Czodiac paste capable of reducing prolactin, promoting digestive absorption and assisting in resisting tumors and preparation method of zodiac paste capable of reducing prolactin, promoting digestive absorption and assisting in resisting tumors

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and discloses a haw traditional Chinese medicine ointment formula capable of reducing prolactin, promoting digestive absorption and assisting in resisting tumors and a preparation method of the haw traditional Chinese medicine ointment formula. The cream formula comprises 12-15% of Chinese dates, 10-15% of fried malt, 8-10% of lalang grass rhizome, 8-10% of chrysanthemum, 7-10% of coix seeds, 7-10% of dandelion, 5-7% of dried tangerine or orange peel, 5-7% of radix polygonati officinalis, 4-6% of hawthorn, 4-5% of Chinese yam, 4-5% of poria cocos, 3-5% of endothelium corneum gigeriae galli, 3-4% of liquorice, 2-3% of platycodon grandiflorum and 2-6% of honey. Wherein the Chinese yam and the poria cocos need to be fermented by lactobacillus acidophilus, and the dried orange peel needs to be subjected to compound enzymolysis by cellulase and pectinase. The traditional Chinese medicine composition has the effects of reducing prolactin, promoting digestion and assisting in resisting tumors. In addition, the traditional Chinese medicine composition has a protection effect on hematopoietic function damage caused by ionizing radiation. The food is suitable for dietary auxiliary conditioning of people in the tumor rehabilitation period, people with hyperprolactinemia and people with weakness of the spleen and the stomach and dyspepsia.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically a Xiaowu ointment with functions of reducing prolactin, promoting digestion and absorption, and assisting in anti-tumor activity, and its preparation method. Background Technology

[0002] With the accelerating pace of life and increasing environmental pressure, breast health problems, digestive system dysfunction, and the incidence of tumors are showing a significant upward trend, posing a serious threat to public health. Current intervention methods for these problems have many limitations: while chemical drugs have clear effects, long-term use can easily lead to drug resistance and gastrointestinal irritation; traditional Chinese medicine decoctions are cumbersome to prepare, have poor taste, and suffer from poor patient compliance. Particularly noteworthy is the significant bottleneck in the deep processing of medicinal and edible ingredients using traditional methods. Conventional water extraction or pulverization methods are insufficient to fully destroy the plant cell wall structure, resulting in low dissolution rates of active ingredients such as flavonoids and volatile oils, leading to poor absorption and utilization by the human body, severely impacting their core efficacy in promoting digestion and absorption. Simultaneously, achieving synergistic effects of innovative Chinese medicine formulas to reduce prolactin levels, promote digestion, and assist in anti-tumor treatment remains a technical challenge in the development of functional herbal paste products. Therefore, developing a medicinal and edible herbal paste product based on modern biotechnology that can synergistically regulate these multiple physiological functions and significantly improve the bioavailability of active ingredients is of significant practical importance for meeting market demand and promoting industrial upgrading. Summary of the Invention

[0003] The purpose of this invention is to overcome the shortcomings of the prior art and provide a medicinal and edible paste with functions of lowering prolactin, promoting digestion and absorption, and assisting in anti-tumor treatment, as well as its preparation method, to solve the problems mentioned in the above-mentioned technical background. This paste is named Xiaowu Paste.

[0004] Specifically, this invention relates to a medicinal and edible herbal paste and its preparation method. The core research and development idea lies in combining modern biotechnology (such as microbial fermentation and enzymatic hydrolysis) with traditional Chinese medicine to improve the bioavailability of active ingredients in Chinese medicinal materials, achieving synergistic effects such as reducing prolactin, promoting digestion and absorption, assisting in anti-tumor activity, and providing radiation protection. This integration of modern biological knowledge with traditional Chinese medicine is a current hot trend, and global TCM development emphasizes the integration of biotechnology into daily life to improve standardization and efficacy. This invention aims to improve the bioavailability of active ingredients in yam and poria cocos in the herbal paste, such as polysaccharides and polyphenolic compounds. These components have low dissolution rates (usually <50%) in traditional water extraction processes, affecting their efficacy in reducing prolactin, promoting digestion, and assisting in anti-tumor activity. Based on the principle of medicinal and edible homology, we considered using probiotic fermentation to break down cell walls and transform active substances. We conducted extensive trials and screenings: In the early stages of research and development, we searched existing literature and found that *Lactobacillus acidophilus* could be used for the fermentation of Chinese medicinal materials (such as yam polysaccharide extraction). We screened various strains, including CICC6094, CICC6081 (used in Comparative Example 1 of this patent), and ATCC7469. Ultimately, we focused on Lactobacillus acidophilus because it can produce lactic acid and enzymes in the fermentation of traditional Chinese medicine, promoting polysaccharide degradation and metabolite generation, thereby enhancing biological activity. During the research and development of this invention, after extensive strain screening and enzyme combination optimization, Lactobacillus acidophilus CICC6094 was finally selected to be used in combination with cellulase-pectinase to process yam, Poria cocos, and tangerine peel. Through multiple iterative experiments (such as comparing strains like CICC6081 with single enzymatic hydrolysis), we obtained an unexpected synergistic mechanism: in the Chinese herbal matrix, the high enzyme activity of this strain and the targeted cell wall-breaking effect of the complex enzyme mutually enhance each other, triggering a multiplied release of polysaccharides and flavonoids and intestinal microbial remodeling, resulting in an overall leap in prolactin reduction, digestion and absorption, and anti-tumor efficacy. This unexpected synergistic effect is only manifested under this specific process, while conventional alternatives (as shown in the comparative example) only achieve partial effects, demonstrating the technical originality of this invention.

[0005] To achieve the above objectives, the present invention provides the following technical solution: In a first aspect, the present invention provides a medicinal and edible paste, which contains, by weight percentage, 12-15% jujube, 10-15% roasted malt, 8-10% Imperata cylindrica root, 8-10% chrysanthemum, 7%-10% coix seed, 7-10% dandelion, 5-7% dried tangerine peel, 5-7% Polygonatum odoratum, 4-6% hawthorn, 4-5% yam, 4-5% Poria cocos, 3-5% chicken gizzard lining, 3-4% licorice, 2-3% Platycodon grandiflorus, and 2-6% honey, and the sum of the weight percentages of the components is 100%.

[0006] The yam and poria cocos, when mixed according to the formula ratio, need to be fermented with Lactobacillus acidophilus CICC 6094; The dried tangerine peel needs to undergo a complex enzymatic hydrolysis using cellulase and pectinase.

[0007] Preferably, the herbal ointment formula contains the following components by weight percentage: 13% jujube, 13% roasted malt, 9% Imperata cylindrica root, 9% chrysanthemum, 8% coix seed, 8% dandelion, 6% dried tangerine peel, 6% Solomon's seal rhizome, 5% hawthorn, 4.5% yam, 4.5% poria cocos, 4% chicken gizzard lining, 3.5% licorice root, 2.5% platycodon root, and 4% honey.

[0008] Secondly, the present invention provides a method for preparing a medicinal and edible paste, comprising the following steps: (1) Weigh out 12-15% jujube, 10-15% roasted malt, 8-10% Imperata cylindrica root, 8-10% chrysanthemum, 7-10% coix seed, 7-10% dandelion, 5-7% dried tangerine peel, 5-7% Solomon's seal rhizome, 4-6% hawthorn, 4-5% yam, 4-5% poria cocos, 3-5% chicken gizzard lining, 3-4% licorice, 2-3% platycodon root, and 2-6% honey according to the following proportions, and the sum of the weight percentages of the above components shall be 100%; (2) Preparation of co-fermented product of yam and poria 1) Activation of Lactobacillus acidophilus: Inoculate the purchased Lactobacillus acidophilus CICC 6094 into MRS medium at a 1% inoculum and incubate at 37°C for 18 hours; then transfer the 1% inoculum to fresh MRS medium and place the bacterial culture at 4°C when OD600≈1~1.2. 2) Weigh 4-5% of yam and 4-5% of poria cocos, pulverize them in a mortar and pestle, then pass them through a 60-mesh sieve (pore size 250μm), add 10 times the weight of distilled water, and sterilize at 121℃ for 20min; 3) Fermentation: After sterilization, cool to 37°C, inoculate with 2% (v / w, based on the total dry weight of yam and poria) Lactobacillus acidophilus CICC 6094, and ferment anaerobically until the pH is approximately 4.2; 4) After fermentation, the bacterial strain in the obtained fermentation product was inactivated with 3% H2O2 solution. After sterilization, the product was centrifuged at 4000 rpm for 15 minutes, and the supernatant was collected and stored at 4℃ for later use. (3) Preparation of enzymatic hydrolysis supernatant of tangerine peel 1) Take 5-7% dried tangerine peel, pulverize it and pass it through a 60-mesh sieve (250 μm) to obtain uniform tangerine peel powder. Add 15 times the weight of distilled water and mix well. Adjust the pH to 5.0. 2) Compound enzymatic hydrolysis: Add cellulase and pectinase at a rate of 100 U / g of dried tangerine peel powder respectively, and enzymatically hydrolyze in a constant temperature water bath at 50℃ for 8-10 hours; 3) Inactivation: Heat in a 90℃ water bath for 15 minutes to inactivate the enzyme, centrifuge at 4000 rpm for 15 minutes, and take the supernatant and store it at 4℃ for later use.

[0009] (4) Grind 12-15% jujube, 10-15% roasted malt, 8-10% Imperata cylindrica root, 8-10% chrysanthemum, 7-10% coix seed, 7-10% dandelion, 5-7% Polygonatum odoratum, 4-6% hawthorn, 3-5% chicken gizzard lining, 3-4% licorice, and 2-3% Platycodon grandiflorus into powder and pass through a 60-mesh sieve. Add 8 times the amount of distilled water, soak for 30 minutes, then heat to boiling and reflux for 1 hour. Reflux the residue again for 30 minutes under the same conditions and combine the two filtrates. Concentrate at 60℃ under negative pressure (-0.09MPa) to obtain a preliminary concentrate with a density of 1.1 (60℃).

[0010] (5) Concentration and extraction: The supernatant of fermentation product obtained in step (2), the supernatant of enzymatic hydrolysis of tangerine peel obtained in step (3) and the preliminary concentrated liquid obtained in step (4) are mixed and concentrated at 60℃ and -0.09MPa to a relative density of about 1.25 (60℃).

[0011] (6) Heat the honey at 80-90℃ until it is slightly darker in color. Then reduce the temperature to 60℃ and slowly add the concentrated medicinal paste while stirring to mix it evenly. This will give you the medicinal and edible paste.

[0012] Preferably, in step (2), the mass ratio of yam and poria is 1:1.

[0013] Preferably, the medicinal and edible paste has the effects of reducing prolactin, promoting digestion, assisting in anti-tumor activity, and providing radiation protection for the blood system.

[0014] Compared with the prior art, the beneficial effects of the present invention are: 1. In this application, Lactobacillus acidophilus CICC 6094 was used to ferment yam and Poria cocos, and cellulase and pectinase were used to enzymatically hydrolyze tangerine peel. Through the non-obvious combination of specific strains and enzymes, the bioavailability of active ingredients was significantly improved.

[0015] 2. The medicinal and edible paste of this application, with the synergistic effects of fermented yam and poria cocos, enzymatic hydrolysate of tangerine peel, as well as roasted malt, chrysanthemum and hawthorn, has significant effects in reducing prolactin, promoting digestion, assisting in anti-tumor activity, and providing radiation protection for the blood system.

[0016] 3. During the research and development process, we also conducted detailed mechanistic speculation: For example, Lactobacillus acidophilus CICC6094 fermentation of yam and Poria cocos may disrupt the plant cell wall structure by producing metabolites such as lactic acid, β-glucanase and protease, and promote the release of polysaccharides, polyphenols and saponins. These active substances further regulate the gut microbiome (such as increasing the abundance of beneficial bacteria and producing short-chain fatty acids), thereby affecting the gut-brain axis and hormone secretion pathways (such as inhibiting pituitary prolactin-releasing hormone and reducing prolactin levels), and activating anti-tumor signaling pathways (such as inhibiting the NF-κB inflammatory pathway and promoting tumor cell apoptosis), while enhancing antioxidant activity to protect against radiation damage. Attached Figure Description

[0017] Figure 1 The figure shows the experimental results of the effect of the food-medicine homology paste of the present invention on prolactin in rats; Figure 2 The figure shows the experimental results of the effect of the food-medicine homology paste of the present invention on the digestive capacity (amylase) of rats; Figure 3 The figure shows the experimental results of the effect of the food-medicine homology paste of the present invention on the absorption capacity (D-xylose) of mice; Figure 4 The figure shows the experimental results of the effect of the food-medicine homology paste of the present invention on the tumor quality of mice.

[0018] Figure 5 and Figure 6 This is a physical image of the herbal paste of the present invention. Detailed Implementation

[0019] 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.

[0020] Some of the raw materials used in this application: The jujubes meet the 2020 Pharmacopoeia standards.

[0021] Roasted malt meets the 2020 Pharmacopoeia standards.

[0022] Imperata cylindrica root meets the 2020 Pharmacopoeia standards.

[0023] Chrysanthemums meet the 2020 Pharmacopoeia standards.

[0024] Job's tears meet the 2020 Pharmacopoeia standards.

[0025] Dandelion meets the 2020 Pharmacopoeia standards.

[0026] Dried tangerine peel meets the 2020 Pharmacopoeia standards.

[0027] Polygonatum odoratum meets the 2020 Pharmacopoeia standards.

[0028] Yam meets the 2020 Pharmacopoeia standards.

[0029] Poria cocos meets the 2020 Pharmacopoeia standards.

[0030] Chicken gizzard lining meets the 2020 Pharmacopoeia standards.

[0031] Licorice meets the 2020 Pharmacopoeia standards.

[0032] Platycodon grandiflorus meets the 2020 Pharmacopoeia standards.

[0033] The honey meets the 2020 Pharmacopoeia standards.

[0034] Lactobacillus acidophilus CICC 6094 was purchased from the China Industrial Microbial Culture Collection Center.

[0035] Lactobacillus acidophilus CICC 6081 was purchased from the China Industrial Microbial Culture Collection Center.

[0036] Cellulase, product number: 9012-54-8, purchased from Shanghai Yuanye Biotechnology Co., Ltd.

[0037] Pectinase, product number: 9032-75-1, purchased from Shanghai Yuanye Biotechnology Co., Ltd.

[0038] Example 1

[0039] A medicinal and edible paste, the formula of which includes: 13% jujube, 13% roasted malt, 9% Imperata cylindrica root, 9% chrysanthemum, 8% coix seed, 8% dandelion, 6% dried tangerine peel, 6% Solomon's seal rhizome, 5% hawthorn, 4.5% yam, 4.5% poria cocos, 4% chicken gizzard lining, 3.5% licorice, 2.5% platycodon grandiflorus and 4% honey.

[0040] The yam and poria cocos mentioned therein are mixed in a certain proportion and then fermented with Lactobacillus acidophilus CICC 6094; The tangerine peel mentioned above is subjected to enzymatic hydrolysis by a combination of cellulase and pectinase.

[0041] Example 2

[0042] A medicinal and edible paste, the formula of which includes: 12% jujube, 15% roasted malt, 8% Imperata cylindrica root, 10% chrysanthemum, 7% coix seed, 10% dandelion, 5% dried tangerine peel, 7% Solomon's seal rhizome, 4% hawthorn, 5% yam, 4% poria cocos, 5% chicken gizzard lining, 3% licorice, 3% platycodon root, and 2% honey.

[0043] The yam and poria cocos mentioned therein are mixed in a certain proportion and then fermented with Lactobacillus acidophilus CICC 6094; The tangerine peel mentioned above is subjected to enzymatic hydrolysis by a combination of cellulase and pectinase.

[0044] The preparation method of the medicinal and edible homology paste in this embodiment is the same as that in Example 1.

[0045] Example 3

[0046] A medicinal and edible paste, the formula of which, by weight percentage, contains: 15% jujube, 10% roasted malt, 10% Imperata cylindrica root, 8% chrysanthemum, 10% coix seed, 7% dandelion, 7% dried tangerine peel, 5% Solomon's seal rhizome, 6% hawthorn, 4% yam, 5% poria cocos, 3% chicken gizzard lining, 4% licorice, 2% platycodon root, and 4% honey.

[0047] The yam and poria cocos mentioned therein are mixed in a certain proportion and then fermented with Lactobacillus acidophilus CICC 6094; The tangerine peel mentioned above is subjected to enzymatic hydrolysis by a combination of cellulase and pectinase.

[0048] The preparation method of the medicinal and edible homology paste in this embodiment is the same as that in Example 1.

[0049] Comparative Example 1 This comparative example is similar to Example 1, except that: the yam and poria cocos are fermented with Lactobacillus acidophilus CICC 6081 instead of Lactobacillus acidophilus CICC 6094.

[0050] Comparative Example 2 This comparative example is similar to Example 1, except that the yam is not fermented with Lactobacillus acidophilus CICC 6094.

[0051] Comparative Example 3 This comparative example is similar to Example 1, except that: Poria cocos is not fermented with Lactobacillus acidophilus CICC 6094.

[0052] Comparative Example 4 This comparative example is similar to Example 1, except that the yam and poria are not fermented.

[0053] Comparative Example 5 This comparative example is similar to Example 1, except that yam is omitted.

[0054] Comparative Example 6 This comparative example is similar to Example 1, except that Poria cocos was removed.

[0055] Comparative Example 7 This comparative example is similar to Example 1, except that the tangerine peel is not enzymatically hydrolyzed.

[0056] Comparative Example 8 This comparative example is similar to Example 1, except that the tangerine peel is only hydrolyzed by cellulase and not by pectinase.

[0057] Comparative Example 9 This comparative example is similar to Example 1, except that the tangerine peel is only hydrolyzed by pectinase and not by cellulase.

[0058] Comparative Example 10 This comparative example is similar to Example 1, except that the dried tangerine peel is omitted.

[0059] Comparative Example 11 This comparative example is similar to Example 1, except that roasted malt was removed.

[0060] Comparative Example 12 This comparative example is similar to Example 1, except that hawthorn is omitted.

[0061] Comparative Example 13 This comparative example is similar to Example 1, except that Imperata cylindrica root is omitted.

[0062] The preparation method of the medicinal and edible homology paste in Example 1 is as follows: (1) Weigh out 13% jujube, 13% roasted malt, 9% Imperata cylindrica root, 9% chrysanthemum, 8% coix seed, 8% dandelion, 6% dried tangerine peel, 6% Solomon's seal rhizome, 5% hawthorn, 4.5% yam, 4.5% poria cocos, 4% chicken gizzard lining, 3.5% licorice, 2.5% platycodon grandiflorus and 4% honey according to the proportion.

[0063] (2) Preparation of co-fermented product of yam and poria 1) Activation of Lactobacillus acidophilus: Inoculate the purchased Lactobacillus acidophilus CICC 6094 into MRS medium at a 1% inoculum and incubate at 37°C for 18 hours; then transfer the 1% inoculum to fresh MRS medium and place the bacterial culture at 4°C when OD600≈1.1. 2) Weigh 4.5% yam and 4.5% poria cocos, pulverize them in a mortar and pestle, then pass them through a 60-mesh sieve (pore size 250μm), add 10 times the weight of distilled water, and sterilize at 121℃ for 20min; 3) Fermentation: After sterilization, cool to 37°C, inoculate with 2% (v / w, based on the total dry weight of yam and poria) Lactobacillus acidophilus CICC 6094, and ferment anaerobically until the pH is approximately 4.2; 4) After fermentation, the bacterial strain in the obtained fermentation product was inactivated with 3% H2O2 solution. After sterilization, the product was centrifuged at 4000 rpm for 15 minutes, and the supernatant was collected and stored at 4℃ for later use. (3) Preparation of enzymatic hydrolysis supernatant of tangerine peel 1) Take 6% dried tangerine peel, crush it and pass it through a 60-mesh sieve (250 μm) to obtain uniform dried tangerine peel powder. Add 15 times the weight of distilled water and mix well. Adjust the pH to 5.0. 2) Compound enzymatic hydrolysis: Add cellulase and pectinase at a rate of 100 U / g of dried tangerine peel, and enzymatically hydrolyze in a constant temperature water bath at 50℃ for 9 hours; 3) Inactivation: Heat in a 90℃ water bath for 15 minutes to inactivate the enzyme, centrifuge at 4000 rpm for 15 minutes, and take the supernatant and store it at 4℃ for later use.

[0064] (4) Crush 13% jujube, 13% roasted malt, 9% Imperata cylindrica root, 9% chrysanthemum, 8% coix seed, 8% dandelion, 6% Polygonatum odoratum, 5% hawthorn, 4% chicken gizzard lining, 3.5% licorice, and 2.5% Platycodon grandiflorus and pass them through a 60-mesh sieve. Add 8 times the amount of distilled water, soak for 30 minutes, then heat to boiling and reflux for 1 hour. Reflux the residue again for 30 minutes under the same conditions and combine the two filtrates. Concentrate at 60℃ under negative pressure (-0.09MPa) to obtain a preliminary concentrate with a density of 1.1 (60℃).

[0065] (5) Concentration and extraction: The supernatant of fermentation product obtained in step (2), the supernatant of enzymatic hydrolysis of tangerine peel obtained in step (3) and the preliminary concentrated liquid obtained in step (4) are mixed and concentrated at 60℃ and -0.09MPa to a relative density of about 1.25 (60℃).

[0066] (6) Mixing and preparing the paste: Heat the honey at 85℃ until it is slightly dark in color, then reduce the temperature to 60℃ and slowly add it to the concentrated medicinal paste while stirring to mix it evenly. This will give you the medicinal and edible paste.

[0067] Preparation method of Comparative Example 1: (2) Preparation of co-fermented product of yam and poria 1) Activation of Lactobacillus acidophilus: Inoculate the purchased Lactobacillus acidophilus CICC 6081 into MRS medium at a 1% inoculum and incubate at 37°C for 18 hours; then transfer the 1% inoculum to fresh MRS medium and place the bacterial culture at 4°C when OD600≈1.1. 2) Weigh 4.5% yam and 4.5% poria cocos, pulverize them in a mortar and pestle, then pass them through a 60-mesh sieve (pore size 250μm), add 10 times the weight of distilled water, and sterilize at 121℃ for 20min; 3) Fermentation: After sterilization, cool to 37°C, inoculate with 2% (v / w, based on the total dry weight of yam and poria) Lactobacillus acidophilus CICC 6081, and ferment anaerobically until the pH is approximately 4.2; 4) After fermentation, the bacterial strain in the obtained fermentation product was inactivated with 3% H2O2 solution. After sterilization, the product was centrifuged at 4000 rpm for 15 minutes, and the supernatant was collected and stored at 4℃ for later use. The remaining steps are the same as the preparation method in Example 1.

[0068] Preparation method of Comparative Example 2: (2) Preparation of Poria cocos fermentation product and yam powder extract 1) Activation of Lactobacillus acidophilus: Inoculate the purchased Lactobacillus acidophilus CICC 6094 into MRS medium at a 1% inoculum and incubate at 37°C for 18 hours; then transfer the 1% inoculum to fresh MRS medium and place the bacterial culture at 4°C when OD600≈1.1. 2) Weigh 4.5% yam and 4.5% poria cocos, pulverize them in a mortar and pestle and pass them through a 60-mesh sieve (pore size 250μm). Add 10 times the weight of distilled water to the 4.5% poria cocos powder and sterilize at 121℃ for 20min. 3) Fermentation: After sterilization, cool to 37°C, inoculate with 2% (v / w, based on the total dry weight of Poria cocos) Lactobacillus acidophilus CICC 6081, and carry out anaerobic fermentation until the pH is approximately 4.2; 4) After fermentation, the bacterial strain in the obtained fermentation product was inactivated with 3% H2O2 solution. After sterilization, the product was centrifuged at 4000 rpm for 15 minutes to obtain the supernatant of the Poria cocos fermentation product, which was then placed at 4℃ for later use. The yam powder was subjected to water extraction treatment, specifically referring to step (4) of Example 1, and was mixed with the Chinese medicinal materials in step (4) and extracted together with water. The remaining steps are the same as the preparation method in Example 1.

[0069] Preparation method of Comparative Example 3: (2) Preparation of a mixture of fermented yam and Poria cocos 1) Activation of Lactobacillus acidophilus: Inoculate the purchased Lactobacillus acidophilus CICC 6094 into MRS medium at a 1% inoculum and incubate at 37°C for 18 hours; then transfer the 1% inoculum to fresh MRS medium and place the bacterial culture at 4°C when OD600≈1.1. 2) Weigh 4.5% yam and 4.5% poria cocos, pulverize them in a mortar and pestle and pass them through a 60-mesh sieve (pore size 250μm). Add 10 times the weight of distilled water to the 4.5% yam powder and sterilize at 121℃ for 20min. 3) Fermentation: After sterilization, cool to 37°C, inoculate with 2% (v / w, based on the total dry weight of yam) Lactobacillus acidophilus CICC 6081, and ferment anaerobically until the pH is approximately 4.2; 4) After fermentation, the bacterial strain in the obtained fermentation product was inactivated with 3% H2O2 solution. After sterilization, the product was centrifuged at 4000 rpm for 15 minutes to obtain the supernatant of the yam fermentation product, which was then placed at 4℃ for later use. The Poria cocos powder was subjected to water extraction treatment, specifically referring to step (4) of Example 1, and was mixed with the Chinese medicinal materials in step (4) and extracted together with water. The remaining steps are the same as the preparation method in Example 1.

[0070] Preparation method of Comparative Example 4: (2) Preparation of a mixture of yam powder and poria powder 1) Weigh 4.5% yam and 4.5% poria, pulverize them in a mortar and pass them through a 60-mesh sieve (pore size 250 μm), mix the 4.5% yam powder and 4.5% poria powder and then perform water extraction treatment, specifically referring to step (4) of Example 1, and then mix them with the Chinese medicinal materials in step (4) and extract them together with water. The preparation steps for the remaining raw materials are the same as those in Example 1.

[0071] Preparation method of Comparative Example 7: (3) Preparation of enzymatic hydrolysis supernatant of tangerine peel 1) Take 6% dried tangerine peel, crush it and pass it through a 60-mesh sieve (250 μm) to obtain uniform dried tangerine peel powder, add 15 times the weight of distilled water and mix well; 2) 50℃ constant temperature water bath for 9 hours; 3) Centrifuge at 4000 rpm for 15 minutes, and collect the supernatant and store at 4℃ for later use.

[0072] The preparation steps for the remaining raw materials are the same as those in Example 1.

[0073] Preparation method of Comparative Example 8: (3) Preparation of enzymatic hydrolysis supernatant of tangerine peel 1) Take 6% dried tangerine peel, crush it and pass it through a 60-mesh sieve (250 μm) to obtain uniform dried tangerine peel powder. Add 15 times the weight of distilled water and mix well. Adjust the pH to 5.0. 2) Compound enzymatic hydrolysis: Add pectinase at a rate of 100 U / g of dried tangerine peel powder, and enzymatically hydrolyze in a constant temperature water bath at 50℃ for 9 hours; 3) Inactivation: Heat in a 90℃ water bath for 15 minutes to inactivate the enzyme, centrifuge at 4000 rpm for 15 minutes, and take the supernatant and store it at 4℃ for later use.

[0074] The preparation steps for the remaining raw materials are the same as those in Example 1.

[0075] Preparation method of Comparative Example 9: (3) Preparation of enzymatic hydrolysis supernatant of tangerine peel 1) Take 6% dried tangerine peel, crush it and pass it through a 60-mesh sieve (250 μm) to obtain uniform dried tangerine peel powder. Add 15 times the weight of distilled water and mix well. Adjust the pH to 5.0. 2) Compound enzymatic hydrolysis: Add cellulase at a rate of 100 U / g of dried tangerine peel powder, and enzymatically hydrolyze in a constant temperature water bath at 50℃ for 9 hours; 3) Inactivation: Heat in a 90℃ water bath for 15 minutes to inactivate the enzyme, centrifuge at 4000 rpm for 15 minutes, and take the supernatant and store it at 4℃ for later use.

[0076] The preparation steps for the remaining raw materials are the same as those in Example 1.

[0077] To further clarify the efficacy of the medicinal and edible homology paste provided in the embodiments of this application, the following performance tests were also conducted in the embodiments of this application: 1. Experiment on the effect of reducing prolactin Female nonpregnant Wistar rats, 200-220g, were purchased from Beijing Vital River Co., Ltd.

[0078] Metoclopramide hydrochloride injection, purchased from Suicheng Pharmaceutical Co., Ltd., specification: 1ml:10mg, batch number: H41021179.

[0079] Bromocriptine mesylate tablets, purchased from Girard Pharmaceuticals in Hungary, specification: 2.5mg, batch number: T55538A.

[0080] Traditional Chinese medicine ointment solution: Prepare with distilled water to a concentration of 7.5 mg / mL.

[0081] Establishment of a rat model of hyperprolactinemia: A rat model of hyperprolactinemia can be established by subcutaneously injecting metoclopramide hydrochloride injection (dopamine D2 receptor blocker) into the back of rats at a dose of 100 mg / kg for 5 consecutive days.

[0082] Experimental Methods and Grouping: Rats were divided into 13 groups, with 8 rats in each group: blank control group, model group, positive control group, Examples 1-3 groups, Comparative Examples 1-6 groups, and Comparative Example 11 group. Each rat in the control group was a normal rat at the same time point. Rats in the model group, bromocriptine positive control group, Examples 1-3, Comparative Examples 1-6, and Comparative Example 11 groups were rats with hyperprolactinemia. The bromocriptine positive control group was administered 0.45 mg / kg of bromocriptine aqueous solution by gavage. Examples 1-3, Comparative Examples 1-6, and Comparative Example 11 were administered 75 mg / kg of traditional Chinese medicine ointment solution by gavage. The normal and model groups were administered an equal volume of distilled water by gavage. This was done once daily for 21 consecutive days. After 21 days, blood was collected from the eyeballs, centrifuged at 3000 rpm for 15 min, and the supernatant was used to detect prolactin (PRL) levels using an ELISA kit (see Table 1).

[0083] Table 1:

[0084] Table 1 shows that the prolactin level in the model group was significantly higher than that in the blank control group, proving the successful establishment of the hyperprolactin rat model. Example 1 showed the best prolactin-lowering effect. The prolactin levels in Comparative Examples 1-6 were higher than in the Example 1, demonstrating that yam and poria cocos, after fermentation with Lactobacillus acidophilus CICC 6094, had a significant prolactin-lowering effect; Comparative Example 11 indicated that roasted malt played a key role in reducing prolactin.

[0085] 2. Digestive and absorption effects Female Wistar rats, 180-220g, were purchased from Beijing Vital River Co., Ltd.

[0086] D-xylose test kit, catalog number: A035-1-1, purchased from Nanjing Jiancheng Biotechnology Institute.

[0087] Amylase test kit, catalog number: BC0615, purchased from Solarbio Biotechnology Co., Ltd.

[0088] Traditional Chinese medicine ointment solution: Prepared with distilled water to a concentration of 7.5 mg / mL.

[0089] Sijunzi Decoction: Codonopsis pilosula 20 g, Atractylodes macrocephala 20 g, Poria cocos 20 g, Glycyrrhiza uralensis (processed) 10 g, decocted in water and processed and concentrated into a certain concentrated medicinal liquid, equivalent to a raw drug concentration of 2 g / mL.

[0090] Xiao Chengqi Decoction: Weigh and mix 12g of rhubarb, 6g of magnolia bark, and 9g of immature bitter orange. Place the raw herbs in a 2000mL beaker, cover the herbs with water, soak at room temperature for 120 minutes, then add an appropriate amount of water and decoct for 30 minutes. Filter. Add water to the dregs to cover the herbs, decoct for 15 minutes, filter, combine the two decoctions, filter and concentrate to 1 mL equivalent to 1g of raw herbs, and store at low temperature for later use.

[0091] Establishing a rat model of spleen deficiency: The single-factor modeling method of Xiao Chengqi Decoction to break up qi and drain purgation was adopted. The rats were administered Xiao Chengqi Decoction by gavage for 7 consecutive days, with each rat receiving 2 mL of Xiao Chengqi Decoction by gavage once a day.

[0092] One hundred and eighty healthy adult male Wistar rats, weighing 200–220 g, were acclimatized and then randomly divided into 18 groups: a blank control group, a spleen deficiency model group, a natural recovery group, a positive drug group, groups of Examples 1–3, groups of Comparative Examples 1–10, and group of Comparative Example 12, with 10 rats in each group. The blank control group consisted of normal rats (gavaged with distilled water according to the method for establishing the spleen deficiency model rats), while the other groups were spleen deficiency model rats. After successful modeling, the blank control group and the spleen deficiency model group were not gavaged, and the natural recovery group was gavaged with distilled water; the positive drug group was gavaged with Sijunzi Decoction, 2 mL / time, twice a day; and groups of Examples 1–3, Comparative Examples 1–10, and Comparative Example 12 were gavaged with the corresponding herbal ointment solution (75 mg / kg) once a day. Seven days after gavage, the patient was anesthetized by intraperitoneal injection of sodium pentobarbital. The thoracic cavity was opened, and 5 mL of blood was collected from the heart. After standing for 2 hours, the blood was centrifuged at 3000 rpm for 15 minutes, and the supernatant was collected. The contents of amylase (AMS) and D-xylose were detected using a kit. See Table 2. Table 2:

[0093] Table 2 shows that the serum amylase and xylose levels in the spleen deficiency model group were significantly lower than those in the blank control group, proving the successful modeling. The amylase and xylose levels in Examples 1-3 were higher than those in the comparative groups. The results of Comparative Examples 1-6 indicate that fermentation of yam and poria cocos with Lactobacillus acidophilus CICC 6094 enhanced their digestive and absorptive effects. The results of Comparative Examples 7-10 indicate that tangerine peel, after being hydrolyzed by a combination of pectinase and cellulase, showed better digestive and absorptive effects. The results of Comparative Example 12 indicate that hawthorn is a key component in the traditional Chinese medicine paste that promotes digestion and absorption.

[0094] 3. Adjunctive anti-tumor experiments SPF-grade male C57BL / 6J mice, male, 20±2g, purchased from Beijing Vital River Co., Ltd.

[0095] Traditional Chinese medicine ointment: Prepared with distilled water to a concentration of 15 mg / mL.

[0096] Human colorectal cancer cell line (MC38) was purchased from Wuhan Pusaino Biotechnology Co., Ltd.

[0097] Establishment of a mouse model of colorectal cancer: A subcutaneous xenograft model was established in mice after one week of adaptive feeding. One day prior to modeling, the right dorsal region of the mice was prepared. Colorectal cancer MC38 cells in logarithmic growth phase were collected by digestion and centrifugation, and then adjusted to a density of 1×10⁻⁶ cells using phosphate-buffered saline (PBS). 7 A single-cell suspension of 0.2 mL / mouse was administered subcutaneously to the right back of the mouse using a 1 mL syringe. After injection, the needle was withdrawn and the injection site was pressed with a cotton ball to prevent backflow of the cell suspension.

[0098] Mice were randomly divided into 15 groups: control group, Examples 1-3 groups, Comparative Examples 1-10 groups, and Comparative Example 13 group, with 10 mice in each group. Except for the control group, all other groups used mice with the model. Three days after modeling, Examples 1-3 and Comparative Examples 1-10 groups were administered 150 mg / kg by gavage, while the control group was administered an equal volume of distilled water by gavage. Gavage was performed once daily for 30 consecutive days. After the administration ended on day 30, the mice were sacrificed, the tumors were removed, and the tumor mass was measured, i.e., tumor mass, as shown in Table 3.

[0099] Table 3:

[0100] Table 3 shows that the tumor mass of mice in Example 1 group was significantly lower than that in the control group, demonstrating its anti-tumor efficacy. Comparative Examples 1-6 indicate that yam and poria cocos showed better anti-tumor effects after fermentation with Lactobacillus acidophilus CICC 6094. Comparative Examples 7-10 show that tangerine peel exhibited better anti-tumor effects after enzymatic hydrolysis with pectinase and cellulase. Comparative Example 13 indicates that Imperata cylindrica root plays an important role in the anti-tumor efficacy of traditional Chinese medicine.

[0101] 4. Protective effect against damage to the blood system caused by ionizing radiation. Male C57 BL / 6J, 6-7 weeks old, purchased from Beijing Vital River Co., Ltd.

[0102] Traditional Chinese medicine ointment solution: Prepared with distilled water to a concentration of 15 mg / mL.

[0103] Berberine hydrochloride, product number: 6078-17-7, purchased from Shanghai Yuanye Biotechnology Co., Ltd.

[0104] Mice were divided into 8 groups: normal control group, whole-body irradiation group, positive control group, Examples 1-3 groups, comparative example 4 group, and comparative example 7 group. Except for the normal control group, which was not irradiated, all other groups received 6 Gy of X-ray irradiation (irradiation rate 6.031 Gy / min). Berberine hydrochloride served as the positive control group, with a dosage of 20 mg / kg. The traditional Chinese medicine ointment intervention lasted 14 days before and after irradiation, administered by gavage (150 mg / kg). The normal control group and the whole-body irradiation group were simultaneously administered an equal volume of physiological saline by gavage daily. Fourteen days after irradiation, the mice were kept on a fasting but not water-dependent diet. 50 μL of whole blood was collected from the orbital sinus to determine the white blood cell and red blood cell counts; the results are shown in Table 4.

[0105] Table 4:

[0106] Table 4 shows that the number of white blood cells, red blood cells, platelets, and hemoglobin in the whole-body irradiation group was significantly lower than that in the normal control group, proving that the radiation damage model was successfully constructed. Examples 1-3 all alleviated radiation-induced blood system damage, with Example 1 showing the best effect. Comparative Examples 4 and 7 indicate that fermented yam and poria cocos products, along with enzymatic hydrolysate of tangerine peel, can synergistically alleviate blood system damage caused by ionizing radiation.

[0107] The medicinal and edible homology paste provided in this application can be used in the preparation of traditional Chinese medicine products. The medicinal and edible homology paste has the effects of reducing prolactin, promoting digestion and absorption, assisting in anti-tumor treatment, and providing radiation protection for the blood system.

[0108] The embodiments described above 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 the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. A compound fermentation agent, characterized in that, The compound fermentation agent includes Lactobacillus acidophilus CICC6094, used for fermenting a mixture of Dioscorea opposita and Poria cocos, wherein the Dioscorea opposita and Poria cocos are mixed in a 1:1 mass ratio, the OD600 of the compound fermentation agent is 1.0~1.2, the inoculum size is 2% (v / w), and the fermentation conditions are anaerobic fermentation at 37°C to pH 4.

2.

2. A traditional Chinese medicine ointment formula for Xiao Wu, characterized in that, The herbal ointment formula contains the following components by weight percentage: 12-15% jujube, 10-15% roasted malt, 8-10% Imperata cylindrica root, 8-10% chrysanthemum, 7%-10% coix seed, 7-10% dandelion, 5-7% dried tangerine peel, 5-7% Solomon's seal rhizome, 4-6% hawthorn, 4-5% yam, 4-5% poria cocos, 3-5% chicken gizzard lining, 3-4% licorice root, 2-3% platycodon root, and 2-6% honey. The sum of the weight percentages of all the components is 100%, wherein the yam and poria cocos are fermented using the compound fermentation agent described in claim 1.

3. The Xiao Wu herbal ointment formula according to claim 2, characterized in that, In the herbal ointment formula, yam and poria cocos are mixed and fermented with Lactobacillus acidophilus CICC 6094, and dried tangerine peel needs to be hydrolyzed by a combination of cellulase and pectinase.

4. The Xiao Wu herbal ointment formula according to claim 3, characterized in that, The herbal ointment is taken orally after being brewed.

5. The Xiao Wu herbal ointment formula according to claim 4, characterized in that, The herbal ointment formula contains the following components by weight percentage: 13% jujube, 13% roasted malt, 9% Imperata cylindrica root, 9% chrysanthemum, 8% coix seed, 8% dandelion, 6% dried tangerine peel, 6% Solomon's seal rhizome, 5% hawthorn, 4.5% yam, 4.5% poria cocos, 4% chicken gizzard lining, 3.5% licorice root, 2.5% platycodon root, and 4% honey.

6. The Xiao Wu herbal ointment formula according to any one of claims 2-5, characterized in that, The herbal ointment has the effects of lowering prolactin levels, promoting digestion, assisting in anti-tumor activity, and providing radiation protection to the blood system.

7. A method for preparing Xiao Wu traditional Chinese medicine ointment according to any one of claims 2-5, characterized in that, Includes the following steps: (1) Weigh out 12-15% jujube, 10-15% roasted malt, 8-10% Imperata cylindrica root, 8-10% chrysanthemum, 7-10% coix seed, 7-10% dandelion, 5-7% dried tangerine peel, 5-7% Solomon's seal rhizome, 4-6% hawthorn, 4-5% yam, 4-5% poria cocos, 3-5% chicken gizzard lining, 3-4% licorice, 2-3% platycodon root, and 2-6% honey according to the following proportions, and the sum of the weight percentages of the above components shall be 100%; (2) Mix 4-5% yam and 4-5% poria cocos according to the ratio, pulverize and pass through a 60-mesh sieve, add 10 times the weight of purified water, sterilize at 121℃ for 20 min, then cool to 37℃, inoculate with 2% Lactobacillus acidophilus bacterial solution, ferment anaerobically at 37℃, stop fermentation when the pH drops to 4.2, after fermentation, inactivate the bacterial strain in the obtained fermentation product with 3% H2O2 solution; after sterilization, centrifuge to obtain the supernatant of fermentation product and store at 4℃ for later use; (3) 5-7% of dried tangerine peel is crushed and passed through a 60-mesh sieve. The dried tangerine peel powder is mixed with water at a ratio of 1:15, the pH is adjusted to 5.0, cellulase and pectinase are added, and the mixture is enzymatically hydrolyzed at 50°C for 9 hours. The enzymes are then inactivated by heating in a 90°C water bath for 15 minutes. The enzymatic hydrolysate of dried tangerine peel is obtained by centrifugation and stored at 4°C for later use. (4) Mix 12-15% jujube, 10-15% roasted malt, 8-10% Imperata cylindrica root, 8-10% chrysanthemum, 7-10% coix seed, 7-10% dandelion, 5-7% Polygonatum odoratum, 4-6% hawthorn, 3-5% chicken gizzard lining, 3-4% licorice, and 2-3% Platycodon grandiflorus according to the formula ratio, pulverize and pass through a 60-mesh sieve, add 8 times the amount of distilled water, soak for 30 minutes, heat to boiling, and reflux for 1 hour; reflux the residue again for 30 minutes, combine the two filtrates, and concentrate under reduced pressure at 60℃ to obtain a preliminary concentrated liquid; (5) Concentration: Mix the supernatant of fermentation product, the supernatant of enzymatic hydrolysis of tangerine peel and the preliminary concentrated liquid, and concentrate under reduced pressure at 60°C to a relative density of 1.25 (60°C). (6) Heat the honey at 80-90℃ until it is slightly darker in color. Then reduce the temperature to 60℃ and slowly add it to the concentrated medicinal paste while stirring to mix it evenly. This will give you the medicinal and edible paste.

8. The method for preparing Xiao Wu traditional Chinese medicine ointment according to claim 7, characterized in that, In step (2), the ratio of yam and poria cocos is 1:1 by mass.

9. The method for preparing Xiao Wu traditional Chinese medicine ointment according to claim 8, characterized in that, The OD600 of the Lactobacillus acidophilus bacterial solution in step (2) is 1.0~1.

2.

10. The method for preparing Xiao Wu traditional Chinese medicine ointment according to claim 9, characterized in that, In step (4), the relative density of the preliminary concentrate is 1.1 (60℃); in step (3), the cellulase and pectinase are added at a rate of 100 U / g of dried tangerine peel.

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