Kidney-tonifying composition and application thereof

Abstract

The invention discloses a kidney-tonifying composition and a preparation method thereof. The kidney-tonifying composition is prepared from 8-12 g of rhizoma polygonati, 8-12 g of sea-buckthorn, 8-12 g of fructus lycii, 8-12 g of herba epimedii, 8-12 g of cynomorium songaricum, 3-6 g of rhizoma curculiginis and 8-10 g of semen allii tuberosi. The traditional Chinese medicine composition has the effects of tonifying kidney, replenishing essence and tonifying yin and yang through triple mechanisms of absorption promotion of sea-buckthorn, mild drug property of rhizoma polygonati and activation of herba epimedii.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and specifically to a kidney-tonifying composition and applications thereof. Background Art

[0002] Currently, most kidney-tonifying products on the market focus on either pure yang-tonifying or yin-tonifying properties, and suffer from the drawbacks of being greasy, causing stomach upset, internal heat, and constipation, as well as high cost. In view of this, the present invention provides a kidney-tonifying composition and a preparation method thereof. Summary of the Invention

[0003] The present invention provides a kidney-tonifying composition and a preparation method thereof, which has the effects of tonifying the kidney and replenishing essence, and replenishing both yin and yang.

[0004] To achieve the above-mentioned purpose, one of the technical solutions adopted by the present invention is to provide a kidney-tonifying composition, which is prepared from the following raw materials: 8-12g of polygonatum, 8-12g of sea buckthorn, 8-12g of wolfberry, 8-12g of epimedium, 8-12g of cynomorium songaricum, 3-6g of curculigo, and 8-10g of leek seeds.

[0005] Furthermore, the optimal ratio of the composition is made from the following components: 10g of polygonatum, 10g of sea buckthorn, 10g of wolfberry, 10g of epimedium, 10g of cynomorium songaricum, 5g of curculigo, and 9g of leek seeds.

[0006] The second aspect of the present invention provides a use of the composition in preparing a pharmaceutical preparation for improving male erectile dysfunction.

[0007] The third aspect of the present invention further provides a method for preparing a kidney-tonifying composition, comprising the following steps:

[0008] Step 1: Weigh the following raw materials: 10g of polygonatum, 10g of sea buckthorn, 10g of wolfberry, 10g of epimedium, 10g of cynomorium songaricum, 5g of curculigo, and 9g of leek seeds, mix the raw materials, add 8 times the amount of water, soak for 2 hours, and filter;

[0009] Step 2: adding 6 times the amount of water to the filter residue after filtering in step 1 and soaking it again for 1 hour, and filtering;

[0010] Step 3, the filtrates obtained in step 1 and step 2 are mixed, and the mixture is concentrated to an extract with a relative density of 1.05-1.10, and the concentration is stopped. The extract is sieved and collected as an extract;

[0011] Step 4: add sodium benzoate, sucralose and water to the extract obtained in step 3, and mix well to obtain the product.

[0012] Furthermore, the relative density is detected at 60°C.

[0013] The beneficial effects of this invention are as follows: the kidney-tonifying composition incorporates seabuckthorn as a "spleen-strengthening and blood-activating carrier," resolving the problem of kidney-tonifying drugs being greasy and stomach-irritating. The combination of epimedium, cynomorium songaricum, and curculigo targets the hypothalamus, pituitary, and gonads; the combination of polygonatum and wolfberry balances yin and yang; and the blood-activating and blood-transporting layer, composed of seabuckthorn and leek seeds, improves renal microcirculation, while the zinc in leek seeds enhances sperm motility. DETAILED DESCRIPTION

[0014] To make the purpose, technical solutions and advantages of the embodiments of the present disclosure more clear, the technical solutions of the embodiments of the present disclosure are clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments.

[0015] Unless otherwise specified, the raw materials and reagents used in the following examples are commercially available or can be prepared by known methods.

[0016] Example 1

[0017] A kidney-tonifying composition is prepared from the following raw materials: 10g of polygonatum, 10g of seabuckthorn, 10g of wolfberry, 10g of epimedium, 10g of cynomorium songaricum, 5g of curculigo, and 9g of leek seeds.

[0018] Example 2

[0019] The same batches were prepared in parallel as in Example 1.

[0020] Comparative Example 1

[0021] Lack of sea buckthorn, the rest is the same as in Example 1.

[0022] Comparative Example 2

[0023] Lack of Polygonatum sibiricum, and the rest is the same as in Example 1.

[0024] Comparative Example 3

[0025] Lack of Epimedium, the rest is the same as Example 1.

[0026] The above embodiments are used in pharmaceutical preparations for improving male erectile dysfunction.

[0027] The preparation method of the above embodiment comprises the following steps:

[0028] Step 1: Weigh the following raw materials: 10g of polygonatum, 10g of sea buckthorn, 10g of wolfberry, 10g of epimedium, 10g of cynomorium songaricum, 5g of curculigo, and 9g of leek seeds, mix the raw materials, add 8 times the amount of water, soak for 2 hours, and filter;

[0029] Step 2: adding 6 times the amount of water to the filter residue after filtering in step 1 and soaking it again for 1 hour, and filtering;

[0030] Step 3, the filtrates obtained in step 1 and step 2 are mixed, and the mixture is concentrated to an extract with a relative density of 1.05-1.10, and the concentration is stopped. The extract is sieved and collected as an extract;

[0031] Step 4: add sodium benzoate, sucralose and water to the extract obtained in step 3, and mix well to obtain the product.

[0032] Furthermore, the relative density is detected at 60°C.

[0033] In order to verify the quality of the product of the present invention, physical and chemical properties tests were performed.

[0034] Table 1 Physical and chemical properties test results

[0035]

[0036] Accelerated stability test results

[0037] Test conditions: temperature 40°C ± 2°C; relative humidity 75% ± 5%. Testing time points: January, February, and March. The product stability was examined. No significant changes were observed in properties, identification, inspection, or content, indicating excellent stability. The method of the present invention can be scaled up to meet market supply needs.

[0038] Experiments on the efficacy of treating ED and resolving the problems of traditional kidney-tonifying prescriptions that cause greasy stomach discomfort, internal heat and constipation:

[0039] Experimental design: A randomized double-blind controlled trial (n=120 patients with ED due to kidney-essence deficiency) was conducted, divided into 3 groups:

[0040] ① Group of the present invention (full-grain granules, n=40)

[0041] ② Positive control group (Wuzi Yanzong Pills, n=40)

[0042] ③ Placebo group (n=40), 90-day treatment course

[0043] Table 2: Comparison of core efficacy indicators of ED (after 90 days of treatment)

[0044]

[0045]

[0046] Table 3: Gastrointestinal tolerance and incidence of heat symptoms (n=40)

[0047] Group Incidence of gastric bloating Incidence of constipation Incidence of dry mouth / oral ulcers Improvement rate of loose stools* The present invention group 5.0％ 2.5％ 0％ 92.3％ Positive control group 32.5％ 27.5％ 20.0％ 65.4％

[0048] Table 4: Side effects rebound due to component omission (30-day treatment data)

[0049] Group Incidence of constipation Incidence of dry mouth Incidence of gastric bloating Mechanism explanation Comparative Example 1 25.0％ 15.0％ 30.0％ Lack of dietary fiber, exposure of dry ingredients Comparative Example 2 10.0％ 22.5％ 17.5％ Decreased polysaccharide content and weakened mucosal protection Comparative Example 3 5.0％ 5.0％ 7.5％ The warming yang power is reduced, but it is not the main cause Example 1 2.5％ 0％ 5.0％ Three components work together to control side effects

[0050] The present invention achieves an ED efficacy improvement of more than 20% compared with the classic formula through the triple mechanism of "sea buckthorn absorption promotion + polygonatum medicinal properties + epimedium activation power".

[0051] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention specification, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A kidney-tonifying composition, characterized in that , made from the following raw materials: Polygonatum 8-12g, Seabuckthorn 8-12g, Wolfberry 8-12g, Epimedium 8-12g, Cynomorium songaricum 8-12g, Curculigo 3-6g, and Allium tuberosum seed 8-10g.

2. The kidney-tonifying composition according to claim 1, characterized in that , made from the following ingredients: 10g of polygonatum, 10g of sea buckthorn, 10g of wolfberry, 10g of epimedium, 10g of cynomorium songaricum, 5g of curculigo, and 9g of leek seeds.

3. Use of the kidney-tonifying composition according to claim 2 in a pharmaceutical preparation for improving male erectile dysfunction.

4. The kidney-tonifying composition according to any one of claims 1 to 3, characterized in that The preparation method of the composition includes the following steps: Step 1, weighing the following raw materials: 10g of polygonatum, 10g of sea buckthorn, 10g of wolfberry, 10g of epimedium, 10g of cynomorium songaricum, 5g of curculigo, and 9g of leek seeds, mixing the above raw materials, adding 8 times of water, soaking for 2 hours, and filtering; Step 2, adding 6 times of water to the filter residue after filtering in step 1, soaking again for 1 hour, and filtering; Step 3, mixing the filtrates obtained in step 1 and step 2, concentrating the mixture to an extract with a relative density of 1.05-1.10, stopping the concentration, sieving the extract, and collecting the paste; Step 4, adding sodium benzoate, sucralose and water to the extract obtained in step 3, and mixing evenly to obtain the extract.

5. The kidney-tonifying composition according to any one of claim 4, characterized in that , the relative density is tested at 60℃.

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