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

Abstract

The application discloses a traditional Chinese medicine composition for treating or preventing female premature aging, a traditional Chinese medicine preparation and a preparation method and application thereof. The composition comprises the following raw materials in parts by weight: 10-20 parts of ginseng, 10-20 parts of radix notoginseng, 10-20 parts of radix polygoni multiflori, 10-20 parts of angelica sinensis, 2-10 parts of herba epimedii, 10-20 parts of semen ecliptae, 10-20 parts of medlar, 10-20 parts of polygonatum, 10-20 parts of acanthopanax, and 10-20 parts of hypericum perforatum. The traditional Chinese medicine composition has a good anti-aging effect, can delay the premature aging and aging symptoms of female patients, and can be taken for a long time.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to a traditional Chinese medicine composition, traditional Chinese medicine preparation, preparation method and application for treating or preventing premature aging in women. 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 women, it can also manifest as premature ovarian failure.

[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] After women enter menopause, as ovarian function gradually declines and estrogen levels drop, symptoms such as decreased libido, memory loss, sleep disorders, mood changes, skin aging, and osteoporosis may occur. Due to increased work and life stress, many women experience premature aging symptoms. In order to prevent premature aging or delay normal aging, many tonic products have appeared on the market, which achieve therapeutic purposes by adding tonic ingredients. However, the use of tonic ingredients can also lead to the problem of excessive supplementation and excessive internal heat, which not only fails to achieve the therapeutic purpose but may also induce other diseases. 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 treating or preventing premature aging in women. The traditional Chinese medicine composition has a good anti-aging effect, can delay premature aging and aging symptoms in female 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 treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 10-20 parts ginseng, 10-20 parts Panax notoginseng, 10-20 parts Polygonum multiflorum, 10-20 parts Angelica sinensis, 2-10 parts Epimedium, 10-20 parts Cuscuta chinensis, 10-20 parts Lycium barbarum, 10-20 parts Polygonatum sibiricum, 10-20 parts Acanthopanax senticosus, and 10-20 parts Hypericum perforatum.

[0007] Furthermore, it includes the following raw materials in parts by weight: 14-17 parts ginseng, 14-17 parts Panax notoginseng, 14-17 parts Polygonum multiflorum, 14-17 parts Angelica sinensis, 4-7 parts Epimedium, 14-17 parts Cuscuta chinensis, 14-17 parts Lycium barbarum, 14-17 parts Polygonatum sibiricum, 14-17 parts Acanthopanax senticosus, and 14-17 parts Hypericum perforatum.

[0008] Furthermore, the ingredients include the following parts by weight: 15 parts ginseng, 15 parts Panax notoginseng, 15 parts Polygonum multiflorum, 15 parts Angelica sinensis, 5 parts Epimedium, 15 parts Cuscuta chinensis, 15 parts Lycium barbarum, 15 parts Polygonatum sibiricum, 15 parts Acanthopanax senticosus, and 15 parts Hypericum perforatum.

[0009] Furthermore, Polygonum multiflorum is processed Polygonum multiflorum, and Polygonatum sibiricum is processed Polygonatum sibiricum.

[0010] Furthermore, Epimedium is prepared as roasted Epimedium.

[0011] Furthermore, dodder seed is salt-treated dodder seed.

[0012] A traditional Chinese medicine preparation for treating or preventing premature aging in women, comprising 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] The preparation method of the above-mentioned traditional Chinese medicine preparation for treating or preventing premature aging in women includes the following steps: combining the above-mentioned ingredients... The substance 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.

[0015] The use of the above composition in the preparation of a medicament for treating or preventing premature aging in women.

[0016] The beneficial effects of this invention are as follows: In this invention, Epimedium is pungent and sweet, warm in nature, and enters the kidney and liver meridians, having the effect of tonifying kidney yang; Cuscuta is pungent and neutral, and enters the liver, kidney, and spleen meridians, having the effect of tonifying the liver and kidneys; the two herbs combined can harmonize liver yin, tonify kidney yang, and benefit essence and qi; processed Polygonum multiflorum is sweet, bitter, and astringent, slightly warm, and enters the liver and kidney meridians, having the effect of tonifying the liver and kidneys and benefiting essence and blood; Lycium barbarum is sweet and neutral, and enters the liver, kidney, and lung meridians, having the effect of tonifying the liver and nourishing the kidneys, and has a good tonifying effect on liver and kidney yin deficiency; the two herbs combined can benefit essence and blood; the above four herbs together serve as the principal herbs, exerting the effects of nourishing liver yin, tonifying kidney yang, and benefiting essence and qi; St. John's wort is pungent and cold in nature, and enters the liver meridian. It can regulate liver qi, relieve depression and calm the mind, and clear heat and promote diuresis. Acanthopanax senticosus is pungent, slightly bitter, and warm in nature, and enters the spleen, kidney, and heart meridians. It can invigorate qi and strengthen the spleen, and nourish the kidney and calm the mind. Polygonatum is sweet and neutral in nature, and enters the spleen, lung, and kidney meridians. It can nourish yin and moisten the lungs. The three herbs work together as assistant herbs to regulate liver qi, invigorate spleen qi, and nourish yin. Angelica sinensis is sweet and warm in nature, and has the effects of nourishing blood, promoting blood circulation, regulating menstruation and relieving pain. Panax notoginseng is sweet, slightly bitter and warm in nature, and enters the liver and stomach meridians. It has the effects of nourishing blood, promoting blood circulation and stopping bleeding. The two are used as adjuvant drugs to promote blood biochemistry, promote blood circulation in the body and improve the effect of drugs. Ginseng has a sweet and bitter taste, is slightly warm in nature, and enters the lung, spleen, heart, and kidney meridians. It has the effects of tonifying the five internal organs, calming the mind, and eliminating pathogenic factors. As an adjuvant, it enhances the tonifying effect of the principal herb. Besides tonifying the kidneys, the key to delaying aging for women lies in nourishing the liver and blood. This application focuses on delaying aging in women. By combining the above-mentioned drugs, it can strengthen the body's foundation, nourish the liver and kidneys, and regulate menstruation and blood, thereby replenishing women's essence, blood, qi, and spirit to achieve the effect of delaying aging. Detailed Implementation

[0017] 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.

[0018] 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.

[0019] 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.

[0020] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0021] Example 1

[0022] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 10 parts ginseng, 20 parts Panax notoginseng, 10 parts processed Polygonum multiflorum, 10 parts Angelica sinensis, 2 parts processed Epimedium, 20 parts salted Cuscuta chinensis, 20 parts wolfberry, 10 parts processed Polygonatum sibiricum, 20 parts Acanthopanax senticosus, and 10 parts Hypericum perforatum.

[0023] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0024] Example 2

[0025] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 20 parts ginseng, 10 parts Panax notoginseng, 20 parts processed Polygonum multiflorum, 20 parts Angelica sinensis, 10 parts processed Epimedium, 10 parts salted Cuscuta chinensis, 10 parts wolfberry, 20 parts processed Polygonatum sibiricum, 10 parts Acanthopanax senticosus, and 20 parts Hypericum perforatum.

[0026] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0027] Example 3

[0028] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 14 parts ginseng, 14 parts Panax notoginseng, 14 parts processed Polygonum multiflorum, 17 parts Angelica sinensis, 4 parts processed Epimedium, 17 parts salted Cuscuta chinensis, 17 parts wolfberry, 17 parts processed Polygonatum sibiricum, 14 parts Acanthopanax senticosus and 14 parts Hypericum perforatum.

[0029] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0030] Example 4

[0031] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 17 parts ginseng, 17 parts Panax notoginseng, 17 parts processed Polygonum multiflorum, 14 parts Angelica sinensis, 7 parts processed Epimedium, 14 parts salted Cuscuta chinensis, 14 parts wolfberry, 14 parts processed Polygonatum sibiricum, 17 parts Acanthopanax senticosus and 17 parts Hypericum perforatum.

[0032] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0033] Example 5

[0034] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 15 parts ginseng, 15 parts Panax notoginseng, 15 parts processed Polygonum multiflorum, 15 parts Angelica sinensis, 5 parts processed Epimedium, 15 parts salted Cuscuta chinensis, 15 parts wolfberry, 15 parts processed Polygonatum sibiricum, 15 parts Acanthopanax senticosus, and 15 parts Hypericum perforatum.

[0035] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0036] Comparative Example 1

[0037] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 15 parts ginseng, 15 parts Panax notoginseng, 15 parts Rehmannia glutinosa, 15 parts Angelica sinensis, 5 parts Epimedium brevicornu, 15 parts Eucommia ulmoides, 15 parts Lycium barbarum, 15 parts Polygonatum sibiricum, 15 parts Acanthopanax senticosus, and 15 parts Hypericum perforatum.

[0038] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0039] Comparative Example 2

[0040] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 15 parts ginseng, 15 parts Panax notoginseng, 15 parts Polygonum multiflorum, 15 parts Angelica sinensis, 5 parts Epimedium, 15 parts Cuscuta chinensis, 15 parts Lycium barbarum, and 15 parts Polygonatum sibiricum.

[0041] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0042] Comparative Example 3

[0043] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 15 parts Astragalus membranaceus, 15 parts Panax notoginseng, 15 parts Polygonum multiflorum, 15 parts Angelica sinensis, 5 parts Epimedium, 15 parts Cuscuta chinensis, 15 parts Lycium barbarum, 15 parts Dioscorea opposita, 15 parts Acanthopanax senticosus, and 15 parts Hypericum perforatum.

[0044] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0045] Comparative Example 4

[0046] A traditional Chinese medicine composition for treating or preventing premature aging in women, comprising the following raw materials in parts by weight: 15 parts ginseng, 15 parts prepared Polygonum multiflorum, 5 parts prepared Epimedium, 15 parts salted Cuscuta chinensis, 15 parts wolfberry, 15 parts prepared Polygonatum sibiricum, 15 parts Acanthopanax senticosus and 15 parts St. John's wort.

[0047] A traditional Chinese medicine preparation for treating or preventing premature aging in women 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.

[0048] Test case

[0049] Clinical observation experiments were conducted using the formulations of Example 5 and Comparative Examples 1-4 as examples, with Qibao Meiran Pills used as the positive control group.

[0050] I. Requirements for Subjects 1. Age and gender requirements: Women aged ≥40 years but <60 years (pre-old age) and women 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, scanty menstruation (or amenorrhea), depression, poor sleep, dizziness; Physical signs: sallow complexion (or pale), 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).

[0051] 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.

[0052] 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 in Example 5, Comparative Examples 1-4 and the existing Qibao Meiran Pill, 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.

[0053] 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.

[0054] 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.

[0055] 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 2 28 6.7% bloating Comparative Example 2 2 28 6.7% Irritability and anger Comparative Example 3 3 27 10% High blood pressure Comparative Example 4 2 28 6.7% dull complexion Positive drugs 15 16 50% Skin rash, loss of appetite, aversion to oily foods, nausea, dark urine, abdominal pain, diarrhea As can be seen from the table above, the compositions in Example 5 and Comparative Examples 1-4 do not produce any adverse side effects, and patients will not experience other symptoms after long-term use. However, after long-term use of the positive drug, patients are prone to symptoms such as rash, loss of appetite, aversion to oily foods, nausea, yellow urine, abdominal pain, and diarrhea, proving that the drug in this application can be taken for a long time.

[0056] The compositions in Comparative Examples 1 and 3 were compared with the composition in Example 5. In Comparative Example 1, Cuscuta chinensis was replaced with Eucommia ulmoides and Polygonum multiflorum was replaced with Rehmannia glutinosa. Although the effects of the medicinal materials before and after the replacement were similar, the composition after the replacement had a poorer effect in tonifying the liver and kidneys and nourishing blood. After the replacement, the overall strength of the formula in tonifying the kidneys and replenishing essence and balancing Yin and Yang was weakened, which was reflected in a weaker effect on improving symptoms such as soreness and weakness of the waist and knees, frequent urination at night, tinnitus, hair loss, and loose teeth. In Comparative Example 3, ginseng was replaced with astragalus and polygonatum was replaced with yam. Although the effects of the herbs before and after the replacement were similar, the combination after the replacement had a poorer effect in replenishing qi and nourishing blood. This was manifested in a weaker effect in improving symptoms such as soreness and weakness of the waist and knees, fatigue, shortness of breath, dizziness, and sallow complexion. Based on the results of Comparative Examples 1 and 3, it is speculated that the interaction between the components was disrupted after the replacement, and the synergistic effect between the drugs disappeared.

[0057] The compositions in Comparative Examples 2 and 4 were compared with the composition in Example 5. In Comparative Example 2, the use of Acanthopanax senticosus and Hypericum perforatum was omitted, resulting in a reduced therapeutic effect on symptoms such as fatigue, poor sleep, and mood improvement. In Comparative Example 4, the use of Panax notoginseng and Angelica sinensis was omitted, resulting in patients experiencing a sallow complexion, pale lips, hair loss, and dizziness. The reduced effectiveness in relieving symptoms such as scanty menstruation, combined with the results of comparative examples 2 and 4, suggests that the elimination of the medicinal materials may have caused the individual effects of the materials to disappear, as well as the interactions between the materials, thus affecting the overall effect of the composition.

Claims

1. A traditional Chinese medicine composition for treating or preventing premature aging in women, characterized in that, It is composed of the following ingredients in parts by weight: ginseng 10-20 parts, Panax notoginseng 10-20 parts, Polygonum multiflorum 10-20 parts, Angelica sinensis 10-20 parts, Epimedium 2-10 parts, Cuscuta chinensis 10-20 parts, Lycium barbarum 10-20 parts, Polygonatum sibiricum 10-20 parts, Acanthopanax senticosus 10-20 parts, and Hypericum perforatum 10-20 parts.

2. The traditional Chinese medicine composition for treating or preventing premature aging in women as described in claim 1, characterized in that, It is composed of the following ingredients in parts by weight: ginseng 14-17 parts, Panax notoginseng 14-17 parts, Polygonum multiflorum 14-17 parts, Angelica sinensis 14-17 parts, Epimedium 4-7 parts, Cuscuta chinensis 14-17 parts, Lycium barbarum 14-17 parts, Polygonatum sibiricum 14-17 parts, Acanthopanax senticosus 14-17 parts, and Hypericum perforatum 14-17 parts.

3. The traditional Chinese medicine composition for treating or preventing premature aging in women as described in claim 1, characterized in that, It is composed of the following ingredients in parts by weight: 15 parts ginseng, 15 parts notoginseng, 15 parts he shou wu, 15 parts angelica, 5 parts epimedium, 15 parts dodder seed, 15 parts wolfberry, 15 parts polygonatum, 15 parts eleutherococcus senticosus and 15 parts hypericum perforatum.

4. The traditional Chinese medicine composition for treating or preventing premature aging in women as described in claim 1, characterized in that, The Polygonum multiflorum mentioned is processed Polygonum multiflorum, and the Polygonatum sibiricum mentioned is processed Polygonatum sibiricum.

5. The traditional Chinese medicine composition for treating or preventing premature aging in women as described in claim 1, characterized in that, The Epimedium mentioned is roasted Epimedium.

6. The traditional Chinese medicine composition for treating or preventing premature aging in women as described in claim 1, characterized in that, The dodder seed mentioned is salt-treated dodder seed.

7. A traditional Chinese medicine preparation for treating or preventing premature aging in women, characterized in that, The traditional Chinese medicine composition included in any one of claims 1-6.

8. The traditional Chinese medicine preparation for treating or preventing premature aging in women 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 treating or preventing premature aging in women according to claim 7, 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 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 treating or preventing premature aging in women.