CN105327151A - Traditional Chinese medicine composition used for treating impotence, prostatitis and climacteric syndrome - Google Patents
Traditional Chinese medicine composition used for treating impotence, prostatitis and climacteric syndrome Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition used for treating impotence, prostatitis and climacteric syndrome, a preparation method and an application thereof. The traditional Chinese medicine composition is composed of silkworm moth, epimeddium, pilose antler, penis cervi, morinda officinalis, cornus officinalis, fruit of Chinese wolfberry, semen cuscutae, eucommia, cinnamon, aconitum carmichaelii, prepared rehmannia root, Chinese yam, Chinese angelica, gen-seng, centipede, and rhizoma gastrodiae. The traditional Chinese medicine composition is sourced from an ancient prescription, also provides an innovation, and can be supported by a newest pharmacology research. The traditional Chinese medicine composition can be used for treating impotence, prostatitis and climacteric syndrome with accurate curative effect. The preparation method of the traditional Chinese medicine composition has the advantages of stable technology, high content of extracted active ingredient, little impurity and strong operationality, and is suitable for industrial large production.
Description
Technical field
The invention belongs to the field of Chinese medicines, in particular to a kind of Chinese medicine composition being used for the treatment of sexual impotence, prostatitis, climacteric syndrome.
Background technology
Also known as erection disturbance, (be called for short: ED), be the one of male sexual disorder, when referring to sexual intercourse, penis anorthosis or maintain erects to meet sexual life sexual impotence, the course of disease more than 3 months persons.It is reported, in state-owned 52% 40 ~ 70 years old male there is erection disturbance in various degree.The probability of Massachusetts, United States to erection disturbance epidemiological investigation display patients with erectile dysfunction other physical diseases concurrent obviously raises.Normal person compares with erection function, it is 19% and 36% respectively that patients with erectile dysfunction suffers from hypertensive probability, the probability of suffering from coronary heart disease is 7% and 17% respectively, the probability of suffering from hypercholesterolemia is 16% and 29% respectively, the probability of suffering from diabetes is 4% and 14% respectively, the probability of trouble anxiety, depression is 13% and 25% respectively, it can thus be appreciated that erection disturbance is the early stage sign of many chronic diseases or symptom.Cause the reason of sexual impotence to have the many reasons such as individual spirit, psychology and complicated social factor, but major part is all treatable.The traditional Chinese medical science thinks that asthenia of renal qi, syndrome of dampness-heat of liver channel, obstruction of collaterals by blood stasis etc. are the principal elements of sexual impotence morbidity.
Prostatitis, be the commonly encountered diseases of Urology Surgery, in Urology Surgery male patient, the right side of fifty group accounts for first place.Wherein chronic nonbacterial prostatitis (also known as aseptic prostatitis) is prostatitis the most common syndromic form, and its prevalence is 8 times of bacterial prostatitis.Prostatitis has presented rejuvenation trend, and a lot of male is annoying by prostatitis.The traditional Chinese medical science thinks that this disease is by suffering from a deficiency of the kidney caused by turbid damp, often occurring soreness of the waist and knees, fatigue and weakness, dizziness and tinnitus, aversion to cold and cold limbs, hyposexuality symptom, and the traditional Chinese medical science thinks that this disease is by suffering from a deficiency of the kidney caused by turbid damp, and normal kidney-reinforcing drug and the heat-clearing and toxic substances removing medicine of using is with the use for the treatment of.
Climacteric syndrome is that women's ovarian function fails to the transition period disappeared completely gradually, due to a series of clinical symptoms that physiology and psychology change and occurs, commonly warms sweating, irritable, palpitation and insomnia or melancholy forgetful etc.According to clinical manifestation, primary disease belongs to the category of " menopausal syndrome " of Chinese medicine.Primary disease be that women is before and after menopause, kidney qi is exhaustion gradually, virtual loss is appointed in punching, asthenia of essence and blood, menses is gradually exhausted, the menstruation physiological change that the menopause that arrives occurs by breaking, but some women is due to the impact of body constitution or Nervous and Mental Factors and other factors, for the moment can not adapt to these physiological changies, make negative and positive disequilibrium, internal organs QI and blood functional disorder and the syndrome of a series of function disorders that occurs.Current treatment by Chinese herbs is based on the kidney invigorating heat clearing away.
In recent years, back to nature, attention traditional medicine become trend at world wide.And Chinese medicine feelings will class disease has long tradition, should develop.The acceptance level of the developed countries such as not only Asian countries is increasing the acceptance level of traditional medicine, American-European is also improving constantly.Existing more than 70 country has worked out medical herbs regulation at present, and there has been various types of traditional medicine mechanism up to a hundred countries and regions.Conventional medicament is derived from natural, and have long-term Popular Utilization basis, development risk is relatively low, shows huge potentiality to be exploited and prospect of industrial development, one of important development direction having become new drug development and world's medicinal industry.
Summary of the invention
For solving above-mentioned problems of the prior art, the invention provides a kind of Chinese medicine composition being used for the treatment of sexual impotence, prostatitis, climacteric syndrome.
Specifically, the invention provides:
(1) be used for the treatment of a Chinese medicine composition for sexual impotence, prostatitis, climacteric syndrome, wherein said Chinese medicine composition is primarily of Bombycis mori, Herba Epimedii, Cornu Cervi Pantotrichum, Penis et testis cervi, Radix Morindae Officinalis, Fructus Corni, Fructus Lycii, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Radix Ginseng, Scolopendra, Rhizoma Gastrodiae composition.
(2) Chinese medicine composition Gen Ju (1), wherein, described Chinese medicine composition is made primarily of the crude drug of following weight proportioning: Bombycis mori 8 ~ 16 parts, Herba Epimedii 8 ~ 16 parts, Radix Morindae Officinalis 8 ~ 12 parts, Radix Rehmanniae Preparata 8 ~ 16 parts, Fructus Corni 2 ~ 8 parts, the Cortex Eucommiae 4 ~ 12 parts, Fructus Lycii 4 ~ 12 parts, Semen Cuscutae 4 ~ 12 parts, Cortex Cinnamomi 2 ~ 6 parts, 4 ~ 12 parts, Cornu Cervi Pantotrichum, 2 ~ 6 parts, Rhizoma Gastrodiae, Penis et testis cervi 1 ~ 3 part, Radix Angelicae Sinensis 3 ~ 12 parts, Scolopendra 1 ~ 3 part, Radix Aconiti Lateralis Preparata 2 ~ 6 parts, Radix Ginseng 2 ~ 6 parts, Rhizoma Dioscoreae 4 ~ 12 parts.
(3) Chinese medicine composition Gen Ju (1), wherein, described Chinese medicine composition and pharmaceutically acceptable adjuvant are prepared into oral solid formulation or liquid preparation, wherein, described oral solid formulation comprises tablet, capsule, granule and powder, and described liquid preparation comprises oral administration solution, medicated wine, syrup and aromatic water.
(4) Chinese medicine composition Gen Ju (3), wherein, the adjuvant of the oral solid formulation of described Chinese medicine composition be selected from pharmaceutically conventional filler, disintegrating agent, binding agent, lubricant one or more.
(5) Chinese medicine composition Gen Ju (3), wherein, the adjuvant of the liquid preparation of described Chinese medicine composition is selected from one or more in pharmaceutically conventional solubilizing agent, cosolvent, cosolvent, antiseptic, coloring agent.
(6) Chinese medicine composition Gen Ju (4), wherein, when described Chinese medicine composition is prepared as oral solid formulation, by described Cortex Cinnamomi, Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder, with described Herba Epimedii, Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori ethanol extraction extractum, add filler and disintegrating agent prepares oral solid formulation, wherein do not make with lubricator and binding agent; Preferably, described filler comprises lactose, microcrystalline Cellulose, starch, dextrin, mannitol, calcium hydrogen phosphate wherein one or more; Preferably, described disintegrating agent comprises carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose wherein one or more.
(7) Chinese medicine composition Gen Ju (5), wherein, when described Chinese medicine composition is prepared as liquid preparation, described Chinese medicine composition comprises extractum, the ethanol of 5 ~ 65% (w/w), sucrose and 0 ~ 15% (w/w) correctives of 5 ~ 65% (w/w) of the described Chinese medicine composition of 20 ~ 70% (w/w), and by pH regulator to 4 ~ 7, wherein do not comprise antiseptic; Preferably, described correctives comprises one or more in glycerol, orange syrup, Cortex cinnamomi japonici (Ramulus Cinnamomi) syrup; Preferably, described pH adjusting agent comprises one or more in citric acid, sodium citrate.
(8) according to the preparation method of the Chinese medicine composition in (1)-(7) described in any one, it comprises:
1) by the Herba Epimedii according to (1), Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori, with ethanol extraction, filter, filtrate is concentrated into the extractum of density 1.10-1.15;
2) Cortex Cinnamomi according to (1), Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder are broken into powder, or with ethanol extraction, filter, filtrate is concentrated into the extractum of density 0.95-1.05; And
3) by step 1) extractum and the step 2 that obtain) powder that obtains or extractum mixes, thus obtains described Chinese medicine composition,
Wherein, step 1) and step 2) in no particular order sequentially, can carry out simultaneously or sequentially.
(9) method Gen Ju (8), wherein, step 1) or step 2) described in the number of times of extraction be 2-4 time, be preferably 2 times.
(10) according to the purposes of the Chinese medicine composition in (1)-(7) described in any one in the medicine for the preparation for the treatment of sexual impotence, prostatitis, climacteric syndrome.
The present invention compared with prior art has the following advantages and good effect:
The present invention is according to Chinese medical theory, the theory of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is adopted to carry out Chinese prescription screening, the Chinese medicine composition proportioning provided is scientific and reasonable, and wherein Bombycis mori, Herba Epimedii are monarch drug, and Bombycis mori is warm in nature, function kidney tonifying tonifying liver, therefore able-bodied sun, " Mingyi Bielu " claims in its " main beneficial vital essence, reinforcing YIN-essence road; join tireless, also only smart "; " the sub-draft of solar corona " fortune " tonifying YANG thing, stopping leak essence, hematuria, warming the kidney ".Bombycis mori belongs to the in love product of flesh and blood, in side, plays the effect of kidney invigorating and YANG supporting replenishing essence.It is warm in nature for Herba Epimedii, and sweet in the mouth is pungent, can kidney invigorating and YANG supporting, nourishing the essence and strengthening QI." herbal classic " is called its " main impotence is hindered absolutely, pains in the penis, diuresis, physical strength profiting, strong will ".Essentials of Matea Medica " mends the gate of vitality, beneficial vital essence, hard muscles and bones, diuresis ".Two medicines phases 5, for impotence due to deficiency of the kidney, have the merit of common kidney invigorating and YANG supporting benefit essence.Cornu Cervi Pantotrichum, Penis et testis cervi, Radix Morindae Officinalis, Fructus Corni, Fructus Lycii, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, when ministerial drug in the side of being classified as.Cornu Cervi Pantotrichum, Penis et testis cervi are the in love product of flesh and blood, help Bombycis mori warming and recuperating the kidney-YANG, benefiting essence and marrow; Radix Morindae Officinalis, Fructus Corni, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata six helps Bombycis mori, Herba Epimedii warming and recuperating the kidney-YANG; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Fructus Lycii four taste Chinese medicine energy replenishing vital essence and blood, controlling nocturnal emission with astringent drugs is only lost, and associate with yang-tonifying drug in side, have treating YANG within YIN, the meaning for the treatment of YIN within YANG, receives warming and recuperating the kidney-YANG altogether, the merit that replenishing essence is enriched blood.Above three groups of compatibility of drugss, common effect of assisting monarch drug to play kidney invigorating and YANG supporting benefiting essence-blood.Adjuvant drug in Radix Ginseng, the Scolopendra side of being, Radix Ginseng strongly invigorating primordial QI, benefiting qi and supporting yang, invigoration spleen qi, cures mainly timidness due to deficiency of QI Mental fatigue, the diseases such as anorexia and loose stool.Scolopendra is the thing of pure sun, and its property is walked to alter, QI and blood regulating, the meridian dredging, smooth vagina, with a little for assistant, assists the merit of the emerging sun of all medicines.Rhizoma Gastrodiae returns liver channel of foot-Jueyin, and it walks few abdomen through following external genitals, Rhizoma Gastrodiae to carry all medicines and enter external genitals for making.
The present invention is studied by modern pharmacology and also shows, Chinese medicine composition of the present invention can regulate neuro-endocrine-immunoregulatory, zest hormone and the effect of promoting sexual gland hormone sample on impact, the promotion bone marrow stem cell proliferation and differentiation of accessory sex organ's generations such as prostaglandin, testis, seminal vesicle and improve involutional various symptom.Experimental result shows, Chinese medicine composition of the present invention not only may be used for sexual impotence erectile problem, weakness due to chronic disease, spiritlessness and weakness, improve mankind spermatozoon quality, promote sperm regeneration, and the discovery that the present inventor is surprised, although pharmaceutical composition of the present invention does not add antipyretic and antidotal type Chinese medicine, but all therapeutical effect is created to male prostatitis (particularly chronic nonbacterial prostatitis) and prolongation Woman climacteric, there is beneficial effect.
Pharmaceutical composition of the present invention comes from ancient prescription, has innovation again, and obtains the support of up-to-date pharmaceutical research, and therefore, Chinese medicine composition of the present invention can be used for sexual impotence, prostatitis, climacteric syndrome, has definite curative effect.
The extract of pharmaceutical composition provided by the invention can facilitate and pharmaceutical carriers is prepared into multiple dosage form, taking convenience clinically, and experimental result to show that pharmaceutical composition provided by the invention has quality safety controlled, be easy to absorb, the feature that life-time service has no side effect.The preparation method of pharmaceutical composition provided by the invention simultaneously, process stabilizing, effective component extracting content is high, and impurity is few, workable, is applicable to industrialized great production.
Detailed description of the invention
Below by way of the description of detailed description of the invention, the invention will be further described, but this is not limitation of the present invention, those skilled in the art are according to basic thought of the present invention, various amendment or improvement can be made, but only otherwise depart from basic thought of the present invention, all within the scope of the present invention.
In the present invention, described part refers to weight portion.
Each Chinese crude drug in Chinese medicine composition of the present invention has the general sense of the respective name used in this area.Main component and the pharmacological properties of each Chinese crude drug are as follows:
Herba Epimedii: be the stem and leaf of the multiple Herba Epimedii such as Berberidaceae plant Herba Epimedii, Epimedium sagittatum, Epimedium wushanense, Herba Epimedii.Taste acrid, sweet, warm, return liver, kidney channel, kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.
Radix Morindae Officinalis: be the dry root of dicotyledon Rubiaceae (Rubiaceae) Radix Morindae Officinalis (MorindaofficinalisHow.).Pungent, sweet, tepor.Return kidney, Liver Channel.
Radix Rehmanniae Preparata: be the fresh of scrophulariaceae rehmannia glutinosa plant Rehm, anniaglutinosaLibosch. or dried root is the Preparation process product of Radix Rehmanniae.Feeble QI, taste is sweet.Sweet, tepor.Return liver, kidney channel.
Fructus Corni: be the drying and ripening sarcocarp of Cornaceae plant Fructus Corni Cornusoj-jZcinalisSieb.etZucc..Sour, puckery, tepor.Return liver, kidney channel.Liver and kidney tonifying, arresting collape syndrome by astringents.
The Cortex Eucommiae: be the dry bark of Eucommiaceae plant Cortex Eucommiae EucommzaulmoidesOliv..This product is blockage or thread.Outer surface light brown or taupe, have obvious wrinkle.Inner surface mulberry, smooth.Section has fine and closely woven, silvery white, rubber thread full of elasticity to be connected.Feeble QI, taste is slightly bitter.Sweet, temperature.Return liver, kidney channel.Invigorating the liver and kidney, bone and muscle strengthening, antiabortive.
Fructus Lycii: be the dry mature fruit of plant of Solanaceae lycium barbarum LyciumbarbarumL..Feeble QI, taste is sweet.Sweet, flat.Return liver, kidney channel.Nourishing the liver and kidney, replenishing vital essence to improve eyesight.
Semen Cuscutae: be the dry mature seed of convolvulaceous plant Cuscuta australis Cuscutaaustralis. or Semen Cuscutae CuscutachinensisLam..Feeble QI, lightly seasoned.Pungent, sweet, flat.Return liver,kidney,spleen warp.Liver and kidney tonifying, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal; External pathogenic wind expelling speckle dispelling.
Bombycis mori: be the male Scorpio of Bombycidae insecticide bombyx mori.Summer, get male silkworm moth, scald with boiling water dead, dry.Salty, temperature.Enter liver, kidney channel.The liver and the kidney tonifying, tonifying YANG arresting seminal emission.
Cortex Cinnamomi: be the dry bark of canella Cortex Cinnamomi CinnamomumcassiaPresl.Strip more than autumn, dry in the shade.Gas is aromatic strong, and taste is sweet, peppery.Pungent, sweet, hot greatly.Return kidney, spleen, the heart, Liver Channel.Mend fire supporing yang, guiding fire to origin, dispersing cold for relieving pain, promoting the flow of QI-blood by warming the meridian.
Cornu Cervi Pantotrichum: the young horn of the unossified close raw fine hair of the stag for animal in deer family Cervus nippon Temminck cervusnipponTemminck or Cervus elaphus linnaeus cervuselaphusLinnaeus.The former practises title " pilose antler of sika ", and the latter practises title " cervus elaphus linnaeus ".Cornu Cervi Pantotrichum got by summer, Qiu Erji saw, after processing, dries in the shade or dries.Sweet, salty, temperature.Return kidney, Liver Channel.Invigorating kidney-YANG, benefiting essence-blood, bone and muscle strengthening, adjusts punching to appoint, holder sore.
Rhizoma Gastrodiae: be the dry tuber of orchid Rhizoma Gastrodiae GastrodiaelataBl..This product is irregular thin slice.Exocuticle is faint yellow to fallow, sometimes the horizontal ring grain lined up of visible point-like.Tangent plane yellow-white is to light brown.Cutin sample is translucent.Feeble QI, sweet in the mouth.Sweet, flat.Return Liver Channel.Endogenous wind stopping relieving convulsion, suppressing liver-YANG, dispelling wind and removing obstruction in the collateral.
Penis et testis cervi: Penis et testis cervi is the external genitalia of animal in deer family, i.e. penis and testis.Gan Xian, temperature.Enter liver, kidney, bladder three warp.Penis et testis cervi, containing protein, fat, font steroid hormone, vitamin C, A and inorganic calcium, phosphorus, ferrum etc., has kidney-replenishing, the merit of benefiting essence-blood.
Radix Angelicae Sinensis: be the dry root of umbelliferae angelica Angelicasin:ensis (Oliv.) Diels.This product gives off a strong fragrance, sweet in the mouth, pungent, micro-hardship.Sweet, acrid, warm.Return liver, the heart, spleen channel.Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Scolopendra: be the dry body of Scolopendridae animal Scolopendpa Subspinipes Mutilans L. KOCH ScolopendrasubspinipesmutilansL.Koch.Spring, Xia Erji catch, and insert end to end with bamboo chip, exceptionally straight, dry.This product is flat strip, and matter is crisp, and section has crack.Feeble QI raw meat, has special pungent foul smell, acrid in the mouth, micro-salty.Pungent, temperature; Poisonous.Return Liver Channel.Endogenous wind stopping spasmolytic, removing obstruction in the collateral to relieve pain, dispersing pathogen accumulation.
Radix Aconiti Lateralis Preparata: be the processed goods of the daughter root of cohosh Aconitum carmichjaelii Debx. AconitumcarmichaeliiDebx.Pungent, sweet, hot greatly; Poisonous.GUIXIN, kidney, spleen channel.Recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, dispersing cold for relieving pain.
Radix Ginseng: be the dry root welding technology of Araliaceae Radix Ginseng PanaxginsengC.A.Mey..Sweet, micro-hardship, tepor.Return spleen, lung, the heart, kidney channel.Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, Fructus Alpiniae Oxyphyllae of calming the nerves.
Rhizoma Dioscoreae: be the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae DioscoreaoppositaThunb..Feeble QI, lightly seasoned, micro-acid, the stickness of chewing.Sweet, flat.Return spleen, dried meat, kidney channel.Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.
An object of the present invention is to provide a kind of Chinese medicine composition being used for the treatment of sexual impotence, prostatitis, climacteric syndrome.
Another object of the present invention is to provide a kind of preparation method of Chinese medicine composition of the present invention.
Another object of the present invention is to provide the purposes of a kind of Chinese medicine composition of the present invention at the medicine for the preparation for the treatment of sexual impotence, prostatitis, climacteric syndrome.
The present inventor is according to the strong point of both tcm theory basis and R&D of modern TCM achievement, large quantifier elimination has been carried out to the Chinese medicine composition of kidney invigorating and YANG supporting, have been surprisingly found that Chinese medicine composition of the present invention has the curative effect of definite kidney invigorating and YANG supporting, can be used in treating sexual impotence, prostatitis, climacteric syndrome.Wherein, described Chinese medicine composition is with Bombycis mori, Herba Epimedii for monarch drug, and two medicines phases 5, for impotence due to deficiency of the kidney, have the merit of common kidney invigorating and YANG supporting benefit essence.With Cornu Cervi Pantotrichum, Penis et testis cervi, Radix Morindae Officinalis, Fructus Corni, Fructus Lycii, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, when being classified as ministerial drug, in above-mentioned ministerial drug, Cornu Cervi Pantotrichum, Penis et testis cervi help Bombycis mori warming and recuperating the kidney-YANG, benefiting essence and marrow; Radix Morindae Officinalis, Fructus Corni, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata Six-element Chinese medicine help Bombycis mori, Herba Epimedii warming and recuperating the kidney-YANG; Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Fructus Lycii four taste Chinese medicine energy replenishing vital essence and blood, controlling nocturnal emission with astringent drugs is only lost, and associate with yang-tonifying drug in side, have treating YANG within YIN, the meaning for the treatment of YIN within YANG, receives warming and recuperating the kidney-YANG altogether, the merit that replenishing essence is enriched blood; Above three groups of compatibility of drugss, common effect of assisting monarch drug to play kidney invigorating and YANG supporting benefiting essence-blood.With Radix Ginseng, Scolopendra for adjuvant drug in side.Carry all medicines with Rhizoma Gastrodiae and enter external genitals and for making.The present inventor, on the basis that this finds, obtains technical scheme of the present invention further.
Specifically, the invention provides:
(1) Chinese medicine composition of sexual impotence, prostatitis, climacteric syndrome is used for the treatment of
The present invention provide firstly a kind of Chinese medicine composition being used for the treatment of sexual impotence, prostatitis, climacteric syndrome, and wherein said Chinese medicine composition is primarily of Bombycis mori, Herba Epimedii, Cornu Cervi Pantotrichum, Penis et testis cervi, Radix Morindae Officinalis, Fructus Corni, Fructus Lycii, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Radix Ginseng, Scolopendra, Rhizoma Gastrodiae composition.
Wherein, in described Chinese medicine composition, with Bombycis mori, Herba Epimedii for monarch drug, with Cornu Cervi Pantotrichum, Penis et testis cervi, Radix Morindae Officinalis, Fructus Corni, Fructus Lycii, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, when being classified as ministerial drug, with Radix Ginseng, Scolopendra for adjuvant drug, with Rhizoma Gastrodiae for making medicine.
Preferably, described Chinese medicine composition is made primarily of the crude drug of following weight proportioning: Bombycis mori 8 ~ 16 parts, Herba Epimedii 8 ~ 16 parts, Radix Morindae Officinalis 8 ~ 12 parts, Radix Rehmanniae Preparata 8 ~ 16 parts, Fructus Corni 2 ~ 8 parts, the Cortex Eucommiae 4 ~ 12 parts, Fructus Lycii 4 ~ 12 parts, Semen Cuscutae 4 ~ 12 parts, Cortex Cinnamomi 2 ~ 6 parts, 4 ~ 12 parts, Cornu Cervi Pantotrichum, 2 ~ 6 parts, Rhizoma Gastrodiae, Penis et testis cervi 1 ~ 3 part, Radix Angelicae Sinensis 3 ~ 12 parts, Scolopendra 1 ~ 3 part, Radix Aconiti Lateralis Preparata 2 ~ 6 parts, Radix Ginseng 2 ~ 6 parts, Rhizoma Dioscoreae 4 ~ 12 parts.
Preferably, described Chinese medicine composition also comprises pharmaceutically acceptable adjuvant.For easy to use, Chinese medicine composition of the present invention also can be made into preparation, and described adjuvant can be selected from the conventional adjuvant of this area, includes but not limited to filler, disintegrating agent, lubricant etc.
Preferably, described Chinese medicine composition and pharmaceutically acceptable adjuvant are prepared into oral solid formulation or liquid preparation, wherein, described oral solid formulation comprises tablet, capsule, granule and powder, and described liquid preparation comprises oral administration solution, medicated wine, syrup and aromatic water.Pharmaceutical composition of the present invention preferred oral administration drug treatment form, can adopt the dosage forms such as conventional tablet, Film coated tablets, capsule, granule, powder, oral administration solution, medicated wine, syrup, aromatic water, be filled to capsule after also can be made into micropill.Method and the auxiliary agent used of preparing these dosage forms are known to those skilled in the art, such as, can see " pharmacy of Chinese materia medica " (Shanghai science tech publishing house, in November, 1986 publishes), " pharmaceutic adjuvant complete works of " (Sichuan science tech publishing house, January nineteen ninety-five publishes), " Chinese Pharmacopoeia 2005 version one (Chemical Industry Press, in January, 2005 publish) etc.
Preferably, the adjuvant of the oral solid formulation of described Chinese medicine composition be selected from pharmaceutically conventional filler, disintegrating agent, binding agent, lubricant one or more.
Preferably, the adjuvant of the liquid preparation of described Chinese medicine composition is selected from one or more in pharmaceutically conventional solubilizing agent, cosolvent, cosolvent, antiseptic, coloring agent.
Preferably, when described Chinese medicine composition is prepared as oral solid formulation, by described Cortex Cinnamomi, Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder, with described Herba Epimedii, Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori ethanol extraction extractum, add filler and disintegrating agent prepares oral solid formulation, wherein do not make with lubricator and binding agent; Preferably, described filler comprises lactose, microcrystalline Cellulose, starch, dextrin, mannitol, calcium hydrogen phosphate wherein one or more; Preferably, described disintegrating agent comprises carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose wherein one or more.
When wherein said Chinese medicine composition is prepared as oral solid formulation (such as tablet), owing to all needing in currently available technology to make with lubricator, described adjuvant also comprises lubricant.
The present inventor is by the beat all discovery of a large amount of experiments: when preparing oral solid formulation, by selecting some specific pharmaceutic adjuvant, Chinese medicine composition of the present invention can be made in the process of preparation without the need to making with lubricator, thus reduce production cost, be particularly suitable for suitability for industrialized production, improve drug safety.Described specific pharmaceutic adjuvant comprises filler and disintegrating agent, not containing lubricant.Filler comprises lactose, microcrystalline Cellulose, starch, dextrin, mannitol, calcium hydrogen phosphate wherein one or more, and disintegrating agent comprises carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose wherein one or more.
Pharmaceutical composition of the present invention, also can be prepared into oral liquid.The present inventor is by the beat all discovery of a large amount of experiments: when preparing oral liquid, by selecting some specific pharmaceutic adjuvant, Chinese medicine composition of the present invention can be made in the process of preparation without the need to using antiseptic, thus reduce production cost, be particularly suitable for suitability for industrialized production, improve drug safety.Sucrose containing the extract drugs extractum of 20 ~ 70% (w/w), 95% ethanol (w/w) of 5 ~ 65% and 5 ~ 65% (w/w) in pharmaceutical composition liquid preparation of the present invention, the correctives of 0 ~ 15% (w/w) also regulates pH to 4 ~ 7 not use antiseptic, and medicine long-term stability is existed.
Preferably, when described Chinese medicine composition is prepared as liquid preparation, described Chinese medicine composition comprises extractum, the ethanol of 5 ~ 65% (w/w), sucrose and 0 ~ 15% (w/w) correctives of 5 ~ 65% (w/w) of the described Chinese medicine composition of 20 ~ 70% (w/w), and by pH regulator to 4 ~ 7, wherein do not comprise antiseptic; Preferably, described correctives comprises one or more in glycerol, orange syrup, Cortex cinnamomi japonici (Ramulus Cinnamomi) syrup; Preferably, described pH adjusting agent comprises one or more in citric acid, sodium citrate.Preferably, this pharmaceutic adjuvant described in drug oral liquid preparation mainly comprises correctives and pH adjusting agent, not containing coloring agent and antiseptic.Correctives comprises glycerol, orange syrup, Cortex cinnamomi japonici (Ramulus Cinnamomi) syrup wherein one or more, and pH adjusting agent comprises one or more in citric acid, sodium citrate.
(2) preparation method of Chinese medicine composition
Present invention also offers a kind of preparation method of the Chinese medicine composition as described in (), it comprises:
1) by the Herba Epimedii as described in (), Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori, with ethanol extraction, filter, filtrate is concentrated into the extractum of density 1.10-1.15;
2) Cortex Cinnamomi as described in (), Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder are broken into powder, or with ethanol extraction, filter, filtrate is concentrated into the extractum of density 0.95-1.05; And
3) by step 1) extractum and the step 2 that obtain) powder that obtains or extractum mixes, thus obtains described Chinese medicine composition.
Wherein, step 1) and step 2) order in no particular order, can simultaneously or sequentially (no matter step 1) front, or step 2) front) carry out.
The number of times of described extraction is 2-4 time, is preferably 2 times.
It will be understood by those skilled in the art that, when the amount of made Chinese medicine composition is larger, or when the dosage form of preparation is different, according to actual needs, can by the crude drug of wherein large usage quantity, separate with other medicines and extract, finally just mixing is concentrated into the extractum of density 1.10-1.15, its effect with before ethanol extraction, all crude drug are mixed after to extract be identical again.
Such as, in a preferred embodiment of the invention, described preparation method comprises the following steps: first by Herba Epimedii, Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 70% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.10-1.15 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi, Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder be broken into powder and make granule with above-mentioned extractum, dry, pulverize into fine powder, add excipient substance mixing, make oral solid formulation.
In another preferred embodiment of the present invention, described preparation method comprises the following steps: first by Herba Epimedii, Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori 70% ethanol as solvent, percolation 24 hours, collects percolate, decompression recycling ethanol.Medicinal residues heat after percolation carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.05-1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi, Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder be broken into powder, use 95% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 75% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 0.95-1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Add suitable excipient substance after extracting extractum mix homogeneously by above-mentioned two kinds and be configured to oral administration solution.
(3) purposes of Chinese medicine composition
The present invention finally provides the purposes of Chinese medicine composition in the medicine for the preparation for the treatment of sexual impotence, prostatitis, climacteric syndrome as described in ().
Present invention also offers a kind of method for the treatment of sexual impotence, prostatitis, climacteric syndrome, the method comprises the Chinese medicine composition of the present invention using effective dose to the patient of needs treatment.Described patient comprises people, also comprises the animal such as cat, Canis familiaris L..Described effective dose can change to some extent with factors such as the disease severity of patient, body weight, body constitution, age, ill history.But doctor or pharmacists have the ability as different patients determines suitable amount of application.For the route of administration preferred oral administering mode of Chinese medicine composition of the present invention.
Mode by the following examples further explains and describes content of the present invention, but these embodiments are not to be construed as limiting the scope of the invention.
In the examples below, if no special instructions, each reagent and Chinese crude drug all commercially, such as, can derive from Kangmei Pharmaceutical Co., Ltd.
The preparation of embodiment 1 conventional tablet
Herba Epimedii 8 parts, Radix Morindae Officinalis 8 parts, Radix Rehmanniae Preparata 8 parts, Fructus Corni 2 parts, the Cortex Eucommiae 4 parts, Fructus Lycii 4 parts, Semen Cuscutae 4 parts, Bombycis mori 8 parts use 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 70% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.10-1.15 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi 6 parts, 6 parts, Cornu Cervi Pantotrichum, 6 parts, Rhizoma Gastrodiae, Penis et testis cervi 3 parts, Radix Angelicae Sinensis 12 parts, Scolopendra 3 parts, Radix Aconiti Lateralis Preparata 6 parts, Radix Ginseng 6 parts, Rhizoma Dioscoreae 6 parts is ground into powder and above-mentioned extractum makes granule, drying, be ground into fine powder, add carboxymethyl starch sodium mixing, make oral solid formulation.
Embodiment 2 capsule
Herba Epimedii 8 parts, Radix Morindae Officinalis 8 parts, Radix Rehmanniae Preparata 8 parts, Fructus Corni 3 parts, the Cortex Eucommiae 8 parts, Fructus Lycii 8 parts, Semen Cuscutae 4 parts, Bombycis mori 16 parts use 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues heat after percolation carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi 2 parts, 12 parts, Cornu Cervi Pantotrichum, 2 parts, Rhizoma Gastrodiae, Penis et testis cervi 1 part, Radix Angelicae Sinensis 3 parts, Scolopendra 1 part, Radix Aconiti Lateralis Preparata 2 parts, Radix Ginseng 2 parts, Rhizoma Dioscoreae 12 parts is ground into powder and above-mentioned extractum makes granule, drying, be ground into fine powder, add starch mixing, make oral solid formulation.
Embodiment 3 medicated wine
Herba Epimedii 16 parts, Radix Morindae Officinalis 12 parts, Radix Rehmanniae Preparata 8 parts, Fructus Corni 3 parts, the Cortex Eucommiae 8 parts, Fructus Lycii 8 parts, Semen Cuscutae 8 parts, Bombycis mori 16 parts use 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 70% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.10-1.15 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi 2 parts, 4 parts, Cornu Cervi Pantotrichum, 2 parts, Rhizoma Gastrodiae, Penis et testis cervi 1 part, Radix Angelicae Sinensis 3 parts, Scolopendra 1 part, Radix Aconiti Lateralis Preparata 2 parts, Radix Ginseng 2 parts, Rhizoma Dioscoreae 4 parts be ground into powder, use 95% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 75% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 0.95-1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum.The medicine getting 30% (w/w) after extracting extractum mix homogeneously by above-mentioned two kinds shifts to an earlier date extractum, 95% ethanol (w/w) of 65% and the sucrose of 5% (w/w), and regulates pH to 4 ~ 5 to make medicated wine.
Embodiment 4 syrup
Herba Epimedii 8 parts, Radix Morindae Officinalis 8 parts, Radix Rehmanniae Preparata 16 parts, Fructus Corni 8 parts, the Cortex Eucommiae 12 parts, Fructus Lycii 12 parts, Semen Cuscutae 7 parts, Bombycis mori 8 parts use 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 70% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.10-1.15 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi 2 parts, 4 parts, Cornu Cervi Pantotrichum, 2 parts, Rhizoma Gastrodiae, Penis et testis cervi 1 part, Radix Angelicae Sinensis 3 parts, Scolopendra 1 part, Radix Aconiti Lateralis Preparata 2 parts, Radix Ginseng 2 parts, Rhizoma Dioscoreae 4 parts be ground into powder, use 95% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 75% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 0.95-1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum.The medicine getting 30% (w/w) after extracting extractum mix homogeneously by above-mentioned two kinds shifts to an earlier date extractum, 95% ethanol (w/w) of 5% and the sucrose of 65% (w/w), and regulates pH to 5 ~ 6 to make syrup.
Embodiment 5 oral administration solution
Herba Epimedii 8 parts, Radix Morindae Officinalis 8 parts, Radix Rehmanniae Preparata 8 parts, Fructus Corni 8 parts, the Cortex Eucommiae 8 parts, Fructus Lycii 12 parts, Semen Cuscutae 12 parts, Bombycis mori 12 parts use 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 70% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.10-1.15 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi 2 parts, 4 parts, Cornu Cervi Pantotrichum, 2 parts, Rhizoma Gastrodiae, Penis et testis cervi 2 parts, Radix Angelicae Sinensis 3 parts, Scolopendra 2 parts, Radix Aconiti Lateralis Preparata 3 parts, Radix Ginseng 2 parts, Rhizoma Dioscoreae 4 parts be ground into powder, use 95% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 75% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 0.95-1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum.Get the extract drugs extractum of 20% (w/w), 95% ethanol (w/w) of 10% and the sucrose of 40% (w/w), the distilled water of 25% (w/w) after extracting extractum mix homogeneously by above-mentioned two kinds, the glycerol of 5% (w/w) also regulates pH to 5 ~ 6 to make oral liquid.
Embodiment 6 oral administration solution
Herba Epimedii 12 parts, Radix Morindae Officinalis 8 parts, Radix Rehmanniae Preparata 12 parts, Fructus Corni 8 parts, the Cortex Eucommiae 10 parts, Fructus Lycii 10 parts, Semen Cuscutae 8 parts, Bombycis mori 8 parts use 70% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 70% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 1.10-1.15 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum; Separately get Cortex Cinnamomi 2 parts, 4 parts, Cornu Cervi Pantotrichum, 2 parts, Rhizoma Gastrodiae, Penis et testis cervi 2 parts, Radix Angelicae Sinensis 3 parts, Scolopendra 2 parts, Radix Aconiti Lateralis Preparata 3 parts, Radix Ginseng 2 parts, Rhizoma Dioscoreae 4 parts be ground into powder, use 95% ethanol as solvent, percolation 24 hours, collect percolate, decompression recycling ethanol.Medicinal residues after percolation 75% ethanol heat carries (90 DEG C) secondary, filters, concentrated, merges with percolate the relative density 0.95-1.05 (50 DEG C-70 DEG C) being concentrated into and being reduced to extractum.The medicine getting 70% (w/w) after extracting extractum mix homogeneously by above-mentioned two kinds shift to an earlier date extractum, 5% 95% ethanol (w/w) and the sucrose of 5% (w/w), the distilled water of 5%, the Cortex cinnamomi japonici (Ramulus Cinnamomi) syrup of 15% (w/w) also regulates pH to 6 ~ 7 to make oral liquid.
Test example 1 pharmacodynamic study
One, on the impact of castrated rats erection
1. experimental technique
Get SD male rat 60, be divided into 6 groups at random, i.e. dosage group (N=10), medicine high dose group (N=10) in positive controls (N=10), testosterone propionate group (N=10), medicine low dose group (N=10), medicine.1% pentobarbital sodium 50mg/kg anaesthetizes, sterilization skin of scrotum, and row bilateral testes enucleation is postoperative using tetracycline medicated powder aqueous solution (500mg/L) as drinking-water.After 7d, positive controls gavage distilled water 6ml/kgd
-1testosterone propionate group intramuscular injection testosterone propionate diluent 0.2mg/ only, medicine low dose group gavage 2% embodiment 6 mixed extraction extractum aqueous solution, dosage group gavage 4% embodiment 6 mixed extraction extractum aqueous solution in medicine, medicine high dose group gavage 8% embodiment 6 mixed extraction extractum aqueous solution.21st day, rat operation plate dorsal position fixes rat, and the multiplex instrument of SRJ-3 type physiological and pharmacological (Guangdong Shan Shan educates medical instrument factory and produces) stimulating electrode is put in rat radix penis part, 100V, 20HZ, continuous electricity irritation, the incubation period of record castrated rats erection.
2. experimental result
Castrated rats gavage pharmaceutical composition, or after intramuscular injection testosterone propionate, eclipse period of penile erection time shorten, compares with positive control type group, has significance or pole significant difference.The yang invigorating functions of its herb liquid high dose and middle dosage group is obviously better than testosterone propionate group.Result is auspicious in table 1.
Table 1: on the impact (X ± SD) of castrated rats eclipse period of penile erection
Note: compare * P < 0.05, * * P < 0.01 with positive controls;
Two, on the impact of male mice mating behavior
1. experimental technique
Get 50 sexual maturity male mices, be divided into blank group (N=10) at random, medicine low dose group (N=10), dosage group (N=10) in medicine, medicine high dose group (N=10).Blank group gavage distilled water 6ml/kgd
-1, medicine low dose group gavage 2% embodiment 6 mixed extraction extractum aqueous solution, dosage group gavage 4% embodiment 6 mixed extraction extractum aqueous solution in medicine, medicine high dose group gavage 8% embodiment 6 mixed extraction extractum aqueous solution, successive administration 15 days.
Mating test observational technique: male mice is put into separately standard mice and raise box, it is made substantially to conform 5 minutes, then, a ready female mice put into by every cage, record the incubation period that male Mus catches female Mus, in 20 minutes, male Mus catches incubation period and the number of times that ejaculation occurs for the number of times of female Mus and male Mus.
2. experimental result
(1) pharmaceutical composition catches the impact of female Mus behavior on male mice: compare with blank group, and each dosage of pharmaceutical composition all can shorten the incubation period that male mice catches female Mus, increases and catches number of times.Wherein the male Mus of low dose group to catch incubation period of female Mus shorter, high dose group increases that to catch number of times more, compares have significance or pole significant difference with blank group.Result is auspicious in table 2:
Table 2: the impact (X ± SD) male Mus being caught to female Mus behavior
Note: compare * P < 0.05 with blank group; * P < 0.01.
(2) pharmaceutical composition is on the impact of male mice ejaculation ability: big-and-middle small dose group all can shorten ejaculation latency, increases ejaculation frequency.Wherein, heavy dose of group obviously can be shortened ejaculation latency, increases ejaculation frequency, compares have significant difference with blank group.Result is auspicious in table 3:
Table 3: the impact (X ± SD) male Mus being caught to female Mus behavior
Note: compare * P < 0.05 with blank group.
Three, acute toxicity test
1. experimental technique:
Experimental animal: Kunming mouse, body weight 18-22g, male, provided by Chengdu University of Traditional Chinese Medicine's Animal Experimental Study center.For subsequent use after quarantine.Get Kunming mouse 20, gavage 30% embodiment 6 extracts extractum aqueous solution 40ml/kg (i.e. every mouse stomach 0.8ml, maximum volume), administration 3 times in 24 hours, Continuous Observation 7 days.
2. experimental result:
After animals administer, have no Behavioral change, dyskinesia, normal to the reaction stimulated; No abnormality seen myosis, mydriasis, curtain coating, shed tears, watery nasal discharge; Breathe normal; Have no diarrhoea, abdominal distention, constipation, perineum filth; Vaginal orifice, perineal position no abnormality seen; Fur is bright and clean, skin high resilience, has no perpendicular hair, fur relaxes, dermexanthesis; Eyes are bright flexibly, have no that eye is convex, nystagmus, blepharoptosis; Have no and become thin or obesity.Motion is ingested normal, and grow normal, spontaneous activity is normal, and all states are normal.
3. conclusion
30% embodiment 6 of Kunming mouse gavage Cmax, maximum volume extracts extractum aqueous solution 120ml/kgd
-1, animal has no animal dead and abnormal toxic reaction, and compare with the clinical consumption per day 0.032g/kg × Bid of people (i.e. every day 4, being equivalent to crude drug in whole 3.2g), animal daily intaking amount is equivalent to 1125 times of the clinical consumption per day of people, without acute toxicity.
Test example 2 is on the impact of chronic nonbacterial prostatitis animal model
1. experimental technique
Get SD male rat 80, be divided into 4 groups at random, be i.e. dosage group (N=20), medicine high dose group (N=20) in positive controls (N=20), medicine small dose group (N=20), medicine.Each group of SD rat with 10% chloral hydrate, 3ml/kg body weight anesthesia after, castration under aseptic condition.Operation gave injection penicillin in the same day and postoperative 2 days
50000 U/ (kgd), intramuscular injection, Incision infection prevention.Give intramuscular injection estradiol benzoate 0.25mg/kg postoperative next day, 1 times/day, continuous 30 days.After modeling success, positive controls gives distilled water 6ml/kgd
-1, medicine small dose group gavage every day 2% embodiment 5 mixed extraction extractum aqueous solution, dosage group gavage every day 4% embodiment 5 mixed extraction extractum aqueous solution in medicine, medicine high dose group gavage every day 8% embodiment 5 mixed extraction extractum aqueous solution.Successive administration administration 8 weeks, use 3.5% chloral hydrate anesthesia, aseptically dissect, cut abdominal cavity, cut off pubic symphysis, take out prostata tissue, rinsed clean, the neutral formalin solution putting into 10% is fixed, specimens paraffin embedding slices, HE dyes, and om observation cell infiltration degree, prostatic acini change, interstitial fibrosis degree.
2. experimental result
(1) positive controls light microscopic is visible: blood vessel is congested expansion obviously, interstitial Severe edema loosens, lumen of gland and the interior visible a large amount of cell infiltration of interstitial, based on lymphocyte, be also shown in neutrophilic granulocyte, phagocyte, plasma cell etc., glandular epithelium is papillary hyperplasia, and the necrosis of part glandular epithelium comes off, and shows in severe chronic inflammation.
(2) medication therapy groups light microscopic after treatment is visible: low dose group and positive controls are without obvious difference; The vasodilation of middle dosage group prostate interstitial, interstitial is loosened edema, visible a small amount of cell infiltration in interstitial, and adenomatosis is not obvious, and part glandular epithelium comes off necrosis.Than positive control treatment group, inflammation alleviates to some extent.High dose group prostate interstitial blood vessel has expansion, and interstitial edema of loosening is not obvious, a small amount of cell infiltration based on lymphocyte as seen in interstitial, and adenomatosis is not obvious, to come off necrosis without glandular epithelium.Than positive control treatment group, inflammation alleviates obviously.
Test example 3 is on the impact of female climacteric syndrome animal model
1. experimental technique
Get female Wistar rats 80, be divided into 4 groups at random, be i.e. dosage group (N=20), medicine high dose group (N=20) in positive controls (N=20), medicine low dose group (N=20), medicine.Each group of rat adopts the method for abdominal operation excision bilateral ovaries, rat body inner estrogen level is declined, causes rat climacteric osteoporosis model.Modeling is after one week, positive controls gives distilled water 6ml/kg every day, medicine low dose group gavage every day 2% embodiment 5 mixed extraction extractum aqueous solution, dosage group gavage every day 4% embodiment 5 mixed extraction extractum aqueous solution in medicine, medicine high dose group gavage every day 8% embodiment 5 mixed extraction extractum aqueous solution.Successive administration administration is after 8 weeks, and sacrificed by decapitation rat, gets blood, and centrifugal 15 minutes of 4000rpm, prepares serum, adopts radio immunoassay to measure estradiol, LH, FSH, RPL content in serum.Put to death rat and cut abdominal cavity, win rat uterus, om observation endometrial epithelial cell after dyeing, body of gland quantity, endometrial stroma.
2. experimental result
(1) pharmaceutical composition is on female modeling rat estradiol, the impact of LH, FSH, RPL content: compare with positive controls, each dosage of pharmaceutical composition all can raise estradiol in rat blood serum, reduces LH, FSH, RPL content.Wherein low dose group rising estradiol is obvious, and it is obvious that middle dosage group reduces FSH, and it is obvious that high dose group reduces LH.Result is auspicious in table 4:
Table 4: on female modeling rat estradiol, LH, FSH, RPL content impact (X ± SD)
Note: compare * P < 0.05 with blank group; * P < 0.01.
1) positive controls light microscopic is visible: the obvious hypertrophy of rat endometrium epithelial cell, and cell is high core shape, body of gland increasing number, and Endometrial stromal cells is loose, and interstitial is loosened.
2) medication therapy groups light microscopic after treatment is visible: low dose group and positive controls are without obvious difference; Middle dosage group rat endometrium epithelial cell has hypertrophy, and body of gland increasing number, interstitial is without significant change.The endometrial epithelium of high dose group sometimes visible cell height differs, and body of gland quantity and interstitial are without significant change.
Claims (10)
1. be used for the treatment of a Chinese medicine composition for sexual impotence, prostatitis, climacteric syndrome, wherein said Chinese medicine composition is primarily of Bombycis mori, Herba Epimedii, Cornu Cervi Pantotrichum, Penis et testis cervi, Radix Morindae Officinalis, Fructus Corni, Fructus Lycii, Semen Cuscutae, the Cortex Eucommiae, Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Radix Ginseng, Scolopendra, Rhizoma Gastrodiae composition.
2. Chinese medicine composition according to claim 1, wherein, described Chinese medicine composition is made primarily of the crude drug of following weight proportioning: Bombycis mori 8 ~ 16 parts, Herba Epimedii 8 ~ 16 parts, Radix Morindae Officinalis 8 ~ 12 parts, Radix Rehmanniae Preparata 8 ~ 16 parts, Fructus Corni 2 ~ 8 parts, the Cortex Eucommiae 4 ~ 12 parts, Fructus Lycii 4 ~ 12 parts, Semen Cuscutae 4 ~ 12 parts, Cortex Cinnamomi 2 ~ 6 parts, 4 ~ 12 parts, Cornu Cervi Pantotrichum, 2 ~ 6 parts, Rhizoma Gastrodiae, Penis et testis cervi 1 ~ 3 part, Radix Angelicae Sinensis 3 ~ 12 parts, Scolopendra 1 ~ 3 part, Radix Aconiti Lateralis Preparata 2 ~ 6 parts, Radix Ginseng 2 ~ 6 parts, Rhizoma Dioscoreae 4 ~ 12 parts.
3. Chinese medicine composition according to claim 1, wherein, described Chinese medicine composition and pharmaceutically acceptable adjuvant are prepared into oral solid formulation or liquid preparation, wherein, described oral solid formulation comprises tablet, capsule, granule and powder, and described liquid preparation comprises oral administration solution, medicated wine, syrup and aromatic water.
4. Chinese medicine composition according to claim 3, wherein, the adjuvant of the oral solid formulation of described Chinese medicine composition be selected from pharmaceutically conventional filler, disintegrating agent, binding agent, lubricant one or more.
5. Chinese medicine composition according to claim 3, wherein, the adjuvant of the liquid preparation of described Chinese medicine composition is selected from one or more in pharmaceutically conventional solubilizing agent, cosolvent, cosolvent, antiseptic, coloring agent.
6. Chinese medicine composition according to claim 4, wherein, when described Chinese medicine composition is prepared as oral solid formulation, by described Cortex Cinnamomi, Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder, with described Herba Epimedii, Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori ethanol extraction extractum, add filler and disintegrating agent prepares oral solid formulation, wherein do not make with lubricator and binding agent; Preferably, described filler comprises lactose, microcrystalline Cellulose, starch, dextrin, mannitol, calcium hydrogen phosphate wherein one or more; Preferably, described disintegrating agent comprises carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose wherein one or more.
7. Chinese medicine composition according to claim 5, wherein, when described Chinese medicine composition is prepared as liquid preparation, described Chinese medicine composition comprises extractum, the ethanol of 5 ~ 65% (w/w), sucrose and 0 ~ 15% (w/w) correctives of 5 ~ 65% (w/w) of the described Chinese medicine composition of 20 ~ 70% (w/w), and by pH regulator to 4 ~ 7, wherein do not comprise antiseptic; Preferably, described correctives comprises one or more in glycerol, orange syrup, Cortex cinnamomi japonici (Ramulus Cinnamomi) syrup; Preferably, described pH adjusting agent comprises one or more in citric acid, sodium citrate.
8., according to the preparation method of the Chinese medicine composition in claim 1-7 described in any one, it comprises:
1) by Herba Epimedii according to claim 1, Radix Morindae Officinalis, Radix Rehmanniae Preparata, Fructus Corni, the Cortex Eucommiae, Fructus Lycii, Semen Cuscutae, Bombycis mori, with ethanol extraction, filter, filtrate is concentrated into the extractum of density 1.10-1.15;
2) Cortex Cinnamomi according to claim 1, Cornu Cervi Pantotrichum, Rhizoma Gastrodiae, Penis et testis cervi, Radix Angelicae Sinensis, Scolopendra, Radix Aconiti Lateralis Preparata, Radix Ginseng, Rhizoma Dioscoreae powder are broken into powder, or with ethanol extraction, filter, filtrate is concentrated into the extractum of density 0.95-1.05; And
3) by step 1) extractum and the step 2 that obtain) powder that obtains or extractum mixes, thus obtains described Chinese medicine composition,
Wherein, step 1) and step 2) in no particular order sequentially, can carry out simultaneously or sequentially.
9. method according to claim 9, wherein, step 1) or step 2) described in the number of times of extraction be 2-4 time, be preferably 2 times.
10. according to the purposes of the Chinese medicine composition in claim 1-7 described in any one in the medicine for the preparation for the treatment of sexual impotence, prostatitis, climacteric syndrome.
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| CN201410253247.4A Pending CN105327151A (en) | 2014-06-09 | 2014-06-09 | Traditional Chinese medicine composition used for treating impotence, prostatitis and climacteric syndrome |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109289012A (en) * | 2017-07-24 | 2019-02-01 | 徐定清 | A kind of medicine pill of replenishing essence Yishen Pills |
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| CN1475237A (en) * | 2002-08-13 | 2004-02-18 | 孙兴望 | Medicine for strengthening yang and tonifying kidney, treating male infecundity and male and female climacteric syndrome |
| CN1903310A (en) * | 2006-08-02 | 2007-01-31 | 赵中华 | Mongolian medicine for body-building and tonifying yang and its prepn. method |
| KR20090031311A (en) * | 2007-09-20 | 2009-03-25 | 김상수 | Method for making pills for impotenc |
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| CN1475237A (en) * | 2002-08-13 | 2004-02-18 | 孙兴望 | Medicine for strengthening yang and tonifying kidney, treating male infecundity and male and female climacteric syndrome |
| CN1903310A (en) * | 2006-08-02 | 2007-01-31 | 赵中华 | Mongolian medicine for body-building and tonifying yang and its prepn. method |
| KR20090031311A (en) * | 2007-09-20 | 2009-03-25 | 김상수 | Method for making pills for impotenc |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109289012A (en) * | 2017-07-24 | 2019-02-01 | 徐定清 | A kind of medicine pill of replenishing essence Yishen Pills |
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