Monascus fermentation product for reducing nodules

Abstract

This invention provides a red yeast rice fermentation product for eliminating nodules. A group of important compositions for eliminating nodules were screened and obtained, including dihydroquercetin, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, platycodon grandiflorus, and black buckwheat. The culture medium was prepared using the traditional Chinese medicine composition, and red yeast rice was inoculated for fermentation. This process transformed the large active molecules in the traditional Chinese medicine composition that eliminate nodules into small active molecules such as aglycones, thereby enhancing the efficacy of eliminating nodules and significantly improving the therapeutic effect of the traditional Chinese medicine composition in eliminating nodules, thus meeting clinical needs.

Description

[0001] This application claims priority to the earlier Chinese application, application number 202310195588X, filed on March 3, 2023; all of its contents are part of this invention. Technical Field

[0002] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a red yeast rice fermentation product for eliminating nodules. Background Technology

[0003] Nodules are tissues with a density different from surrounding tissues, found during physical examinations or imaging studies. Cystic nodules have a lower density than surrounding tissues, while firm nodules have a higher density. Mixed nodules also exist. Pathologically, nodules can be classified as benign or malignant. Common nodules include thyroid nodules, breast nodules, lung nodules, uterine fibroids, and cysts. There are many causes of nodules, such as bacterial infections, viral infections, parasitic diseases, autoimmune reactions, foreign bodies, or chemical irritants.

[0004] Currently, some traditional Chinese medicines have been found to be effective in eliminating nodules. Common methods include oral and external application of Chinese medicine, acupuncture, and massage, which are used to treat nodular lesions in the human body, including lung nodules and lymph node nodules. Treatment of nodules is still mainly based on traditional Chinese medicine, often using expectorant and blood-stasis-removing drugs, such as Wendan Decoction, Xuefu Zhuyu Decoction, and Shaofu Zhuyu Decoction, to treat nodules in different locations. However, the efficacy is not particularly ideal, mainly because: 1. Existing Chinese herbal formulas are not yet perfect, and their effect on eliminating nodules is not ideal; 2. The active ingredients in Chinese medicine are large molecules, which are not easily absorbed by the human body, resulting in a significant reduction in efficacy.

[0005] Therefore, it is hoped that a more effective traditional Chinese medicine formula can be found to eliminate nodules. At the same time, technological improvements can be made to convert the active macromolecular components in traditional Chinese medicine into active small molecules, making them easier for the human body to absorb, enhancing their efficacy, and significantly improving the treatment effect of eliminating nodules. Summary of the Invention

[0006] To address the aforementioned problems, this invention provides a red yeast rice fermentation product for eliminating nodules. A group of traditional Chinese medicine compositions for eliminating nodules were screened and obtained, including dihydroquercetin, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, platycodon grandiflorus, and black buckwheat. A culture medium was prepared using this traditional Chinese medicine composition, and red yeast rice was inoculated for fermentation. This process transformed the large active molecules in the traditional Chinese medicine composition that eliminate nodules into small active molecules such as aglycones, thereby enhancing the efficacy of eliminating nodules and significantly improving the therapeutic effect of the traditional Chinese medicine composition in eliminating nodules, thus meeting clinical needs.

[0007] On one hand, the present invention provides a red yeast rice fermentation product for eliminating nodules, wherein the red yeast rice fermentation product is a fermentation product obtained by inoculating red yeast rice into a culture medium for fermentation, wherein the culture medium contains dihydroquercetin and black buckwheat.

[0008] Red yeast rice is a fermented product obtained by fermenting rice with Monascus purpureus. During fermentation, Monascus purpureus produces numerous physiologically active components such as Monacolins, GABA, polysaccharides, and pigments. These active components endow red yeast rice with remarkable effects in lowering lipids, regulating blood pressure and blood sugar, and preventing cardiovascular and cerebrovascular diseases.

[0009] Red yeast rice can be cultured in a medium with traditional Chinese medicine composition as the main matrix.

[0010] Furthermore, the culture medium also contains a culture of Tian Shan snow lotus.

[0011] Furthermore, the culture medium also contains chicken gizzard lining.

[0012] Furthermore, the culture medium also contains dandelion.

[0013] Furthermore, the culture medium also contains Prunella vulgaris.

[0014] Furthermore, the culture medium also contains Platycodon grandiflorus.

[0015] Furthermore, by mass ratio, the culture medium contains 0.1-1.5% dihydroquercetin, 50-90% black buckwheat, 0.1-2.0% Tian Shan snow lotus culture, 5-16% chicken gizzard lining, 5-18% dandelion, 1-10% selfheal, and 1-10% platycodon.

[0016] Furthermore, by mass ratio, the culture medium contains 0.8% dihydroquercetin, 75% black buckwheat, 0.9% Tian Shan snow lotus culture, 8.3% chicken gizzard lining, 9% dandelion, 4% prunella vulgaris, and 2% platycodon grandiflorus.

[0017] Furthermore, the red yeast rice is any one or more of the following: purple red yeast rice, red red yeast rice, tufted red yeast rice, and red red yeast rice.

[0018] In some embodiments, the red yeast rice is *Monascus purpureus*.

[0019] Research has shown that the fermentation products obtained by fermenting red yeast rice using this culture medium can produce more active ingredients such as Monacolins, GABA, polysaccharides, and pigments. At the same time, the active macromolecules in traditional Chinese medicine can be converted into active small molecules, making them easier for the human body to absorb and effectively eliminate various nodules in the human body.

[0020] On the other hand, the present invention provides a method for preparing a red yeast rice fermentation product for eliminating nodules, the method comprising the following steps:

[0021] Prepare a culture medium containing dihydroquercetin and black buckwheat;

[0022] Red yeast rice is introduced for fermentation.

[0023] Furthermore, the culture medium described in step (1) also contains one or more of the following: Tian Shan snow lotus culture, chicken gizzard lining, dandelion, selfheal, and platycodon.

[0024] Further, by mass ratio, the culture medium described in step (1) contains 0.1-1.5% dihydroquercetin, 50-90% black buckwheat, 0.1-2.0% Tian Shan snow lotus culture, 5-16% chicken gizzard lining, 5-18% dandelion, 1-10% selfheal, and 1-10% platycodon.

[0025] Furthermore, by mass ratio, the culture medium described in step (1) contains 0.8% dihydroquercetin, 75% black buckwheat, 0.9% Tian Shan snow lotus culture, 8.3% chicken gizzard lining, 9% dandelion, 4% selfheal, and 2% platycodon.

[0026] Furthermore, the fermentation described in step (2) is solid-state fermentation or liquid-state fermentation.

[0027] Further, the specific method of fermentation in step (2) is as follows: inoculate with red yeast liquid bacteria at an inoculation rate of 15%, shake well, and culture at 30-35℃ for three days. After scattering, transfer to 23-25℃ for 20 days of culture, pour out the material and dry to obtain red yeast fermentation product.

[0028] In another aspect, the present invention provides a traditional Chinese medicine composition for eliminating nodules, the traditional Chinese medicine composition comprising dihydroquercetin, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, platycodon grandiflorus, and black buckwheat.

[0029] Further, by mass ratio, the composition contains 0.1-1.5% dihydroquercetin, 50-90% black buckwheat, 0.1-2.0% Tian Shan snow lotus culture, 5-16% chicken gizzard lining, 5-18% dandelion, 1-10% prunella vulgaris, and 1-10% platycodon grandiflorus.

[0030] Furthermore, by mass ratio, the composition contains 0.8% dihydroquercetin, 75% black buckwheat, 0.9% Tian Shan snow lotus culture, 8.3% chicken gizzard lining, 9% dandelion, 4% prunella vulgaris, and 2% platycodon grandiflorus.

[0031] The present invention has proven that the above-mentioned traditional Chinese medicine composition can effectively treat various nodules in the human body, such as pulmonary nodules, thyroid nodules, and breast nodules.

[0032] On another aspect, the present invention provides the use of red yeast rice fermentation to enhance the efficacy of a traditional Chinese medicine composition in eliminating nodules, wherein the traditional Chinese medicine composition includes dihydroquercetin, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, platycodon grandiflorus, and black buckwheat.

[0033] On another aspect, the present invention provides the use of red yeast rice in preparing a reagent to enhance the efficacy of a traditional Chinese medicine composition in eliminating nodules, wherein the traditional Chinese medicine composition includes dihydroquercetin, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, platycodon grandiflorus, and black buckwheat.

[0034] Furthermore, the red yeast rice needs to be fermented in a culture medium prepared from the traditional Chinese medicine composition.

[0035] The beneficial effects of this invention are as follows:

[0036] 1. A traditional Chinese medicine composition with excellent efficacy in eliminating nodules was obtained through screening;

[0037] 2. Using the traditional Chinese medicine composition as a culture medium, red yeast rice is inoculated for fermentation, which transforms the active macromolecules in the traditional Chinese medicine composition into smaller molecules that are more easily absorbed by the human body, significantly improving the efficacy of eliminating nodules. Attached Figure Description

[0038] Figure 1 A photograph of the red yeast rice fermentation product in Example 2;

[0039] Figure 2 A comparison of medical diagnostic reports before and after a patient with breast nodules in Example 2 took red yeast rice fermentation products;

[0040] Figure 3 A comparison of medical diagnostic reports before and after a uterine fibroid patient in Example 2 took red yeast rice fermentation products;

[0041] Figure 4 This is a comparison of the medical diagnostic reports of a patient with thyroid nodules in Example 2 before and after taking red yeast rice fermentation products. Detailed Implementation

[0042] The present invention will be further described in detail below with reference to embodiments. It should be noted that the embodiments described below are intended to facilitate understanding of the present invention and are not intended to limit it in any way. In this embodiment, unless otherwise specified, the raw materials and equipment used can be purchased from the market or are commonly used in the art. Unless otherwise specified, the methods in the following embodiments are conventional methods in the art.

[0043] Example 1: Preparation of Traditional Chinese Medicine Composition

[0044] This embodiment, through extensive research and screening, yielded a group of traditional Chinese medicine compositions with excellent nodule-eliminating effects, including dihydroquercetin, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, platycodon grandiflorus, and black buckwheat. Clinical trials have verified that these compositions indeed possess good efficacy in eliminating nodules.

[0045] The preparation method of the traditional Chinese medicine composition is as follows: Take 1-15g of dihydroquercetin (Shaanxi Haoyang Biotechnology) (preferably 8g in this example), add 1-20g of Tian Shan snow lotus culture (Shaanxi Youerlv Biological Products Co., Ltd.) (preferably 9g in this example), add 50-160g of chicken gizzard lining (preferably 83g in this example), add 50-180g of dandelion (preferably 90g in this example), add 10-100g of prunella vulgaris (preferably 40g in this example), add 10-100g of platycodon grandiflorus (preferably 20g in this example), and add 500-900g of black buckwheat (preferably 750g in this example) to obtain the traditional Chinese medicine composition.

[0046] Example 2: Preparation of Red Yeast Rice Fermentation Products

[0047] The traditional Chinese medicine composition prepared in Example 1 (8g of dihydroquercetin, 9g of Tian Shan snow lotus culture, 83g of chicken gizzard lining, 90g of dandelion, 40g of prunella vulgaris, 20g of platycodon grandiflorus, and 750g of black buckwheat) was used as the culture medium matrix. A small amount of excipients (20g of soybean flour, 20g of wheat bran, and 20g of rice flour) can be added to prepare the fermentation medium. Red yeast rice was inoculated and fermented, and the fermentation products of red yeast rice were collected.

[0048] 1. The culture medium is prepared as follows: Take 1000g of the traditional Chinese medicine composition prepared in Example 1, add 100g of excipients and 100ml of water to prepare 1200g of culture medium.

[0049] 2. Inoculate with red yeast rice (Monascus purpureus) for fermentation. The specific fermentation method is as follows: Inoculate with a liquid inoculum of Monascus purpureus at an inoculation rate of 15% (10 6 (cfu / mL), shake well, incubate at 30-35℃ for three days, then break up, transfer to 23-25℃ for 20 days, pour out the material and dry to obtain red yeast fermentation product, yielding 497g of red yeast fermentation product.

[0050] The obtained red yeast rice fermentation product can be directly packaged into a product, as shown in the photo. Figure 1 As shown, where Figure 1The top left and top right images are photos of the fermentation products of red yeast rice, and the bottom image is a photo of the packaged finished product (this product is the flagship product of Qianjiexiao (Zhejiang) Biotechnology Co., Ltd. - "Qianjiexiao"). The Monacolin K (mg / g) and total flavonoids were determined by high performance liquid chromatography, and the test results are shown in Table 1.

[0051] Table 1. Detection Indicators of Red Yeast Rice Fermentation Products

[0052]

[0053] The efficacy of the red yeast rice fermentation product prepared in this embodiment in eliminating nodules was verified. The specific verification method was as follows: A total of 30 volunteers participated, including 10 patients with breast nodules, 10 patients with thyroid nodules, and 10 patients with uterine fibroids, all of whom had been confirmed by medical imaging. They took the red yeast rice fermentation product for 70 days, twice daily, at a dose of 5g each time. After the treatment period, medical imaging verification showed that all nodules had significantly shrunk, by more than 24%. A comparison of the medical imaging and diagnostic reports before and after treatment for one randomly selected breast nodule patient is shown in the attached image. Figure 2 As shown in the image, the left image is the diagnostic report before taking the medication, and the right image is the diagnostic report after taking the medication. It can be seen that the maximum diameter of the nodules has been significantly reduced. Figure 3 The diagnostic reports of one of the uterine fibroid patients before and after taking red yeast rice fermentation products are shown. The left image is the diagnostic report before taking the products, and the right image is the diagnostic report after taking the products. It can be seen that the maximum diameter of the nodules has been significantly reduced. Figure 4 The images show the diagnostic reports of one patient with thyroid nodules before and after taking red yeast rice fermentation products. The left image is the diagnostic report before taking the products, and the right image is the diagnostic report after taking the products. It can be seen that the maximum diameter of the nodules has been significantly reduced.

[0054] Example 3: Screening of Traditional Chinese Medicine Compositions

[0055] This embodiment prepared the traditional Chinese medicine composition according to the method provided in Example 1. Ten groups of traditional Chinese medicine compositions, as shown in Table 2, were used, with the dosage of each component consistent with Example 1. The compositions were decocted with 10 times the amount of water to form a traditional Chinese medicine decoction. The efficacy of this traditional Chinese medicine composition in eliminating nodules was investigated. The investigation method was as follows: 100 volunteers with thyroid nodules (verified by medical imaging) were randomly divided into 10 groups of 10 people each. They took the traditional Chinese medicine decoction for 70 days, twice daily, with each dose being 100ml. After the treatment period, the condition of the nodules was verified by medical imaging. The results are shown in Table 2.

[0056] Table 2. Screening of different traditional Chinese medicine compositions

[0057]

[0058] As can be seen from Table 2, the effect of the traditional Chinese medicine composition in Group 4 is significantly better than that in other groups, and it has a very obvious effect in eliminating nodules. Therefore, the most preferred traditional Chinese medicine composition is the formula in Group 4, which includes dihydroquercetin, black buckwheat, Tian Shan snow lotus culture, chicken gizzard lining, dandelion, prunella vulgaris, and platycodon grandiflorus.

[0059] Example 4: The effect of red yeast rice fermentation

[0060] This embodiment prepares a traditional Chinese medicine composition according to the method provided in Example 1, and then uses it to treat nodules in the following two ways: 1. Directly prepare a traditional Chinese medicine decoction (the dosage of each component is the same as in Example 1, and it is decocted into a traditional Chinese medicine decoction, which is the same as the fourth group in Example 3); 2. Prepare a red yeast rice fermentation product according to the method described in Example 2, wherein no excipients are added to the culture medium of the traditional Chinese medicine composition. The difference in efficacy between the traditional Chinese medicine decoction and the red yeast rice fermentation product in eliminating nodules is investigated. The investigation method is as follows: 30 volunteers with thyroid nodules (verified by medical imaging) are randomly divided into 3 groups of 10 people each. They take the medicine for 70 days, twice a day, with each dose being 5g (or 100ml). After the treatment period, the condition of the nodules is verified by medical imaging. The results of the detection and analysis are shown in Table 3.

[0061] Table 3. Comparison of the effects of traditional Chinese medicine decoction and red yeast rice fermentation products

[0062]

[0063] As shown in Table 3, the nodules in the third group of volunteers remained unchanged, while over 75% of the nodules in the first group showed significant shrinkage. In the second group, all nodules shrank by 20%. This indicates that using traditional Chinese medicine decoction as a culture medium and fermenting it with red yeast rice significantly increases the concentration of active substances, thus significantly improving the effectiveness in treating nodules. This may be because red yeast rice fermentation converts the large active molecules in traditional Chinese medicine into smaller active aglycones, making them easier for the body to absorb and enhancing their efficacy.

[0064] Example 5: The effect of the formulation of the traditional Chinese medicine composition culture medium on the fermentation of red yeast rice

[0065] In this embodiment, the traditional Chinese medicine composition was prepared according to the method provided in Example 1. Different excipients as shown in Table 4 were added to the composition to prepare culture media, and the results were compared with those without excipients. Red yeast rice fermentation products were prepared according to the method described in Example 2. The differences in efficacy of red yeast rice fermentation products prepared with different culture media and excipient formulations for eliminating nodules were investigated. The investigation method was as follows: 50 volunteers with thyroid nodules (verified by medical imaging) were randomly divided into 5 groups of 10 each. The volunteers took the medication for 70 days, twice daily, with each dose being 5g (or 100ml). After the treatment period, medical imaging was used to verify the nodule status, and the results are shown in Table 4.

[0066] Table 4. Comparison of the effects of traditional Chinese medicine decoction and red yeast rice fermentation products

[0067]

[0068] As shown in Table 4, the content of active ingredients in the fermented red yeast rice products prepared by adding different excipients to the culture medium in the traditional Chinese medicine composition varies significantly, as does their effectiveness in eliminating nodules. This is mainly because adding excipients provides more abundant nutrients to the red yeast rice fermentation process. Therefore, the optimal excipient composition is: 20g soybean flour + 20g wheat bran + 20g rice flour.

[0069] Example 6: The Influence of Different Types of Red Yeast Rice

[0070] In this embodiment, the traditional Chinese medicine composition was prepared according to the method provided in Example 1, and excipients were added according to Example 2 to prepare the culture medium. Two species of Monascus purpureus and Monascus pilosus were used to prepare red yeast fermentation products according to the method described in Example 2. The differences in efficacy of red yeast fermentation products prepared from different species of Monascus purpureus for eliminating nodules were investigated. The investigation method is as shown in Example 3, and the detection and analysis results are shown in Table 5.

[0071] Table 5. Effects of different types of red yeast rice

[0072]

[0073] As shown in Table 5, the fermentation products prepared using different types of red yeast rice exhibit significant differences in the content of active ingredients and their effectiveness in eliminating nodules. Therefore, the optimal red yeast rice is purple red yeast rice.

[0074] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. A Monascus fermentation product for reducing nodule, characterized in that, After Monascus is inoculated into a culture medium for fermentation, the obtained fermentation product is obtained. The culture medium is as follows: 8 g of dihydroquercetin, 9 g of cultured Saussurea involucrata, 83 g of chicken gizzard-membrane is added, 90 g of dandelion is added, 40 g of selfheal is added, 20 g of platycodon root is added, 750 g of black tartary buckwheat is added, and a small amount of auxiliary materials are added. The auxiliary materials are 20 g of soybean powder, 20 g of bran, and 20 g of rice flour; the nodules are any one or more of breast nodules, thyroid nodules, and uterine fibroids.

2. A method for preparing a Monascus fermentation product for reducing nodule, characterized in that, It includes the following steps: (1) Prepare the culture medium. The culture medium is as follows: 8 g of dihydroquercetin, 9 g of cultured Saussurea involucrata, 83 g of chicken gizzard-membrane is added, 90 g of dandelion is added, 40 g of selfheal is added, 20 g of platycodon root is added, 750 g of black tartary buckwheat is added, and a small amount of auxiliary materials are added. The auxiliary materials are 20 g of soybean powder, 20 g of bran, and 20 g of rice flour; (2) Inoculate Monascus for fermentation; the nodules are any one or more of breast nodules, thyroid nodules, and uterine fibroids.

3. A traditional Chinese medicine composition for reducing nodules, characterized in that, The traditional Chinese medicine composition is composed of 8 g of dihydroquercetin, 9 g of cultured Saussurea involucrata, 83 g of chicken gizzard-membrane, 90 g of dandelion, 40 g of selfheal, 20 g of platycodon root, and 750 g of black tartary buckwheat; the nodules are thyroid nodules.

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