Traditional Chinese medicine composition with effect of improving male sexual function as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with a male sexual function improving effect and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from centipede, angelica sinensis, parched white peony root, ligusticum wallichii, rhizoma cyperi, radix bupleuri, honey ephedra, notopterygium root, radix angelicae, cassia twig, platycladi seed, herba epimedii and American ginseng. The traditional Chinese medicine composition disclosed by the invention has the effects of soothing liver-qi stagnation, and invigorating yang to generate wilt. Experimental results show that the traditional Chinese medicine composition has a remarkable improvement effect on erectile dysfunction, NO level and ET-1 level of vascular ED model rats, the improvement effect of the traditional Chinese medicine composition on the indexes is close to that of tadalafil, and the traditional Chinese medicine composition is obviously superior to that of kidney tonifying granules which are commonly used clinically and are used for improving male sexual functions. Therefore, the traditional Chinese medicine composition disclosed by the invention is particularly suitable for being prepared into medicines for improving male sexual functions, and has wide clinical application prospects and commercial values.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition having the function of improving male sexual function, and a preparation method and use thereof. Background Art

[0002] Male sexual dysfunction is a relatively serious male disease. Patients are incapable of sexual function and sexual satisfaction, which is manifested by symptoms such as sexual desire disorder, impotence, premature ejaculation, spermatorrhea, anejaculation and retrograde ejaculation. Sexual function is a physiological process that occurs through the coordinated action of the nervous system, endocrine system, sexual organs and other aspects. Organic lesions such as reproductive system diseases and systemic diseases can be regarded as sexual dysfunction if any link is blocked. This disease can affect the patient's normal life and even 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 sexual life of patients.

[0003] At present, many hospitals and research institutions at home and abroad are actively researching drugs to treat such diseases. For example, oral sildenafil tablets and topical prostaglandin E cream have certain clinical effects, but the former is contraindicated for patients with cardiovascular diseases, especially those taking vasodilator drugs, and the latter has a considerable number of patients experiencing penis pain, urethral pain and urethral burning. The side effects of sex hormones and gonadotropin are that they can easily lead to hypercalcemia, water and sodium retention, allergies, male breast development, etc.

[0005] For example, Chinese patent application CN118806844A discloses a Chinese medicine composition for treating impotence, which includes the following raw materials in parts by weight: 5-10 parts of Heishun Tablets, 5-15 parts of Actinolite, 5-15 parts of Raw Cinnamon Twigs, 5-10 parts of Epimedium, 5-15 parts of Cuscuta Seeds, 5-15 parts of Lycium Barbarum, 9-15 parts of Rehmannia Glutinosa, 5-15 parts of Cuscuta Seeds, 6-15 parts of Cornus Officinalis, 5-15 parts of Viscum Sativum, 3-9 parts of Cloves, 10-30 parts of Dioscorea Opposita, 10-20 parts of Poria, 5-15 parts of Tangerine Peel, 3-10 parts of Orientalis, 3-9 parts of Processed Polygala, 5-15 parts of Ziziphus Ziziphi Spinosae, and 1-5 parts of Scolopendra. The whole recipe has the functions of warming the kidney and strengthening Yang, replenishing the kidney and essence, soothing the liver, strengthening the spleen and calming the heart. Chinese patent application CN117159676A discloses a Chinese medicine composition for treating premature ejaculation and impotence and its preparation method and application, wherein the raw materials include 5-20 parts of bupleurum, 5-15 parts of scutellaria, 5-15 parts of cassia twig, 5-20 parts of dried ginger, 5-20 parts of pinellia, 5-15 parts of fructus aurantii, 5-30 parts of dried orange peel, 10-30 parts of tuckahoe, 5-15 parts of calamus, 5-15 parts of polygala, 10-40 parts of oyster and 3-15 parts of raw liquorice by weight. The Chinese medicine composition can be used for treating liver depression and spleen deficiency phlegm-dampness type premature ejaculation and erectile dysfunction, and the prepared mixture, granules, etc. are easy to carry and convenient to take. However, the medicines with the effect of improving male sexual function sold in the market generally have the disadvantages of unscientific prescription composition, high medication cost, unreasonable administration method, and unclear therapeutic effect.

[0006] In view of this, in order to meet the needs of clinical treatment, the inventors have developed a Chinese medicine composition that has good efficacy, no toxic side effects, easily available raw materials and low cost and has the effect of improving male sexual function. Summary of the invention

[0007] 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 and a preparation method and use thereof.

[0008] Specifically, the present invention is realized through the following technical solutions:

[0009] 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, 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.

[0010] As an optional manner, 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, 5-10 parts of angelica dahurica, 5-10 parts of cassia twig, 20-40 parts of pine nuts, 10-20 parts of epimedium, and 5-15 parts of American ginseng.

[0011] 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 pine nuts, 15 parts of epimedium, and 10 parts of American ginseng.

[0012] 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.

[0013] In the second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect, the preparation method comprising the following steps: crushing centipede, angelica, stir-fried white peony root, chuanxiong, cyperus rotundus, bupleurum, honey ephedra, notopterygium, angelica dahurica, cassia twig, cypress seed, epimedium, and American ginseng, adding water for decoction, mixing the filtrate, and concentrating to obtain a concentrated solution.

[0014] As an optional manner, in the above preparation method, the decoction is performed twice, and after the first decoction for 1-3 hours, a primary filtrate is obtained by filtering, the filter residue is further decocted with water for 1-3 hours, and a secondary filtrate is obtained by filtering, and the primary filtrate and the secondary filtrate are combined.

[0015] 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 for the first decoction and the second decoction is distilled water.

[0016] Preferably, the concentration is concentration under reduced pressure.

[0017] 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 drug having the effect of improving male sexual function.

[0018] As an optional mode, in the above-mentioned use, the effect of improving male sexual function is to improve male sexual loss and improve male sexual dysfunction.

[0019] Preferably, the male sexual dysfunction includes loss of libido, impotence, premature ejaculation, spermatorrhea, anejaculation or retrograde ejaculation.

[0020] As an optional mode, in the above-mentioned use, the dosage form of the drug is granules, tablets, oral liquid or capsules.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] (1) The Chinese medicine composition of the present invention has the effects of soothing the liver and relieving depression, and stimulating 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.

[0023] (2) The experimental results show that the Chinese herbal composition of the present invention has a significant improvement effect on the erectile dysfunction of vascular ED model rats, and also has a significant improvement effect on the NO level and ET-1 level of 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 treatment of impotence.

[0024] (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

[0025] 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 medicines for improving male sexual function.

[0026] The efficacy and main treatment of each medicinal ingredient in the Chinese medicine composition of the present invention are as follows:

[0027] "Centipede" is the whole body of Scolopendra subspinipes multilans L.Koch., an animal of the Scolopendae family. It is warm in nature and pungent in taste. It enters the liver meridian. Centipede can calm wind and relieve spasm, attack poison and dissipate stagnation, and relieve pain. It belongs to the category of wind-calming and wind-calming drugs. It is used to treat infantile convulsions, convulsions and spasms, crooked mouth caused by stroke, hemiplegia, tetanus, rheumatism, sores, scrofula, and snake bites.

[0028] "Danggui" is the root of Angelica sinensis (Oliv.) Diels., a plant of the Umbelliferae family. It is warm in nature, sweet and pungent in taste. It enters the liver meridian, heart meridian, and spleen meridian. It nourishes blood and activates blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It is a blood tonic under the category of tonic drugs. It is used to treat blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, dry intestines and constipation, rheumatic arthralgia, injuries from falls, and carbuncles and ulcers.

[0029] White peony root is the root of Paeonia lactiflora Pall., a plant of the genus Paeonia in the family Ranunculaceae. It tastes bitter and sour, and is slightly cold in nature. It enters the liver and spleen meridians. It has the effects of nourishing blood and restraining yin, softening the liver and relieving pain, and calming liver yang. It is mainly used to treat liver blood deficiency, irregular menstruation, liver-spleen disharmony, chest and flank abdominal pain, cramps and pain in the limbs, hyperactivity of liver yang, headache and dizziness, etc.

[0030] "Chuanxiong" is the rhizome of the plant Chuanxiong Ligusticum chuam.iong Hort. of the Umbelliferae family. It is warm in nature and pungent in taste. It enters the liver meridian, gallbladder meridian, and pericardium meridian. It promotes blood circulation and qi, dispels wind and relieves pain. It is a blood-activating and analgesic drug under the category of blood-activating and stasis-removing drugs. It is used for chest pain, chest and flank pain, swelling and pain caused by falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain caused by urinary tract infections, headache, and rheumatic pain.

[0031] "Xiangfu" is the rhizome of Cyperus rotundus L., a plant of the Cyperaceae family. It is mild in nature, pungent and bitter in taste. It enters the liver meridian and spleen meridian. It can break blood and promote qi circulation, eliminate stagnation and relieve pain. It belongs to the blood-breaking and stagnation-eliminating medicine under the category of blood-activating and stasis-removing medicine. It can treat stagnation and lumps, blood stasis and amenorrhea, food stagnation and pain, heart and stomach pain, dysmenorrhea, and traumatic injuries.

[0032] Bupleurum is the root of Bupleurum scorzonerifolium Willd. (commonly known as "Southern Bupleurum"), or Bupleurum chinense DC. (commonly known as "Northern Bupleurum"), a plant of the Umbelliferae family. It is slightly cold in nature and bitter in taste. It enters the liver meridian, gallbladder meridian, and lung meridian. It can harmonize the exterior and interior, soothe the liver, and raise the yang. It is a pungent and cool antipyretic drug under the category of antipyretic drugs. It is used to treat colds and fever, alternating cold and heat, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0033] "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 taste. It enters the lung meridian and bladder meridian. It can induce sweating and dispel cold, clear the lungs and relieve asthma, and promote diuresis and reduce swelling. It is a pungent and warm antipyretic drug under the category of antipyretic drugs. It is used to treat colds caused by wind and cold, chest tightness, cough and wheezing, edema caused by wind and water, and bronchial asthma. It is often used to treat the symptoms of the exterior, asthma and cough.

[0034] Qianghuo is the dried rhizome and root of Notopterygium incisum Ting ex HTChang or Notopterygium, franchetii H. de Boiss. of the Umbelliferae family. It is warm in nature, pungent and bitter in taste. It enters the bladder meridian and kidney meridian. It can dispel cold, expel wind and dampness, and relieve pain. It belongs to the pungent and warm antipyretic drugs under the category of antipyretic drugs. It is used to treat colds caused by wind and cold, headaches and stiff necks, rheumatic pain, and shoulder and back pain.

[0035] "Angelica dahurica" ​​is the root of Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f.var.formosana (Boiss.) Shan et Yuan or Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. of the Umbelliferae family. It is warm in nature and pungent in taste. It enters the stomach meridian, large intestine meridian, and lung meridian. It dispels wind and dampness, relieves pain, and relieves swelling and discharges pus. It is a pungent and warm antipyretic drug under the category of antipyretic drugs. It is used to treat colds, headaches, brow pain, nasal congestion, sinusitis, toothache, leucorrhea, and sores. It has a good analgesic effect, especially for headaches, and has detoxification and anti-inflammatory effects. Recently, it has been found to have a dilating effect on the coronary arteries of the heart, so it can be considered for the treatment of coronary heart disease.

[0036] "Guizhi" is the young branch of Cinnamomum cassia Presl., a plant of Lauraceae. It tastes spicy and sweet, and is warm in nature. It enters the bladder meridian, heart meridian, and lung meridian. It has the functions of releasing the exterior, relieving muscles, warming the meridians and unblocking the blood vessels, promoting yang and transforming qi, and balancing and lowering qi. It is a spicy and warm antipyretic drug. It is used to treat colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, phlegm and fluid retention, edema, palpitations, and running pig.

[0037] "Pineapple Seed" is the seed kernel of Platycladus orientails (L.) Franco, a plant of the Cupressaceae family. It is mild in nature and sweet in taste. It enters the heart meridian, kidney meridian, and large intestine meridian. It nourishes the heart and calms the mind, stops sweating, and moistens the intestines. It is a heart-nourishing and calming medicine under the category of calming medicine. It is used to treat insomnia due to deficiency, palpitations, night sweats due to yin deficiency, and constipation due to dry intestines.

[0038] Epimedium is the leaves of Epimedium Brevicornu Max-Im., Epimedium sagittatum (Sieb.et Zucc.) Maxim., Epimedium pubescens Maxim. or Epimedium koreanum Nakai, which are plants of the Berberidaceae family. It is warm in nature, pungent and sweet in taste. It enters the liver meridian and kidney meridian. It replenishes kidney yang, strengthens tendons and bones, and removes rheumatism. It is a yang-tonifying drug under the category of tonic drugs. It is used to treat impotence and spermatorrhea, weakness of tendons and bones, rheumatic pain, numbness and cramps; and menopausal hypertension.

[0039] "American ginseng" is the root of Panax quinquefolium L., a plant of the Araliaceae family. It is cool in nature, sweet and slightly bitter in taste. It enters the heart meridian, lung meridian, and kidney meridian. It replenishes qi and nourishes yin, clears away heat and produces body fluid. It is a qi-tonifying medicine under the category of tonic medicine. It is used for qi deficiency and yin deficiency, internal heat, cough and asthma, sputum and blood, deficiency heat and fatigue, thirst, dry mouth and throat. For red intestines: steamed longan with American ginseng. In addition, it also has anti-fatigue, anti-hypoxia, anti-shock, anti-tumor and anti-viral effects.

[0040] The centipede, angelica, Chuanxiong, stir-fried white peony root, Cyperus rotundus, and Bupleurum in the formula can soothe the liver and relieve depression; Notopterygium wilfordii, Angelica dahurica, cinnamon twig, and honeyed ephedra can invigorate the yang; Torreya grandis can nourish the heart and calm the mind; Epimedium can invigorate the yang, and when combined with centipede, it can invigorate the yang and cure impotence; American ginseng can replenish qi and produce body fluid, preventing the pungent dryness from damaging the yin.

[0041] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0042] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0043] 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.

[0044] Preparation Example:

[0045] Embodiment 1:

[0046] A traditional Chinese medicine composition with the effect of improving male sexual function, the 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, 15g of cyperus rotundus, 10g of bupleurum, 3g of honey ephedra, 15g of notopterygium, 6g of angelica dahurica, 6g of cassia twig, 30g of cypress seed, 15g of epimedium, and 10g of American ginseng.

[0047] 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, angelica dahurica, cassia twig, cypress seed, epimedium, and American ginseng, adding water for decoction, and decoction twice, 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, the water used for the first decoction and the second decoction is distilled water, and after decoction, the filtrate is mixed, and concentrated under reduced pressure to obtain 80 mL of concentrated solution.

[0048] Embodiment 2:

[0049] A traditional Chinese medicine composition with the effect of improving male sexual function, the traditional Chinese medicine composition 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 honey ephedra, 15g of notopterygium, 6g of angelica dahurica, 6g of cassia twig, 28g of cypress seed, 10g of epimedium, and 10g of American ginseng.

[0050] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0051] Comparative Example 1:

[0052] 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 honey ephedra, 15g of notopterygium, 6g of angelica dahurica, 6g of cassia twig, 30g of cypress seed, 15g of epimedium, and 10g of American ginseng.

[0053] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0054] Comparative Example 2:

[0055] 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 honey ephedra, 15g of notopterygium, 6g of angelica dahurica, 6g of cassia twig, 30g of cypress seed, 15g of epimedium, and 10g of American ginseng.

[0056] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0057] Comparative Example 3:

[0058] The formula of Yishenling Granules includes 20g of wolfberry, 20g of Ligustrum lucidum (processed), 2g of Aconitum (processed), 30g of Euryale ferox (fried), 10g of Plantago seed (fried), 20g of Psoralea corylifolia (fried), 20g of Rubus idaeus, 5g of Schisandra chinensis, 20g of Morus alba, 25g of Astragalus membranaceus, 10g of Allium sativum seed (fried), 15g of Epimedium, and 20g of Rosa laevigata.

[0059] The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0060] Effect embodiment:

[0061] Effect example: Experimental study on the effect of the Chinese medicine composition of the present invention in treating impotence

[0062] 1. Animal grouping and modeling

[0063] Healthy male SD rats (8 weeks old, weighing 200-220 g) were obtained (purchased from the Experimental Animal Center of Heilongjiang University of Traditional Chinese Medicine) and fed normally for 1 week. The vascular ED rat model was established by bilateral internal iliac artery ligation. For the sham operation group, the rats were fixed on the operating table, and a midline incision was made in the middle and lower abdomen. After opening the abdominal cavity, the bilateral internal iliac arteries were found and exposed without ligation, and then the abdominal tissue and internal organs were reset, and the peritoneum, muscle, subcutaneous fat and skin were sutured in sequence.

[0064] The 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 part every day, and the model group and the sham operation group rats were not intervened, and only 1 mL of normal saline was gavaged every day. After continuous gavage for 2 weeks, the test was carried out. In addition, a blank group was set up, with a total of 8 rats.

[0065] 2. Evaluation indicators

[0066] 2.1 Evaluation of erectile function in rats

[0067] 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.

[0068] 2.2 Determination of serum biochemical index levels

[0069] The blood of each group of experimental animals was collected using a centrifuge tube containing an anticoagulant. The blood samples of each group of mice were centrifuged at 3000g for 15 minutes using a low-speed centrifuge, and the supernatant was taken to measure the NO level and endothelin-1 (ET-1) level in the serum of each group of animals using a kit.

[0070] 3. Statistical methods

[0071] The results were analyzed using SPSS 27.0 statistical software, and the data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and t-test was used for comparison between two groups. P < 0.05 indicated statistically significant differences.

[0072] 4. Experimental Results

[0073] 4.1 Results of rat erectile function test

[0074] 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.

[0075] 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 the erectile dysfunction of 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 clinical treatment of impotence (see comparative example group 3).

[0076] It can also be seen from the experimental results of Comparative Example 1 and Comparative Example 2 that when the medicinal flavors in the Chinese medicine composition of the present invention are replaced or removed, the effect of the Chinese medicine composition on improving the erectile dysfunction in vascular ED model rats is significantly weakened, which indicates that the improvement effect of the Chinese medicine composition of the present invention on erectile dysfunction in rats is closely related to the types of medicinal flavors in the Chinese medicine composition.

[0077] Table 1: Effects of the Chinese medicine composition of the present invention on the erectile function of rats

[0078] 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 27.5±3.3 Comparative Example 2 28.1±2.7 Comparative Example 3 <![CDATA[32.4±3.1 * ]]>

[0079] Note: Compared with the model group, * p<0.05; ** p<0.01; *** p<0.001.

[0080] 4.2 Results of serum biochemical indexes

[0081] The results of the determination of serum NO level and ET-1 level of rats in each group are shown in Table 2. Compared with the blank group and the sham operation group, the NO level and ET-1 level of the model group were significantly increased, indicating that the model was successfully established.

[0082] The NO level and ET-1 level 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 medicine 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, and the effect of the Chinese medicine composition of the present invention is better than Yishenling Granules commonly used in clinical treatment of impotence (see Comparative Example 3). Yishenling Granules basically have no effect on these two indicators of model rats.

[0083] It can also be seen from the experimental results of Comparative Example 1 and Comparative Example 2 that when the medicinal flavors in the Chinese medicine composition of the present invention are replaced or removed, the effect of the Chinese medicine composition on improving the NO level and ET-1 level is significantly weakened, which indicates that the improvement effect of the 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 Chinese medicine composition.

[0084] Table 2: Effects of the Chinese medicine composition of the present invention on NO level and ET-1 level in rat serum

[0085]

[0086] Note: Compared with the model group, ** p<0.01; *** p<0.001.

[0087] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition having the effect of improving male sexual function, characterized in that: 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, 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.

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: 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, 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.

3. The Chinese medicine composition according to claim 2, characterized in that: The 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 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.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition has the effects of soothing the liver and relieving depression, invigorating yang and relieving atrophy.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method comprises the following steps: crushing centipede, angelica, stir-fried white peony root, chuanxiong, cyperus rotundus, bupleurum, honey ephedra, notopterygium, angelica dahurica, cassia twig, cypress seed, epimedium and American ginseng, adding water for decoction, mixing filtrate and concentrating to obtain concentrated solution.

6. The preparation method according to claim 5, characterized in that: 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 1-3 hours, and a secondary filtrate is obtained by filtering. The primary filtrate and the secondary filtrate are combined.

7. The preparation method according to claim 6, characterized in that: The material-to-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.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 7 in the preparation of a medicament for improving male sexual function.

9. The use according to claim 8, characterized in that: The effect of improving male sexual function is to improve male sexual desire loss and male sexual dysfunction. Preferably, the male sexual dysfunction includes sexual desire loss, impotence, premature ejaculation, spermatorrhea, anejaculation or retrograde ejaculation.

10. The use according to claim 8, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid or capsules.

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