Use of a traditional Chinese medicine composition in the preparation of a medicine for treating male sexual function and resisting fatigue

Abstract

The application provides an application of a traditional Chinese medicine composition in preparation of a medicine for treating male sexual function and resisting fatigue, and belongs to the technical field of traditional Chinese medicine.The traditional Chinese medicine composition is mainly composed of Astragalus membranaceus (Fisch.) Bunge, Scutellaria baicalensis Georgi, Alisma orientale (Sam.) Juzep, Salvia miltiorrhiza Bunge and Panax ginseng C.A.Meyer.Experiments prove that the traditional Chinese medicine composition can obviously improve male sexual function and resistance to fatigue.The traditional Chinese medicine composition can effectively solve the problems of unsatisfactory treatment effect and excessive components in existing compositions, and the safety of the oral traditional Chinese medicine composition preparation is high, and the toxic and side effects are small.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating male sexual function and resisting fatigue. BACKGROUND

[0002] With the continuous improvement of the quality of life, more and more men begin to pay attention to their own health status, and the harmony of the couple relationship is increasingly concerned by people. Among them, male sexual dysfunction has become a key factor affecting the harmony of the couple relationship. The main clinical manifestations of the disorder include impotence, premature ejaculation, spermatorrhea and other symptoms, which makes the patient unable to successfully carry out sexual life, greatly interferes with the daily life of the patient, and in severe cases, may cause infertility. The main treatment for male sexual dysfunction now adopts western medicine, which has greater side effects, such as headache, nasal congestion, muscle pain, blurred vision, facial flushing, etc., and cannot be taken for a long time. Even, taking hormone drugs may aggravate sexual dysfunction or even completely lose it. Traditional Chinese medicine treatment has the advantages of less adverse reactions, suitable for long-term use, safe and reliable, low price, etc., and is increasingly widely used in the clinical treatment of the disease.

[0003] Fatigue is a complex physiological and psychological phenomenon of mental or physical tiredness and decreased endurance, which can be divided into central fatigue and peripheral fatigue, and its occurrence is related to many factors, including accumulation of metabolites in tissues, insufficient energy supply, oxidative stress, muscle damage, etc. Long-term fatigue may trigger the occurrence of diseases such as cancer, depression, multiple sclerosis, etc., and is also a warning signal of the "fragility" of the body. In addition, when muscle fatigue occurs, the input of sensory information and the output of motor information of the body change, the muscle strength and posture control ability decrease, and it may also have some impact on sexual activity. It may take a long time to improve or relieve fatigue symptoms, but long-term use of chemical drugs may cause some adverse reactions or toxic effects.

[0004] Whether it is sexual dysfunction or chronic fatigue, it seriously affects the quality of life and health of people, and it is of positive significance to develop traditional Chinese medicine agents or health care products with clear active functions.

[0005] Chinese patent CN103566087A discloses a kind of drug composition for treating cognitive dysfunction, which is composed of Huangqi, Huangqin, Zexie, Danshen and Renshen, and can improve cognitive dysfunction, treat Alzheimer's disease, improve sugar metabolism level and increase the content of monoamine neurotransmitters in brain. The drug composition can inhibit the expression of APP, A beta-40 and A beta-42 in brain tissue, significantly improve the learning and memory ability of scopolamine-induced dementia mice, reduce the activity of brain tissue ACHE, and has good anti-dementia effect. In the treatment of senile dementia, it can significantly improve the sugar metabolism level of dementia model mice, and increase the content of norepinephrine, dopamine and serotonin in the cerebral cortex of rapid brain aging mice.

[0006] At present, there is no research or report on the use of the drug composition for treating cognitive dysfunction disclosed in Chinese patent CN103566087A in the treatment of male sexual function and anti-fatigue. SUMMARY

[0007] The present application is a new use of the drug composition for treating cognitive dysfunction disclosed in Chinese patent CN103566087A, and specifically provides the use of a traditional Chinese medicine composition in the preparation of a medicine for treating male sexual function and anti-fatigue.

[0008] Preferably, the traditional Chinese medicine composition is mainly composed of Huangqi, Huangqin, Zexie, Danshen and Renshen.

[0009] Preferably, the traditional Chinese medicine composition mainly includes the following components by weight fraction: Huangqi 15 parts, Huangqin 9 parts, Zexie 9 parts, Danshen 9 parts and Renshen 6 parts.

[0010] Preferably, the pharmaceutical preparation is composed of the traditional Chinese medicine composition described above and pharmaceutically acceptable excipients.

[0011] Preferably, the traditional Chinese medicine composition pharmaceutical preparation is in the form of capsules, tablets, granules, mixtures, pills, dripping pills, effervescent tablets, syrup, oral liquid, powder or decoction, etc. The freeze-dried powder for parenteral administration and injection liquid, etc.

[0012] Preferably, the traditional Chinese medicine composition preparation is in the form of granules.

[0013] Preferably, the granules are prepared from the traditional Chinese medicine composition described above and pharmaceutically acceptable excipients in a weight ratio of 1:1.5-8.5; preferably, the traditional Chinese medicine composition and pharmaceutically acceptable excipients are prepared in a weight ratio of 1:2.0-5.5.

[0014] Preferably, the pharmaceutically acceptable adjuvant of the granules comprises a filler and a binder, the filler is one or more of mannitol, lactose, sorbitol, sucrose, cyclodextrin; the binder is one or more of 3% PVP in 75% ethanol solution, 3% hydroxypropyl methylcellulose in 50% ethanol solution, 10% povidone K30 in water solution, 30% starch paste.

[0015] Preferably, the filler is a mixture of cyclodextrin and sorbitol, and the ratio of cyclodextrin to sorbitol is 1:0.5-1.4 by weight; preferably, the cyclodextrin is hydroxypropyl-β-cyclodextrin.

[0016] Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0017] (1) grinding and sieving ginseng into fine powder for standby;

[0018] (2) weighing and taking astragalus, radix scrophulariae and alisma according to the proportion, soaking, boiling, filtering, and concentrating to obtain a concentrated solution;

[0019] (3) removing impurities, washing and drying salvia miltiorrhiza, grinding and sieving to obtain fine powder;

[0020] (4) combining the fine powder obtained in step (1) and the concentrated solution obtained in step (2), mixing uniformly, concentrating into thick paste, drying under reduced pressure, and then crushing and sieving to mix with the fine powder in step (3) to obtain a traditional Chinese medicine composition;

[0021] (5) mixing the traditional Chinese medicine composition in step (4) with the filler uniformly, and then mixing with the binder to granulate, to obtain a traditional Chinese medicine composition pharmaceutical preparation.

[0022] Compared with the prior art, the present application has the beneficial effects that:

[0023] The present application provides a new use of a traditional Chinese medicine composition in preparing a medicine for treating male sexual function and resisting fatigue, and proves through animal experiments and clinical trials that it has obvious improving effect on male sexual function, and proves through animal experiments that it has anti-fatigue effect.

[0024] The traditional Chinese medicine composition formula is simple, the number of medicinal ingredients and the amount of medicinal materials used are both small, which saves resources and reduces the cost of medicine, has high safety, and has small side effects. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 Effect of the traditional Chinese medicine composition on the capture frequency of ICR male mice (n=10)

[0026] Figure 2 Effect of the traditional Chinese medicine composition on the capture latency of ICR male mice (n=10)

[0027] Figure 3 Effect of Chinese medicine combination on the ejaculation latency of ICR male mice (n=10)

[0028] Figure 4 Effect of Chinese medicine combination on the ejaculation frequency of ICR male mice (n=10)

[0029] Figure 5 Effect of Chinese medicine combination on the serum testosterone and NO content of ICR male mice (n=10)

[0030] Figure 6 Effect of Chinese medicine combination on the gonadal organ index of ICR male mice (n=10)

[0031] Figure 7 Effect of Chinese medicine combination on the corpus cavernosum cGMP content of ICR male mice (n=10)

[0032] Figure 8 Effect of Chinese medicine combination on the corpus cavernosum PDE5 content of ICR male mice (n=10)

[0033] Figure 9 Effect of Chinese medicine combination on the LDH of ICR male mice (n=10)

[0034] Figure 10 Effect of Chinese medicine combination on the LA of ICR male mice (n=10)

[0035] Figure 11 Effect of Chinese medicine combination on the BUN of ICR male mice (n=10)

[0036] Figure 12 Effect of Chinese medicine combination on the liver glycogen of ICR male mice (n=10)

[0037] Figure 13 Effect of Chinese medicine combination on the muscle glycogen of ICR male mice (n=10)

[0038] Figure 14 Effect of Chinese medicine combination on the MDA of ICR male mice (n=10) DETAILED DESCRIPTION

[0039] The following are specific embodiments of the present application, which further illustrate the technical solutions of the present application, but should not be understood as limiting the above main scope of the present application to the following embodiments. Any corresponding replacement or modification made according to ordinary technical knowledge and conventional means without departing from the above technical premise of the present application is included in the present application.

[0040] I. Preparation of Chinese medicine composition granules

[0041] Example 1

[0042] The granules described in this example have the following prescription:

[0043] Take 15 g of Huangqi, 9 g of Huangqin, 9 g of Zexie, 9 g of Danshen, and 6 g of Renshen;

[0044] The preparation method of the granules is as follows:

[0045] (1) Grind the Renshen of the prescription amount through an 80-mesh sieve to obtain fine powder, which is reserved;

[0046] (2) Take Huangqi, Huangqin, and Zexie according to the prescription ratio, and soak them in 12 times the amount of water for 1.5 hours. Boil them with a strong fire for 15 minutes, and then filter to obtain filtrate, and reserve the filter residue. Add 6 times the amount of water to the filter residue, and boil it with a strong fire, and then simmer it with a weak fire for 1.5 hours. Filter it to obtain filtrate, and combine the two filtrates. Concentrate the filtrate to a relative density of 1.10 at 70°C to obtain concentrated liquid;

[0047] (3) Take Danshen according to the prescription ratio, remove impurities, wash, dry, grind, and sieve through a 60-80 mesh sieve to obtain fine powder;

[0048] (4) Combine the concentrated liquid obtained in step (2) and the fine powder obtained in step (1), mix them evenly, concentrate them into thick paste, adjust the pH value to 5.5, dry them under reduced pressure, crush them, sieve them through a 70-mesh sieve, and mix them with the fine powder of step (3) to obtain traditional Chinese medicine composition.

[0049] (5) Weigh the traditional Chinese medicine composition obtained in step (4), and mix 1.5 times the weight of sorbitol and hydroxypropyl-β-cyclodextrin (the weight ratio of sorbitol to hydroxypropyl-β-cyclodextrin is 1:1) evenly, and then mix them with an appropriate amount of 3% hydroxypropyl methyl cellulose 50% ethanol solution with a pH value of 6.0 to granulate, and thus granules are obtained.

[0050] Example 2

[0051] Step (5) in the preparation method of the granules described in this example is as follows: weigh the traditional Chinese medicine composition obtained in step (4), and mix 1.5 times the weight of hydroxypropyl-β-cyclodextrin and sorbitol (the weight ratio of hydroxypropyl-β-cyclodextrin to sorbitol is 1:0.8) evenly, and then mix them with an appropriate amount of 3% hydroxypropyl methyl cellulose 50% ethanol solution with a pH value of 6.0 to granulate, and thus granules are obtained.

[0052] Example 3

[0053] Step (5) in the granule preparation method described in this example is: the traditional Chinese medicine composition obtained in step (4) is weighed, 1.5 times the weight of hydroxypropyl-p-cyclodextrin and sorbitol is added and uniformly mixed (the weight ratio of hydroxypropyl-p-cyclodextrin to sorbitol is 1:1.2), and then an appropriate amount of 3% hydroxypropyl methyl cellulose 50% ethanol solution with a pH value of 6.0 is added to mix and granulate, to obtain the granules.

[0054] Comparative Example 1

[0055] Step (5) in the granule preparation method described in this example is: the traditional Chinese medicine composition obtained in step (4) is weighed, 1.5 times the weight of hydroxypropyl-p-cyclodextrin and sorbitol is added and uniformly mixed (the weight ratio of hydroxypropyl-p-cyclodextrin to sorbitol is 1:1.2), and then an appropriate amount of 3% hydroxypropyl methyl cellulose 50% ethanol solution with a pH value of 6.0 is added to mix and granulate, to obtain the granules.

[0056] Comparative Example 2

[0057] Step (5) in the granule preparation method described in this example is: the traditional Chinese medicine composition obtained in step (4) is weighed, 1.5 times the weight of hydroxypropyl-p-cyclodextrin and sorbitol is added and uniformly mixed (the weight ratio of hydroxypropyl-p-cyclodextrin to sorbitol is 1:1.2), and then an appropriate amount of 3% hydroxypropyl methyl cellulose 50% ethanol solution with a pH value of 6.0 is added to mix and granulate, to obtain the granules.

[0058] Verification Example:

[0059] The physicochemical indexes of Examples 1-3 and Comparative Examples 1-2 of the present application are determined.

[0060] The granules prepared in Examples 1-3 and Comparative Examples 1-2 of the present application are subjected to tests for water content, particle size, loss on drying and long-term storage detection, and the test results are shown in Table 1.

[0061] The determination method of water content: the water content of the granules is calculated by drying method, which should not exceed 8.0%.

[0062] The detection method of particle size: the granules prepared in Examples 1-3 and Comparative Examples 1-2 are subjected to particle size determination by the double sieve method of Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0982 Method 2, and the sum of the particles that can pass through No. 1 sieve and No. 5 sieve should not exceed 15%.

[0063] Loss on drying: the granules prepared in Examples 1-3 and Comparative Examples 1-2 are subjected to loss on drying determination by the loss on drying determination method of Chinese Pharmacopoeia 2020 Edition Part IV General Rule 0831, and the weight loss should not exceed 2.0% after drying at 105℃.

[0064] Long-term testing: The granules prepared in Examples 1-3 and Comparative Examples 1-2 were placed at a temperature of 25℃±2℃ and a relative humidity of 60%±10% for 12 months, and then the moisture content and loss on drying were tested.

[0065] Table 1. Stability test results for each example group

[0066]

[0067]

[0068] Note: One indicates that long-term testing was not conducted because the quality did not meet the requirements.

[0069] As shown in Table 1, the granules of Examples 1 to 3 of the present invention meet the requirements for moisture content, particle size, and loss on drying, and have passed long-term testing. In particular, the indicators of Example 1 are superior to those of the other examples. In contrast, the filler weight of Examples 1 to 2 is not within the scope of the present invention, and the moisture content, particle size, and loss on drying are all unqualified, failing to achieve the technical effect of the present invention.

[0070] II. Animal Experiments

[0071] 1. Materials

[0072] Animals: Healthy ICR mice.

[0073] Reagents: Nitric oxide (NO) kit, testosterone (T) enzyme-linked immunosorbent assay (ELISA) kit, cyclic guanosine monophosphate (cGMP) kit, phosphodiesterase 5 (PDE5) kit, lactate (LA) kit, lactate dehydrogenase (LDH) kit, blood urea nitrogen (BUN) kit, malondialdehyde (MDA), liver glycogen (LG), and muscle glycogen (MG) kits.

[0074] 2 methods

[0075] 2.1 Feeding

[0076] Healthy ICR mice were acclimatized for one week, and their health was observed during this period. Ten mice were per cage, with sterilized cork shavings as bedding. The animal laboratory temperature was maintained at 23–25°C, relative humidity at 50%–60%, ventilation at approximately 12 times / hour, and a 12-hour light / 12-hour dark lighting cycle. The mice were fed in rod-shaped, dried feed and had free access to water.

[0077] 2.2 Grouping and Medication

[0078] Forty healthy adult male ICR mice, weighing 35-40 g, were randomly divided into low-dose and high-dose groups of the traditional Chinese medicine composition, a whey protein positive control group, and a blank control group, 10 mice in each group. The mice in the low-dose and high-dose groups of the traditional Chinese medicine composition were respectively given 0.24 g / kg and 0.48 g / kg by gavage, with pure water as the solvent. The mice in the positive control group were given 0.50 g / kg of whey protein by gavage, with pure water as the solvent. The mice in the blank control group were given pure water by gavage. Gavage was performed twice a day for 30 consecutive days.

[0079] Forty female mice were given ordinary feed and allowed to eat and drink freely.

[0080] 2.3 Male mouse mating experiment

[0081] The mating experiment was performed 60 min after the last gavage administration of the male mice. The female mice were given benzoic acid estradiol 3 days before the mating experiment, with 10 μg per mouse administered by subcutaneous injection, and were given progesterone 5 h before the experiment, with 40 μg per mouse administered by subcutaneous injection, so as to make them enter the estrus period. On the night of the end of gavage of the male mice, 20:00-23:00, the male mice in each group were respectively placed in cages with a size of 30 cm×15 cm×15 cm in a quiet and weakly light room for 15 min of adaptation, and then the female mice were put in, and the mating behavior of the mice was observed within 30 min. The sexual behavior parameters of the male mice in each group were counted, including the number of captures (the number of times that the male mice captured the female mice), the capture latency (the time interval for the male mice to appear for the first time), the ejaculation latency (the time interval from the placement of the female mice to the first ejaculation of the male mice), and the number of ejaculations (the total number of ejaculations of the male mice).

[0082] 2.4 Detection of the contents of NO and testosterone in the serum of male mice

[0083] The body weight of the animals was measured one day before sacrifice, and the animals were deprived of food but not water for 16 h on the night before sacrifice. The blood was collected from the eyeball after anesthesia with diethyl ether, and the serum was separated by centrifugation at 4℃ and 3000 r / min for 15 min. The contents of NO and testosterone in the serum were determined.

[0084] 2.5 Determination of the organ index, cGMP, and PDE5 content of the sexual organs

[0085] After the blood collection, the mice were sacrificed by cervical dislocation, and the testis, epididymis, preputial gland, seminal vesicle, and prostate tissues of the mice were stripped and weighed, and the organ index (organ weight / mouse body weight×100) was calculated. The corpus cavernosum tissues on both sides of the penis of the mice were stripped in an ice bath, and the contents of cGMP and PDE5 were detected.

[0086] 2.6 Evaluation of the anti-fatigue function

[0087] Forty male mice were randomly divided into 4 groups, grouping, drug dose and administration method were the same as 2.2, and the administration lasted for 30 days. After the last administration, all animals rested for 30 min, and then performed 30 min unloaded swimming in the pool. Blood samples were collected from the retrobulbar vein immediately after 30 min swimming, centrifuged at 3000 r / min for 10 min to obtain serum, and the activities of LDH, the contents of LA and BUN in mouse serum were determined.

[0088] The mouse skeletal muscle was stripped for determination of muscle glycogen and MDA content, and the mouse liver tissue was stripped for determination of liver glycogen content.

[0089] 2.7 Statistical method

[0090] The results of the above indexes were expressed as mean ± standard deviation. GraphPad Prism 8 statistical software was used for statistical analysis by One-way ANOVA, P<0.05 indicated that the difference was statistically significant, P<0.01 indicated that the difference was statistically significant.

[0091] 3 Experimental results

[0092] 3.1 Effect of traditional Chinese medicine combination on mating behavior of ICR male mice

[0093] Table 2 Effect of traditional Chinese medicine combination on mating behavior of mice

[0094]

[0095]

[0096] Note: a indicates P<0.05 compared with the blank control group; b indicates P<0.01 compared with the blank control group; c indicates P<0.05 compared with the whey protein group; d indicates P<0.01 compared with the whey protein group.

[0097] Compared with the blank control group, the number of captures and ejaculation times within 30 min of mice in the whey protein group increased slightly but the difference was not statistically significant (P>0.05), the number of captures and ejaculation times within 30 min of mice in the low-dose traditional Chinese medicine combination group increased (P<0.05), and the number of captures and ejaculation times within 30 min of mice in the high-dose traditional Chinese medicine combination group increased significantly (P<0.01); compared with the blank control group, the capture latency and ejaculation latency within 30 min of mice in the whey protein group and the low-dose traditional Chinese medicine combination group were shortened (P<0.05), and the capture latency and ejaculation latency within 30 min of mice in the high-dose traditional Chinese medicine combination group were shortened significantly (P<0.01).

[0098] Compared with the whey protein group, the number of capture and ejaculation times of mice within 30 min of the low-dose group of the traditional Chinese medicine combination slightly increased but the difference was not statistically significant (P>0.05), and the high-dose group of the traditional Chinese medicine combination significantly increased (P<0.01); the capture latency and ejaculation latency of mice within 30 min of the low-dose group of the traditional Chinese medicine combination shortened (P<0.05), and the high-dose group of the traditional Chinese medicine combination significantly shortened (P<0.01).

[0099] The experimental results show that the traditional Chinese medicine combination of the application increases the number of capture and ejaculation times of male mice, shortens the capture latency and ejaculation latency, and indicates that the traditional Chinese medicine combination of the application can improve the sexual function of mice.

[0100] 3.2 Influence of the traditional Chinese medicine combination on the content of serum testosterone and NO of ICR male mice

[0101] Table 3 Influence of the traditional Chinese medicine combination on the content of serum testosterone and NO of mice

[0102] Group Control group Whey protein group Low-dose traditional Chinese medicine group High-dose traditional Chinese medicine group Testosterone concentration (nmol / L) 53.16±21.40 54.30±21.11 60.28 ± 19.95 ac ]] 67.28 ± 12.11 bd ]] NO concentration (nmol / L) 44.18±10.77 45.20±20.81 51.07 ± 14.12 ac ]] 59.27 ± 20.90 bd ]]

[0103] Note: a indicates P<0.05 compared with the blank control group; b indicates P<0.01 compared with the blank control group; c indicates P<0.05 compared with the whey protein group; d indicates P<0.01 compared with the whey protein group.

[0104] Compared with the blank control group, the content of testosterone and NO in the serum of the whey protein group increased, but both were not statistically significant (P>0.05); the content of testosterone and NO of the low-dose group of the traditional Chinese medicine combination increased (P<0.05); and the content of testosterone and NO of the high-dose group of the traditional Chinese medicine combination in the serum of mice significantly increased (P<0.01).

[0105] Compared with the whey protein group, the content of testosterone and NO in the serum of the low-dose group of the traditional Chinese medicine combination increased (P<0.05); and the content of testosterone and NO in the serum of the high-dose group of the traditional Chinese medicine combination significantly increased (P<0.01).

[0106] NO is a non-cholinergic and non-adrenal neurotransmitter, which can cause relaxation of penile smooth muscle, so that blood enters the cavernous body, and with the significant increase of the concentration of NO, the ability to stimulate penile erection is enhanced. The experimental results show that the traditional Chinese medicine combination group can increase the testosterone and NO levels of male mice, and indicate that the traditional Chinese medicine combination of the application can improve the ability of penile erection.

[0107] 3.3 Influence of the traditional Chinese medicine combination on the index of gonadal organs of ICR male mice

[0108] Table 4 Influence of the traditional Chinese medicine combination on the index of gonadal organs of mice

[0109] Group Control group Whey protein group Low-dose traditional Chinese medicine group High-dose traditional Chinese medicine group Testis (both sides) 0.77±0.03 0.78±0.03 0.81±0.09 0.83±0.07 Epididymis (both sides) 0.25±0.05 0.26±0.05 0.30±0.08 0.31±0.02 Preputial gland (both sides) 0.29±0.07 0.30±0.02 0.32±0.03 0.32±0.08 Seminal vesicle + prostate 0.56±0.05 0.57±0.07 0.62±0.09 0.73 ± 0.04ac

[0110] Note: a indicates P<0.05 compared with the blank control group; c indicates P<0.05 compared with the whey protein group.

[0111] Compared with the blank control group, the mouse gonadal organ index of the whey protein group had no statistical significance (P>0.05); the mouse gonadal organ index of the low-dose traditional Chinese medicine combination group had an increasing trend but no statistical significance (P>0.05), and the mouse gonadal organ (seminal vesicle + prostate) index of the high-dose traditional Chinese medicine combination group increased (P<0.05).

[0112] Compared with the whey protein group, the mouse gonadal organ index of the low-dose traditional Chinese medicine combination group had no statistical significance (P>0.05), and the mouse gonadal organ index (seminal vesicle + prostate) of the high-dose traditional Chinese medicine combination group increased (P<0.05).

[0113] The experimental results show that the traditional Chinese medicine combination can increase the mouse gonadal organ (seminal vesicle + prostate) index and improve the sexual function of the male mice.

[0114] 3.4 Influence of the traditional Chinese medicine combination on the corpus cavernosum cGMP and PDE5 content of ICR male mice

[0115] Table 5 Influence of the traditional Chinese medicine combination on the corpus cavernosum cGMP and PDE5 content of mice

[0116] Group Control group Whey protein group Low-dose traditional Chinese medicine group High-dose traditional Chinese medicine group cGMP (nmol / L) 25.26±2.16 27.26±1.22 28.18±3.19 33.22 ± 2.11 bc ]] PDE5 (pg / L) 355.42±28.19 340.40±20.11 304.14 ± 31.24 ac ]] 270.20 ± 30.02 bd ]]

[0117] Note: a indicates P<0.05 compared with the blank control group; b indicates P<0.01 compared with the blank control group; c indicates P<0.05 compared with the whey protein group; d indicates P<0.01 compared with the whey protein group.

[0118] Compared with the blank control group, the corpus cavernosum cGMP and PDE5 content of the mice in the whey protein group had no statistical difference (P>0.05); the cGMP content of the mice in the low-dose traditional Chinese medicine combination group slightly increased but had no statistical difference (P>0.05), and the PDE5 content decreased (P<0.05); the cGMP content of the mice in the high-dose traditional Chinese medicine combination group significantly increased (P<0.01), and the PDE5 content significantly decreased (P<0.01).

[0119] Compared with the whey protein group, the cGMP content of the mice in the low-dose traditional Chinese medicine combination group slightly increased but had no statistical difference (P>0.05), and the PDE5 content decreased (P<0.05); the cGMP content of the mice in the high-dose traditional Chinese medicine combination group increased (P<0.05), and the PDE5 content significantly decreased (P<0.01).

[0120] The decrease of PDE5 level and the increase of cGMP level can make the penile arteriole and the cavernous smooth muscle relax, and blood is pumped into the cavernous sinus to cause the erection. The experimental results show that the traditional Chinese medicine combination can increase the cGMP level and decrease the PDE5 level of the male mice, and can improve the erection ability of the male mice.

[0121] 3.5 Influence of the traditional Chinese medicine combination on the anti-fatigue related indexes of the mice

[0122] Table 6 Influence of the traditional Chinese medicine combination on the anti-fatigue related indexes of the mice

[0123] Group Control group Whey protein group Low-dose traditional Chinese medicine group High-dose traditional Chinese medicine group LDH (U / L) 422.55±26.77 413.27±22.56 400.77 ± 23.39 ac ]] 393.22 ± 20.11 bd ]] LA (nmol / L) 1.31±0.25 1.23±0.11 1.10 ± 0.13 ac ]] 0.57 ± 0.17 bd ]] BUN (nmol / L) 4.75±1.11 4.55±1.54 3.93 ± 2.01 ac ]] 3.22 ± 0.90 bd ]] Liver glycogen (mg / g) 4.71±0.22 5.03±0.35 7.34 ± 0.97 ac ]] 9.08 ± 0.88 bd ]] Muscle glycogen (mg / g) 0.11±0.01 0.15±0.04 0.18 ± 0.02 ac ]] 0.25 ± 0.11 bd ]] MDA (nmol / ml) 6.02±0.37 5.80±0.54 4.75 ± 0.22 ac ]] 3.99 ± 1.05 bd ]]

[0124] Note: a represents P<0.05 compared with the blank control group; b represents P<0.01 compared with the blank control group; c represents P<0.05 compared with the whey protein group; d represents P<0.01 compared with the whey protein group.

[0125] Compared with the blank group, the LDH, LA, BUN, liver glycogen, muscle glycogen and MDA contents of the mice in the whey protein group had no statistically significant difference (P>0.05); the low-dose traditional Chinese medicine combination can decrease the LDH, LA, BUN and MDA levels of the mice (P<0.05), and increase the muscle glycogen and liver glycogen levels of the mice (P<0.05). The high-dose traditional Chinese medicine combination can significantly decrease the LDH, LA, BUN and MDA levels of the mice (P<0.01), and significantly increase the muscle glycogen and liver glycogen levels of the mice (P<0.01).

[0126] The experimental results show that the traditional Chinese medicine combination can increase the liver glycogen and muscle glycogen contents, decrease the LA, BUN and MDA contents, delay the fatigue generation or accelerate the fatigue elimination, increase the energy storage capacity of the organism, and accelerate the elimination of metabolites.

[0127] III. Comparison of the clinical application of the drugs

[0128] 1. Selection and grouping of the case objects

[0129] 100 patients with impotence, premature ejaculation and spermatorrhea were collected, and the patients were divided into an observation group and a control group by using a random number table, with 50 patients in each group. The observation group was aged 33-65 years old, with an average age of (47.7±8.1) years old. The control group was aged 33-64 years old, with an average age of (46.5±8.5) years old. All the patients had different degrees of lumbago and weakness, dizziness, chill, impotence, premature ejaculation, spermatorrhea and other conditions, and the patients with reproductive tract infection factors and organic diseases were excluded. There was no statistically significant difference in the age, condition and other general information of the patients in the two groups (P>0.05).

[0130] Control group: oral administration of Shenbao tablets (manufacturer: Hui Ren Group, product batch number 2401014), 3 tablets at a time, 3 times a day, continuous administration for 6 months, and kidney function reexamination.

[0131] Observation group: taking the traditional Chinese medicine composition of the application, 3 times a day, once in the morning, noon and evening, continuous use for 6 months, and kidney function reexamination.

[0132] 2. Therapeutic effect evaluation

[0133] Marked effect: the clinical symptoms such as lumbago and weakness, dizziness and coldness disappeared, the kidney function recovered, impotence and premature ejaculation disappeared, and the sexual function completely recovered.

[0134] Effectiveness: the clinical symptoms such as lumbago and weakness, dizziness and coldness improved, the kidney function improved, impotence and premature ejaculation reduced, and the sexual function basically recovered.

[0135] Ineffectiveness: the clinical symptoms such as lumbago and weakness, dizziness and coldness did not improve, the kidney function did not improve, impotence and premature ejaculation still existed, and the sexual dysfunction even lost.

[0136] 3. Results

[0137] All patients' lumbago and weakness, dizziness and coldness, kidney function, and sexual function such as impotence and premature ejaculation were observed and recorded. The treatment results of the control group and the observation group are shown in Table 7.

[0138] Table 7 Treatment results of the control group and the observation group

[0139] Group Number of cases Effective Effective Ineffective Total effective rate Observation group 50 26 20 4 92 Control group 50 17 23 10 80

[0140] As can be seen from Table 7, the traditional Chinese medicine composition of the application has a significant effect on improving male sexual function, with a significant effect rate of 52% and a total effective rate of 92%. Compared with the control group, the significant effect rate is increased by 53%, and the total effective rate is increased by 15%.

[0141] Case collection

[0142] Case one

[0143] Jia, a 55-year-old man from Shandong Province, was diagnosed with impotence in March 2023. The hospital treatment effect was not obvious, and the function was basically lost. He started using the traditional Chinese medicine composition of the application in May 2023, and after 3 months of treatment, he could erect, and after 6 months of use, he basically recovered the function.

[0144] Case two

[0145] Li, a 41-year-old man from Guangdong Province, had premature ejaculation. The hospital treatment effect was not obvious, and he could only maintain for 2 minutes or less. He started using the traditional Chinese medicine composition of the application in May 2023, and after 1 month of treatment, he could maintain for 3-5 minutes, and after 4 months of use, he basically recovered the function.

[0146] Case three

[0147] Zhu, 33 years old, male, Jiangsu Province, has a long history of masturbation, has a serious emission, and the effect of treatment is not ideal, uses the traditional Chinese medicine composition of the application, after 1 month of treatment, the disease begins to improve, and after 5 months of use, the function is basically restored.

[0148] Case four

[0149] Liu, 59 years old, male, Dongguan City, was diagnosed with impotence by the hospital in February 2023, and the effect of hospital treatment was not obvious, and the function was basically lost. Since May 2023, the traditional Chinese medicine composition of the application has been used, and after 4 months of treatment, it can be erected, and after 6 months of use, the function is basically restored.

[0150] The above-mentioned embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it cannot be understood as a limitation on the scope of the patent. It should be pointed out that for ordinary skilled persons in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of a medicine for treating male sexual function and anti-fatigue, characterized in that, the traditional Chinese medicine composition comprises the following components in a proportion by weight: The traditional Chinese medicine composition is composed of 15 parts of Astragalus membranaceus, 9 parts of Scutellaria baicalensis, 9 parts of Alisma orientalis, 9 parts of Salvia miltiorrhiza and 6 parts of Panax ginseng by weight; the male sexual function includes but is not limited to impotence, premature ejaculation and spermatorrhea. ​

Images