A traditional Chinese medicine composition for preventing or treating male premature aging, a traditional Chinese medicine preparation, a preparation method thereof and application

Abstract

The application discloses a traditional Chinese medicine composition for preventing or treating male premature aging, a traditional Chinese medicine preparation and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. The composition comprises the following raw medicinal materials in parts by weight: radix ginseng 0.5-4 parts, cornu cervi 0.5-4 parts, epimedium 0.1-3 parts, lycium barbarum 0.5-3 parts, radix astragali 0.5-4 parts, ligustrum lucidum 0.5-3 parts, panax notoginseng 0.5-3 parts, ginkgo leaves 0.5-3 parts, rhizoma alpiniae 0.5-2 parts and polygala 0.1-1.5 parts. The traditional Chinese medicine composition has a good anti-aging effect, can delay the symptoms of premature aging and normal aging of patients, and can be taken for a long time.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition, preparation method and application for the prevention or treatment of premature male aging. Background Technology

[0002] Aging is a biological process that occurs slowly and universally with increasing age. Human aging can manifest as wrinkled skin, gray hair, slow movement, related hormone secretion disorders, memory decline, and degenerative changes in various tissues and organs. In men, it can also manifest as kidney deficiency, weak sperm, and decreased libido.

[0003] Premature aging refers to the phenomenon where an individual's physical functions decline at a faster rate than those of their peers as they age. High levels of stress, unhealthy eating habits, staying up late, drinking alcohol, and smoking can all contribute to premature aging.

[0004] Furthermore, around the age of 40, men often experience a decline in testosterone levels, leading to a sub-healthy state characterized by decreased physical strength, mental stress, weakened immunity, and insomnia. Currently, some health products on the market claim to treat premature aging and sub-health issues, often by adding tonifying medicinal ingredients. However, the use of tonifying ingredients can also lead to over-tonification and excessive internal heat, which not only fails to achieve the desired therapeutic effect but may also induce other illnesses. Summary of the Invention

[0005] In view of the above-mentioned deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method thereof, and an application thereof for preventing or treating premature aging in men. The traditional Chinese medicine composition has a good anti-aging effect, can delay premature aging and aging symptoms in male patients, and can be taken for a long time.

[0006] To achieve the above objectives, the technical solution adopted by the present invention to solve its technical problem is as follows: A traditional Chinese medicine composition for preventing or treating premature male aging includes the following raw materials in parts by weight: ginseng 0.5-4 parts, deer antler glue 0.5-4 parts, epimedium 0.1-3 parts, wolfberry 0.5-3 parts, astragalus 0.5-4 parts, privet fruit 0.5-3 parts, notoginseng 0.5-3 parts, ginkgo leaf 0.5-3 parts, acorus tatarinowii 0.5-2 parts, and polygala tenuifolia 0.1-1.5 parts.

[0007] Furthermore, the raw materials include the following parts by weight: ginseng 1-3 parts, deer antler glue 1-3 parts, epimedium 0.5-2 parts, wolfberry 1-2 parts, astragalus 1.5-2.5 parts, privet fruit 0.5-1.5 parts, notoginseng 1-2 parts, ginkgo leaf 1-2 parts, acorus tatarinowii 0.5-1.5 parts, and polygala tenuifolia 0.2-1 parts.

[0008] Furthermore, the raw materials include the following parts by weight: 2 parts ginseng, 2 parts deer antler glue, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part privet fruit, 1.5 parts notoginseng, 1.5 parts ginkgo leaf, 1 part acorus tatarinowii and 0.5 parts polygala tenuifolia.

[0009] Furthermore, Epimedium is prepared as roasted Epimedium.

[0010] Furthermore, privet fruit is called wine privet fruit.

[0011] Furthermore, Yuanzhi is used to prepare Yuanzhi.

[0012] A traditional Chinese medicine preparation for the prevention or treatment of premature male aging, made from the above-mentioned traditional Chinese medicine composition.

[0013] Furthermore, traditional Chinese medicine preparations include powders, pills, granules, capsules, tablets, ointments, medicated wines, or mixtures.

[0014] Further, the method includes the following steps: extracting the above composition with a solvent, concentrating and drying it, and then adding excipients to prepare the corresponding dosage form; or directly pulverizing the above composition into a fine powder to prepare the corresponding dosage form.

[0015] The above-described composition is used in the preparation of a medicament for the prevention or treatment of premature male aging.

[0016] The beneficial effects of this invention are as follows: In this invention, deer antler glue is sweet and salty in taste, warm in nature, and enters the kidney and liver meridians. It has the effects of warming and tonifying kidney yang, and nourishing essence and blood. Epimedium is pungent, sweet, and warm in nature. It enters the kidney and liver meridians. It has the effects of tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness. When used together with deer antler glue, it is mainly used to warm and tonify kidney yang, and nourish essence and blood. Goji berries, sweet and neutral in nature, enter the liver, kidney, and lung meridians. They nourish the liver and kidneys, benefit essence and improve eyesight, and are considered a mild tonic. Ligustrum lucidum, sweet and bitter, also neutral in nature, enters the liver and kidney meridians and is a yin-tonifying herb, nourishing the liver and kidneys. The combination of goji berries and privet fruit focuses on tonifying the liver and kidneys and replenishing yin essence. The combination of deer antler glue and epimedium, along with goji berries and privet fruit, collectively tonifies the kidneys and replenishes essence, balancing yin and yang. This generates kidney qi, ensuring a source for qi transformation and promoting blood circulation. It is the principal herb for treating the symptoms of "kidney qi deficiency" as the main pathogenesis of premature male aging. The above combination seeks both yin within yang and yang within yin to prevent excessive tonification and the generation of dryness and heat.

[0017] Panax notoginseng is sweet and slightly bitter in taste, warm in nature, and enters the liver and stomach meridians. It has the effects of removing blood stasis, stopping bleeding, and reducing swelling. Ginkgo biloba leaves are slightly bitter in taste and enter the heart and lung meridians. They have the effects of promoting blood circulation and removing blood stasis. The combination of the two herbs can promote blood circulation and remove blood stasis, and can be used to improve blood circulation and promote human metabolism. Acorus tatarinowii, pungent and warm in nature, enters the heart and liver meridians. It has the effects of resolving phlegm, regulating qi, promoting blood circulation, and eliminating dampness. Polygala tenuifolia, bitter, pungent and warm in nature, enters the heart, kidney, and lung meridians. It has the effects of resolving phlegm, opening the orifices, reducing swelling and dissipating nodules. The combination of the two herbs can effectively remove phlegm and turbidity. Panax notoginseng, Ginkgo biloba, Acorus tatarinowii and Polygala tenuifolia work together to remove blood stasis, promote blood circulation, open the orifices, resolve phlegm, expel stagnation in the body, promote the smooth flow of qi, and coordinate qi and blood. These herbs are the assistant herbs. Ginseng is sweet and bitter in taste, slightly warm in nature, and enters the lung, spleen, heart, and kidney meridians. It is an essential medicine for tonifying qi and strengthening the body. It not only greatly replenishes the original qi and treats qi deficiency and impending collapse, but also effectively tonifies the spleen and lung qi, enhances the function of the spleen and lungs, and can also generate body fluids and promote the production of body fluids. Astragalus is sweet and warm in nature and enters the lung and spleen meridians. Astragalus is sweet and warm and purely yang in nature. It replenishes all deficiencies, benefits the original qi, strengthens the spleen and stomach, clears muscle heat, drains pus and relieves pain, and invigorates blood and generates blood. The two are used together as adjuvant medicines to enhance the efficacy of the principal medicine. In this invention, the various herbs work together to strengthen the body's foundation and nourish its vital energy. Furthermore, the key to delaying male aging lies in tonifying kidney yang. The formula in this application focuses on delaying male aging, primarily by tonifying kidney yang, supplemented by tonifying the kidney and spleen, replenishing qi and blood, and resolving phlegm and promoting blood circulation. With a strong spleen and kidney, the production of qi and blood is abundant, promoting blood circulation, clearing blood stasis, promoting the vaporization of body fluids, and reducing the production of phlegm. This achieves the effect of regulating and nourishing the body's essence, qi, and spirit, enhancing memory, and increasing sexual interest, thus playing a role in delaying aging. Detailed Implementation

[0018] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are only for explaining the invention and are not intended to limit the invention; that is, the described embodiments are merely some embodiments of the invention, and not all embodiments.

[0019] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0020] It should be noted that relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

[0021] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0022] Example 1

[0023] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 0.5 parts ginseng, 0.5 parts deer antler glue, 3 parts processed epimedium, 0.5 parts wolfberry, 4 parts astragalus, 3 parts wine-processed privet fruit, 0.5 parts notoginseng, 3 parts ginkgo leaf, 0.5 parts acorus tatarinowii, and 1.5 parts processed polygala tenuifolia.

[0024] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0025] Example 2

[0026] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: ginseng 4 parts, deer antler glue 4 parts, processed epimedium 0.1 parts, wolfberry 3 parts, astragalus 0.5 parts, wine-processed privet fruit 0.5 parts, notoginseng 3 parts, ginkgo leaf 0.5 parts, acorus tatarinowii 2 parts and processed polygala tenuifolia 0.1 parts.

[0027] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0028] Example 3

[0029] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 1 part ginseng, 1 part deer antler glue, 2 parts epimedium, 1 part wolfberry, 2.5 parts astragalus, 1.5 parts privet fruit, 1 part notoginseng, 2 parts ginkgo leaf, 0.5 parts acorus and 1 part polygala.

[0030] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0031] Example 4

[0032] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 3 parts ginseng, 3 parts deer antler glue, 0.5 parts epimedium, 2 parts wolfberry, 1.5 parts astragalus, 0.5 parts privet fruit, 2 parts notoginseng, 1 part ginkgo leaf, 1.5 parts acorus and 0.2 parts polygala.

[0033] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0034] Example 5

[0035] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 2 parts ginseng, 2 parts deer antler glue, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part privet fruit, 1.5 parts notoginseng, 1.5 parts ginkgo leaf, 1 part acorus and 0.5 parts polygala.

[0036] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0037] Comparative Example 1

[0038] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 2 parts ginseng, 2 parts deer antler powder, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part mulberry, 1.5 parts notoginseng, 1.5 parts ginkgo leaf, 1 part acorus and 0.5 parts polygala.

[0039] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0040] Comparative Example 2

[0041] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 2 parts ginseng, 2 parts deer antler glue, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part privet fruit, 1.5 parts notoginseng, and 1.5 parts ginkgo leaf.

[0042] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0043] Comparative Example 3

[0044] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 2 parts ginseng, 2 parts deer antler glue, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part privet fruit, 1 part acorus and 0.5 parts polygala.

[0045] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0046] Comparative Example 4

[0047] A traditional Chinese medicine composition for preventing or treating premature male aging is made from the following raw materials in parts by weight: 2 parts ginseng, 2 parts deer antler glue, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part privet fruit, 1.5 parts notoginseng, 1.5 parts salvia miltiorrhiza, 1 part acorus tatarinowii, and 0.5 parts arborvitae seed.

[0048] A traditional Chinese medicine preparation for preventing or treating premature male aging is made from the above-mentioned traditional Chinese medicine composition; when the traditional Chinese medicine preparation is in powder form, the preparation method is as follows: the above-mentioned medicinal materials are pulverized into fine powder.

[0049] Test case

[0050] Clinical observation experiments were conducted using the formulations of Example 5 and Comparative Examples 1-4 as examples, with Bazibu Shen Capsules used as the positive control group.

[0051] I. Requirements for Subjects 1. Age and gender requirements: Men aged ≥40 years but <60 years (pre-old age) and men aged ≥60 years (old age); 2. Number of participants: 30 people per group, totaling 180 people. There is no significant difference between patients in different groups. 3. Symptom / sign requirements: 2 main symptoms + 3 secondary symptoms + 1 physical sign Main symptoms: soreness or pain in the lower back and knees, fatigue and weakness Concurrent symptoms: frequent urination at night (or dribbling after urination), spontaneous sweating, shortness of breath, tinnitus (or hearing loss), hair loss (or graying), forgetfulness, loose teeth, decreased libido, poor sleep, dizziness; Physical signs: pale (or waxy yellow) complexion, pale and swollen tongue with white coating, and weak pulse; 4. Other requirements: No serious heart, brain, lung, liver, kidney, or endocrine diseases (normal liver and kidney function).

[0052] II. Aging Witness Scoring Method and Therapeutic Effect Evaluation Method Clinical symptoms / signs that are significant (or frequently occurring) are scored as follows: 3 points; symptoms / signs that are intermittent (or mild); 1 point; and 0 points for no symptoms / signs. The sum of all scores for each aging symptom / sign is calculated as the aging witness score for each subject. A difference of ≥10 points in the aging witness score before and after treatment is considered significant; a score between 5 and 9 points is considered effective; a score between 0 and 4 points is considered ineffective; and a negative score is considered a deterioration.

[0053] Effectiveness rate = (Number of people with significant effects + Number of people with effective results) / Total number of people * 100% Side effect incidence rate = (Number of people experiencing side effects / Total number of people) * 100% III. Observation Methods 1. Administration method: Each group of subjects took 7 grams of the drug from Example 5, Comparative Examples 1-4 and the existing Bazibu Shen Capsules, respectively. The drugs in Example 5 and Comparative Examples 1-4 were taken twice a day, and the existing drugs were taken according to the instructions.

[0054] 2. Observation period: 8 weeks. During this period, no other medications will be used except for those urgently needed for treatment. Changes in symptoms / signs will be recorded every 4 weeks during treatment.

[0055] IV. Results Feedback Table 1: Statistical Table of Witness Point Difference Witness points difference ≥ 10 points (per person) Witness points difference of 5-9 points (per person) Witness points difference: 0-4 points (per person) Witness score difference < 0 points (per person) Effectiveness (%) Example 5 8 16 6 0 80.0% Comparative Example 1 2 13 15 0 50.0% Comparative Example 2 4 13 13 0 56.7% Comparative Example 3 4 14 12 0 60.0% Comparative Example 4 3 13 14 0 53.3% Positive drugs 5 15 10 0 66.7% The data in the table above shows that patients who took the composition of Example 5 experienced significant symptom relief with an effectiveness rate of 80%, while patients who used the compositions of Comparative Examples 1-4 experienced weaker symptom relief than those in Example 5. This demonstrates that the composition claimed in this application has good anti-aging and aging-relieving effects.

[0056] Table 2: Statistics on the incidence of side effects Side effects exist (in humans). No side effects were observed (in individuals). Incidence of side effects (%) Side effects Example 5 0 30 0 none Comparative Example 1 1 29 3.3% bloating Comparative Example 2 2 28 6.7% nausea Comparative Example 3 2 28 6.7% dull complexion Comparative Example 4 1 29 3.3% Increased frequency of bowel movements Positive drugs 16 14 53.3% Yellow urine, abdominal distension, loss of appetite, yellow and greasy tongue coating, bad breath, dry mouth and tongue, mouth ulcers, swollen and painful gums, and constipation. As can be seen from the table above, the compositions in Example 5 and Comparative Examples 1-4 generally do not produce adverse side effects, and long-term use by patients will not induce other symptoms. However, after long-term use of the positive drug, patients are prone to symptoms such as yellow urine, abdominal distension, loss of appetite, yellow and greasy tongue coating, halitosis, dry mouth and tongue, oral ulcers, swollen and painful gums, and constipation, which proves that the drug in this application can be taken for a long time.

[0057] The composition in Comparative Example 1 was compared with the composition in Example 5. In Comparative Example 1, deer antler glue was replaced with deer antler powder and privet fruit was replaced with mulberry. Although the effects of the medicinal materials before and after the replacement were similar, the anti-aging effect of the composition after the replacement was significantly different. It is speculated that the interaction between the compositions was disrupted after the replacement, and the synergistic effect disappeared, resulting in a weakening of the overall kidney-tonifying and essence-replenishing, and yin-yang balancing power of the formula. This was manifested in a weaker improvement in the main symptom: soreness and weakness (or pain) of the waist and knees. At the same time, the improvement in the secondary symptoms: frequent urination at night (or dribbling after urination), tinnitus (or deafness), hair loss (or graying), loose teeth, and decreased libido was also weakened.

[0058] The compositions in Comparative Examples 2 and 3 were compared with the composition in Example 5. In Comparative Example 2, the use of Acorus tatarinowii and Polygala tenuifolia was omitted. The results showed that after omitting the medicinal materials, the improvement of symptoms such as mental fatigue, weakness, insomnia, and forgetfulness in patients was not significant. In Comparative Example 3, the use of Panax notoginseng and Ginkgo biloba was omitted. The results showed that the improvement of symptoms such as sallow complexion, pale complexion, dark lips, and dizziness was not significant. It is speculated that after omitting the use of the medicinal materials, the effects of the medicinal materials themselves disappeared, and the interaction between them and other medicinal materials also disappeared, affecting the overall effect of the composition.

[0059] The composition in Comparative Example 4 was compared with the composition in Example 5. In Comparative Example 4, Ginkgo biloba was replaced with Salvia miltiorrhiza and Polygala tenuifolia was replaced with Platycladus orientalis seed. Although the effects of the medicinal materials before and after the replacement were similar, the overall blood-activating and stasis-removing and heart-kidney-harmonizing effects of the composition were weakened after the replacement. As a result, the improvement effect on forgetfulness and poor sleep was not obvious. It is speculated that the interaction between the compositions was destroyed after the replacement, and the synergistic effect disappeared.

Claims

1. A traditional Chinese medicine composition for preventing or treating premature male aging, characterized in that, It is composed of the following raw materials in parts by weight: ginseng 0.5-4 parts, deer antler glue 0.5-4 parts, epimedium 0.1-3 parts, wolfberry 0.5-3 parts, astragalus 0.5-4 parts, privet fruit 0.5-3 parts, notoginseng 0.5-3 parts, ginkgo leaf 0.5-3 parts, acorus tatarinowii 0.5-2 parts, and polygala tenuifolia 0.1-1.5 parts.

2. The traditional Chinese medicine composition for preventing or treating premature male aging as described in claim 1, characterized in that, It is composed of the following raw materials in parts by weight: ginseng 1-3 parts, deer antler glue 1-3 parts, epimedium 0.5-2 parts, wolfberry 1-2 parts, astragalus 1.5-2.5 parts, privet fruit 0.5-1.5 parts, notoginseng 1-2 parts, ginkgo leaf 1-2 parts, acorus tatarinowii 0.5-1.5 parts, and polygala tenuifolia 0.2-1 parts.

3. The traditional Chinese medicine composition for preventing or treating premature male aging as described in claim 1, characterized in that, It is composed of the following raw materials in parts by weight: 2 parts ginseng, 2 parts deer antler glue, 1 part epimedium, 1.5 parts wolfberry, 2 parts astragalus, 1 part privet fruit, 1.5 parts notoginseng, 1.5 parts ginkgo leaf, 1 part acorus and 0.5 parts polygala.

4. The traditional Chinese medicine composition for preventing or treating premature male aging as described in any one of claims 1-3, characterized in that, The Epimedium mentioned is roasted Epimedium.

5. The traditional Chinese medicine composition for preventing or treating premature male aging as described in any one of claims 1-3, characterized in that, The privet mentioned is the wine privet.

6. The traditional Chinese medicine composition for preventing or treating premature male aging as described in any one of claims 1-3, characterized in that, The Yuanzhi mentioned is processed Yuanzhi.

7. A traditional Chinese medicine preparation for the prevention or treatment of premature male aging, characterized in that, Made from the traditional Chinese medicine composition according to any one of claims 1-6.

8. The traditional Chinese medicine preparation for preventing or treating premature male aging as described in claim 7, characterized in that, The traditional Chinese medicine preparations include powders, pills, granules, capsules, tablets, ointments, medicated wines, or mixtures.

9. The method for preparing the traditional Chinese medicine preparation for preventing or treating premature male aging as described in claim 8, characterized in that, Includes the following steps: The above composition is extracted with a solvent, concentrated, dried, and then excipients are added to prepare the corresponding dosage form; or the above composition is directly pulverized into a fine powder to prepare the corresponding dosage form.

10. Use of the composition of any one of claims 1-6 in the preparation of a medicament for the prevention or treatment of premature male aging.