Preparation method and application of special quality herbal ointment for resisting allergy, relieving itching, swelling and eczema and rhinitis

Abstract

The application belongs to the technical field of traditional Chinese medicine, and mainly relates to a preparation method of a herbal plaster, in particular to a preparation method of a special herbal plaster and application thereof. The formula comprises a herbal fermentation liquor, a herbal enzymolysis liquor and a herbal extraction liquor. The herbal fermentation liquor is obtained by filtering after fermenting peppermint, perilla, chrysanthemum, baizhi and dried tangerine or orange peel by probiotics; the herbal enzymolysis liquor is obtained by enzymolysis and extraction of bitter almonds and poria cocos; and the herbal extraction liquor is obtained by water extraction of Fructus Mume, lily and licorice. The herbal plaster prepared by the application has the effects of resisting allergy, stopping itching, eliminating swelling and relieving eczema and rhinitis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and mainly relates to a method for preparing herbal paste, specifically a method for preparing a special herbal paste and its application. Background Technology

[0002] Individuals with a special constitution often have weakened immunity and poor self-regulation, making them more susceptible to allergens and prone to allergic rhinitis, eczema, and other diseases. Currently, Western medicine often treats these diseases with hormones and antihistamines, which have problems such as unsatisfactory long-term efficacy and significant side effects. Traditional Chinese medicine (TCM) has unique advantages in preventing and treating diseases related to a special constitution, offering a comprehensive approach to addressing the root cause. While some existing TCM compositions exist for regulating a special constitution, there are few inventions related to herbal ointments that simultaneously possess multiple effects such as anti-allergy, antipruritic, anti-swelling, and relief of eczema and rhinitis. Therefore, this invention aims to provide a simple-to-prepare herbal ointment for individuals with a special constitution that effectively combats allergies, relieves itching, reduces swelling, and alleviates symptoms of eczema and rhinitis. Summary of the Invention

[0003] In view of this, the purpose of this invention is to prepare a special herbal ointment and its application. The herbal ointment prepared by this invention has the effects of anti-allergy, antipruritic, anti-swelling and relieving eczema and rhinitis.

[0004] Firstly, this invention provides a special herbal paste, the formulation of which is based on the weight parts of raw medicinal materials, comprising: a herbal fermentation liquid obtained from 165-215 parts of raw medicinal materials; a herbal enzymatic hydrolysate obtained from 100-120 parts of raw medicinal materials; a herbal extract obtained from 155-185 parts of raw medicinal materials; and a sweetener of 45-65 parts. The herbal fermentation liquid is obtained by fermenting peppermint, perilla, chrysanthemum, angelica, and tangerine peel with probiotics and then filtering. The herbal enzymatic hydrolysate is obtained by enzymatic hydrolysis and extraction of bitter almond and poria cocos. The herbal extract is obtained by water extraction of dried plum, lily, and licorice. The probiotics are a complex of bacteria including *Lactobacillus rhamnosus* SD-SLTRLGJ and *Saccharomyces boulardii* CNCMI-1079. The enzymes used in the enzymatic hydrolysis are a complex of enzymes including cellulase and β-glucosidase.

[0005] Furthermore, the herbal fermentation liquid contains peppermint, perilla, chrysanthemum, angelica, and dried tangerine peel in the following weight proportions: peppermint 20-40 parts, perilla 30-50 parts, chrysanthemum 30-50 parts, angelica 20-40 parts, and dried tangerine peel 20-40 parts.

[0006] Furthermore, the herbal fermentation liquid contains peppermint, perilla, chrysanthemum, angelica, and dried tangerine peel in the following weight proportions: peppermint 30-40 parts, perilla 40-50 parts, chrysanthemum 35-45 parts, angelica 30-40 parts, and dried tangerine peel 30-40 parts.

[0007] Furthermore, the bitter almond and poria cocos in the herbal enzymatic hydrolysate are in the following proportions by weight: 30-50 parts bitter almond and 50-80 parts poria cocos.

[0008] Furthermore, the herbal enzymatic hydrolysate contains bitter almonds and Poria cocos in the following proportions by weight: 40-50 parts bitter almonds and 60-70 parts Poria cocos.

[0009] Furthermore, the herbal extract contains the following proportions by weight: 50-80 parts of dried plum, 50-80 parts of lily, and 20-40 parts of licorice.

[0010] Furthermore, the herbal extract contains the following proportions by weight: 60-70 parts dried plum, 65-75 parts lily, and 30-40 parts licorice.

[0011] Furthermore, the herbal ointment of the present invention also includes 30-40 parts xylitol and 15-25 parts fructooligosaccharides.

[0012] Secondly, this invention provides a method for preparing a special herbal ointment, the steps of which are as follows: (1) Weigh each component raw material according to the above formula. Except for xylitol and fructooligosaccharides, all other raw materials are cleaned, dried at low temperature in an oven, and pulverized to 80 mesh. (2) Preparation of herbal fermentation broth; (3) Preparation of herbal enzymatic hydrolysate; (4) Preparation of herbal extracts; (5) After mixing the herbal fermentation liquid obtained in step (2), the herbal enzymatic hydrolysate obtained in step (3), and the herbal extract obtained in step (4) evenly, xylitol and fructooligosaccharides are added and the mixture is concentrated under reduced pressure to a relative density of 1.2 (60℃) to obtain herbal paste.

[0013] Furthermore, in step (2): the preparation method of the herbal fermentation broth is as follows: S1, cultivation of Lactobacillus rhamnosus SD-SLTRLGJ: Lactobacillus rhamnosus SD-SLTRLGJ is inoculated into MRS agar medium and activated at 37℃ for 21h. The activated strain is then inoculated into MRS liquid medium and cultured for another 15h under the same conditions before stopping the culture to obtain a concentration of 2.2×10 8 CFU / mL *Lactobacillus rhamnosus* culture; S2, culture of *Saccharomyces boulardii* CNCMI-1079: *Saccharomyces boulardii* CNCMI-1079 was inoculated into YPD agar medium and activated at 28℃ for 21 h. The activated strain was then inoculated into YPD liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 3.0 × 10⁻⁶ CFU / mL. 8CFU / mL Saccharomyces boulardii culture; S3, Preparation of herbal fermentation broth: Take the peppermint, perilla, chrysanthemum, angelica and tangerine peel obtained in step (1) and mix them evenly. Add Saccharomyces boulardii culture at an inoculation rate of 2-4% (v / w) and ferment aerobically at 28℃ for 20h. Then add Lactobacillus rhamnosus culture at an inoculation rate of 2-4% (v / w) and ferment aerobically at 37℃ for 20h. After fermentation, sterilize with 3% H2O2 solution and let stand for 3h. Take the supernatant and centrifuge at 5000r / min and 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane to obtain herbal fermentation broth.

[0014] Further, the preparation method of the herbal enzymatic hydrolysate in step (3) is as follows: after mixing the bitter almond and poria cocos obtained in step (1) evenly, add water at a solid-liquid ratio of 1:8, stir evenly, and adjust the pH of the system to 4.5; first add cellulase (enzyme addition amount is 5000U / g substrate), and enzymatically hydrolyze for 2.5h at 50-55℃, then add β-glucosidase (enzyme addition amount is 2000U / g substrate), and continue enzymatic hydrolysis for 3h at a temperature of 45-50℃ and pH=5.0, while maintaining slight stirring to promote enzyme-substrate contact. After the enzymatic hydrolysis is completed, raise the temperature to 90℃ and keep it at 12min to inactivate the enzyme. After inactivation, let it stand for 3h, take the supernatant and centrifuge it at 5000r / min and 4℃ for 15min in a refrigerated centrifuge, take the supernatant, filter it through a 0.45μm filter membrane, and concentrate the filtrate to 1 / 8 of the filtrate volume to obtain the herbal enzymatic hydrolysate.

[0015] Furthermore, the preparation of the herbal extract in step (4) is as follows: take the dried plum, lily and licorice obtained in step (1), mix them evenly, add 6 times the amount of water and decoct twice, each time for 1.2 hours, combine the decoctions and concentrate them to 1 / 8 of the total volume of the combined decoctions.

[0016] Further, the specific steps of step (5) are as follows: after mixing all the herbal fermentation liquid obtained in step (2), all the herbal enzymatic hydrolysate obtained in step (3), and all the herbal extract obtained in step (4) evenly, xylitol and fructooligosaccharides are added to it, and after mixing evenly, it is concentrated under reduced pressure at 60°C to a relative density of 1.2 (60°C) to obtain herbal paste.

[0017] Thirdly, the present invention provides that the herbal ointment prepared by the above-described method has the effects of anti-allergy, antipruritic, anti-swelling and relieving eczema and rhinitis.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. The herbal ointment prepared by this invention uses all natural herbal Chinese medicinal materials. Through scientific formulation and processing, it achieves synergistic effects and can simultaneously exert anti-allergic, antipruritic, and anti-swelling effects. It can also specifically relieve eczema, rhinitis and other special constitution-related symptoms. The efficacy is comprehensive and highly targeted, avoiding the limitations of single-effect products.

[0019] 2. This invention employs fermentation processes on peppermint, perilla, chrysanthemum, angelica, and dried tangerine peel to enhance the bioavailability and stability of their active ingredients; enzymatic hydrolysis of bitter almonds and poria cocos transforms toxic components and breaks down large molecules into easily absorbed small molecules; and decoction extraction of dried plum, lily bulb, and licorice fully preserves water-soluble active ingredients, achieving a harmonizing effect. These three processes are tailored to the characteristics of the medicinal materials, synergistically enhancing the overall efficacy and safety of the herbal paste, and making it more easily absorbed by the human body.

[0020] 3. In the selection of sweeteners, this invention uses a combination of xylitol and fructooligosaccharides, which not only improves the taste of the product and makes it suitable for all types of people, but also ensures that xylitol does not participate in blood sugar metabolism and that fructooligosaccharides have the effect of regulating intestinal flora. The combination of the two takes into account both taste and health, and avoids the blood sugar fluctuations or tooth decay risks that may be caused by traditional sweeteners such as sucrose, which is more in line with modern health needs. Attached Figure Description

[0021] Figure 1 This is a comparison chart of the number of sneezes in mice in Examples 1-3 and Comparative Examples 1-8.

[0022] Figure 2 This is a comparison chart of the number of times mice scratched their noses in Examples 1-3 and Comparative Examples 1-8.

[0023] Figure 3 This is a comparison chart of the number of scratches by mice in Examples 1-3 and Comparative Examples 1-8.

[0024] Figure 4 This is a comparison chart of the weight of mouse ear pieces in Examples 1-3 and Comparative Examples 1-8.

[0025] Figure 5 This is a picture of the herbal ointment obtained in Example 1. Detailed Implementation

[0026] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0027] Peppermint, perilla, chrysanthemum, angelica, bitter almond, poria, dried plum, lily, and licorice were all purchased from Bozhou Ziting Pharmaceutical Co., Ltd.; cellulase and β-glucosidase were purchased from Nanjing Hongyou Biotechnology Co., Ltd.; Lactobacillus rhamnosus SD-SLTRLGJ was purchased from Shanxi Shangda Biotechnology Co., Ltd.; and Saccharomyces boulardii CNCMI-1079 was purchased from Xi'an Fenghe Biotechnology Co., Ltd.

[0028] Example 1

[0029] This embodiment provides a special herbal ointment, the specific steps of which are as follows: (1) Pretreatment of raw materials: accurately weigh 30g of peppermint, 40g of perilla, 35g of chrysanthemum, 30g of angelica dahurica, 30g of dried tangerine peel, 40g of bitter almond, 60g of poria cocos, 60g of dried plum, 65g of lily bulb, 30g of licorice, 30g of xylitol, and 15g of fructooligosaccharides. Except for xylitol and fructooligosaccharides, all other raw materials are cleaned, dried at low temperature in an oven, and pulverized to 80 mesh. (2) Preparation of herbal fermentation broth: Lactobacillus rhamnosus SD-SLTRLGJ was inoculated into MRS agar medium and activated at 37℃ for 21 h. The activated strain was then inoculated into MRS liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 2.2 × 10⁻⁶. 8 CFU / mL *Lactobacillus rhamnosus* culture; *Saccharomyces boulardii* CNCMI-1079 was inoculated into YPD agar medium and activated at 28°C for 21 h. The activated culture was then inoculated into YPD liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 3.0 × 10⁻⁶ CFU / mL. 8 CFU / mL Saccharomyces boulardii culture; take the peppermint, perilla, chrysanthemum, angelica and tangerine peel obtained in step (1) and mix them evenly. Add Saccharomyces boulardii culture at an inoculation amount of 2% (v / w) and ferment aerobically at 28℃ for 20h. Then add Lactobacillus rhamnosus culture at an inoculation amount of 2% (v / w) and ferment aerobically at 37℃ for 20h. After fermentation, sterilize with 3% H2O2 solution and let stand for 3h. Take the supernatant and centrifuge at 5000r / min, 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane to obtain herbal fermentation broth. The MRS agar medium consists of the following components: 10g casein peptone, 10g beef extract, 5g yeast extract, 20g glucose, 1g Tween 80, 5g sodium acetate, 2g triammonium citrate, 2g K2HPO4, and MgSO4·7H2O. 0.2g of glucose, 0.05g of MnSO4·H2O, 15g of agar, and 1000mL of distilled water. The components of YPD agar medium are: 20g of glucose, 20g of peptone, 10g of yeast extract, 20g of agar, and 1000mL of distilled water.

[0030] (3) Preparation of herbal enzymatic hydrolysate: After mixing bitter almond and Poria cocos obtained in step (1) evenly, add water at a solid-liquid ratio of 1:8, stir evenly and adjust the pH of the system to 4.5; first add cellulase (enzyme addition amount is 5000U / g substrate), and enzymatically hydrolyze at 50℃ for 2.5h, then add β-glucosidase (enzyme addition amount is 2000U / g substrate), keep the temperature at 45℃ and pH=5.0 and continue enzymatic hydrolysis for 3h, during which time keep gently stirring to promote enzyme-substrate contact. After the enzymatic hydrolysis is completed, raise the temperature to 90℃ and keep it at 12min to inactivate the enzyme. After inactivation, let it stand for 3h, take the supernatant and centrifuge at 5000r / min and 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane. The resulting filtrate is concentrated to 1 / 8 of the filtrate volume to obtain herbal enzymatic hydrolysate.

[0031] (4) Preparation of herbal extract: Take the dried plum, lily and licorice obtained in step (1), mix them evenly, add 6 times the amount of water and decoct twice, each time for 1.2 hours. Combine the decoctions and concentrate them to 1 / 8 of the total volume of the combined decoctions to obtain the herbal extract.

[0032] (5) Preparation of herbal paste: After thoroughly mixing the herbal fermentation broth obtained in step (2), the herbal enzymatic hydrolysate obtained in step (3), and the herbal extract obtained in step (4), xylitol and fructooligosaccharides are added, and the mixture is concentrated under reduced pressure at 60°C to a relative density of 1.2 (60°C) to obtain the herbal paste. A physical image of the herbal paste product in this embodiment is shown below. Figure 5 As shown.

[0033] Example 2

[0034] This embodiment provides a special herbal ointment, the specific steps of which are as follows: (1) Pretreatment of raw materials: accurately weigh 35g of peppermint, 45g of perilla, 40g of chrysanthemum, 35g of angelica dahurica, 35g of dried tangerine peel, 45g of bitter almond, 65g of poria cocos, 65g of dried plum, 70g of lily bulb, 35g of licorice, 35g of xylitol, and 20g of fructooligosaccharides. Except for xylitol and fructooligosaccharides, all other raw materials are cleaned, dried at low temperature in an oven, and pulverized to 80 mesh. (2) Preparation of herbal fermentation broth: Lactobacillus rhamnosus SD-SLTRLGJ was inoculated into MRS agar medium and activated at 37℃ for 21 h. The activated strain was then inoculated into MRS liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 2.2 × 10⁻⁶. 8CFU / mL *Lactobacillus rhamnosus* culture; *Saccharomyces boulardii* CNCMI-1079 was inoculated into YPD agar medium and activated at 28°C for 21 h. The activated culture was then inoculated into YPD liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 3.0 × 10⁻⁶ CFU / mL. 8 CFU / mL Saccharomyces boulardii culture; take the peppermint, perilla, chrysanthemum, angelica and tangerine peel obtained in step (1) and mix them evenly. Add Saccharomyces boulardii culture at an inoculation amount of 3% (v / w) and ferment aerobically at 28℃ for 20h. Then add Lactobacillus rhamnosus culture at an inoculation amount of 3% (v / w) and ferment aerobically at 37℃ for 20h. After fermentation, sterilize with 3% H2O2 solution and let stand for 3h. Take the supernatant and centrifuge at 5000r / min and 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane to obtain the herbal fermentation broth.

[0035] (3) Preparation of herbal enzymatic hydrolysate: After mixing bitter almond and Poria cocos obtained in step (1) evenly, add water at a solid-liquid ratio of 1:8, stir evenly and adjust the pH of the system to 4.5; first add cellulase (enzyme addition amount is 5000U / g substrate), and enzymatically hydrolyze at 52℃ for 2.5h, then add β-glucosidase (enzyme addition amount is 2000U / g substrate), keep the temperature at 47℃ and pH=5.0 and continue enzymatic hydrolysis for 3h, during which time keep gently stirring to promote enzyme-substrate contact. After the enzymatic hydrolysis is completed, raise the temperature to 90℃ and keep it at 12min to inactivate the enzyme. After inactivation, let it stand for 3h, take the supernatant and centrifuge at 5000r / min, 4℃ for 15min in a refrigerated centrifuge, take the supernatant, filter it through a 0.45μm filter membrane, and concentrate the filtrate to 1 / 8 of the filtrate volume to obtain herbal enzymatic hydrolysate.

[0036] (4) Preparation of herbal extract: Take the dried plum, lily and licorice obtained in step (1), mix them evenly, add 6 times the amount of water and decoct twice, each time for 1.2 hours. Combine the decoctions and concentrate them to 1 / 8 of the total volume of the combined decoctions to obtain the herbal extract.

[0037] (5) Preparation of herbal paste: After mixing the herbal fermentation liquid obtained in step (2), the herbal enzymatic hydrolysate obtained in step (3), and the herbal extract obtained in step (4) evenly, xylitol and fructooligosaccharides are added to it and mixed evenly. Then, the mixture is concentrated under reduced pressure at 60°C to a relative density of 1.2 (60°C) to obtain herbal paste.

[0038] Example 3

[0039] This embodiment provides a special herbal ointment, the specific steps of which are as follows: (1) Pretreatment of raw materials: accurately weigh 40g of peppermint, 50g of perilla, 45g of chrysanthemum, 40g of angelica dahurica, 40g of dried tangerine peel, 50g of bitter almond, 70g of poria cocos, 70g of dried plum, 75g of lily bulb, 40g of licorice, 40g of xylitol, and 25g of fructooligosaccharides. Except for xylitol and fructooligosaccharides, all other raw materials are cleaned, dried at low temperature in an oven, and pulverized to 80 mesh. (2) Preparation of herbal fermentation broth: Lactobacillus rhamnosus SD-SLTRLGJ was inoculated into MRS agar medium and activated at 37℃ for 21 h. The activated strain was then inoculated into MRS liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 2.2 × 10⁻⁶. 8 CFU / mL *Lactobacillus rhamnosus* culture; *Saccharomyces boulardii* CNCMI-1079 was inoculated into YPD agar medium and activated at 28°C for 21 h. The activated culture was then inoculated into YPD liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 3.0 × 10⁻⁶ CFU / mL. 8 CFU / mL Saccharomyces boulardii culture; take the peppermint, perilla, chrysanthemum, angelica and tangerine peel obtained in step (1) and mix them evenly. Add Saccharomyces boulardii culture at an inoculation amount of 4% (v / w) and ferment aerobically at 28℃ for 20h. Then add Lactobacillus rhamnosus culture at an inoculation amount of 4% (v / w) and ferment aerobically at 37℃ for 20h. After fermentation, sterilize with 3% H2O2 solution and let stand for 3h. Take the supernatant and centrifuge at 5000r / min, 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane to obtain the herbal fermentation broth.

[0040] (3) Preparation of herbal enzymatic hydrolysate: After mixing bitter almond and Poria cocos obtained in step (1) evenly, add water at a solid-liquid ratio of 1:8, stir evenly and adjust the pH of the system to 4.5; first add cellulase (enzyme addition amount is 5000U / g substrate), and enzymatically hydrolyze at 55℃ for 2.5h, then add β-glucosidase (enzyme addition amount is 2000U / g substrate), keep the temperature at 50℃ and pH=5.0 and continue enzymatic hydrolysis for 3h, during which time keep gently stirring to promote enzyme-substrate contact. After the enzymatic hydrolysis is completed, raise the temperature to 90℃ and keep it at 12min to inactivate the enzyme. After inactivation, let it stand for 3h, take the supernatant and centrifuge at 5000r / min and 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane. The resulting filtrate is concentrated to 1 / 8 of the filtrate volume to obtain herbal enzymatic hydrolysate.

[0041] (4) Preparation of herbal extract: Take the dried plum, lily and licorice obtained in step (1), mix them evenly, add 6 times the amount of water and decoct twice, each time for 1.2 hours. Combine the decoctions and concentrate them to 1 / 8 of the total volume of the combined decoctions to obtain the herbal extract.

[0042] (5) Preparation of herbal paste: After mixing the herbal fermentation liquid obtained in step (2), the herbal enzymatic hydrolysate obtained in step (3), and the herbal extract obtained in step (4) evenly, xylitol and fructooligosaccharides are added to it and mixed evenly. Then, the mixture is concentrated under reduced pressure at 60°C to a relative density of 1.2 (60°C) to obtain herbal paste.

[0043] Comparative Example 1: It is basically the same as Example 1, except that fermentation is not carried out in step (2), that is, Lactobacillus rhamnosus and Saccharomyces boulardii are not added.

[0044] Comparative Example 2: It is basically the same as Example 1, except that Lactobacillus rhamnosus is not added in step (2).

[0045] Comparative Example 3: It is basically the same as Example 1, except that Saccharomyces boulardii is not added in step (2).

[0046] Comparative Example 4: It is basically the same as Example 1, except that in step (2), Lactobacillus rhamnosus SD-SLTRLGJ is replaced with Lactobacillus rhamnosus TGSW-1024-368 (purchased from Shanxi Tiangu Biotechnology Co., Ltd.).

[0047] Comparative Example 5: It is basically the same as Example 1, except that in step (2), Saccharomyces boulardii CNCMI-1079 is replaced with Saccharomyces boulardii 265987 (purchased from Xi'an Minglang Biotechnology Co., Ltd.).

[0048] Comparative Example 6: It is basically the same as Example 1, except that enzymatic hydrolysis is not performed in step (3), that is, cellulase and β-glucosidase are not added.

[0049] Comparative Example 7: It is basically the same as Example 1, except that cellulase is not added in step (3).

[0050] Comparative Example 8: It is basically the same as Example 1, except that β-glucosidase is not added in step (3).

[0051] Experiment 1: A study on the relief of eczema with herbal ointment Animals: SPF-grade male Balb / c mice, weighing 18-22g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. Mice were provided with free access to food and water during the rearing period. The ambient temperature was controlled at 22-24℃, and the relative humidity was maintained at 40%-60%. Before the experiment, all mice underwent a one-week acclimatization feeding period. After observing that their fur was glossy, their diet and activity were normal, and no abnormalities were observed, the experiment was officially launched.

[0052] Modeling: Mice were randomly divided into a blank control group, a model group, Examples 1-3, and Comparative Examples 1-8, with 8 mice in each group. One hour before the start of the experiment, the mice's abdomen and back were shaved (each shaved area was 2.2 cm × 2.2 cm). Simultaneously, 2,4-dinitrochlorobenzene was dissolved in a 1:4 volume ratio acetone-olive oil mixture to prepare 2% and 7% DNCB solutions for later use. On days 1-2 of the experiment, 50 μL of 7% 2,4-dinitrochlorobenzene solution was applied to the shaved area on the abdomen daily for sensitization, once a day for a total of 2 times. On day 5 of the experiment, 50 μL of 2% 2,4-dinitrochlorobenzene solution was applied to the back for challenge, once a day for 3 times, for a total of 4 times. Successful modeling was indicated by red, swollen, thickened skin, accumulated scales, and frequent scratching. During the modeling process, mice in the control group were treated with an equal dose of acetone solvent; after successful modeling, 25 μL of 2% 2,4-dinitrochlorobenzene solution was applied to the back of the eczema model mice every 3 days to maintain symptoms.

[0053] Drug administration: After successful modeling, the drugs were administered. Specifically, the corresponding herbal paste 2g / kg was administered by gavage to the groups of Examples 1-3 and Comparative Examples 1-8 once a day. The blank group and the model group were not administered drugs for 14 days.

[0054] Detection: After the administration of the drug, the mice were scored according to the EASI scoring criteria. The scoring criteria are shown in Table 1, and the experimental results are shown in Table 2.

[0055] Table 1

[0056] Table 2

[0057] Table 2 compares the dermatitis scores of mice in Examples 1-3 and Comparative Examples 1-8. The results show that the dermatitis score in the blank control group was 0, indicating good skin condition and no eczema-related symptoms. Compared to the blank control group, the dermatitis score in the model group was significantly higher, exhibiting typical and obvious eczema symptoms, specifically dark red infiltrative erythema, severe swelling, fused papules, dense deep scratch marks, and abundant thick scales, indicating successful model establishment. Compared to the model group, the dermatitis scores in both the Example and Comparative Example groups decreased to varying degrees after intervention with the corresponding herbal ointment, and the eczema symptoms were alleviated to varying degrees, manifested as lighter erythema, reduced swelling and papules, shallower and sparser scratch marks, and reduced scales. The Example control group showed the best improvement. In conclusion, the herbal ointment prepared in this invention has a significant effect in alleviating eczema in mice, and its effect is superior to that of the comparative example groups.

[0058] The herbal ointment prepared by this invention significantly enhances its anti-eczema activity through the synergistic effect of two core technologies: microbial fermentation and enzymatic extraction. This synergistic effect is not a simple additive effect, but rather a significant 1+1>2 synergistic effect: experimental data show that the efficacy of Example 1 (dermatitis score 2.12), which uses the complete process, is far superior to the theoretical effects achievable by simple combinations of single technical pathways such as enzymatic extraction alone (Comparative Example 1, score 6.62) and fermentation alone (Comparative Example 6, score 5.62). Within this collaborative framework, during the microbial fermentation process, the synergistic effect of *Lactobacillus rhamnosus* SD-SLTRLGJ and *Saccharomyces boulardii* CNCMI-1079 not only promotes the biotransformation of flavonoids and phenolic acids in the herbal raw materials but also potentially generates a series of small-molecule anti-inflammatory active substances, directly inhibiting excessive immune responses in the skin. Simultaneously, in the enzymatic hydrolysis process, the synergistic action of cellulase and β-glucosidase directionally cleaves plant cell wall polysaccharides, releasing and transforming functional components such as amygdalin and poria triterpenes into more easily absorbed active forms. Ultimately, these two technologies, through dual-pathway regulation of key inflammatory signaling pathways, effectively reduce the expression of pruritogenic factors, jointly achieving efficient extraction of active ingredients and a comprehensive improvement in bioavailability, thereby significantly reducing the severity of eczema.

[0059] Experiment 2: Research on the improvement of rhinitis with herbal ointment Animals: SPF-grade C57BL / 6J mice, male, weighing 18-22g, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. They were provided with free access to food and water, housed in an environment of 22-24℃ and 40%-60% relative humidity. Mice were given an acclimatization period of one week before the experiment, and the experiment officially began after observation showed no abnormalities in fur color, diet, or activity.

[0060] Modeling: Mice were randomly divided into a blank control group, a model group, a positive control group (dexamethasone), Example 1-3 groups, and Comparative Example 1-8 groups, with 8 mice in each group. Except for the blank control group, the mice in the other groups underwent modeling in two stages. Sensitization stage: Starting from day 1 of the experiment, mice were intraperitoneally injected with 200 μL of phosphate buffer solution containing ovalbumin and aluminum hydroxide (containing 25 μg ovalbumin and 2 mg aluminum hydroxide) every 5 days for a total of 4 times. The blank control group received an equal volume of phosphate buffer solution. Challenge stage: 20 μL of phosphate buffer solution containing ovalbumin at a concentration of 25 µg / µL was administered into each nostril daily, once a day. The blank control group received an equal volume of phosphate buffer solution daily for 7 consecutive days. When all mice exhibited symptoms such as nose scratching and sneezing, the allergic rhinitis mouse model was considered successfully established.

[0061] Administration: 1.5 hours before nasal drops, the corresponding herbal paste 2g / kg was administered by gavage to groups 1-3 and 1-8 once a day; the positive control group was administered 1mg / kg dexamethasone by gavage; the blank group and model group were administered an equal volume of purified water by gavage once a day for 1 week.

[0062] Test: After the last nasal drop, observe and record the number of sneezes and nose scratches in mice within 10 minutes. The experimental results are as follows: Figure 1 and Figure 2 As shown.

[0063] Figure 1 This is a comparison chart of the number of sneezes in mice in Examples 1-3 and Comparative Examples 1-8. As shown in the chart, the number of sneezes in the control group was extremely low; compared to the control group, the number of sneezes in the model group was significantly higher, indicating successful model establishment; compared to the model group, the number of sneezes in the Example groups was much lower than that in the model group and also lower than that in each comparative example group, indicating that the ointment prepared in this invention can effectively reduce the frequency of sneezing and significantly improve sneezing symptoms caused by rhinitis.

[0064] Figure 2 This is a comparison chart of the number of times mice scratched their noses in Examples 1-3 and Comparative Examples 1-8. As shown in the chart, the number of times mice in the blank group scratched their noses was very low; compared to the blank group, the number of times mice in the model group scratched their noses increased significantly, indicating successful modeling; compared to the model group, the number of times mice in Examples 1-3 scratched their noses was much lower than that of the model group and also lower than that of each comparative example group, indicating that the ointment prepared in this invention can alleviate discomfort such as nasal itching caused by rhinitis and reduce nose-scratching behavior.

[0065] In summary, based on the sneezing and nose-scratching indicators in mice, the ointment prepared in this invention has a significant effect on improving the typical symptoms of rhinitis and can effectively relieve the rhinitis condition in mice.

[0066] The herbal ointment prepared in this invention enhances its anti-allergic rhinitis activity through two core technologies: microbial fermentation and enzymatic extraction. (1) Fermentation of specific strains of *Lactobacillus rhamnosus* SD-SLTRLGJ and *Saccharomyces boulardii* CNCMI-1079 significantly transforms the polyphenols and flavonoids in the herbal raw materials, potentially generating active metabolites with immunomodulatory functions, such as lactic acid and low molecular weight peptides, effectively inhibiting Th2-type immune responses and reducing IgE-mediated histamine release. (2) Enzymatic hydrolysis (cellulase + β-glucosidase) efficiently releases benzaldehyde glycosides from bitter almonds and triterpenoids from *Poria cocos*, and enhances their bioavailability through glycosidic bond hydrolysis, directly downregulating the expression of pro-inflammatory factors such as IL-5 and IL-13 in the nasal mucosa and reducing eosinophil infiltration. The combined effect of these two technologies significantly reduces the frequency of sneezing and nose scratching.

[0067] Experiment 3: Verification of the anti-allergic, antipruritic, and anti-swelling effects of herbal ointment (1) Sample selection Animals: SPF-grade male BALB / c mice, weighing 18-22g, purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd. They were provided with free access to food and water, housed in an environment of 22-24℃ and 40%-60% relative humidity. Mice were given an acclimatization period of one week before the experiment, and the experiment officially began after observation showed no abnormalities in fur color, diet, or activity.

[0068] Modeling: Mice were randomly divided into a blank control group, a model group, a positive control group (loratadine), Example 1-3 groups, and Comparative Example 1-8 groups, with 8 mice in each group. One hour before the start of the experiment, the backs of the mice were shaved (the shaved area was 2.2 cm × 2.2 cm). After the start of the experiment, except for the blank control group, all mice in the other groups were sensitized by intravenous injection of 0.5 mL of anti-DNP-IgE monoclonal antibody (purchased from Beijing Bolide Biotechnology Co., Ltd.) at a concentration of 1:5000. 24 hours later, 50 μL of 0.15% dinitrofluorobenzene (purchased from Tianjin Baima Technology Co., Ltd.) was applied to the back of both ears of the mice. The blank control group was challenged with an equal volume of physiological saline.

[0069] Administration: After successful modeling, the corresponding herbal paste 2g / kg was administered by gavage to groups 1-3 and 1-8 of the comparative examples once a day; the positive control group was administered 1.84 mg / kg loratadine by gavage; the blank group and the model group were administered an equal volume of purified water by gavage once a day for one week.

[0070] Detection of scratching frequency: 24 hours after provocation, the number of scratches per 10 minutes was observed and recorded for each group of mice. The experimental results are as follows: Figure 3 As shown.

[0071] Detection of ear changes: After the last administration, holes were punched in the same location in both ears of mice in each group using a puncher. Ear pieces were removed and weighed. The measurement was repeated three times. The experimental results are as follows: Figure 4 As shown.

[0072] Figure 3 This is a comparison chart of the number of scratches by mice in Examples 1-3 and Comparative Examples 1-8. The mice in the control group scratched very little; compared to the control group, the mice in the model group scratched significantly more, reflecting obvious skin itching and allergic symptoms; compared to the model group, the mice in the examples group scratched far less than the model group and less than the comparative examples, indicating that the ointment prepared in this invention can effectively alleviate discomfort caused by skin itching and allergies, inhibit scratching behavior, and demonstrate anti-allergic and antipruritic effects.

[0073] Figure 4This is a comparison of the ear tissue weights of mice in Examples 1-3 and Comparative Examples 1-8. Compared with the control group, the ear tissue weight of mice in the model group was significantly increased, indicating the presence of swelling and successful modeling. Compared with the model group, the ear tissue weight of mice in the Example groups was significantly lower than that of the model group and was superior to that of the comparative examples, indicating that the ointment prepared in this invention can effectively reduce ear swelling and has an anti-swelling effect. In summary, the ointment prepared by this invention has the effects of improving anti-allergy, relieving itching, and reducing swelling.

[0074] The herbal ointment prepared in this invention significantly enhances its comprehensive efficacy in anti-allergy, antipruritic, and anti-swelling through the synergistic effect of two key technologies: microbial fermentation and enzymatic extraction. Microbial fermentation utilizes specific strains, *Lactobacillus rhamnosus* SD-SLTRLGJ and *Saccharomyces boulardii* CNCMI-1079, to biotransform the herbs, potentially greatly increasing the dissolution rate of active ingredients such as flavonoids and organic acids. It may also generate small molecules with immunomodulatory functions through microbial metabolism, effectively inhibiting IgE antibody production, stabilizing mast cell membranes, and systemically blocking the initiation of type I allergic reactions. Simultaneously, enzymatic extraction, through the synergistic action of cellulase and β-glucosidase, precisely breaks down the cell walls of raw materials such as bitter almonds and *Poria cocos*, converting large-molecule anti-inflammatory components into more easily absorbed small-molecule compounds. This may enhance its inhibitory ability on pruritus mediators such as histamine and serotonin, and strongly reduce local tissue edema caused by increased vascular permeability. These two technologies together form a highly efficient system that achieves multi-target synergistic inhibition of scratching behavior and ear swelling through a dual pathway of systemic anti-allergy and local antipruritic and anti-swelling.

[0075] The above-described embodiments are merely illustrative of specific implementations of the present invention, and while the descriptions are detailed, they should not be construed as limiting the scope of protection of the present invention. It should be noted that for those skilled in the art, any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention should be considered equivalent substitutions and are included within the scope of protection of the present invention.

Claims

1. A special herbal ointment, characterized in that, The herbal paste formula is based on the weight parts of the raw herbs, consisting of 165-215 parts of herbal fermentation liquid obtained from the raw herbs, 100-120 parts of herbal enzymatic hydrolysate obtained from the raw herbs, 155-185 parts of herbal extract obtained from the raw herbs, and 45-65 parts of sweetener. The herbal fermentation liquid is obtained by fermenting 30-40 parts of peppermint, 40-50 parts of perilla, 35-45 parts of chrysanthemum, 30-40 parts of angelica dahurica, and 30-40 parts of dried tangerine peel with probiotics and then filtering. The herbal enzymatic hydrolysate was obtained by enzymatic hydrolysis and extraction of 40-50 parts bitter almonds and 60-70 parts Poria cocos. The herbal extract was obtained by water extraction of 60-70 parts of dried plum, 65-75 parts of lily bulb, and 30-40 parts of licorice root. The probiotics are a compound bacteria, consisting of Lactobacillus rhamnosus SD-SLTRLGJ and Saccharomyces boulardii CNCMI-1079; The enzymes used in the enzymatic hydrolysis are complex enzymes, including cellulase and β-glucosidase.

2. The special herbal ointment according to claim 1, characterized in that, The sweetener is in the following proportions by weight: 30-40 parts xylitol and 15-25 parts fructooligosaccharides.

3. The method for preparing the special herbal ointment according to claim 2, characterized in that, The preparation method of the herbal ointment is as follows: (1) Weigh each component raw material accurately according to the formula. Except for xylitol and fructooligosaccharides, all other raw materials are cleaned, dried at low temperature in an oven, and pulverized to 80 mesh. (2) Preparation of herbal fermentation broth; (3) Preparation of herbal enzymatic hydrolysate; (4) Preparation of herbal extracts; (5) After mixing the herbal fermentation liquid obtained in step (2), the herbal enzymatic hydrolysate obtained in step (3), and the herbal extract obtained in step (4) evenly, xylitol and fructooligosaccharides are added and the mixture is concentrated under reduced pressure to a relative density of 1.2 (60℃) to obtain herbal paste.

4. The processing method according to claim 3, characterized in that, The preparation method of the herbal fermentation broth in step (2) is as follows: S1. Cultivation of *Lactobacillus rhamnosus* SD-SLTRLGJ: *Lactobacillus rhamnosus* SD-SLTRLGJ was inoculated into MRS agar medium and activated at 37℃ for 21 h. The activated strain was then inoculated into MRS liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 2.2 × 10⁻⁶. 8 CFU / mL Lactobacillus rhamnosus bacterial suspension; S2. Cultivation of *Saccharomyces boulardii* CNCMI-1079: *Saccharomyces boulardii* CNCMI-1079 was inoculated into YPD agar medium and activated at 28℃ for 21 h. The activated strain was then inoculated into YPD liquid medium and cultured for another 15 h under the same conditions before stopping the culture, yielding a concentration of 3.0 × 10⁻⁶. 8 CFU / mL Saccharomyces boulardii culture; S3. Preparation of herbal fermentation liquid: Take the peppermint, perilla, chrysanthemum, angelica and tangerine peel obtained in step (1) and mix them evenly. Add Saccharomyces boulardii culture at an inoculation rate of 2-4% (v / w) and ferment aerobicly at 28℃ for 20h. Then add Lactobacillus rhamnosus culture at an inoculation rate of 2-4% (v / w) and ferment aerobicly at 37℃ for 20h. After fermentation, sterilize with 3% H2O2 solution and let stand for 3h. Take the supernatant and centrifuge it at 5000r / min and 4℃ for 15min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45μm filter membrane to obtain herbal fermentation liquid.

5. The processing method according to claim 4, characterized in that, The preparation method of the herbal enzymatic hydrolysate in step (3) is as follows: Take the bitter almond and poria cocos obtained in step (1) and mix them evenly. Add water at a solid-liquid ratio of 1:8 and stir evenly. Adjust the pH of the system to 4.

5. First, add cellulase at a substrate addition of 5000 U / g and enzymatically hydrolyze at 50-55℃ for 2.5 h. Then, add β-glucosidase at a substrate addition of 2000 U / g and continue enzymatic hydrolysis at 45-50℃ and pH=5.0 for 3 h. After the enzymatic hydrolysis is completed, raise the temperature to 90℃ and keep it at 12 min to inactivate the enzyme. After inactivation, let it stand for 3 h. Take the supernatant and centrifuge it at 5000 r / min and 4℃ for 15 min in a refrigerated centrifuge. Take the supernatant and filter it through a 0.45 μm filter membrane. Concentrate the filtrate to 1 / 8 of the filtrate volume to obtain the herbal enzymatic hydrolysate. Preparation of herbal extract in step (4): Take the dried plum, lily and licorice obtained in step (1), mix them evenly, add 6 times the amount of water and decoct twice, each time for 1.2 hours. Combine the decoctions and concentrate them to 1 / 8 of the total volume of the combined decoction.

6. The herbal paste prepared according to any one of claims 3-5.

7. The use of a complex of bacteria consisting of Lactobacillus rhamnosus SD-SLTRLGJ and Saccharomyces boulardii CNCMI-1079 in the preparation of the special herbal ointment of claim 1.

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