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 at once ejaculation of sex time, what have can not finish sexual intercourse at all, some penises not yet contact with the women, or rigidly connect pudendum or the vaginal orifice that touches the women, or just inserted behind the vagina less than 2 minutes, just ejaculate, penis is thereupon weak after the ejaculation, can not keep a kind of disease of normal sexuality.Comprise 3 key elements: 1) incubation period of ejaculation is short; 2) control ejaculation ability; 3) the 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 the 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 is let out the patient significantly reduces, the somatosensory evoked potential of Glans penis Induced by Stimulation significantly shortens than normal healthy controls group incubation period, and the reason that proposes premature ejaculation increases relevant with reduction and the nerve excitability of penile sense threshold value.This discovery is let out for medicine for external use treatment drought undoubtedly and has been found the strongest evidence.Although and Western medicine local anaesthetics beyond the region of objective existence can effectively reduce sensitivity with treatment, its shortcoming is the Glans penis nerve can occur experience degradation untoward reaction under pleasant sensation obstacle, the libido, even causes sexual impotence.Therefore remain to be developed 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 purpose of the present invention is to provide the new purposes of 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 portions, Herba Epimedii 20 weight portions, Cortex Cinnamomi 10 weight portions, Herba Asari 10 weight portions, Fructus Cnidii 20 weight portions, Galla Chinensis 20 weight portions, Pericarpium Granati 10 weight portions, Venenum Bufonis 5 weight portions, Radix Polygalae 15 weight portions, Rhizoma Acori Graminei 15 weight portions, Moschus 6 weight portions and Borneolum Syntheticum 6 weight portions.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Semen Cuscutae 19 weight portions, Herba Epimedii 21 weight portions, Cortex Cinnamomi 9 weight portions, Herba Asari 11 weight portions, Fructus Cnidii 19 weight portions, Galla Chinensis 21 weight portions, Pericarpium Granati 9 weight portions, Venenum Bufonis 6 weight portions, Radix Polygalae 14 weight portions, Rhizoma Acori Graminei 16 weight portions, Moschus 5 weight portions and Borneolum Syntheticum 7 weight portions.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Semen Cuscutae 21 weight portions, Herba Epimedii 19 weight portions, Cortex Cinnamomi 11 weight portions, Herba Asari 9 weight portions, Fructus Cnidii 21 weight portions, Galla Chinensis 19 weight portions, Pericarpium Granati 11 weight portions, Venenum Bufonis 4 weight portions, Radix Polygalae 16 weight portions, Rhizoma Acori Graminei 14 weight portions, Moschus 7 weight portions and Borneolum Syntheticum 5 weight portions.
Weigh the crude drug of respectively distinguishing the flavor of by described pharmaceutical composition crude drug composition for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 3-5cm, decocted 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, the ethanol N parts by volume of adding 70%, N=80-120 soaks 8-12 day, filter and remove residue, with Venenum Bufonis, Moschus and Borneolum Syntheticum add in the filtrate makes its dissolving, add 70% ethanol for subsequent use to the N parts by volume, get decocting liquid and ethanol and merge, stir evenly, left standstill 20-28 hour, and filtered and get final product.
Preferably, weigh the crude drug of respectively distinguishing the flavor of by described pharmaceutical composition crude drug composition for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, and 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, ethanol 100 parts by volume of adding 70% were soaked filter and remove residue 10, with Venenum Bufonis, Moschus and Borneolum Syntheticum add in the filtrate makes its dissolving, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol and merge, stir evenly, left standstill 24 hours, and filtered and get final product.
Preferably, weigh the crude drug of respectively distinguishing the flavor of by described pharmaceutical composition crude drug composition for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, and 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, ethanol 100 parts by volume of adding 70% were soaked filter and remove residue 10, with Venenum Bufonis, Moschus and Borneolum Syntheticum add in the filtrate makes its dissolving, add 70% ethanol to 100 parts by volume for subsequent use, get decocting liquid and ethanol and merge, stir evenly, left standstill 24 hours, and filtered and get final product.
Preferably, weigh the crude drug of respectively distinguishing the flavor of by described pharmaceutical composition crude drug composition for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, and 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, ethanol 110 parts by volume of adding 70% were soaked filter and remove residue 11, with Venenum Bufonis, Moschus and Borneolum Syntheticum add in the filtrate makes its dissolving, add 70% ethanol to 110 parts by volume for subsequent use, get decocting liquid and ethanol and merge, stir evenly, left standstill 26 hours, and filtered and get final product.
Pharmaceutical composition of the present invention is through clinical practice, and treatment premature ejaculation effect significantly and have 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 the pharmaceutical composition of the present invention, beneficial marrow, shape Yang Dao; Fructus Cnidii warming the kidney to invigorate YANG, removing dampness and killing parasites, modern pharmacological research Fructus Cnidii extractum has gonadotropic Effect, can prolong the rutting phase, and is clinical multiplex in the treatment of sexual impotence; Herba Epimedii kidney invigorating and YANG supporting, expelling wind and removing dampness, modern pharmacological research Herba Epimedii extract have gonadotropic Effect energy sexual function improving; Galla Chinensis arresting seminal emission antidiarrheal, the modern pharmacological research Gallotannin has precipitation to protein, after mucocutaneous the contact, its histone namely is solidified, and the surface forms one deck tunicle, causes behind the glandular cell protein coagulating that in addition secretion suppresses, the generation mucosa is dry, and produces the local anesthesia effect; Cortex Cinnamomi is controlled first YANG deficiency, decline of the fire from the gate of life, loose penis cold and the gas of logical penis; The Herba Asari cold expelling is had one's ideas straightened out, and modern pharmacology has a local anesthesia effect to mucocutaneous, can suppress the conduction of Glans penis sexual excitation, reduces Glans penis sensitivity; Pericarpium Granati is sour and astringent, and Glans penis is produced convergence astringency inducing effect and makes local desiccation; Venenum Bufonis modern pharmacology local anesthesia effect; Moschus, the Borneolum Syntheticum collateral dredging of having one's ideas straightened out; Radix Polygalae benefit essence, hard tonifying YANG road; The Rhizoma Acori Graminei collateral dredging of having one's ideas straightened out, mind tranquilizing and the heart calming.All medicines share, and through clinical repeatedly research, get pharmaceutical composition of the present invention, and pharmaceutical composition of the present invention has warming the kidney to invigorate YANG, the effect of controlling nocturnal emission with astringent drugs stopping leak.
The below's experiment and the specific embodiment are used for further specifying but are not limited to the present invention.
Experimental example
Experimental example 1
The standard of international medical association is adopted in the diagnostic criteria of premature ejaculation:
1. ejaculation always or almost always occurs in penis and inserts in the vagina 1 minute;
2. can not after entering vagina all or almost all, penis postpone ejaculation;
3. passive individual spirit psychological factor is such as worried, worry, sense of frustration and/or avoidance activity etc.
The clinical practice data:
380 routine patients, all patients are all married or live together, and the sexual life of stable and rule is arranged, and 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:
Soak when fluid temperature is suitable penis after 10-20 minute clear water clean.3 times weekly, 4 weeks were 1 course for the treatment of.
Observational technique:
Observe in the questionnaire of the average intravagina ejaculation latency (getting the meansigma methods of forward and backward each 3 sexual life for the treatment of) before and after the patient treatment, Chinese Patients with Premature Ejaculation sexual function evaluation table-5(CIPE-5) the scoring of sexual life satisfaction with and the spouse to the satisfaction scoring of sexual life, and the untoward reaction during the record treatment.
China's Patients with Premature Ejaculation sexual function evaluation table 5 is totally 10 problems, this experimental example application problem 6 and problem 7, and problem following (sequence number is score value):
Q6 in general, to the satisfaction of sexual life how you?
1. very dissatisfied
2. dissatisfied
3. general
4. satisfied
5. very satisfied
Q7 in general, to the satisfaction of sexual life how your spouse
1. very dissatisfied
2. dissatisfied
3. general
4. satisfied
5. very satisfied
Statistical method:
Use the SPSS13.0 statistical software, measurement data all uses x ± s to represent, adopts the t check, take P<0.05 as difference statistical significance is arranged.
Therapeutic outcome:
Sexual life satisfaction scoring after the treatment in the intravagina ejaculation latency (IELT), CIPE-5 questionnaire with and the spouse to the satisfaction scoring of sexual life all than obviously increasing (P<0.01) before the treatment, and have no adverse reaction.
Every observation index variation sees Table 1 before and after the treatment
Intravagina ejaculation latency, patient and spouse's sexual life satisfaction scoring comparison before and after table 1 treatment (x ± s)
As shown in Table 1, intravagina ejaculation latency, patient's sexual life satisfaction and spouse's sexual life satisfaction all obviously increase than treatment is front after the treatment.
Embodiment 1-embodiment 9 all can realize the effect of experimental example 1.
Experimental example 2
Model case:
The king * *, 31 years old, 2 years after marriage, vagina ejaculation latency occurred less than 1 minute without obvious cause nearly half a year, and often the vagina situation of namely ejaculating is not yet inserted in appearance, can't make the spouse satisfied.Thought pressure is large, and is depressed.Give the pharmaceutical composition external treatment of embodiment 1, soak when namely fluid temperature is suitable penis after 10-20 minute clear water clean, 3 times weekly, 4 weeks were 1 course for the treatment of.The vagina ejaculation latency reaches 10-15 minute after 4 weeks of medication, and drug withdrawal after adhering to using February is followed up a case by regular visits to 1 year vagina ejaculation latency and remained on about 10 minutes, and couple are satisfied.
The specific embodiment
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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 4cm, decocted 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 70% ethanol 100 parts by volume, soaked 10, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 100 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 4cm, decocted 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 70% ethanol 100 parts by volume, soaked 10, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 100 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 4cm, decocted 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 70% ethanol 100 parts by volume, soaked 10, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 100 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 5cm, decocted 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 70% ethanol 100 parts by volume, soaked 10, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 100 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 5cm, decocted 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 70% ethanol 100 parts by volume, soaked 10, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 100 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 5cm, decocted 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 70% ethanol 100 parts by volume, soaked 10, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 100 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 3cm, decocted 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 70% ethanol 110 parts by volume, soaked 11, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 110 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 3cm, decocted 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 70% ethanol 110 parts by volume, soaked 11, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 110 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left 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 are for subsequent use, get Semen Cuscutae, Herba Epimedii, Fructus Cnidii, Galla Chinensis, Pericarpium Granati, Radix Polygalae and Rhizoma Acori Graminei are put into the container of boiling medicine, add water and do not have powder 3cm, decocted 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 70% ethanol 110 parts by volume, soaked 11, filter and remove residue is with Venenum Bufonis, Moschus and Borneolum Syntheticum add makes its dissolving in the filtrate, add 70% ethanol to 110 parts by volume for subsequent use, getting decocting liquid and ethanol merges, stir evenly, left standstill 26 hours, filter and get final product.