Plant extraction complexing agent as well as preparation method and application thereof

Abstract

The invention relates to a plant extraction complexing agent as well as a preparation method and application thereof. The plant extraction complexing agent is prepared from the following raw material components: rhizoma zingiberis, flos caryophylli, cortex cinnamomi, herba schizonepetae, fructus evodiae, radix aucklandiae, pepper, fennel, herba asari, pericarpium zanthoxyli, fistular onion stalk and radix ginseng. The hot-pungent / warm-pungent herbal medicine plants are selected and contain rich volatile oil, and sesquiterpenoids, monoterpenoids and aromatic compounds contained in the latter have a transdermal penetration enhancing effect, are suitable for in-vitro application, have the effects of stimulating an immune system, resisting inflammation, resisting viruses, easing pain and the like and are prepared into the instant granules through a special proportion formula. When in use, the sauna / atomization mode is utilized to promote the active ingredients to enter the body to stimulate the immune system so as to achieve the anti-inflammatory and anti-virus effects. The plant extract complexing agent provided by the invention can increase the total number of leukocytes, increase the number of lymphocytes and adjust the percentage distribution of unbalanced neutrophils and lymphocytes to tend to be normalized, and the effect shows a good dose-effect relationship.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of plant extract, in particular to a plant extraction composite agent, a preparation method and application thereof. BACKGROUND

[0002] Common cold is an upper respiratory tract infectious disease caused by various viruses such as rhinovirus and coronavirus. Although it is generally considered as a self-limiting disease, its impact on individual health and public health cannot be ignored. Common cold not only causes symptoms such as headache, fever, cough, sore throat and general malaise, but also significantly reduces the quality of life and work efficiency of patients. In addition, for the elderly, children and people with weak immunity, common cold can cause serious complications such as bronchitis, pneumonia and even cardiovascular diseases. According to statistics, common cold causes huge economic burden worldwide every year, including medical expenses and economic losses due to absence from work. Therefore, it is of great practical significance to prevent common cold and improve immunity.

[0003] Currently, the commonly used immune enhancer in clinic mainly includes Pidotimod. As an immunomodulator, Pidotimod enhances the non-specific immunity of the body by activating macrophages and T lymphocytes. However, this drug has certain limitations in practical application. First, its mechanism of action is not completely clear, and the therapeutic effect varies greatly among individuals; second, long-term use may lead to drug resistance or side effects such as gastrointestinal discomfort and allergic reactions. In addition, Pidotimod is relatively expensive, which limits its popular application in large populations. Therefore, developing a safer, more effective and economical alternative therapy has become the focus of current research.

[0004] In recent years, the potential of traditional herbal plants in enhancing immunity has attracted widespread attention. Many herbs such as dried ginger, clove, ginseng and cumin are widely used in traditional Chinese medicine treatment due to their natural origin and multiple biological activities. These pungent / hot herbs contain rich volatile oils, which contain sesquiterpenes, monoterpenes and aromatic compounds, have transdermal penetration effect, are suitable for in vitro application, and have the effects of stimulating the immune system, anti-inflammatory, antiviral and analgesic. Studies have shown that these herbs are rich in polysaccharides, saponins and flavonoids, which can enhance the body's immunity by regulating immune cell function, promoting cytokine secretion and antioxidant effects. Compared with chemically synthesized drugs, herbal preparations have the advantages of small toxic and side effects, low price and easy access. In addition, traditional Chinese medicine theory emphasizes "supporting the body and eliminating pathogens", that is, by regulating the overall function of the human body to resist diseases, which provides a unique perspective for the prevention of common cold. SUMMARY

[0005] Based on the above description, the present application provides a plant extraction composite agent, a preparation method and application thereof, to solve the problems of high cost and large side effects of existing immunomodulators.

[0006] The technical solution of the present application to solve the above technical problems is as follows: The present application provides a plant extraction composite agent, comprising the following raw material components: Dried ginger, clove, cassia, catnip, evodia, costus, pepper, fennel, asarum, zanthoxylum, onion white and ginseng.

[0007] Further, the external use plant extraction composite agent comprises the following raw material components in terms of mass fraction: Dried ginger 2 parts, clove 1 part, cassia 1 part, catnip 1 part, evodia 2 parts, costus 1 part, pepper 2 parts, fennel 1 part, asarum 1 part, zanthoxylum 2 parts, onion white 6 parts, and ginseng 1 part.

[0008] The present application also provides a preparation method of the plant extraction composite agent as described above, comprising the following steps: S1. After the raw materials are crushed, they are mixed with water and heated to reflux, the volatile oil phase is collected, the raw materials are filtered, and the water phase is collected; S2. The water phase is concentrated and mixed with the volatile oil phase, and dried to obtain the plant extraction composite agent.

[0009] Further, in step S1, the mass ratio of the raw materials to water is 1: (5-7).

[0010] Further, in step S2, the water phase is concentrated by rotary evaporation. The pressure of the rotary evaporation is 0.1-0.5 MPa.

[0011] Further, in step S2, in the drying step, spray drying is used to prepare particles for standby.

[0012] The present application also provides the use of the plant extraction composite agent as described above in the preparation of a preparation for preventing viral respiratory tract infection.

[0013] The present application also provides the use of the plant extraction composite agent as described above in the preparation of an immune enhancer.

[0014] Further, the immune enhancer is an in vitro and inhalation type bidirectional immune enhancer.

[0015] The present application also provides an external agent comprising the plant extraction composite agent as described above, wherein the content of the plant extraction composite agent in the external agent is 15-60 mg / mL.

[0016] Compared with the prior art, the technical solution of the present application has the following beneficial technical effects: 1. The plant extraction complex provided by the present application can greatly reduce the occurrence and development of colds and influenza, effectively avoid the occurrence of complications of colds and influenza, and play a positive role in protecting human body health when used in the early stage of colds and influenza. 2. The plant extraction complex provided by the present application can significantly improve the thymus weight and spleen weight of dexamethasone-induced immunocompromised mice, and their thymus coefficient and spleen coefficient, showing a good effect of improving the immune function of the body, and can improve the abnormal distribution of total white blood cell count, neutrophil and lymphocyte count in blood, increase the total white blood cell count, increase the number of lymphocytes, and adjust the unbalanced percentage distribution of neutrophils and lymphocytes to tend to normalization, and the effect shows a good dose-effect relationship. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 The results graph of the influence of the plant extraction complex provided by examples 2 to 4 of the present application on the viscera of mice; Figure 2 The results graph of the influence of the plant extraction complex provided by examples 2 to 4 of the present application on the blood routine of mice; Figure 3 The results graph of the influence of the plant extraction complex provided by example 2 of the present application on the blood routine of mice. DETAILED DESCRIPTION

[0018] In order to facilitate the understanding of the present application, the present application will be described more fully below with reference to the relevant drawings. The drawings show embodiments of the present application. However, the present application can be implemented in many different forms, and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thorough and comprehensive.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application belongs. The terms used in the specification of the present application herein are only for the purpose of describing the specific embodiments of the present application, and are not intended to limit the present application.

[0020] It will be understood that the terms spatially relative to one another, such as "under", "below", "lower", "on", "above", "upper", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if a device is turned over, elements described as "below" or "under" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The devices can also be oriented in the other directions (such as rotated 90 degrees or at other orientations) and the spatial descriptions used herein interpreted accordingly.

[0021] Currently, the commonly used immune enhancer in clinical practice mainly includes Pidotimod. As an immunomodulator, Pidotimod enhances the body's non-specific immunity by activating macrophages and T lymphocytes. However, the drug has certain limitations in practical application. First, its mechanism of action is not completely clear, and the individual differences in efficacy are large; second, long-term use may lead to drug resistance or side effects, such as gastrointestinal discomfort and allergic reactions. In addition, the price of Pidotimod is relatively high, which limits its popular application in large-scale population. Therefore, developing a safer, more effective and economical alternative therapy has become the focus of current research.

[0022] In recent years, the potential of traditional herbal plants in enhancing immunity has attracted widespread attention. Many herbs, such as dried ginger, clove, ginseng, and fennel, are widely used in traditional Chinese medicine treatment due to their natural origin and multiple biological activities. These pungent / sweet and warm herbs contain rich volatile oils, which contain sesquiterpenes, monoterpenes, and aromatic compounds that have transdermal penetration effects, are suitable for in vitro application, and have the effects of stimulating the immune system, anti-inflammatory, anti-viral, and analgesic. Studies have shown that these plants are rich in polysaccharides, saponins, and flavonoids, which can enhance the body's immunity by regulating immune cell function, promoting cytokine secretion, and antioxidant effects. Compared with chemically synthesized drugs, plant preparations have the advantages of small toxic and side effects, low price, and easy access. In addition, traditional Chinese medicine theory emphasizes "supporting the body to expel pathogens", that is, by regulating the overall function of the human body to resist diseases, which provides a unique perspective for the prevention of colds.

[0023] In view of this, the present application provides a plant extraction composite agent, which comprises the following raw material components: Dried ginger, clove, cassia, catnip, evodia, costus, pepper, fennel, asarum, zanthoxylum, onion white, and ginseng.

[0024] In the technical solution of the present application, the above-mentioned grass-herb plants of the warm and warm type are selected, which contain rich volatile oil. The sesquiterpenes, monoterpenes and aromatic compounds contained in the volatile oil have the effect of promoting penetration through the skin, are suitable for in vitro application, and have the effects of stimulating the immune system, anti-inflammatory, anti-viral and analgesic. The special proportion formula is used to prepare instant granules, and when used, the effective components are promoted into the body by using sauna or atomization method to stimulate the immune system, so as to achieve the effects of anti-inflammatory and anti-viral.

[0025] Further, the external use plant extraction composite agent includes the following raw material components in mass fraction: Dried ginger 2 parts, clove 1 part, cassia 1 part, schizonepeta 1 part, evodia 2 parts, costus 1 part, pepper 2 parts, fennel 1 part, asarum 1 part, zanthoxylum 2 parts, green onion 6 parts, ginseng 1 part.

[0026] The plant extraction composite agent provided by the present application can greatly reduce the occurrence and development of colds / influenza, effectively avoid the occurrence of cold / influenza complications, and play a positive role in protecting human body health; can significantly improve the thymus weight and spleen weight of dexamethasone-induced immunocompromised mice and their thymus coefficient and spleen coefficient, showing a good effect of improving the immune function of the body; at the same time, it can also improve the abnormal distribution of total white blood cell count, neutrophil and lymphocyte count of dexamethasone-induced immunocompromised mice, increase the total white blood cell count, increase the number of lymphocytes, and adjust the unbalanced percentage distribution of neutrophils and lymphocytes to normal, which shows a good dose-effect relationship.

[0027] The present application also provides a preparation method of the plant extraction composite agent, comprising the following steps: S1. After the raw materials are crushed, they are mixed with water and heated to reflux, the volatile oil phase is collected, and the raw materials are filtered to collect the water phase; S2. The water phase is concentrated and mixed with the volatile oil phase, and dried to obtain the plant extraction composite agent.

[0028] Further, in step S1, the mass ratio of the raw materials to water is 1: (5-7).

[0029] Further, in step S2, the step of concentrating the water phase is performed by rotary evaporation. The pressure of the rotary evaporation is 0.1-0.5 MPa.

[0030] Further, in step S2, in the drying step, spray drying is used to prepare granules for standby.

[0031] The present application also provides the use of the plant extraction composite agent in the preparation of a preparation for preventing viral respiratory tract infection.

[0032] In the technical scheme of the present application, through the synergistic effect of multiple natural active ingredients, the non-specific immunity and specific immune response of the body are enhanced, so as to improve the resistance of the host to viral infection and bacterial invasion, and reduce the incidence of respiratory tract infection; the plants used are traditional Chinese medicine commonly used medicinal materials, which are widely sourced, mild in nature, and not easy to produce drug resistance or obvious toxic side effects after long-term use.

[0033] The present application also provides a use of the plant extraction composite agent as described above in the preparation of an immune enhancer.

[0034] Further, the immune enhancer is an in vitro and inhalation type bidirectional immune enhancer.

[0035] In the technical scheme of the present application, by preparing the immune enhancer as an in vitro and inhalation type bidirectional immune enhancer, in terms of inhalation, compared with the traditional oral or injection administration mode, the in vitro and inhalation type bidirectional immune enhancer can directly act on the respiratory mucosa surface, especially the nasal cavity, trachea and lung, and other parts susceptible to viral infection, which makes the inhalation type immune enhancer more targeted and efficient in preventing cold, influenza and other respiratory viral infections; at the same time, the inhalation preparation is absorbed through the lungs or the nasal cavity, the drug can bypass the liver first-pass effect, directly enter the blood circulation or local tissue, reduce the whole body circulation, and therefore can significantly reduce the side effects such as gastrointestinal irritation or long-term use leading to metabolic burden or liver and kidney toxicity caused by the traditional oral or injection mode.

[0036] The present application also provides an external agent comprising the plant extraction composite agent as described above, wherein the content of the plant extraction composite agent in the external agent is 15-60 mg / mL.

[0037] The technical scheme of the present application will be further described in detail in combination with specific embodiments. It should be understood that the following embodiments are only used to explain the present application, and are not used to limit the present application.

[0038] Experimental materials Pidotimod (PID) oral solution (batch number: B143845): purchased from the Plc Chemical Industry Company and the Italy Dopa Pharmaceutical Co., Ltd.; Dexamethasone injection (batch number: N23011513): purchased from the Chenxin Pharmaceutical Co., Ltd.; Experimental mice: variety and strain: BALB / c mice, level: SPF level, gender: male, source: Shanghai Sylab Experimental Animal Co., Ltd.

[0039] Example 1 The present embodiment provides a plant extraction composite agent (FFTQW) comprising the following raw material components: Dried ginger 2 parts, clove 1 part, cassia 1 part, catnip 1 part, evodia 2 parts, costus 1 part, pepper 2 parts, fennel 1 part, asarum 1 part, zanthoxylum 2 parts, green onion 6 parts, ginseng 1 part.

[0040] Example 2 This example provides an in-vitro inhalation bidirectional composite agent. Take 15 g of the plant extraction composite agent provided in Example 1, dissolve in 250 ml of ultrapure water, and obtain 60 mg / ml of compound plant extract 1.

[0041] Example 3 This example provides an in-vitro inhalation bidirectional composite agent. Take 100 mL of the compound plant extract 1 provided in Example 2, dilute to 200 mL with an equal volume of ultrapure water, and obtain 30 mg / mL of compound plant extract 2.

[0042] Example 4 This example provides an in-vitro inhalation bidirectional composite agent. Take 100 mL of the compound plant extract 2 provided in Example 2, dilute to 200 mL with an equal volume of ultrapure water, and obtain 15 mg / mL of compound plant extract 3.

[0043] Animal experiment The efficacy of the test substance on dexamethasone-induced immunocompromised mice was evaluated using a continuous 3-day sauna nebulization inhalation administration method to determine whether the test substance has the effect of enhancing the immune function of the body.

[0044] Environment: The environment of the animal house was maintained at a temperature of 23±2℃ and a humidity of 40-70%, with 12 hours of light and dark alternation. During the adaptation period, 5 animals were housed per cage, and the bedding (corn cob bedding, Suzhou Daichuan Business and Trade Co., Ltd.) was changed twice a week.

[0045] Food and water: SPF mouse growth and reproduction feed was sterilized with Co60 and purchased from Beijing Kaohua Cooperation Feed Co., Ltd. Filtered water was used for the experimental animals.

[0046] Animal selection and fasting: The animals used for the experiment will be in good health. During the experiment, the animals were allowed to freely eat and drink.

[0047] After the adaptation period, the mice were evenly divided into 6 groups according to body weight, with 8 animals in each group. The 6 groups were the control group, the model group, the pidotimod group, the low-dose extract group, the medium-dose extract group, and the high-dose extract group.

[0048] After the animals were adaptively fed, they were grouped. Except for the normal control group, the mice in the other groups were injected intraperitoneally with dexamethasone (20 mg / kg). Drug administration began on the second day after modeling. The positive control drug (pirdomod) was administered orally by gavage, and the test substance was administered by in vitro sauna inhalation, once a day for 3 consecutive days. After the last administration, the animals were deeply anesthetized by CO2 inhalation, and blood was collected from the heart for blood routine test. The animals were dissected: the thymus and spleen were removed and weighed to calculate the organ coefficient and observe the effect of the test drug on the immune organs of the body. The administration standards of each group are shown in Table 1.

[0049] Table 1 Group administration standards

[0050] Note: The positive control drug pirdomod oral solution (PID) is administered at a dose of 800 mg / person for adults (60 kg) in clinical administration, which is equivalent to a dose of 0.125 g / kg for mice; The clinical use dose of the compound plant extract is 100 g / L (100 mg / ml) fumigation, and the extract yield is 30%, i.e. the extract aerosol concentration is 30 mg / ml (single aerosol volume 10 ml) as the medium dose, and 15 mg / ml and 60 mg / ml as the low dose and the high dose, respectively; i.g.: oral gavage, sn.: in vitro sauna inhalation administration, qd.: once a day.

[0051] Detection index: organ weight and organ coefficient: at the end of the experiment, the thymus and spleen were bluntly separated and weighed, and the organ coefficient was calculated based on the body weight. The organ coefficient calculation formula is as follows: Organ coefficient = organ weight ÷ body weight × 100.

[0052] Blood routine examination: impedance method was used to determine the blood routine index.

[0053] The experimental data is expressed as Mean ± SD; the data between the blank group and the model group was analyzed by T test to verify the model, and the data between the model group and each administration group was analyzed by one-way ANOVA using IBM SPSS Statistics 21 software, followed by Tamhane's analysis. P<0.05 is considered to have significant difference, and P<0.01 is considered to have extremely significant difference. The final data was plotted using GraphPad Prism 6.

[0054] Test results After clinical observation, the mice showed weight loss, disheveled back hair, and decreased activity after modeling.

[0055] The results of the effects of the test substances on the organ weights and their coefficients of the dexamethasone-induced immunocompromised mice are shown in Table 2 and Figure 1 Figure 1 Fig. A shows the results of the effects of the test substances on the thymus weights of the mice, Fig. B shows the results of the effects of the test substances on the thymus coefficients of the mice, Fig. C shows the results of the effects of the test substances on the spleen weights of the mice, and Fig. D shows the results of the effects of the test substances on the spleen coefficients of the mice.

[0056] Table 2 Effects of the test substances on the organs of the mice (n=8)

[0057] ## p <0.01 vs. normal control group, ** p <0.01 vs. model group.

[0058] The results of Table 2 and Figure 1 can be concluded as follows: ① The thymus weight and the spleen weight of the normal control group were 70.94±10.28 mg and 104.00±6.79 mg, respectively, while the thymus weight and the spleen weight of the model mice were decreased to 19.59±3.54 mg and 49.42±6.41 mg, respectively, showing the obvious inhibitory effect of dexamethasone on the immune organs; the thymus coefficient of the model animals was also significantly decreased to 0.07±0.01 g, showing a statistically significant difference (p<0.01 vs. Control) as compared with that of the control group (0.21±0.03 g). The spleen coefficient of the model animals (0.26±0.06 g) was higher than that of the normal control group (0.15±0.02 g). The reason was analyzed to be mainly due to the decrease in the thymus weight / body weight ratio being lower than that in the spleen weight / body weight ratio, but the significant decrease in the spleen weight of the model animals could not be ignored; ② After the administration of the positive drug pidotimod at 125 mg / kg, the thymus weight and the spleen weight were increased to 31.48±5.21 mg and 51.89±3.37 mg, respectively, and the thymus coefficient and the spleen coefficient were 0.11±0.02 g / 100 g and 0.17±0.02 g / 100 g, respectively, and the differences between the average values of the model group and the normal group were reduced, showing the improvement effect on the inhibited immune organs; ​③ After the mice were given the compound water extract by sauna nebulization, the thymus weights of the low, medium and high dose groups were increased to 24.77±7.23 mg, 30.42±6.55 mg and 32.74±5.96 mg, and the thymus coefficients were 0.09±0.03 g, 0.10±0.02 g and 0.12±0.02 g, respectively; the spleen weights were increased to 49.08±3.85 mg, 50.44±3.76 mg and 58.92±8.23 mg, and the spleen coefficients were 0.22±0.09 g, 0.17±0.03 g and 0.18±0.04 g, respectively. The differences between the model group and the normal group were also reduced, indicating that the compound water extract had a significant improvement effect on the inhibited immune organs and showed a good dose-effect relationship.

[0059] The effects of the test substances on the blood routine of the dexamethasone-induced immunocompromised mice are shown in Table 3 and Figure 2 Figure 2 Among them, Figure A shows the effect of the test substances on the total number of white blood cells in mice, Figure B shows the effect of the test substances on the number of neutrophils in mice, Figure C shows the effect of the test substances on the number of lymphocytes in mice, Figure D shows the effect of the test substances on the percentage of neutrophils in mice, and Figure E shows the effect of the test substances on the percentage of lymphocytes in mice.

[0060] Table 3 Effects of test substances on the blood routine of mice (n=8)

[0061] # p <0.05, ## p <0.01 vs. normal control group, * p <0.05 vs. model group.

[0062] The results of Table 3 and Figure 2 can be concluded as follows: ① The total number of white blood cells in the normal control group of mice was 7.61±2.22 10 9 / L, the number of neutrophils was 1.36±0.57 10 9 / L, and the number of lymphocytes was 5.82±1.41 10 9 / L. The percentage of lymphocytes was much higher than that of neutrophils, which were 77.17±10.57 10 9 / L and 17.33±4.39 10 9 ​ / L, because the count of neutrophil and lymphocyte and their percentage in rodents are different from that in human, i.e. the count of lymphocyte is much higher than that of neutrophil, and the percentage of lymphocyte is also much higher than that of neutrophil; ②The total number of white blood cell and the count of lymphocyte in the model group were decreased to 4.81±1.02 10 9 / L and 1.78±0.83 10 9 / L, the count of neutrophil was increased to 2.85±1.65 10 9 / L. While the percentage of lymphocyte was significantly decreased (35.46±14.31 10 9 / L), the percentage of neutrophil was relatively increased (49.32±12.33 10 9 / L), which indicated that dexamethasone significantly inhibited the immune organs, and the generation of lymphocyte with immune function was significantly inhibited; ③After administration of 125 mg / kg of the positive control drug pidotimod, the count of lymphocyte and its percentage were increased, and the percentage of neutrophil was decreased, which showed the positive regulation of immune function. The effects of the low, medium and high doses of the compound water extract on increasing the count of lymphocyte and its percentage were significantly better than that of 125 mg / kg of the positive control drug pidotimod, and the count of neutrophil was gradually decreased, which made the distribution of lymphocyte and neutrophil gradually normalized. Especially the effect of the high dose (60 mg / mL) of the compound water extract was more significant, and all the detected blood indicators showed statistically significant differences (p<0.05 vs. Model) compared with the model animals. The effect of the compound water extract showed a good dose-effect relationship.

[0063] The decrease of white blood cell count is often seen in immune suppression or viral infection. Dexamethasone is a corticosteroid, which is often used to establish an immune suppression animal model. It can produce significant inhibition on immune organs, and cause atrophy of immune organs, decrease of lymphocyte, etc. It can also inhibit the generation of blood cells in bone marrow hematopoietic system, and affect all three blood cell lines.

[0064] In this experiment, the compound traditional Chinese medicine extract was administered to the dexamethasone-induced immune function low mice by in vitro sauna nebulization, and the experimental results were as follows: ①The in vitro sauna nebulization administration of plant extract (30 and 60 mg / mL) can significantly improve the thymus weight and spleen weight, and their thymus coefficient and spleen coefficient in dexamethasone-induced immune function low mice, which shows a good effect of improving the immune function of the body; ②15, 30, 60 mg / mL of the traditional Chinese medicine extract can improve the abnormal distribution of the total number of white blood cells, the number of neutrophils and lymphocytes in the blood of the mice with low immune function induced by dexamethasone, especially the dose of 60 mg / mL, which can significantly increase the total number of white blood cells, increase the number of lymphocytes, and adjust the percentage distribution of unbalanced neutrophils and lymphocytes to be normalized, and the effect shows a good dose-effect relationship; ③The effective dose of the plant extract in the in-vitro sauna atomization administration is 30 mg / mL, and the dose of 60 mg / mL has the optimal effect on regulating the immune function of the body.

[0065] Human test Test subjects: 30 adult volunteers susceptible to colds / influenza in winter were randomly divided into a prevention group and a non-prevention group, each group having 15 people.

[0066] Administration mode: the in-vitro inhalation bidirectional complex provided in Example 2 was used for in-vitro sauna atomization inhalation of the prevention group, and pure water was used for in-vitro sauna atomization inhalation of the non-prevention group.

[0067] Test method: the subjects used the corresponding administration to perform in-vitro sauna atomization inhalation through a sauna generator at the early stage of colds / influenza, once a day, for three consecutive days.

[0068] Test evaluation standard: the judgment standard for diagnosis of colds and influenza was used. Test result statistical analysis: the test results are shown in Tables 2 and Figure 3 .

[0069] Table 4: Incidence statistical results of the prevention group and the non-prevention group

[0070] Note: P<0.001 for the prevention group, and P<0.001 for the non-prevention group.

[0071] According to the results in Table 4, it can be seen that the in-vitro inhalation bidirectional complex provided in Example 2 has a significant effect on preventing the occurrence and development of colds / influenza, with a total effective rate of 86%, which is increased by 60% compared with the non-prevention group, and is convenient and simple to use, and has a wide application prospect.

[0072] The above only describes the preferred embodiments of the present application, and is not intended to limit the present application, and any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

[0073] In summary, the technical scheme of the present application has the following beneficial technical effects: 1. The plant extraction complex provided by the present application can greatly reduce the occurrence and development of colds and influenza, effectively avoid the occurrence of complications of colds and influenza, and play a positive role in protecting human body health when used in the early stage of colds and influenza. 2. The plant extraction complex provided by the present application can significantly improve the thymus weight and spleen weight of dexamethasone-induced immunocompromised mice, and the thymus coefficient and spleen coefficient thereof, show a good effect of improving the immune function of the body, and can improve the abnormal distribution of the total number of white blood cells, neutrophils and lymphocytes in the blood, increase the total number of white blood cells, increase the number of lymphocytes, and adjust the unbalanced percentage distribution of neutrophils and lymphocytes to tend to normalization, and the effect shows a good dose-effect relationship.

Claims

1. A plant extract compound, characterized in that, Includes the following raw material components: Dried ginger, cloves, cinnamon, catnip, evodia, costus root, pepper, fennel, asarum, Sichuan pepper, scallion, and ginseng.

2. The plant extract compound according to claim 1, characterized in that, The topical plant extract compound comprises the following raw material components by mass fraction: 2 parts dried ginger, 1 part cloves, 1 part cinnamon, 1 part catnip, 2 parts evodia, 1 part costus root, 2 parts pepper, 1 part fennel, 1 part asarum, 2 parts Sichuan pepper, 6 parts scallion whites, and 1 part ginseng.

3. A method for preparing the plant extract compound as described in claim 1 or 2, characterized in that, Includes the following steps: S1. After crushing the raw material, mix it with water, heat and reflux, collect the volatile oil phase, filter the raw material, and collect the aqueous phase; S2. The aqueous phase is concentrated and then mixed with the volatile oil phase, and dried to obtain a plant extract compound.

4. The method for preparing the plant extract compound according to claim 3, characterized in that, In step S1, the mass ratio of raw material to water is 1:(5~7).

5. The method for preparing the plant extract compound according to claim 3, characterized in that, In step S2, the aqueous phase is concentrated by rotary evaporation. The pressure for rotary evaporation is 0.1~0.5MPa.

6. The method for preparing the plant extract compound according to claim 3, characterized in that, In step S2, the drying step involves spray drying to produce granules for later use.

7. The use of a plant extract compound as described in claim 1 or 2 in the preparation of an agent for the prevention of viral respiratory infections.

8. The application of a plant extract compound as described in claim 1 or 2 in the preparation of an immune enhancer.

9. The application of the plant extract compound according to claim 8 in the preparation of immune enhancers, characterized in that, The immune enhancer is a bidirectional immune enhancer that can be administered both in vitro and inhaled.

10. A topical agent, characterized in that, The external application includes the plant extract compound as described in claim 1 or 2, wherein the content of the plant extract compound is 15-60 mg / mL.

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