A kind of pharmaceutical composition for the treatment of premature ejaculation and preparation method thereof
Technical field
The invention belongs to field of medicaments, relate to a kind of pharmaceutical composition, particularly relate to a kind of pharmaceutical composition for the treatment of premature ejaculation.
Background technology
Premature ejaculation is a kind of common Ejaculatory dysfunction disease, refer to the very short ejaculation at once of sex time, what have can not complete sexual intercourse at all, some penises not yet contact with women, or just contact pudendum or the vaginal orifice of women, or less than 2 minutes after firm insertion vagina, just ejaculate, after ejaculation, penis is thereupon weak, can not maintain a kind of disease of normal sexuality.Comprise 3 key elements: the incubation period of 1) ejaculating is short; 2) ejaculation ability is controlled; 3) sexual satisfaction degree is low.
The common method for the treatment of of primary disease has psychology, sexual behaviour treatment, serotonin reuptake inhibitors (SSRI) and the treatment of local anaesthetics thing etc., but said method clinical efficacy is not good enough.Recent study shows, the healthier matched group of the biological threshold of feelings of Glans penis that drought lets out patient significantly reduces, the somatosensory evoked potential of Glans penis Induced by Stimulation significantly shortens than normal healthy controls group incubation period, proposes the reason of premature ejaculation and increases relevant with the reduction of penile sense threshold value and nerve excitability.This discovery is let out for medicine for external use treatment drought undoubtedly and be have found the strongest evidence.And although Western medicine local anaesthetics thing external curing effectively can reduce sensitivity, its shortcoming Glans penis nerve can occur experience degradation untoward reaction under pleasant sensation obstacle, libido, even causes sexual impotence.Therefore need to develop the effective medicine for the treatment of premature ejaculation.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition for the treatment of premature ejaculation and preparation method thereof.
Another object of the present invention is the novelty teabag providing this pharmaceutical composition.
The present invention is achieved through the following technical solutions:
The crude drug of pharmaceutical composition of the present invention consists of:
Semen Cuscutae 18-22 weight portion, Herba Epimedii 18-22 weight portion, Cortex Cinnamomi 8-12 weight portion, Herba Asari 8-12 weight portion, Fructus Cnidii 18-22 weight portion, Galla Chinensis 18-22 weight portion, Pericarpium Granati 8-12 weight portion, Venenum Bufonis 3-7 weight portion, Radix Polygalae 13-17 weight portion, Rhizoma Acori Graminei 13-17 weight portion, Moschus 4-8 weight portion and Borneolum Syntheticum 4-8 weight portion.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Semen Cuscutae 20 weight portion, Herba Epimedii 20 weight portion, Cortex Cinnamomi 10 weight portion, Herba Asari 10 weight portion, Fructus Cnidii 20 weight portion, Galla Chinensis 20 weight portion, Pericarpium Granati 10 weight portion, Venenum Bufonis 5 weight portion, Radix Polygalae 15 weight portion, Rhizoma Acori Graminei 15 weight portion, Moschus 6 weight portion and Borneolum Syntheticum 6 weight portion.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Semen Cuscutae 19 weight portion, Herba Epimedii 21 weight portion, Cortex Cinnamomi 9 weight portion, Herba Asari 11 weight portion, Fructus Cnidii 19 weight portion, Galla Chinensis 21 weight portion, Pericarpium Granati 9 weight portion, Venenum Bufonis 6 weight portion, Radix Polygalae 14 weight portion, Rhizoma Acori Graminei 16 weight portion, Moschus 5 weight portion and Borneolum Syntheticum 7 weight portion.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Semen Cuscutae 21 weight portion, Herba Epimedii 19 weight portion, Cortex Cinnamomi 11 weight portion, Herba Asari 9 weight portion, Fructus Cnidii 21 weight portion, Galla Chinensis 19 weight portion, Pericarpium Granati 11 weight portion, Venenum Bufonis 4 weight portion, Radix Polygalae 16 weight portion, Rhizoma Acori Graminei 14 weight portion, Moschus 7 weight portion and Borneolum Syntheticum 5 weight portion.
Each taste crude drug is weighed for subsequent use by described pharmaceutical composition crude drug composition, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 3-5cm, decoct 25-35 minute, filter, medicinal residues add water and did not have powder 1-2cm, decoct 15-25 minute for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add the ethanol N parts by volume of 70%, N=80-120, soak 8-12 day, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol for subsequent use to N parts by volume, get decocting liquid and ethanol merges, stir evenly, leave standstill 20-28 hour, filter and get final product.
Preferably, each taste crude drug is weighed for subsequent use by described pharmaceutical composition crude drug composition, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 4cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Preferably, each taste crude drug is weighed for subsequent use by described pharmaceutical composition crude drug composition, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 5cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 1cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Preferably, each taste crude drug is weighed for subsequent use by described pharmaceutical composition crude drug composition, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 3cm, decoct 28 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 22 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 110 parts by volume of 70%, soak 11, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 110 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 26 hours, filter and get final product.
Pharmaceutical composition of the present invention, through clinical practice, is treated premature ejaculation Be very effective and has no side effect.
The pass of weight portion/parts by volume of the present invention is the relation of g/ml.
Semen Cuscutae invigorating the liver and kidney in pharmaceutical composition of the present invention, beneficial marrow, Zhuan Yang road; Fructus Cnidii warming the kidney to invigorate YANG, removing dampness and killing parasites, modern pharmacological research Fructus Cnidii extractum has gonadotropic Effect, can extend the rutting phase, the clinical treatment being used for sexual impotence; Herba Epimedii kidney invigorating and YANG supporting, expelling wind and removing dampness, modern pharmacological research Herba Epimedii extract has gonadotropic Effect energy sexual function improving; Galla Chinensis arresting seminal emission antidiarrheal, modern pharmacological research Gallotannin has precipitation to protein, after mucocutaneous contact, namely its histone is solidified, and surface forms one deck tunicle, causes secretion to suppress in addition after glandular cell protein coagulating, generation mucosa is dry, and produces local anesthesia effect; Cortex Cinnamomi controls first YANG deficiency, decline of the fire from the gate of life, the gas of fall apart trembling with fear of penis and logical penis; Herba Asari cold expelling is had one's ideas straightened out, and modern pharmacology has local anesthesia effect to mucocutaneous, can suppress the conduction of Glans penis sexual excitation, reduces Glans penis sensitivity; Pericarpium Granati is sour and astringent, produces convergence astringency inducing effect and make local desiccation to Glans penis; Venenum Bufonis modern pharmacology local anesthesia effect; Moschus, Borneolum Syntheticum are had one's ideas straightened out dredging collateral; Radix Polygalae benefit essence, hard tonifying YANG road; Rhizoma Acori Graminei is had one's ideas straightened out dredging collateral, mind tranquilizing and the heart calming.All medicines share, and repeatedly study through clinical, obtain pharmaceutical composition of the present invention, and pharmaceutical composition of the present invention has warming the kidney to invigorate YANG, effect of controlling nocturnal emission with astringent drugs stopping leak.
Experiment and detailed description of the invention are used for further illustrating but are not limited to the present invention below.
experimental example
Experimental example 1
The diagnostic criteria of premature ejaculation adopts the standard of international medical association:
1. ejaculate and always or almost always occur in penis insertion vagina within 1 minute;
2. ejaculation can not be postponed after penis enters vagina all or almost all;
3. passive individual spirit psychological factor, such as worries, worry, sense of frustration and/or avoidance activity etc.
Clinical practice data:
380 routine patients, all patients are all married or live together, and have sexual life that is stable and rule, at 23 ~ 48 years old age, average 34 years old, the course of disease was the longest 30 years, the shortest half a year.All cases all meet the diagnostic criteria of premature ejaculation.The primary diseases such as all patients are not in the mood for, liver, kidney, hemopoietic system, nervous system.
Medication:
When fluid temperature is suitable for soak penis after 10-20 minute clear water clean.3 times weekly 4 weeks was 1 course for the treatment of.
Observational technique:
Observe average intravagina ejaculation latency (getting the meansigma methods of treat forward and backward each 3 sexual lifes), the Chinese Patients with Premature Ejaculation sexual function evaluation table-5(CIPE-5 before and after patient treatment) sexual intercourse satisfaction in questionnaire is marked and its spouse marks to the satisfaction of sexual life, and record the untoward reaction of treatments period.
China's Patients with Premature Ejaculation sexual function evaluation table 5 totally 10 problems, this experimental example application problem 6 and problem 7, problem following (sequence number is score value):
In general, to the satisfaction of sexual life how you for Q6?
1. very dissatisfied
2. dissatisfied
3. general
4. satisfied
5. very satisfaction
In general, to the satisfaction of sexual life how your spouse for Q7
1. very dissatisfied
2. dissatisfied
3. general
4. satisfied
5. very satisfaction
Statistical method:
Application SPSS13.0 statistical software, measurement data all represents with x ± s, and adopting t inspection, is that difference has statistical significance with P<0.05.
Therapeutic outcome:
Sexual intercourse satisfaction scoring after treatment in intravagina ejaculation latency (IELT), CIPE-5 questionnaire and the satisfaction scoring of its spouse to sexual life all obviously increase (P<0.01) than before treatment, and have no adverse reaction.
Before and after treatment, every observation index change is in table 1
Table 1 is treated front and back intravagina ejaculation latency, patient and the scoring of spouse's sexual intercourse satisfaction and is compared (x ± s)
As shown in Table 1, after treatment, intravagina ejaculation latency, sexual life satisfaction degree and spouse's sexual intercourse satisfaction all obviously increase than before treatment.
Embodiment 1-embodiment 9 all can realize the effect of experimental example 1.
Experimental example 2
Model case:
King's ××, 31 years old, 2 years after marriage, without obvious cause, nearly half a year occurred that vagina ejaculation latency is less than 1 minute, often occurred not yet inserting vagina and namely to ejaculate situation, spouse cannot be made satisfied.Thought pressure is large, depressed.Give the pharmaceutical composition external treatment of embodiment 1, when namely fluid temperature is suitable for soak penis after 10-20 minute clear water clean, 3 times weekly 4 weeks was 1 course for the treatment of.Medication 4 weeks rear vagina ejaculation latencies reach 10-15 minute, and drug withdrawal after adhering to applying February, follows up a case by regular visits to 1 year vagina ejaculation latency and remain on about 10 minutes, and couple are satisfied.
Detailed description of the invention
Embodiment 1
Weigh Semen Cuscutae 20g, Herba Epimedii 20g, Cortex Cinnamomi 10g, Herba Asari 10g, Fructus Cnidii 20g, Galla Chinensis 20g, Pericarpium Granati 10g, Venenum Bufonis 5g, Radix Polygalae 15g, Rhizoma Acori Graminei 15g, Moschus 6g and Borneolum Syntheticum 6g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 4cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Embodiment 2
Weigh Semen Cuscutae 19g, Herba Epimedii 21g, Cortex Cinnamomi 9g, Herba Asari 11g, Fructus Cnidii 19g, Galla Chinensis 21g, Pericarpium Granati 9g, Venenum Bufonis 6g, Radix Polygalae 14g, Rhizoma Acori Graminei 16g, Moschus 5g and Borneolum Syntheticum 7g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 4cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Embodiment 3
Weigh Semen Cuscutae 21g, Herba Epimedii 19g, Cortex Cinnamomi 11g, Herba Asari 9g, Fructus Cnidii 21g, Galla Chinensis 19g, Pericarpium Granati 11g, Venenum Bufonis 4g, Radix Polygalae 16g, Rhizoma Acori Graminei 14g, Moschus 7g and Borneolum Syntheticum 5g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 4cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Embodiment 4
Weigh Semen Cuscutae 20g, Herba Epimedii 20g, Cortex Cinnamomi 10g, Herba Asari 10g, Fructus Cnidii 20g, Galla Chinensis 20g, Pericarpium Granati 10g, Venenum Bufonis 5g, Radix Polygalae 15g, Rhizoma Acori Graminei 15g, Moschus 6g and Borneolum Syntheticum 6g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 5cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 1cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Embodiment 5
Weigh Semen Cuscutae 19g, Herba Epimedii 21g, Cortex Cinnamomi 9g, Herba Asari 11g, Fructus Cnidii 19g, Galla Chinensis 21g, Pericarpium Granati 9g, Venenum Bufonis 6g, Radix Polygalae 14g, Rhizoma Acori Graminei 16g, Moschus 5g and Borneolum Syntheticum 7g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 5cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 1cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Embodiment 6
Weigh Semen Cuscutae 21g, Herba Epimedii 19g, Cortex Cinnamomi 11g, Herba Asari 9g, Fructus Cnidii 21g, Galla Chinensis 19g, Pericarpium Granati 11g, Venenum Bufonis 4g, Radix Polygalae 16g, Rhizoma Acori Graminei 14g, Moschus 7g and Borneolum Syntheticum 5g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 5cm, decoct 30 minutes, filter, medicinal residues add water and did not have powder 1cm, decoct 20 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 100 parts by volume of 70%, soak 10, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 24 hours, filter and get final product.
Embodiment 7
Weigh Semen Cuscutae 20g, Herba Epimedii 20g, Cortex Cinnamomi 10g, Herba Asari 10g, Fructus Cnidii 20g, Galla Chinensis 20g, Pericarpium Granati 10g, Venenum Bufonis 5g, Radix Polygalae 15g, Rhizoma Acori Graminei 15g, Moschus 6g and Borneolum Syntheticum 6g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 3cm, decoct 28 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 22 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 110 parts by volume of 70%, soak 11, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 110 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 26 hours, filter and get final product.
Embodiment 8
Weigh Semen Cuscutae 19g, Herba Epimedii 21g, Cortex Cinnamomi 9g, Herba Asari 11g, Fructus Cnidii 19g, Galla Chinensis 21g, Pericarpium Granati 9g, Venenum Bufonis 6g, Radix Polygalae 14g, Rhizoma Acori Graminei 16g, Moschus 5g and Borneolum Syntheticum 7g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 3cm, decoct 28 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 22 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 110 parts by volume of 70%, soak 11, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 110 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 26 hours, filter and get final product.
Embodiment 9
Weigh Semen Cuscutae 21g, Herba Epimedii 19g, Cortex Cinnamomi 11g, Herba Asari 9g, Fructus Cnidii 21g, Galla Chinensis 19g, Pericarpium Granati 11g, Venenum Bufonis 4g, Radix Polygalae 16g, Rhizoma Acori Graminei 14g, Moschus 7g and Borneolum Syntheticum 5g is for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei put into decocting container, add water and do not have powder 3cm, decoct 28 minutes, filter, medicinal residues add water and did not have powder 2cm, decoct 22 minutes for subsequent use, Herba Asari and Cortex Cinnamomi powder are broken into coarse powder, insert container, add ethanol 110 parts by volume of 70%, soak 11, filter and remove residue, by Venenum Bufonis, Moschus and Borneolum Syntheticum add in filtrate makes it dissolve, add 70% ethanol to 110 parts by volume for subsequent use, get decocting liquid and ethanol merges, stir evenly, leave standstill 26 hours, filter and get final product.