CN102423335B - Medicine combination for treating impotence and premature ejaculation and preparation method thereof - Google Patents

Medicine combination for treating impotence and premature ejaculation and preparation method thereof Download PDF

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CN102423335B
CN102423335B CN2011103699851A CN201110369985A CN102423335B CN 102423335 B CN102423335 B CN 102423335B CN 2011103699851 A CN2011103699851 A CN 2011103699851A CN 201110369985 A CN201110369985 A CN 201110369985A CN 102423335 B CN102423335 B CN 102423335B
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radix
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acanthopanacis senticosi
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郭凯
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Chengdu front road Biotechnology Co., Ltd.
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Abstract

The invention discloses a medicine combination for treating impotence and premature ejaculation and a preparation method thereof. The medicine combination is a preparation prepared by the following main raw materials: fried caltrop, acanthopanax, hypericum perforatum, rhodiola and black ants. The medicine combination disclosed by the invention has the effects of soothing liver and tonifying kidney, and tonifying qi and promoting blood circulation and removing obstruction in channels, and has the advantages that the curative effect is exact, the price is cheap, no side effects are produced, the erectile function of a patient can be quickly improved, the hardness of the erection is increased, the erection duration and the ejaculatory latency are prolonged, the total effective rate is 88%, the total effectual rate is 68%, and the clinical curative rate is 28%. The invention also discloses a preparation method of the medicine combination. In the preparation method, according to the different characteristics of traditional Chinese medicines, the traditional Chinese medicines are preprocessed respectively through grinding or solvent extraction, and other methods, and are then proportioned to be prepared into the product.

Description

A kind of pharmaceutical composition for the treatment of sexual impotence, premature ejaculation and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of sexual impotence, premature ejaculation.Be the Chinese patent medicine that primary raw material is prepared from stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca specifically.The invention still further relates to manufacturing method for above mentioned medicine.
Background technology
Sexual impotence claims erection disturbance (being called for short ED in the world) again, refer to that when having libido to require penis anorthosis or erect not hardly erects and to a certain degree hardness is arranged though perhaps have, but the enough time that can not keep sexual intercourse, thereby hinder sexual intercourse maybe can not finish sexual intercourse.Sexual impotence is divided two kinds of congenital and pathologic, and the former is rare, is difficult for curing; The latter sees that clinical treatment has certain curative effect more, and 52% sexual impotence of suffering from was in various degree arranged among the man according to statistics in 40~70 years old.When the definition of premature ejaculation refers to sexual intercourse ejaculate after can not controlling the sufficiently long time in the bridegroom's or husband's side, causes in the normal women's at least 50% of sexual function the normal sexual intercourse to be not being met.Sexual impotence and premature ejaculation often happen in company with clinically.Therapeutic Method has behavior therapy, operation and Drug therapy.Behavior therapy generally adopts sexy training and " squeezing " therapy concentrated, uncertain therapeutic efficacy cut and onset slow; Operative treatment has certain risk, and in the art, postoperative can leave over complication, the patient is difficult for accepting; Drug therapy has viagra, Ai Lida, Xi Aili etc., mostly is the import medicine, and is expensive, and side effect such as headache, Blushing, dyspepsia, visual disorder, cardiovascular accident are arranged.
Though research at present has the Chinese patent medicine of some treatment sexual impotence, premature ejaculation, but still can not satisfy patient's needs, and its prescription composition is all complicated, flavour of a drug are more, and price is higher, unsatisfactory curative effect.
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
Figure BSA00000616293900021
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)
Figure BSA00000616293900041
Notes: * * represents and preceding relatively p<0.01 for the treatment of (down together).
The scoring of table 4 tcm syndrome changes
Figure BSA00000616293900042
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.

Claims (10)

1. a pharmaceutical composition for the treatment of sexual impotence, premature ejaculation is characterized in that it is to be made by following raw materials by weight proportions: 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.
2. pharmaceutical composition according to claim 1 is characterized in that each drug weight ratio range is in the crude drug: 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.
3. a pharmaceutical composition for the treatment of sexual impotence, premature ejaculation is characterized in that it is to be made by following raw materials by weight proportions: 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. a pharmaceutical composition for the treatment of sexual impotence, premature ejaculation is characterized in that it is to be made by following raw materials by weight proportions: 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.
5. a pharmaceutical composition for the treatment of sexual impotence, premature ejaculation is characterized in that it is to be made by following raw materials by weight proportions: 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.
6. a pharmaceutical composition for the treatment of sexual impotence, premature ejaculation is characterized in that it is to be made by following raw materials by weight proportions: 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.
7. according to each described pharmaceutical composition in the claim 1 to 6, it is characterized in that the dosage form of said pharmaceutical composition is selected from granule or tablet or capsule.
8. prepare each described preparation of drug combination method in the claim 1 to 2, it is characterized in that: stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca water or alcoholic solution are extracted according to a conventional method, then each extract is mixed evenly, make required forms of pharmaceutical compositions.
9. prepare preparation of drug combination method described in the claim 3, it is characterized in that: stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, Herba Epimedii, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca water or alcoholic solution are extracted according to a conventional method, then each extract is mixed evenly, make required forms of pharmaceutical compositions.
10. preparation of drug combination method described in the preparation claim 6 is characterized in that: with the Scolopendra ethanol extraction, reclaim solvent, get extract; Stir-baked FRUCTUS TRIBULI, Radix Et Caulis Acanthopanacis Senticosi, the Radix Paeoniae Alba, Herba Hyperici Monogyni, Radix Rhodiolae, Formica fusca water or alcoholic solution are extracted according to a conventional method, then each extract is mixed evenly, make required forms of pharmaceutical compositions.
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CN102988505B (en) * 2012-12-24 2014-02-26 郭凯 Medicine composition for treating erectile dysfunction and preparation method thereof
CN103087889A (en) * 2012-12-28 2013-05-08 广西东兴市创新特色医药科技发展有限公司 Aphrodisiac wine and preparation method thereof
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