Traditional Chinese medicine composition for treating prostatic cancer and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating prostatic cancer and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw materials: prepared rehmannia root, dogwood, moutan bark, Chinese yam, poria cocos, rhizoma alismatis, trogopterus dung, pollen typhae, herba epimedii, curcuma zedoary, rhizoma polygonati, pseudo-ginseng, oldenlandia diffusa and the like. The preparation method comprises the steps of solid-state fermentation, water extraction, concentration, drying and the like. The solid state fermentation is carried out by using a composite fermentation inoculant, and the composite fermentation inoculant is composed of bacillus subtilis, lactobacillus plantarum and lactic streptococci. Through the compatibility principle of monarch, minister, assistant and guide and the treatment rules of tonifying kidney and consolidating root, activating blood and removing stasis, clearing away heat and toxic materials and the like, the microenvironment of the body is adjusted from multiple ways, and tumor growth is inhibited. In the solid-state fermentation process, ineffective components in the traditional Chinese medicines can be converted, the medicine effect is improved, potential toxic components in the medicinal materials are degraded, and the medication safety is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating prostate cancer and a preparation method thereof. Background Art

[0002] Prostate cancer (PCa) is the most common tumor type in the male urinary system and is the second leading cause of cancer-related death in men after lung cancer. The incidence of prostate cancer continues to increase with age. Most patients have no obvious manifestations in the early stage, and when diagnosed, the disease has progressed to the advanced or terminal stage, with a poor prognosis.

[0003] PCa is a malignant tumor that depends on androgen for growth. Testosterone is the main androgen in the male body regulated by hypothalamic and pituitary hormones. Reducing the androgen level in the body can interfere with the gene expression of tumor growth factors, thereby mediating apoptosis of cancer cells. Surgical castration and estrogen can effectively delay the progression of prostate cancer, indicating that this cancer is responsive to androgen blockade. Therefore, ADT (androgen deprivation therapy) has become the main treatment method for advanced prostate cancer. ADT usually achieves the castration effect through surgical or drug treatment. However, statistical results show that after 18 to 36 months of ADT treatment, recurrence often occurs and progresses to more dangerous CRPC (Castration-Resistant Prostate Cancer), and the survival period of patients is greatly shortened. If accompanied by metastasis, the prognosis is worse, and the treatment is more limited. Therefore, the treatment methods for reducing androgen levels are difficult to achieve satisfactory results. Although the use of paclitaxel drugs and PARP inhibitors can improve the survival rate of prostate cancer patients, the resulting drug resistance also brings new challenges.

[0004] The invention patent with the publication number of CN 112245520 A discloses a traditional Chinese medicine composition for inhibiting prostate cancer and a preparation method thereof, which is composed of 20 - 30 g of Rehmannia glutinosa, 15 - 30 g of Anemarrhena asphodeloides, 30 - 80 g of Astragalus membranaceus, 10 - 20 g of Epimedium brevicornu, 15 - 30 g of Morinda officinalis, 3 - 10 g of Scorpio, 15 - 30 g of Atractylodes macrocephala, 15 - 30 g of Poria cocos, 6 - 20 g of Glycyrrhiza uralensis, 9 - 20 g of Phellodendron amurense, 10 - 20 g of Panax quinquefolius, 30 - 60 g of Testudinis carapax, and 10 - 30 g of Hedyotis diffusa; the preparation form is a traditional Chinese medicine decoction compound or a granular traditional Chinese medicine compound. The traditional Chinese medicine composition for inhibiting prostate cancer provided by this technical solution is prepared by selecting raw materials for compatibility according to the theory of traditional Chinese medicine and the pathogenesis of prostate cancer. The proportion of each component is rigorous, taking into account both pathogenic factors and healthy qi, and has a significant anti-tumor effect. It can inhibit the growth of prostate cancer, delay the development of prostate cancer, and improve the quality of life of patients.

[0005] The invention patent with the publication number CN 107096003 A discloses a traditional Chinese medicine composition for treating prostate cancer, which comprises the following traditional Chinese medicine raw materials in parts by weight: 9 - 30 parts of astragalus membranaceus, 6 - 15 parts of ginseng, 6 - 15 parts of wolfberry fruit, 6 - 15 parts of epimedium, 3 - 10 parts of turmeric, 9 - 20 parts of salvia miltiorrhiza, 9 - 20 parts of paris polyphylla, 3 - 10 parts of scorpio, 6 - 15 parts of ganoderma lucidum. The traditional Chinese medicine composition for treating prostate cancer provided by this technical solution is applicable to prostate cancer patients with deficiency in origin and excess in superficiality in traditional Chinese medicine syndrome differentiation, and has the effects of inhibiting the proliferation and promoting the apoptosis of castration-resistant prostate cancer cells PC3 and DU145.

[0006] Thus, traditional Chinese medicine has unique advantages in improving the quality of life of prostate cancer patients, prolonging the progression-free survival time, enhancing the reduction of toxic and side effects, etc., and plays an important role in the treatment of prostate cancer. Summary of the Invention

[0007] In view of this, in order to further complement the shortcomings of the existing prostate cancer treatment plan, prolong the patient's survival period, improve the patient's quality of life, delay the progression of prostate cancer, and improve the prognosis effect, the present invention provides a traditional Chinese medicine composition for treating prostate cancer and its preparation method. By adjusting the raw material ratio of the formula and combining specific solid-state fermentation, extraction, and concentration processes, the present invention improves the medicinal effect and obtains a traditional Chinese medicine composition that can inhibit tumor growth and has an inhibitory effect on the PI3K / Akt / mTOR pathway at the gene expression level.

[0008] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating prostate cancer, which specifically comprises the following raw materials in parts by weight:

[0009] 10 - 20 parts of rehmannia glutinosa, 5 - 15 parts of cornelian cherry fruit, 5 - 15 parts of moutan bark, 10 - 20 parts of Chinese yam, 5 - 15 parts of poria cocos, 5 - 15 parts of alisma orientale, 10 - 20 parts of weeping forsythia, 10 - 15 parts of cattail pollen, 10 - 20 parts of epimedium, 10 - 20 parts of zedoary turmeric, 5 - 15 parts of polygonatum sibiricum, 5 - 15 parts of notoginseng, 10 - 20 parts of oldenlandia diffusa.

[0010] Preferably, the traditional Chinese medicine composition for treating prostate cancer specifically comprises the following raw materials in parts by weight:

[0011] 15 parts of rehmannia glutinosa, 10 parts of cornelian cherry fruit, 10 parts of moutan bark, 15 parts of Chinese yam, 10 parts of poria cocos, 10 parts of alisma orientale, 15 parts of weeping forsythia, 12 parts of cattail pollen, 15 parts of epimedium, 15 parts of zedoary turmeric, 10 parts of polygonatum sibiricum, 10 parts of notoginseng, 15 parts of oldenlandia diffusa.

[0012] The second aspect of the present invention is to provide a preparation method of a traditional Chinese medicine composition for treating prostate cancer, which specifically comprises the following steps:

[0013] S1. The fermentation substrate is mixed with the compound fermentation inoculant and then undergoes solid-state fermentation, followed by drying to obtain the fermented raw material;

[0014] S2. The fermented raw material is extracted with water and then filtered, and this process is repeated 2 - 3 times. The filtrates are combined to obtain the water extract;

[0015] S3. The water extract is concentrated and then dried to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0016] Preferably, the fermentation substrate is composed of traditional Chinese medicine raw materials, soybean meal, and water, and the mass ratio of the traditional Chinese medicine raw materials, soybean meal, and water is (3.5 - 5):(0.8 - 1.5):(2 - 3). More preferably, the mass ratio of the traditional Chinese medicine raw materials, soybean meal, and water in the fermentation substrate is 4:1:2.5; the dosage of the compound fermentation inoculant is 1.8 - 2.5 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal. More preferably, the dosage of the compound fermentation inoculant is 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal.

[0017] Preferably, the compound fermentation inoculant is composed of Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis in a ratio of viable cell counts of (0.5 - 1.5):(1.5 - 2.5):(0.5 - 1.5). More preferably, the compound fermentation inoculant is composed of Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis in a ratio of viable cell counts of 1:2:1; the Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis are added in the form of bacterial liquid or bacterial powder. The effective viable cell count of the bacterial liquid is ≥10 9 CFU / mL, more preferably ≥2.5×10 9 CFU / mL, and the effective viable cell count of the bacterial powder is ≥10 9 CFU / mL, more preferably ≥3×10 9 CFU / mL.

[0018] Preferably, the drying temperature ≤55°C, and the water content of the fermented raw material <15 wt.%.

[0019] Preferably, the fermentation temperature is 28°C - 37°C, more preferably 35°C - 37°C, and the fermentation time is 48 - 72 h, more preferably 60 h.

[0020] Preferably, the weight - volume ratio of the fermented raw material to water is 1 g:(8 - 12) mL, more preferably 1 g:10 mL. The water extraction temperature is 80°C - 100°C, more preferably 90°C - 95°C, further preferably 95°C, and the water extraction time is 1 - 3 h, more preferably 1 - 2 h, further preferably 1.5 h.

[0021] Preferably, the mass concentration of the water extract after concentration is 240 - 260 g / L, more preferably 250 g / L.

[0022] Compared with the prior art, the beneficial technical effects of the present invention are as follows:

[0023] By following the compatibility principle of monarch, minister, assistant, and envoy, the present invention combines multiple Chinese medicinal materials such as Rehmannia glutinosa, Cornus officinalis, Paeonia suffruticosa, Dioscorea opposita, Poria cocos, Alisma orientale, Trogopterus dung, Typha angustifolia, Epimedium brevicornu, Curcuma zedoaria, Polygonatum sibiricum, Panax notoginseng, and Hedyotis diffusa, integrates the therapeutic principles of tonifying the kidney and consolidating the root, promoting blood circulation and dissipating stasis, and clearing heat and detoxifying, and regulates the body's microenvironment from multiple pathways to inhibit tumor growth.

[0024] During the solid-state fermentation process of the present invention, the enzyme system metabolized by the compound microbial agent can convert the ineffective components in traditional Chinese medicine and improve the medicinal efficacy. Moreover, solid-state fermentation can utilize microorganisms to degrade the potential toxic components of medicinal materials and improve the safety of drug use.

[0025] The present invention adopts a gradient extraction process, combines multiple dynamic water extractions with vacuum concentration to improve the retention rate of active ingredients. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The following further describes the present invention with reference to the accompanying drawings.

[0027] Figure 1 It is the detection result of the expression level of PI3K / Akt / mTOR pathway proteins, where * indicates P < 0.05 compared with group E1, and ** indicates P < 0.01 compared with group E1;

[0028] Figure 2 It is the process flow chart of the preparation of the traditional Chinese medicine composition of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0029] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating prostate cancer, specifically including the following raw materials in parts by weight:

[0030] 10 - 20 parts of Rehmannia glutinosa, 5 - 15 parts of Cornus officinalis, 5 - 15 parts of Paeonia suffruticosa, 10 - 20 parts of Dioscorea opposita, 5 - 15 parts of Poria cocos, 5 - 15 parts of Alisma orientale, 10 - 20 parts of Trogopterus dung, 10 - 15 parts of Typha angustifolia, 10 - 20 parts of Epimedium brevicornu, 10 - 20 parts of Curcuma zedoaria, 5 - 15 parts of Polygonatum sibiricum, 5 - 15 parts of Panax notoginseng, and 10 - 20 parts of Hedyotis diffusa.

[0031] Prepared Rehmannia Root is the rhizome of Rehmannia glutinosa Libosch. or Rehmannia glutinosa Libosch. f. hueichingensis (Chao) Hsiao & Keng, which is made through steaming and drying processes. It tastes sweet and is slightly warm in nature, belonging to the liver and kidney meridians, with the effects of nourishing yin and tonifying blood, etc.; Medicinal Cornel Fruit is the ripe pulp of Cornus officinalis Sieb. et Zucc. of the Cornaceae family. It tastes sour and astringent and is slightly warm in nature, belonging to the liver and kidney meridians, with the effects of tonifying the liver and kidney, astringing and consolidating, etc.; Moutan Bark is the dried root bark of Paeonia suffruticosa of the Ranunculaceae family. Its nature and flavor are bitter, pungent, and slightly cold, belonging to the heart, liver, and kidney meridians, with the effects of clearing heat and cooling blood, promoting blood circulation to disperse stasis, clearing the liver and reducing blood pressure, etc.; Poria is the dried sclerotium of Poria cocos (Schw.) Wolf of the Polyporaceae family. It tastes sweet and bland and is neutral in nature, belonging to the heart, lung, spleen, and kidney meridians, with the effects of promoting diuresis to eliminate dampness, strengthening the spleen, and calming the mind, etc.; Alisma Rhizome is the dried tuber of Alisma orientalis (Sam.) Juzep. of the Alismataceae family. It tastes sweet and bland and is cold in nature, belonging to the kidney and bladder meridians, with the effects of promoting diuresis to eliminate dampness, clearing heat, and reducing turbidity and lipid, etc.; Trogopterus Dung is the dried feces of Trogopterus xanthipes of the Sciuridae family. It tastes bitter and sweet and is warm in nature, belonging to the liver and spleen meridians, with the effects of promoting blood circulation to disperse stasis and stopping bleeding when stir-fried into charcoal, etc.; Cattail Pollen is the dried pollen of Typha angustifolia L., Typha orientalis Presl of the Typhaceae family, or plants of the same genus. It is sweet in nature and flat in flavor, belonging to the liver and pericardium meridians, with the effects of stopping bleeding, removing stasis, and promoting diuresis, etc.; Epimedium Herb is the dried aerial part of Epimedium brevicornum Maxim., Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium pubescens Maxim., Epimedium wushanense T.S.Ying, or Epimedium koreanum Nakai of the Berberidaceae family. It tastes pungent and sweet and is warm in nature, with the effects of tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness, etc.; Rhizoma Zedoariae is the dried rhizome of Curcuma phaeocaulis Val., Curcuma kwangsiensis S.G.Lee et C.F.Liang, or Curcuma wenyujin Y.H.Chen et C.Ling of the Zingiberaceae family. It tastes pungent and bitter and is warm in nature, belonging to the liver and spleen meridians, with the effects of promoting qi circulation to break blood stasis, reducing accumulation and relieving pain, etc.; Polygonatum Rhizome is the rhizome of Polygonatum kingianum Coll. et Hemsl. of the Liliaceae family) The dry rhizome of Polygonatum sibiricum Red. or Polygonatum cyrtonema Hua is sweet in taste and neutral in nature, and belongs to the spleen, lung, and kidney meridians, with the effects of replenishing qi and nourishing yin, strengthening the spleen, moistening the lung, and tonifying the kidney; The dry root of Panax notoginseng (Burk.) F.H.Chen, a plant of the Araliaceae family, is sweet and bitter in taste and warm in nature, and belongs to the liver and stomach meridians, with the effects of promoting blood circulation to remove stasis, stopping bleeding, and reducing swelling and pain; Hedyotis diffusa is the whole herb of Hedyotis diffusa Willd. [Oldenlandia diffusa (Willd.) Roxb.], a plant of the genus Hedyotis in the Rubiaceae family. It is sweet and light in taste and cool in nature, and belongs to the stomach, large intestine, and small intestine meridians, with the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling, and promoting blood circulation to relieve pain..

[0032] The traditional Chinese medicine formula of the present invention is based on nourishing the kidney yin, combined with the treatment methods of promoting blood circulation to remove stasis, clearing heat and detoxifying, etc., reflecting the dialectical thinking of traditional Chinese medicine in treating prostate cancer of "tonifying the kidney and consolidating the root, promoting blood circulation to disperse stasis, and clearing heat and detoxifying". The monarch drug in the formula of the present invention is Rehmannia glutinosa preparata, which mainly plays the role of nourishing the kidney yin and consolidating the kidney qi, laying the foundation for strengthening the healthy qi; Cornus officinalis, Dioscorea opposita, and Epimedium brevicornu are ministerial drugs, which cooperate with Rehmannia glutinosa preparata to supplement both qi and yin, eliminate masses and disperse stasis, and enhance the overall medicinal power. The four drugs together help to improve the healthy qi of the body; Paeonia suffruticosa, Alisma orientale, Poria cocos, Trogopterus dung, Pollen Typhae, Curcuma zedoaria, Polygonatum sibiricum, and Hedyotis diffusa are adjuvant drugs. Paeonia suffruticosa clears heat and cools blood, promotes blood circulation to remove stasis. Alisma orientale promotes diuresis and percolates dampness, clears heat and purges fire. Poria cocos strengthens the spleen and promotes diuresis. Trogopterus dung and Pollen Typhae cooperate to promote blood circulation to relieve pain and promote blood stasis and relieve stranguria. Curcuma zedoaria promotes blood circulation to activate qi, removes blood stasis and relieves pain. Polygonatum sibiricum supplements qi and nourishes yin, strengthens the spleen and tonifies the kidney. Hedyotis diffusa clears heat and detoxifies, and has anti-tumor effects. Acting simultaneously in multiple ways, it improves the lesion environment, alleviates symptoms, guides pathogenic factors downward, and inhibits tumors; Panax notoginseng is used as the envoy drug, which can not only lead all the drugs directly to the disease site, but also promote blood circulation to remove stasis, stop bleeding and relieve pain, relieve bleeding and pain, harmonize all the drugs, and enhance the overall effect of the prescription. The monarch, minister, adjuvant, and envoy drugs in the whole prescription are properly combined, strengthening the healthy qi and eliminating pathogenic factors, treating both the symptoms and the root causes, and jointly playing the role of treating and improving prostate cancer. Through this compatibility method, the present invention enhances the absorption and utilization of drugs, and achieves good therapeutic and improvement effects on prostate cancer.

[0033] In some specific embodiments of the present invention, the traditional Chinese medicine composition for treating prostate cancer specifically comprises the following raw materials in parts by weight:

[0034] 15 parts of Rehmannia glutinosa preparata, 10 parts of Cornus officinalis, 10 parts of Paeonia suffruticosa, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Pollen Typhae, 15 parts of Epimedium brevicornu, 15 parts of Curcuma zedoaria, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, and 15 parts of Hedyotis diffusa.

[0035] The second aspect of the present invention is to provide a preparation method of a traditional Chinese medicine composition for treating prostate cancer, which specifically includes the following steps:

[0036] S1. Mix the fermentation substrate with the compound fermentation bacterium agent and carry out solid-state fermentation, and then dry it to obtain the fermentation raw material;

[0037] S2. Add water to the fermentation raw material for extraction and then filter, repeat 2-3 times, and combine the filtrates to obtain the water extract;

[0038] S3. Concentrate and dry the water extract to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0039] The fermentation substrate of the present invention is composed of traditional Chinese medicine raw materials, soybean meal, and water. The mass ratio of the traditional Chinese medicine raw materials, soybean meal, and water is (3.5-5):(0.8-1.5):(2-3). The dosage of the compound fermentation bacterium agent is 1.8-2.5 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal; the compound fermentation bacterium agent is composed of Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis in a ratio of viable bacteria numbers of (0.5-1.5):(1.5-2.5):(0.5-1.5); the Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis are added in the form of bacterial liquid or bacterial powder, the effective viable bacteria number of the bacterial liquid ≥ 10 9 CFU / mL, the effective viable bacteria number of the bacterial powder ≥ 10 9 CFU / mL, the drying temperature ≤ 55°C, and the water content of the fermentation raw material < 15 wt.%. In some preferred embodiments of the present invention, the mass ratio of the traditional Chinese medicine raw materials, soybean meal, and water in the fermentation substrate is 4:1:2.5, the dosage of the compound fermentation bacterium agent is 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, the compound fermentation bacterium agent is composed of Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis in a ratio of viable bacteria numbers of 1:2:1, the effective viable bacteria number of the bacterial liquid ≥ 2.5×10 9 CFU / mL, the effective viable bacteria number of the bacterial powder ≥ 3×10 9 CFU / mL

[0040] The fermentation temperature of the present invention is 28°C - 37°C, and the fermentation time is 48 - 72 h. In some preferred embodiments of the present invention, the fermentation temperature is 35°C - 37°C, and the fermentation time is 60 h.

[0041] The solid-state fermentation process of the present invention plays a role of "sifting" for the traditional Chinese medicine raw materials. Through microbial metabolism and enzymatic hydrolysis reactions, it selectively decomposes toxic or ineffective components, and at the same time promotes the release and transformation of active components, realizing "taking the essence and discarding the dregs" of the traditional Chinese medicine raw materials, breaking through the limitations of the extraction of all components of traditional Chinese medicine raw materials, and realizing the screening of components at the molecular level.

[0042] In the water extraction process of the present invention, the weight-to-volume ratio of the fermentation raw material to water is 1 g:(8 - 12) mL, the water extraction temperature is 80°C - 100°C, and the water extraction time is 1 - 3 h. In some preferred embodiments of the present invention, the weight-to-volume ratio of the fermentation raw material to water is 1 g:10 mL, the water extraction temperature is 90°C - 95°C, and the water extraction time is 1 - 2 h. In some more preferred embodiments of the present invention, the water extraction temperature is 95°C and the water extraction time is 1.5 h.

[0043] The mass concentration of the water extract after concentration in the present invention is 240 - 260 g / L. In some preferred embodiments of the present invention, the mass concentration of the water extract after concentration is 250 g / L.

[0044] The technical solutions provided by the present invention are further described below in conjunction with embodiments.

[0045] Unless otherwise specified, all experiments were repeated 3 times, ANOVA (Analysis of Variance) and Duncan's multiple comparison analysis were performed using SPSS 21.0, the results were expressed as mean ± standard deviation, and graphs were made using Origin 2021 software.

[0046] Example 1 A traditional Chinese medicine composition for treating prostate cancer, which is composed of the following raw materials in parts by mass:

[0047] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Paeonia suffruticosa, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Pollen Typhae, 15 parts of Epimedium brevicornu, 15 parts of Curcuma zedoaria, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0048] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0049] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation matrix, inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37°C for 60 h, and then dry at 45°C until the water content < 15 wt.% to obtain a fermentation raw material;

[0050] The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum bacterial liquid (2.7×10 9 CFU / mL), and Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) in a ratio of viable bacteria numbers of 1:2:1;

[0051] S2. Add water (1 g:10 mL) to the fermentation raw material, extract at 95°C for 1.5 h and then filter, repeat 3 times, and combine the filtrates to obtain a water extract;

[0052] S3. Concentrate the water extract to a mass concentration of 250 g / L and then lyophilize it to obtain a traditional Chinese medicine composition for treating prostate cancer.

[0053] Comparative Example 1

[0054] The difference from Example 1 is that: Curcuma zedoaria and Hedyotis diffusa were not used.

[0055] Comparative Example 2

[0056] The difference from Example 1 is that: The compound fermentation agent is composed of Lactobacillus plantarum bacterial liquid (2.7×10 9 CFU / mL) and Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) in a ratio of 2:1 by the number of viable bacteria.

[0057] Comparative Example 3

[0058] The difference from Example 1 is that: The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL) and Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) in a ratio of 1:1 by the number of viable bacteria.

[0059] Comparative Example 4

[0060] The difference from Example 1 is that: The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL) and Lactobacillus plantarum bacterial liquid (2.7×10 9 CFU / mL) in a ratio of 1:2 by the number of viable bacteria.

[0061] Comparative Example 5

[0062] The difference from Example 1 is that: Fermentation is carried out after extraction, and the specific steps are as follows:

[0063] S1. Add water (1 g:10 mL) to the traditional Chinese medicine raw materials, extract at 95°C for 1.5 h and then filter, repeat 3 times, and combine the filtrates to obtain a water extract;

[0064] S2. Concentrate the water extract to a mass concentration of 250 g / L, then inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the concentrate, ferment at 37°C for 60 h and then lyophilize to obtain a traditional Chinese medicine composition.

[0065] Establishment of a subcutaneous RM-1 cell tumor model in mice

[0066] All animal experiments were approved by the Ethics Committee of Hunan University of Chinese Medicine (LLBH-202303240004). Male C57BL / 6 mice and RM-1 cells (AW-CCM416, Abiowell) at 6 weeks of age were purchased from SJA Laboratory Animal Co., Ltd. (Hunan, China). The mice were adaptively fed for 1 week before the experiment. PC-3 cells in the logarithmic growth phase were collected, digested with trypsin, centrifuged, and adjusted to a concentration of 1×10 7 cells / mL. 0.1 mL was drawn and inoculated into the mid-rear part of the axilla of nude mice. The mental state, diet, defecation, activity, death, and tumor growth of the mice were observed and recorded.

[0067] Twenty-one days after subcutaneous injection of PC3 cells, 65 surviving tumor-bearing mice were obtained. Eleven mice with larger or smaller tumor volumes were excluded. The remaining 48 mice were randomly divided into 7 groups (6 mice in each group): Example 1 group (E1), Comparative Example 1-5 groups (C1-5), and Model group (PC3).

[0068] E1 and C1-5: The traditional Chinese medicine composition was dissolved and diluted with normal saline to a concentration of 1.5 g / mL of crude drug content, and then gavaged at a standard of 1 mL / (100 g·d) for 21 days;

[0069] E1, C1-5, and DOC were the drug administration groups;

[0070] PC3: Gavage with the same amount of normal saline as E1 and C1-5.

[0071] Twelve hours after the last administration, the mice were sacrificed by cervical dislocation. The tumor bodies were completely dissected, the tumor weights were weighed, and the tumor inhibition rate was calculated. The results are shown in Table 1.

[0072] Tumor inhibition rate (%) = [(Average tumor mass of PC3 - Average tumor mass of the drug administration group) / Average tumor mass of PC3]×100%

[0073] Table 1 Tumor mass and tumor inhibition rate after intervention

[0074]

[0075]

[0076] Note: Different lowercase letters in the same column in the table indicate significant differences between the two, P < 0.05.

[0077] Effect of the traditional Chinese medicine composition on the protein levels of the PI3K / Akt / mTOR signaling pathway in prostate cancer-bearing mice

[0078] As can be seen from Table 1, curcuma zedoaria and oldenlandia diffusa are beneficial to improving the efficacy of the composition, and the synergistic mechanism may stem from the synergistic effect of their active ingredients. It can be seen that the present invention improves the tumor inhibition rate of the composition by "adding flavor" to the traditional Chinese medicine formula. In addition, from the test results of C2, C3, and C4, it can be known that the composition of the strains in the compound fermentation agent has a relatively significant impact on the efficacy of the composition, and the reason may lie in the synergistic effect between the metabolites of different strains in a specific matrix. Finally, from the test result of C5, it can be known that although extracting, concentrating the raw materials first and then fermenting has advantages such as reducing the dosage of the agent, in view of the large loss of many effective ingredients in the traditional Chinese medicine raw materials after extraction, the efficacy of the composition is significantly reduced after fermentation. That is, the order of fermentation and extraction concentration significantly affects the efficacy of the composition.

[0079] The expression levels of PI3K / Akt / mTOR pathway proteins in each group were detected by Western blot, and the results were as Figure 1 shown.

[0080] From Figure 1 it can be known that the traditional Chinese medicine composition of the present invention can down-regulate the mRNA level of PI3K / Akt / mTOR in tumor tissues. That is, the traditional Chinese medicine composition of the present invention has an inhibitory effect on the PI3K / Akt / mTOR pathway at the gene expression level and may inhibit tumor progression through multi-cascade reactions. In addition, Figure 2 it also proves that the use of curcuma zedoaria and oldenlandia diffusa, the composition of the compound fermentation agent, and the technological order of fermentation and extraction concentration affect the mRNA level of PI3K / Akt / mTOR.

[0081] Example 2 A traditional Chinese medicine composition for treating prostate cancer is composed of the following raw materials in parts by mass:

[0082] 10 parts of rehmannia glutinosa, 5 parts of cornel, 5 parts of moutan cortex, 10 parts of Chinese yam, 5 parts of poria cocos, 5 parts of alisma orientale, 10 parts of weeping forsythia, 10 parts of cattail pollen, 10 parts of epimedium, 10 parts of curcuma zedoaria, 5 parts of polygonatum sibiricum, 5 parts of notoginseng, and 10 parts of oldenlandia diffusa.

[0083] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0084] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, ferment solidly at 37 °C for 60 h, and then dry at 45 °C until the water content < 15 wt.% to obtain a fermented raw material;

[0085] The compound fermentation agent consists of bacillus subtilis bacterium solution (3.2×10 9 CFU / mL), lactobacillus plantarum bacterium solution (2.7×109 CFU / mL), Lactococcus lactis liquid (2.9×10 9 CFU / mL) are composed in a ratio of viable bacteria numbers of 1:2:1;

[0086] S2. Add water (1 g:10 mL) to the fermentation raw materials, extract at 95°C for 1.5 h and then filter. Repeat 3 times and combine the filtrates to obtain the water extract;

[0087] S3. Concentrate the water extract to a mass concentration of 250 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0088] Example 3 A traditional Chinese medicine composition for treating prostate cancer is composed of the following raw materials by mass:

[0089] Prepared Rehmannia Root 20 parts, Asiatic Cornelian Cherry Fruit 15 parts, Moutan Bark 15 parts, Chinese Yam 20 parts, Poria 15 parts, Alisma Rhizome 15 parts, Trogopterus Dung 20 parts, Cattail Pollen 15 parts, Epimedium Herb 20 parts, Zedoary 20 parts, Polygonatum Sibiricum 15 parts, Notoginseng 15 parts, Oldenlandia Diffusa 20 parts.

[0090] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0091] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37°C for 60 h, and then dry at 45°C until the water content < 15 wt.% to obtain the fermentation raw materials;

[0092] The compound fermentation agent is composed of Bacillus subtilis liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum liquid (2.7×10 9 CFU / mL), Lactococcus lactis liquid (2.9×10 9 CFU / mL) are composed in a ratio of viable bacteria numbers of 1:2:1;

[0093] S2. Add water (1 g:10 mL) to the fermentation raw materials, extract at 95°C for 1.5 h and then filter. Repeat 3 times and combine the filtrates to obtain the water extract;

[0094] S3. Concentrate the water extract to a mass concentration of 250 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0095] Example 4 A traditional Chinese medicine composition for treating prostate cancer is composed of the following raw materials by mass:

[0096] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Cortex Moutan, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Pollen Typhae, 15 parts of Epimedium brevicornu, 15 parts of Rhizoma Curcumae, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0097] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0098] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 3.5:0.8:2 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 1.8 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37°C for 60 h, and then dry at 45°C until the water content is <15 wt.% to obtain a fermentation raw material;

[0099] The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum bacterial liquid (2.7×10 9 CFU / mL), and Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) in a ratio of viable bacteria numbers of 1:2:1;

[0100] S2. Add water (1 g:10 mL) to the fermentation raw material, extract at 95°C for 1.5 h and then filter, repeat 3 times, and combine the filtrates to obtain a water extract;

[0101] S3. Concentrate the water extract to a mass concentration of 252 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0102] Example 5 A traditional Chinese medicine composition for treating prostate cancer, which is composed of the following raw materials in parts by mass:

[0103] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Cortex Moutan, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Pollen Typhae, 15 parts of Epimedium brevicornu, 15 parts of Rhizoma Curcumae, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0104] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0105] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 5:1.5:3 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2.5 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37°C for 60 h, and then dry at 45°C until the water content is <15 wt.% to obtain a fermentation raw material;

[0106] The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum bacterial liquid (2.7×109 CFU / mL), Lactococcus lactis liquid (2.9×10 9 CFU / mL) in a ratio of viable cell counts of 1:2:1;

[0107] S2. Add water to the fermentation raw material (1 g:10 mL), extract at 95 °C for 1.5 h and then filter. Repeat 3 times and combine the filtrates to obtain the water extract;

[0108] S3. Concentrate the water extract to a mass concentration of 250 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0109] Example 6 A traditional Chinese medicine composition for treating prostate cancer, which is composed of the following raw materials in parts by mass:

[0110] Prepared rehmannia root 15 parts, cornel 10 parts, moutan bark 10 parts, Chinese yam 15 parts, poria 10 parts, alisma 10 parts, weeping forsythia 15 parts, cattail pollen 12 parts, epimedium 15 parts, zedoary 15 parts, polygonatum 10 parts, notoginseng 10 parts, oldenlandia diffusa 15 parts.

[0111] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0112] S1. Mix the traditional Chinese medicine raw materials, soybean meal and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2.3 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37 °C for 60 h, and then dry at 45 °C until the water content < 15 wt.% to obtain the fermentation raw material;

[0113] The compound fermentation agent is composed of Bacillus subtilis liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum liquid (2.7×10 9 CFU / mL), Lactococcus lactis liquid (2.9×10 9 CFU / mL) in a ratio of viable cell counts of 0.5:1.5:0.5;

[0114] S2. Add water to the fermentation raw material (1 g:10 mL), extract at 95 °C for 1.5 h and then filter. Repeat 3 times and combine the filtrates to obtain the water extract;

[0115] S3. Concentrate the water extract to a mass concentration of 260 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0116] Example 7 A traditional Chinese medicine composition for treating prostate cancer, which is composed of the following raw materials in parts by mass:

[0117] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Cortex Moutan, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Typha angustifolia, 15 parts of Epimedium brevicornu, 15 parts of Rhizoma Zedoariae, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0118] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0119] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2.5 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37 °C for 60 h, and then dry at 45 °C until the water content is < 15 wt.% to obtain a fermentation raw material;

[0120] The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum bacterial liquid (2.7×10 9 CFU / mL), and Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) in a ratio of viable bacteria numbers of 1.5:2.5:1.5;

[0121] S2. Add water (1 g:10 mL) to the fermentation raw material, extract at 95 °C for 1.5 h and then filter, repeat 3 times, and combine the filtrates to obtain an aqueous extract;

[0122] S3. Concentrate the aqueous extract to a mass concentration of 250 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0123] Example 8 A traditional Chinese medicine composition for treating prostate cancer is composed of the following raw materials in parts by mass:

[0124] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Cortex Moutan, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Typha angustifolia, 15 parts of Epimedium brevicornu, 15 parts of Rhizoma Zedoariae, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0125] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0126] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 28 °C for 72 h, and then dry at 45 °C until the water content is < 15 wt.% to obtain a fermentation raw material;

[0127] The compound fermentation agent is composed of Bacillus subtilis bacterial liquid (3.2×10 9(CFU / mL), Lactobacillus plantarum liquid (2.7×10 9 (CFU / mL), Streptococcus lactis liquid (2.9×10 9 (CFU / mL) are composed in a ratio of 1:2:1 by viable count;

[0128] S2. Add water (1 g:10 mL) to the fermentation raw material, extract at 95 °C for 1.5 h and then filter. Repeat 3 times, and combine the filtrates to obtain the water extract;

[0129] S3. Concentrate the water extract to a mass concentration of 250 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0130] Example 9 A traditional Chinese medicine composition for treating prostate cancer is composed of the following raw materials by mass parts:

[0131] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Paeonia suffruticosa, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Pollen typhae, 15 parts of Epimedium brevicornu, 15 parts of Curcuma zedoaria, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0132] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0133] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation matrix, inoculate a compound fermentation bacterium agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37 °C for 48 h, and then dry at 45 °C until the water content < 15 wt.% to obtain the fermentation raw material;

[0134] The compound fermentation bacterium agent is composed of Bacillus subtilis liquid (3.2×10 9 (CFU / mL), Lactobacillus plantarum liquid (2.7×10 9 (CFU / mL), Streptococcus lactis liquid (2.9×10 9 (CFU / mL) are composed in a ratio of 1:2:1 by viable count;

[0135] S2. Add water (1 g:10 mL) to the fermentation raw material, extract at 95 °C for 1.5 h and then filter. Repeat 3 times, and combine the filtrates to obtain the water extract;

[0136] S3. Concentrate the water extract to a mass concentration of 240 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0137] Example 10 A traditional Chinese medicine composition for treating prostate cancer is composed of the following raw materials by mass parts:

[0138] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Paeonia suffruticosa, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Typha angustifolia, 15 parts of Epimedium brevicornu, 15 parts of Curcuma zedoaria, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0139] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0140] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37°C for 60 h, and then dry at 45°C until the water content < 15 wt.% to obtain a fermentation raw material;

[0141] The compound fermentation agent consists of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum bacterial liquid (2.7×10 9 CFU / mL), and Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) in a ratio of viable bacteria count of 1:2:1;

[0142] S2. Add water (1 g:8 mL) to the fermentation raw material, extract at 90°C for 2 h and then filter, repeat 3 times, and combine the filtrates to obtain an aqueous extract;

[0143] S3. Concentrate the aqueous extract to a mass concentration of 250 g / L and then freeze-dry to obtain the traditional Chinese medicine composition for treating prostate cancer.

[0144] Example 11 A traditional Chinese medicine composition for treating prostate cancer, which is composed of the following raw materials in parts by mass:

[0145] 15 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Paeonia suffruticosa, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Typha angustifolia, 15 parts of Epimedium brevicornu, 15 parts of Curcuma zedoaria, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

[0146] The preparation method of the traditional Chinese medicine composition for treating prostate cancer is as follows:

[0147] S1. Mix the traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of 4:1:2.5 to obtain a fermentation substrate, inoculate a compound fermentation agent accounting for 2 wt.% of the total amount of the traditional Chinese medicine raw materials and soybean meal, perform solid-state fermentation at 37°C for 60 h, and then dry at 45°C until the water content < 15 wt.% to obtain a fermentation raw material;

[0148] The compound fermentation agent consists of Bacillus subtilis bacterial liquid (3.2×10 9 CFU / mL), Lactobacillus plantarum bacterial liquid (2.7×109 CFU / mL), Streptococcus lactis bacterial liquid (2.9×10 9 CFU / mL) are composed in a ratio of viable bacteria count of 1:2:1;

[0149] S2. Add water to the fermentation raw material (1 g:12 mL), extract at 100 °C for 1 h and then filter, repeat 3 times, and combine the filtrates to obtain the water extract;

[0150] S3. Concentrate the water extract to a mass concentration of 250 g / L and then freeze-dry to obtain a traditional Chinese medicine composition for treating prostate cancer.

[0151] After detection, there was no significant difference in the action effect between the traditional Chinese medicine compositions obtained in Examples 2-11 and Example 1 (P>0.05)

[0152] In this article, specific examples are used to elaborate on the principle and implementation mode of the present invention. The description of the above examples is only used to help understand the method and its core idea of the present invention; at the same time, for those of ordinary skill in the art, based on the idea of the present invention, there will be changes in the specific implementation mode and application scope. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. A traditional Chinese medicine composition for treating prostate cancer, characterized in that, Comprising the following raw materials in parts by weight: 10 - 20 parts of Rehmannia glutinosa preparata, 5 - 15 parts of Cornus officinalis, 5 - 15 parts of Cortex Moutan, 10 - 20 parts of Dioscorea opposita, 5 - 15 parts of Poria cocos, 5 - 15 parts of Alisma orientale, 10 - 20 parts of Trogopterus dung, 10 - 15 parts of Pollen Typhae, 10 - 20 parts of Epimedium brevicornu, 10 - 20 parts of Rhizoma Zedoariae, 5 - 15 parts of Polygonatum sibiricum, 5 - 15 parts of Panax notoginseng, 10 - 20 parts of Hedyotis diffusa; The preparation method of the traditional Chinese medicine composition for treating prostate cancer comprises the following steps: S1. Mix the fermentation substrate and the compound fermentation agent, carry out solid - state fermentation, and then dry to obtain the fermentation raw material; S2. Add water to extract the fermentation raw material and then filter, repeat 2 - 3 times, and combine the filtrates to obtain the water extract; S3. Concentrate and dry the water extract to obtain the traditional Chinese medicine composition for treating prostate cancer; The compound fermentation agent is composed of Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis in a ratio of effective viable bacteria numbers of (0.5 - 1.5):(1.5 - 2.5):(0.5 - 1.5).

2. The traditional Chinese medicine composition for treating prostate cancer according to claim 1, wherein Comprising the following raw materials in parts by weight: 15 parts of Rehmannia glutinosa preparata, 10 parts of Cornus officinalis, 10 parts of Cortex Moutan, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 10 parts of Alisma orientale, 15 parts of Trogopterus dung, 12 parts of Pollen Typhae, 15 parts of Epimedium brevicornu, 15 parts of Rhizoma Zedoariae, 10 parts of Polygonatum sibiricum, 10 parts of Panax notoginseng, 15 parts of Hedyotis diffusa.

3. The traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that, The fermentation substrate is composed of traditional Chinese medicine raw materials, soybean meal, and water in a mass ratio of (3.5 - 5):(0.8 - 1.5):(2 - 3).

4. A traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that The dosage of the compound fermentation agent is 1.8 - 2.5 wt.% of the total amount of traditional Chinese medicine raw materials and soybean meal.

5. The traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that, The compound fermentation agent is composed of Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis in a ratio of effective viable bacteria numbers of 1:2:

1.

6. The traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that, The Bacillus subtilis, Lactobacillus plantarum, and Streptococcus lactis are added in the form of bacterial liquid or bacterial powder, and the effective viable count of the bacterial liquid is ≥ 10 9 CFU / mL, and the effective viable count of the bacterial powder is ≥ 10 9 CFU / mL.

7. A traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that, The drying temperature ≤ 55 °C, and the water content of the fermentation raw material < 15 wt.%.

8. The traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, wherein, The fermentation temperature is 28 °C - 37 °C, and the fermentation time is 48 - 72 h.

9. The traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that The weight - volume ratio of the fermentation raw material to water is 1 g:(8 - 12) mL, the water extraction temperature is 80 °C - 100 °C, and the water extraction time is 1 - 3 h.

10. The traditional Chinese medicine composition for treating prostate cancer according to claim 1 or 2, characterized in that, The mass concentration of the concentrated water extract is 240 - 260 g / L.

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