CN103191297B - Traditional Chinese medicine composition for treating male infertility and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating male infertility and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating male infertility, relating to the field of traditional Chinese medicines. The composition for treating or preventing male infertility is prepared from the following raw materials in parts by weight: 10-50 parts of great burdock achene, 10-20 parts of cassia bark, 5-20 parts of Chinese angelica, 5-15 parts of Chinese yam, 5-10 parts of Chinese magnoliavine fruit, 5-15 parts of Indian bread, 5-15 parts of heterophylly falsestarwort root, 1-10 parts of ginseng, 5-15 parts of barbary wolfberry fruit, 9-15 parts of radix astragali, 9-15 parts of coptis root, 5-15 parts of China dodder, 1.5-9 parts of dwarf lilyturf tuber, 5.5-15 parts of white paeony root, 6-9 parts of asiatic cornelian cherry fruit and 10-15 parts of liquorice. The traditional Chinese medicine composition has good treatment or prevention effects on male infertility and has low side effects and obvious clinical popularization value.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of Chinese medicine composition for the treatment of male infertility and preparation method thereof.
Background technology
Male sterility refers to that man and wife lives together more than 1 year after marriage, does not take contraceptives, because bridegroom's or husband's side reason causes the infertile person in the wife's side.Male infertility may be the result that multiple composite factor causes, and commonly encountered diseases is because having: congenital defect, and kidney essense is not filled; Deficiency of kidney-QI, essence is closed solid or kidney essense loss, and slippage be can't help, or excess of sexual intercourse, and kidney is store essential substances not, or feelings will anxiety, vital essence imbalance etc., in a word, this disease cause of disease is from kidney, kidney essense, the deficiency of vital energy and to insufficiency of kidney-YANG, deficiency of the kidney yin, kidney insufficiency.The man who causes is for above-mentioned reasons most male infertility principal characters without sperm, oligospermatism, sperm count normality infertility, many sperms disease and asthenospermia disease etc., causes great misery often to patient and family.Along with accelerating and the deterioration of human habitat of rhythm of life, male infertility is more and more higher at China's sickness rate, how to prevent and treat male infertility to be still a problem that is worth research.
Thereby in normal situation, in testis, make male's seminal fluid discord blood contact make the immune system in male's blood system to produce harm to semen because exist blood-testis barrier, thereby thereby but when blood-testis barrier because some factor can make the immune system of self be destroyed to normal morphology and the function of the antigen generation immunoreation sperm in seminal fluid the generation that makes male infertility by immune system when destroyed.The immunopathogenesis of testis changes, and has caused testis and spermatogenic cell physiological change.Antibody is by damaged blood-testis barrier, and in seminiferous tubule wall deposition, damage basement membrane, makes basement membrane thickened and fibrosis, for want of nutrition of sustenticular cell and spermatogenic cell and degeneration changes spermatogenesis microenvironment in convoluted seminiferous tubule.Antibody, by impaired basement membrane, directly acts on spermatogenic cell, destroys the function of spermatogenic cell.Antibody deposits in interstitial blood vessel wall, cause damage and the fiber of blood vessel wall to thicken, stroma ischemia, anoxia, the spermatogenesis microenvironment obstacle that increases the weight of testis, the spermatogenesis of testis is further destroyed, and shows as spermatogenesis low, spermatogenesis retardance, spermatogenic cell arrangement disorder, spermatogenic cell comes off, and causes spermatogenesis to reduce or disappears.Show as clinically oligospermatism, even azoospermia.
Doctor trained in Western medicine has obtained remarkable progress in etiological diagnosis and the treatment of male sterility, has changed the treatment situation of male sterility taking sperm injection (ICSI) technology in follicle slurry as the auxiliary procreation technology (ART) of representative.But property that what ART not only brought is separates with reproduction, also exist huge risk (as potential genetic risk, birth defect, impact on filial generation etc.), be also faced with many ethics, law and social dispute.In China, Chinese medicine, having brought into play certain advantage aspect treatment male infertility, has obtained more satisfied curative effect, is one of Main Means for the treatment of male sterility.The traditional Chinese medical science thinks, the sick position of male infertility is how dirty relevant with kidney, liver, the heart, spleen etc., and deficiency of kidney-QI is weak, stagnation of QI due to depression of the liver, damp invasion of lower energizer, QI and blood deficiency are sterile common pathogenesis, and its Therapeutic Principle is also how around this pathogenesis and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs.
Make a general survey of the research direction of world's new drug, be mainly single chemicals and preparations thereof of research and development the eighties in the past, starts to develop biotechnology and natural medicinal plants after the eighties, and drug research direction is tending towards multiformity.In conjunction with modern Chinese medicine theory of development, from improving the angle of curative effect of medication, reduction side effect, through Chinese medicine ingredients being screened to the preparation that extraction and/or compatibility make, its side effect is little, safe, has the advantage that chemical synthetic drug can not be compared.
Summary of the invention
Large in order to overcome existing male infertility chemotherapeutic agent toxic and side effects, the prior art deficiency that male infertility therapeutic effect is not good, a kind of Chinese medicine composition for the treatment of male infertility of the present invention is made by the raw material of following weight portion: Fructus Arctii 10-50 part, Cortex Cinnamomi 10-20 part, Radix Angelicae Sinensis 5-20 part, Rhizoma dioscoreae 5-15 part, Fructus Schisandrae Chinensis 5-10 part, Poria 5-15 part, Radix Pseudostellariae 5-15 part, Radix Ginseng 1-10 part, Fructus Lycii 5-15 part, Radix Astragali 9-15 part, Rhizoma Coptidis 9-15 part, Semen Cuscutae 5-15 part, Radix Ophiopogonis 1.5-9 part, Radix Paeoniae Alba 5.5-15 part, Fructus Corni 6-9 part, Radix Glycyrrhizae 10-15 part.
Fructus Arctii has another name called Fructus Arctii, FRUCTUS ARCTII, is the fruit of feverfew Fructus Arctii, when annual 8～JIUYUE fruit maturation, gathers in batches, after drying, gets fruit, removes impurity, then shines to absolutely dry can being used as medicine.It is cool in nature, and acrid in the mouth hardship enters lung, stomach warp, has effect of dispelling wind and heat pathogens, lung qi dispersing rash, subduing swelling and detoxicating, is used for the treatment of the diseases such as cough due to pathogenic wind-heat, laryngopharynx swelling and pain, macule are saturating, rubella is had an itch, carbuncle sore tumefacting virus, is the key medicine of loose wind except thermal detoxification.Modern pharmacology confirmation, Fructus Arctii has effect of two-ways regulation body immune system.
Cortex Cinnamomi is canella, has the fire of benefit supporing yang, let the fire back to its origin, dispersing cold for relieving pain, effect of promoting blood circulation to restore menstrual flow.It can warming the spleen and stomach, removing accumulated cold, promoting blood circulation.Clinically be mainly used in controlling decline of the fire from the gate of life, cold extremities faint pulse, YANG-depletion collapse, stomachache is had loose bowels, colic of cold type renal mass, chills and pain of the waist and kness, amenorrhea lump in the abdomen, carbuncle of yin nature, multiple abscess, and empty sun is more floating, the diseases such as heat in the upper and cold in the lower.
Conventional enrich blood when being classified as, regulating menstruation, Traditional Chinese medicine used as analgesic, its sweet-bitter flavor, warm in nature, having enriches blood invigorates blood circulation, menstruction regulating and pain relieving, the effect of moisturizing laxation, cures mainly that all cards of blood deficiency, menoxenia, amenorrhea dysmenorrhea, lump in the abdomen knot are poly-, the disease such as weight, ulcer sores after asthenia cold abdominalgia, numbness of the skin, dryness of the intestine dyschezia, bloody dysentery.Modern pharmacology studies show that it all has multiple pharmacological effect for blood system, cardiovascular system.
Rhizoma dioscoreae refers to the Rhizoma Dioscoreaes that is produced from ground such as Anhui, modern Jiangsu, and Rhizoma dioscoreae stem is with aubergine conventionally, cures mainly insufficiency of the spleen lack of appetite, incessant chronic diarrhea, has spleen reinforcing nourishing the stomach, the lung benefiting that promotes the production of body fluid, effect of the kidney invigorating arresting seminal emission.The Radix Rehmanniae, is also Radix Rehmanniae, Scrophulariaceae herbaceos perennial.Sweet-bitter flavor, cold nature, GUIXIN, liver, kidney channel.Matter profit is fallen and is let out, and has the nourishing YIN to relieve dryness effect of promoting the production of body fluid.Rhizoma Polygonati is used as medicine with rhizome.There is boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney benefiting functions.Be used for the treatment of weakness of the spleen and stomach, fatigue and asthenia, xerostomia lack of appetite, deficiency of the lung cough caused by dryness, asthenia of essence and blood, the interior-heat disease such as quench one's thirst.
Fructus Schisandrae Chinensis, is commonly called as Fructus Zanthoxyli Plansipini, sliding weight of steelyard, medicine Fructus Schisandrae Chinensis, face rattan, five Fructus Armeniacae Mumes etc., and " the sweet acid of five tastes skin and flesh, works hard in core, has saline taste " carried in Tang etc. " Newly Revised Canon of Materia Medica ", therefore there is the name of Fructus Schisandrae Chinensis.Ancient medical book Cheng Ta Chi Zhu, profound and, meeting and, list in the earliest Sheng Nong's herbal classic top grade, herbal function is the power of strengthening by means of tonics, medical value is high, and it has astringes the lung, nourishing kidney, promote the production of body fluid, receive antiperspirant, effect of arresting seminal emission, clinically be mainly used in controlling the deficiency of the lung and breath with cough, xerostomia is done thirsty, spontaneous perspiration, night sweat, impairment caused by overstrain weakness and emaciation, emission, the diseases such as chronic diarrhea chronic dysentery.Modern pharmacology confirmation, its extract has stronger hepatoprotective and sedation.
Poria, is commonly called as Poria, Song Ling, Poria, and for colonizing in the fungi plant on pinaster root, shape is as Rhizoma Dioscoreae esculentae, crust pitchy, the inside white or pink.Its protozoa is the dry sclerotia of On Polyporaceae Poria, and multiparasitization is in the root of Pinus massoniana Lamb or Pinus densiflora.Originate in the ground such as Yunnan, Anhui, Hubei, Henan, Sichuan.Ancients claim that Poria is " god medicine " at 4 o'clock, because its effect is very extensive, regardless of the four seasons, by it and various compatibility of drugs, no matter cold, temperature, wind, all diseases that wets can be brought into play its unique effects.Poria sweet in the mouth, light, property are flat, be used as medicine there is promoting diuresis to eliminate damp pathogen, the function of strengthening the spleen stomach function regulating, mind tranquilizing and the heart calming.Modern medicine study: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.
Radix Pseudostellariae, has another name called Radix Ginseng, Tong Can.For the tuber of Caryophyllaceae herbaceos perennial pseudostellaria heterophylla.Have invigorating qi and benefiting blood, promote the production of body fluid, the effect of tonifying the spleen and stomach.Be suitable for children's's summer heat of a specified duration do not move back, the disease of the weakness such as diet is depressed, the deficiency of the lung, cough, cardiopalmus and children's weak unable, spontaneous perspiration, night sweat, mouthful equality disease after being ill.
The medical value of Radix Ginseng is high, in Shennong's Herbal, just thinks, Radix Ginseng has the effect of " tonifying five ZANG-organs, peace spirit, determine soul, pathogen, the happy Fructus Alpiniae Oxyphyllae of improving eyesight are throbbed with fear, removed to spasmolytic ".Pharmacological research shows that Radix Ginseng all has the effect of the blood glucose of reduction to Normal Canine and alloxan male infertility dog, has obvious hypoglycemic activity to alloxan male infertility Mus.After Radix Ginseng total saponins can obviously suppress the hyperglycemia of alloxan male infertility Mus and drug withdrawal, its effect still can maintain 1～2 week.Clinical research shows, Radix Ginseng treatment male infertility not only can be improved general symptom as weak, thirsty, weak etc., and can reduce blood glucose and glucose in urine.Be applicable to light, medium-sized male infertility patient, Chinese medical discrimination is suffered from a deficiency of the kidney, gas deficiency of YIN person better efficacy, and the deficiency of YIN scorching person should not take.
Fructus Lycii (formal name used at school: Lycium chinense) is the multi-branched shrub plant of Solanaceae Lycium, and high 0.5-1 rice, can reach more than 2 meters when cultivation.All there is distribution both at home and abroad.Fructus Lycii whole body is precious, and bright Li Shizhen (1518-1593 A.D.) Compendium of Material Medica is recorded: " spring is adopted Folium Lycii, name day essence grass; Summer picks flowers, name Sempervivum tectorum; Qiu Caizi, name Fructus Lycii; Dong Caigen, name Cortex Lycii ".Fructus Lycii tender leaf also claims Fructus Lycii head, edible or make Fructus Lycii tea.Modern study, Fructus Lycii has the blood glucose of reduction, lipotropy, and can antiatherogenic effect.
The Chinese crude drug Radix Astragali is the root of leguminous herbaceous plant's Radix Astagali, Radix Astragali, has the effects such as invigorating QI to consolidate the body surface resistance, diuretic detumescent, expelling pus and toxin by strengthening QI, granulation promoting.The medicinal history of existing more than 2000 year so far of the Radix Astragali, it has enhancing human body immunity function, protects the liver, diuresis, defying age, anti-stress, blood pressure lowering and antibacterial action more widely.But table excess pathogen is contained, retention of dampness due to stagnation of QI, food stagnation is stagnated, carbuncle from the beginning of or burst after the excess syndrome such as pyretic toxicity Shang Sheng, and hyperactivity of YANG due to deficiency of YIN person, must prohibit clothes.
Rhizoma Coptidis has another name called Wang Lian, and bitter in the mouth is cold in nature, nontoxic.GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.There is heat clearing and damp drying, effect of eliminating fire and detoxication.For damp and hot feeling of fullness, vomiting acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, hyperactivity of heart-fire, dysphoria and insomnia, heat in blood is told nosebleed, conjunctival congestion, toothache, quenches one's thirst, carbuncle furuncle; External treatment eczema, eczema, auditory meatus is suppurated.The kind clear part of the body cavity above the diaphragm housing the heart and lungs of Rhizoma Coptidis (processed with wine) is burning hot.For conjunctival congestion, aphtha.Prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice clearing stomach stomach function regulating preventing or arresting vomiting.Tie mutually damp and hot middle resistance, feeling of fullness vomiting for cold and heat.Cornel Rhizoma Coptidis soothing liver-QI stomach function regulating preventing or arresting vomiting.For incoordination between the liver and stomach, vomiting acid regurgitation.
Semen Cuscutae is listed in top grade in Shennong's Herbal, and abnormal smells from the patient is pungent, sweet, flat nontoxic.There is the kidney invigorating and essence nourishing, effect of nourishing the liver to improve visual acuity, the waist knee joint muscles and bones that is applicable to deficiency of the liver and kindey is ached, the diseases such as legs and feet weakness, impotence and seminal emission, crazy talk, frequent micturition, dripping urination, dizziness and blurred vision, blurring of vision, Hiccough and deaf and women's leukorrhagia, habitual abortion.Generally being listed in top grade can taking for a long time takes for a long time improving eyesight and makes light of one's life by commiting suicide and prolong life.Modern pharmacology studies confirm that it has significant Yang-strengthening effect, and reduces blood pressure, delays the multiple effects such as cataract process.
Radix Ophiopogonis, has another name called Radix Ophiopogonis, is Liliaceae Ophiopogon plant.Be used as medicine Radix Ophiopogonis with tuber.Nature,taste and action: sweet, micro-hardship, cool, Yin-nourishing and body fluid promoting, nourishing the lung to arrest cough, relieving restlessness clears away heart-fire.Cure mainly consumption of body fluid caused by febrile disease, vexed, thirsty, dry pharynx lung-heat, cough, pulmonary tuberculosis.
The Radix Paeoniae Alba is the famous traditional parts of generic medicinal plants of China, and applicating history is long, and Radix Paeoniae begins to be loaded in Eastern Han Dynasty's Shennong's Herbal, classifies middle product as, and note has " main pathogen, Radix Paeoniae Alba stomachache, removes arthralgia due to stagnation of blood, broken hard long-pending, cold and heat hernia abdominal mass, pain relieving, diuresis, QI invigorating ".Nourishing blood to suppress the hyperactive liver, slow middle pain relieving, yin fluid astringing is received antiperspirant.Control the breast abdomen pain over the hypochondriac region, dysentery stomachache, spontaneous sweating, fever due to yin deficiency, menoxenia, metrorrhagia, is with inferior disease.Modern pharmacology studies show that, the intestine in vitro of paeoniflorin to Cavia porcellus, rat and in stomach motion, and rat uterus smooth muscle all shows inhibition, and can the caused contraction of antagonism oxytocin; With acetic acid injection in mouse peritoneal, the index using writhing response as pain, paeoniflorin has significant analgesic effect; The caused convulsions of extractum energy antagonism strychnine of Radix Paeoniae; Radix Paeoniae Alba decoct has bacteriostasis to dysentery bacterium in vitro, and preserved material also has inhibitory action to some pathogenic fungus.Paeoniflorin has cooling effect to white mice normal body temperature, and the mice of artificial fever is also had to refrigeration function.Rat experiment metapedes sole of the foot edema is had to antiinflammatory action; Paeoniflorin has inhibitory action to the rat platelet aggregation of adenosine diphosphate (ADP) induction in vitro or when intravenous injection; Paeoniflorin has obvious inhibitory action to irritate the digestive tract in rats ulcer of bringing out due to anxiety.
Fructus Corni, has another name called Fructus Corni, medicine Fructus Jujubae, real Fructus Jujubae, Fructus Corni, meat Fructus Jujubae etc., is the conventional rare Chinese medicine of China, and applicating history is long.It is gentle with its benefit power, tonifying YANG and do not help fire, YIN nourishing and oiliness diaphragm, convergence and do not stay the evil special efficacy that waits by successive dynasties use that medical science is liked.Zhang Zhongjing has been formulated " JINGUI SHENQI WAN " taking Fructus Corni as monarch.According to chemical analysis, Fructus Corni contains the effective ingredient such as cornin, tartaric acid, gallic acid, malic acid, resin, tannin and the multivitamin that physiologically active is stronger, having the immunity, antiinflammatory of enhancing, the pharmacological action such as antibacterial, is Herba indigoferae Pseudotinctoriae conventional in tcm clinical practice.Compendium of Material Medica is carried: " Fructus Corni, cures mainly pathogen cold and heat under the heart, and warming middle-JIAO, by cold warm numbness, goes three worms, and clothes are made light of one's life by commiting suicide for a long time; The merit of have reinforcing YIN-essence benefit essence, settling five organs, logical nine orifices, stopping dribbling urination; Take for a long time improving eyesight, brute force all the year round ".Domestic Fructus Corni, Gu is had it by oneself.
Chinese medicine composition of the present invention with except long-pending numbness, kidney tonifying essence, tune immunity, fills blood as main standard on Chinese medicinal components is selected, and after Chinese medicine composition combination of the present invention, has significant antiinflammatory, immunomodulating effect.The present invention has carried out preferably the parts by weight of above-mentioned all taste Chinese medicine, and preferred condition is the enhancing of medicine to male infertility therapeutic effect after drug matching is used.As a preferred embodiment of the present invention, Chinese medicine composition of the present invention is made by the raw material of following weight portion: 30 parts of Fructus Arctiis, 15 parts of Cortex Cinnamomis, 15 parts of Radix Angelicae Sinensis, 10 parts of Rhizoma dioscoreaes, 8 parts of Fructus Schisandrae Chinensis, 10 parts, Poria, 10 parts of Radix Pseudostellariaes, 6 parts of Radix Ginsengs, 10 parts of Fructus Lyciis, 12 parts of the Radixs Astragali, 12 parts of Rhizoma Coptidis, 10 parts of Semen Cuscutae, 5.5 parts of Radix Ophiopogonis, 10 parts of the Radix Paeoniae Albas, 8 parts of Fructus Corni, 12 parts, Radix Glycyrrhizae.
Preferably, Chinese medicine composition of the present invention also further contains 7 parts of Caulis Spatholobis, 5 parts of the Rhizoma Anemarrhenaes, 9 parts of Radix Polygalaes.For the rattan of pulse family Climbing Plant spatholobus suberectus, Millettia dielsiana, evergreen mucuna etc.Someone thinks that this medicine comes from supplementary Amplifications of the Compendium of Materia Medica, but examines its plant description and accompanying drawing from different now.Its name that really name conforms to reality comes from the Wang Ang of Qing Dynasty essentials of Matea Medica, and other this agrostology is also loaded with the another name such as " Radix seu Caulis Verntilaginis Leiocarpae ", " Caulis seu Radix Schisandrae Henryi ".Property bitter but sweet flavor temperature, returns Liver Channel, has promoting the circulation of blood to enrich blood, regulating menstruation, the effects such as relaxing muscles and tendons and activating QI and blood in the collateral, can treat that the gynaecopathia such as menoxenia, blockage of menstruation, dysmenorrhea, blood deficiency amenorrhea and rheumatic arthralgia, numb hand and foot, limbs are weak and limp, blood deficiency dull yellowish colored skin etc., and controlling leukopenia also has certain curative effect.Rhizoma Anemarrhenae hardship, sweet, cold.Return lung, stomach, kidney channel.There is clearing away heat-fire, promote the production of body fluid and moisturize.Clearing away heat-fire, the effect of promoting the production of body fluid and moisturizing.Be mainly used in fever caused by exogenous pathogenic factors, high hot excessive thirst, lung-heat type cough, osteopyrexia and fever, interior-heat is quenched one's thirst, dryness of the intestine constipation.Radix Polygalae is conventional Chinese medicine, be recorded in the earliest Shennong's Herbal, classify as top grade, and be regarded as support life key medicine, warm in nature, bitter in the mouth, pungent, the function of there is the Fructus Alpiniae Oxyphyllae of calming the nerves, eliminate the phlegm, subsiding a swelling, the insomnia and dreamful sleep causing for disarmony between the heart and kidney, forgetful palpitation with fear, staring spells, expectoration is not well, sore swollen toxin, breast swell and pain.
In order to express better Chinese medicine composition of the present invention, Chinese medicine composition of the present invention can be prepared into conventional clinically dosage form.Such as, the preparations such as powderous preparations, powder, pill, sublimed preparation, unguentum, granule, oral liquid, syrup, tablet, capsule.Preferably, Chinese medicine composition of the present invention is prepared into powder, water preparation, tablet or capsule according to conventional preparation technology.
The present invention also provides a kind of preparation method of Chinese medicine composition described above, it mainly comprises following step: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, adding volumetric concentration according to 4～9 times of coarse powder gross weight is 40%～95% alcoholic solution, reflux, extract, three times, return time is 2～5h, filters, filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method, as tablet, capsule etc.
The present invention also asks to protect the purposes of above-mentioned Chinese medicine composition in preparation treatment male sterility disease drug.Pharmaceutical composition of the present invention, in the time for the treatment of male infertility, demonstrates significant antiinflammatory, immune tune machine and activating blood circulation to dissipate blood stasis activity.Drug effect embodiment 19 of the present invention shows, with model group comparison, the low middle Senior Three of a Chinese medicine composition of the present invention dosage group all can significantly reduce dimethylbenzene induced mice ear swelling value (
p< 0.01), show that Chinese medicine composition of the present invention has the effect of the mice ear of remarkable inhibition dimethylbenzene induction, and there is significant dose-effect relationship in its reduction effect to ear swelling.Under same experiment condition, positive control drug LIUWEI DIHUANG WAN group also significantly reduce ear swelling value (
p< 0.05), but its antiphlogistic effects is obviously not as good as Chinese medicine composition of the present invention.This motility of sperm that shows that pharmaceutical composition of the present invention is caused by prostatitis in treatment declines and has important treatment meaning.Drug effect embodiment 20 of the present invention shows, a) model group aspect testicular weight and epididymis weight with the blank group of decline by significance, modeling success.Compared with model group, after each treatment group administration, testicular weight and the epididymis weight of the each group of Six-element group and compositions all have significance or utmost point significant difference, wherein each group of compositions compared with Six-element group in the rising aspect testicular weight and epididymis weight with significance.Model group aspect sperm quantity, sperm motility, vigor score and straight line power with the blank group of decline by significance, modeling success.B) compared with model group, after each treatment group administration, all there are significance or utmost point significant difference in sperm quantity, sperm motility, vigor score and the straight line power aspect of the each group of Six-element group and compositions, wherein each group of compositions compared with Six-element group in the rising aspect sperm quantity, sperm motility, vigor score and straight line power with significance.
In a word, pharmaceutical composition of the present invention, aspect treatment male infertility, compared with prior art has following advantage:
1) compared with positive control drug LIUWEI DIHUANG WAN group, pharmaceutical composition Chinese medicine composition of the present invention is more remarkable aspect antiinflammatory, and aspect immunomodulating, being also significantly better than positive drug, this shows that the present composition has significant synergism in male infertility treatment.
2) compared with the chemotherapeutic agent of current treatment male infertility, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, significantly improve male infertility patient's compliance, and improved patient's quality of life.
3) in Chinese medicine composition of the present invention, contain multi-medicament component, action target spot is numerous, has effectively solved male infertility patient necrospermia or azoospermia, and its therapeutic effect to male infertility has played the effect for the treatment of both the principal and secondary aspects of a disease.
Detailed description of the invention
Further describe the present invention by specific embodiment below, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, change, combination or replacement that the present invention is carried out, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Part I Chinese medicinal composition preparation of the present invention, preparation and using method thereof
Embodiment 1-6 Chinese medicine composition composition powders
Table 1 Chinese medicine composition composition powders prescription of the present invention
Embodiment 1 preparation method: get each medical material in compositions, grind to form powdery according to common process, cross 100 mesh sieves, little fire drying is for subsequent use, obtains powder.When use, with directly taking after mixing it with water after water dissolution.Embodiment 2-6 preparation method is with embodiment 1.
Embodiment 7-12 Chinese medicine composition water preparation
Table 2 Chinese medicine composition water preparation prescription of the present invention
Embodiment 7 preparation methoies: get each medical material in prescription, according to conventional decocting for Chinese herbal medicine technological operation, filtering medicinal residues and get final product.When this water preparation (or claiming decoction) is treated for male infertility, take 2-3 every day.Embodiment 8-12 preparation method and using method are with embodiment 7.
Embodiment 13-18 Chinese medicine composition tablet/capsule of the present invention
Table 3 Chinese medicine composition tablet of the present invention/capsule prescription
Embodiment 13 preparation technologies: each traditional Chinese medicine powder of getting recipe quantity is broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 80% alcoholic solution, reflux, extract, three times, the each 3h of return time, filters filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete drying, pulverizing are made to dried cream powder, add conventional adjunct ingredient to utilize prior art to be prepared into tablet or capsule.
Embodiment 14-18 preparation technology is with embodiment 13.
Part II Chinese medicine composition pharmacodynamic study of the present invention
Embodiment 19 Chinese medicine composition xylol of the present invention causes the impact of mice ear
Get 72 of healthy ICR mices, ♀ ♂ half and half, divides 6 groups, and 12/group, i.e. model group, LIUWEI DIHUANG WAN group, Chinese medicine composition of the present invention (making by Chinese medicine composition prescription and preparation technology described in embodiment 1) low dose group, middle dosage group and high dose group.1 time/d of every ig administration; Administration 14 d, 60 min after last medicine, mouse right ear is evenly smeared dimethylbenzene 0.03 mL/ and is only caused swollenly, cuts ears and beat auricle and weigh after 2h, calculates ear swelling value (mg).Swelling value=auris dextra weight-left ear weight.
Result show, with model group comparison, the low middle Senior Three of a Chinese medicine composition of the present invention dosage group all can significantly reduce dimethylbenzene induced mice ear swelling value (
p< 0.01), show that Chinese medicine composition of the present invention has the effect of the mice ear of remarkable inhibition dimethylbenzene induction, and there is significant dose-effect relationship in its reduction effect to ear swelling.Under same experiment condition, positive control drug LIUWEI DIHUANG WAN group also significantly reduce ear swelling value (
p< 0.05), but its antiphlogistic effects is obviously not as good as Chinese medicine composition of the present invention.This motility of sperm that shows that pharmaceutical composition of the present invention is caused by prostatitis in treatment declines and has important treatment meaning.
The impact of table 4 Chinese medicine composition xylol of the present invention induced mice ear swelling (
)
Note: with model group comparison, *
p< 0.05, * *
p< 0.01
Embodiment 20 Chinese medicine composition of the present invention is observed the clinical treatment situation of mother and baby's ABO incompatibility
Testis is the place that generates sperm, and head of epididymis and body section are spermioteleosis parts, and rear is Sperm storage position.Sperm continues growth at epididymis and reaches the maturation period, and obtains motor capacity, set ovum zona pellucida ability and fertility.And experimental allergic orchitis Main Function is organized in Testes And Epididymides, germinal epithelium is peeled off and spermatid generation degeneration, cause convoluted seminiferous tubule atrophy and interstitial fibrosis, Testes And Epididymides weight is declined, affect the interior environment that spermatogenesis is grown, and then sperm quality is declined.
, experimental animal model make and grouping administration
Choose maturation, health, have fertility, 42 of body weight 300～330g (4 monthly age) male guinea pigs, 22～28 degrees Celsius of room temperatures, illumination 12 hours/day, animal freely drinks water and takes food.Weigh weekly 1 time, to regulate dosage.Get 6 of male guinea pigs, put to death, get testis and epididymis, shred, homogenate, is aided with freund adjuvant, divides 4 subcutaneous injections in spinal column both sides, starts experiment after 15 days.36 Cavia porcelluss of remainder are divided into 6 groups at random, 6 every group, wherein 5 groups of duplicating models, 1 group is blank group.Grouping situation is as follows:
Blank group: gavage is given and isopyknic normal saline.
Model group: gavage is given and isopyknic normal saline
Six-element group: gavage gives commercially available LIUWEI DIHUANG WAN suspension, perfusion dosage be 1.5g crude drug amount/pcs/day;
Low group of compositions: gavage gives Chinese medicine composition described in the embodiment of the present invention 1, perfusion dosage be 0.5g crude drug amount/pcs/day
Group in compositions: gavage gives Chinese medicine composition described in the embodiment of the present invention 1, perfusion dosage be 2.5g crude drug amount/pcs/day
Combination object height group: gavage gives Chinese medicine composition described in the embodiment of the present invention 1, perfusion dosage be 12.5g crude drug amount/pcs/day
Each administration group successive administration 50 days, administration every day 1 time.When experiment finishes, disconnected neck is put to death animal, weighs each treatment group testis and epididymis weight, dissects Cavia porcellus and gets cauda epididymis, is placed in 2ml Tyroid liquid and shreds, 37 DEG C of constant temperature 5 minutes.Get supernatant 0.02ml, add people 0.38ml spermatozoa diluent, send sperm analytical review.Measure sperm relevant parameter: sperm quantity, survival rate, energy and rectilinear motion.Each group laboratory animal body weight sustainable growth with the continuity for the treatment of time in experimentation, its empty group rate of rise is slightly fast, but blank group and modeling group are relatively without significant difference (P>0.05).Relatively there was no significant difference (P>005) of body weight difference in change before and after each group treatment.
2, experimental result
After each group treatment, testis, epididymis weight situation are in table 5.
The impact of table 5 Chinese medicine composition of the present invention on Cavia porcellus testis and epididymis weight
Compared with blank group, * * P < 0.01, compared with model group, $ P < 0.05, $ $ P < 0.01;
Compared with Six-element group, #P < 0.05, ##P < 0.01;
Can be found out by 5 tables, model group aspect testicular weight and epididymis weight with the blank group of decline by significance, modeling success.Compared with model group, after each treatment group administration, testicular weight and the epididymis weight of the each group of Six-element group and compositions all have significance or utmost point significant difference, wherein each group of compositions compared with Six-element group in the rising aspect testicular weight and epididymis weight with significance.
After each administration group treatment, quantity, survival rate, energy and the rectilinear motion situation of tail of epididymis sperm are in table 6.
The impact of table 6 Chinese medicine composition of the present invention on Cavia porcellus epididymal sperm quality
Compared with blank group, * * P < 0.01, compared with model group, $ P < 0.05, $ $ P < 0.01;
Compared with Six-element group, #P < 0.05, ##P < 0.01;
As can be seen from the above table, model group aspect sperm quantity, sperm motility, vigor score and straight line power with the blank group of decline by significance, modeling success.Compared with model group, after each treatment group administration, all there are significance or utmost point significant difference in sperm quantity, sperm motility, vigor score and the straight line power aspect of the each group of Six-element group and compositions, wherein each group of compositions compared with Six-element group in the rising aspect sperm quantity, sperm motility, vigor score and straight line power with significance.
Claims (4)
1. treat a Chinese medicine composition for male infertility, it is characterized in that being made by the raw material of following weight portion: 30 parts of Fructus Arctiis, 15 parts of Cortex Cinnamomis, 15 parts of Radix Angelicae Sinensis, 10 parts of Rhizoma dioscoreaes, 8 parts of Fructus Schisandrae Chinensis, 10 parts, Poria, 10 parts of Radix Pseudostellariaes, 6 parts of Radix Ginsengs, 10 parts of Fructus Lyciis, 12 parts of the Radixs Astragali, 12 parts of Rhizoma Coptidis, 10 parts of Semen Cuscutae, 5.5 parts of Radix Ophiopogonis, 10 parts of the Radix Paeoniae Albas, 8 parts of Fructus Corni, 12 parts, Radix Glycyrrhizae, 7 parts of Caulis Spatholobis, 5 parts of the Rhizoma Anemarrhenaes, 9 parts of Radix Polygalaes.
2. the Chinese medicine composition for the treatment of male infertility as claimed in claim 1, is characterized in that: described Chinese medicine composition is powder, water preparation, tablet or capsule.
3. prepare the method for the Chinese medicine composition for the treatment of male infertility as claimed in claim 1 for one kind, it is characterized in that comprising the following steps: get the above-mentioned Chinese crude drug of recipe quantity and be broken into coarse powder, adding volumetric concentration according to 4～9 times of coarse powder gross weight is 40%～95% alcoholic solution, reflux, extract, three times, return time is 2～5h, filters, filtrate recycling ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete.
4. the purposes of the Chinese medicine composition for the treatment of male infertility as claimed in claim 1 in preparation treatment male sterility disease drug.
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