Traditional Chinese medicine composition for treating diabetic erectile dysfunction and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetic erectile dysfunction and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises medicine powder and a medicament, the medicine powder comprises the following raw materials: stiff silkworm, centipede and pseudo-ginseng powder; the medicament is prepared from the following raw materials: ginseng, rhodiola rosea, rehmannia, astragalus membranaceus, radix puerariae, caulis spatholobi, loofah sponge, peach kernels, safflower carthamus, angelica sinensis, radix paeoniae alba, pubescent holly roots, morinda officinalis, fructus lycii, herba epimedii and radix bupleuri. The traditional Chinese medicine composition disclosed by the invention has a remarkable treatment effect on diabetes mellitus complicated with erectile dysfunction and diabetic erectile dysfunction, and can be used for obviously improving the erectile function and improving the traditional Chinese medicine syndromes such as low sexual desire, fatigue and fatigue. The traditional Chinese medicine composition has a good curative effect and a certain clinical popularization value in the aspect of treating diabetes mellitus erectile dysfunction.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating diabetic erectile dysfunction and its application. Background Art

[0002] Erectile dysfunction (ED) is one of the most common disorders that plague men. Generally, it refers to a disorder in which the penis cannot erect normally, or the erection is not firm enough, or the erection lasts for a short time, resulting in the inability to complete normal sexual intercourse. In 1993, the NIH conference in the United States unified the description as the penis being unable to achieve and maintain a sufficient erection for at least 6 months to obtain a satisfactory sexual life. Although ED is a benign disease, it affects the physical and mental health of patients and is closely related to the quality of life of patients, the relationship with sexual partners, and family stability. A recent epidemiological survey found that approximately 5% - 20% of men suffer from moderate to severe ED. The differences in various epidemiological surveys are related to different methods and the different ages and socioeconomic statuses of the study populations. Diabetes Mellitus (DM) is a complex metabolic disease characterized by abnormally elevated blood glucose levels. Its pathogenesis is usually caused by the combined action of genetic and / or environmental factors, resulting in an imbalance in insulin secretion. The long-term hyperglycemic state can damage multiple systems of the body, including the nervous system, cardiovascular and cerebrovascular systems, and urinary system. In the past fifty years, with the change of people's lifestyle and the continuous increase in the proportion of obese people, the prevalence of diabetes has shown a rapid upward trend. Among the large number of diabetic patients, about three-quarters of the patients will be troubled by diabetes mellitus with erectile dysfunction (DMED) to varying degrees, which indicates that the complication problems caused by diabetes cannot be ignored and are closely related to the quality of life of patients. Compared with the general population of the same age, sexual dysfunction occurs earlier and the incidence is significantly higher in the diabetic population. There have been many studies on erectile dysfunction in diabetic patients. Multiple studies have shown that the prevalence of sexual dysfunction in diabetic patients is significantly higher than that in the general population.

[0003] Modern medical research shows that the pathogenesis of diabetes combined with erectile dysfunction involves multiple aspects such as blood vessels, endothelial cells, neurotransmitters, endocrine and cavernous smooth muscle. These factors interact with each other and jointly lead to the occurrence of erectile dysfunction. Diabetic patients are often accompanied by cardiovascular diseases, hypertension, microvascular diseases, etc. The long-term high level of blood sugar in their blood will cause thickening of blood vessel walls and reduced elasticity, thereby affecting the blood circulation of the penis. These vascular diseases are the main causes of DMED. In addition, diabetes may also cause endothelial dysfunction, affect the production and action of nitric oxide (NO), and thus affect the relaxation of the penis cavernous smooth muscle. In addition, diabetes can also cause neuropathy, which will reduce the sensitivity of sexual nerves and affect the penile erection mechanism.

[0004] Phosphodiesterase type 5 inhibitors (PDE5i) are commonly used drugs in Western medicine treatment of diabetes mellitus with erectile dysfunction (DMED). It inhibits PDE5 activity, increases cyclic guanosine monophosphate (cGMP) levels, promotes vasodilation of the corpus cavernosum and relaxation of smooth muscles, and optimizes the blood supply to the penis, thereby alleviating erectile dysfunction. PDE5i has a direct effect in the treatment of DMED and has significant efficacy. However, PDE5i also has side effects, such as headaches and stomach discomfort, which affect patients' medication experience. Long-term use may also lead to drug resistance, and some patients need to increase the dose to maintain the effect. This not only increases the risk of adverse reactions, but also increases the economic and psychological burden on patients.

[0005] In the classic literature of ancient Chinese medicine, diabetes is classified as "Xiao Ke", and erectile dysfunction is called "impotence", "Yin Fei", "Jin Fei", "Jin Zong Relaxation" or "Useless Device". Xiao Ke disease is closely related to kidney deficiency. If the treatment is unbalanced, or excessive worry and depression may lead to damage of Qi and Yin. Long-term Xiao Ke causes the leakage of fine substances with urine, which cannot nourish the spleen and kidney Zong Jin, and then affects the kidney function as the key pathogenesis. The impotence caused by long-term Xiao Ke is either hard but not long, or hard but not hard, which makes it impossible to satisfy sexual life. The name of diabetes first appeared in "Suwen. Qibinglun": "This is caused by fat and delicious food. This person must eat sweet and delicious food frequently and a lot of fat. Fat makes people feel hot inside, and sweet food makes people feel full, so the qi overflows and turns into diabetes." Traditional Chinese medicine believes that diabetes over time will lead to yin deficiency affecting kidney yang, which will lead to imbalance of kidney yin and yang. Kidney yang deficiency is unable to warm yang and transform qi, and qi transformation cannot be achieved. Body fluid cannot be distributed throughout the body, and the limbs and seven orifices are not nourished, resulting in diabetes. Ancient doctors believed that impotence is mainly related to the kidney, and the disease is mainly deficiency and cold. "Suwen. Wei Lun" mentioned that "the relaxation of the main tendons leads to tendon atrophy", which refers to impotence caused by abnormal tendon strength, which can actually correspond to erectile dysfunction. At the same time, "Zhubingyuanhou Lun. Deficiency Yin Wei Hou" pointed out that "fatigue hurts the kidney", which suggests that kidney deficiency, especially kidney yang deficiency, may be the main pathological basis of erectile dysfunction.

[0006] From the perspective of traditional Chinese medicine, the onset of diabetes is closely related to multiple causes, such as stomach heat, lung dryness, damp heat, kidney deficiency, liver depression, etc., and these factors will also aggravate the pathology of erectile dysfunction. In particular, in "Danxi's Heart Method·Xiao Ke", it is mentioned that "the internal organs generate heat, and the dryness and heat are blazing", which also shows that the pathological mechanism of Yin deficiency and internal heat is an important feature of DMED. Long-term Yin deficiency and internal heat can cause blood stasis, which in turn aggravates the manifestation of ED. Modern Chinese medicine research has further proved that the pathogenesis of DMED has two pathological characteristics of "Xiao Ke" and "impotence", and the basic pathological mechanism is the joint action of kidney deficiency and blood stasis. In recent years, studies on diabetes and its vascular complications have shown that the main mechanism of vascular lesions in the late stage of diabetes is "vascular stasis" caused by deficiency of both Qi and Yin. Increased blood viscosity, a significant increase in plasma fibrinogen, and accelerated erythrocyte sedimentation rate all indicate that blood flow is blocked, leading to microcirculation disorders and the formation of blood stasis, further causing ischemia and hypoxia of the corpus cavernosum of the penis, resulting in erectile difficulties. Therefore, blood stasis is not only a pathological product of poor blood flow, but it is also closely related to yin deficiency and internal heat, which runs through the entire course of diabetes. According to traditional Chinese medicine, blood stasis is the key pathological mechanism of chronic vascular complications of diabetes. The blood abnormalities and venous changes caused by DM eventually lead to erectile dysfunction. How to find a method with few side effects and effective improvement of DMED is currently a hot topic in the andrology community. Since traditional Chinese medicine itself has a multi-target, multi-pathway onset mode and relatively no obvious side effects, and has long-lasting effects, the intervention of traditional Chinese medicine is receiving more and more attention. In view of the complexity of the etiology of DMED, the model of using traditional Chinese medicine combined with or replacing PDE5 inhibitors to treat ED has been recognized by more and more urologists. Summary of the invention

[0007] The purpose of the present invention is to provide a Chinese medicine composition for treating diabetic erectile dysfunction and its application, so as to solve the problems existing in the above-mentioned prior art.

[0008] To achieve the above object, the present invention provides the following solutions:

[0009] The present invention provides a Chinese medicine composition for treating diabetic erectile dysfunction, comprising medicine powder and medicine;

[0010] The medicinal powder comprises the following raw materials by weight: 3-6 parts of silkworm pupa, 2-3 parts of centipede and 2-3 parts of notoginseng powder;

[0011] The medicament comprises the following raw materials by weight: 5-10 parts of ginseng, 12-20 parts of rhodiola rosea, 30-60 parts of rehmannia root, 15-60 parts of astragalus, 20-40 parts of kudzu root, 15-30 parts of millettia reticulata, 9-12 parts of luffa, 6-9 parts of peach kernel, 3-6 parts of safflower, 9-12 parts of angelica sinensis, 9-15 parts of white peony root, 30-45 parts of ilex pubescens root, 10-20 parts of morinda officinalis, 10-20 parts of wolfberry, 10-20 parts of epimedium and 6-9 parts of bupleurum.

[0012] Optionally, the medicinal powder comprises the following raw materials by weight: 3 parts of silkworm pupa, 3 parts of centipede and 2 parts of Panax notoginseng powder;

[0013] The medicine comprises the following raw materials by weight: 6 parts of ginseng, 20 parts of rhodiola rosea, 30 parts of rehmannia root, 30 parts of astragalus, 30 parts of kudzu root, 20 parts of millettia reticulata, 10 parts of luffa, 6 parts of peach kernel, 6 parts of safflower, 10 parts of angelica sinensis, 12 parts of white peony root, 40 parts of ilex tomentosa root, 15 parts of morinda officinalis, 15 parts of wolfberry, 15 parts of epimedium and 6 parts of bupleurum.

[0014] Optionally, the medicinal powder comprises the following raw materials by weight: 3 parts of silkworm pupa, 2 parts of centipede and 2 parts of Panax notoginseng powder;

[0015] The medicine comprises the following raw materials by weight: 5 parts of ginseng, 15 parts of rhodiola rosea, 30 parts of rehmannia root, 30 parts of astragalus, 30 parts of kudzu root, 15 parts of millettia reticulata, 9 parts of luffa, 9 parts of peach kernel, 6 parts of safflower, 9 parts of angelica, 15 parts of white peony root, 30 parts of ilex tomentosa root, 15 parts of morinda officinalis, 15 parts of wolfberry, 15 parts of epimedium and 6 parts of bupleurum.

[0016] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0017] (1) crushing silkworm pupa, centipede and Panax notoginseng powder to obtain medicinal powder;

[0018] (2) Mix ginseng, rhodiola rosea, rehmannia root, astragalus root, kudzu root, millettia reticulata, loofah, peach kernel, safflower, angelica root, white peony root, ilex tomentosa root, Morinda officinalis, wolfberry fruit, epimedium and bupleurum, and soak in water;

[0019] (3) boiling the soaked medicinal materials with water, collecting the decoction, filtering, and obtaining a medicine.

[0020] Optionally, after the pulverization, the product is passed through a No. 5 sieve and the material under the sieve is taken.

[0021] Optionally, the soaking time is 20-40 minutes.

[0022] Optionally, the decoction is performed twice; the amount of water added in the first decoction is 6 times the mass of the soaked medicinal materials, and the amount of water added in the second decoction is 5 times the mass of the soaked medicinal materials.

[0023] Optionally, the decocting time each time is 15 - 25 min after boiling.

[0024] The present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a medicament for treating diabetes mellitus complicated with erectile dysfunction.

[0025] The present invention also provides the use of the above traditional Chinese medicine composition in the preparation of a medicament for treating diabetic erectile dysfunction.

[0026] The present invention discloses the following technical effects:

[0027] According to the pathological mechanism of diabetic erectile dysfunction, the present invention prepares a traditional Chinese medicine composition based on the characteristics of "treating from the heart". The composition uses ginseng, rhodiola rosea, and rehmannia glutinosa as the monarch drugs, taking the meaning of the three talents of heaven, earth, and man; uses astragalus membranaceus, angelica sinensis, peach kernel, safflower, notoginseng, millettia reticulata, root of ilex pubescens, pueraria lobata, and luffa cylindrica as the ministerial drugs to supplement qi and activate blood circulation, remove stasis and dredge collaterals; uses epimedium brevicornu, morinda officinalis, wolfberry fruit, and white peony root as the adjuvant drugs to regulate and tonify the liver and kidney; uses bupleurum chinense, bombyx batryticatus, and scolopendra subspinipes as the messenger drugs to soothe the liver and regulate qi, dredge the heart (vessel) collaterals, disperse stasis nodules, and assist the medicinal power to flow smoothly and reach the affected area directly. Together, they build the functions of supplementing qi and strengthening the heart, activating blood circulation and dredging meridians, and regulating and tonifying the liver and kidney. The traditional Chinese medicine composition of the present invention has a significant therapeutic effect on diabetes mellitus complicated with erectile dysfunction and diabetic erectile dysfunction, can significantly improve erectile function, and improve traditional Chinese medicine syndromes such as low libido and fatigue. It has good curative effect and certain clinical popularization value in the treatment of diabetic erectile dysfunction. Detailed implementation manners

[0028] Now, various exemplary implementation manners of the present invention will be described in detail. This detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, characteristics, and implementation schemes of the present invention.

[0029] It should be understood that the terms described in the present invention are only for describing specific implementation manners and are not used to limit the present invention. In addition, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.

[0030] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which this invention pertains. Although this invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the practice or testing of this invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the said documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0031] Without departing from the scope or spirit of this invention, various improvements and changes can be made to the specific embodiments of the description of this invention, which are obvious to those skilled in the art. Other embodiments obtained from the description of this invention are obvious to those skilled in the art. The description and examples of this invention are merely exemplary.

[0032] Regarding the use of "comprising", "including", "having", "containing", etc. in this article, they are all open-ended terms, meaning including but not limited to.

[0033] The traditional Chinese medicine composition of this invention was condensed by Professor Yu Chao around diabetic erectile dysfunction in the field of andrology. After clinical and experimental research and summarizing treatment experience, it is considered that the main pathogenesis is deficiency of both liver and kidney, qi deficiency and blood stasis, and it is combined with the characteristic of treating from the heart. This traditional Chinese medicine composition is also known as "Sancai Junxiang Prescription", which is a personal agreement prescription created by Professor Yu Chao under the treatment principle of "tonifying the fire of the heart yang (sovereign fire) upward and the fire of the kidney yang (ministerial fire) downward". The name "Junxiang" is the embodiment of the theory of "the heart is the sovereign fire and the kidney is the ministerial fire; the sovereign fire is clear and the ministerial fire is in its place", and it is also the embodiment of the characteristic of treating impotence, a "kidney" disease, from the "heart" in the Shanghai school of andrology.

[0034] The traditional Chinese medicine composition of this invention is formulated by combining ginseng, rhodiola, rehmannia (prepared rehmannia root and / or raw rehmannia root), astragalus membranaceus, peach kernel, safflower, angelica sinensis, white peony root, root of ilex pubescens, morinda officinalis, wolfberry fruit, epimedium, millettia reticulata, luffa cylindrica, kudzu root, bombyx batryticatus, bupleurum chinense, centipede and notoginseng powder. Its formulation characteristics are as follows: In the formula, ginseng has the effect of greatly tonifying primordial qi, can tonify the heart qi and benefit the mind; rhodiola has the effect of supplementing qi and promoting blood circulation, and can dredge the heart vessels; rehmannia nourishes the kidney and generates essence, and is used to nourish the kidney yin. These three herbs together are the sovereign herbs according to the meaning of the three talents of heaven, earth and man. Astragalus membranaceus, together with angelica sinensis, peach kernel, safflower and notoginseng, supplements qi and promotes blood circulation; millettia reticulata, root of ilex pubescens, kudzu root and luffa cylindrica remove stasis and dredge the collaterals as the ministerial herbs, and epimedium, morinda officinalis, wolfberry fruit and white peony root are used together to regulate and tonify the liver and kidney as the assistant herbs, and bupleurum chinense, bombyx batryticatus and centipede soothe the liver and regulate qi, dredge the heart (vessels) collaterals, disperse stasis nodules, assist the medicinal power to flow smoothly and reach the disease site directly as the envoy herbs. Together, they build the functions of supplementing qi and strengthening the heart, promoting blood circulation and dredging the vessels, and regulating and tonifying the liver and kidney.

[0035] Furthermore, the effects of each raw material drug in the traditional Chinese medicine composition of this invention are as follows:

[0036] Ginseng is slightly warm in nature, sweet and slightly bitter in taste. It acts on the spleen, lung, heart, and kidney meridians. It has the effects of greatly tonifying primordial qi, restoring pulse and securing collapse, invigorating the spleen and benefiting the lung, promoting fluid production and nourishing blood, calming the mind and enhancing intelligence; Ginseng contains various ginsenosides, which have antioxidant effects, improve insulin sensitivity, and regulate blood sugar metabolism. Ginsenosides can significantly increase the activity of superoxide dismutase (SOD) and reduce the generation of reactive oxygen species (ROS), thereby reducing oxidative stress. These components can reduce oxidative stress damage by regulating multiple signaling pathways, thus improving the symptoms of diabetic patients; They can also inhibit inflammatory signaling pathways and reduce the release of pro-inflammatory cytokines, thereby effectively improving the inflammation caused by diabetes. Some studies have found that ginsenoside Rh1 regulates inflammatory and apoptotic signaling pathways through the AMPK / PI3K / Akt pathway, improves insulin sensitivity, and thus reduces blood sugar levels. Compound K (CK) in ginseng significantly reduces the blood sugar levels of type 2 diabetic mice induced by high-fat diet / streptozotocin (HFD / STZ) by downregulating the expression of PEPCK and G6Pase.

[0037] Rhodiola is cold in nature, sweet and bitter in taste. It acts on the lung and spleen meridians. It has the effects of replenishing qi and activating blood circulation, dredging meridians and relieving asthma; Rhodiola contains components such as salidroside, which have antioxidant, anti-fatigue, and improve microcirculation effects. These effects help to improve the general symptoms and erectile dysfunction of diabetic patients. Salidroside can enhance the antioxidant capacity of cells by regulating the Nrf2 signaling pathway.

[0038] Rehmannia is divided into raw rehmannia and prepared rehmannia. Raw rehmannia is cold in nature and sweet in taste. It acts on the heart, liver, and kidney meridians and has the effects of clearing heat and cooling blood, nourishing yin and promoting fluid production. Prepared rehmannia is warm in nature and sweet in taste. It acts on the liver and kidney meridians and has the effects of nourishing yin and replenishing blood, filling essence and marrow. Raw rehmannia and prepared rehmannia contain various chemical components, such as rehmannia polysaccharides and rehmanniosides, which have hypoglycemic, antioxidant, and anti-inflammatory effects. These components help to improve blood sugar control and reduce inflammatory responses in diabetic patients. Rehmannia polysaccharides in raw rehmannia can improve insulin resistance by regulating the AMPK signaling pathway. Research shows that the active ingredient catalpol in raw rehmannia has the potential to reduce blood sugar. There are also studies showing that rehmannia polysaccharides can reduce oxidative stress in a diabetic rat model with insulin resistance by regulating the Nrf2 antioxidant system. This antioxidant effect may help protect vascular endothelial cells, improve vascular function, and thus play a certain role in improving erectile dysfunction.

[0039] Astragalus membranaceus is slightly warm in nature and sweet in taste. It acts on the lung and spleen meridians. It has the effects of invigorating qi and lifting yang, strengthening the exterior and consolidating the superficial resistance, promoting diuresis and reducing edema, and expelling toxins and promoting granulation. Astragalus membranaceus contains astragalus polysaccharides and astragalus saponins, which have the functions of immunomodulation, anti-inflammation and improving microcirculation. Astragalus polysaccharides (APS) is one of the main active components in Astragalus membranaceus and has been proven to have a significant hypoglycemic effect. Research shows that astragalus polysaccharides can improve insulin sensitivity by activating the AMPK signaling pathway, thereby reducing blood glucose levels. The polysaccharide and saponin components in Astragalus membranaceus have significant antioxidant activity, can scavenge free radicals and reduce oxidative stress damage. This helps to protect pancreatic islet β cells and maintain their normal function, thus having a positive impact on blood glucose control. On the other hand, active components such as astragalus polysaccharides and astragalosides in Astragalus membranaceus have been proven to improve vascular endothelial function. These components regulate the metabolism of vascular endothelial cells, increase the production of nitric oxide (NO), thereby improving vascular dilation function and having a potential therapeutic effect on erectile dysfunction.

[0040] Caulis Spatholobi is warm in nature and bitter and sweet in taste. It acts on the liver meridian. It has the functions of enriching blood and promoting blood circulation, relaxing tendons and activating collaterals, and improving microcirculation. These functions help to improve the blood stasis symptoms of diabetic patients and the blood supply of the corpus cavernosum of the penis. The active components in Caulis Spatholobi can improve microcirculation by regulating hemorheology. The polysaccharide component in Caulis Spatholobi has been proven to have a significant hypoglycemic effect. Research shows that Caulis Spatholobi polysaccharides can improve insulin sensitivity by activating the AMPK signaling pathway, thereby reducing blood glucose levels. In addition, the extract of Caulis Spatholobi can significantly inhibit the activity of α-glucosidase, thereby delaying the digestion of carbohydrates and the absorption of glucose, and reducing postprandial blood glucose levels. The polyphenol components in Caulis Spatholobi have significant antioxidant activity, can scavenge free radicals and reduce oxidative stress damage. Oxidative stress is one of the important pathological mechanisms of erectile dysfunction. The antioxidant effect of Caulis Spatholobi helps to protect vascular endothelial cells and improve vascular function, thus having a positive impact on erectile dysfunction. Active components such as flavonoids in Caulis Spatholobi have been proven to improve vascular endothelial function. These components regulate the metabolism of vascular endothelial cells, increase the production of nitric oxide (NO), thereby improving vascular dilation function and having a potential therapeutic effect on erectile dysfunction.

[0041] Luffa cylindrica (L.) Roem. is cold in nature and sweet in taste. It belongs to the lung, liver, and stomach meridians, and has the effects of clearing heat and resolving phlegm, cooling blood and dredging meridians, promoting blood circulation to relieve pain, as well as reducing blood lipid, diuresis, anti-inflammatory and analgesic effects. Disorders of water metabolism are important factors leading to the deterioration of diabetic nephropathy, and aquaporins play an important role in water metabolism disorders. Diabetic patients may develop edema due to protein loss, resulting in hypoproteinemia, making diuretics insensitive and ineffective. Studies have shown that Luffa cylindrica (L.) Roem. is involved in regulating the expression of aquaporin 2, and combined with aerobic exercise can significantly improve the urine volume of diabetic rats; the combined exercise intervention of Luffa cylindrica (L.) Roem. may affect the water permeability of the collecting duct by reducing the expression of AQP-2, thereby reducing electrolyte disorders caused by diuretics, etc., which has great reference value for clinical drug selection.

[0042] Paeonia lactiflora Pall. is slightly cold in nature and bitter and sour in taste. It belongs to the liver and spleen meridians. It has the effects of nourishing blood and softening the liver, relieving spasm and pain, and suppressing hyperactive liver yang. Paeonia lactiflora Pall. contains components such as paeoniflorin, which has anti-inflammatory, analgesic, and immunomodulatory effects. These components help relieve the pain symptoms and improve the general symptoms of diabetic patients. Paeoniflorin can play its anti-inflammatory role by regulating the inflammatory signaling pathway, and has been proven to improve vascular endothelial function. These components regulate the metabolism of vascular endothelial cells, increase the production of nitric oxide (NO), thereby improving vascular relaxation function, and have potential therapeutic effects on erectile dysfunction. The polyphenolic components in Paeonia lactiflora Pall. can also promote angiogenesis and improve local blood circulation, which is of great significance for the treatment of erectile dysfunction.

[0043] Angelica sinensis (Oliv.) Diels is warm in nature and sweet and pungent in taste. It belongs to the liver, heart, and spleen meridians. It has the effects of enriching blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relaxing bowel movements. The polysaccharide component (Angelica sinensis polysaccharides, ASP) in Angelica sinensis (Oliv.) Diels has been proven to have a significant hypoglycemic effect. Studies have shown that ASP can reduce blood glucose levels through various pathways. Active ingredients such as ferulic acid in Angelica sinensis (Oliv.) Diels have been proven to improve vascular endothelial function. These components regulate the metabolism of vascular endothelial cells, increase the production of nitric oxide (NO), thereby improving vascular relaxation function, and have potential therapeutic effects on erectile dysfunction.

[0044] Peach kernels are of neutral nature, bitter and sweet in taste. They pertain to the heart, liver and large intestine meridians. They have the effects of promoting blood circulation to remove blood stasis and loosening the bowels to relieve constipation. Peach kernels contain components such as amygdalin, which have the effects of promoting blood circulation to remove blood stasis and anti-inflammation. These components help to improve the blood stasis symptoms of diabetic patients and the blood supply of the corpus cavernosum of the penis. Amygdalin can play its role in promoting blood circulation to remove blood stasis by regulating hemorheology. In addition, it has also been found that the extract of peach kernels not only reduces the blood glucose level, but also improves the dyslipidemia of diabetic rats, and reduces the levels of serum total cholesterol (TC) and triglyceride (TG). Moreover, the active components in peach kernels such as quercetin and luteolin have been proven to be able to improve vascular endothelial function. These components improve the vasodilation function by regulating the metabolism of vascular endothelial cells and increasing the production of nitric oxide (NO), and have potential therapeutic effects on erectile dysfunction.

[0045] Safflower is of warm nature and pungent in taste. It pertains to the heart and liver meridians. It has the effects of promoting blood circulation to dredge the meridian and dissipating stasis to relieve pain; Holly root is of cool nature and bitter in taste. It has the effects of clearing heat and detoxifying, and promoting blood circulation to relieve pain. Safflower contains components such as carthamin, which have the effects of promoting blood circulation to remove blood stasis and anti-inflammation. These components help to improve the blood stasis symptoms of diabetic patients and the blood supply of the corpus cavernosum of the penis. Carthamin in safflower can play its role in promoting blood circulation to remove blood stasis by regulating hemorheology. It has been proven that safflower extract can reduce the contents of malondialdehyde (TBARS) and protein carbonyl (CP) in plasma and liver tissues, indicating that safflower extract has antioxidant effects and can reduce the oxidative stress caused by diabetes. The flavonoids in safflower have been proven to be able to improve vascular endothelial function. These components improve the vasodilation function by regulating the metabolism of vascular endothelial cells and increasing the production of nitric oxide (NO), and have potential therapeutic effects on erectile dysfunction.

[0046] Ilex pubescens Hook. et Arn. is bitter, astringent and of cool nature. It pertains to the heart and lung meridians. It promotes blood circulation and dredges vessels, clears heat and detoxifies. Holly root has the effects of clearing heat and detoxifying and promoting blood circulation to relieve pain. These effects help to improve the inflammatory symptoms of diabetic patients and the blood supply of the corpus cavernosum of the penis. The active components in holly root can play its anti-inflammatory role by regulating the inflammatory signaling pathway. According to some studies, the saponin components in holly root and bark have significant hypoglycemic effects. These components lower the blood glucose level by stimulating the remaining pancreatic islet β cells and improving insulin secretion.

[0047] Notoginseng is of warm nature, sweet and slightly bitter in taste. It pertains to the liver and stomach meridians. It has the effects of dissipating stasis to stop bleeding and detumescence and relieving pain. Research shows that the total saponins of notoginseng in notoginseng can increase the intracavernous pressure / average dynamic and static pressure, eNOS expression, NO and CGMP levels in the corpus cavernosum of the penis of diabetic rats, and reduce apoptosis, proving that the total saponins of notoginseng can restore the endothelial function in the penis of diabetic rats through the NO / cGMP signaling pathway.

[0048] Epimedium is warm in nature, pungent and sweet in taste. It belongs to the liver and kidney meridians. It has the effects of warming the kidney and strengthening yang, dispelling wind and removing dampness. Epimedium and its main active ingredient icariin have shown significant potential in the treatment of DMED. NO is a key neuromodulatory factor in the process of penile erection. Research shows that icariin can improve erectile function by enhancing the production of NO. The specific mechanisms include regulating the central and peripheral nervous systems, activating the PI3K / Akt signaling pathway, increasing the levels of eNOS (endothelial nitric oxide synthase) in penile endothelial cells and NO in serum, thereby promoting penile erection. Icariin significantly enhances the erectile effect by inhibiting the activity of phosphodiesterase 5 (PDE5) and increasing the concentration of cGMP in penile cavernous tissue. This mechanism is similar to that of sildenafil, but icariin shows stronger efficacy in some studies. Oxidative stress is one of the important pathological mechanisms of diabetes and its complications (including erectile dysfunction). Icariin has the effects of scavenging free radicals, reducing oxidative stress damage, and protecting penile cavernous tissue.

[0049] Bombyx batryticatus is neutral in nature, salty and pungent in taste. It belongs to the liver, lung and stomach meridians and has the effects of dispelling wind and relieving convulsion, resolving phlegm and dissipating nodules. It can dispel wind and dredge collaterals, and improve local blood circulation. Modern pharmacological research has found that the pharmacological effects of Bombyx batryticatus mainly include anticoagulation, antithrombosis, anticonvulsion, hypoglycemic, anti-cancer, sedation and hypnosis. The flavonoids in Bombyx batryticatus mainly include quercetin, kaempferol, etc. Both of them are mostly present in plants. However, some scholars used reverse-phase high-performance liquid chromatography to analyze that the content of quercetin in Bombyx batryticatus is 0.22 mg / g, and the content of kaempferol is 0.64 mg / g. Some studies have found that quercetin and kaempferol are the main chemical components that play hypoglycemic effects, and their mechanism of action may be related to quercetin activating the fibroblast growth factor 21 / adenosine monophosphate-activated protein kinase signaling pathway in pancreatic tissue. Kaempferol can also improve renal injury and renal fibrosis caused by DN by increasing the release of glucagon-like peptide-1 and insulin and inhibiting RhoA / Rho kinase.

[0050] In the present invention, "diabetes mellitus complicated with erectile dysfunction" refers to the condition that simultaneously meets diabetes mellitus and erectile dysfunction; "diabetic erectile dysfunction" refers to the situation where the onset of diabetes mellitus is earlier than that of erectile dysfunction, and there is a causal correlation between the two in terms of medical history.

[0051] Example 1

[0052] In this example, a traditional Chinese medicine composition for treating diabetic erectile dysfunction was prepared, including medicament and medicinal powder.

[0053] The formula is as follows:

[0054] 5g of ginseng, 15g of rhodiola rosea, 30g of rehmannia glutinosa, 30g of astragalus membranaceus, 30g of pueraria lobata, 15g of millettia reticulata, 9g of luffa cylindrica, 9g of peach kernel, 6g of safflower, 9g of angelica sinensis, 15g of white peony root, 30g of ilex pubescens root, 15g of morinda officinalis, 15g of wolfberry fruit, 15g of epimedium, 6 parts of bupleurum chinense, 3g of bombyx batryticatus, 2g of scolopendra subspinipes, 2g of panax notoginseng powder.

[0055] The preparation process is as follows:

[0056] Soak ginseng, rhodiola rosea, rehmannia glutinosa, astragalus membranaceus, pueraria lobata, millettia reticulata, luffa cylindrica, peach kernel, safflower, angelica sinensis, white peony root, ilex pubescens root, morinda officinalis, wolfberry fruit, epimedium and bupleurum chinense in water for 30 minutes, with the water level 2 - 5 cm above the drug surface. After soaking, take out the medicinal materials and conduct two decoctions. Add 6 times the mass of water for the first decoction and 5 times the mass of water for the second decoction. Each decoction time is 20 minutes after boiling. Combine the filtrates of the two times and remove the medicinal residues to obtain the medicinal agent.

[0057] Pulverize bombyx batryticatus, scolopendra subspinipes and panax notoginseng powder, pass through a No. 5 sieve, and take the material under the sieve to obtain the medicinal powder.

[0058] Test Example 1

[0059] 1. Data and Methods

[0060] 1.1 Case Selection:

[0061] Select 50 patients with diabetes mellitus complicated with erectile dysfunction admitted to the outpatient and inpatient wards of the Department of Urology, Longhua Hospital from June 2023 to February 2025.

[0062] 1.2 Diagnostic Criteria

[0063] (1) Western Medicine Diagnostic Criteria: Refer to the "2022 ADA Diabetes Care Standards" and the "2018 AUA Guidelines on the Management of Erectile Dysfunction": When the penis cannot achieve or maintain sufficient erection to complete satisfactory sexual intercourse and the course of the disease exceeds 3 months, use the International Index of Erectile Function (IIEF - 5) to evaluate the patients. According to the IIEF - 5 scoring criteria, a score ≤ 21 points indicates that the patient has ED, among which 12 - 21 points is mild ED, 8 - 11 points is moderate ED, and 5 - 7 points is severe ED. Diabetes laboratory tests: Fasting plasma glucose FPG ≥ 7.0 mmol / L or 2 - hour plasma glucose during oral glucose tolerance test OGTT ≥ 11.1 mmol / L or random plasma glucose GLU ≥ 11.1 mmol / L or glycated hemoglobin HbA1c ≥ 48 mmol / L.

[0064] Diagnostic Requirements: The patient needs to meet the clinical symptoms of both diabetes and erectile dysfunction simultaneously. In addition, the IIEF - 5 scale evaluation and laboratory tests support this diagnosis.

[0065] (2) Traditional Chinese Medicine (TCM) Syndrome Criteria: Patients with erectile dysfunction belonging to the kidney deficiency and blood stasis type. In terms of TCM diagnosis criteria, referring to the relevant syndrome formulation criteria in the "Guidelines for Clinical Research of New Chinese Medicines for the Treatment of Impotence", the specific details are as follows: Main symptoms: Erectile dysfunction of the penis, specifically including the inability of the penis to erect normally, weak erection or difficulty in maintaining the erection state, or accompanied by soreness and weakness in the waist and knees, low libido, and stuffiness or pain in the perineum. Minor symptoms: Fatigue and weakness, fear of cold and cold limbs, tinnitus and dizziness. Tongue and pulse: Red tongue with ecchymosis or purplish dark color, greasy or yellowish greasy coating, deep and thready pulse, deep and slow or thready and unsmooth pulse.

[0066] Diagnostic requirements: When the patient meets two of the main symptoms, one of the minor symptoms, and combines with the characteristics of the tongue and pulse, the corresponding diagnosis can be made.

[0067] 1.3 Inclusion Criteria

[0068] (1) Meeting the above-mentioned Chinese and Western medicine diagnosis criteria simultaneously;

[0069] (2) Married male patients aged between 20 and 65 years old with normal libido, and at the same time can ensure the willingness and conditions for sexual life attempts during the treatment period;

[0070] (3) Blood glucose control: Fasting blood glucose (FBG) maintained between 4.4 mmol / L and 7.0 mmol / L, or 2-hour postprandial blood glucose (P2HBG) within the range of 4.4 mmol / L to 10.0 mmol / L, or glycated hemoglobin (HbA1c) not higher than 48 mmol / L;

[0071] (4) The patient needs to meet the Western medicine diagnosis criteria for both diabetes and erectile dysfunction simultaneously;

[0072] (5) The course of diabetes ≤ 60 months, and the course of diabetes combined with erectile dysfunction ≥ 3 months;

[0073] (6) Have not used or discontinued other drugs or methods for treating ED in the three months before treatment;

[0074] (7) The IIEF-5 score is between mild and moderate: 8 points ≤ IIEF-5 score ≤ 21;

[0075] (8) Have voluntarily signed the informed consent form.

[0076] 1.4 Exclusion Criteria

[0077] (1) Under 20 years old or over 65 years old;

[0078] (2) The IIEF-5 score is severe: IIEF-5 score ≤ 7;

[0079] (3) Have a history of alcoholism or drug abuse;

[0080] (4) Patients with diseases such as acute prostatitis, urethritis, penile lesions, urinary system stones, spinal cord injuries, etc.;

[0081] (5) Any severe psychological abnormalities or use of psychotropic drugs;

[0082] (6) Patients who have long-term used hormonal drugs, sedatives, antihypertensive drugs, antidepressant drugs, diuretic drugs and related drugs;

[0083] (7) Patients with severe cerebrovascular diseases, cardiovascular diseases, neuropathy, hematopoietic system diseases, liver and kidney dysfunctions, and other complications caused by diabetes;

[0084] (8) Conditions such as erosion, ulcer, blister and suppuration at the penile affected area or patients with damaged skin.

[0085] 1.5 Treatment method:

[0086] Basic treatment: All patients were given diabetes health education popularization, received medical nutrition guidance, actively exercised, monitored the changes of the condition, and on this basis, according to the standards of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", conventional basic treatment for diabetes was given (the enrolled patients took metformin hydrochloride tablets (Merck Pharmaceutical (Jiangsu) Co., Ltd. / Manufacturer: Sino-US Shanghai Squibb Pharmaceutical Co., Ltd., specification: 0.5g / tablet) with meals, and insulin was combined if the effect was not obvious), and the blood glucose was controlled at 4.4 mmol / L ≤ FBG ≤ 7.0 mmol / L, 4.4 mmol / L ≤ P2HBG ≤ 10.0 mmol / L, and the blood glucose was controlled at the ideal level as much as possible (if blood glucose fluctuations occurred, the treatment plan could be adjusted in time). At the same time, patients were required not to smoke and limit alcohol consumption.

[0087] Experimental treatment: Oral administration of the traditional Chinese medicine composition of Example 1, 200 mL of each dose, taken warm, 3.5 g of each dose of powder, swallowed; twice a day; 8 weeks in a row was a course of treatment.

[0088] 1.6 Observation indicators

[0089] Each observation item was tested and evaluated within 1 week before treatment and within 1 month after 8 weeks (one course of treatment).

[0090] (1) In terms of the main efficacy indicators:

[0091] Core indicator: The corresponding scoring situation of the "International Index of Erectile Function Questionnaire (abbreviated as "IIEF-15")".

[0092] (2) Secondary observation indicators:

[0093] 1) Erectile Hardness Score (EHS) before and after treatment;

[0094] 2) TCM syndrome scores, physical signs, tongue manifestations, and pulse conditions before and after treatment;

[0095] 3) Sex hormones (TE, E2, FSH, LH, PRL) before and after treatment;

[0096] 4) Body mass index (BMI) before and after treatment;

[0097] 5) Insulin-like growth factor-1 before and after treatment.

[0098] (3) Safety observation indicators:

[0099] General physical examination items: measuring blood pressure and heart rate; laboratory tests: blood and urine routine; electrocardiogram, liver function (ALT), and renal function (BUN, Scr) examinations.

[0100] 1.7 Efficacy evaluation criteria

[0101] Referring to the "2022 ADA Diabetes Care Standards", the "2018 AUA Guidelines on the Management of Erectile Dysfunction", and the "2022 Multidisciplinary Chinese Expert Consensus on Diabetes Mellitus Complicated with Male Sexual Dysfunction", the efficacy criteria for the IIEF-15 score are as follows:

[0102] Ineffective: The IIEF-15 score after treatment is < 60 points, and the integral improvement is < 30%;

[0103] Effective: The IIEF-15 score after treatment is < 60 points, and 30% ≤ integral improvement < 60%;

[0104] Markedly effective: The IIEF-15 score after treatment ≥ 60 points, or the IIEF-15 score after treatment is < 60 points but the integral improvement ≥ 60%.

[0105] Note: The calculation formula for integral improvement is: [(total integral after treatment - total integral before treatment)] / total integral before treatment × 100%

[0106] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0107] 1.8 Statistical methods

[0108] After the clinical data were collected, all the data were used to establish a database. The professional statistical software package SPSS 25.0 was used for statistical analysis. Measurement data were described by the mean and standard deviation (x±s). For measurement data conforming to the normal distribution, an independent samples t-test was selected for difference comparison. For measurement data that did not conform to the normal distribution, the rank sum test (Mann-Whitney U test) was used; for count data, the rank sum test and chi-square test were used. Hypothesis testing was uniformly performed using a two-sided test, and the test statistic and its corresponding P value were given. A P<0.05 was considered to have significant statistical significance.

[0109] 2. Results

[0110] 2.1 Case Completion

[0111] After one month of treatment, 2 cases (lost to follow-up) were lost among 50 patients, and 48 patients completed the follow-up after receiving efficacy evaluation one month after treatment.

[0112] 2.2 Clinical Efficacy

[0113] (1) Detection of Main Efficacy Indicators

[0114] For 48 patients, the marked effective rate was 10.42%, the effective rate was 41.67%, the ineffective rate was 47.92%, and the total effective rate was 52.08%. The specific results are shown in Table 1.

[0115] Table 1 Determination of Clinical Efficacy

[0116] Time Number of cases (dropouts) Marked effect (%) Effective (%) Ineffective (%) Effective rate (%) After treatment 48(-2) 5(10.42) 20(41.67) 23(47.92) 52.08

[0117] For DMED patients, the IIEF-15 scores: After 8 weeks of treatment, the total IIEF-15 scores of DMED patients were analyzed. The results showed that the IIEF-15 scores after treatment were significantly higher than those before treatment (P<0.05). The specific results are shown in Table 2.

[0118] Table 2 Comparison of Total IIEF-15 Scores of DMED Patients Before and After Treatment

[0119]

[0120] Note: * P<0.05 compared with before treatment.

[0121] (2) Detection of Secondary Observation Indicators:

[0122] Sex hormones in DMED patients: After 8 weeks of treatment, the sex hormone levels of DMED patients were analyzed before and after treatment. The results showed that the TE after treatment was significantly higher than that before treatment, the E2 was significantly lower than that before treatment, and there were no significant differences in FSH, LH, and PRL compared with before treatment. The specific results are shown in Table 3.

[0123] Table 3 Comparison of hormone levels in DMED patients before and after treatment

[0124] Time TE (nmol / L) E2 (pmol / L) FSH (IU / L) LH (IU / L) PRL (mIU / L) Before treatment 12.19±2.23 106.54±35.01 6.71±3.07 5.29±1.87 197.35±65.06 After treatment 14.18±3.42* 95.96±36.79* 6.43±3.16 5.42±1.93 197.52±66.98

[0125] Note: *P < 0.05 compared with before treatment.

[0126] TCM syndrome scores in DMED patients: After 8 weeks of treatment, the TCM syndrome scores of DMED patients were analyzed. The results showed that the scores of the main TCM symptoms and secondary symptoms after treatment were significantly lower than those before treatment (P < 0.05). The specific results are shown in Table 4 and Table 5.

[0127] Table 4 Comparison of scores of main TCM symptoms in DMED patients before and after treatment

[0128] Time Erectile function Weakness and soreness of the waist and knees Low libido Distending pain or dull pain in perineum Before treatment 4.25±1.49 2.94±1.80 3.06±0.43 1.25±1.62 After treatment 2.69±2.25* 2.38±1.75* 1.94±1.45* 0.50±1.13*

[0129] Table 5 Comparison of scores of secondary TCM symptoms in DMED patients before and after treatment

[0130] Time Feeling cold with cold limbs Lassitude Tinnitus and dizziness Before treatment 0.81±0.70 1.00±0.68 0.31±0.51 After treatment 0.44±0.54* 0.46±0.50* 0.29±0.46

[0131] Note: *P < 0.05 compared with before treatment.

[0132] 2.3 Safety analysis

[0133] During the treatment period, 1 case in the treatment group had nausea and vomiting after taking the medicine. The patient was instructed to warm the medicine before taking it, and the symptoms were relieved after the course of treatment was completed; 1 patient had diarrhea. There were no obvious changes in the blood pressure, heart rate, blood routine, renal function, and electrocardiogram examination results before and after treatment in the rest of the patients.

[0134] 2.4 Conclusion

[0135] Oral administration of the traditional Chinese medicine composition of Example 1 can effectively improve the clinical symptoms of diabetes complicated with erectile dysfunction, improve the erectile function, insertion satisfaction, orgasm, libido, and erectile hardness of patients, enhance the overall sexual life satisfaction, relieve the clinical TCM symptoms, have few side effects, and is clinically safe and effective.

[0136] Example 2

[0137] In this example, a traditional Chinese medicine composition for treating diabetic erectile dysfunction was prepared, including a medicament and a medicinal powder.

[0138] The formula is as follows:

[0139] Ginseng 6g, Rhodiola rosea 20g, Rehmannia glutinosa 30g (15g of raw and cooked Rehmannia glutinosa each), Astragalus membranaceus 30g (15g of raw and roasted Astragalus membranaceus each), Pueraria lobata 30g, Spatholobus suberectus 20g, Luffa cylindrica 10g, Prunus persica 6g, Carthamus tinctorius 6g, Angelica sinensis 10g, Paeonia lactiflora 12g, Radix Ilicis Pubescentis 40g, Morinda officinalis 15g, Lycium barbarum 15g, Epimedium brevicornu 15g, Bupleurum chinense 6g, Bombyx batryticatus 3g, Scolopendra subspinipes 3g, Notoginseng powder 2g.

[0140] The preparation process is as follows:

[0141] Soak ginseng, Rhodiola rosea, Rehmannia glutinosa, Astragalus membranaceus, Pueraria lobata, Spatholobus suberectus, Luffa cylindrica, Prunus persica, Carthamus tinctorius, Angelica sinensis, Paeonia lactiflora, Radix Ilicis Pubescentis, Morinda officinalis, Lycium barbarum, Epimedium brevicornu, and Bupleurum chinense in water for 30 minutes, with the water level 2 - 5 cm above the drug surface. After soaking, take out the medicinal materials and conduct two decoctions. Add 6 times the amount of water for the first decoction and 5 times the amount of water for the second decoction. Each decoction time is 20 minutes after boiling. Combine the two filtrates and remove the medicinal residues to obtain the medicament.

[0142] Pulverize Bombyx batryticatus, Scolopendra subspinipes, and Notoginseng powder, sieve through a No. 5 sieve, and take the material under the sieve to obtain the medicinal powder.

[0143] Experimental Example 2

[0144] 1. Data and Methods

[0145] 1.1 Case Selection: Select 80 patients with diabetic erectile dysfunction admitted to the outpatient and inpatient departments of the Department of Urology, Longhua Hospital from September 2022 to February 2025.

[0146] 1.2 Diagnostic Criteria:

[0147] (1) The western medicine diagnostic criteria refer to the diagnostic criteria of the "2022 ADA Diabetes Care Standards" and the "2018 AUA Erectile Dysfunction Guidelines": When the penis cannot achieve or maintain sufficient erection to complete satisfactory sexual intercourse, and the course of the disease exceeds 3 months, use the International Index of Erectile Function (IIEF - 5) to evaluate the patients. According to the IIEF - 5 scoring criteria, a score ≤ 21 points indicates that the patient has ED, among which 12 - 21 points is mild ED, 8 - 11 points is moderate ED, and 5 - 7 points is severe ED. Diabetic laboratory tests: Fasting plasma glucose FPG ≥ 7.0 mmol / L or 2 - hour plasma glucose during oral glucose tolerance test OGTT ≥ 11.1 mmol / L or random plasma glucose GLU ≥ 11.1 mmol / L or glycated hemoglobin HbA1c ≥ 48 mmol / L.

[0148] Diagnostic requirements: The patient needs to simultaneously meet the clinical symptoms of diabetes and erectile dysfunction. In addition, scale evaluation and laboratory tests support this diagnosis. And the onset of diabetes is earlier than that of erectile dysfunction, and there is a causal correlation between the two in terms of medical history.

[0149] (2) Traditional Chinese Medicine (TCM) Syndrome Criteria: Patients with erectile dysfunction belonging to the kidney deficiency and blood stasis type. In terms of the TCM diagnosis criteria, referring to the relevant syndrome formulation criteria in the "Guiding Principles for Clinical Research of New Chinese Medicines for the Treatment of Impotence", the specific criteria are as follows: Main symptoms: Erectile dysfunction of the penis, specifically including the inability of the penis to erect normally, weak erection or difficulty in maintaining the erection state, or accompanied by soreness and weakness of the waist and knees, low libido, dullness or pain in the perineum. Secondary symptoms: Fatigue, fear of cold and cold limbs, tinnitus and dizziness. Tongue and pulse: Red tongue with ecchymosis or purple and dark color, greasy or yellowish-greasy coating, deep and thready pulse, deep and slow or thready and unsmooth pulse.

[0150] Diagnosis Criteria: When the patient meets two of the main symptoms, one of the secondary symptoms, and combines with the characteristics of their tongue and pulse, the corresponding diagnosis can be made.

[0151] 1.3 Inclusion Criteria:

[0152] (1) Meeting the above-mentioned Chinese and Western medicine diagnosis criteria simultaneously;

[0153] (2) Married male patients aged between 20 and 65 years old, with normal libido, and at the same time can ensure the willingness and conditions for sexual life attempts with their spouses during the treatment period; At least one sexual life every 2 weeks during the treatment period, and at least 4 sexual lives throughout the treatment course;

[0154] (3) Blood glucose control situation: Fasting blood glucose (FBG) maintained between 4.4 mmol / L and 7.0 mmol / L, or 2-hour postprandial blood glucose (P2HBG) in the range of 4.4 mmol / L to 10.0 mmol / L, or glycated hemoglobin (HbA1c) not higher than 48 mmol / L;

[0155] (4) The patient needs to meet the Western medicine diagnosis criteria for both diabetes and erectile dysfunction simultaneously, and the diagnosis time of erectile dysfunction (ED) should not be earlier than the diagnosis of diabetes (DM);

[0156] (5) The course of diabetes ≤ 60 months, and the course of diabetes combined with erectile dysfunction ≥ 3 months;

[0157] (6) Have not used or discontinued other drugs or methods for treating ED in the three months before treatment;

[0158] (7) The IIEF-5 score is between mild and moderate: 8 points ≤ IIEF-5 score ≤ 21;

[0159] (8) Have voluntarily signed the informed consent form.

[0160] 1.4 Exclusion Criteria:

[0161] (1) Under 20 years old or over 65 years old;

[0162] (2) Severe IIEF-5 score: IIEF-5 score ≤ 7;

[0163] (3) History of alcoholism or drug abuse;

[0164] (4) Patients with diseases such as acute prostatitis, urethritis, penile lesions, urinary system stones, spinal cord injury, etc.; Exclude patients with vascular ED and gonad-related diseases;

[0165] (5) Any severe psychological abnormalities or use of psychotropic drugs;

[0166] (6) Patients who have long-term used hormonal drugs, sedatives, antihypertensive drugs, antidepressant drugs, diuretic drugs and related drugs;

[0167] (7) Patients with severe cerebrovascular diseases, cardiovascular diseases, neuropathy, hematopoietic system diseases, liver and kidney dysfunctions, and other complications caused by diabetes;

[0168] (8) Conditions such as erosion, ulcer, blister and suppuration at the penile affected area or skin breakage of the patient.

[0169] 1.5 Random grouping method

[0170] Use SPSS 29.0 statistical software for random grouping. The specific operations are as follows: First, set the starting fixed value of the random number generator to 72021046. Then, use the Rv.Uniform function to generate 80 random numbers between 0 and 1. Subsequently, with the help of the visual binning tool in the conversion function of the software, set the split point to 1 and the split width to 50% to evenly divide the 80 numbered random numbers into two groups, where number 1 represents the control group and number 2 represents the treatment group. At the same time, when admitting patients, assign a number to each patient in the order of admission and record the basic information of the patients. According to the patient number, find the corresponding random number in the random number table. For example, if the patient number is 1, take the number with the number 1 in the random number table; if the number is 35, assign the patient to the control group; if the number is 68, assign the patient to the treatment group. Record the grouping information (control group or treatment group) of the patients together with the patient numbers and basic information in a special table or database to ensure the accuracy and integrity of the data for subsequent research and analysis.

[0171] 1.6 Treatment plan

[0172] Basic treatment: On the basis of providing diabetes health education popularization, receiving medical nutrition guidance, conducting active physical exercise, and monitoring the changes in the condition for all patients, referring to the standards of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", routine basic treatment for diabetes was given (for the enrolled patients, metformin hydrochloride tablets (manufactured by Merck Pharmaceutical (Jiangsu) Co., Ltd. / manufacturer: Sino-American Shanghai Squibb Pharmaceutical Co., Ltd., specification: 0.5 g / tablet) were orally taken with meals, and insulin was combined for those with ineffective results), and the blood glucose was controlled at 4.4 mmol / L ≤ FBG ≤ 7.0 mmol / L, 4.4 mmol / L ≤ P2HBG ≤ 10.0 mmol / L, and the blood glucose was controlled at the ideal level as much as possible (if blood glucose fluctuations occurred, the treatment plan could be adjusted in a timely manner). At the same time, the patients were required not to smoke and limit alcohol consumption.

[0173] Control group: On the basis of basic treatment, sildenafil was orally administered (manufacturer: Pfizer Pharmaceutical Co., Ltd., specification: 50 mg / tablet), 1 tablet each time, once a night, and taken 1 hour before sexual intercourse, and 8 consecutive weeks were taken as a course of treatment.

[0174] Observation group: The traditional Chinese medicine composition of Example 2 was added on the basis of the control group. Each dose of the medicine was 200 mL, taken warm, and each dose of the powder was 4 g, swallowed, twice a day; 8 consecutive weeks were taken as a course of treatment.

[0175] 1.7 Efficacy and observation indicators

[0176] Each observation item was tested and evaluated within 1 week before treatment and within 1 month after 8 weeks (one course of treatment) of treatment.

[0177] (1) In terms of the main efficacy indicators:

[0178] Core indicator: That is, the corresponding scoring situation of the "International Index of Erectile Function Questionnaire (abbreviated as 'IIEF-15')".

[0179] (2) Secondary observation indicators:

[0180] The TCM syndrome scores, physical signs, tongue manifestations, and pulse conditions before and after treatment.

[0181] (3) Safety observation indicators:

[0182] Mainly observe whether there is physical discomfort during the treatment period, and ask whether there is an allergic reaction to the treatment, etc.

[0183] 1.8 Efficacy evaluation

[0184] (1) Referring to the "2022 ADA Diabetes Care Standards", the "2018 AUA Erectile Dysfunction Guidelines" and the "2022 Multidisciplinary Chinese Expert Consensus on Diabetes Complicated with Male Sexual Dysfunction", the efficacy criteria for the IIEF-15 score are as follows:

[0185] Ineffective: After treatment, the IIEF-15 score < 60 points, and the integral improvement < 30%;

[0186] Effective: After treatment, the IIEF-15 score < 60 points, and 30% ≤ integral improvement < 60%;

[0187] Markedly effective: After treatment, the IIEF-15 score ≥ 60 points, or after treatment, the IIEF-15 score < 60 points but the integral improvement ≥ 60%.

[0188] Note: The formula for calculating the integral improvement is: [(total integral after treatment - total integral before treatment)] / total integral before treatment × 100%

[0189] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0190] (2) The TCM efficacy criteria refer to the relevant syndrome determination criteria and expert guidance in the "Guiding Principles for Clinical Research of Traditional Chinese Medicines in the Treatment of Impotence", and the TCM syndrome scoring scale is used. The efficacy criteria are as follows:

[0191] Cured: The primary and secondary syndromes basically disappear or completely disappear, and the score decreases by ≥ 95% compared with before treatment;

[0192] Markedly effective: The primary and secondary syndromes are significantly relieved, and the score decreases by 60% ≤ and < 95% compared with before treatment;

[0193] Effective: The primary and secondary syndromes are partially relieved, and the score decreases by 30% ≤ and < 60% compared with before treatment;

[0194] Ineffective: The primary and secondary syndromes are not relieved or aggravated, and the score decreases by < 30% compared with before treatment.

[0195] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0196] (3) EHS score: According to the erectile hardness score (EHS) standard, observe and compare the changes in the EHS scores of the two groups of patients before and after treatment.

[0197] 1.9 Handling of adverse events

[0198] Predict and identify possible negative events. When these events occur, record their characteristics, severity, duration, and impact on the study participants in detail. According to the nature and severity of the events, take appropriate countermeasures, which may involve stopping treatment, adjusting the dose or treatment frequency, etc.

[0199] 1.10 Statistical methods

[0200] SPSS 29.0 software was used for data analysis. First, the continuous data were tested for normal distribution and homogeneity of variance. When the data conformed to the normal distribution and the variance was homogeneous, the t-test was used to analyze the data: the independent sample t-test was used to compare the two independent groups of samples; for the comparison of the same group of samples at different time points, the paired sample t-test was used, and the statistical results were presented in the form of mean plus or minus standard deviation (±s). If the data did not conform to the normal distribution or the variance was not homogeneous, non-parametric test methods were used instead. For multi-classified and ordered hierarchical data, such as the comparison of clinical efficacy between two groups, the rank sum test was used for analysis. All tests were judged at a significance level of α = 0.05.

[0201] 2. Results

[0202] 2.1 Basic clinical data

[0203] A total of 80 cases were collected, with 40 cases in the treatment group and 40 cases in the control group. Four cases in the treatment group and three cases in the control group dropped out for some reason, and the final effective cases were 36 cases in the treatment group and 37 cases in the control group. Before treatment, the age, severity of ED, IIEF-15 score, TCM syndrome score, fasting blood sugar level, and erection hardness score of the two groups were compared. The results showed that there was no statistically significant difference in each index (P>0.05).

[0204] 2.2 Clinical efficacy

[0205] After 8 weeks of treatment, the effectiveness of IIEF-15 score was compared and analyzed between the two groups of patients. In the treatment group, 8 patients reached the marked effect standard, 14 patients showed effectiveness, 14 patients were ineffective, and the total effective rate was 61.1%; in the control group, 2 patients were markedly effective, 12 patients were effective, 21 patients were ineffective, and the total effective rate was 38.8%. The clinical efficacy of the treatment group was significantly better than that of the control group. The efficacy data of the two groups were statistically analyzed by the chi-square test method, and the results showed that P<0.05, which indicated that the difference in efficacy results between the treatment group and the control group was statistically significant. The specific results are shown in Table 6.

[0206] Table 6 Comparison of clinical efficacy of two groups of DMED patients after treatment

[0207]

[0208] IIEF-15 scores of DMED patients: After 8 weeks of treatment, the total IIEF-15 scores of the two groups of DMED patients were analyzed. The results showed that the IIEF-15 scores of both groups after treatment were significantly higher than those before treatment (*P<0.05), which fully demonstrated that the treatment could improve erectile function; in terms of between-group comparison, the total IIEF-15 score of the treatment group was significantly higher than that of the control group, and the difference was statistically significant (P<0.05). The specific results are shown in Table 7.

[0209] Table 7 Comparison of IIEF-15 scores between two groups of DMED patients

[0210]

[0211] Note: *P<0.05 for within-group comparison before and after treatment; ▲P<0.05 for between-group comparison of the treatment compared with the control group after treatment.

[0212] Traditional Chinese medicine (TCM) syndrome scores of DMED patients: After 8 weeks of treatment, the overall TCM syndrome scores of the two groups of DMED patients were analyzed. The results showed that the overall TCM syndrome scores of both groups after treatment were significantly lower than those before treatment (*P<0.05) in within-group comparison, which indicated that the treatment could improve TCM syndromes; in terms of between-group comparison, the improvement of TCM syndrome scores in the treatment group was significantly better than that in the control group, and the difference was statistically significant (▲P<0.05). The specific results are shown in Table 8.

[0213] Table 8 Comparison of TCM syndrome scores between two groups of DMED patients before and after treatment

[0214]

[0215] Note: *P<0.05 for within-group comparison before and after treatment; ▲P<0.05 for between-group comparison of the treatment compared with the control group after treatment.

[0216] 2.3 Safety evaluation

[0217] No gastrointestinal reactions, skin sensitivity and other adverse reactions possibly related to the trial occurred in both groups of patients before, during and after treatment. There were no obvious abnormal fluctuations in blood pressure and heart rate before and after treatment. The liver function, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of the patients were within the normal range before and after the trial intervention, suggesting that the intervention treatment measures of this trial did not cause adverse damage.

[0218] 2.4 Conclusion

[0219] Oral administration of the traditional Chinese medicine composition of the present invention in combination with the western medicine sildenafil can significantly increase the erectile function of patients with diabetic erectile dysfunction compared with the sole use of western medicine, significantly relieve clinical symptoms, and the traditional Chinese medicine composition of the present invention plays a "synergistic effect" of modern drugs, and is safe without obvious side effects.

[0220] Test Example 3

[0221] 1. Data and Methods

[0222] 1.1 Case Selection

[0223] 80 patients with diabetes mellitus complicated with erectile dysfunction admitted to the outpatient and inpatient wards of the Department of Urology, Longhua Hospital from July 2022 to February 2025 were selected.

[0224] 1.2 Diagnostic criteria are the same as those in Test Example 1

[0225] 1.3 Inclusion criteria are the same as those in Test Example 1

[0226] 1.4 Exclusion criteria are the same as those in Test Example 1

[0227] 1.5 Treatment methods:

[0228] Basic treatment: On the basis of giving diabetes health education popularization, receiving medical nutrition guidance, carrying out active physical exercise, and monitoring the condition changes for all patients, referring to the standards of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", conventional basic treatment for diabetes was given (the patients in the study group took metformin hydrochloride tablets (manufactured by Merck Pharmaceutical (Jiangsu) Co., Ltd. / manufacturer: Sino-US Shanghai Squibb Pharmaceutical Co., Ltd., specification: 0.5 g / tablet) with meals, and insulin was combined if the effect was not obvious), and the blood glucose was controlled at 4.4 mmol / L ≤ FBG ≤ 7.0 mmol / L, 4.4 mmol / L ≤ P2HBG ≤ 10.0 mmol / L, and the blood glucose was controlled at the ideal level as much as possible (if blood glucose fluctuations occurred, the treatment plan could be adjusted in time). At the same time, the patients were required not to smoke and limit alcohol consumption.

[0229] Experimental group: Oral administration of the traditional Chinese medicine composition of Example 1. Each dose was 200 mL, taken warm, and each dose of powder was 3.5 g, swallowed; twice a day; continuous administration for 8 weeks was regarded as one course of treatment.

[0230] Control group: Oral administration of the traditional Chinese medicine composition in Chinese Patent "CN 112972562 B". Twice a day, 200 mL each time, taken warm; continuous administration for 8 weeks was regarded as one course of treatment.

[0231] 1.6 Observation indicators

[0232] Each observation item was tested and evaluated within 1 week before treatment and within 1 month after 8 weeks (one course of treatment).

[0233] (1) In terms of the main efficacy indicators:

[0234] Core indicator: The corresponding score of the "International Index of Erectile Function (abbreviated as "IIEF-15")" questionnaire.

[0235] (2) Secondary observation indicators:

[0236] 1) Erectile Hardness Score (EHS) before and after treatment;

[0237] 2) TCM syndrome scores, signs, tongue manifestations, and pulse conditions before and after treatment.

[0238] (3) Safety observation indicators:

[0239] General physical examination items: Measuring blood pressure and heart rate; Laboratory tests: Blood and urine routine; Electrocardiogram, liver function (ALT), and kidney function (BUN, Scr) examinations.

[0240] 1.7 Efficacy evaluation criteria

[0241] Referring to the "2022 ADA Diabetes Care Standards", the "2018 AUA Guidelines on the Management of Erectile Dysfunction", and the "2022 Multidisciplinary Chinese Expert Consensus on Diabetes Complicated with Male Sexual Dysfunction", the efficacy criteria for IIEF-15 scores are as follows:

[0242] Ineffective: The IIEF-15 score after treatment is < 60 points, and the integral improvement is < 30%;

[0243] Effective: The IIEF-15 score after treatment is < 60 points, and 30% ≤ integral improvement < 60%;

[0244] Markedly effective: The IIEF-15 score after treatment is ≥ 60 points, or the IIEF-15 score after treatment is < 60 points but the integral improvement is ≥ 60%.

[0245] Note: The calculation formula for integral improvement is: [(total score after treatment - total score before treatment)] / total score before treatment × 100%

[0246] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0247] 1.8 Statistical methods

[0248] After the clinical data were collected, all the data were entered into a database. Statistical analysis was performed using the professional statistical software package SPSS 25.0. Measurement data were described by the mean and standard deviation (x±s). For measurement data that conformed to a normal distribution, an independent samples t-test was selected for comparison of differences. For measurement data that did not conform to a normal distribution, the rank sum test (Mann-Whitney U test) was used; for count data, the rank sum test and chi-square test were used. Hypothesis testing was uniformly performed using two-sided tests, and the test statistic and its corresponding P value were given. A P<0.05 was considered to indicate significant statistical significance.

[0249] 2. Results

[0250] 2.1 Basic clinical data

[0251] A total of 80 cases of pathology were collected and randomly divided into a treatment group and a control group, with 40 cases in each group. Three cases in the treatment group and two cases in the control group dropped out due to reasons. Finally, the effective cases were 37 in the treatment group and 38 in the control group; the age of the treatment group was 28 - 61 years old, with an average of (39.05±9.15) years; the course of disease was 6 - 36 months, with an average of (19.03±9.58) months. The age of the control group was 26 - 63 years old, with an average of (40.38±10.37) years; the course of disease was 6 - 44 months, with an average of (18.52±11.16) months. There was no significant difference in the basic data between the two groups (P>0.05), and they were comparable.

[0252] 2.2 Clinical efficacy

[0253] After 8 weeks of treatment, a comparative analysis of the effective rate of the IIEF-15 score was performed on the two groups of patients. In the treatment group, 4 patients reached the marked improvement standard, 15 patients showed effectiveness, and 18 patients were ineffective, with a total effective rate of 51.35%; while in the control group, 1 patient had marked improvement, 8 patients were effective, and 29 patients were ineffective, with a total effective rate of 23.68%. The clinical efficacy of the treatment group was significantly better than that of the control group. Statistical analysis of the efficacy data of the two groups was performed using the chi-square test method, and the results showed P<0.05, indicating that the difference in the efficacy results between the treatment group and the control group was statistically significant. The specific results are shown in Table 9.

[0254] Table 9 Comparison of clinical efficacy of two groups of DMED patients after treatment

[0255]

[0256] IIEF-15 scores of DMED patients: After 8 weeks of treatment, the total IIEF-15 scores of the two groups of DMED patients were analyzed. The results showed that the IIEF-15 scores of both groups were significantly higher after treatment than before (*P<0.05), which fully demonstrated that the treatment could improve erectile function; in terms of between-group comparison, the total IIEF-15 score of the treatment group was significantly higher than that of the control group, and the difference was statistically significant (▲P<0.05). The specific results are shown in Table 10.

[0257] Table 10 Comparison of IIEF-15 scores between two groups of DMED patients

[0258]

[0259] Note: *P<0.05 for within-group comparison before and after treatment; ▲P<0.05 for between-group comparison of the treatment group compared with the control group after treatment. TCM syndrome scores of DMED patients: After 8 weeks of treatment, the overall TCM syndrome scores of the two groups of DMED patients were analyzed. The results showed that the overall TCM syndrome scores of both groups were lower after treatment than before within the group (*P<0.05), which indicated that the two groups of treatments could improve TCM syndromes; in terms of between-group comparison, there was no significant difference in the TCM syndrome scores between the treatment group and the control group (▲P>0.05). The specific results are shown in Table 11.

[0260] Table 11 Comparison of TCM syndrome scores between two groups of DMED patients before and after treatment

[0261]

[0262]

[0263] Note: *P<0.05 for within-group comparison before and after treatment; ▲P<0.05 for between-group comparison of the treatment group compared with the control group after treatment.

[0264] EHS scores of DMED patients: After 8 weeks of treatment, the overall TCM syndrome scores of the two groups of DMED patients were analyzed. The results showed that the EHS scores of both groups were higher after treatment than before within the group (*P<0.05), which indicated that the two groups of treatments could improve erectile hardness; in terms of between-group comparison, the improvement of the EHS score in the treatment group was significantly better than that in the control group, and the difference was statistically significant (▲P<0.05). The specific results are shown in Table 12.

[0265] Table 12 Comparison of EHS scores between two groups of DMED patients before and after treatment

[0266]

[0267] Note: *P<0.05 for within-group comparison before and after treatment; ▲P<0.05 for between-group comparison of the treatment compared with that of the control group after treatment.

[0268] 2.3 Conclusion

[0269] The traditional Chinese medicine composition of the present invention has better treatment effects in improving the erectile function and erectile hardness of patients with diabetes complicated with erectile dysfunction than the traditional Chinese medicine composition in the prior art. The traditional Chinese medicine composition in the prior art is targeted at erectile dysfunction in middle-aged and elderly men. On the basis of the composition in the prior art, the traditional Chinese medicine composition of the present invention combines the clinical manifestations and TCM syndromes of diabetes-related erectile dysfunction, re-compounds and combines the medicines, and prepares a formula with significant therapeutic effects on diabetes-related erectile dysfunction, which is more effective in treating diabetes erectile dysfunction.

[0270] The embodiments described above are only descriptions of the preferred modes of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic erectile dysfunction, characterized in that, It includes medicinal powder and medicinal agent; The medicinal powder, by weight parts, comprises the following raw materials: 3 - 6 parts of Bombyx Batryticatus, 2 - 3 parts of Scolopendra, and 2 - 3 parts of Radix Notoginseng powder; The medicinal agent, by weight parts, comprises the following raw materials: 5 - 10 parts of Ginseng, 12 - 20 parts of Rhodiola Rosea, 30 - 60 parts of Rehmannia Glutinosa, 15 - 60 parts of Astragalus Membranaceus, 20 - 40 parts of Pueraria Lobata, 15 - 30 parts of Spatholobus Suberectus, 9 - 12 parts of Luffa Cylindrica, 6 - 9 parts of Prunus Persica, 3 - 6 parts of Carthamus Tinctorius, 9 - 12 parts of Angelica Sinensis, 9 - 15 parts of Paeonia Lactiflora, 30 - 45 parts of Radix Ilicis Pubescentis, 10 - 20 parts of Morinda Officinalis, 10 - 20 parts of Lycium Barbarum, 10 - 20 parts of Epimedium Brevicornu, and 6 - 9 parts of Bupleurum Chinense.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It includes medicinal powder and medicinal agent; The medicinal powder, by weight parts, comprises the following raw materials: 3 parts of Bombyx Batryticatus, 3 parts of Scolopendra, and 2 parts of Radix Notoginseng powder; The medicinal agent, by weight parts, comprises the following raw materials: 6 parts of Ginseng, 20 parts of Rhodiola Rosea, 30 parts of Rehmannia Glutinosa, 30 parts of Astragalus Membranaceus, 30 parts of Pueraria Lobata, 20 parts of Spatholobus Suberectus, 10 parts of Luffa Cylindrica, 6 parts of Prunus Persica, 6 parts of Carthamus Tinctorius, 10 parts of Angelica Sinensis, 12 parts of Paeonia Lactiflora, 40 parts of Radix Ilicis Pubescentis, 15 parts of Morinda Officinalis, 15 parts of Lycium Barbarum, 15 parts of Epimedium Brevicornu, and 6 parts of Bupleurum Chinense.

3. The traditional Chinese medicine composition according to claim 1, wherein It includes medicinal powder and medicinal agent; The medicinal powder, by weight parts, comprises the following raw materials: 3 parts of Bombyx Batryticatus, 2 parts of Scolopendra, and 2 parts of Radix Notoginseng powder; The medicinal agent, by weight parts, comprises the following raw materials: 5 parts of Ginseng, 15 parts of Rhodiola Rosea, 30 parts of Rehmannia Glutinosa, 30 parts of Astragalus Membranaceus, 30 parts of Pueraria Lobata, 15 parts of Spatholobus Suberectus, 9 parts of Luffa Cylindrica, 9 parts of Prunus Persica, 6 parts of Carthamus Tinctorius, 9 parts of Angelica Sinensis, 15 parts of Paeonia Lactiflora, 30 parts of Radix Ilicis Pubescentis, 15 parts of Morinda Officinalis, 15 parts of Lycium Barbarum, 15 parts of Epimedium Brevicornu, and 6 parts of Bupleurum Chinense.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, It includes the following steps: (1) Crush Bombyx Batryticatus, Scolopendra, and Radix Notoginseng powder to obtain medicinal powder; (2) Mix Ginseng, Rhodiola Rosea, Rehmannia Glutinosa, Astragalus Membranaceus, Pueraria Lobata, Spatholobus Suberectus, Luffa Cylindrica, Prunus Persica, Carthamus Tinctorius, Angelica Sinensis, Paeonia Lactiflora, Radix Ilicis Pubescentis, Morinda Officinalis, Lycium Barbarum, Epimedium Brevicornu, and Bupleurum Chinense, and soak them in water; (3) Decoct the soaked medicinal materials with water, collect the decoction, and filter to obtain the medicinal agent.

5. The preparation method according to claim 4, characterized in that, After the crushing, it is passed through a No. 5 sieve, and the undersize is taken.

6. The preparation method according to claim 4, characterized in that, The soaking time is 20 - 40 min.

7. The preparation method according to claim 4, wherein The number of decocting times is 2 times; the water addition amount for the first decocting is 6 times the mass of the soaked medicinal materials, and the water addition amount for the second decocting is 5 times the mass of the soaked medicinal materials.

8. The preparation method according to claim 7, wherein, The decocting time for each time is 15 - 25 min after boiling.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 - 3 in the preparation of a drug for treating diabetes mellitus combined with erectile dysfunction.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 - 3 in the preparation of a drug for treating diabetic erectile dysfunction.

Images