Herba epimedii, rhodiola rosea and ginseng capsule for invigorating kidney and strengthening yang and preparation method thereof

Abstract

The invention discloses a herba epimedii, rhodiola rosea and ginseng capsule for invigorating kidney and strengthening yang and a preparation method thereof, and mainly relates to the technical field of pharmaceutical preparations containing traditional herbal medicines. Compared with the prior art, the technical problem to be solved by the invention is to provide the kidney-tonifying and yang-strengthening capsule with small liver burden, epimedium, rhodiola rosea, ginseng, medlar, cinnamon, rehmannia and schisandra chinensis are taken as main raw materials, and auxiliary materials including inulin, a lubricant, a binder and a protective agent are added to complete a capsule filling step. The burdens on the liver and the kidney are reduced through the ways of regulating an endocrine system, enhancing the antioxidant capacity, regulating the activity of immune cells, improving energy metabolism and the like, and a better protection effect is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations containing traditional herbal medicines, and in particular to an Epimedium, Rhodiola rosea and Ginseng capsule for tonifying the kidney and strengthening yang, and a preparation method thereof. Background Art

[0002] Kidney-tonifying and yang-strengthening health products usually use traditional Chinese medicine as their main ingredients, and are intended to improve sexual dysfunction and related symptoms caused by kidney yang deficiency in men. They contain a variety of Chinese medicinal materials such as ginseng, deer antler, epimedium, wolfberry, and dodder seed. These ingredients are believed to have the effects of tonifying the kidneys and improving essence, strengthening muscles and bones, and improving sexual function in traditional Chinese medicine theory.

[0003] Active ingredients such as alkaloids and glycosides contained in traditional Chinese medicines can burden liver metabolism. Long-term use or overdose can lead to elevated liver enzymes and even liver cell damage. To reduce this burden on the liver, existing technologies often combine liver-protecting tablets with other drugs or add functional excipients to the preparation to influence drug metabolism, reduce the burden on the liver and kidneys, and provide better protection.

[0004] CN118787676A discloses a medicinal composition for tonifying the kidney and strengthening yang, and resisting fatigue, and a preparation method thereof. The medicinal composition is prepared by combining extracts of ginseng, sika deer penis, red deer antler, sea cucumber, oyster, polygonatum, wolfberry, maca, yam, epimedium, Cistanche deserticola, Cordyceps militaris, Eucommia ulmoides, okra, silkworm pupae, dodder seed, Rosa laevigata fruit, Acanthopanax senticosus, Rhodiola rosea, royal jelly, pumpkin seed oil, lycopene, pyrroloquinoline quinone, taurine, gamma-aminobutyric acid, Artemisia africana, and Pelargonium angustifolia to obtain a medicinal composition having the therapeutic effects of tonifying the kidney and strengthening yang, resisting fatigue, impotence, premature ejaculation, and hypolibido.

[0005] CN114796436A discloses a kidney-tonifying and yang-strengthening capsule and a preparation method thereof. The capsule is prepared by soaking, steaming, slicing, decocting, and boiling Cynomorium songaricum into a paste, then adding white cloves, leeches, roasted ginger, processed Tianxiong, and processed beehives, and finally making the mixture into powder and filling the powder into capsules to obtain a capsule with the effects of tonifying the kidney, strengthening yang, and relieving inflammation. Summary of the Invention

[0006] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide a kidney-tonifying and yang-strengthening capsule with less burden on the liver.

[0007] To achieve the above object, the present invention provides a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea and ginseng capsule and a preparation method thereof.

[0008] The preparation method of the epimedium, rhodiola rosea and ginseng capsule for tonifying the kidney and strengthening yang comprises the following steps, calculated by weight:

[0009] (1) respectively grinding epimedium, rhodiola rosea, ginseng, wolfberry, cinnamon bark, rehmannia root, and schisandra chinensis through a 40-60 mesh sieve; weighing 80-120 parts of epimedium powder, 80-120 parts of rhodiola rosea powder, 100-150 parts of ginseng powder, 50-100 parts of wolfberry powder, 20-40 parts of cinnamon bark, 10-30 parts of rehmannia root powder, and 10-30 parts of schisandra chinensis powder into 1500-2500 parts of water, soaking, adding 2500-3500 parts of water for decoction, filtering to obtain a first decoction; then adding 3500-4500 parts of water for decoction, filtering to obtain a second decoction; combining the decoctions, concentrating, and obtaining a fluid extract;

[0010] (2) Mixing 150-250 parts of fluid extract, 150-250 parts of inulin, 15-25 parts of protective agent, 2-4 parts of lubricant, and 80-120 parts of 8-12 wt% aqueous binder solution, drying, cooling to room temperature, crushing, sieving, and granulating to obtain a material powder;

[0011] (3) Filling the material powder into capsules to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0012] Specifically, the preparation method of the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang comprises the following steps, calculated in parts by weight:

[0013] (1) respectively grinding epimedium, rhodiola rosea, ginseng, wolfberry, cinnamon bark, rehmannia root, and schisandra chinensis through a 40-60 mesh sieve; weighing 80-120 parts of epimedium powder, 80-120 parts of rhodiola rosea powder, 100-150 parts of ginseng powder, 50-100 parts of wolfberry powder, 20-40 parts of cinnamon bark, 10-30 parts of rehmannia root powder, and 10-30 parts of schisandra chinensis powder, adding them to 1500-2500 parts of water, soaking them at 35-45°C for 24 hours, adding 2500-3500 parts of water, decocting them for 0.5-1.5 hours, and filtering to obtain a first decoction; then adding 3500-4500 parts of water, decocting them for 0.5-1.5 hours, and filtering to obtain a second decoction; combining the decoctions, concentrating them at 75-85°C for 4-8 hours, and obtaining a fluid extract;

[0014] (2) Mix 150-250 parts of fluid extract, 150-250 parts of inulin, 15-25 parts of protective agent, 2-4 parts of lubricant, and 80-120 parts of 8-12 wt% aqueous binder solution, dry at 65-75° C. to a water content of less than 5 wt%, cool to room temperature, crush, sieve, and granulate to obtain a material powder;

[0015] (3) Filling the material powder into capsules to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0016] The protective agent in step (2) is one of β-cyclodextrin, modified β-cyclodextrin, and composite modified β-cyclodextrin. The modified β-cyclodextrin is obtained by including seabuckthorn seed oil in β-cyclodextrin; and the composite modified β-cyclodextrin is obtained by including seabuckthorn seed oil and polysaccharide in β-cyclodextrin.

[0017] The preparation method of the modified β-cyclodextrin is as follows, in parts by weight:

[0018] 8-12 parts of β-cyclodextrin are added to 500-600 parts of water and stirred at room temperature for 1-2 hours to prepare a β-cyclodextrin aqueous solution; 0.5-1.5 parts of sea buckthorn seed oil are added to 8-12 parts of a 45-55 wt% ethanol-acetone mixed solution to prepare an 8-12 wt% sea buckthorn seed oil solution; 8-12 parts of the 8-12 wt% sea buckthorn seed oil solution are added to the β-cyclodextrin aqueous solution, stirred for 4-6 hours, and allowed to stand at 5-15° C. for 24 hours; and the modified β-cyclodextrin is obtained by filtering, washing the filter cake with water 2-4 times, drying, crushing, and sieving.

[0019] The preparation method of the composite modified β-cyclodextrin is as follows, in parts by weight:

[0020] Add 4-8 parts of polysaccharide and 4-8 parts of pectin to 80-120 parts of water and stir for 1-2 hours, add 8-12 parts of modified β-cyclodextrin and continue stirring for 1-2 hours, ultrasonically disperse for 10-20 minutes, dry, and grind through a 15-25 mesh sieve to obtain composite modified β-cyclodextrin.

[0021] The polysaccharide is one of kelp polysaccharide, lentinan and astragalus polysaccharide.

[0022] The lubricant in step (2) is magnesium stearate.

[0023] In the step (2), the sieving after the crushing is to pass through a 15-25 mesh sieve after the crushing.

[0024] The binder aqueous solution in step (2) is a 5-15 wt% binder aqueous solution; the binder is one of microcrystalline cellulose, hydroxypropyl methylcellulose, and carboxymethyl cellulose.

[0025] In step (3), 0.4-0.6 g of each capsule is filled into the capsule.

[0026] Epimedium can regulate the endocrine system, increase the secretion of androgens, thereby improving sexual function and exerting significant effects in nourishing the kidneys and strengthening yang.

[0027] Rhodiola contains a variety of bioactive substances such as salidroside, which can enhance the body's resistance to fatigue and improve the body's adaptability to various stresses. Its antioxidant properties help to eliminate free radicals in the body and protect kidney cells from oxidative damage.

[0028] In regulating the endocrine system, ginseng can promote the balanced secretion of related hormones and have a positive impact on kidney function and sexual ability.

[0029] The effect of wolfberry on the kidneys is to promote the repair and regeneration of kidney cells, thereby nourishing the liver and kidneys, and assisting other medicinal materials in maintaining the normal function of the kidneys.

[0030] Cinnamon can replenish heat and yang, promoting blood circulation. It can specifically dilate renal blood vessels, increasing blood perfusion to the kidneys and providing them with more oxygen and nutrients, helping them better perform metabolic functions. It also boosts the body's yang energy, improving overall physical weakness. Rehmannia root regulates yin and yang imbalances, particularly for kidney yin deficiency.

[0031] Schisandra chinensis has astringent properties, invigorates Qi and promotes fluid secretion, nourishes the kidneys and calms the mind. Its active ingredients can regulate nervous system excitability, improve sleep quality, and maintain normal kidney metabolism and endocrine function. Inulin, as a carrier, absorbs moisture from the fluid extract, improving the material's fluidity and dispersibility, facilitating smoother subsequent mixing and drying processes.

[0032] Magnesium stearate has excellent lubricating properties and is evenly dispersed on the surface of the material particles in the present invention, reducing friction between the particles and improving the fluidity of the material. This allows the material to enter the capsule shell more smoothly during the capsule filling process, improving filling efficiency and quality, and ensuring the smooth progress of the capsule preparation process. The binder tightly binds the fluid extract, inulin, protective agent, and other ingredients together during material mixing, forming a plastic whole that facilitates subsequent drying, pulverization, and granulation operations.

[0033] The present invention adds a protective agent, which is one of β-cyclodextrin, modified β-cyclodextrin, and composite modified β-cyclodextrin. β-cyclodextrin has a unique cyclic molecular structure, which encloses the drug molecules in the fluid extract in its internal cavity, thereby improving the stability, solubility and bioavailability of the drug; reducing the degradation and transformation of drug components in the gastrointestinal tract, and maintaining the balanced state of liver metabolism.

[0034] The various bioactive components in seabuckthorn seed oil, such as unsaturated fatty acids and vitamins, are further enhanced by seabuckthorn seed oil-modified β-cyclodextrin to protect and stabilize the drug components. This enhances the liver's antioxidant capacity, scavenges excess free radicals within the liver, mitigates oxidative stress damage to liver cells, and thus maintains normal liver function. The composite modified β-cyclodextrin incorporates laminarin, lentinan, or astragalus polysaccharide. Laminaria polysaccharide, rich in sulfate groups, interacts with surface receptors on immune cells in the liver, activating immunomodulatory signaling pathways and enhancing the liver's immune defenses. Furthermore, its antioxidant capacity scavenges free radicals that accumulate within the liver, mitigates oxidative stress damage to liver cells, prevents lipid peroxidation in the liver cell membrane, and maintains normal liver cell structure and function. Lentinan can modulate immune cell activity in the liver, promote cytokine secretion, and inhibit the excessive release of inflammatory factors, thereby alleviating inflammatory damage to the liver. Astragalus polysaccharide can regulate the endocrine system, influencing or promoting the secretion of reproductive hormones. It also regulates liver energy metabolism, providing sufficient energy for liver cells and reducing the burden on the liver.

[0035] Beneficial effects of the present invention:

[0036] Compared with the prior art, the kidney-tonifying and yang-strengthening capsule of the present invention uses epimedium, rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis as main raw materials, and further adds inulin, a lubricant, a binder, and a protective agent auxiliary material to complete the capsule filling step. The protective agent is one of β-cyclodextrin, modified β-cyclodextrin, and composite modified β-cyclodextrin. It reduces the burden on the liver and kidneys by regulating the endocrine system, enhancing antioxidant capacity, regulating immune cell activity, improving energy metabolism, and other pathways, and has a better protective effect. DETAILED DESCRIPTION

[0037] The parameters of the specific chemical substances used in the examples are derived from the following sources:

[0038] β-cyclodextrin: The manufacturer is Zibo Qianhui Biotechnology Co., Ltd.

[0039] Sea buckthorn seed oil: The manufacturer is Wuhan Pushida Biotechnology Co., Ltd., and the product number is 20211201.

[0040] Laminarin: The manufacturer is Shaanxi Snot Biotechnology Co., Ltd., with a purity of 30 wt%.

[0041] Lentinan: The manufacturer is Shaanxi Sinuote Biotechnology Co., Ltd., with a purity of 30wt%.

[0042] Astragalus polysaccharide: The manufacturer is Xi'an Tianbao Biotechnology Co., Ltd., with a purity of 30wt%.

[0043] Epimedium, originating from Henan Province.

[0044] Ginseng, produced in Changbai Mountain, Jilin.

[0045] Wolfberry, originating from Ningxia.

[0046] Cinnamon, originating from Guangxi.

[0047] Rehmannia root, originating from Henan Province.

[0048] Schisandra chinensis, originating from Liaoning.

[0049] Example 1

[0050] A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea, and ginseng capsule comprises the following steps:

[0051] (1) Epimedium, Rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis were respectively ground and passed through a 50-mesh sieve; 100 g of epimedium powder, 100 g of rhodiola rosea powder, 125 g of ginseng powder, 70 g of wolfberry powder, 30 g of cinnamon powder, 25 g of rehmannia root powder, and 25 g of schisandra chinensis powder were weighed and added to 2000 g of water, soaked at 40°C for 24 hours, and then 3000 g of water was added and decocted for 1 hour, and the first decoction was obtained by filtering; then 4000 g of water was added and decocted for 1 hour, and the second decoction was obtained by filtering; the decoctions were combined and concentrated at 80°C for 6 hours to obtain a fluid extract;

[0052] (2) 200 g of fluid extract, 200 g of inulin, 20 g of β-cyclodextrin, 3 g of magnesium stearate, and 100 g of a 10 wt% aqueous solution of hypromellose were mixed, dried at 70° C. to a water content of less than 5 wt%, taken out and cooled to room temperature, crushed, and passed through a 20-mesh sieve to obtain a powder;

[0053] (3) Filling the material powder into capsules at a rate of 0.5 g per capsule to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0054] Example 2

[0055] A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea, and ginseng capsule comprises the following steps:

[0056] (1) Epimedium, Rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis were respectively ground and passed through a 50-mesh sieve; 100 g of epimedium powder, 100 g of rhodiola rosea powder, 125 g of ginseng powder, 70 g of wolfberry powder, 30 g of cinnamon powder, 25 g of rehmannia root powder, and 25 g of schisandra chinensis powder were weighed and added to 2000 g of water, soaked at 40°C for 24 hours, and then 3000 g of water was added and decocted for 1 hour, and the first decoction was obtained by filtering; then 4000 g of water was added and decocted for 1 hour, and the second decoction was obtained by filtering; the decoctions were combined and concentrated at 80°C for 6 hours to obtain a fluid extract;

[0057] (2) 200 g of fluid extract, 200 g of inulin, 20 g of modified β-cyclodextrin, 3 g of magnesium stearate, and 100 g of a 10 wt% aqueous solution of hypromellose were mixed, dried at 70° C. to a water content of less than 5 wt%, taken out and cooled to room temperature, crushed, and passed through a 20-mesh sieve, and granulated to obtain a material powder;

[0058] (3) Filling the material powder into capsules at a rate of 0.5 g per capsule to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0059] The preparation method of the modified β-cyclodextrin is as follows:

[0060] 10 g of β-cyclodextrin was added to 600 g of water and stirred at room temperature for 1.5 hours to prepare a β-cyclodextrin aqueous solution; 1 g of sea buckthorn seed oil was added to 10 g of a 50 wt% ethanol-acetone mixed solution to prepare a 10 wt% sea buckthorn seed oil solution; 10 g of the 10 wt% sea buckthorn seed oil solution was added to the β-cyclodextrin aqueous solution and stirred for 5 hours, and allowed to stand at 10° C. for 24 hours; and the modified β-cyclodextrin was obtained by filtering, washing the filter cake with water three times, drying, crushing, and sieving.

[0061] Example 3

[0062] A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea, and ginseng capsule comprises the following steps:

[0063] (1) Epimedium, Rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis were respectively ground and passed through a 50-mesh sieve; 100 g of epimedium powder, 100 g of rhodiola rosea powder, 125 g of ginseng powder, 70 g of wolfberry powder, 30 g of cinnamon powder, 25 g of rehmannia root powder, and 25 g of schisandra chinensis powder were weighed and added to 2000 g of water, soaked at 40°C for 24 hours, and then 3000 g of water was added and decocted for 1 hour, and the first decoction was obtained by filtering; then 4000 g of water was added and decocted for 1 hour, and the second decoction was obtained by filtering; the decoctions were combined and concentrated at 80°C for 6 hours to obtain a fluid extract;

[0064] (2) 200 g of fluid extract, 200 g of inulin, 20 g of composite modified β-cyclodextrin, 3 g of magnesium stearate, and 100 g of a 10 wt% aqueous solution of hypromellose were mixed, dried at 70° C. to a water content of less than 5 wt%, taken out and cooled to room temperature, crushed, and passed through a 20-mesh sieve to obtain a powder;

[0065] (3) Filling the material powder into capsules at a rate of 0.5 g per capsule to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0066] The preparation method of the composite modified β-cyclodextrin is as follows:

[0067] M1. Add 10 g of β-cyclodextrin to 600 g of water and stir at room temperature for 1.5 hours to obtain a β-cyclodextrin aqueous solution; add 1 g of sea buckthorn seed oil to 10 g of a 50 wt% ethanol-acetone mixed solution to obtain a 10 wt% sea buckthorn seed oil solution; add 10 g of the 10 wt% sea buckthorn seed oil solution to the β-cyclodextrin aqueous solution, stir for 5 hours, and let stand at 10° C. for 24 hours; filter, wash the filter cake with water three times, dry, crush and sieve to obtain modified β-cyclodextrin;

[0068] M2. Add 6 g of kelp polysaccharide and 6 g of pectin to 100 g of water and stir for 1.5 hours. Add 10 g of modified β-cyclodextrin and continue stirring for 1 hour. Ultrasonic dispersion for 15 minutes, dry, and crush through a 20-mesh sieve to obtain composite modified β-cyclodextrin.

[0069] Example 4

[0070] A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea, and ginseng capsule comprises the following steps:

[0071] (1) Epimedium, Rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis were respectively ground and passed through a 50-mesh sieve; 100 g of epimedium powder, 100 g of rhodiola rosea powder, 125 g of ginseng powder, 70 g of wolfberry powder, 30 g of cinnamon powder, 25 g of rehmannia root powder, and 25 g of schisandra chinensis powder were weighed and added to 2000 g of water, soaked at 40°C for 24 hours, and then 3000 g of water was added and decocted for 1 hour, and the first decoction was obtained by filtering; then 4000 g of water was added and decocted for 1 hour, and the second decoction was obtained by filtering; the decoctions were combined and concentrated at 80°C for 6 hours to obtain a fluid extract;

[0072] (2) 200 g of fluid extract, 200 g of inulin, 20 g of composite modified β-cyclodextrin, 3 g of magnesium stearate, and 100 g of a 10 wt% aqueous solution of hypromellose were mixed, dried at 70° C. to a water content of less than 5 wt%, taken out and cooled to room temperature, crushed, and passed through a 20-mesh sieve to obtain a powder;

[0073] (3) Filling the material powder into capsules at a rate of 0.5 g per capsule to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0074] The preparation method of the composite modified β-cyclodextrin is as follows:

[0075] M1. Add 10 g of β-cyclodextrin to 600 g of water and stir at room temperature for 1.5 hours to obtain a β-cyclodextrin aqueous solution; add 1 g of sea buckthorn seed oil to 10 g of a 50 wt% ethanol-acetone mixed solution to obtain a 10 wt% sea buckthorn seed oil solution; add 10 g of the 10 wt% sea buckthorn seed oil solution to the β-cyclodextrin aqueous solution, stir for 5 hours, and let stand at 10° C. for 24 hours; filter, wash the filter cake with water three times, dry, crush and sieve to obtain modified β-cyclodextrin;

[0076] M2. Add 6 g of Lentinan and 6 g of pectin to 100 g of water and stir for 1.5 hours. Add 10 g of modified β-cyclodextrin and continue stirring for 1 hour. Ultrasonic disperse for 15 minutes, dry, and grind through a 20-mesh sieve to obtain composite modified β-cyclodextrin.

[0077] Example 5

[0078] A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea, and ginseng capsule comprises the following steps:

[0079] (1) Epimedium, Rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis were respectively ground and passed through a 50-mesh sieve; 100 g of epimedium powder, 100 g of rhodiola rosea powder, 125 g of ginseng powder, 70 g of wolfberry powder, 30 g of cinnamon powder, 25 g of rehmannia root powder, and 25 g of schisandra chinensis powder were weighed and added to 2000 g of water, soaked at 40°C for 24 hours, and then 3000 g of water was added and decocted for 1 hour, and the first decoction was obtained by filtering; then 4000 g of water was added and decocted for 1 hour, and the second decoction was obtained by filtering; the decoctions were combined and concentrated at 80°C for 6 hours to obtain a fluid extract;

[0080] (2) 200 g of fluid extract, 200 g of inulin, 20 g of composite modified β-cyclodextrin, 3 g of magnesium stearate, and 100 g of a 10 wt% aqueous solution of hypromellose were mixed, dried at 70° C. to a water content of less than 5 wt%, taken out and cooled to room temperature, crushed, and passed through a 20-mesh sieve to obtain a powder;

[0081] (3) Filling the material powder into capsules at a rate of 0.5 g per capsule to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0082] The preparation method of the composite modified β-cyclodextrin is as follows:

[0083] M1. Add 10 g of β-cyclodextrin to 600 g of water and stir at room temperature for 1.5 hours to obtain a β-cyclodextrin aqueous solution; add 1 g of sea buckthorn seed oil to 10 g of a 50 wt% ethanol-acetone mixed solution to obtain a 10 wt% sea buckthorn seed oil solution; add 10 g of the 10 wt% sea buckthorn seed oil solution to the β-cyclodextrin aqueous solution, stir for 5 hours, and let stand at 10° C. for 24 hours; filter, wash the filter cake with water three times, dry, crush and sieve to obtain modified β-cyclodextrin;

[0084] M2. Add 6 g of astragalus polysaccharide and 6 g of pectin to 100 g of water and stir for 1.5 hours. Add 10 g of modified β-cyclodextrin and continue stirring for 1 hour. Ultrasonic dispersion for 15 minutes, dry, and crush through a 20-mesh sieve to obtain composite modified β-cyclodextrin.

[0085] Comparative Example 1

[0086] A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea, and ginseng capsule comprises the following steps:

[0087] (1) Epimedium, Rhodiola rosea, ginseng, wolfberry, cinnamon, rehmannia root, and schisandra chinensis were respectively ground and passed through a 50-mesh sieve; 100 g of epimedium powder, 100 g of rhodiola rosea powder, 125 g of ginseng powder, 70 g of wolfberry powder, 30 g of cinnamon powder, 25 g of rehmannia root powder, and 25 g of schisandra chinensis powder were weighed and added to 2000 g of water, soaked at 40°C for 24 hours, and then 3000 g of water was added and decocted for 1 hour, and the first decoction was obtained by filtering; then 4000 g of water was added and decocted for 1 hour, and the second decoction was obtained by filtering; the decoctions were combined and concentrated at 80°C for 6 hours to obtain a fluid extract;

[0088] (2) 200 g of fluid extract, 200 g of inulin, 10 g of β-cyclodextrin, 1 g of sea buckthorn seed oil, 6 g of astragalus polysaccharide, 3 g of magnesium stearate, and 100 g of a 10 wt% aqueous solution of hypromellose were mixed, dried at 70° C. to a water content of less than 5 wt%, taken out and cooled to room temperature, crushed, and passed through a 20-mesh sieve to obtain a powder;

[0089] (3) Filling the material powder into capsules at a rate of 0.5 g per capsule to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

[0090] Test Example 1

[0091] The material powder in step (2) of the preparation of the Epimedium, Rhodiola and Ginseng Capsules for tonifying the kidney and strengthening yang obtained by the preparation method of Examples 1-5 was used as a test sample, and 0.1 g of the test sample was added to 1 g of water to prepare a test sample solution.

[0092] 0.5 g of agar and 0.5 g of corn starch were added to 100 g of water and stirred at 60° C. for 1 hour until a paste formed. 0.5 g of sucrose was then added and stirred at 60° C. for 0.5 hour until dissolved. The mixture was cooled to 40° C., yeast powder was added and fermented for 1 hour, 0.01 g of propionic acid and 0.01 g of 10 wt% methyl parahydroxybenzoate were added and stirred for 0.5 hour to obtain a culture medium. 5 g of the culture medium was respectively dispensed into culture tubes while hot, 1 g of the test sample solution of Examples 1-5 was added to each culture tube, and the culture was continued.

[0093] 1000 Drosophila eggs were placed in a culture medium and cultured at 25°C and 60% relative humidity. The culture medium was replaced on the third day, and the eggs were transferred from the original culture medium to a new culture medium and cultured for another day until they were fully hatched. After CO2 anesthesia, the eggs were separated into males and females and cultured separately for 10 days. Male and female Drosophila were then randomly divided into 6 groups (Examples 1-5) and a blank control group, each containing 100 Drosophila, 40 male Drosophila and 60 female Drosophila. A sexual activity test was performed for 1 hour. After the sexual activity test was completed, the female Drosophila were promptly transferred to a basal culture medium according to the group and cultured for another 3 days. The adults were killed, and the number of larvae that emerged after 12 days of culture in the culture medium of each group was counted. The emergence rate of the larvae in each group was calculated, and the summary is shown in Table 1.

[0094] Table 1 Larval emergence rate after mating of male and female Drosophila

[0095]

[0096] Note: Compared with the blank group, the differences in Examples 1-5 were statistically significant (P<0.05).

[0097] Example 1 added β-cyclodextrin, Example 2 modified β-cyclodextrin on the basis of Example 1, and Examples 3-5 further added composite modified β-cyclodextrin. It can be seen from the above table that the emergence rates of Examples 1-5 are much higher than those of the blank control group, indicating that Epimedium, Rhodiola Rosea and Ginseng Capsules have a significant effect on improving sexual vitality. The modified β-cyclodextrin of Example 2 is prepared by inclusion reaction of β-cyclodextrin and sea buckthorn seed oil, and the composite modified β-cyclodextrins of Examples 3-5 are further added with kelp polysaccharide, lentinan, astragalus polysaccharide and pectin, and the modified β-cyclodextrin is used to include the polysaccharides. The reproductive activity of fruit flies is regulated by a variety of hormones. After kelp polysaccharide enters the body of fruit flies, its sulfate groups interact with receptors or enzymes related to hormone secretion in the fruit flies, promote the rational secretion and regulation of hormones closely related to sexual vitality, help maintain the normal development and function of the reproductive organs of fruit flies, and thus enhance their sexual vitality. At the same time, kelp polysaccharide has antioxidant properties, which can eliminate excessive free radicals produced by metabolism in the fruit flies, reduce the oxidative damage of free radicals to reproductive cells and related tissues, and maintain the health of the reproductive system. Lentinan can indirectly play a role by enhancing the immune function of fruit flies. The enhancement of immune function is beneficial for fruit flies to maintain a good overall physiological state, ensuring the smooth progress of reproductive-related physiological processes, thereby improving their sexual vitality; Lentinan may also be involved in the regulation of energy metabolism in fruit flies, providing more sufficient energy for reproductive activities, and further promoting the improvement of sexual vitality. Astragalus polysaccharide can regulate the endocrine system, affect or promote the secretion of reproductive hormones, and make fruit flies more physiologically inclined to engage in reproductive activities, thereby improving sexual vitality; Astragalus polysaccharide has significant antioxidant and anti-stress capabilities, reducing the damage of stress to the reproductive system, maintaining the normal function of reproductive cells, and thus improving sexual vitality. The emergence rate of fruit fly larvae cultured in Examples 3-5 is relatively higher, and the emergence rate varies with the compounding of different polysaccharides, among which the larvae in Example 5 have the highest emergence rate.

[0098] Test Example 2

[0099] The powder of the material in step (2) of the preparation of the Epimedium, Rhodiola and Ginseng Capsules for tonifying the kidney and strengthening yang obtained by the preparation method of Examples 1-5 and Comparative Example 1 was used as a test sample, and liver function tests were performed on experimental mice. Male experimental mice were randomly divided into 7 groups, namely, a blank group, a group of Examples 1-5, and a group of Comparative Example 1, with 10 mice in each group. The mice were placed in a feeding box at 25°C and 60% humidity for 30 days. The groups of Examples 1-5 and Comparative Example 1 were fed 0.5g of the test sample once a day, while the blank group was not fed with this operation. After the feeding, orbital venous blood and liver tissue of the experimental mice were respectively taken for liver function tests. The test indicators were alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). The average values of the test data were summarized as shown in Table 1.

[0100] Table 1 Liver function tests

[0101] Alanine aminotransferase (U / L) Aspartate aminotransferase (U / L) Alkaline phosphatase (U / L) Blank group 426.5±0.7 39.4±0.2 218.2±0.5 Example 1 454.4±1.0 48.6±0.4 230.2±0.6 Example 2 451.3±1.1 46.3±0.3 228.3±0.7 Example 3 448.5±1.0 45.0±0.3 224.6±0.6 Example 4 441.0±1.2 43.2±0.2 221.5±0.5 Example 5 430.5±1.1 41.1±0.4 220.1±0.5 Comparative Example 1 448.3±1.0 44.7±0.2 227.1±0.6

[0102] Note: There were statistically significant differences between Examples 1-5 and Comparative Example 1 and the blank group (P<0.05).

[0103] When the liver is damaged, the concentrations of alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase will be higher than those of the blank group, and it is usually necessary to take liver protection tablets. The difference between Examples 1 and 2 lies in whether the β-cyclodextrin is encapsulated and modified. The liver function index of the untreated Example 1 is relatively high. The β-cyclodextrin modified with sea buckthorn seed oil in Example 2 may enhance the protection and stabilization of the active ingredients in the drug due to the antioxidant properties of sea buckthorn seed oil, thereby reducing the impact of the drug on the liver during metabolism in the body. However, Comparative Example 1 simply mixes β-cyclodextrin, sea buckthorn seed oil, and astragalus polysaccharide, lacking a complex combination, and has limited effect on reducing the burden on the liver. The difference between Examples 3-5 is that kelp polysaccharide, lentinan and astragalus polysaccharide are added for compounding. The kelp polysaccharide, lentinan and astragalus polysaccharide in the composite modified β-cyclodextrin added in Examples 3-5 have multiple functions such as immune regulation, anti-oxidation, and metabolism regulation. Through synergistic action with modified β-cyclodextrin, the damage of the drug to the liver is further reduced, and the liver function indicators are lowered; among them, Example 5 has the best effect, which may be because the synergistic effect of astragalus polysaccharide and other components in regulating liver metabolism and reducing liver oxidative stress is more significant.

[0104] The above describes in detail the preferred embodiments of the present invention. It should be understood that those skilled in the art can make numerous modifications and variations based on the concepts of the present invention without inventive effort. Therefore, any technical solutions that can be derived by those skilled in the art through logical analysis, reasoning, or limited experimentation based on the concepts of the present invention and the prior art should be within the scope of protection defined by the claims.

Claims

1. A method for preparing a kidney-tonifying and yang-strengthening epimedium, rhodiola rosea and ginseng capsule, characterized in that: The method comprises the following steps, in parts by weight: (1) respectively grinding epimedium, rhodiola rosea, ginseng, wolfberry, cinnamon bark, rehmannia root, and schisandra chinensis through a 40-60 mesh sieve; weighing 80-120 parts of epimedium powder, 80-120 parts of rhodiola rosea powder, 100-150 parts of ginseng powder, 50-100 parts of wolfberry powder, 20-40 parts of cinnamon bark, 10-30 parts of rehmannia root powder, and 10-30 parts of schisandra chinensis powder into 1500-2500 parts of water, soaking, adding 2500-3500 parts of water for decoction, filtering to obtain a first decoction; then adding 3500-4500 parts of water for decoction, filtering to obtain a second decoction; combining the decoctions, concentrating, and obtaining a fluid extract; (2) Mixing 150-250 parts of fluid extract, 150-250 parts of inulin, 15-25 parts of protective agent, 2-4 parts of lubricant, and 80-120 parts of 8-12 wt% aqueous binder solution, drying, cooling to room temperature, crushing, sieving, and granulating to obtain a material powder; (3) filling the material powder into a capsule to obtain the Epimedium, Rhodiola and Ginseng capsule for tonifying the kidney and strengthening yang; In step (2), the protective agent is one of β-cyclodextrin, modified β-cyclodextrin, and composite modified β-cyclodextrin; The modified β-cyclodextrin is obtained by including sea buckthorn seed oil in β-cyclodextrin; The composite modified beta-cyclodextrin is obtained by compounding seabuckthorn seed oil and polysaccharide with beta-cyclodextrin.

2. The preparation method of the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The preparation method comprises the following steps, in parts by weight: (1) respectively grinding epimedium, rhodiola rosea, ginseng, wolfberry, cinnamon bark, rehmannia root, and schisandra chinensis through a 40-60 mesh sieve; weighing 80-120 parts of epimedium powder, 80-120 parts of rhodiola rosea powder, 100-150 parts of ginseng powder, 50-100 parts of wolfberry powder, 20-40 parts of cinnamon bark, 10-30 parts of rehmannia root powder, and 10-30 parts of schisandra chinensis powder, adding them to 1500-2500 parts of water, soaking them at 35-45°C for 24 hours, adding 2500-3500 parts of water, decocting them for 0.5-1.5 hours, and filtering to obtain a first decoction; then adding 3500-4500 parts of water, decocting them for 0.5-1.5 hours, and filtering to obtain a second decoction; combining the decoctions, concentrating them at 75-85°C for 4-8 hours, and obtaining a fluid extract; (2) Mix 150-250 parts of fluid extract, 150-250 parts of inulin, 15-25 parts of protective agent, 2-4 parts of lubricant, and 80-120 parts of 8-12 wt% aqueous binder solution, dry at 65-75° C. to a water content of less than 5 wt%, cool to room temperature, crush, sieve, and granulate to obtain a material powder; (3) Filling the material powder into capsules to obtain the Epimedium, Rhodiola and Ginseng capsules for tonifying the kidney and strengthening yang.

3. The preparation method of the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The preparation method of the modified β-cyclodextrin is as follows, in parts by weight: 8-12 parts of β-cyclodextrin are added to 45-55 parts of water and stirred at room temperature for 1-2 hours to prepare a β-cyclodextrin aqueous solution; 0.5-1.5 parts of sea buckthorn seed oil are added to 8-12 parts of a 45-55wt% ethanol-acetone mixed solution to prepare an 8-12wt% sea buckthorn seed oil solution; 8-12 parts of the 8-12wt% sea buckthorn seed oil solution are added to the β-cyclodextrin aqueous solution, stirred for 4-6 hours, and allowed to stand at 5-15°C for 24 hours; and filtered, the filter cake is washed with water 2-4 times, dried, crushed, and sieved to obtain modified β-cyclodextrin.

4. The preparation method of the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The preparation method of the composite modified β-cyclodextrin is as follows, in parts by weight: Add 4-8 parts of polysaccharide and 4-8 parts of pectin to 80-120 parts of water and stir for 1-2 hours, add 8-12 parts of modified β-cyclodextrin and continue stirring for 1-2 hours, ultrasonically disperse for 10-20 minutes, dry, and grind through a 15-25 mesh sieve to obtain composite modified β-cyclodextrin; The preparation method of the modified β-cyclodextrin is as follows, in parts by weight: 8-12 parts of β-cyclodextrin are added to 500-600 parts of water and stirred at room temperature for 1-2 hours to prepare a β-cyclodextrin aqueous solution; 0.5-1.5 parts of sea buckthorn seed oil are added to 8-12 parts of a 45-55 wt% ethanol-acetone mixed solution to prepare an 8-12 wt% sea buckthorn seed oil solution; 8-12 parts of the 8-12 wt% sea buckthorn seed oil solution are added to the β-cyclodextrin aqueous solution, stirred for 4-6 hours, and allowed to stand at 5-15° C. for 24 hours; and the modified β-cyclodextrin is obtained by filtering, washing the filter cake with water 2-4 times, drying, crushing, and sieving.

5. The method for preparing the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The polysaccharide is one of kelp polysaccharide, lentinan and astragalus polysaccharide.

6. The method for preparing the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The lubricant in step (2) is magnesium stearate.

7. The method for preparing the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: In the step (2), the sieving after the crushing is to pass through a 15-25 mesh sieve after the crushing.

8. The method for preparing the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The binder aqueous solution in step (2) is a 5-15 wt % binder aqueous solution.

9. The method for preparing the Epimedium, Rhodiola and Ginseng Capsule for tonifying the kidney and strengthening yang according to claim 1, characterized in that: The binder is one of microcrystalline cellulose, hypromellose and carboxymethyl cellulose.

10. A capsule of epimedium, rhodiola rosea and ginseng, characterized in that: The compound is prepared by the preparation method according to any one of claims 1 to 9.

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