Traditional Chinese medicine composition for treating diabetic erectile dysfunction, preparation method, preparation and application

Abstract

The invention provides a traditional Chinese medicine composition for treating diabetic erectile dysfunction, a preparation method, a preparation and application, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw materials: salvia miltiorrhiza and ligusticum wallichii, wherein the mass ratio of the salvia miltiorrhiza to the ligusticum wallichii is (0.1-10): 1. The raw materials of the traditional Chinese medicine composition are only composed of the salvia miltiorrhiza and the ligusticum wallichii, the composition is simple, the quality is easy to control, the raw materials are easy to obtain and low in price, the traditional Chinese medicine composition has a remarkable treatment effect on the diabetic erectile dysfunction, and the action effect is superior to that of each pair of medicines; according to the traditional Chinese medicine composition, the combined use of the two medicines has a better positive regulation effect than the single medicine effect, and the medicine synergistic effect is achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating diabetic erectile dysfunction, a preparation method, a preparation and application thereof. Background Art

[0002] Erectile dysfunction (ED) is a common sexual dysfunction, which refers to the inability of men to continuously obtain and maintain sufficient penile erection to complete a satisfactory sexual life. The occurrence of ED is closely related to many factors, such as lifestyle, age, psychological status, and related diseases such as nerves, blood vessels, and endocrines. Among them, diabetes is a common risk factor. Erectile dysfunction caused by diabetes is called diabetic erectile dysfunction (DMED), which is one of the most common complications of diabetic patients, and the incidence rate is increasing year by year. The incidence of DMED reported worldwide is 20%-75%. The occurrence and development of DMED is a complex process mediated by multiple factors and multiple steps, which is related to vascular endothelial dysfunction, vascular neuropathy, abnormal hormone levels, and psychological diseases. Modern medicine has no specific drugs for the treatment of this disease, and most of them are based on PDE5 inhibitors. However, due to the complexity of the mechanism of DMED, the sensitivity to traditional drugs is poor, and there is a certain bottleneck in clinical efficacy, which cannot meet the needs of most patients.

[0003] According to traditional Chinese medicine, erectile dysfunction caused by diabetes belongs to diabetes combined with impotence. In terms of treatment, diabetes should be the basis and impotence should be the symptom. As a chronic disease, the cause and pathogenesis of diabetes will gradually change as the disease progresses. In the early stage, it is mainly caused by deficiency of yin and fluid, and the dryness and heat are dominant. The lesions are mainly in the lungs, stomach, and kidneys, but kidney yin deficiency is the most critical. In the later stage, yin is damaged and yang is even deficient, or both yin and yang are deficient, then there will be pathological changes such as long-term illness entering the collaterals and long-term illness causing blood stasis, and the syndrome of kidney deficiency and blood stasis will be formed, which will make the qi and blood flow poorly, blood vessels stagnant, and the tendons lose their nourishment, thus causing impotence.

[0004] At present, there are Chinese medicine formulas for treating diabetic erectile dysfunction, such as: Chinese invention patent CN116350706B discloses a Chinese medicine composition for treating diabetic impotence and its preparation method, the Chinese medicine composition is composed of Chuanxiong, Danshen, Angelica, Rehmannia glutinosa, Cornus officinalis, Chinese yam, Atractylodes, Bupleurum, Lycium barbarum, Cnidium monnieri, Cuscuta australis, Leech, Ephedra, Deer Horn Glue, Epimedium, Millettia reticulata, Silkworm Cocoon and Tortoise Shell. The Chinese medicine formula has many Chinese medicinal flavors, and some raw materials are not easy to obtain, and the cost is high. Chinese invention patent publication number CN104922202A discloses a composition for treating diabetic erectile dysfunction and its preparation method, the preparation method includes preparing outer layer particles with hypoglycemic effect and middle layer particles with aphrodisiac and anti-fatigue function; and then pressing the outer layer particles and the middle layer particles into tablets. However, the effect of the composition needs to be further improved.

[0005] Therefore, there is an urgent need to provide a Chinese medicine composition for treating diabetic erectile dysfunction with simple prescription, readily available raw materials, low cost and good effect. Summary of the invention

[0006] The present invention aims at the problems existing in the prior art and provides a Chinese medicine composition, a preparation method, a preparation and an application for treating diabetic erectile dysfunction. The composition consists of only two Chinese medicine raw materials, namely, salvia miltiorrhiza and chuanxiong. The pharmacological action results show that the Chinese medicine composition has a good effect in treating diabetic erectile dysfunction.

[0007] To achieve the above purpose, the technical solution adopted by the present invention is as follows: The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating diabetic erectile dysfunction. The raw materials of the traditional Chinese medicine composition include salvia miltiorrhiza and chuanxiong rhizome, and the mass ratio of salvia miltiorrhiza to chuanxiong rhizome is 0.1-10:1.

[0008] Preferably, the mass ratio of Salvia miltiorrhiza to Ligusticum chuanxiong is 0.5-3:1.

[0009] Furthermore, the mass ratio of Salvia miltiorrhiza to Ligusticum chuanxiong is 0.1:1.

[0010] Furthermore, the mass ratio of Salvia miltiorrhiza to Ligusticum chuanxiong is 0.5:1.

[0011] Furthermore, the mass ratio of Salvia miltiorrhiza to Ligusticum chuanxiong is 1:1.

[0012] Furthermore, the mass ratio of Salvia miltiorrhiza to Ligusticum chuanxiong is 2:1.

[0013] Furthermore, the mass ratio of Salvia miltiorrhiza to Ligusticum chuanxiong is 10:1.

[0014] The second aspect of the present invention relates to a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps: (1) taking raw materials of Danshen and Chuanxiong according to proportion, decocting in water, filtering and obtaining a water extract; (2) Add ethanol to the aqueous extract, let it stand, take the supernatant, recover the ethanol under reduced pressure, concentrate, and dry to obtain the product.

[0015] Preferably, the decoction in step (1) is performed 1-3 times, the amount of water added for a single decoction is 6-10 times the weight of the raw material, and the single decoction time is 1-2 hours.

[0016] Further preferably, the water decoction in step (1) is performed three times, the amount of water added for a single decoction is 8 times the weight of the raw material, the first decoction is performed for 2 hours, and the second and third decoctions are performed for 1.5 hours each.

[0017] Preferably, in step (2), the aqueous extract is concentrated before adding ethanol, and ethanol is added after the aqueous extract is concentrated to a crude drug concentration of 0.8-1.2 mg / mL, the volume concentration of ethanol in the concentrate is 70-95%, and the standing time is 8-15 hours.

[0018] Further preferably, in step (2), the water extract is concentrated to a crude drug concentration of 1 mg / mL before adding ethanol, the volume concentration of ethanol in the concentrate is 85%, and the standing time is 10 h.

[0019] The third aspect of the present invention is a preparation comprising the above-mentioned Chinese medicine composition, wherein the preparation is in the form of an oral solution, tablet, capsule, granule, paste, pill or mixture.

[0020] Preferably, the preparation further comprises a pharmaceutically acceptable excipient.

[0021] The fourth aspect of the present invention is the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared according to the above-mentioned preparation method or the preparation containing the above-mentioned composition in the preparation of a drug for treating diabetic erectile dysfunction.

[0022] Compared with the prior art, the present invention has the following beneficial effects: (1) The raw materials of the Chinese medicine composition of the present invention are composed of only two herbs, namely, Danshen and Chuanxiong, and the medicinal composition is simple, the quality is easy to control, the raw materials are easy to obtain, and the price is low; (2) The Chinese medicine composition of the present invention has a significant therapeutic effect on diabetic erectile dysfunction, and the effect is better than that of each comparative example; (3) The combination of the two herbs in the Chinese medicine composition of the present invention has a better positive regulatory effect than the single drug effect, and has a drug synergistic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 : Statistical diagram of the effects of different embodiments and comparative examples on body weight; Figure 2 : Statistical graph of the effects of different embodiments and comparative examples on fasting blood glucose. DETAILED DESCRIPTION

[0024] The present invention will be further described below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer as the description proceeds. However, these embodiments are exemplary only and do not constitute any limitation to the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

[0025] It is worth noting that the raw materials used in the present invention are all common commercially available products, and their sources are not specifically limited.

[0026] Embodiment 1: This embodiment provides a Chinese medicine composition for treating diabetic erectile dysfunction, which is composed of raw materials Danshen and Chuanxiong in a weight ratio of 0.5:1. Preparation process: Take Danshen and Chuanxiong, decoct in water three times, add 8 times the amount of water each time, decoct for 2 hours for the first time, and decoct for 1.5 hours for the second and third times respectively, combine the filtrate to obtain a water extract, concentrate the concentrated water extract to a crude drug concentration of 1 mg / mL, add ethanol, the volume concentration of ethanol in the concentrate is 85%, stand for 10 hours, take the supernatant, recover the ethanol under reduced pressure, and obtain a clear paste after concentration.

[0027] Embodiment 2: This embodiment provides a Chinese medicine composition for treating diabetic erectile dysfunction, which is composed of raw materials Danshen and Chuanxiong in a weight ratio of 1:1. Preparation process: Take Danshen and Chuanxiong, decoct in water three times, add 8 times the amount of water each time, decoct for 2 hours for the first time, and decoct for 1.5 hours for the second and third times respectively, combine the filtrate to obtain a water extract, concentrate the concentrated water extract to a crude drug concentration of 1 mg / mL, add ethanol, the volume concentration of ethanol in the concentrate is 85%, stand for 10 hours, take the supernatant, recover the ethanol under reduced pressure, and obtain a clear paste after concentration.

[0028] Embodiment 3: This embodiment provides a Chinese medicine composition for treating diabetic erectile dysfunction, which is composed of raw materials Danshen and Chuanxiong in a weight ratio of 2:1. Preparation process: Take Danshen and Chuanxiong, decoct in water three times, add 8 times the amount of water each time, decoct for 2 hours for the first time, decoct for 1.5 hours for the second and third times, combine the filtrate to obtain a water extract, concentrate the concentrated water extract to a crude drug concentration of 1 mg / mL, add ethanol, the volume concentration of ethanol in the concentrate is 85%, stand for 10 hours, take the supernatant, recover the ethanol under reduced pressure, and obtain a clear paste after concentration.

[0029] Comparative Example 1: This comparative example provides salvianolic acid B, an active ingredient in Salvia miltiorrhiza miltiorrhiza, which has been disclosed to be able to treat diabetic complications.

[0030] Comparative Example 2: This comparative example provides ferulic acid, an active ingredient in Ligusticum chuanxiong, which has been disclosed to be able to treat diabetic complications.

[0031] Comparative Example 3: This embodiment provides a Chinese medicine composition for treating diabetic erectile dysfunction, which is composed of raw materials Danshen and Epimedium in a weight ratio of 1:1. Preparation process: Take Danshen and Epimedium, decoct in water three times, add 8 times the amount of water each time, decoct for 2 hours for the first time, decoct for 1.5 hours for the second and third times, combine the filtrate to obtain a water extract, concentrate the concentrated water extract to a crude drug concentration of 1 mg / mL, add ethanol, the volume concentration of ethanol in the concentrate is 85%, stand for 10 hours, take the supernatant, recover the ethanol under reduced pressure, and concentrate to obtain a clear paste.

[0032] The difference from Example 2 is that the raw material is replaced by Epimedium brevicornum. The rest is the same as Example 2.

[0033] Comparative Example 4: A Chinese medicine extract for treating diabetic erectile dysfunction comprises the following steps: taking salvia miltiorrhiza, decocting it in water for three times, adding 8 times the amount of water each time, decocting it for 2 hours for the first time, decocting it for 1.5 hours for the second and third times respectively, combining the filtrates to obtain a water extract, concentrating the concentrated water extract to a crude drug concentration of 1 mg / mL, adding ethanol, wherein the volume concentration of ethanol in the concentrated solution is 85%, standing for 10 hours, taking the supernatant, recovering the ethanol under reduced pressure, and concentrating to obtain a clear paste.

[0034] The difference from Example 2 is that the raw material contains only Salvia miltiorrhiza. Other ingredients are the same as Example 2.

[0035] Comparative Example 5: A Chinese medicine extract for treating diabetic erectile dysfunction comprises the following steps: taking Chuanxiong, decocting it in water for three times, adding 8 times the amount of water each time, decocting it for 2 hours for the first time, decocting it for 1.5 hours for the second and third times respectively, combining the filtrates to obtain a water extract, concentrating the concentrated water extract to a crude drug concentration of 1 mg / mL, adding ethanol, wherein the volume concentration of ethanol in the concentrated solution is 85%, standing for 10 hours, taking the supernatant, recovering the ethanol under reduced pressure, and concentrating to obtain a clear paste.

[0036] The difference from Example 2 is that the raw material contains only Chuanxiong. Others are the same as Example 2.

[0037] Comparative Example 6: A Chinese medicine composition for treating diabetic erectile dysfunction is composed of raw materials Danshen and Chuanxiong in a weight ratio of 20:1. Preparation process: Danshen and Chuanxiong are taken, decocted in water for three times, 8 times the amount of water is added each time, the first decoction is 2 hours, the second and third decoctions are 1.5 hours each, the filtrate is combined to obtain a water extract, the concentrated water extract is concentrated to a crude drug concentration of 1 mg / mL, and ethanol is added, the volume concentration of ethanol in the concentrated solution is 85%, the standing time is 10 hours, the supernatant is taken, the ethanol is recovered under reduced pressure, and the clear paste is obtained after concentration.

[0038] The difference from Example 2 is that the ratio of Salvia miltiorrhiza and Chuanxiong in the raw materials is different, the ratio of the two in Example 2 is 1:1, while the ratio of the two in this comparative example is 20:1. The rest is the same as Example 2.

[0039] Comparative Example 7: This embodiment provides a Chinese medicine composition for treating diabetic erectile dysfunction, which is composed of raw materials Danshen and Chuanxiong in a weight ratio of 1:20. Preparation process: Take Danshen and Chuanxiong, decoct in water three times, add 8 times the amount of water each time, decoct for 2 hours for the first time, decoct for 1.5 hours for the second and third times, combine the filtrate to obtain a water extract, concentrate the concentrated water extract to a crude drug concentration of 1 mg / mL, add ethanol, the volume concentration of ethanol in the concentrate is 85%, stand for 10 hours, take the supernatant, recover the ethanol under reduced pressure, and concentrate to obtain a clear paste.

[0040] The difference from Example 2 is that the ratio of Salvia miltiorrhiza and Chuanxiong in the raw materials is different, the ratio of the two in Example 2 is 1:1, while the ratio of the two in this comparative example is 1:20. The rest is the same as Example 2.

[0041] Comparative Example 8: This embodiment provides a Chinese medicine composition for treating diabetic erectile dysfunction, which is composed of raw materials Danshen and Chuanxiong in a weight ratio of 1:1. Preparation process: Take Danshen and Chuanxiong, decoct in water three times, add 8 times the amount of water each time, decoct for 2 hours for the first time, and decoct for 1.5 hours for the second and third times respectively, combine the filtrate to obtain a water extract, and concentrate the water extract to obtain a clear paste.

[0042] The difference from Example 2 is that the preparation process is different, and the alcohol precipitation process after water extraction is omitted in this comparative example.

[0043] Experimental Example 1: Effect on diabetic erectile dysfunction (DMED) Experimental Animals The animal model used in this experiment was 8-week-old male SD rats weighing 260-300 g provided by the Experimental Animal Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The entire experimental process strictly followed the Welfare and Use Standards for Laboratory Animals of Tongji Medical College, Huazhong University of Science and Technology (TJH-202205016) to ensure that all animals received reasonable care and treatment.

[0044] Construction of DMED rat model After the rats were adaptively fed for 1 week, they were fasted for 12 hours, and the body weight and fasting blood glucose measured by the tail vein of the rats were recorded. Then, except for 10 normal rats as the control group, the remaining rats were injected with 1% streptozotocin (STZ. 60mg / kg) dissolved in the dark intraperitoneal cavity, and the control group was injected with the same dose of saline. After injection, the abdominal blood glucose of the rats was measured to be higher than 16.7mmol / L for three consecutive days, and the DM model was considered to be successful. In the 8th week after the successful DM modeling, apomorphine (APO) was injected subcutaneously in the neck of the rats at 100μg / kg, and the erection of the rats was observed. The number of times the glans penis of the rats was exposed or the penis body grew was recorded. The rats were observed for 30 minutes after the injection of APO, and the total number of erections of the rats was recorded during the period. If no erection occurred, the DMED rat model was considered to be successful.

[0045] According to the above experimental determination, the rats with successful DMED modeling were screened and randomly divided into 12 groups, namely: DMED group, drug administration group (Example 1-3 group, Comparative Example 1-8 group), 10 rats in each group. In addition, 10 normal rats without modeling were used as the control group. After Examples 1-3 and Comparative Examples 1-8 were diluted to a certain concentration with normal saline, they were gavaged once a day, wherein the dosage of Examples 1-3 and Comparative Examples 3-8 groups was 1.2 g crude drug / kg / d, the dosage of Comparative Example 1 group was 12 mg / kg / d, and the dosage of Comparative Example 2 group was 0.3 mg / kg / d; the control group and the DMED group were gavaged with an equal amount of normal saline daily; for 4 weeks.

[0046] Evaluation of erectile dysfunction After 4 weeks of drug administration, rats were anesthetized with an intraperitoneal injection of 20 mg / kg 0.4% sodium pentobarbital solution, and a carotid artery catheter was placed to expose the cavernous nerves on both sides of the prostate and provide electrical stimulation (15 Hz, 5 V, 1 min) using a BL-420F biosignal acquisition system (Techman Soft, Chengdu, China). Arterial pressure (MAP) and intracavitary pressure (ICP) were monitored and recorded.

[0047] Histopathological evaluation After measuring the MAP and ICP of rats, the rat corpus cavernosum was completely cut off using tissue scissors, and then the rats were killed by carbon dioxide inhalation. The tissues were fixed in 4% paraformaldehyde for 24 h, embedded in paraffin and cut into 5-µm sections. After dewaxing and hydration, antigen retrieval was performed. The smooth muscle / collagen ratio of the corpus cavernosum tissue was calculated by Masson staining to evaluate the degree of fibrosis.

[0048] Results The body weight and fasting blood glucose levels of all rats were monitored after DM modeling (8th week of the experiment) and after the end of drug administration (12th week of the experiment). Figure 1 , Figure 2 . Figure 1 It shows that after the experiment started, the weight of the rats in the control group increased significantly; the weight of the rats in the DMED group hardly increased; the weight of the rats in Example 2 group increased slightly, and the weight of the rats in Example 1, Group 3, and Comparative Example 1-8 groups did not increase significantly. Figure 2 The results showed that after 4 weeks of continuous oral administration of the drug, the degree of reduction in fasting blood glucose in the rats in each group did not show significant changes. This result indicated that the drug had no significant effect on the glucose metabolism state of DM rats.

[0049] The ICP and MAP of each group were detected, and the ratio of MAX ICP / MAP was calculated to evaluate the effects of different interventions on the erectile function of rats. The specific results are shown in Table 1.

[0050] Table 1: Comparison of erectile function in rats of each group ( x̄ ± s )

[0051] Note: Compared with the normal group, a: P < 0.001; compared with the DMED group, each drug-treated group b: P < 0.05, c: P < 0.01, d: P < 0.001; compared with Example 3, each comparative example e: P < 0.05, f: P < 0.01; compared with Example 2, each comparative example g: P < 0.05.

[0052] Compared with the control group, the MAX ICP / MAP ratio of rats in the DMED group was significantly reduced; compared with the DMED group, the drugs in Examples 1-3, Comparative Example 3, and Comparative Example 6-8 groups can significantly increase the MAX ICP / MAP ratio of model rats. Compared with Example 3, the positive regulatory effect of the drugs in each comparative example group on the MAX ICP / MAP ratio of rats is significantly weaker than that in Example 3. Among the examples, the effect of Example 2 is significantly better than that of Example 1 and Example 3. Therefore, the drugs in each example can significantly increase the MAX ICP / MAP ratio of model rats, and the effect is better than that of the drugs in each comparative example group. And among Examples 1-3, the effect of Example 2 is the best.

[0053] The smooth muscle / collagen ratio of the corpus cavernosum tissue was calculated by Masson staining to evaluate the degree of fibrosis. The specific results are shown in Table 2.

[0054] Table 2: Smooth muscle / collagen ratio of the corpus cavernosum tissue of each group of rats ( x̄ ± s )

[0055] Note: Compared with the normal group, a: P < 0.001; compared with the DMED group, each drug-treated group b: P < 0.05, c: P < 0.01, d: P < 0.001; compared with Example 3, each comparative example e: P < 0.05, f: P < 0.01; compared with Example 2, each comparative example g: P < 0.05.

[0056] Compared with the control group, the degree of fibrosis of the corpus cavernosum of the rats in the DMED group was significantly increased; each embodiment group can improve the degree of fibrosis of the corpus cavernosum of the rats in the model group, and the difference is statistically significant (P < 0.05) or significantly different (P < 0.01) or extremely significant (P < 0.001) compared with the DMED group. Compared with the Example 3 group, the effects of each comparative example are significantly worse than those of Example 3, and the differences are statistically significant (P < 0.05) or significantly different (P < 0.01). Among the embodiments, Example 2 has the best effect, which is better than Example 1 and Example 3.

[0057] In summary, the Chinese medicine composition with specific composition and specific ratio provided by the present invention has a significant improvement effect on diabetic erectile dysfunction. And Example 2 (Danshen and Chuanxiong in a weight ratio of 1:1, 1200 mg / kg / d) has the best effect, which is better than Example 1 and Example 3.

[0058] Medical Case 1 Patient Zhang, male, 52 years old, visited the hospital on September 8, 2020. Main complaint: impotence for more than 5 years. At present: erection is not firm, erection is not long, less than 2 minutes, dry nasal cavity, backache, drowsiness, easy to sleep, fatigue, severe scrotal moisture, frequent urination, large amount, good appetite, normal bowel movements. Red tongue, less coating, sublingual collaterals swollen, thin pulse. Meal Blood sugar before 9.0 mmol / L. Past history: Type 2 diabetes for more than 10 years. TCM diagnosis: diabetes combined with impotence. Western medicine diagnosis: diabetic erectile dysfunction. Syndrome differentiation: liver and kidney yin deficiency, with blood stasis. Take the prescription of Example 2 (Danshen and Chuanxiong in a weight ratio of 1:1) for 2 weeks.

[0059] The second visit showed that the blood sugar before meals was 8.6, fatigue improved, tongue was red, and pulse was weak. Continue taking the medicine for 2 weeks; Third visit: All symptoms improved, and the above medicine was continued for 2 weeks. The patient was advised to control blood sugar and sexual intercourse frequency, and regulate emotions. After follow-up, all symptoms were gone.

[0060] Medical Case 2 Patient Chen, male, 49 years old, was admitted on June 8, 2021. The patient had no obvious cause 6 months ago.

[0061] During sexual intercourse, the penis erection hardness decreases and morning erection disappears. However, the patient does not pay enough attention to it and does not receive standardized treatment. Later, the symptoms gradually worsen and it becomes difficult to complete sexual intercourse. Current symptoms: Erectile function decreases, and the penis can be erected from time to time but the hardness is insufficient.

[0062] To complete sexual intercourse, with the disappearance of morning erections, low libido, damp scrotum, depression, fatigue, dry mouth, bitter mouth, cold hands and feet, occasional tingling in the flanks, soreness of waist and knees. Poor appetite, no desire to eat, abdominal distension after eating a little, poor sleep, difficulty falling asleep, easy to wake up, frequent urination, dry stool, dark tongue, ecchymosis, tooth marks on the edges, thin white fur, fine and astringent. Past history of diabetes for 5 years, oral hypoglycemic drug treatment, irregular diet, irregular blood sugar detection. Traditional Chinese medicine diagnosis: impotence; Western medicine diagnosis: erectile dysfunction; Traditional Chinese medicine differentiation: Qi stagnation and blood stasis, Qi and Yin deficiency syndrome. Treatment: Qi and blood circulation, nourishing yin and qi. Take Example 2 (Danshen and Chuanxiong according to the weight ratio of 1:1) for 2 weeks.

[0063] Second visit on June 22, 2021. After taking the medicine, the patient had sexual intercourse 3 times, 1 of which was successful. The erection hardness was better than before, the morning erection was restored than before, and the morning erection was about 4 times in the past 2 weeks. The sexual desire was enhanced, the scrotal moisture was reduced, the pain in the two ribs was relieved, the physical strength was restored than before, and the dry mouth and bitter mouth were relieved. The appetite was slightly restored, but there was still abdominal distension from time to time. The tongue was dark red with ecchymosis, the fur was thin and white, and the pulse was stringy and astringent. Continue to take the prescription of Example 2 (Danshen and Chuanxiong in a weight ratio of 1:1) for 2 weeks.

[0064] On July 8, 2021, the patient had sexual intercourse 4 times after taking the medicine, 3 times successfully, the erection hardness further improved, the morning erection recovered, and the morning erection was about 10 times in the past 2 weeks. The scrotal moisture was relieved, the physical strength was restored, the sleep quality was improved, and the sleep was better than before. The tongue was dark red, the fur was thin and white, and the pulse was slightly stringy. Continue to take the prescription of Example 2 (Danshen and Chuanxiong according to the weight ratio of 1:1) for 2 weeks. The method of administration is the same as before.

[0065] Telephone follow-up on July 22, 2021: The couple’s sexual intercourse is normal, all symptoms have improved significantly, and the therapeutic effect is satisfactory.

[0066] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating diabetic erectile dysfunction, characterized in that: The raw materials of the traditional Chinese medicine composition include salvia miltiorrhiza and chuanxiong rhizome, and the mass ratio of salvia miltiorrhiza to chuanxiong rhizome is 0.1-10:

1.

2. The Chinese medicine composition according to claim 1, characterized in that: The mass ratio of the salvia miltiorrhiza and chuanxiong is 0.5-3:

1.

3. The Chinese medicine composition according to claim 1, characterized in that The mass ratio of the salvia miltiorrhiza and chuanxiong is 0.5:

1.

4. The Chinese medicine composition according to claim 1, characterized in that: The mass ratio of the salvia miltiorrhiza and chuanxiong is 1:

1.

5. The Chinese medicine composition according to claim 1, characterized in that: The mass ratio of the salvia miltiorrhiza and chuanxiong is 2:

1.

6. A method for preparing the Chinese medicine composition according to any one of claims 1 to 5, comprising the following steps: (1) taking raw materials of Danshen and Chuanxiong according to proportion, decocting in water, filtering and obtaining a water extract; (2) Add ethanol to the aqueous extract, let it stand, take the supernatant, recover the ethanol under reduced pressure, concentrate, and dry to obtain the product.

7. The preparation method according to claim 6, characterized in that: The number of times of water decoction in step (1) is 1-3 times, the amount of water added for a single decoction is 6-10 times the weight of the raw material, and the single decoction time is 1-2 hours.

8. The preparation method according to claim 6, characterized in that: In step (2), the aqueous extract is concentrated before adding ethanol. After the aqueous extract is concentrated to a crude drug concentration of 0.8-1.2 mg / mL, ethanol is added. The volume concentration of ethanol in the concentrated solution is 70-95%, and the standing time is 8-15 hours.

9. A preparation comprising the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method according to any one of claims 6 to 8, characterized in that: The dosage form of the preparation is selected from oral liquid, tablet, capsule, granule, paste, pill or mixture.

10. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method according to any one of claims 6 to 8 or the preparation according to claim 9 in the preparation of a drug for treating diabetic erectile dysfunction.

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