CN117159676A

CN117159676A - Traditional Chinese medicine composition for treating premature ejaculation and impotence as well as preparation method and application thereof

Info

Publication number: CN117159676A
Application number: CN202311215823.1A
Authority: CN
Inventors: 孙大林; 金保方; 朱树丽; 张新东; 蔡滨; 邓伟民; 金亦涵
Original assignee: Southeast University
Current assignee: Southeast University
Priority date: 2023-09-20
Filing date: 2023-09-20
Publication date: 2023-12-05

Abstract

A traditional Chinese medicine composition for treating premature ejaculation and impotence and a preparation method and application thereof relate to the technical field of medicines. The traditional Chinese medicine composition for treating premature ejaculation and impotence comprises, by weight, 5-20 parts of bupleurum, 5-15 parts of scutellaria baicalensis, 5-15 parts of cassia twig, 5-20 parts of dried ginger, 5-20 parts of pinellia ternate, 5-15 parts of fructus aurantii, 5-30 parts of dried orange peel, 10-30 parts of poria cocos, 5-15 parts of rhizoma acori graminei, 5-15 parts of polygala tenuifolia, 10-40 parts of oyster and 3-15 parts of raw liquorice. The traditional Chinese medicine composition can be used for treating liver depression and spleen deficiency phlegm-dampness type premature ejaculation and erectile dysfunction, has the characteristics of good curative effect, low recurrence rate, no side effect and the like, and the preparation method is simple, quick and efficient, is easy to operate, and the prepared mixture, granules and the like are convenient to carry and take.

Description

Traditional Chinese medicine composition for treating premature ejaculation and impotence as well as preparation method and application thereof

Technical Field

The application relates to the technical field of medicines, in particular to a traditional Chinese medicine composition for treating premature ejaculation and impotence, and a preparation method and application thereof.

Background

Premature Ejaculation (PE) and Erectile Dysfunction (ED) are the most common two sexual dysfunction diseases in clinic, and are frequently accompanied by the existence of interrelations due to pathogenesis.

PE is the most common sexual dysfunction in clinic, and the factors of the pathogenesis of PE may include genetic tendency, poor overall health condition and obesity, prostatitis, thyroid hormone imbalance, mood problems and stress and traumatic sexual experience, PE can be divided into primary premature ejaculation, secondary premature ejaculation, natural variant premature ejaculation, premature ejaculation-like ejaculation dysfunction and the like, medicines which are clinically commonly used for treating PE comprise 5-hydroxytryptamine reuptake inhibitors (SSRIs), local anesthetics, psychological/behavioral treatments, alpha receptor antagonists and the like, but the overall curative effect is poor, traditional Chinese medicine is discussed for PE earlier, is called "semen spilling", "chicken essence", "semen discharging" and the like in succession, PE is considered to be related to five viscera dysfunction, renal failure is firm, liver failure, heart failure is dominant, spleen failure is taken, lung failure is reduced, PE can be caused due to the fact that PE is complicated in pattern and frequency of occurrence is different, and the most commonly used treatment scheme is still lacking.

ED refers to the fact that the penis can not achieve or maintain enough erection for more than 3 months to complete satisfactory sexual life, is closely related to the life quality, sexual partner relationship and family stability of patients, is more early warning signals of a plurality of somatic diseases, has more clinical symptoms, is often divided into liver qi stagnation, life gate fire failure, damp-heat of liver channel, qi stagnation and blood stasis and the like, and is described as flaccidity but not hard but soon as impotence in traditional Chinese medicine.

The applicant finds that the type of phlegm-dampness due to liver depression and spleen deficiency is most common in the traditional Chinese medicine symptoms of patients with premature ejaculation and erectile dysfunction through clinical observation, and the type of phlegm-dampness is possibly related to life habits and modes of modern society, such as overfeeding with sweet and thick taste, being cold and greasy, being too much in pressure, staying up all night and the like. Therefore, finding a therapeutic drug or a therapeutic scheme for premature ejaculation and erectile dysfunction is an important problem to be solved, and therefore, the application provides a traditional Chinese medicine composition for treating premature ejaculation and impotence, and a preparation method and application thereof.

Disclosure of Invention

Technical problems: in order to solve the problems in the prior art, the application provides a traditional Chinese medicine composition for treating premature ejaculation and impotence, and a preparation method and application thereof.

The technical scheme is as follows: in order to achieve the above purpose, the present application adopts the following technical scheme:

a Chinese medicinal composition for treating liver depression and spleen deficiency phlegm dampness type premature ejaculation and impotence comprises, by weight, 5-20 parts of radix bupleuri, 5-15 parts of radix Scutellariae, 5-15 parts of ramulus Cinnamomi, 5-20 parts of rhizoma Zingiberis, 5-20 parts of rhizoma Pinelliae, 5-15 parts of fructus Aurantii, 5-30 parts of pericarpium Citri Tangerinae, 10-30 parts of Poria, 5-15 parts of rhizoma Acori Graminei, 5-15 parts of radix Polygalae, 10-40 parts of Concha Ostreae and 3-15 parts of radix Glycyrrhrizae.

Further, the raw materials comprise, by weight, 10-15 parts of bupleurum, 9-12 parts of scutellaria baicalensis, 9-12 parts of cassia twig, 6-15 parts of dried ginger, 6-20 parts of pinellia ternate, 6-15 parts of fructus aurantii, 10-20 parts of dried orange peel, 10-20 parts of poria cocos, 6-12 parts of rhizoma acori graminei, 6-12 parts of polygala tenuifolia, 15-30 parts of oyster and 6-10 parts of raw liquorice.

Further, the raw materials comprise 12 parts of bupleurum, 10 parts of baical skullcap root, 10 parts of cassia twig, 15 parts of dried ginger, 15 parts of pinellia ternate, 10 parts of fructus aurantii, 20 parts of dried orange peel, 15 parts of poria cocos, 10 parts of grassleaf sweelflag rhizome, 10 parts of polygala tenuifolia, 20 parts of oyster and 6 parts of raw liquorice.

The preparation method of the traditional Chinese medicine composition comprises the following steps: placing the raw materials in a container, adding an extracting agent, extracting, and concentrating the extracting solution to obtain the final product, wherein the extracting agent is at least one of water, ethanol, wine, diethyl ether, chloroform and glycerol.

Further, adding water 5-15 times the total weight of the raw materials, soaking for 30-60 minutes, decocting for 1-3 times, each time for 0.5-2 hours, filtering, mixing the filtrates, concentrating the filtrate to prepare a liquid preparation or adding auxiliary agents to prepare a solid preparation.

Further, the preparation method of the solid preparation comprises the following steps: concentrating the filtrate under reduced pressure to obtain an extract with the relative density of 1.00-1.20, adding 45% -70% ethanol solution, standing for 24 hours, taking supernatant, recovering ethanol in the supernatant, continuously concentrating to obtain a thick paste with the relative density of 1.15-1.35, adding medicinal auxiliary materials, mixing, and preparing into a solid agent.

Further, the pharmaceutical excipients comprise at least one of honey, sucrose and xylitol, and the solid agent is tablet, powder, capsule or granule.

Further, the preparation method of the liquid preparation comprises the following steps: concentrating the filtrate under reduced pressure, centrifuging and diluting to obtain a liquid preparation.

A compound preparation contains the above Chinese medicinal composition.

The application of the traditional Chinese medicine composition or the compound preparation in preparing the medicine for treating liver depression and spleen deficiency phlegm dampness type premature ejaculation and impotence.

The beneficial effects are that: the traditional Chinese medicine composition is used for treating liver depression, spleen deficiency, phlegm-damp type premature ejaculation, erectile dysfunction and the like, has the characteristics of good curative effect, low recurrence rate, no side effect and the like, and the preparation method is simple, quick and efficient, easy to operate, and the prepared mixture, granules and the like are convenient to carry and take.

Detailed Description

The application is further described below in connection with specific embodiments.

Clinical verification shows that the traditional Chinese medicine compound medicine has the effects of soothing liver, strengthening spleen, eliminating phlegm, promoting qi circulation, eliminating dampness and soothing nerves, and mainly treats: patients with excessive rapid ejaculation, erection, spermatorrhea, cold feeling, hand and foot coldness, fatigue, debilitation, excessive sweat, dizziness, dry mouth, bitter taste, palpitation, chest distress, gastric distention, acid regurgitation, nausea, loose stool, insomnia, dreaminess, pale red tongue with white or greasy coating, etc.

In the traditional Chinese medicine composition provided by the application, bupleurum soothing liver qi stagnation relieving; bai Huang clears heat of shaoyang, and both are combined to dispel liver meridian heat. Ramulus Cinnamomi warms and unblocks meridians, and invigorates yang and qi-transforming; dry Jiang Jianpi, with the actions of warming spleen and stomach, dispelling cold and resolving fluid retention, both are combined with the actions of warming spleen and yang and resolving dampness and dispelling cold. Oyster has effects of relieving mental stress, suppressing yang hyperactivity and nourishing yin; licorice root, radix Glycyrrhizae Praeparata has the effects of invigorating spleen and replenishing qi, and harmonizing the drugs. The above medicines are combined into the bupleurum, cassia twig and dried ginger decoction, and have the effects of dispelling the liver and strengthening the spleen.

Pinellia tuber has the effects of eliminating dampness and phlegm, and lowering adverse qi to arrest vomiting; dried orange peel can regulate qi, remove stagnation, dry dampness and phlegm; poria cocos has effects of strengthening spleen, excreting dampness, calming heart and tranquilizing mind; fructus Aurantii has effects of lowering qi, removing food stagnation, eliminating phlegm, and relieving distention. The four are combined to be the basic prescription of the soup for warming the gallbladder, and have the effects of regulating qi, resolving phlegm, promoting bile flow and soothing the nerves. The pinellia tuber, bupleurum root, baikal skullcap root and licorice root are combined to form the basic composition of the bupleurum root decoction, and have the effects of cold-heat phase formation, ascending and descending phase cause and resolving the stagnation of the shaoyang qi.

The bupleurum, cassia twig and dried ginger decoction is used for soothing liver, strengthening spleen and warming gallbladder to regulate qi, resolving phlegm and being mutually cooperated, soothing liver, relieving depression and being beneficial to regulating qi, promoting qi circulation and resolving phlegm; qi regulating and qi moving cause liver qi stagnation and spleen qi self-strengthening; spleen likes dryness and dislikes dampness, phlegm and dampness are removed, qi is not clear, liver depression is eliminated, and spleen functions are favorable for recovery.

Rhizoma Acori Graminei has effects of inducing resuscitation, eliminating phlegm, refreshing mind and improving intelligence; radix polygalae tranquilizes and controls the essence and transportation of heart and kidney; it is combined with Fu Ling to dispel phlegm, strengthen heart and arrest spontaneous emission.

The whole formula has the effects of soothing liver, strengthening spleen, eliminating phlegm, resolving dampness, soothing nerves and securing essence. Can be used for treating premature ejaculation and impotence due to liver depression and spleen deficiency and phlegm dampness, has remarkable clinical effect, and can improve the physical condition of patients and prevent recurrence.

A traditional Chinese medicine composition for treating liver depression and spleen deficiency phlegm dampness type premature ejaculation and impotence comprises the following raw material extracts in parts by weight:

5-20 parts of radix bupleuri, 5-15 parts of radix scutellariae, 5-15 parts of cassia twig, 5-20 parts of dried ginger, 5-20 parts of pinellia ternate, 5-15 parts of fructus aurantii, 5-30 parts of dried orange peel, 10-30 parts of poria cocos, 5-15 parts of rhizoma acori graminei, 5-15 parts of polygala tenuifolia, 10-40 parts of oyster and 3-15 parts of raw liquorice.

The raw materials comprise the following components in parts by weight:

5 parts of radix bupleuri, 9-12 parts of radix scutellariae, 9-12 parts of cassia twig, 6-15 parts of dried ginger, 6-20 parts of pinellia ternate, 6-15 parts of fructus aurantii, 10-20 parts of dried orange peel, 10-20 parts of poria cocos, 6-12 parts of rhizoma acori graminei, 6-12 parts of polygala tenuifolia, 15-30 parts of oyster and 6-10 parts of raw liquorice.

The raw materials comprise the following components in parts by weight: 20 parts of bupleurum, 9-12 parts of scutellaria baicalensis, 9-12 parts of cassia twig, 6-15 parts of dried ginger, 6-20 parts of pinellia ternate, 6-15 parts of fructus aurantii, 10-20 parts of dried orange peel, 10-20 parts of poria cocos, 6-12 parts of rhizoma acori graminei, 6-12 parts of polygala tenuifolia, 15-30 parts of oyster and 6-10 parts of raw liquorice.

The raw materials comprise the following components in parts by weight: 12 parts of bupleurum, 10 parts of scutellaria baicalensis, 10 parts of cassia twig, 15 parts of dried ginger, 15 parts of pinellia ternate, 10 parts of fructus aurantii, 20 parts of dried orange peel, 15 parts of poria cocos, 10 parts of rhizoma acori graminei, 10 parts of polygala tenuifolia, 20 parts of oyster and 6 parts of raw liquorice.

The application also provides a preparation method of the traditional Chinese medicine composition, the raw materials are placed in a container, an extracting agent is added for extraction, and the extract is concentrated to obtain the traditional Chinese medicine composition.

For example, adding water 5-15 times the total weight of the raw materials, soaking for 30-60 minutes, decocting for 1-3 times each time for 0.5-2 hours, filtering, mixing the filtrates, concentrating the filtrate to obtain a liquid preparation or adding auxiliary agents to obtain a solid preparation.

The preparation method of the solid preparation comprises the following steps: concentrating the filtrate under reduced pressure to obtain an extract with a relative density of 1.00-1.20, adding 45% -70% ethanol solution, standing for 24 hours, collecting supernatant, recovering ethanol in the supernatant, concentrating to obtain a thick paste with a relative density of 1.15-1.35, adding pharmaceutical adjuvants, mixing, and preparing into solid agent, wherein the pharmaceutical adjuvants comprise at least one of starch, dextrin, sucrose, lactose, microcrystalline cellulose, mannitol or hypromellose, etc.

The preparation method of the liquid preparation comprises the following steps: concentrating the filtrate under reduced pressure, centrifuging and diluting to obtain liquid preparation, wherein the liquid preparation comprises solution, emulsion or cream.

The application also provides a compound preparation which contains the traditional Chinese medicine composition, namely the compound preparation is a preparation prepared from the traditional Chinese medicine composition or the traditional Chinese medicine composition and excipient (used for preparing the traditional Chinese medicine composition into a solid or liquid state) or combining other auxiliary agents by utilizing the traditional Chinese medicine composition, and the preparation can be a liquid preparation or a solid preparation:

liquid preparations, for example, may be solutions, emulsions or creams;

the solid preparation may be, for example, a granule, powder, tablet, pill, mixture or capsule.

The extraction method of the traditional Chinese medicine composition can be as follows:

the extraction method comprises the following steps: extracting the raw materials one by one, and merging the liquid obtained by the independent extraction to obtain filtrate;

extracting any two or more of the above materials, and mixing the extracted liquids to obtain filtrate.

Example 1

For example, the raw materials can be weighed according to the following proportion:

12 parts of bupleurum, 10 parts of scutellaria baicalensis, 10 parts of cassia twig, 15 parts of dried ginger, 15 parts of pinellia ternate, 10 parts of fructus aurantii, 20 parts of dried orange peel, 15 parts of poria cocos, 10 parts of rhizoma acori graminei, 10 parts of polygala tenuifolia, 20 parts of oyster and 6 parts of raw liquorice.

Example 2

10 parts of bupleurum, 12 parts of scutellaria baicalensis, 10 parts of cassia twig, 6 parts of dried ginger, 6 parts of pinellia ternate, 15 parts of fructus aurantii, 10 parts of dried orange peel, 20 parts of poria cocos, 6 parts of rhizoma acori graminei, 6 parts of polygala tenuifolia, 30 parts of oyster and 6 parts of raw liquorice.

Example 3

15 parts of bupleurum, 9 parts of scutellaria baicalensis, 12 parts of cassia twig, 15 parts of dried ginger, 20 parts of pinellia ternate, 6 parts of fructus aurantii, 20 parts of dried orange peel, 10 parts of poria cocos, 12 parts of rhizoma acori graminei, 12 parts of polygala tenuifolia, 15 parts of oyster and 10 parts of raw liquorice.

Example 4

5 parts of radix bupleuri, 5 parts of radix scutellariae, 5 parts of cassia twig, 5 parts of dried ginger, 5 parts of pinellia ternate, 5 parts of fructus aurantii, 5 parts of dried orange peel, 10 parts of poria cocos, 5 parts of rhizoma acori graminei, 5 parts of polygala tenuifolia, 10 parts of oyster and 3 parts of raw liquorice.

Example 5

20 parts of bupleurum, 15 parts of scutellaria baicalensis, 15 parts of cassia twig, 20 parts of dried ginger, 20 parts of pinellia ternate, 15 parts of fructus aurantii, 30 parts of dried orange peel, 30 parts of poria cocos, 15 parts of rhizoma acori graminei, 15 parts of polygala tenuifolia, 40 parts of oyster and 15 parts of raw liquorice.

A method of preparing the compositions of examples 1-5 comprising the steps of:

mixing all above materials, placing into a container, adding water 10 times the weight of the mixture into the container, soaking for 60min, decocting for 2 times each for 1 hr, and filtering to obtain filtrate.

Example 6

Preparing the filtrate obtained by extracting any of the above embodiments into a solid preparation:

for example, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.00, adding 45% ethanol, standing for 24 hr, collecting supernatant, recovering ethanol from supernatant, concentrating to obtain soft extract with relative density of 1.15, adding medicinal adjuvants such as sucrose or starch, mixing, and making into granule, powder, tablet, pill, mixture or capsule.

Example 7

For example, concentrating the filtrate under reduced pressure to obtain extract with relative density of 1.20, adding 75% ethanol, standing for 24 hr, collecting supernatant, recovering ethanol from supernatant, concentrating to obtain soft extract with relative density of 1.35, adding medicinal adjuvants such as sucrose or starch, mixing, and making into granule, powder, tablet, pill, mixture or capsule.

Comparative example 1

A traditional Chinese medicine composition for treating premature ejaculation and impotence comprises the following components in parts by weight: 12 parts of bupleurum, 10 parts of scutellaria baicalensis, 10 parts of cassia twig, 15 parts of dried ginger, 20 parts of oyster and 6 parts of raw liquorice.

Comparative example 2

A traditional Chinese medicine composition for treating premature ejaculation and impotence comprises the following components in parts by weight: 15 parts of pinellia ternate, 10 parts of fructus aurantii, 20 parts of dried orange peel, 15 parts of poria cocos, 10 parts of rhizoma acori graminei, 10 parts of polygala tenuifolia and 6 parts of raw liquorice.

Comparative example 3

A traditional Chinese medicine composition for treating premature ejaculation and impotence comprises the following components in parts by weight: 15 parts of pinellia ternate, 15 parts of caulis bambusae in taeniam, 10 parts of fructus aurantii, 20 parts of pericarpium citri reticulatae, 15 parts of poria cocos, 10 parts of rhizoma acori graminei, 10 parts of polygala tenuifolia, 30 parts of dragon bone, 30 parts of oyster, 20 parts of hypericum perforatum, 6 parts of raw liquorice, 15 parts of ginger and 15 parts of red date.

The compositions of comparative examples 1-3 were prepared in the same manner as in example 1.

Clinical test of the Chinese medicinal composition

1. General data: the patients 240 cases of primary premature ejaculation with liver depression and spleen deficiency and phlegm dampness type erection dysfunction (impotence) are selected from the patients 240 cases of the primary premature ejaculation with liver depression and spleen deficiency and phlegm dampness type erection dysfunction (impotence) in the auxiliary middle-large and large hospitals of southeast university in combination with the clinic diagnosis of men in the year of 8 months in 2020 to 6 months in 2023. Patients with premature ejaculation and impotence were each divided into 8 groups, examples 1 to 5 and comparative examples 1 to 3, each group having 30 cases, by the random digital grouping method. General data between groups, including age, disease course, were statistically tested for no differences (p < 0.05), and were comparable.

2. Primary premature ejaculation with selection criteria of liver depression and spleen deficiency and phlegm dampness: (1) age: 18-45 years old; (2) there is a fixed sex partner and regular life; (3) Diagnostic criteria for primary PE in Manual of diagnosis and statistics of mental diseases V: (1) the following symptoms last at least 6 months and are all or almost all the way through sexual activity (about 75%): during sexual activity, ejaculation patterns occur continuously or repeatedly within 2 minutes and earlier than the sexual partner expects; (2) the premature ejaculation problem causes obvious pain or trouble; (3) the sexual dysfunction is not caused by certain types of mental disorders, nor is it caused by certain factors (such as drug use or drug intake); (4) Meets the requirements of the Chinese medical society on the classification of constitutions of liver depression, spleen deficiency and phlegm dampness in the Chinese medical science; (5) no similar drug treatment was used 1 month prior to treatment; (6) No drugs affecting sexual function are taken during treatment; (7) patients were informed and agreed to participate in the study. Exclusion criteria: (1) Premature ejaculation caused by a circumstance and a problem (specific environment or specific partner); (2) suffering from acute and chronic urogenital infections; (3) Patients suffering from mental disorders in need of treatment or undergoing treatment; (4) a history of abuse or drug administration for 2 years; (5) There are Erectile Dysfunction (ED), retrograde ejaculation, hyposexuality, etc.; (6) Other drug trials for PE treatment were enrolled in approximately 3 months; (7) Systemic diseases such as heart brain system diseases, liver and kidney system diseases, etc., or other related organic lesions; (8) receiving surgery during treatment, such as circumcision, etc.; (9) allergy sufferers of orally administered SSRIs drugs; (10) Patients who do not take medicine, exit midway, lose contact and lose interview are not required.

The liver depression and spleen deficiency and phlegm dampness type erection dysfunction inclusion criteria: (1) age: 18-45 years old; (2) there is a fixed sex partner and regular life; (3) Meets the diagnostic criteria for ED, an International erectile function index score (IIEF-5) <22 points; (4) Meets the liver depression, spleen deficiency and phlegm dampness constitution typing in the Chinese medicine constitution classification and judgment table; (5) no similar drug treatment was used 1 month prior to treatment; (6) No drugs affecting sexual function are taken during treatment; (7) patients were informed and agreed to participate in the study.

Exclusion criteria: (1) congenital genital deformity and dysplasia; (2) severe reproductive system infections; (3) ED which occurs after genitourinary surgery and lower abdominal surgery; (4) severe cardiac, hepatic, renal dysfunction; (5) Severe hypertension, diabetes, hematopathy are not controlled; (6) severe psychological disorders.

3. Treatment protocol: examples 1-5 and comparative examples 1-3 were administered in the same dose, one serving as one gram, and one dose per day, two times per day, and a treatment period of 4 weeks.

4. And (3) observing the indexes: before and after observation treatment, the primary premature ejaculation patients record the Intravaginal Ejaculation Latency (IELT), the premature ejaculation diagnostic scale (PEDT) and adverse reactions respectively; patients with erectile dysfunction were observed for IIEF-5 scores, erectile stiffness (EHS) scores, and adverse effects before and after treatment.

5. Results: 240 primary premature ejaculation patients were collected, and there was no difference in the IELT and PEDT scores (p < 0.05) before treatment for each group, with comparability. 12 (5%) patients were shed during the treatment, 228 (95%) were finally completed, with 1 for each of example 1, example 2, comparative example 2 and comparative example 3 and 2 for the remaining 4 groups. The results of the IELT and PEDT scores for each group after 4 weeks of treatment are shown in table 1.

TABLE 1

Note that: compared with the prior treatment, p<0.05; compared with the treatment of the groups of the examples 2-5 and the comparative examples 1-3, ^# p<0.05。

240 patients with erectile dysfunction were collected, 11 patients with loss of access (4.6%) and finally 229 patients with abscission (95.4%) were tested. Wherein example 2, example 5 and comparative example 3 each fall off 1 example, example 3, example 4, comparative example 1 and comparative example 2 each fall off 2 examples. The IIEF-5 scoring results for each group after 4 weeks of treatment are shown in Table 2.

TABLE 2

as can be seen from tables 1 and 2, the composition of the present application can effectively improve ejaculation latency of patients suffering from premature ejaculation due to liver depression and spleen deficiency and phlegm dampness, and reduce PEDT score; the IIEF-5 and EHS scores of the liver depression spleen deficiency phlegm dampness type erectile dysfunction patients are improved, and the comparison between each group and the treatment is obvious (p is less than 0.05), so that the preparation composition can effectively treat premature ejaculation and erectile dysfunction diseases. Examples 1-5 showed improved ejaculation time and score, and erectile function and hardness score (p < 0.05) compared to pre-treatment, demonstrating that the pharmaceutical combination of the application was effective against premature ejaculation and impotence, wherein the pharmaceutical combination of example 1 was more efficacious than the pharmaceutical combination of examples 2-5 (p < 0.05), suggesting that the dosage and formulation of the drug is critical for improving efficacy. Comparative examples 1-2 are the formulations of the split formulation of example 1, namely the formulation of the bupleurum and cassia twig Jiang Shanghe decoction for warming gallbladder. Although both had some efficacy (p < 0.05) compared to pre-treatment of premature ejaculation and impotence, the latter efficacy was more pronounced (p < 0.05) compared to the combined example 1 group. Comparative example 3 is the flavored recipe of Wendan decoction, and this experiment was also used as one of the controls, and the treatment effect of example 1 group of the combined recipe was found to be better (p < 0.05). The synergistic effect of the bupleurum and cassia twig Jiang Shanghe decoction for warming the gall is verified, and the effects of soothing the liver and strengthening the spleen and regulating qi and reducing phlegm are verified to supplement each other, so that the efficacy of treating premature ejaculation and impotence can be improved by combining the medicines.

And (3) safety observation: no abnormalities were found in the routine detection of liver, kidney function, blood and urine before and after treatment in both groups of patients.

Therefore, the traditional Chinese medicine composition can be used for treating liver depression and spleen deficiency phlegm-dampness type premature ejaculation and erectile dysfunction, has the characteristics of good curative effect, low recurrence rate, no side effect and the like, and the preparation method is simple, quick and efficient, is easy to operate, and the prepared mixture or granule and the like are convenient to carry and take.

The foregoing is only a part of the specific embodiments of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art, who is within the scope of the present application, should make equivalent substitutions or modifications according to the technical solution of the present application and the inventive concept thereof, and should be covered by the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating premature ejaculation and impotence is characterized by comprising, by weight, 5-20 parts of bupleurum, 5-15 parts of scutellaria baicalensis, 5-15 parts of cassia twig, 5-20 parts of dried ginger, 5-20 parts of pinellia ternate, 5-15 parts of fructus aurantii, 5-30 parts of dried orange peel, 10-30 parts of poria cocos, 5-15 parts of rhizoma acori graminei, 5-15 parts of polygala tenuifolia, 10-40 parts of oyster and 3-15 parts of raw liquorice.

2. The traditional Chinese medicine composition for treating premature ejaculation and impotence according to claim 1, wherein the raw materials comprise, by weight, 10-15 parts of bupleurum, 9-12 parts of scutellaria baicalensis, 9-12 parts of cassia twig, 6-15 parts of dried ginger, 6-20 parts of pinellia ternate, 6-15 parts of fructus aurantii, 10-20 parts of dried orange peel, 10-20 parts of poria cocos, 6-12 parts of rhizoma acori graminei, 6-12 parts of polygala tenuifolia, 15-30 parts of oyster and 6-10 parts of raw licorice.

3. The traditional Chinese medicine composition for treating premature ejaculation and impotence according to claim 1, wherein the raw materials comprise, by weight, 12 parts of bupleurum, 10 parts of scutellaria baicalensis, 10 parts of cassia twig, 15 parts of dried ginger, 15 parts of pinellia ternate, 10 parts of fructus aurantii, 20 parts of dried orange peel, 15 parts of poria cocos, 10 parts of rhizoma acori graminei, 10 parts of polygala tenuifolia, 20 parts of oyster and 6 parts of raw licorice.

4. A method for preparing a traditional Chinese medicine composition for treating premature ejaculation and impotence according to any one of claims 1-3, comprising the following steps: placing the above materials in a container, adding extractant, extracting, and concentrating the extractive solution.

5. The method for preparing a Chinese medicinal composition for treating premature ejaculation and impotence according to claim 4, wherein the extracting agent is water, water 5-15 times of the total weight of the raw materials is added, soaking is carried out for 30-60 min, decocting is carried out for 1-3 times, each time is 0.5-2 h, filtering is carried out, the filtrate is combined, and concentrated filtrate is prepared into a liquid preparation or auxiliary agent is added into the liquid preparation to prepare a solid preparation.

6. The method for preparing a traditional Chinese medicine composition for treating premature ejaculation and impotence according to claim 5, wherein the preparation method of the solid preparation is as follows: concentrating the filtrate under reduced pressure to obtain an extract with the relative density of 1.00-1.20, adding 45% -70% ethanol solution, standing, collecting supernatant, recovering ethanol in the supernatant, concentrating to obtain a thick paste with the relative density of 1.15-1.35, adding medicinal auxiliary materials, mixing, and preparing into solid agent.

7. The method for preparing a Chinese medicinal composition for treating premature ejaculation and impotence according to claim 6, wherein the pharmaceutical excipients comprise at least one of starch, dextrin, sucrose, lactose, honey, microcrystalline cellulose, mannitol, hypromellose and xylitol, and the solid agent is a tablet, powder, capsule or granule.

8. The method for preparing a traditional Chinese medicine composition for treating premature ejaculation and impotence according to claim 5, wherein the preparation method of the liquid preparation is as follows: concentrating the filtrate under reduced pressure, centrifuging and diluting to obtain a liquid preparation.

9. A compound preparation, characterized in that the compound preparation contains the traditional Chinese medicine composition according to any one of claims 1-3.

10. The use of a Chinese medicinal composition according to any one of claims 1-3 or a compound preparation according to claim 9 in the preparation of a medicament for treating premature ejaculation and impotence.