throat (0 points for no symptoms, 1 point for mild symptoms, 2 points for moderate symptoms, and 3 points for severe symptoms).

[0140] (4) Result determination

[0141] Each person scored one day before taking the Qingyan lozenge for the first time and one day after taking the Qingyan lozenge for the last time. The test results (taking the average score of each group) are shown in Table 4 below.

[0142] Table 4 Human evaluation test results

[0143] 3. Sensory profile evaluation test

[0144] According to the general theory of sensory analysis methodology of GB / 10220, the Qingyan lozenges prepared in Example 2 and Example 6-15 and the commercial Qingyan dripping pills products 1-5 were subjected to sensory profile evaluation test. There were 16 evaluators in total, and all the evaluators first rinsed their mouths with water, and then tasted the Qingyan lozenges prepared in the order of commercial Qingyan dripping pills products 1-5, Example 2, and Example 6-15, and scored them one by one according to the tasting order; rinsed their mouths with water after tasting each sample, and then tasted the next sample. The number of evaluation rounds was 2 rounds.

[0145] 16 evaluators scored the overall sensory quality of different samples. The specific scoring criteria are shown in Table 5 below.

[0146] Table 5 Sensory profile scoring table

[0147] The scoring results are shown in Table 6 below.

[0148] Table 6 Sensory profile scoring results

[0149] Note: “ / ” means does not exist.

[0150] From the above results, it can be seen that when β-cyclodextrin and γ-cyclodextrin are used alone in the composition, the masking effect of bitterness and astringency is not very good; however, when β-cyclodextrin and γ-cyclodextrin are used together in a certain mass ratio, they have a good masking effect on both bitterness and astringency.

[0151] The above description is only a preferred embodiment of the present application and is 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 in the scope of protection of the present application.

Claims

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

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

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

1.

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

5. The throat clearing and relieving 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 relieving composition according to claim 1, wherein: The method for preparing the extraction mixture comprises the steps of: Mix honeysuckle, momordica grosvenori, mint, platycodon grandiflorum, tangerine peel, dendrobium officinale and citron, add water for extraction, and obtain an extract; Concentrating the extract to obtain a concentrated solution; Centrifuging the concentrated solution, filtering the supernatant, and collecting the filtrate; The filtrate is dried to obtain the extraction mixture.

7. The throat clearing and relieving composition according to claim 6, wherein: The extraction temperature is 90-100°C, the extraction times are 3-4 times, and the extraction time for each time is 1-3h; The weight of the water is 4-8 times the total weight of the honeysuckle, monk fruit, mint, platycodon, tangerine peel, dendrobium officinale and citron; The relative density of the concentrated solution is 1.05-1.15; The centrifugal speed is 6000-8000rpm, and the centrifugal time is 10-15min; 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 relieving composition according to any one of claims 1 to 7, wherein: The composition further comprises: at least one of green kumquat powder, lemon powder and a sweetener.

9. The throat clearing and relieving composition according to claim 8, wherein: The sweetener includes at least one of sucralose and steviol glycoside.

10. A method for preparing the throat clearing and relieving composition according to any one of claims 3 to 7, wherein: Includes steps: The extraction mixture is included in a cyclodextrin saturated aqueous solution to obtain the throat clearing and relieving composition.

11. The preparation method according to claim 10, wherein: The inclusion temperature is 35-55° C.; stirring is continued for 1-3 hours during the inclusion process.

12. The preparation method according to claim 10, wherein: The method further comprises filtering and drying steps after the inclusion.

13. Use of the throat clearing and relieving composition according to any one of claims 1 to 9 or the throat clearing and relieving composition prepared according to any one of claims 10 to 12 in preparing a product for improving throat discomfort.

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