Traditional Chinese medicine composition for treating damp-heat downward flow type erectile dysfunction as well as preparation and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating damp-heat downward flow type erectile dysfunction. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3-9 parts of radix gentianae, 1-3 parts of centipede, 5-10 parts of earthworm, 3-9 parts of fructus cnidii, 3-9 parts of radix et rhizoma rhei, 3-9 parts of radix angelicae sinensis, 3-9 parts of radix rehmanniae recen, 3-9 parts of bupleurum chinense, 6-15 parts of semen plantaginis, 3-9 parts of caulis clematidis armandii, 3-9 parts of rhizoma alismatis, 15-30 parts of poria cocos and 10-30 parts of herba epimedii. According to the pathogenesis characteristics of damp-heat downward flow type, especially erectile dysfunction caused by stasis obstruction caused by damp-heat accumulation in bladder and prostate, the radix gentianae liver purging decoction is adopted as a basic formula, and the traditional Chinese medicine is prepared through addition and subtraction. All the medicines are compatible, the effects of clearing damp-heat in lower jiao and soothing liver and vibrating yang are further enhanced compared with a basic formula, and the whole formula has the effects of clearing heat and promoting diuresis, promoting blood circulation to remove meridian obstruction and soothing liver and eliminating wilt together.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating erectile dysfunction caused by damp-heat pouring downward, and its preparation and application. Background Art

[0002] Erectile dysfunction (ED), clinically manifested as the penis being unable to achieve or maintain sufficient erection to meet the requirements of normal sexual life, is a relatively common type of male sexual dysfunction. The main Western medicine categories of ED include vascular, psychological, neurological, organic, and mixed types, etc. In clinical treatment, oral type 5 phosphodiesterase inhibitors (PDE5I) are currently the preferred method for treating ED, and representative drugs include sildenafil, tadalafil, vardenafil, etc. Although PDE5I has a rapid onset and can improve the penile erection hardness, there are still some ED patients who do not respond well to it clinically and cannot obtain satisfactory efficacy, such as refractory erectile dysfunction accompanied by psychological problems, diabetes, hypertension, hyperlipidemia, etc. It is difficult to achieve ideal results with PDE5I. At the same time, the common side effects of PDE5I include dizziness, headache, palpitation, visual abnormalities, etc., and it is ineffective after drug withdrawal, difficult to cure and prone to recurrence, and there are still certain limitations in clinical use.

[0003] Traditional Chinese medicine describes ED as impotence, that is, the penis is weak and unable to erect, or the erection is not firm, or the erection cannot be maintained for a long time. Damp-heat is one of the main syndromes of impotence in traditional Chinese medicine. Among them, damp-heat pouring downward has the highest proportion in damp-heat type impotence, accounting for 53.3%, and it is the main subdivision type of damp-heat type impotence. Damp-heat pouring downward is mainly due to improper diet, overeating rich and sweet foods, stagnation and indigestion, which damage the spleen and stomach, leading to abnormal transportation and transformation, accumulation of dampness and generation of heat, and finally damp-heat pouring downward, resulting in relaxation of the penis tendon and formation of impotence. Damp-heat pouring downward mainly refers to damp-heat pouring downward into the liver and gallbladder, bladder, large intestine, uterus and vagina, etc., and the clinical manifestations include urgent urination, frequent urination, scrotal dampness and heat, weak erection, etc. The clinical symptoms of erectile dysfunction caused by damp-heat pouring downward are similar to those of erectile dysfunction complicated with chronic prostatitis in Western medicine. Although PDE5I has certain curative effects in clinical treatment, the results are not satisfactory, and there are still few relevant drug studies for this syndrome.

[0004] Based on this, the present invention is specifically proposed. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating erectile dysfunction caused by damp-heat pouring downward, and its preparation and application.

[0006] The technical solution adopted by the present invention is as follows:

[0007] On the one hand, the present invention provides a traditional Chinese medicine composition for treating erectile dysfunction caused by damp-heat pouring downward, comprising the following raw materials in parts by weight:

[0008] 3 - 9 parts of Gentiana scabra, 1 - 3 parts of Scolopendra subspinipes, 5 - 10 parts of Pheretima aspergillum, 3 - 9 parts of Fructus Cnidii, 3 - 9 parts of Rheum palmatum, 3 - 9 parts of Angelica sinensis, 3 - 9 parts of Rehmannia glutinosa, 3 - 9 parts of Bupleurum chinense, 6 - 15 parts of Plantago asiatica, 3 - 9 parts of Caulis Akebiae, 3 - 9 parts of Alisma orientale, 15 - 30 parts of Poria cocos, 10 - 30 parts of Epimedium brevicornu.

[0009] A traditional Chinese medicine composition for treating erectile dysfunction caused by damp - heat pouring downward proposed by the present invention is mainly aimed at the type of damp - heat pouring downward, especially the pathogenesis characteristics of erectile dysfunction caused by stasis obstruction due to damp - heat accumulating in the bladder and prostate. Based on the basic formula of Longdan Xiegan Decoction, it is formed by addition, subtraction and modification. In this formula, Gentiana scabra is good at clearing away the excessive fire of the liver and gallbladder. Scolopendra subspinipes is pungent, warm and running through, mainly entering the liver meridian. Its nature is good at dredging the meridian and expelling pathogenic factors, which can make the liver qi smooth, the meridian unobstructed, and the qi and blood flow. And modern pharmacological research reveals that the active peptide components in the aqueous extract of Scolopendra subspinipes have the effects of anti - atherosclerosis and improving microcirculation, and can significantly promote the opening of microvessels and the dilation of their diameters. This mechanism highly coincides with the traditional Chinese medicine theory of " dredging the liver meridian", especially suitable for the treatment of impotence caused by blood stasis obstruction. The combination of the two reflects the method of " clearing and dredging simultaneously": on the basis of Gentiana scabra clearing away damp - heat in the liver and gallbladder, Scolopendra subspinipes focuses on cracking the pathogenesis of blood stasis and collateral obstruction, removing both the pathogenic factors of damp - heat and the stagnation of the liver meridian, and jointly achieving the effects of clearing heat and promoting diuresis, activating blood circulation and invigorating yang, and they are both the monarch drugs; Rheum palmatum and Fructus Cnidii are used to replace Scutellaria baicalensis and Gardenia jasminoides in the original formula, aiming to strengthen the effect of clearing and promoting damp - heat in the lower energizer. Among them, Rheum palmatum is good at purging accumulation and promoting defecation, purging fire and detoxifying. Its drastic purgative effect is beneficial to clearing away the damp - heat accumulation in the bladder and large intestine. Fructus Cnidii has the effects of warming the kidney and strengthening yang, drying dampness and relieving itching. It can not only dispel damp - turbidity in the lower energizer, but also warm and nourish the kidney yang to strengthen the root and cultivate the yuan. And modern pharmacological research shows that osthole contained in Fructus Cnidii has the effect of inhibiting the activity of PDE5 enzyme and enhancing the activity of c - GMP. The combination of the two warms the kidney and strengthens yang on the basis of purging damp - heat, complementing each other, and they are both the minister drugs; Caulis Akebiae, Plantago asiatica and Alisma orientale clear and promote damp - heat in the lower energizer, and Poria cocos is added to enhance the effect of promoting diuresis and percolating dampness, helping to remove the damp - heat moisture in the body, and they are all the assistant drugs; Pheretima aspergillum has the effects of clearing heat and calming endogenous wind, dredging the meridian and activating collaterals, clearing heat and promoting diuresis, etc. It can enhance the effects of Angelica sinensis and Rehmannia glutinosa in promoting blood circulation and nourishing blood, Bupleurum chinense in soothing the liver and regulating qi, and Epimedium brevicornu in warming the kidney yang, preventing the excessive purging of heat - clearing drugs such as Gentiana scabra, Rheum palmatum, Plantago asiatica and Alisma orientale, and it is the envoy drug. The compatibility of various drugs further strengthens the effect of clearing and promoting damp - heat in the lower energizer and soothing the liver and invigorating yang compared with the basic formula. The whole formula jointly achieves the effects of clearing heat and promoting diuresis, activating blood circulation and dredging collaterals, soothing the liver and treating impotence.

[0010] In addition, the research results also show that the traditional Chinese medicine composition of the present invention has the effects of enhancing erectile function, reducing the symptoms of urgent urination and frequent urination, improving mating ability, etc., has a good regulatory and therapeutic effect on refractory damp - heat pouring downward type erectile dysfunction with modern drugs, and has no toxic and side effects, and has certain clinical promotion value.

[0011] Preferably, it contains raw materials in the following parts by weight:

[0012] 6 parts of Gentiana scabra, 1 part of Scolopendra subspinipes, 8 parts of Pheretima aspergillum, 6 parts of Fructus Cnidii, 4 parts of Rheum officinale, 6 parts of Angelica sinensis, 6 parts of Rehmannia glutinosa, 5 parts of Bupleurum chinense, 9 parts of Plantago asiatica, 5 parts of Caulis Akebiae, 6 parts of Alisma orientale, 15 parts of Poria cocos, 15 parts of Epimedium brevicornu.

[0013] On the other hand, the present invention provides a preparation method of a traditional Chinese medicine composition for treating erectile dysfunction of damp-heat pouring downward type as described in the above technical solution, including the following steps:

[0014] Weigh Gentiana scabra, Scolopendra subspinipes, Pheretima aspergillum, Fructus Cnidii, Rheum officinale, Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Plantago asiatica, Caulis Akebiae, Alisma orientale, Poria cocos and Epimedium brevicornu according to the ratio, then add water for extraction, combine the water extraction liquid and filter it, concentrate the filtrate under reduced pressure to a thick paste, dry and pulverize it to obtain a dry paste powder, which is the traditional Chinese medicine composition.

[0015] Preferably, the extraction conditions include: the weight of water for each extraction is 10 times the total weight of the traditional Chinese medicine raw materials, the number of extractions is 1 - 3 times, and the extraction time for each time is 1 - 3 h.

[0016] Preferably, the relative density of the thick paste is 1.05 - 1.20 g / mL.

[0017] On yet another aspect, the present invention provides an application of the traditional Chinese medicine composition as described in the above technical solution in the preparation of a drug for treating erectile dysfunction of damp-heat pouring downward type.

[0018] Preferably, the drug further includes pharmaceutically acceptable excipients, and the dosage form of the drug is any one of tablets, granules, pills or oral liquids.

[0019] The preparation method of the present invention is simple, rapid, efficient, easy to operate, and the prepared drug preparation is convenient to carry and take, and has good application value. Description of the Drawings

[0020] Figure 1 It is a graph of the 3-hour urine output test results of mice in each group in the experimental examples of the present invention. Among them, A is the total urine output in 3 hours, B is the number of urinations in 3 hours, and C is the urine output per urination;

[0021] Figure 2 It is a graph of the erection test results of mice in each group in the experimental examples of the present invention. Among them, A is the number of erections within 30 minutes, B is the erection duration, and C is the erection latency;

[0022] Figure 3 It is a comparison graph of the appearance of mice in each group in the experimental examples of the present invention;

[0023] Figure 4 It is a comparison graph of the comprehensive scores of mice in each group in the experimental examples of the present invention. Detailed Embodiments

[0024] To better understand the above technical solution, the exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present invention can be understood more clearly and thoroughly, and the scope of the present invention can be completely conveyed to those skilled in the art.

[0025] Example 1

[0026] A traditional Chinese medicine composition for treating erectile dysfunction caused by damp-heat pouring downward, comprising raw materials in the following parts by weight:

[0027] Gentiana scabra 6g, Scolopendra subspinipes mutilans 1g, Pheretima aspergillum 8g, Fructus Cnidii 6g, Rheum officinale 4g, Angelica sinensis 6g, Rehmannia glutinosa 6g, Bupleurum chinense 5g, Plantago asiatica 9g, Caulis Akebiae 5g, Alisma orientale 6g, Poria cocos 15g, Epimedium brevicornu 15g.

[0028] It is prepared by the following method, including the following steps:

[0029] Weigh Gentiana scabra, Scolopendra subspinipes mutilans, Pheretima aspergillum, Fructus Cnidii, Rheum officinale, Angelica sinensis, Rehmannia glutinosa, Bupleurum chinense, Plantago asiatica, Caulis Akebiae, Alisma orientale, Poria cocos and Epimedium brevicornu according to the ratio, then add water for extraction. The weight of water for each extraction is 10 times the total weight of the traditional Chinese medicine raw materials. Extract for 2 times, 2h each time. After combining the water extracts, filter through a 200-mesh sieve, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.1 g / mL, dry and pulverize to obtain dry paste powder, which is the traditional Chinese medicine composition.

[0030] Further add pharmaceutically acceptable excipients, such as sucrose or starch, to the above dry paste powder, mix and then prepare into tablets, granules, pills or oral liquids.

[0031] Experimental Example

[0032] 1. Animal model establishment, grouping, and administration

[0033] 1.1 Animal screening

[0034] Select 70 male KM mice and feed them adaptively for 1 week, fast for 12h, weigh and record. Use apomorphine (APO) 1.5 mg·kg -1 , inject subcutaneously at the soft part of the skin at the back of the neck. Consider penile head congestion, penile body growth, and the appearance of the end of the penile body as 1 erection. Select mice with more than 1 penile erection within 30 min after giving APO.

[0035] 1.2 Model construction

[0036] Randomly divide 70 eligible experimental mice into 2 groups: 8 mice in the blank control group (C), and 62 mice in the damp-heat pouring downward type erectile dysfunction model group (referred to as the model group).

[0037] The blank control group was given a basal diet, and the model group was given a high-fat and high-sugar diet (70% basal diet, 15% lard, 2% cholesterol, 13% sucrose). At the same time, the model group was given alcohol-honey water (5% vol alcohol, 5 wt% honey), and the blank control group was given an equal amount of pure water.

[0038] After the model group was fed with a high-fat diet for 1 week, on the 8th day of modeling, it was placed in an external high-temperature and high-humidity damp-heat environment (at a temperature of 35°C and a relative humidity of 75%) and exposed for 4 h, once a day until the end of the experiment. On the 15th, 20th, and 25th days after modeling, subcutaneous injection of prostate tissue emulsion and intraperitoneal injection of cyclophosphamide injection were carried out once respectively, and the injection volume each time was 10 mL·kg -1 body weight.

[0039] Among them, the preparation of prostate tissue emulsion includes the following steps: Take SD male rats, sacrifice them, disinfect the local skin, make a midline incision in the lower abdomen, cut open the abdominal skin and muscles of the rats, dissect the prostate tissue, wash it with normal saline, and store it at -80°C for later use. Take out and weigh the rat prostate tissue, place it in an EP centrifuge tube, add 20 times the weight of 1% carrageenan, and make a homogenate with a high-speed tissue homogenizer (6000 rpm, 1 min). Then, centrifuge the homogenate in a high-speed centrifuge at 5000 rpm for 10 min, take the supernatant, and add 1% carrageenan to dilute the mass concentration of the prostate tissue homogenate to 20 mg·mL -1 . Dilute the prostate tissue homogenate with Freund's complete adjuvant according to a volume ratio of 1:1, and emulsify it with a tissue homogenizer at 1000 rpm for 20 s to obtain it.

[0040] The preparation of cyclophosphamide injection includes the following steps: Take cyclophosphamide test drug, and prepare it into a solution with a concentration of 8 mg·mL -1 solution.

[0041] The judgment criteria for successfully establishing the damp-heat pouring downward type erectile dysfunction model: Refer to the damp-heat pouring downward type in the Clinical Diagnosis and Treatment Guidelines of Traditional Chinese Medicine Surgery (Impotence): Erectile weakness, or inability to last. Scrotal dampness, itching, or foul smell and distension, bitter taste in the mouth and dry throat, yellow urine and constipation, stuffiness in the chest and reduced appetite, lumbosacral distending pain, soreness and weakness in the lower limbs, red tongue, yellow and greasy tongue coating, slippery or string-taut and rapid pulse. Combining with the physiological state of the mice: symptoms such as withered and dull luster, yellowish-red urine, and increased frequency of urination were used to determine the mice with qualified modeling of damp-heat pouring downward type erectile dysfunction.

[0042] 1.3 Administration

[0043] Administration began on the 30th day after model establishment. The model group was divided into a model group (M), a sildenafil group (XDNF), a Longdan Xiegan Tablet group (LDXG), a low-dose group of the traditional Chinese medicine composition of Example 1 (ZL-L), a medium-dose group of the traditional Chinese medicine composition of Example 1 (ZL-M), and a high-dose group of the traditional Chinese medicine composition of Example 1 (ZL-H). The administration duration for the administration groups was 6 weeks. Each group of mice was given intragastric administration, and the administration volume was 10 mL·kg -1 .

[0044] The dose of the traditional Chinese medicine composition of Example 1 of the present invention was calculated by the equivalent dose method according to the animal body surface area ratio: the low dose for mice was 92×0.0026÷0.02 = 11.96 g crude drug·kg -1 body weight, the medium dose was 23.92 g crude drug·kg -1 body weight, and the high dose was 47.84 g crude drug·kg -1 body weight.

[0045] Sildenafil citrate: Qilu Pharmaceutical Co., Ltd., national drug approval number; Sildenafil dose conversion: the mouse dose was 50×0.0026÷0.02 = 6.5 mg / kg, dissolved in normal saline for intragastric administration.

[0046] Longdan Xiegan Tablets: The dose of Longdan Xiegan Tablets (oral, 4 - 6 tablets at a time, 2 - 3 times a day) was = 0.45×18×0.0026÷0.02 = 1.05 g·kg -1 (body weight), dissolved in normal saline for intragastric administration.

[0047] The blank control group and each model control group were given an equal volume of normal saline at the above doses, once a day. Each test group was continuously administered for 6 weeks. During the administration period, the body weight of the mice was recorded weekly, and the administration amount was adjusted according to the body weight change. After the administration ended, relevant traditional Chinese medicine symptoms were observed, urination tests, mating tests, and APO tests were carried out.

[0048] Preparation of female mice: Before the mating test, bilateral ovariectomy was performed on female mice under 10% chloral hydrate anesthesia. After the operation, 20,000 U of penicillin was intramuscularly injected per mouse, and erythromycin ointment was applied to the local operation site for a total of 3 days to prevent infection.

[0049] 2. Index determination and methods

[0050] 2.1 Urination test

[0051] The water-loading urination urine spot test was used. Mice were fasted for 12 h before the experiment without water restriction. 1 h before the experiment, each group was respectively given intragastric administration of normal saline, the traditional Chinese medicine composition, and the positive drugs (sildenafil, Longdan Xiegan Tablets). 35 min later, the abdomen was gently squeezed to drain the remaining urine. First, 1.0 mL of normal saline (containing 1 mg·mL of neutral red staining solution) was given to each group of mice -1)Gavage was performed as a water load. After 5 min, the mice were placed in the corresponding breeding cages with two layers of clean filter paper at the bottom. The weights of the filter paper before and after 3 h were recorded, and the weight increase of the paper was calculated. The results were expressed as the mean and standard deviation, and the P-value was calculated using variance test to determine the results.

[0052] 2.2 Erection test (APO test)

[0053] The experimental mice were placed in a transparent box of 45×45×45 cm and allowed to adapt for 10 min. Then, apomorphine (APO) at a dose of 1.5 mg·kg -1 was subcutaneously injected into the loose skin at the back of the neck. A camera was used to record the video for 30 min to count the number of penile erections (one erection was counted when the glans penis was congested, the penile shaft grew, and the distal penile shaft appeared); the erection latency and the maintenance time of erection were also recorded.

[0054] 2.3 Mating behavior test

[0055] Before the mating test, male mice were given mating training. Female mice needed to be prepared for the estrus period. Estradiol was injected at a dose of 2 mL·kg -1 3 days before mating, and progesterone was injected at a dose of 2 mL·kg -1 4 h before mating. During the test, male mice were placed in a transparent box of 45 cm×45 cm×45 cm and observed in a quiet and dimly lit room. Starting from 7 pm at night, after each male mouse was placed in the observation cage, it was allowed to adapt to the environment for 10 min, and then one female mouse was placed in the same cage with it, and the timing started. The time (latency) and the number of chases when the male mouse first licked the female mouse's vulva within 30 min were recorded, the time (i.e., latency) and the number of times when the male mouse first straddled and climbed on the female mouse were recorded, and the time (latency) and the number of times when the male mouse first ejaculated were recorded.

[0056] 2.4 Observation and scoring of traditional Chinese medicine symptoms

[0057] According to the Classification of Traditional Chinese Medicine Syndromes of Erectile Dysfunction in the Multidisciplinary Diagnosis and Treatment Guidelines for Erectile Dysfunction Integrating Traditional Chinese and Western Medicine (2022 Edition), damp-heat pouring downward belongs to damp-heat in the penis tendon. The main clinical symptoms are: weak erection, damp scrotum, drowsiness and heaviness of the body, bitter and sticky mouth, burning and short and red urine, occasional dribbling of white fluid from the urethral orifice, sticky and uncomfortable stools, red tongue, yellow and greasy tongue coating, slippery and rapid pulse. According to relevant literature, the relevant symptoms of damp-heat syndrome in humans and animals were transformed. The general conditions of the mice, including mental state, hair, defecation and urination, were observed and recorded daily to judge whether the damp-heat syndrome mouse model was successfully established. The scores were recorded as 3, 2, 1, and 0 points according to the absence, mild, moderate, and severe degrees of symptoms. The symptom scores of the mice were recorded at the end of modeling and the experiment. The mice in the model group showed listlessness, reduced food and water intake, lethargy, dull hair, loose stools, and yellow and smelly urine (mostly bright yellow or orange-yellow), which met the evaluation criteria of the damp-heat syndrome model in the literature.

[0058] According to the above primary and secondary clinical symptoms, a scoring table for the model was developed (Table 1).

[0059] Table 1 Scoring Table for the Model of Erectile Dysfunction with Damp-Heat Pouring Downward

[0060]

[0061] 2.5 Data Statistical Methods

[0062] The results were statistically analyzed using Prism 8.0 software. Measurement data were expressed in the form of mean plus or minus standard deviation (x±SD). For those that followed a normal distribution and had homogeneous variances, one-way ANOVA was used for comparison among multiple groups; when the one-way ANOVA among multiple groups was not significant but there were still differences, the pairwise comparison method of t-test between groups was used; p<0.05 indicated that the difference was statistically significant, and p<0.01 indicated that the difference was extremely significant.

[0063] 3. Experimental Results

[0064] 3.1 Urination Test

[0065] As can be seen from Table 2 and Figure 1 It can be known that compared with the normal blank control group, there were significant differences in the total urine volume, urination frequency, and single-urination weight at 3 h in the model group compared with the normal control group (F-test, P<0.05 or P<0.01), indicating that the model was established; there was no difference in the total urine volume at 3 h in each drug administration group compared with the model group; each drug administration group significantly reduced the urination frequency, with a significant difference (P<0.01); each dose of the traditional Chinese medicine composition in Example 1 of the present invention could increase the weight of single urination in mice after modeling, with a significant difference (P<0.05 or P<0.01, t-test). The above results indicate that the traditional Chinese medicine composition of the present invention is beneficial to improving the phenomena of urgency and frequency of urination in model mice.

[0066] Table 2 Comparison of Total Urine Volume, Urination Frequency, and Single-Urination Volume in the 3-h Urination Test n = 8

[0067]

[0068] Note: F-test compared with the model group, *P < 0.05, **P < 0.01; t-test compared with the model group, #P < 0.05, ##P < 0.01.

[0069] 3.2 Erection Test

[0070] As can be seen from Table 3 and Figure 2It can be seen that compared with the blank control, there were significant differences in the number of erections, erection latency, and erection duration within 30 minutes in the model group, indicating the establishment of the model (P<0.05, t-test); there were significant differences in the number of erections and erection duration between the sildenafil group and the model control (P<0.05, t-test); in the Longdan Xiegan Pills group, although each index improved to some extent, there was no statistical difference; compared with the model group, there was a significant difference in the number of erections in the low-dose group of the traditional Chinese medicine composition in Example 1 of the present invention (P<0.05, t-test), and there were significant differences in the number of erections and erection duration between the medium-dose group and the high-dose group and the control (P<0.05, t-test). The above results show that the traditional Chinese medicine composition of the present invention is beneficial to improving the erection duration and number of erections in model mice.

[0071] Table 3 Comparison of erection duration, number, and latency in the erection test n = 8

[0072]

[0073] Note: Compared with the model group by F-test, *P < 0.05, **P < 0.01; compared with the model group by t-test, #P < 0.05, ##P < 0.01.

[0074] 3.3 Mating behavior test

[0075] As can be seen from Table 4, compared with the normal control group, there were significant differences in the latency of licking and sniffing and chasing, the number of licking and sniffing and chasing, the latency of mounting and straddling, the number of mounting and straddling, the ejaculation latency, and the number of ejaculations in the model group (P<0.01 or P<0.05), indicating the establishment of the model; there were significant differences in the number of licking and sniffing and chasing, the latency of mounting and straddling, the number of mounting and straddling, the ejaculation latency, and the number of ejaculations between the positive drug sildenafil group and the model (P<0.01 or P<0.05); there were no significant differences in each index in the Longdan Xiegan Pills group; the low-dose and medium-dose groups of the traditional Chinese medicine composition in Example 1 of the present invention significantly improved the latency of licking and sniffing and chasing and the number of licking and sniffing and chasing (P<0.01 or P<0.05), and the high-dose group significantly improved the number of licking and sniffing and chasing, the latency of mounting and straddling, the number of mounting and straddling, and the ejaculation latency (P<0.01 or P<0.05). The above results show that the traditional Chinese medicine composition of the present invention can shorten the latency of chasing and mounting behaviors in model mice, increase the number of chasing and mounting, and has a certain dose-dependence on the effect on mating behavior.

[0076] Table 4 Comparison of the latency and number of chasing, mounting and straddling, and ejaculation in the mating behavior experiment n = 8

[0077]

[0078] Note: Compared with the model group, F test, *P<0.05, **P<0.01; compared with the model group, t test, #P<0.05, ##P<0.01.

[0079] 3.4 Overall Rating

[0080] Based on the appearance of the mouse (see Figure 3 ), the results of the two stools, tongue coating, urination test, erection test, and mating test were combined with the scoring criteria in Table 1 to give the mice a comprehensive score, which was recorded in Figure 4 and Table 5.

[0081] from Figure 3 It can be seen that the model mice were listless and squinting, and the symptoms of the model mice in the experiment included yellow and red urine, frequent urination, red tongue and greasy yellow coating, indicating that the model was established; after drug administration, the appearance of mice in each group was significantly improved. Figure 4 Comprehensive comparison shows that the positive drug sildenafil group and each dosage group of the Chinese medicine composition of the present invention can effectively improve the symptoms of mice with erectile dysfunction caused by damp-heat infiltration, P<0.01.

[0082] Table 5 Comparison of comprehensive scores of each group

[0083]

[0084] Note: The data in the table are all means, compared with the model group by F test, *P<0.05, **P<0.01.

[0085] In summary:

[0086] After the model mice took the Chinese medicine composition of the present invention, their appearance was significantly improved, their fur became white and smooth, their spirits were lifted, their activities were strengthened, the symptoms of squinting disappeared, their tongue coating changed from yellow to light red, and their urine color changed from yellow to light yellow, indicating that the fever was relieved; through the erection test, it was shown that the Chinese medicine composition of the present invention could improve the number and time of erections of the model mice; through the urination test, it was shown that the Chinese medicine composition of the present invention could reduce the number of urine spots of the model mice, increase the weight of a single urine spot, and improve their urinary urgency and frequent urination; through the mating test, it was shown that the Chinese medicine composition of the present invention could shorten the latent period of the model mice's chasing and mounting behaviors, increase the number of chasing and mounting, and thus improve their penis erection ability. The Chinese medicine composition of the present invention has significant efficacy in treating erectile dysfunction caused by damp-heat, can significantly improve erectile function, improve sexual mating ability, and improve TCM syndromes.

[0087] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A Chinese medicine composition for treating erectile dysfunction caused by damp-heat, characterized in that: Contains the following raw materials in parts by weight: 3-9 parts of gentian, 1-3 parts of centipede, 5-10 parts of earthworm, 3-9 parts of cnidium monnieri, 3-9 parts of rhubarb, 3-9 parts of angelica, 3-9 parts of raw rehmannia, 3-9 parts of bupleurum, 6-15 parts of plantain seeds, 3-9 parts of chuanketong, 3-9 parts of oriental water plantain, 15-30 parts of tuckahoe, and 10-30 parts of epimedium.

2. The Chinese medicine composition for treating erectile dysfunction caused by damp-heat as claimed in claim 1, characterized in that: Contains the following raw materials in parts by weight: 6 parts of Gentiana, 1 part of Scolopendra, 8 parts of Pheretima, 6 parts of Fructus Cnidium, 4 parts of Radix Rhei, 6 parts of Radix Angelicae Sinensis, 6 parts of Radix Rehmanniae, 5 parts of Radix Bupleuri, 9 parts of Semen Plantaginis, 5 parts of Caulis Atractylodes, 6 parts of Rhizoma Alismatis, 15 parts of Poria, and 15 parts of Herba Epimedii.

3. A method for preparing the Chinese medicine composition for treating damp-heat type erectile dysfunction as claimed in claim 1, characterized in that: The following steps are involved: Weigh gentian, centipede, earthworm, cnidium monnieri, rhubarb, angelica, raw rehmannia root, bupleurum, plantain, chuanxiong, oriental water plantain, tuckahoe and epimedium according to the proportion, then add water for extraction, combine the water extracts and filter, decompress and concentrate the filtrate into a thick paste, dry and grind to obtain a dry paste powder, which is the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The extraction conditions include: the weight of water extracted each time is 10 times the total weight of the Chinese medicine raw material, the number of extractions is 1-3 times, and the time of each extraction is 1-3 hours.

5. The preparation method according to claim 3, characterized in that: The relative density of the thick paste is 1.05-1.20 g / mL.

6. Use of the Chinese medicine composition as claimed in claim 1 in the preparation of a medicine for treating erectile dysfunction caused by damp-heat infiltration.

7. The use according to claim 6, characterized in that The medicine further comprises pharmaceutically acceptable excipients, and the dosage form of the medicine is any one of tablets, granules, pills or oral liquid.

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