Traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The composition is prepared from radix bupleuri, radix paeoniae alba, radix rehmanniae preparata, Chinese yam, fructus corni, cortex moutan, poria cocos, rhizoma alismatis, herba cistanche, centipede, flos carthami, cortex eucommiae, radix angelicae sinensis and liquorice root. Clinical research proves that the total treatment effective rate of the traditional Chinese medicine composition reaches 78.13% which is obviously superior to 28.13% of a control group, the IIEF-5 score can be obviously improved, the traditional Chinese medicine symptoms can be improved, the effect on the aspects of improving sexual confidence and sexual nature indexes, reducing time worry and other psychological indexes is outstanding, and meanwhile the adverse drug reaction occurrence rate is not obviously different from that of the control group. The traditional Chinese medicine composition has the advantages of definite curative effect, integral regulation and simultaneous treatment of mind and body, and can be popularized and applied on a large scale.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction, its preparation method, and its application. Background Technology

[0002] Erectile dysfunction (ED) is one of the most common chronic complications of type 2 diabetes mellitus (T2DM), clinically known as diabetic erectile dysfunction (DMED). Statistics show that the prevalence of ED in T2DM patients is as high as 35%-90%, and its incidence increases significantly with patient age and disease duration. DMED not only seriously affects patients' quality of life and marital relationships but also brings enormous psychological stress, posing a serious challenge to diabetes management.

[0003] A domestic multicenter survey report based on diabetes outpatient clinics showed that 75.1% of diabetic patients developed erectile dysfunction (ED), and more than 50% of men had varying degrees of ED symptoms 6 years after being diagnosed with diabetes [1]. Therefore, DMED is one of the most common complications of diabetes, and its prevalence increases year by year with the increase in the prevalence of diabetes. Modern expert consensus believes that it affects erectile function by causing changes in nerves, blood vessels, endocrine system, penile corpus cavernosum and psychology through oxidative stress, advanced glycation end products (AGEs), polyol pathway, and protein kinase C (PKC) pathway [2]. Its mechanism is complex, and it is difficult to treat erectile dysfunction caused by multiple mechanisms with a single drug. The treatment is difficult and seriously affects the patient's physical health, mental health and quality of life.

[0004] In traditional Chinese medicine, this disease falls under the category of "wasting and thirsting syndrome" followed by "impotence." Traditional Chinese medicine theory holds that its core pathogenesis lies in the prolonged "wasting and thirsting syndrome," which depletes qi and injures yin, leading to deficiency of both qi and yin—this is the root cause of the disease. Qi deficiency weakens the body's ability to circulate blood, while yin deficiency causes internal heat that scorches fluids, further resulting in blood stasis and damp-heat accumulation—this is the manifestation. The combination of deficiency and excess, with the root cause being deficient in the body's sinews and muscles, leads to flaccidity and impotence. Currently, although many traditional Chinese medicine formulas are used to treat impotence or diabetic complications, most suffer from the following problems: 1. Lack of specificity: Most prescriptions either focus on simply tonifying the kidneys and strengthening yang, ignoring the essential nature of DMED (Depression of Qi and Yin) and the superficial manifestations of blood stasis and damp heat, which can easily lead to "the body being unable to tolerate tonification" or exacerbate damp heat, thus worsening the condition; or they focus on promoting blood circulation and removing blood stasis, neglecting to support the body's vital energy, making it difficult to maintain the therapeutic effect.

[0005] 2. The prescription approach is too simplistic: it fails to accurately grasp the core and complex pathogenesis of DMED, which is "deficiency of both Qi and Yin as the root cause and blood stasis and damp heat as the symptoms." The treatment principles and methods are not comprehensive enough, making it difficult to achieve both symptomatic and root cause treatment.

[0006] 3. Lack of evidence-based support: Many empirical formulas lack sufficient modern pharmacological research, and their material basis and mechanism of action are unclear, making them difficult to be widely accepted and promoted.

[0007] Therefore, there is an urgent clinical need for a drug that is effective, has few side effects, and can regulate the body holistically from multiple targets and stages, improving erectile function while also addressing the underlying pathological changes of diabetes mellitus to treat type 2 diabetic erectile dysfunction (DMED). Based on this, the inventors, drawing on years of clinical experience, have conducted in-depth research into the TCM pathogenesis of DMED and proposed a novel TCM composition. This composition aims to address the root cause by tonifying Qi and nourishing Yin, and to treat the symptoms by promoting blood circulation, clearing heat, and eliminating dampness, providing a safer, more effective, and more radical TCM treatment option for DMED patients.

[0008] [1]Yang G, Pan C, Lu J. Prevalence of erectile dysfunction among Chinese men with type 2 diabetes mellitus [J]. Int J Impot Res. 2010, 22(5):310-317. [2] Expert Committee for the Drafting of the Multidisciplinary Chinese Expert Consensus on Diabetes Mellitus Complicated with Male Sexual Dysfunction. Chinese Journal of Andrology. 2022. Summary of the Invention

[0009] In view of this, the present invention provides a traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction, its preparation method and application, in order to solve the above problems.

[0010] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction, comprising the following components in parts by weight: Bupleurum chinense 8-10 parts, Paeonia lactiflora 13-17 parts, Rehmannia glutinosa 18-22 parts, Dioscorea opposita 13-17 parts, Cornus officinalis 10-15 parts, Paeonia suffruticosa 5-7 parts, Poria cocos 13-17 parts, Alisma plantago-aquatica 10-15 parts, Cistanche deserticola 10-15 parts, Scolopendra subspinipes 1.5-2.5 parts, Carthamus tinctorius 8-10 parts, Eucommia ulmoides 10-15 parts, Angelica sinensis 8-12 parts, and Glycyrrhiza uralensis 5-7 parts.

[0011] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: Bupleurum chinense 9 parts, Paeonia lactiflora 15 parts, Rehmannia glutinosa 20 parts, Dioscorea opposita 15 parts, Cornus officinalis 12 parts, Paeonia suffruticosa 6 parts, Poria cocos 15 parts, Alisma plantago-aquatica 12 parts, Cistanche deserticola 12 parts, Scolopendra subspinipes 2 parts, Carthamus tinctorius 9 parts, Eucommia ulmoides 12 parts, Angelica sinensis 10 parts, and Glycyrrhiza uralensis 6 parts.

[0012] Preferably, the Cistanche deserticola is Cistanche tubulosa, the Eucommia ulmoides is Eucommia ulmoides with salt, and the Glycyrrhiza uralensis is Glycyrrhiza uralensis prepared by roasting.

[0013] In Traditional Chinese Medicine (TCM), diabetic erectile dysfunction (ED) falls under the category of "Xiao Ke" (wasting and thirsting syndrome) followed by "Yang Wei" (impotence), with its core pathogenesis being "deficiency of the root and excess of the branch." The root deficiency primarily involves liver and kidney yin deficiency, which over time can damage kidney yang. The basic pathogenesis of diabetes (Xiao Ke) is yin deficiency, which, with prolonged illness, affects the kidneys, leading to kidney essence deficiency and malnourishment of the reproductive organs. The branch excess is characterized by liver qi stagnation and blood stasis. Emotional factors and long-term disease stress lead to liver dysfunction; while prolonged diabetes affects the blood vessels, causing "yin deficiency and blood stasis," resulting in microcirculatory disorders of blood vessels and nerves, damaging the structural basis of erectile function, and ultimately leading to diabetic ED.

[0014] The formula of this invention improves the complex pathological state of diabetic erectile dysfunction through multiple targets and pathways by "soothing the liver, tonifying the kidney, promoting blood circulation, and clearing the meridians".

[0015] I. Soothe the liver and relieve stagnation, regulate the flow of Qi—addressing the symptoms of "liver stagnation" Psychological stress and anxiety are significant factors that exacerbate erectile dysfunction (ED) in diabetic patients. The liver governs the free flow of Qi and regulates emotions; the liver meridian encircles the genitals.

[0016] Chief herbs: Bupleurum chinense, Paeonia lactiflora Bupleurum soothes the liver and relieves stagnation, regulating liver qi; white peony nourishes the blood and softens the liver, relieving spasms and pain. The two, one dispersing and the other astringent, harmonize liver qi and eliminate emotional factors that lead to erectile dysfunction.

[0017] Mechanism: Modern research suggests that soothing the liver and regulating qi can regulate the function of the autonomic nervous system, relieve excessive tension in smooth muscles, and create a favorable neural environment for erection. II. Nourishing the kidneys and replenishing essence, warming and assisting kidney yang—strengthening the root of "kidney deficiency".

[0018] II. Nourishing the Kidneys and Replenishing Essence, Warming and Assisting Kidney Yang—Strengthening the Root Cause of Kidney Deficiency The kidneys store essence, govern reproduction, and open into the two lower orifices (urethra and anus). Deficiency of kidney essence and insufficiency of kidney yang are the root causes of erectile dysfunction.

[0019] The herbal ingredients are: Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis; Cistanche deserticola, Eucommia ulmoides. Rehmannia glutinosa, Dioscorea opposita, and Cornus officinalis (the "Three Tonics"): These three ingredients are the core of the classic formula "Liuwei Dihuang Wan" (Six-Ingredient Rehmannia Pill), which greatly tonifies the Yin of the kidney, liver, and spleen, with the core function of nourishing the kidney and replenishing essence, providing the material basis ("Yin") for erection.

[0020] Cistanche deserticola and Eucommia ulmoides, while nourishing Yin, also warm and tonify Kidney Yang, strengthen the lower back and knees, and fortify muscles and bones. Cistanche deserticola is moistening without being drying, while Eucommia ulmoides tonifies the liver and kidneys and strengthens muscles and bones. Together, they warm and stimulate Kidney Yang, which is the source of erectile function ("Yang").

[0021] Mechanism: Kidney-tonifying drugs have been shown to regulate the function of the hypothalamus-pituitary-gonadal axis, potentially improving testosterone levels and enhancing the activity of nitric oxide synthase (NOS), thus promoting the production of nitric oxide (NO), a key mediator of erection.

[0022] III. Promoting Blood Circulation and Removing Blood Stasis, Unblocking Channels and Invigorating Yang – Overcoming the Obstruction of “Blood Stasis” This is the most targeted aspect of treating diabetic erectile dysfunction (ED). In Traditional Chinese Medicine (TCM), the vascular endothelial damage, neuropathy, and microcirculatory disturbances caused by diabetes are considered "prolonged illness affecting the collaterals" and "collateral obstruction." Without sufficient blood flow to the penis, erection becomes impossible.

[0023] Adjuvant herbs: centipede, safflower, angelica, peony bark Centipede and safflower promote blood circulation and unblock meridians. Centipede dispels wind and unblocks meridians with its powerful and penetrating properties, reaching directly to the affected area and clearing the deepest blockages in the meridians; safflower promotes blood circulation, unblocks meridians, removes blood stasis, relieves pain, and improves macroscopic blood circulation. Both are key to opening up vascular and nerve pathways.

[0024] Angelica sinensis and Paeonia suffruticosa nourish and invigorate the blood. Angelica sinensis replenishes and invigorates the blood without harming it; Paeonia suffruticosa clears heat, cools the blood, and invigorates the blood, while also counteracting the drying properties of warming tonics.

[0025] Mechanism: Blood-activating and stasis-removing drugs can significantly improve blood rheology, dilate blood vessels, inhibit platelet aggregation, and increase blood flow to the corpora cavernosa of the penis. Centipede, in particular, has been shown to have nerve growth factor-like effects, which may help repair nerve damage caused by diabetes.

[0026] IV. Strengthening the spleen and eliminating dampness, harmonizing the effects of various herbs—taking a holistic approach Diabetes (wasting and thirsting syndrome) is closely related to spleen deficiency (dysfunction in the transformation and transportation of food essence).

[0027] The adjuvant herbs, Poria cocos and Alisma plantago-aquatica, combined with Dioscorea opposita (which also tonifies the spleen), work together to strengthen the spleen and eliminate dampness. This prevents nourishing kidney-tonifying herbs (such as Rehmannia glutinosa) from harming the stomach, while simultaneously promoting diuresis to help the Yang Qi rise.

[0028] Licorice is used as an adjuvant to harmonize the various herbs, easing their effects and balancing their properties, so that the entire prescription works synergistically without producing a strong imbalance.

[0029] The formula of this invention works by "soothing the liver" to regulate the mind, "tonifying the kidneys" to strengthen the body's foundation, and "activating blood circulation" to unblock the meridians. These actions work together to address multiple pathological aspects of diabetic erectile dysfunction, including psychological, endocrine, vascular, and neurological factors, thereby achieving a comprehensive treatment for this complex disease.

[0030] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating type 2 diabetic erectile dysfunction.

[0031] Preferably, the dosage form of the drug is a decoction, granules, pills, powder, or ointment.

[0032] This invention also provides a method for preparing a decoction for treating type 2 diabetic erectile dysfunction, comprising the following steps: (1) Mix the Chinese herbal medicine composition with water, soak for 8-12 hours, decoct, filter, and collect the residue and filtrate 1 respectively; (2) Mix the filter residue with water, boil again, filter, and collect the filtrate 2; (3) Combine filtrate 1 and filtrate 2 to obtain the final product.

[0033] Preferably, the mass-to-volume ratio of the traditional Chinese medicine composition to water is 1g:15~20mL, and the mass-to-volume ratio of the filter residue to water is 1g:8~12mL.

[0034] Preferably, the simmering time is 20-30 minutes.

[0035] The present invention also provides a decoction prepared according to the preparation method described above.

[0036] By adopting the above technical solution, the present invention has the following beneficial effects: The composition of the present invention is composed of Bupleurum chinense, Paeonia lactiflora, Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Paeonia suffruticosa, Poria cocos, Alisma plantago-aquatica, Cistanche deserticola, Scolopendra subspinipes, Carthamus tinctorius, Eucommia ulmoides, Angelica sinensis, and Glycyrrhiza uralensis. The total effective rate of this traditional Chinese medicine composition was 78.13%, significantly higher than the 28.13% of the control group. p<0.05 Regarding IIEF-5 scores, the traditional Chinese medicine treatment group showed a significant difference compared to the control group. p<0.05 In terms of TCM symptom scores, there were significant differences between the two groups (p<0.05); in terms of sexual confidence and sexual naturalness index scores, both groups increased after treatment, but the increase in the TCM treatment group was significantly greater than that in the control group; in terms of time-related concerns scores, both groups decreased, but the decrease in the TCM treatment group was significantly less than that in the control group. p< 0.05 There was no significant difference in the incidence of adverse drug reactions between the two groups. p>0.05 In summary, the traditional Chinese medicine composition of the present invention not only significantly improves erectile dysfunction in patients with type 2 diabetes mellitus due to liver and kidney deficiency and blood stasis, but also effectively improves the patients' psychological and interpersonal relationships. Detailed Implementation

[0037] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0038] Example 1 A traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction consists of the following components: Bupleurum chinense 8 g, Paeonia lactiflora 13 g, Rehmannia glutinosa 18 g, Dioscorea opposita 13 g, Cornus officinalis 10 g, Paeonia suffruticosa 5 g, Poria cocos 13 g, Alisma plantago-aquatica 10 g, Cistanche deserticola 10 g, Scolopendra subspinipes 1.5 g, Carthamus tinctorius 8 g, Eucommia ulmoides 10 g, Angelica sinensis 8 g, and Glycyrrhiza uralensis 5 g.

[0039] Preparation method of decoction of traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction: Mix the above traditional Chinese medicine composition with water at a ratio of 1g:15mL, decoct for 20min, and collect the residue and filtrate 1 respectively; mix the residue with water at a ratio of 1g:8mL, decoct again for 20min, filter, collect filtrate 2, combine filtrate 1 and filtrate 2 to obtain the decoction.

[0040] Example 2 A traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction consists of the following components: Bupleurum chinense 9 g, Paeonia lactiflora 15 g, Rehmannia glutinosa 20 g, Dioscorea opposita 15 g, Cornus officinalis 12 g, Paeonia suffruticosa 6 g, Poria cocos 15 g, Alisma plantago-aquatica 12 g, Cistanche deserticola 12 g, Scolopendra subspinipes 2 g, Carthamus tinctorius 9 g, Eucommia ulmoides 2 g, Angelica sinensis 10 g, and Glycyrrhiza uralensis 6 g.

[0041] Preparation method of decoction of traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction: Mix the above traditional Chinese medicine composition with water at a ratio of 1g:18mL, decoct for 25min, and collect the residue and filtrate 1 respectively; mix the residue with water at a ratio of 1g:10mL, decoct again for 25min, filter, collect filtrate 2, combine filtrate 1 and filtrate 2 to obtain the decoction.

[0042] Example 3 A traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction consists of the following components: Bupleurum chinense 10 g, Paeonia lactiflora 17 g, Rehmannia glutinosa 22 g, Dioscorea opposita 17 g, Cornus officinalis 15 g, Paeonia suffruticosa 7 g, Poria cocos 17 g, Alisma plantago-aquatica 15 g, Cistanche deserticola 15 g, Scolopendra subspinipes 2.5 g, Carthamus tinctorius 10 g, Eucommia ulmoides 15 g, Angelica sinensis 12 g, and Glycyrrhiza uralensis 7 g.

[0043] Preparation method of decoction of traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction: Mix the above traditional Chinese medicine composition with water at a ratio of 1g:20mL, decoct for 30min, and collect the residue and filtrate 1 respectively; mix the residue with water at a ratio of 1g:12mL, decoct again for 30min, filter, collect filtrate 2, combine filtrate 1 and filtrate 2 to obtain the decoction.

[0044] Experimental Example 1. General Information Sixty-four patients with type 2 diabetic erectile dysfunction due to liver and kidney deficiency and blood stasis syndrome, admitted to the Department of Diabetes and Department of Traditional Chinese Medicine of Minhang District Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, from January 2024 to June 2025, were selected. They were randomly divided into a study group and a control group, with 32 patients in each group.

[0045] The study group consisted of 32 patients, aged 30–59 (47.6±7.4) years, with a disease duration of 3 months–3 years (20.28±10.03) months. The control group consisted of 32 patients, aged 32–60 (48.86±7.74) years, with a disease duration of 4 months–3 years (20.66±8.86) months. There was no statistically significant difference in age between the two groups at baseline. p >0.05).

[0046] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria: A. Diagnosis of diabetes: If the patient meets the diagnostic criteria for diabetes established by the American Diabetes Association (2024 version), namely fasting plasma glucose (FPG) ≥7.0 mmol / L, random plasma glucose ≥11.1 mmol / L, accompanied by symptoms of diabetes, and glycated hemoglobin ≥6.5%, the patient is diagnosed with type 2 diabetes.

[0047] B. Symptoms of sexual dysfunction For men: The criteria are mainly based on the 2022 Chinese Guidelines for the Diagnosis and Treatment of Andrological Diseases and Expert Consensus, which define it as the inability of men to consistently achieve and maintain sufficient penile erection for satisfactory sexual intercourse, with a duration of more than 3 months. The International Index of Erectile Function (IIEF-15) questionnaire is used for assessment (≤21 points indicate ED).

[0048] 2.2 TCM Syndrome Diagnostic Criteria: The syndrome criteria are mainly based on "Traditional Chinese Surgery" and "Practical Traditional Chinese Andrology". Symptoms include penile flaccidity and weak erection; soreness and weakness of the lower back and knees, fatigue, cold extremities, low mood, dizziness and tinnitus, dark tongue, and a thready or wiry pulse.

[0049] (1) Inclusion criteria: Males aged 20-60 years. Good cognitive function; no use of related medications in the past week. Have a stable life partner and regular sexual activity; no sexually transmitted diseases or mental illnesses; informed consent to participate in this study and complete the questionnaire.

[0050] (2) Exclusion and dropout criteria: No other endocrine diseases; no cardiovascular or cerebrovascular diseases; no infectious diseases; no malignant tumors. Patients with poor compliance who are unable to complete the observation period.

[0051] 3. Treatment methods Both groups of patients underwent dietary and exercise interventions, along with intensive metformin therapy to lower blood glucose levels. Blood glucose levels were monitored regularly, and treatment plans were adjusted as needed to maintain glycated hemoglobin levels below 7%, fasting blood glucose at 4.4-7.0 mmol / L, and random blood glucose below 10 mmol / L. The treatment group received the following herbal formula, while the control group received the same amount of deionized water.

[0052] Ingredients: Bupleurum chinense 9g; Paeonia lactiflora 15g; Rehmannia glutinosa 20g; Dioscorea opposita 15g; Cornus officinalis 12g; Paeonia suffruticosa 6g; Poria cocos 15g; Alisma plantago-aquatica 12g; Cistanche deserticola 12g; Scolopendra subspinipes 2g; Carthamus tinctorius 9g; Eucommia ulmoides (processed with salt) 12g; Angelica sinensis 10g; Glycyrrhiza uralensis (processed with honey) 6g. Decoct in water and take warm, one dose daily, twice a day (morning and evening). The total treatment course is one month.

[0053] Erectile function score: based on the IIEF-15 score. It is categorized as cured, significantly effective, effective, and ineffective. See Table 1 for specific criteria.

[0054] Table 1 IIEF-15 Scoring Criteria Classification Score criteria Score Cure After treatment with traditional Chinese medicine, erectile function can return to normal, and can complete a satisfactory sexual life ≥22 points Markedly effective The penis can be erected and achieve satisfactory insertion hardness, but lack of duration or firmness, and can still complete a satisfactory sexual life 12-21 points Effective Visible penile erection, can barely complete sexual life, with lower satisfaction 8-11 points Ineffective The penis cannot be erected and cannot complete sexual life ≤7 points Traditional Chinese Medicine Symptom Scoring: The scoring is based on the "General Principles of Clinical Research on New Traditional Chinese Medicine Drugs".

[0055] Psychological and social interpersonal relationship assessment: Based on the changes in the patient's psychological and social interpersonal relationships before and after treatment, the SF-PAIRS scale was used for assessment, including sexual confidence (3 items, 12 points); sexual naturalness index (4 items, 16 points); and time concerns (8 items, 32 points), for a total of 15 items. Sexual confidence: A higher score indicates better confidence in penile erection and achieving satisfactory sexual intercourse; Sexual naturalness index: A higher index indicates a more natural and relaxed intimate experience; Time concerns: A higher score indicates a stronger sense of urgency during sexual intercourse.

[0056] Adverse reaction rate: Record the number of cases of skin rash, gastrointestinal reactions, etc. in the treatment group.

[0057] Data were processed using SPSS 26; measurement data are expressed as (x ± s); t Test; use χ² for count data 2 test; p＜ 0.05 The difference is statistically significant.

[0058] 4. Results (1) The clinical efficacy and IIEF-5 scores of the two groups of patients after treatment are shown in Table 2 and Table 3, respectively: Table 2 Comparison of clinical efficacy Group Number of cases Cure Markedly effective Effective Ineffective Total effective rate Treatment group 32 7 14 4 7 78.13% Control group 32 1 2 6 23 28.13% Table 3 Comparison of IIEF-5 scores (scores, x±s) Number of cases Before treatment After treatment Adverse reactions Treatment group 32 10.19±4.57 15.16±6.05 1 case of diarrhea Control group 32 4.88±1.91 6.13±2.71 None As shown in Tables 2 and 3, based on clinical efficacy observation, the total effective rate in the treatment group after traditional Chinese medicine treatment was 78.13%, while the total effective rate in the control group was 28.13%. χ 2 The test showed that the difference in clinical efficacy between the two groups of patients was statistically significant. p <0.05), see Table 2. According to the IIEF-5 score: the scores of both groups improved before and after treatment, and there were significant differences between the two groups before and after treatment ( p <0.05). The scores of patients in the traditional Chinese medicine treatment group were significantly higher than those in the control group. t The test showed that there was a statistically significant difference in scores between the two groups of patients. p <0.05).

[0059] (2) The TCM symptom scores of the two groups of patients before and after treatment are shown in Table 4: Table 4 Comparison of TCM symptom scores (scores, x±s)

[0060] Table 4 shows that the TCM symptom scores of both groups of patients improved. p＜0.05 Furthermore, the TCM symptom scores in the TCM treatment group were significantly higher than those in the control group, and the difference in TCM symptom scores between the two groups was statistically significant. p ＜0.05 ).

[0061] (3) The SF-PAIRS scores of the two groups of patients before and after treatment are shown in Table 5: Table 5 Comparison of SF-PAIRS scores (scores, x±s)

[0062] *Note: Items marked with "a" indicate a comparison with the group before treatment. p <0.05. Table 5 shows that the SF-PAIRS scores of both groups increased in terms of sexual confidence and sexual naturalness index, while the time concern score decreased. The group receiving traditional Chinese medicine treatment showed significantly better scores in sexual confidence and sexual naturalness index than the control group, while the group receiving traditional Chinese medicine treatment had a lower score in time concern. The difference in SF-PAIRS scores between the two groups was statistically significant. p <0.05).

[0063] (4) Adverse reactions in the two groups of patients Only one case of mild diarrhea occurred in the treatment group, with an adverse reaction rate of 3%, and the difference was not statistically significant. p＞ 0.05 ).

[0064] As can be seen from the above embodiments, the present invention provides a traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction, its preparation method and application. The traditional Chinese medicine composition of the present invention has significant efficacy in treating type 2 diabetic erectile dysfunction.

[0065] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating type 2 diabetic erectile dysfunction, characterized in that, The formula comprises the following components in parts by weight: Bupleurum chinense 8-10 parts, Paeonia lactiflora 13-17 parts, Rehmannia glutinosa 18-22 parts, Dioscorea opposita 13-17 parts, Cornus officinalis 10-15 parts, Paeonia suffruticosa 5-7 parts, Poria cocos 13-17 parts, Alisma plantago-aquatica 10-15 parts, Cistanche deserticola 10-15 parts, Scolopendra subspinipes 1.5-2.5 parts, Carthamus tinctorius 8-10 parts, Eucommia ulmoides 10-15 parts, Angelica sinensis 8-12 parts, and Glycyrrhiza uralensis 5-7 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients include the following components in parts by weight: Bupleurum chinense 9 parts, Paeonia lactiflora 15 parts, Rehmannia glutinosa 20 parts, Dioscorea opposita 15 parts, Cornus officinalis 12 parts, Paeonia suffruticosa 6 parts, Poria cocos 15g parts, Alisma plantago-aquatica 12 parts, Cistanche deserticola 12 parts, Scolopendra subspinipes 2 parts, Carthamus tinctorius 9 parts, Eucommia ulmoides 12 parts, Angelica sinensis 10 parts, and Glycyrrhiza uralensis 6 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The Cistanche deserticola is Cistanche tubulosa, the Eucommia ulmoides is Eucommia ulmoides with salt, and the Glycyrrhiza uralensis is Glycyrrhiza uralensis prepared by roasting.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating type 2 diabetic erectile dysfunction.

5. The application according to claim 4, characterized in that, The dosage form of the drug is decoction, granules, pills, powder, or ointment.

6. A method for preparing a decoction for treating type 2 diabetic erectile dysfunction, characterized in that, Includes the following steps: (1) Mix the traditional Chinese medicine composition according to any one of claims 1 to 3 with water, soak for 8 to 12 hours, decoct, filter, and collect the residue and filtrate 1 respectively; (2) Mix the filter residue with water, boil again, filter, and collect the filtrate 2; (3) Combine filtrate 1 and filtrate 2 to obtain the final product.

7. The preparation method according to claim 6, characterized in that, The mass-to-volume ratio of the traditional Chinese medicine composition to water is 1g:15~20mL, and the mass-to-volume ratio of the filter residue to water is 1g:8~12mL.

8. The preparation method according to claim 6, characterized in that, The simmering time is 20-30 minutes.

9. The decoction prepared by the preparation method according to any one of claims 6 to 8.

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