A traditional Chinese medicine composition for improving male sexual function and a preparation method and use thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with the function of improving male sexual function, and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw medicinal materials: centipede, angelica, fried white peony root, chuanxiong, cyperus rotundus, bupleurum, honey ephedra, notopterygium, baishu, cassia twig, cypress seed, epimedium, and western ginseng. The traditional Chinese medicine composition has the functions of soothing liver stagnation and promoting yang and erection. Experimental results show that the traditional Chinese medicine composition has a significant improvement effect on the erectile dysfunction of vascular ED model rats, and the levels of NO and ET-1 are also improved. The improvement effect of the traditional Chinese medicine composition on the above indexes is close to that of tadalafil, and is obviously superior to that of Yishenling granules which is a commonly used medicine for improving male sexual function. Therefore, the traditional Chinese medicine composition is particularly suitable for being prepared into a medicine for improving male sexual function, and has a wide clinical application prospect and commercial value.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with the function of improving male sexual function, and a preparation method and use thereof. BACKGROUND

[0002] Male sexual dysfunction is a relatively serious andrology disease, and the patient is insufficient in sexual function and sexual satisfaction, and the specific manifestations are sexual desire disorder, impotence, premature ejaculation, spermatorrhea, non-ejaculation and retrograde ejaculation and the like. Sexual function is a physiological process caused by the synergistic action of nervous system, endocrine system, sex organ and the like, and the organic lesion of reproductive system disease and systemic disease, and any link disorder can be considered as performance disorder. This disease can affect the normal life of the patient, and even the mental health. Therefore, it is extremely important to study and explore the risk factors of male sexual dysfunction, and then take corresponding effective treatment measures to improve the quality of life of the patient.

[0003] At present, many hospitals and scientific research institutions at home and abroad are actively researching the drugs for treating this kind of disease. For example, orally taken sildenafil tablets and externally used prostaglandin E cream have certain clinical effects, but the former has contraindications for patients with cardiovascular diseases, especially for patients taking vasodilator drugs, and the latter has considerable patients with penile swelling pain, urethral pain and urethral burning sensation. The side effects of sex hormones and adrenotrophic hormones are easy to cause hypercalcemia, water and sodium retention, allergy, male breast development and the like.

[0004] For example, Chinese patent application CN118806844A discloses a traditional Chinese medicine composition for treating impotence, comprising the following raw materials in parts by weight: 5-10 parts of Heishun Pian, 5-15 parts of Actinolite, 5-15 parts of Raw Cinnamon Twig, 5-10 parts of Epimedium, 5-15 parts of Cuscuta Seed, 5-15 parts of Lycium Barbarum Fruit, 9-15 parts of Rehmannia Glutinosa, 5-15 parts of Cuscuta Seed, 6-15 parts of Cornus Officinalis, 5-15 parts of Morus Altissima, 3-9 parts of Caryophyllus Caryophyllus, 10-30 parts of Dioscorea Opposita, 10-20 parts of Poria, 5-15 parts of Tangerine Peel, 3-10 parts of Alisma Orientalis, 3-9 parts of Processed Polygala Tenuifolia, 5-15 parts of Ziziphus Ziziphi Spinosae Semen, and 1-5 parts of Scolopendra. The whole composition has the effects of warming the kidney and strengthening yang, replenishing kidney essence, soothing the liver, strengthening the spleen, and calming the mind. Chinese patent application CN117159676A discloses a Chinese medicine composition for treating premature ejaculation and impotence and its preparation method and application, wherein its raw material comprises 5-20 parts of Radix Bupleuri, 5-15 parts of Radix Scutellariae, 5-15 parts of Ramulus Cinnamomi, 5-15 parts of Rhizoma Zingiberis, 5-20 parts of Rhizoma Pinelliae, 5-15 parts of Fructus Aurantii Immaturus, 5-30 parts of Pericarpium Citri Reticulatae, 10-30 parts of Poriae, 5-15 parts of Rhizoma Acorus Graminei, 5-15 parts of Radix Polygalae, 10-40 parts of Concha Ostreae and 3-15 parts of Radix Glycyrrhizae by weight.This Chinese medicine composition can be used for treating liver depression and spleen deficiency phlegm-damp type premature ejaculation and erectile dysfunction, and the mixture, granule etc. prepared are easy to carry, convenient to take.But the medicine with the effect of improving male sexual function sold in the market generally exists prescription composition unscientific, medication cost is high, administration mode is unreasonable, therapeutic effect is not obvious and other drawbacks.

[0005] In view of this, in order to meet the needs of clinical treatment, the inventors have developed a Chinese medicine composition with good efficacy, no toxic side effects, easily available raw materials and low cost, which has the effect of improving male sexual function. Summary of the Invention

[0006] The purpose of the present invention is to overcome the deficiencies in the prior art and provide a Chinese medicine composition having the effect of improving male sexual function, as well as a preparation method and use thereof.

[0007] Specifically, the present invention is achieved through the following technical solutions:

[0008] In the first aspect, the present invention provides a traditional Chinese medicine composition having the effect of improving male sexual function, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-10 parts of centipede, 10-40 parts of angelica, 5-30 parts of stir-fried white peony root, 5-30 parts of chuanxiong, 5-30 parts of cyperus rotundus, 1-20 parts of bupleurum, 1-10 parts of honey ephedra, 5-30 parts of notopterygium wilfordii, 1-10 parts of angelica dahurica, 1-10 parts of cassia twig, 15-50 parts of cypress seed, 5-30 parts of epimedium, and 1-20 parts of American ginseng.

[0009] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 1-5 parts of centipede, 15-30 parts of angelica, 10-20 parts of stir-fried white peony root, 10-20 parts of Chuanxiong, 10-20 parts of Cyperus rotundus, 5-15 parts of bupleurum, 1-5 parts of honey ephedra, 10-20 parts of Notopterygium wilfordii, 5-10 parts of Angelica dahurica, 5-10 parts of cinnamon twig, 20-40 parts of cypress seed, 10-20 parts of epimedium, and 5-15 parts of American ginseng.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 4 parts of centipede, 20 parts of angelica, 15 parts of stir-fried white peony root, 15 parts of chuanxiong, 15 parts of cyperus rotundus, 10 parts of bupleurum, 3 parts of honey ephedra, 15 parts of notopterygium, 6 parts of angelica dahurica, 6 parts of cassia twig, 30 parts of cypress seed, 15 parts of epimedium, and 10 parts of American ginseng.

[0011] As an optional mode, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of soothing the liver and relieving depression, and invigorating yang and relieving atrophy.

[0012] In the second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect, which comprises the following steps: crushing centipede, angelica, stir-fried white peony root, chuanxiong, cyperus rotundus, bupleurum, honeyed ephedra, notopterygium wilfordii, angelica dahurica, cassia twig, cypress seed, epimedium, and American ginseng, boiling them with water, mixing the filtrate, and concentrating to obtain a concentrated solution.

[0013] As an optional method, in the above preparation method, the decoction is performed twice, the first decoction is performed for 1-3 hours and then filtered to obtain a primary filtrate, the filter residue is then decocted with water for 1-3 hours and filtered to obtain a secondary filtrate, and the primary filtrate and the secondary filtrate are combined.

[0014] As an optional manner, in the above preparation method, the material-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 2 hours, and the water used in the first decoction and the second decoction is distilled water.

[0015] Preferably, the concentration is concentration under reduced pressure.

[0016] In a third aspect, the present invention provides use of the Chinese medicine composition described in the first aspect or the Chinese medicine composition prepared by the preparation method described in the second aspect in preparing a medicament for improving male sexual function.

[0017] As an optional mode, in the above-mentioned use, the effect of improving male sexual function is to improve male sexual desire loss and improve male sexual dysfunction.

[0018] Preferably, the male sexual dysfunction includes loss of libido, impotence, premature ejaculation, spermatorrhea, anejaculation or retrograde ejaculation.

[0019] As an optional mode, in the above use, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] (1) The Chinese medicine composition of the present invention has the effects of soothing the liver and relieving depression, and promoting yang and relieving impotence. The Chinese medicine composition of the present invention is particularly suitable for preparing a medicine for improving male sexual function, and has broad clinical application prospects and commercial value.

[0022] (2) The experimental results show that the Chinese herbal composition of the present invention has a significant improvement effect on erectile dysfunction in vascular ED model rats. The Chinese herbal composition of the present invention also has a significant improvement effect on the NO level and ET-1 level in vascular ED model rats. The improvement effect of the Chinese herbal composition of the present invention on the above indicators is close to that of tadalafil, and is significantly better than Yishenling Granules commonly used in clinical practice for the treatment of impotence.

[0023] (3) The Chinese medicine composition of the present invention is based on the traditional Chinese medicine formula, uses modern preparation technology and is deeply optimized. The preparation method is simple and the Chinese medicine composition of the present invention can be made into various dosage forms such as granules, tablets, oral liquids or capsules. DETAILED DESCRIPTION

[0024] The Chinese medicine composition of the present invention has the effects of soothing the liver and relieving depression, invigorating yang and relieving impotence. The Chinese medicine composition of the present invention is particularly suitable for preparing medicine for improving male sexual function.

[0025] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0026] Centipede refers to the entire species of Scolopendra subspinipes multilans L. Koch., a member of the Scolopendae family. It is warm in nature and pungent in taste. It enters the Liver Meridian. It calms wind and spasms, eliminates toxins and resolves stagnation, and relieves pain. It belongs to the category of wind-calming and antispasmodic drugs, which are used to treat infantile convulsions, convulsions and spasms, facial paralysis caused by stroke, hemiplegia, tetanus, stubborn rheumatic arthritis, sores, scrofula, and snake bites.

[0027] Angelica sinensis (Danggui) is the root of the Apiaceae plant Angelica sinensis (Oliv.) Diels. It is warm in nature, sweet and pungent in flavor. It enters the Liver, Heart, and Spleen meridians. It nourishes blood, promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It is a blood-tonifying herb, a subcategory of tonics. It is used to treat sallow complexion due to blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to cold deficiency, constipation due to dry intestines, rheumatic pain, injuries from falls, and carbuncles and ulcers.

[0028] White peony root is the root of Paeonia lactiflora Pall., a plant of the Ranunculaceae family. It has a bitter and sour taste and a slightly cold nature. It enters the liver and spleen meridians. It nourishes blood and restrains yin, softens the liver and relieves pain, and calms liver yang. It is primarily used to treat liver blood deficiency, menstrual irregularities, liver-spleen disharmony, chest, flank, and abdominal pain, cramps and pain in the limbs, hyperactivity of liver yang, and headaches and dizziness.

[0029] Chuanxiong (Chuanxiong) is the rhizome of the plant Ligusticum chuam.iong Hort., part of the Apiaceae family. It is warm in nature and pungent in flavor. It enters the Liver, Gallbladder, and Pericardium meridians. It promotes blood circulation and qi, dispels wind and relieves pain. It belongs to the blood-activating and analgesic category of blood-activating and stasis-removing drugs. It is used to treat chest pain, heart pain, stabbing pain in the chest and ribs, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to urinary tract infections, headaches, and rheumatic pain.

[0030] Cyperus rotundus L. is a rhizome of the Cyperus rotundus L. plant of the Cyperaceae family. It is neutral in nature, with a pungent and bitter taste. It enters the Liver and Spleen meridians. It promotes blood circulation, promotes qi circulation, and relieves pain. It belongs to the blood-activating and stasis-removing category, a type of herbal remedy. It is used to treat lumps and masses, amenorrhea due to blood stasis, bloating and pain caused by food stagnation, abdominal pain, dysmenorrhea, and traumatic injuries.

[0031] Bupleurum (Bupleurum chinense) is the root of Bupleurum scorzonerifolium Willd. (commonly known as "Southern Bupleurum") or Bupleurum chinense DC. (commonly known as "Northern Bupleurum"), both plants of the Umbelliferae family. It is slightly cold in nature and bitter in taste. It enters the Liver, Gallbladder, and Lung meridians. It harmonizes the exterior and interior, soothes the liver, and elevates yang. It belongs to the category of pungent and cool antipyretics, a subcategory of antipyretics. It is used to treat colds, fever, alternating chills and fever, chest and flank pain, menstrual irregularities, uterine prolapse, and rectal prolapse.

[0032] Ephedra is the herbaceous stem of Ephedra equisetina Bge., a plant of the Ephedraceae family. It is warm in nature, pungent, and slightly bitter in flavor. It enters the Lung and Bladder meridians. It induces diaphoresis, dispels cold, clears the lungs and relieves asthma, and promotes diuresis and reduces swelling. It belongs to the category of pungent-warm antipyretic drugs, a subcategory of antipyretic drugs. It is used to treat colds caused by wind and cold, chest tightness, wheezing and coughing, edema caused by wind and water retention, and bronchial asthma. It is often used to relieve superficial symptoms and treat asthma and cough.

[0033] Qianghuo (Notopterygium incisum Ting ex HTChang) or Notopterygium franchetii H. de Boiss. (Umbelliferae) is a plant of the family Apiaceae. It is warm in nature, pungent and bitter in flavor. It enters the bladder and kidney meridians. It dispels cold, expels wind and dampness, and relieves pain. It belongs to the pungent-warm antipyretic drug category, a subcategory of antipyretic drugs. It is used to treat colds, headaches, stiff necks, rheumatic pain, and shoulder and back pain.

[0034] Angelica dahurica (Angelica dahurica) is the root of the Apiaceae family, Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. var. formosana (Boiss.) Shan et Yuan. It is warm in nature and pungent in taste. It enters the Stomach, Large Intestine, and Lung meridians. It dispels wind and dampness, relieves pain, and reduces swelling and pus. It belongs to the pungent-warm antipyretic category of antipyretic drugs. It is used to treat colds, headaches, brow pain, nasal congestion, sinusitis, toothache, leucorrhea, and sores. It has excellent analgesic properties, especially for headaches, and also has detoxifying and anti-inflammatory properties. Recently, it has been found to dilate coronary arteries, making it a potential treatment for coronary heart disease.

[0035] Guizhi (Guizhi) is a twig from the cinnamon bark of the Lauraceae family. It has a pungent, sweet, and warm nature. It enters the bladder, heart, and lung meridians. It has the effects of dispelling wind and relieving muscles, warming the meridians and unblocking blood vessels, invigorating yang and transforming qi, and balancing and descending qi. It is a pungent and warm herb for diaphoresis. It is used to treat colds, abdominal pain due to cold blood, amenorrhea, joint pain, phlegm and fluid retention, edema, palpitations, and thrush.

[0036] "Pine Nuts" are the seeds of Platycladus orientails (L.) Franco, a plant of the Cupressaceae family. They are mild in nature and sweet in taste. They enter the Heart, Kidney, and Large Intestine meridians. They nourish the heart and calm the mind, stop sweating, and moisten the intestines. They belong to the category of tranquilizers, a type of heart-nourishing and tranquilizing medicine. They are used to treat insomnia due to deficiency, palpitations, night sweats due to yin deficiency, and constipation due to dry intestines.

[0037] Epimedium (Epimedium brevicornu Max-Im.), Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium pubescens Maxim., or Epimedium koreanum Nakai (Epimedium koreanum Nakai), all members of the Berberidaceae family. It is warm in nature, with a pungent and sweet taste. It enters the liver and kidney meridians. It tonifies kidney yang, strengthens the bones and muscles, and dispels rheumatism. It belongs to the yang-tonifying category of tonics. It is used to treat impotence, spermatorrhea, muscle and bone weakness, rheumatic pain, numbness and cramps, and menopausal hypertension.

[0038] American ginseng is the root of Panax quinquefolium L., a plant of the Araliaceae family. It has a cool nature, sweet and slightly bitter flavor, and enters the Heart, Lung, and Kidney meridians. It replenishes Qi and nourishes Yin, clears heat and promotes fluid production. It is classified as a Qi-tonifying herb under the category of tonics. It is used for Qi and Yin deficiency, internal heat, cough and asthma, blood in sputum, deficiency-heat fatigue, thirst, and dry mouth and throat. For intestinal redness, steamed longan with American ginseng is recommended. It also has anti-fatigue, hypoxia, shock, anti-tumor, and antiviral effects.

[0039] The centipede, angelica, Chuanxiong, stir-fried white peony root, Cyperus rotundus, and Bupleurum in the formula soothe the liver and relieve depression; Notopterygium wilfordii, Angelica dahurica, cinnamon twig, and honeyed ephedra invigorate yang; Platycladus orientalis nourishes the heart and calms the mind; Epimedium invigorates yang, and when combined with centipede, invigorates yang and relieves impotence; American ginseng invigorates qi and produces body fluid, preventing the pungent and dry ingredients from damaging yin.

[0040] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to illustrate the present invention and are not intended to limit the scope of the present invention.

[0041] If no specific techniques or conditions are specified in the examples, the experiments were carried out according to the techniques or conditions described in the literature in the field or according to the product instructions. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0042] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0043] Preparation Example:

[0044] Example 1:

[0045] A traditional Chinese medicine composition having the effect of improving male sexual function is prepared from the following raw materials: 4g of centipede, 20g of angelica, 15g of stir-fried white peony root, 15g of chuanxiong, 15g of cyperus rotundus, 10g of bupleurum, 3g of honeyed ephedra, 15g of notopterygium wilfordii, 6g of angelica dahurica, 6g of cassia twig, 30g of cypress seed, 15g of epimedium, and 10g of American ginseng.

[0046] The preparation method of the traditional Chinese medicine composition comprises the following steps: crushing centipede, angelica, stir-fried white peony root, chuanxiong, cyperus rotundus, bupleurum, honey ephedra, notopterygium wilfordii, angelica dahurica, cassia twig, cypress seed, epimedium, and American ginseng, adding water for decocting twice, wherein the material-liquid ratio of the first decoction and the second decoction are both 1:4, the decoction time of the first decoction and the second decoction are both 2 hours, the water used for the first decoction and the second decoction is distilled water, and after decoction, the filtrates are mixed and concentrated under reduced pressure to obtain 80 mL of concentrated solution.

[0047] Example 2:

[0048] A traditional Chinese medicine composition having the effect of improving male sexual function is prepared from the following raw materials: 6g of centipede, 20g of angelica, 15g of stir-fried white peony root, 15g of chuanxiong, 15g of cyperus rotundus, 15g of bupleurum, 3g of honeyed ephedra, 15g of notopterygium wilfordii, 6g of angelica dahurica, 6g of cassia twig, 28g of cypress seed, 10g of epimedium, and 10g of American ginseng.

[0049] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0050] Comparative Example 1:

[0051] A traditional Chinese medicine composition is prepared from the following raw materials: 4g of earthworm, 20g of angelica, 15g of stir-fried white peony root, 15g of chuanxiong, 15g of cyperus rotundus, 10g of bupleurum, 3g of honeyed ephedra, 15g of notopterygium wilfordii, 6g of angelica dahurica, 6g of cassia twig, 30g of cypress seed, 15g of epimedium, and 10g of American ginseng.

[0052] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0053] Comparative Example 2:

[0054] A traditional Chinese medicine composition is prepared from the following raw materials: 4g of centipede, 20g of angelica, 15g of stir-fried white peony root, 15g of chuanxiong, 25g of bupleurum, 3g of honeyed ephedra, 15g of notopterygium wilfordii, 6g of angelica dahurica, 6g of cassia twig, 30g of cypress seed, 15g of epimedium, and 10g of American ginseng.

[0055] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0056] Comparative Example 3:

[0057] The formula of Yishenling Granules is 20g of wolfberry fruit, 20g of processed Ligustrum lucidum fruit, 2g of processed aconite root, 30g of fried Euryale ferox, 10g of fried Plantago seed, 20g of fried Psoralea corylifolia, 20g of Rubus idaeus, 5g of Schisandra chinensis, 20g of Morus alba, 25g of Astragalus membranaceus fruit, 10g of fried Allium chinense seed, 15g of Epimedium, and 20g of Rosa laevigata fruit.

[0058] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0059] Effect embodiment:

[0060] Effect example: Experimental study on the effect of the Chinese medicine composition of the present invention in treating impotence

[0061] 1. Animal Grouping and Modeling

[0062] Healthy male Sprague-Dawley rats (8 weeks old, weighing 200-220 g) (purchased from the Experimental Animal Center of Heilongjiang University of Chinese Medicine) were fed normally for 1 week and a vascular ED rat model was established by bilateral ligation of the internal iliac arteries. For the sham-operated group, rats were secured on an operating table, and a midline incision was made in the lower abdomen. After opening the abdominal cavity, the bilateral internal iliac arteries were located and exposed without ligation. The abdominal viscera were then repositioned, and the peritoneum, muscle, subcutaneous fat, and skin were sutured sequentially.

[0063] Vascular ED model rats were randomly divided into groups (sham operation group, model group, positive control group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group), with 8 rats in each group. The positive control group rats were gavaged with 1 mL of 0.2 mg / mL tadalafil aqueous dispersion every day, the Example 1-2 group and the Comparative Example 1-3 group were gavaged with 1 mL of the test drug prepared in the Preparation Example section every day, and the model group and sham operation group rats were not intervened and were only gavaged with 1 mL of normal saline every day. After 2 weeks of continuous gavage, the test was performed. In addition, a blank group was set up, with a total of 8 rats.

[0064] 2. Evaluation indicators

[0065] 2.1 Evaluation of Erectile Function in Rats

[0066] Penile erection was induced by stimulating the rat's cavernous nerves, and the maximum intracavernous pressure (ICP) of the penis was measured using a multi-channel physiological signal acquisition and processing system. max , evaluate the erection of rats. The same method was used to stimulate the cavernous nerve of the penis twice continuously, with an interval of 10 minutes between the two times. The ICP measured after the second stimulation was max As the rat's penile ICP max data.

[0067] 2.2 Determination of serum biochemical index levels

[0068] Blood was collected from each group of experimental animals using centrifuge tubes containing anticoagulant. The collected blood samples from each group of mice were centrifuged at 3000g for 15 minutes using a low-speed centrifuge. The supernatant was then collected and the NO and endothelin-1 (ET-1) levels in the serum of each group of animals were measured using a kit.

[0069] 3. Statistical methods

[0070] The results were analyzed using SPSS 27.0 statistical software, and the data are expressed as mean ± standard deviation. One-way analysis of variance was used for comparisons between multiple groups, and the t-test was used for comparisons between two groups. A p < 0.05 indicated a statistically significant difference.

[0071] 4. Experimental Results

[0072] 4.1 Results of rat erectile function test

[0073] Penile ICP of rats in each group max The results are shown in Table 1. Compared with the blank group and the sham operation group, the ICP max The significant decrease indicated that the model was successful.

[0074] ICP of rats in the positive control group, Example 1 and Example 2 groups max Compared with the model group, the** p<0.01; *** p<0.001), indicating that the Chinese medicine composition of the present invention has a significant improvement effect on erectile dysfunction in vascular ED model rats, and its effect is close to that of the positive control drug tadalafil, and the effect of the Chinese medicine composition of the present invention is better than Yishenling Granules commonly used in the clinical treatment of impotence (see Comparative Example Group 3).

[0075] It can also be seen from the experimental results of Comparative Example 1 and Comparative Example 2 that when the medicinal flavors in the traditional Chinese medicine composition of the present invention are replaced or removed, the effect of the traditional Chinese medicine composition in improving erectile dysfunction in vascular ED model rats is significantly weakened, which indicates that the improvement effect of the traditional Chinese medicine composition of the present invention on erectile dysfunction in rats is closely related to the types of medicinal flavors in the traditional Chinese medicine composition.

[0076] Table 1: Effects of the Chinese medicine composition of the present invention on the erectile function of rats

[0077] Group <![CDATA[ICP max (mmHg)]]> Blank group 66.2±3.7 Sham operation group 65.3±4.1 Model group 20.5±2.9 Positive control group <![CDATA[49.7±2.8 *** ]]> Example 1 group <![CDATA[45.1±3.2 *** ]]> Example 2 group <![CDATA[40.8±2.5 ** ]]> Comparative example 1 group 27.5±3.3 Comparative example 2 group 28.1±2.7 Comparative example 3 group <![CDATA[32.4±3.1 * ]]>

[0078] Note: Compared with the model group, * p<0.05; ** p<0.01; *** p<0.001.

[0079] 4.2 Results of serum biochemical indexes

[0080] The results of serum NO and ET-1 levels in rats of each group are shown in Table 2. Compared with the blank group and the sham operation group, the NO and ET-1 levels in the model group were significantly increased, indicating that the model was successfully established.

[0081] The NO and ET-1 levels of the rats in the positive control group, Example 1 and Example 2 groups were significantly lower than those in the model group ( ** p<0.01; *** p<0.001), indicating that the Chinese herbal composition of the present invention has a significant improvement effect on the NO level and ET-1 level of vascular ED model rats, and its effect is close to that of the positive control drug tadalafil. In addition, the effect of the Chinese herbal composition of the present invention is better than Yishenling Granules commonly used in the clinical treatment of impotence (see Comparative Example 3). Yishenling Granules basically have no effect on these two indicators of model rats.

[0082] It can also be seen from the experimental results of Comparative Example 1 and Comparative Example 2 that when the medicinal flavors in the traditional Chinese medicine composition of the present invention are replaced or removed, the effect of the traditional Chinese medicine composition on improving the NO level and ET-1 level is significantly weakened, which indicates that the improvement effect of the traditional Chinese medicine composition of the present invention on the NO level and ET-1 level of rats is closely related to the types of medicinal flavors in the traditional Chinese medicine composition.

[0083] Table 2: Effects of the Chinese medicine composition of the present invention on NO and ET-1 levels in rat serum

[0084]

[0085] Note: Compared with the model group, ** p<0.01; *** p<0.001.

[0086] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if such changes and modifications fall within the scope of the claims and their equivalents, the present invention is intended to include such changes and modifications.

Claims

1. A Chinese medicine composition for improving male erectile dysfunction, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-5 parts of centipede, 15-30 parts of angelica, 10-20 parts of stir-fried white peony root, 10-20 parts of chuanxiong, 10-20 parts of cyperus rotundus, 5-15 parts of bupleurum, 1-5 parts of honey ephedra, 10-20 parts of notopterygium wilfordii, 5-10 parts of angelica dahurica, 5-10 parts of cassia twig, 20-40 parts of cypress seed, 10-20 parts of epimedium, and 5-15 parts of American ginseng. The traditional Chinese medicine composition has the effects of soothing liver qi, relieving depression, and invigorating yang and relieving atrophy.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4 parts of centipede, 20 parts of angelica, 15 parts of stir-fried white peony root, 15 parts of chuanxiong, 15 parts of cyperus rotundus, 10 parts of bupleurum, 3 parts of honeyed ephedra, 15 parts of notopterygium wilfordii, 6 parts of angelica dahurica, 6 parts of cassia twig, 30 parts of cypress seed, 15 parts of epimedium, and 10 parts of American ginseng.

3. The method for preparing the Chinese medicine composition according to claim 1 or claim 2, characterized in that: The preparation method comprises the following steps: crushing centipede, angelica, stir-fried white peony root, chuanxiong, cyperus rotundus, bupleurum, honeyed ephedra, notopterygium wilfordii, angelica dahurica, cassia twig, cypress seed, epimedium and American ginseng, adding water for decoction, mixing the filtrate and concentrating to obtain a concentrated solution.

4. The preparation method according to claim 3, wherein: The decoction is performed twice. After the first decoction for 1-3 hours, a primary filtrate is obtained by filtering. The filter residue is then decocted with water for another 1-3 hours, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined.

5. The preparation method according to claim 4, characterized in that: The material-liquid ratio of the first decoction and the second decoction was 1:4, the decoction time of the first decoction and the second decoction was 2 hours, and the water used in the first decoction and the second decoction was distilled water.

6. Use of the traditional Chinese medicine composition according to claim 1 or claim 2, or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 5, in the preparation of a medicament for improving male erectile dysfunction.

7. The use according to claim 6, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

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