Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine and corresponding preparations thereof for the treatment of sexual impotence, premature ejaculation determined curative effect.Its characteristics have: can comparatively fast improve patient's erection function, the hardness of increase erecing, prolong erect persistent period and ejaculation latency, and low price, have no side effect.
The traditional Chinese medical science is thought sexual impotence, premature ejaculation pathogeny and stagnation of liver-QI blood stasis, the smart not intrinsic pass of closing of suffering from a deficiency of the kidney.Liver governing tendons, external genitals are the remittance of penis, if feelings will is unsuccessful, and anxiety and rage, the liver failing to maintain the normal flow of QI bar reaches, obstruction of collaterals by blood stasis, and then penis gathers incapability, says as " cloudy source and course behind the miscellaneous diseases source and course rhinoceros candle external genitalia ": " people that mental confusion is arranged; depressed impairing the liver, edema with the liver involved can not be dredged and be reached, and also causes impotence and does not rise "; Again because of excess of sexual intercourse, or the juvenile masturbation of frequently violating, or marriage and childbirth too early, or fear impairing kidney, so that vital essence is deficient, causes impotence.
Solution of the present invention is based on motherland's medical science to the understanding of the basic pathogenesis of sexual impotence, premature ejaculation, according to oneself clinical experience for many years, from numerous Chinese medicines, determine a series for the treatment of sexual impotence, the effective Chinese medicine of premature ejaculation earlier, again through clinical checking repeatedly, the compound Chinese medicinal preparation that screens.Effect with soothing the liver the kidney invigorating, benefiting QI for activating blood circulation collateral dredging can comparatively fast be improved patient's erection function, the hardness that increase is erected, and prolongs erect persistent period and ejaculation latency.
The present invention is a kind of pharmaceutical composition for the treatment of sexual impotence, premature ejaculation, it is characterized in that it is is that primary raw material is prepared from stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca.
Weight proportion is composed as follows:
(1) stir-baked FRUCTUS TRIBULI 10-50 part, Radix Et Caulis Acanthopanacis Senticosi 10-50 part, Herba Hyperici Monogyni 5-30 part, Radix Rhodiolae 10-40 part, Formica fusca 10-40 part.
The preferred weight proportioning is:
(2) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part.
Medicine composition of the present invention can also contain one or more in the Chinese medicines such as the Radix Paeoniae Alba, Scolopendra, Herba Epimedii.
Medicine of the present invention can be the medicine of said dosage form on any pharmaceutics.
The preparation of this medicine can prepare by the conventional method on the various medicaments, as:
Scolopendra is ground into fine powder, or uses ethanol extraction; Stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca, the Radix Paeoniae Alba, Herba Epimedii are extracted according to a conventional method with ethanol or water etc., concentrate, drying gets extract, makes the medicine of required dosage form.
In the above preparation process, if necessary, can add adjuvant commonly used in an amount of pharmaceutics, as starch, dextrin, microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, sucrose, carboxymethyl starch sodium etc.
For verifying that further the present invention treats the effect of sexual impotence, premature ejaculation, has carried out following pharmacodynamics test.
The influence of 1 pair of castration mouse sexual function
Select healthy Male Kunming strain mice for use, body weight 18~20g, except normal blank group (N group), all the other animals are excised bilateral testes under the ether light anaesthesia, and the postoperative local wound is dripped with gentamycin sulfate.Behind the operation 3d, animal is divided into castration model group (M group), of the present invention group (F group), soothing the liver Yiyang Capsules group (S group), Fructus Tribuli extract group (J group), 10 every group at random.Each treated animal gastric infusion every day 1 time, N group and M group only wait the capacity distilled water to irritate stomach, continuous 28d.Other gets female mice with condition cage raising in addition.
After the administration of animal last, 1 male Mus is put into transparent observing case 10min, can enough shake down, every case adds 1 with batch female mice of raising then.Record following index: 1. be fed into male Mus from female Mus and pounce on the time (pounce on and catch incubation period) of catching female Mus for the first time; 2. be fed into male Mus ejaculate the time for the first time (ejaculation latency) from female Mus; 3. male Mus pounces on and catches number of times in the 20min; 4. each treated animal is pounced on the number of animals of catching, ejaculating in the 20min, pounces on the rate of catching (%) and ejaculation rate (%).The results are shown in Table 1.
Table 1 respectively organize mice pounce on catch, ejaculation latency (s) and number of times relatively
Annotate:
*Compare with the M group, P<0.05,
*Compare P<0.01 with the M group;
△Compare with the F group, P<0.05, down together
By table 1 as seen, compare with the N group, M group mice pounces on to catch and obviously prolongs incubation period, and ejaculation latency shortens, and pounces on and catches number of times minimizing (P<0.05 and P<0.01); Male Mus mating ability obviously strengthens after giving of the present invention group of (F group) 28d, show as to pounce on after mating and catch female Mus and obviously shorten incubation period, the number of times increase is caught in pouncing on of finishing in the 20min, ejaculation latency obviously prolongs simultaneously, full treated animal is pounced on the rate of catching, mating rate increases, of the present invention group (F group) obviously is better than soothing the liver Yiyang Capsules group (S group) and Fructus Tribuli extract group (J group), illustrates that of the present invention group can strengthen erection and sexual potency, improves ejaculation functions such as premature ejaculation.
The experimentation of 2 pairs of depression of liver-QI rat model sexual activity influences
2.1 laboratory animal
50 of the male adult rats of Wistar, body constitution amount 200~240g provides (No. 8, the real moving Guan Zhidi in river) by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.
2.2 experimental technique
2.2.1 the animal grouping is divided into 5 groups at random with rat: blank group (N group), model group (M group), of the present invention group (F group), Fructus Tribuli extract group (J group) and soothing the liver Yiyang Capsules group (S group), 10 every group.
2.2.2 modelling and administration are with reference to the unsettled pedal hanging reduction that repeats of reports such as Lian Xiaoyuan, every day 1 time, continuous 10d, and increase the suspention time in proper order, to cause liver qi stagnation type sexual dysfunction model, press the 10ml/Kg gastric infusion, 1 time/d, N group and M group only wait the capacity distilled water to irritate stomach, successive administration 28d.
2.2.3 behind the last administration 12h of the observation of rat sexual activity, in the darkroom, get a male Mus and put into observation cage 10min, it is conformed, drop into 2 female Mus of estrogenization then, shooting is synchronously observed male Mus and is smelt the perineum of licking female Mus, the number of times of mouth, catches the number of times that the interior male Mus of incubation period, ejaculation latency and 20min catches female Mus.
2.3 result: each is organized the rat sexual activity and relatively sees Table 2.
Table 2 is respectively organized rat sexual activity situation
By table 2 as seen, compare with the N group, M group rat smells and licks number of times, catches number of times minimizing (P<0.05 and P<0.01), catches obviously to prolong (P<0.01) incubation period, and ejaculation latency shortens (P<0.05); Male Mus sexuality obviously strengthens after giving of the present invention group of 28d, show as to pounce on to catch and smell and lick number of times and increase, catch and shorten incubation period, ejaculation latency obviously prolongs simultaneously, of the present invention group obviously is better than soothing the liver Yiyang Capsules group (S group) and Fructus Tribuli extract group (J group), illustrate that the liver qi stagnation type impotence model that this experiment copies is successful, of the present invention group can strengthen the erection of depression of liver-QI rat model and sexual potency, improve ejaculation functions such as premature ejaculation.
For further showing clinical effectiveness of the present invention, with reference to " the clinical research guideline of new Chinese medicine treatment sexual impotence, premature ejaculation ", select 20~60 years old, be diagnosed as patient's 50 examples of sexual impotence, premature ejaculation, through the objective clinical observation of system.Minimum 25 years old of age, maximum 59 years old, average 46.77 ± 12.05 years old.The course of disease is the shortest 7 months, and is the longest 36 months, average 23.19 ± 5.22 months.9 examples that the state of an illness is slight (18%), moderate 26 examples (52%), severe 15 examples (30%).One month observation period.Respectively at taking medicine preceding and taking medicine the back observation:
(1) safety indexes: blood pressure, pulse, blood, urine, stool three big routines and electrocardiogram, liver, kidney function test.
(2) health giving quality index:
1. IIEF-5 scoring.
2. tcm syndrome scoring.
(3) untoward reaction is observed
Comprise gastrointestinal reaction, nervous system abnormality, skin abnormality etc.
Every index changes shown in table 3~5 before and after the treatment
(IIEF-5) variation of marking of table 3 international index of erectile function (questionnaire)
Notes: * * represents and preceding relatively p<0.01 for the treatment of (down together).
The scoring of table 4 tcm syndrome changes
Annotate: the p value representation is the same.
The evaluation of table 5 total effects
Do not see obvious adverse reaction in the drug administration process, electrocardiogram before and after taking medicine, liver, renal function, blood, urine, stool routine examination do not have significant change.
Clinical drug of the present invention uses the result to show that following advantage is arranged:
(1) obviously improve the tcm symptom of sexual impotence, premature ejaculation, and not hard, feelings will is not smooth as sexual impotence erectile problem or act, and ambition is gloomy, fullness and distention in the chest and hypochondrium, soreness of the waist and knees, premature ejacuation emission, insomnia and dreamful sleeps etc. increase international index of erectile function (questionnaire) and (IIEF-5) mark, and improve the quality of living;
(2) obviously increase patient's erection hardness;
(3) obviously prolong the erection persistent period;
(4) obviously prolong ejaculation latency;
(5) have no side effect.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
The present invention is composed as follows by weight ratio:
(1) stir-baked FRUCTUS TRIBULI 10-50 part, Radix Et Caulis Acanthopanacis Senticosi 10-50 part, Herba Hyperici Monogyni 5-30 part, Radix Rhodiolae 10-40 part, Formica fusca 10-40 part.
Preferred weight proportioning of the present invention is:
(2) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part.
Medicine composition of the present invention can also contain one or more in the Chinese medicines such as the Radix Paeoniae Alba, Scolopendra, Herba Epimedii, and proportioning is composed as follows:
(3) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Epimedii 10-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part.
(4) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Radix Paeoniae Alba 10-30 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part.
(5) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part, Scolopendra 0.5-10 part.
(6) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Epimedii 10-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part, Scolopendra 0.5-10 part.
(7) stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Radix Paeoniae Alba 10-30 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part, Scolopendra 0.5-10 part.
1, the preparation method of medicine of the present invention is example with stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part, can be with reference to following method:
(1) the Radix Et Caulis Acanthopanacis Senticosi water is pressed decocting method and extracted, concentrate, get water extract; With stir-baked FRUCTUS TRIBULI, Herba Hyperici Monogyni, Formica fusca, Radix Rhodiolae ethanol extraction, reclaim solvent, concentrate, get alcohol extract, with water extract mixing, drying, granulate, be processed into tablet, capsule or granule.
(2) stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca water are pressed decocting method and extracted, concentrate, drying is granulated, and is processed into tablet, capsule or granule.
2, the preparation method of medicine of the present invention, the preparation that consists of stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Herba Epimedii 10-40 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part, can be with reference to following method:
(1) Radix Et Caulis Acanthopanacis Senticosi, Herba Epimedii water are pressed decocting method and extracted, concentrate, get water extract; With stir-baked FRUCTUS TRIBULI, Herba Hyperici Monogyni, Formica fusca, Radix Rhodiolae ethanol extraction, reclaim solvent, concentrate, get alcohol extract, with water extract mixing, drying, granulate, be processed into tablet, capsule or granule.
(2) stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Epimedii, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca water are pressed decocting method and extracted, concentrate, drying is granulated, and is processed into tablet, capsule or granule.
3, the preparation method of medicine of the present invention, the preparation that consists of stir-baked FRUCTUS TRIBULI 20-40 part, Radix Et Caulis Acanthopanacis Senticosi 20-40 part, Radix Paeoniae Alba 10-30 part, Herba Hyperici Monogyni 5-20 part, Radix Rhodiolae 10-30 part, Formica fusca 10-30 part, Scolopendra 0.5-10 part, can be with reference to following method:
(1) Radix Et Caulis Acanthopanacis Senticosi, Radix Paeoniae Alba water are pressed decocting method and extracted, concentrate, get water extract; With stir-baked FRUCTUS TRIBULI, Herba Hyperici Monogyni, Formica fusca, Radix Rhodiolae, Scolopendra ethanol extraction, reclaim solvent, concentrate, get alcohol extract, with water extract mixing, drying, granulate, be processed into tablet, capsule or granule.
(2) Scolopendra is ground into fine powder; Radix Et Caulis Acanthopanacis Senticosi, Radix Paeoniae Alba water are pressed decocting method extract, concentrate, get extract; With stir-baked FRUCTUS TRIBULI, Herba Hyperici Monogyni, Formica fusca, Radix Rhodiolae ethanol extraction, reclaim solvent, concentrate, get alcohol extract, with water extract, Scolopendra fine powder mix homogeneously, drying, granulate, be processed into tablet, capsule or granule.
(3) Scolopendra is ground into fine powder; Stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, the Radix Paeoniae Alba, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca water are pressed decocting method extract, concentrate, drying is granulated, and is processed into tablet, capsule or granule.