A bird's nest composition with preventive and therapeutic effects on benign prostatic hyperplasia, its preparation method and application.

Abstract

This invention discloses a bird's nest composition with preventive and therapeutic effects on benign prostatic hyperplasia (BPH), its preparation method, and its application, belonging to the field of composition technology. The bird's nest composition is prepared from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 3-5 parts bird's nest, 0.001-0.024 parts ZnCl2, 2-6 parts peony stamens, 10-30 parts Codonopsis pilosula, 10-30 parts Astragalus membranaceus, 5-15 parts Poria cocos, and 10-30 parts Imperata cylindrica root. The bird's nest composition of this invention has a clear efficacy in preventing and treating BPH. Experiments using a rat BPH model show that the bird's nest composition of this invention can significantly improve the endocrine disorders in the animal model and has a good preventive and therapeutic effect on testosterone propionate-induced BPH.

Description

Technical Field

[0001] This invention relates to a bird's nest composition with the efficacy of preventing and treating benign prostatic hyperplasia, its preparation method and application, and in particular to a pharmaceutical composition for the prevention and treatment of benign prostatic hyperplasia prepared from bird's nest and traditional Chinese medicine as raw materials, belonging to the field of composition technology. Background Technology

[0002] Bird's nest is a traditional Chinese tonic, often combined with various Chinese herbs to further enhance its restorative effects. According to the *Compendium of Materia Medica*, "Bird's nest is sweet, bland, and neutral in nature; it resolves phlegm and stops coughs, nourishing while clearing heat, making it a holy medicine for treating weakness and fatigue." In traditional Chinese medicine, it is mainly used to treat coughs, asthma, tuberculosis, various internal heat syndromes, and menopausal syndrome. Modern pharmacological research on the effects of bird's nest focuses primarily on improving skin, accelerating metabolism, boosting immunity, and anti-oxidation, emphasizing its beauty and skin-nourishing effects. Little attention is paid to its role in preventing and treating male diseases, and relevant research data is lacking. Furthermore, some people with weak gastrointestinal function may experience bloating, abdominal pain, or indigestion after consuming bird's nest, placing a greater burden on their bodies.

[0003] Benign prostatic hyperplasia (BPH) is a common urinary system disease in middle-aged and elderly men. Anatomically, it is characterized by an enlarged prostate. Clinically, it presents as a series of lower urinary tract symptoms, including urinary tract irritation (frequency, urgency, increased nocturia) and obstruction (weak urine stream, interrupted urine flow, progressive difficulty urinating), severely impacting patients' quality of life. Studies show that BPH has a high incidence rate after age 40, exceeding 70% after age 60, and exceeding 90% in those over 85. However, recent research has found that the incidence of BPH is gradually increasing among young men. This is attributed to the prevalence of sedentary lifestyles, spicy and oily diets, frequent consumption of stimulants such as tobacco and alcohol, and a lack of nutritious fruits and vegetables among modern men, which accelerates the progression of prostatic hyperplasia.

[0004] Traditional Chinese medicine classifies BPH under the categories of "Lin syndrome" and "urinary retention". Its main cause is Yang deficiency. Yang deficiency leads to insufficient kidney Yang, spleen Yang deficiency, liver Qi sinking, and bladder Qi transformation failure, resulting in Qi stagnation, water retention, and damp heat accumulation in the lower Jiao. Over time, this can lead to prostatic hyperplasia, obstructing the urinary tract and causing difficulty in urination. In severe cases, it can lead to complete urinary retention.

[0005] Currently, selective laser vaporization of the prostate (PVP) is the most common treatment for benign prostatic hyperplasia (BPH). However, some patients still experience complications such as urethral stricture and urinary incontinence after the procedure. Clinical treatment primarily involves alpha-adrenergic receptor blockers and 5α-reductase inhibitors. Alpha-adrenergic receptor blockers, such as phentolamine, selectively act on the smooth muscle of the prostate and bladder by blocking the binding of neurotransmitters and adrenaline to receptors, reducing their tension and relaxing the urethral smooth muscle to improve urinary obstruction symptoms. 5α-reductase inhibitors inhibit the conversion of testosterone to dihydrotestosterone (DHT), reducing DHT levels in prostate tissue and decreasing prostate volume, thereby improving lower urinary tract symptoms. However, all of these drugs have side effects including decreased libido, erectile dysfunction, ejaculation disorders, gynecomastia, and breast pain.

[0006] Herbal preparations are widely used in the treatment of benign prostatic hyperplasia (BPH), such as Qianliekang, Shenitong, and Tongniaoling. They are rich in phytosterols, which can interfere with the synthesis and metabolism of prostaglandins in the glands, reduce the concentration of sex hormone-binding proteins, and have diuretic, bactericidal, anti-inflammatory, and prostate tissue congestion-reducing effects. However, their pharmacological mechanisms remain unclear, and there is a lack of research on their effects in preventing BPH.

[0007] Traditional Chinese medicine emphasizes "treating disease before it occurs," which means preventing disease before it manifests and preventing its progression after it occurs, embodying the highest medical ideal of preserving life. Therefore, to cope with modern life and take control of our health, there is an urgent need for a bird's nest composition that combines good preventive and therapeutic effects for BPH, has no obvious side effects, is convenient to take, and provides nourishment and health benefits. Summary of the Invention

[0008] The purpose of this invention is to address the problems existing in the prior art by providing a bird's nest composition that has the effect of preventing and treating benign prostatic hyperplasia. In this composition, the bird's nest is modified bird's nest after being complexed with zinc ions, which can increase the dissolution of bird's nest protein components and reduce the digestive burden.

[0009] Another object of the present invention is to provide a method for preparing a bird's nest composition having the effect of preventing and treating benign prostatic hyperplasia.

[0010] Another object of the present invention is to provide an application of a bird's nest composition having the effect of preventing and treating benign prostatic hyperplasia.

[0011] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0012] A bird's nest composition with the efficacy of preventing and treating benign prostatic hyperplasia is prepared from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 3-5 parts bird's nest, 0.001-0.024 parts ZnCl2, 2-6 parts peony stamens, 10-30 parts Codonopsis pilosula, 10-30 parts Astragalus membranaceus, 5-15 parts Poria cocos, and 10-30 parts Imperata cylindrica root.

[0013] Preferably, a bird's nest composition with the effect of preventing and treating benign prostatic hyperplasia is prepared from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 5 parts bird's nest, 0.024 parts ZnCl2, 6 parts peony stamens, 30 parts Codonopsis pilosula, 30 parts Astragalus membranaceus, 15 parts Poria cocos, and 30 parts Imperata cylindrica.

[0014] Preferably, a bird's nest composition with the effect of preventing and treating benign prostatic hyperplasia is prepared from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 3 parts bird's nest, 0.001 parts ZnCl2, 2 parts peony stamens, 10 parts Codonopsis pilosula, 10 parts Astragalus membranaceus, 10 parts Imperata cylindrica root, and 5 parts Poria cocos.

[0015] A method for preparing a bird's nest composition with preventive and therapeutic effects on benign prostatic hyperplasia includes the following steps:

[0016] S1. Weigh out the dried bird's nest, add 2 to 3 times the amount of pure water and soak for at least 2 hours. Tear it into strips along the texture, pick out the impurities and drain the water. Then add pure water again and soak for 4 to 5 hours. Set aside.

[0017] S2, add pure water to fully soaked bird's nest to cover the bird's nest, add ZnCl2 at the same time, simmer over low heat for 30 to 40 minutes to obtain modified bird's nest, then freeze dry and grind into fine powder to obtain modified bird's nest fine powder;

[0018] S3, weigh out peony stamens, codonopsis, astragalus, imperata root, and poria, add 10 to 12 times the amount of pure water, decoct 1 to 2 times, each time for 1 to 1.5 hours, filter, combine the filtrates, concentrate into a thick paste, freeze dry, and pulverize into fine powder to obtain fine powder of water extract of other raw materials.

[0019] S4. Weigh out the corresponding weight parts of modified bird's nest fine powder and mix it evenly with the corresponding weight parts of other raw material drug fine powders to obtain freeze-dried bird's nest composition powder.

[0020] Preferably, in S2, the freeze-drying method is as follows: the modified bird's nest is pre-frozen in a -80℃ refrigerator for 2 hours or more, and then freeze-dried in a freeze dryer for at least 72 hours, with the freeze dryer having a vacuum degree ≤-0.1 MPa and a temperature ≤-80℃.

[0021] Preferably, in S3, the concentration method is vacuum concentration, with a vacuum degree ≤ -0.08 MPa and a temperature ≤ 70°C, followed by cooling to obtain a thick paste; in S3, the freeze-drying method is as follows: the thick paste is pre-frozen in a -80°C refrigerator for 2 hours or more, and then freeze-dried in a freeze dryer for at least 72 hours, with a vacuum degree ≤ -0.1 MPa and a temperature ≤ -80°C.

[0022] The application of a bird's nest composition with the efficacy of preventing and treating benign prostatic hyperplasia in the preparation of a drug for preventing and treating benign prostatic hyperplasia.

[0023] The combination of these drugs in this invention exerts a variety of pharmacological effects, such as anti-inflammatory, diuretic, and immune-enhancing effects, to achieve the effects of warming and tonifying the original yang, promoting qi circulation and removing blood stasis, thereby preventing and treating BPH.

[0024] This invention establishes a benign prostatic hyperplasia (BPH) rat model by subcutaneous injection of testosterone propionate into male SD rats. The effects of the bird's nest composition of this invention on BPH rats during the prevention and treatment stages were observed, with finasteride used as a positive control. Experimental results show that the bird's nest composition of this invention can improve the endocrine disorders in the animal model and significantly reduce prostate volume, indicating that the bird's nest composition of this invention has good preventive and therapeutic effects on testosterone propionate-induced BPH.

[0025] Compared with the prior art, the advantages of the present invention are: (1) The composition of the present invention is all traditional Chinese medicine, which has the characteristics of being natural and safe, reducing the risk of drug abuse and side effects, and not only playing the role of preventing and treating BPH, but also providing nutritional value; (2) The composition of the present invention adheres to the pathogenesis and is well-matched. It mainly uses modified bird's nest and peony stamen to tonify the kidney and replenish qi, supplemented by Codonopsis pilosula, Astragalus membranaceus, Poria cocos and Imperata cylindrica to promote diuresis and remove blood stasis, and regulates the whole body, which can effectively prevent and treat BPH; (3) The composition of the present invention provides strong evidence for the efficacy of bird's nest in preventing and treating BPH, and provides a solid foundation for the development of new efficacy and new applications of bird's nest.

[0026] This invention discloses a bird's nest composition with preventive and therapeutic effects on benign prostatic hyperplasia (BPH), its preparation method, and its application. The bird's nest composition includes the following components: bird's nest, ZnCl2, peony stamens, codonopsis, astragalus, poria cocos, and imperata cylindrica root. The bird's nest composition of this invention has a clear efficacy in preventing and treating BPH. Experiments using a rat model of BPH have shown that the bird's nest composition of this invention can significantly improve the endocrine disorders in the animal model and has a good preventive and therapeutic effect on testosterone propionate-induced BPH. Attached Figure Description

[0027] Figure 1 This invention relates to the effect of zinc ions on the dissolution of protein components in bird's nest.

[0028] Figure 2 The effect of the bird's nest composition of the present invention on the prevention of BPH on the prostate morphology of rats;

[0029] Figure 3 The preventive effect of the bird's nest composition of the present invention on BPH and its influence on the pathological characteristics of rat prostate tissue;

[0030] Figure 4 The effect of the bird's nest composition of the present invention on the morphology of the prostate gland in rats on the therapeutic effect of BPH;

[0031] Figure 5 The therapeutic effect of the bird's nest composition of the present invention on BPH and its influence on the histopathology of rat prostate tissue. Detailed Implementation

[0032] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. The following embodiments are for illustrative purposes only and are not intended to limit the scope of the invention.

[0033] Example 1

[0034] Effect of zinc ions on the dissolution properties of protein components in bird's nest

[0035] 1. Materials

[0036] Bird's nest (Dongguan Guimao Industrial Co., Ltd., batch number: M20230901); Zinc chloride (purity ≥99%, Maclean, batch number: C14675080); BCA reagent kit (Nanjing Novizan Biotechnology Co., Ltd., batch number: 7E710H3)

[0037] 2. Experimental Methods

[0038] 2.1. Preparation of ordinary bird's nest and modified bird's nest

[0039] Weigh out 10 parts by weight of dried bird's nest, add twice the amount of pure water and soak for 2 hours. Then tear it into strips along the texture, pick out the impurities and drain the water. Add pure water again and soak for 4 hours. Set aside.

[0040] After fully soaking and draining the water, the bird's nests were divided into two groups: one group of ordinary bird's nests and one group of modified bird's nests. Pure water was added to each group to cover the bird's nests. 0.024 parts by weight of ZnCl2 was added to the modified bird's nest group, while no additional treatment was done to the ordinary bird's nest group. All bird's nests were simmered over low heat for 30 minutes, then pre-frozen in a -80℃ freezer for 2 hours, and then freeze-dried in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours. After that, they were weighed and ground into fine powder to obtain ordinary bird's nest fine powder and modified bird's nest fine powder.

[0041] 2.2. Determination of the dissolution content of protein components in ordinary bird's nest and modified bird's nest

[0042] Accurately weigh 0.17g each of ordinary bird's nest powder and modified bird's nest powder (equivalent to 0.25g of dried bird's nest), and repeat the process three times for each group. Place each sample in a 15mL EP tube, add 10mL of ultrapure water to dissolve it completely, sonicate for 1 hour, centrifuge at 3000rpm for 10 minutes, and take the supernatant as the test solution.

[0043] Mix 20 μL of the test solution with 200 μL of BCA working solution, add to a 96-well microplate, shake for 1 min to mix evenly, incubate at 37℃ for 30 min, cool to room temperature, and measure the absorbance at 562 nm using a microplate reader to calculate the amount of bird's nest protein dissolved in each group.

[0044] 3. The experimental results are shown in Table 1 below.

[0045] Table 1. Effect of zinc ions on the dissolution of protein components in bird's nest.

[0046]

[0047] Note: Compared with the regular bird's nest group, *** indicates p<0.001; ** indicates p<0.01; * indicates p<0.05.

[0048] Table 1 and Figure 1 The results showed that compared with the ordinary bird's nest group, the protein dissolution in the modified bird's nest group was significantly increased (p<0.001), proving that after bird's nest chelates zinc ions, it can enhance the solubility of its protein components, which may be more conducive to the absorption and utilization of bird's nest in the body.

[0049] Example 2

[0050] This embodiment provides a bird's nest composition with the effect of preventing and treating benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 3 parts bird's nest, 0.001 parts ZnCl2, 2 parts peony stamens, 10 parts Codonopsis pilosula, 10 parts Astragalus membranaceus, 10 parts Imperata cylindrica root, and 5 parts Poria cocos, which are prepared into freeze-dried powder.

[0051] The preparation method includes the following steps:

[0052] (1) Weigh out the dried bird's nest, add twice the amount of pure water and soak for 2 hours. Then tear it into strips according to the texture, pick out the impurities and drain the water. Then add pure water again and soak for 4 hours. Set aside.

[0053] (2) Add pure water to the fully soaked bird's nest to cover the bird's nest, and add ZnCl2 at the same time. Simmer over low heat for 30 minutes to obtain modified bird's nest. Pre-freeze in a -80℃ refrigerator for 2 hours, freeze dry in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind into fine powder to obtain modified bird's nest fine powder.

[0054] (3) Weigh out the peony stamens, codonopsis, astragalus, imperata root, and poria cocos, add 10 times the amount of pure water, decoct and extract for 1 hour, filter, and obtain filtrate A and residue.

[0055] (4) Add 10 times the amount of pure water to the filter residue described in step (3), decoct and extract for 1 hour, filter to obtain filtrate B, combine filtrate A and filtrate B to obtain other raw material drug water extracts;

[0056] (5) Concentrate the aqueous extracts of other raw materials under reduced pressure (vacuum degree ≤ -0.08mpa, temperature ≤ 70℃), cool them, and after obtaining a thick paste, pre-freeze them in a -80℃ freezer for 2 hours, freeze-dry them in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind them into fine powder to obtain fine powder of the aqueous extracts of other raw materials.

[0057] (6) Mix the modified bird's nest powder with other raw material drug water extract powder evenly to obtain the freeze-dried bird's nest composition powder.

[0058] Example 3

[0059] This embodiment provides a bird's nest composition with the effect of preventing and treating benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 4 parts bird's nest, 0.012 parts ZnCl2, 4 parts peony stamens, 20 parts Codonopsis pilosula, 20 parts Astragalus membranaceus, 20 parts Imperata cylindrica root, and 10 parts Poria cocos, which are prepared into freeze-dried powder.

[0060] The preparation method includes the following steps:

[0061] (1) Weigh out the dried bird's nest, add 3 times the amount of pure water and soak for 2 hours. Then tear it into strips according to the texture, pick out the impurities and drain the water. Then add pure water again and soak for 5 hours. Set aside.

[0062] (2) Add pure water to the fully soaked bird's nest to cover the bird's nest, and add ZnCl2 at the same time. Simmer over low heat for 30 minutes to obtain modified bird's nest. Pre-freeze in a -80℃ refrigerator for 3 hours, freeze dry in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind into fine powder to obtain modified bird's nest fine powder.

[0063] (3) Weigh out the peony stamens, codonopsis, astragalus, imperata root, and poria cocos, add 10 times the amount of pure water, decoct and extract for 1.5 hours, filter, and obtain filtrate A and residue.

[0064] (4) Add 10 times the amount of pure water to the filter residue in step (3), decoct and extract for 1.5 hours, filter to obtain filtrate B, combine filtrate A and filtrate B to obtain other raw material drug water extracts;

[0065] (5) Concentrate the aqueous extracts of other raw materials under reduced pressure (vacuum degree ≤ -0.08mpa, temperature ≤ 70℃), cool them, and after obtaining a thick paste, pre-freeze them in a -80℃ freezer for 3 hours, freeze-dry them in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind them into fine powder to obtain fine powder of the aqueous extracts of other raw materials.

[0066] (6) Weigh out the corresponding weight parts of the modified bird's nest fine powder and mix it evenly with the corresponding weight parts of other raw material drug water extract fine powder to obtain the freeze-dried bird's nest composition powder.

[0067] Example 4

[0068] This embodiment provides a bird's nest composition with the effect of preventing and treating benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 5 parts bird's nest, 0.024 parts ZnCl2, 6 parts peony stamens, 30 parts Codonopsis pilosula, 30 parts Astragalus membranaceus, 30 parts Imperata cylindrica root, and 15 parts Poria cocos, which are prepared into freeze-dried powder.

[0069] The preparation method includes the following steps:

[0070] (1) Weigh out the dried bird's nest, add twice the amount of pure water and soak for 2 hours. Then tear it into strips according to the texture, pick out the impurities and drain the water. Then add pure water again and soak for 5 hours. Set aside.

[0071] (2) Add pure water to the fully soaked bird's nest to cover the bird's nest, and add ZnCl2 at the same time. Simmer over low heat for 40 minutes to obtain modified bird's nest. Pre-freeze in a -80℃ refrigerator for 2 hours, freeze dry in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 80 hours, and then grind into fine powder to obtain modified bird's nest fine powder.

[0072] (3) Weigh out the peony stamens, codonopsis, astragalus, imperata root, and poria cocos, add 10 times the amount of pure water, decoct and extract for 1 hour, filter, and obtain the water extract of other raw materials.

[0073] (4) Concentrate the aqueous extracts of other raw materials under reduced pressure (vacuum degree ≤ -0.08mpa, temperature ≤ 70℃), cool them, and after obtaining a thick paste, pre-freeze them in a -80℃ freezer for 2 hours, freeze-dry them in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 80 hours, and then grind them into fine powder to obtain fine powder of the aqueous extracts of other raw materials.

[0074] (5) Weigh out the corresponding weight parts of the modified bird's nest fine powder and mix it evenly with the corresponding weight parts of other raw material drug water extract fine powder to obtain the freeze-dried bird's nest composition powder.

[0075] Example 5

[0076] This embodiment provides a bird's nest composition for treating benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 3 parts bird's nest, 0.001 parts ZnCl2, 2 parts peony stamens, 10 parts Codonopsis pilosula, 10 parts Astragalus membranaceus, 10 parts Imperata cylindrica root, and 5 parts Poria cocos, which are prepared into freeze-dried powder.

[0077] The preparation method includes the following steps:

[0078] (1) Weigh out the dried bird's nest, add twice the amount of pure water and soak for 2 hours. Then tear it into strips according to the texture, pick out the impurities and drain the water. Then add pure water again and soak for 4 hours. Set aside.

[0079] (2) Add pure water to the fully soaked bird's nest to cover the bird's nest, and add ZnCl2 at the same time. Simmer over low heat for 30 minutes to obtain modified bird's nest. Pre-freeze in a -80℃ refrigerator for 2 hours, freeze dry in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind into fine powder to obtain modified bird's nest fine powder.

[0080] (3) Weigh out the peony stamens, codonopsis, astragalus, imperata root, and poria cocos, add 10 times the amount of pure water, decoct and extract for 1 hour, filter, and obtain filtrate A and residue.

[0081] (4) Add 10 times the amount of pure water to the filter residue described in step (3), decoct and extract for 1 hour, filter to obtain filtrate B, combine filtrate A and filtrate B to obtain other raw material drug water extracts;

[0082] (5) Concentrate the aqueous extracts of other raw materials under reduced pressure (vacuum degree ≤ -0.08mpa, temperature ≤ 70℃), cool them, and after obtaining a thick paste, pre-freeze them in a -80℃ freezer for 2 hours, freeze-dry them in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind them into fine powder to obtain fine powder of the aqueous extracts of other raw materials.

[0083] (6) Weigh out the corresponding weight parts of the modified bird's nest fine powder and mix it evenly with the corresponding weight parts of other raw material drug water extract fine powder to obtain the freeze-dried bird's nest composition powder.

[0084] Example 6

[0085] This embodiment provides a bird's nest composition for treating benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 4 parts bird's nest, 0.012 parts ZnCl2, 4 parts peony stamens, 20 parts Codonopsis pilosula, 20 parts Astragalus membranaceus, 20 parts Imperata cylindrica root, and 10 parts Poria cocos, which are prepared into freeze-dried powder.

[0086] The preparation method includes the following steps:

[0087] (1) Weigh out the dried bird's nest, add 3 times the amount of pure water and soak for 2 hours. Then tear it into strips according to the texture, pick out the impurities and drain the water. Then add pure water again and soak for 5 hours. Set aside.

[0088] (2) Add pure water to the fully soaked bird's nest to cover the bird's nest, and add ZnCl2 at the same time. Simmer over low heat for 30 minutes to obtain modified bird's nest. Pre-freeze in a -80℃ refrigerator for 3 hours, freeze dry in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind into fine powder to obtain modified bird's nest fine powder.

[0089] (3) Weigh out the peony stamens, codonopsis, astragalus, imperata root, and poria cocos, add 10 times the amount of pure water, decoct and extract for 1.5 hours, filter, and obtain filtrate A and residue.

[0090] (4) Add 10 times the amount of pure water to the filter residue in step (3), decoct and extract for 1.5 hours, filter to obtain filtrate B, combine filtrate A and filtrate B to obtain other raw material drug water extracts;

[0091] (5) Concentrate the aqueous extracts of other raw materials under reduced pressure (vacuum degree ≤ -0.08mpa, temperature ≤ 70℃), cool them, and after obtaining a thick paste, pre-freeze them in a -80℃ freezer for 3 hours, freeze-dry them in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 72 hours, and then grind them into fine powder to obtain fine powder of the aqueous extracts of other raw materials.

[0092] (6) Weigh out the corresponding weight parts of the modified bird's nest fine powder and mix it evenly with the corresponding weight parts of other raw material drug water extract fine powder to obtain the freeze-dried bird's nest composition powder.

[0093] Example 7

[0094] This embodiment provides a bird's nest composition for treating benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 5 parts bird's nest, 0.024 parts ZnCl2, 6 parts peony stamens, 30 parts Codonopsis pilosula, 30 parts Astragalus membranaceus, 30 parts Imperata cylindrica root, and 15 parts Poria cocos, which are prepared into freeze-dried powder.

[0095] The preparation method includes the following steps:

[0096] (1) Weigh out the dried bird's nest, add 2.5 times the amount of pure water and soak for 3 hours. Then tear it into strips according to the texture, pick out the impurities and drain the water. Then add pure water again and soak for 4.5 hours.

[0097] (2) Add pure water to the fully soaked bird's nest to cover the bird's nest, and add ZnCl2 at the same time. Simmer over low heat for 40 minutes to obtain modified bird's nest. Pre-freeze in a -80℃ refrigerator for 4 hours, freeze dry in a freeze dryer (vacuum degree ≤ -0.1mpa, temperature ≤ -80℃) for 90 hours, and then grind into fine powder to obtain modified bird's nest fine powder.

[0098] (3) Weigh the peony stamens, codonopsis pilosula, astragalus membranaceus, imperata cylindrica, and poria cocos again, add pure water 11 times the amount of the medicinal materials, decoct and extract for 1 h, filter, and obtain the water extract of other raw material medicines;

[0099] (4) Carry out vacuum concentration on the water extract of other raw material medicines (vacuum degree ≤ -0.08 mpa, temperature ≤ 70 °C), let it cool, obtain a thick paste, then put it into a -80 °C refrigerator for pre-freezing for 4 h, freeze-dry in a freeze dryer (vacuum degree ≤ -0.1 mpa, temperature ≤ -80 °C) for 72 h, and crush it into fine powder to obtain the fine powder of the water extract of other raw material medicines;

[0100] (5) Weigh the corresponding weight parts of the modified bird's nest fine powder, mix it evenly with the corresponding weight parts of the fine powder of the water extract of other raw material medicines to obtain the freeze-dried powder of the bird's nest composition.

[0101] Example 8

[0102] Effect of the bird's nest composition on preventing the rat benign prostatic hyperplasia model induced by testosterone propionate

[0103] 1. Materials

[0104] 1.1. Experimental animals

[0105] 48 SPF-grade male SD rats, (180 - 200 g, experimental animal certificate number: 20230525Aazz0100000921, Qinglongshan Animal Breeding Farm, Jiangning District, Nanjing City, license number: SCXK(Zhe)2019 - 0002)

[0106] 1.2. Reagents and drugs

[0107] Bird's nest (Dongguan Guimao Industrial Co., Ltd., batch number: M20230901); Peony stamens (Heze Kangpu Biotechnology Co., Ltd., batch number: 20230816); Testosterone propionate (TP, purity ≥98%, Maclean's, batch number: C15902507); Soybean oil (reagent grade, Maclean's, batch number: C15031012); Finasteride (purity ≥98%, Maclean's, batch number: C14856974); Sodium carboxymethyl cellulose (CMC-Na, chemically pure, Shanghai Husheng Laboratory Equipment Co., Ltd., batch number: 20190604); Zinc chloride (purity ≥99%, Maclean's, batch number: C 14675080); Rat Interleukin-6 (IL-6) ELISA Kit (Hunan Aifang Biotechnology Co., Ltd., Batch No.: AF3066-A); Rat Cyclooxygenase 2 (COX-2) ELISA Kit (Hunan Aifang Biotechnology Co., Ltd., Batch No.: AF8509-A); Rat C-Reactive Protein (CRP) ELISA Kit (Hunan Aifang Biotechnology Co., Ltd., Batch No.: AF2957-A); Rat Matrix Metalloproteinase-1 (MMP-1) ELISA Kit (Hunan Aifang Biotechnology Co., Ltd., Batch No.: AF2985-A).

[0108] 2. Experimental Methods

[0109] 2.1. Modeling and Drug Administration

[0110] Forty-eight male SPF-grade SD rats weighing 180–200 g were selected. Eight rats were randomly selected as the blank group, and the remaining 40 rats were randomly divided into the model group, finasteride group, low-dose bird's nest composition group, medium-dose bird's nest composition group, and high-dose bird's nest composition group.

[0111] After one week of acclimatization, the bird's nest composition dosage groups were administered the drug composition by gavage. The low, medium, and high dosage groups were given 0.81 g / kg / d, 1.62 g / kg / d, and 3.24 g / kg / d of the drug composition of this invention (equivalent to 0.5, 1, and 2 times the clinical dose, respectively), with an administration volume of 1 mL / 100 g. After 7 consecutive days of administration, except for the control group, all other groups were injected subcutaneously into the neck and back with testosterone propionate (TP) 5 mg / kg / d (equivalent to 1 times the clinical dose) to establish the model. During the modeling process, the bird's nest composition dosage groups continued to be administered the drug composition by gavage, while the finasteride group was administered finasteride 1 mg / kg / d by gavage. The modeling and gavage administration were carried out continuously for 28 days, during which time the animals were fed normally.

[0112] 2.2. Specimen Collection

[0113] After administration, the animals were fasted for 24 hours but allowed free access to water. They were weighed and anesthetized with 20% urethane via intraperitoneal injection. Blood was collected from the abdominal aorta to collect serum samples, which were then stored at -80°C.

[0114] Rats were euthanized by cervical dislocation, and their liver, kidneys, and spleen were removed and weighed. Prostate tissue samples were collected, surrounding adipose tissue was removed, bloodstains on the gland surface were washed with physiological saline, surface moisture was blotted dry with filter paper, and the weight was recorded. A portion of the tissue was stored at -80℃ for later use, while the remaining tissue was fixed with 4% paraformaldehyde.

[0115] 2.3. Indicator Measurement

[0116] 2.3.1. Measurement of the prostate index

[0117] The prostate, liver, kidney, and spleen of rats were isolated, rinsed with physiological saline, and the surface moisture was absorbed with filter paper. The volume of the prostate was measured, and the wet weight of each tissue was weighed. The organ indices of the prostate, liver, kidney, and spleen were calculated.

[0118] Organ Index = (Tissue wet mass (g) / Body mass (g)) × 100%

[0119] 2.3.2. Prostate Pathological Examination

[0120] Prostate tissues from rats in each group were fixed with 4% paraformaldehyde for 24 hours, dehydrated using routine methods, embedded in paraffin, cut into 4μm sections, stained with hematoxylin and eosin (HE), and the pathological changes of the prostate tissue sections were observed under an optical microscope.

[0121] 2.3.3. Rat serum analysis

[0122] The levels of interleukin-6 (IL-6), cyclooxygenase-2 (COX-2), C-reactive protein (CRP), and matrix metalloproteinase-1 (MMP-1) in rat serum were determined using an ELISA kit. The procedure followed the ELISA kit instructions, specifically including: standard dilution, sample addition, solution preparation, washing, color development, and termination. The absorbance (OD value) of each well was measured at 450 nm using an automated microplate reader. A standard curve was plotted, and the concentrations of IL-6, COX-2, CRP, and MMP-1 were obtained from the OD values ​​on the standard curve.

[0123] 3. Statistical processing

[0124] The experimental results were statistically analyzed using GraphPad Prism 9.0 software and expressed as Mean ± SD. One-way ANOVA was performed on each component, and p < 0.05 was considered statistically significant.

[0125] 4. Experimental Results

[0126] 4.1. Rats' body weight and organ indices

[0127] 4.1.1. The rat body weight and liver, kidney, and spleen organ indices are shown in Table 2 below.

[0128] Table 2. Results of rat body weight and liver, kidney, and spleen organ indices (n=8)

[0129]

[0130] Note: Results are expressed as Mean±SD; compared with the control group, ** indicates p<0.01; * indicates p<0.05.

[0131] Table 2 shows that there was no significant difference in body weight among the different groups of rats (p>0.05), but the body weight of the medium and high dose groups of the bird's nest composition was greater than that of the finasteride group, indicating that the bird's nest composition of the present invention can improve the weight loss induced by the positive drug to a certain extent. The liver index of the model group rats was significantly reduced (p<0.05), indicating that the prostate hyperplasia model induced by testosterone propionate in rats had a certain effect on the liver; there were no significant differences among the other groups. The kidney index of the low dose group of the bird's nest composition was significantly increased (p<0.05), indicating that the bird's nest composition can affect the kidneys to a certain extent; there were no significant differences among the other groups. There was no significant difference in spleen index among the different groups of rats (p>0.05).

[0132] 4.1.2. The prostate index and prostate volume of rats are shown in Table 3 below.

[0133] Table 3. Results of prostate wet weight, prostate index, and prostate volume measurements (n=8)

[0134]

[0135] Note: Results are expressed as Mean±SD; compared with the model group, **** indicates p<0.0001; *** indicates p<0.001; ** indicates p<0.01; * indicates p<0.05.

[0136] Table 3 shows that compared with the blank group, the prostate index in the model group was significantly increased (p<0.0001), proving the successful establishment of the model. Compared with the model group, both finasteride and high-dose bird's nest composition significantly reduced prostate wet weight, prostate index, and prostate volume in rats (p<0.05); the low- and medium-dose bird's nest composition groups showed no significant difference in prostate wet weight, prostate index, and prostate volume compared with the model group (p>0.05), but still showed a certain downward trend. This indicates that the bird's nest composition of the present invention has a certain preventive effect against benign prostatic hyperplasia.

[0137] 4.2. Morphological changes in rat prostate tissue

[0138] Rat prostate tissue morphology as follows Figure 2As shown, the prostate tissue in the blank group was of moderate size, smooth, shiny, and soft in texture. The prostate tissue in the model group was significantly enlarged, with a slightly harder texture and a less smooth surface. In the finasteride group and the low, medium, and high dose groups of the bird's nest composition, which had preventative and therapeutic effects, the prostate tissue was significantly smaller, firmer, and had a smoother surface than in the model group.

[0139] Histopathological analysis of rat prostate tissue, such as Figure 3 As shown, in the blank group, the prostate epithelial cells were arranged in a single, tightly packed layer, with few folds in the acinar epithelium and smooth epithelium, and the stroma was normal. In the model group, the prostate tissue of rats showed obvious hyperplasia, with multi-layered arrangement of epithelial cells, which protruded into the lumen in a papillary manner, and the roughness and folds increased. In the low-dose group of bird's nest composition, some cells still showed increased papillary protrusion into the glandular lumen. The medium-dose group of bird's nest composition showed significant improvement compared to the model group, with some glandular epithelial cells returning to a single layer arrangement, occasional papillary protrusions, and the glandular lumen basically returning to normal. Compared with the model group, the finasteride group and the high-dose group of bird's nest composition showed significantly reduced hyperplasia, with most glandular epithelial cells arranged in a single layer, the glandular lumen returning to normal, and no obvious hyperplasia of fibrous tissue. Figure 3 In the diagram, A represents the blank group, B represents the model group, C represents the finasteride group, D represents the low-dose group of the bird's nest composition, E represents the medium-dose group of the bird's nest composition, and F represents the high-dose group of the bird's nest composition.

[0140] 4.3. Analysis results of serum CRP, IL-6, COX-2 and MMP-1 in rats

[0141] The occurrence and development of benign prostatic hyperplasia (BPH) are closely related to changes in inflammatory factors and sex hormone imbalances in the body. Studies have shown that 30% to 43% of BPH samples are accompanied by inflammatory features; multiple studies have reported elevated expression of pro-inflammatory cytokines in BPH tissues, suggesting that inflammatory markers should be emphasized in the prevention and treatment of BPH.

[0142] Table 4. Results of serum CRP, IL-6, COX-2 and MMP-1 levels in rats (n=8)

[0143]

[0144]

[0145] Note: Results are expressed as Mean±SD; compared with the model group, **** indicates p<0.0001; *** indicates p<0.001; ** indicates p<0.01; * indicates p<0.05.

[0146] C-reactive protein (CRP) is an important acute protein produced by the body when stimulated by inflammation. Compared with healthy people, the CRP level in patients with benign prostatic hyperplasia (BPH) is significantly elevated, and there is a significant positive correlation with prostate volume, indicating that inflammation increases the prostate volume in BPH patients. Interleukin-6 (IL-6) is a lymphokine produced by activated T cells and fibroblasts, which is rapidly and transiently produced during infection and tissue injury, and promotes host defense by stimulating acute-phase responses, hematopoiesis, and immune responses. Studies have found that the IL-6 level in BPH patients is significantly higher than that in healthy people, confirming that IL-6 is involved in the pathogenesis of benign prostatic hyperplasia. Cyclooxygenase 2 (COX-2) is a downstream protein of IL-6, which is induced by IL-6 to express and promotes prostate hyperplasia. Matrix metalloproteinase 1 (MMP-1) produced by endothelial cells belongs to metal-dependent proteases, and its upregulation leads to tissue damage and inflammation, and is a potential target for inflammation and tissue repair.

[0147] The results in Table 4 show that: compared with the blank group, the serum CRP, IL-6, COX-2, and MMP-1 in the model group rats were all extremely significantly increased (p < 0.0001), proving that the model was successfully established. Compared with the model group, both the finasteride group and the high-dose bird's nest composition group could significantly reduce the serum CRP, IL-6, COX-2, and MMP-1 in rats (p < 0.001); indicating that the bird's nest composition of the present invention has a good down-regulating effect on the inflammatory factors produced in benign prostatic hyperplasia, and can well inhibit the progression of benign prostatic inflammation and repair the prostate tissue.

[0148] Example 9

[0149] Effect of Bird's Nest Composition on the Treatment of Benign Prostatic Hyperplasia Model Induced by Testosterone Propionate in Rats

[0150] 1. Materials

[0151] 1.1. Experimental Animals

[0152] 48 SPF-grade male SD rats, (180 - 200 g, experimental animal certificate number: 20230525Aazz01******921, Qinglongshan Animal Breeding Farm, Jiangning District, Nanjing City, license number: SCXK(Zhe)2019 - 0002)

[0153] 1.2. Reagents and Drugs

[0154] Bird's nest (Guangdong Zhenkang Pharmaceutical Technology Co., Ltd., batch number: Q / ZKYY0006S); Peony stamens (Heze Kangpu Biotechnology Co., Ltd., batch number: 20230816); Testosterone propionate (TP, purity ≥98%, Maclean's, batch number: C15902507); Soybean oil (reagent grade, Maclean's, batch number: C15031012); Finasteride (purity ≥98%, Maclean's, batch number: C14856974); Sodium carboxymethyl cellulose (CMC-Na, chemically pure, Shanghai Husheng Laboratory Equipment Co., Ltd., batch number: 20190604); Zinc chloride (purity ≥99%, Maclean's, batch number: C15902507). Rat interleukin-6 (IL-6) ELISA kit (Hunan Aifang Biotechnology Co., Ltd., batch number: AF3066-A); Rat cyclooxygenase 2 (COX-2) ELISA kit (Hunan Aifang Biotechnology Co., Ltd., batch number: AF8509-A); Rat C-reactive protein (CRP) ELISA kit (Hunan Aifang Biotechnology Co., Ltd., batch number: AF2957-A); Rat matrix metalloproteinase-1 (MMP-1) ELISA kit (Hunan Aifang Biotechnology Co., Ltd., batch number: AF2985-A);

[0155] 2. Experimental Methods

[0156] 2.1. Modeling and Drug Administration

[0157] Forty-eight male SPF-grade SD rats weighing 180–200 g were used. After one week of acclimatization, eight rats were randomly selected as the control group, and the remaining 40 rats were selected as the model group. The rats were injected subcutaneously into the neck and back with TP injection solution at 5 mg / kg / d, while the control group was injected with an equal volume of soybean oil. The injections were repeated for 28 days, and the rats were fed normally to establish a BPH rat model.

[0158] After modeling, the blank group remained unchanged. The 40 rats in the model group were randomly divided into four groups: model group, finasteride group, low-dose group of bird's nest composition, medium-dose group of bird's nest composition, and high-dose group of bird's nest composition. On day 1 after modeling, the rats were administered the drug composition by gavage. The low-, medium-, and high-dose groups were given 0.81 g / kg / d, 1.62 g / kg / d, and 3.24 g / kg / d of the drug composition of this invention, respectively (equivalent to 0.5, 1, and 2 times the clinical dose, respectively). The finasteride group was given 1 mg / kg / d of finasteride by gavage (equivalent to 1 time the clinical dose). The administration volume for all groups was 1 mL / 100 g, and the administration continued for 28 days.

[0159] 2.2. Specimen Collection

[0160] After administration, the animals were fasted for 24 hours but allowed free access to water. They were weighed and anesthetized with 20% urethane via intraperitoneal injection. Blood was collected from the abdominal aorta to collect serum samples, which were then stored at -80°C.

[0161] Rats were euthanized by cervical dislocation, and their liver, kidneys, and spleen were removed and weighed. Prostate tissue samples were collected, surrounding adipose tissue was removed, bloodstains on the gland surface were washed with physiological saline, surface moisture was blotted dry with filter paper, and the weight was recorded. A portion of the tissue was stored at -80℃ for later use, while the remaining tissue was fixed with 4% paraformaldehyde.

[0162] 2.3. Indicator Measurement

[0163] 2.3.1. Measurement of the prostate index

[0164] The prostate, liver, kidney, and spleen of rats were isolated, rinsed with physiological saline, and the surface moisture was absorbed with filter paper. The volume of the prostate was measured, and the wet weight of each tissue was weighed. The organ indices of the prostate, liver, kidney, and spleen were calculated.

[0165] Organ Index = (Tissue wet mass (g) / Body mass (g)) × 100%

[0166] 2.3.2. Prostate Pathological Examination

[0167] Prostate tissues from rats in each group were fixed with 4% paraformaldehyde for 24 hours, dehydrated using routine methods, embedded in paraffin, cut into 4μm sections, stained with hematoxylin and eosin (HE), and the pathological changes of the prostate tissue sections were observed under an optical microscope.

[0168] 2.3.3. Rat serum analysis

[0169] The levels of interleukin-6 (IL-6), cyclooxygenase-2 (COX-2), C-reactive protein (CRP), and matrix metalloproteinase-1 (MMP-1) in rat serum were determined using an ELISA kit. The procedure followed the ELISA kit instructions, specifically including: standard dilution, sample addition, solution preparation, washing, color development, and termination. The absorbance (OD value) of each well was measured at 450 nm using an automated microplate reader. A standard curve was plotted, and the concentrations of IL-6, COX-2, CRP, and MMP-1 were obtained from the OD values ​​on the standard curve.

[0170] 3. Statistical processing

[0171] The experimental results were statistically analyzed using GraphPad Prism 9.0 software and expressed as Mean ± SD. One-way ANOVA was performed on each component, and p < 0.05 was considered statistically significant.

[0172] 4. Experimental Results

[0173] 4.1. Rats' body weight and organ indices

[0174] 4.1.1. Rats' body weight and liver, kidney, and spleen organ indices

[0175] Table 5. Results of rat body weight and liver, kidney, and spleen organ indices (n=8)

[0176]

[0177] Note: Results are expressed as Mean±SD; compared with the control group, ** indicates p<0.01; * indicates p<0.05.

[0178] Table 5 shows that there was no significant difference in body weight among the different groups of rats (p>0.05). However, the body weight of the medium and high dose groups of the bird's nest composition was greater than that of the finasteride group, and the body weight of rats showed an increasing trend with increasing dose, indicating that the bird's nest composition of the present invention can improve the weight loss caused by positive drugs to a certain extent. The kidney index of the high dose group of the bird's nest composition was significantly increased (p<0.05), indicating that the bird's nest composition can affect the kidneys to a certain extent. There were no significant differences among the other groups. There were no significant differences in liver and spleen indices among the different groups of rats (p>0.05).

[0179] 4.1.2. Rats' prostate index and prostate volume

[0180] Table 6. Results of prostate index and prostate volume measurement (n=8)

[0181]

[0182] Note: Results are expressed as Mean±SD; compared with the model group, **** indicates p<0.0001; *** indicates p<0.001; ** indicates p<0.01; * indicates p<0.05.

[0183] Table 6 shows that compared with the blank group, the prostate index of the model group increased significantly (p<0.0001), proving the successful establishment of the model. Compared with the model group, the finasteride group and each dose group of the bird's nest composition significantly reduced the wet weight of the rat prostate, the prostate index and the prostate volume (p<0.05), inhibited prostate hyperplasia, and the inhibitory effect increased with the increase of the dosage. The high dose group of the bird's nest composition significantly reduced the prostate index and volume (p<0.001), indicating that the bird's nest composition of the present invention has a good therapeutic effect on benign prostatic hyperplasia induced by testosterone propionate in rats.

[0184] 4.2. Morphological changes in rat prostate tissue

[0185] Rat prostate tissue morphology as follows Figure 4As shown, the prostate tissue in the blank group was of moderate size, smooth, shiny, and soft in texture. The prostate tissue in the model group was significantly enlarged, with a slightly harder texture and a less smooth surface. In the finasteride group and the low, medium, and high dose groups of the bird's nest composition, which had preventative and therapeutic effects, the prostate tissue was significantly smaller, firmer, and had a smoother surface than in the model group.

[0186] Histopathological analysis of rat prostate tissue, such as Figure 5 As shown, in the blank group, the prostate epithelial cells were arranged in a single, tightly packed layer, with few folds in the acinar epithelium and smooth epithelium, and the stroma was normal. In the model group, the prostate tissue of rats showed obvious hyperplasia, with multi-layered arrangement of epithelial cells, which protruded into the lumen in a papillary manner, and the roughness and folds increased. In the low-dose group of bird's nest composition, some cells still showed increased papillary protrusion into the glandular lumen. The medium-dose group of bird's nest composition showed significant improvement compared to the model group, with some glandular epithelial cells returning to a single layer arrangement, occasional papillary protrusions, and the glandular lumen basically returning to normal. Compared with the model group, the finasteride group and the high-dose group of bird's nest composition showed significantly reduced hyperplasia, with most glandular epithelial cells arranged in a single layer, the glandular lumen returning to normal, and no obvious hyperplasia of fibrous tissue. Figure 5 In the diagram, A represents the blank group, B represents the model group, C represents the finasteride group, D represents the low-dose group of the bird's nest composition, E represents the medium-dose group of the bird's nest composition, and F represents the high-dose group of the bird's nest composition.

[0187] 4.3. Analysis results of serum CRP, IL-6, COX-2 and MMP-1 in rats

[0188] Table 7. Results of serum CRP, IL-6, COX-2 and MMP-1 levels in rats (n=8)

[0189]

[0190]

[0191] Note: Results are expressed as Mean±SD; compared with the model group, **** indicates p<0.0001; *** indicates p<0.001; ** indicates p<0.01; * indicates p<0.05.

[0192] Table 7 shows that, compared with the blank group, the serum CRP, IL-6, COX-2, and MMP-1 levels in the model group rats were significantly increased (p<0.0001), proving the successful establishment of the model. Compared with the model group, both the finasteride group and the high-dose bird's nest composition group significantly reduced the serum CRP, IL-6, COX-2, and MMP-1 levels in rats (p<0.001), indicating that the bird's nest composition of the present invention has a good inhibitory effect on inflammatory factors produced in benign prostatic hyperplasia.

[0193] The above experimental results show that the high-dose group of the bird's nest composition of the present invention can significantly reduce the wet weight of the prostate and the prostate index; HE results show that the glandular epithelium, glandular lumen, and stroma of the prostate basically returned to normal. Observation of serum inflammatory factors CRP, IL-6, COX-2, and MMP-1 all suggest that the bird's nest composition of the present invention has good preventive and therapeutic effects on benign prostatic hyperplasia model rats.

[0194] It should be understood that, in order to simplify this disclosure and aid in understanding one or more of the various aspects of the invention, features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof in the above description of exemplary embodiments of the invention. However, this method of disclosure should not be interpreted as reflecting an intention that the claimed invention requires more features than expressly recited in each claim. Rather, as reflected in the claims, inventive aspects lie in fewer than all the features of the foregoingly disclosed embodiments. Therefore, the claims, following the detailed description, are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of the invention.

[0195] Although the invention has been described with reference to a limited number of embodiments, those skilled in the art will understand from the foregoing description that other embodiments are conceivable within the scope of the invention described herein. Furthermore, it should be noted that the language used in this specification has been chosen primarily for readability and instructional purposes, and not for the purpose of interpreting or limiting the subject matter of the invention. Therefore, many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the appended claims. The disclosure of the invention is illustrative and not restrictive, and the scope of the invention is defined by the appended claims.

[0196] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A bird's nest composition with preventive and therapeutic effects on benign prostatic hyperplasia, characterized in that, The preparation is made from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 3-5 parts bird's nest, 0.001-0.024 parts ZnCl2, 2-6 parts peony stamens, 10-30 parts codonopsis, 10-30 parts astragalus, 5-15 parts poria cocos and 10-30 parts imperata cylindrica root; the bird's nest is modified bird's nest with zinc ion complexation.

2. The bird's nest composition according to claim 1, which has the effect of preventing and treating benign prostatic hyperplasia, is characterized in that, The preparation was made from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 5 parts bird's nest, 0.024 parts ZnCl2, 6 parts peony stamens, 30 parts codonopsis, 30 parts astragalus, 15 parts poria cocos, and 30 parts imperata cylindrica root.

3. The bird's nest composition according to claim 1, which has the effect of preventing and treating benign prostatic hyperplasia, is characterized in that... The preparation was made from the following parts by weight of bird's nest and traditional Chinese medicine as raw materials: 3 parts bird's nest, 0.001 parts ZnCl2, 2 parts peony stamens, 10 parts codonopsis, 10 parts astragalus, 10 parts imperata root, and 5 parts poria.

4. A method for preparing a bird's nest composition with preventive and therapeutic effects on benign prostatic hyperplasia according to any one of claims 1 to 3, characterized in that, Includes the following steps: S1. Weigh out the dried bird's nest, add 2 to 3 times the amount of pure water and soak for at least 2 hours. Tear it into strips along the texture, pick out the impurities and drain the water. Then add pure water again and soak for 4 to 5 hours. Set aside. S2, add pure water to fully soaked bird's nest to cover the bird's nest, add ZnCl2 at the same time, simmer over low heat for 30-40 minutes to obtain modified bird's nest, then freeze dry and grind into fine powder to obtain modified bird's nest fine powder; S3, weigh out peony stamens, codonopsis, astragalus, imperata root, and poria, add 10 to 12 times the amount of pure water, decoct 1 to 2 times, each time for 1 to 1.5 hours, filter, combine the filtrates, concentrate into a thick paste, freeze dry, and pulverize into fine powder to obtain fine powder of water extract of other raw materials. S4. Weigh out the corresponding weight parts of modified bird's nest fine powder and mix it evenly with the corresponding weight parts of other raw material drug fine powders to obtain freeze-dried bird's nest composition powder.

5. The preparation method according to claim 4, characterized in that, In S2, the freeze-drying method is as follows: the modified bird's nest is pre-frozen in a -80℃ refrigerator for 2 hours or more, and then freeze-dried in a freeze dryer for at least 72 hours. The vacuum degree of the freeze dryer is ≤-0.1mpa and the temperature is ≤-80℃.

6. The preparation method according to claim 4, characterized in that, In S3, the concentration method is vacuum concentration, with a vacuum degree ≤ -0.08 MPa and a temperature ≤ 70℃, followed by cooling to obtain a thick paste; In S3, the freeze-drying method is as follows: the thick paste is pre-frozen in a -80℃ refrigerator for 2 hours or more, and then freeze-dried in a freeze dryer for at least 72 hours, with a vacuum degree ≤ -0.1 MPa and a temperature ≤ -80℃.

7. The use of the bird's nest composition with the efficacy of preventing and treating benign prostatic hyperplasia according to any one of claims 1 to 3 in the preparation of a medicament for preventing and treating benign prostatic hyperplasia.

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