CN1263490C - Yang reinforcing medicine and its preparation method - Google Patents
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Abstract
一种助阳药配方及制备方法，属于中成药技术领域。主要成份是淫羊藿、狗肾、羊肾(带鞭)、大青虾、韭籽、菟丝子等组方，经提取后做成胶囊。本助阳药未见有毒副作用，临床验证对肾阳虚命门火衰型疗效最佳。The invention discloses a formula and a preparation method of a yang-supporting medicine, which belong to the technical field of Chinese patent medicines. The main ingredients are epimedium, dog kidney, sheep kidney (with whip), large green shrimp, leek seeds, dodder and other ingredients, which are extracted and made into capsules. This yang-assisting medicine has no toxic and side effects, and it has the best curative effect on kidney-yang deficiency and Mingmen-fire decline type through clinical verification.
Description
(1) technical field
The present invention relates to a kind of Chinese patent medicine and preparation method thereof, be specifically related to a kind of Yang-strengthening drug and preparation method thereof.
(2) background technology
Since ancient times, the research of kidney invigorating and YANG supporting medicine is flourishing long time, and the flourish work of mulberry " the wonderful art of the long-lived odd-prescription of the kidney invigorating " (Heilungkiang science tech publishing house, 1993) records 361 sides, medicated wine 52 sides, dietetic therapy 70 sides.Two health product fascicles (People's Health Publisher, 1991) of cold Fang Nan chief editor " the basic Chinese patent medicine of China " record 38 doses of warming the kidney to invigorate YANGs, 12 doses of Yin-nourishing and Yang-supportings.Relevant tonifying YANG, supporing yang prescription are all on the books on many books.Commercially available " NANBAO " selected for use more than 30 kind of valuable ingredient of Chinese medicine to make with extra care according to folk secret and formed, have the strengthening yang and invigorating kidney effect.Be used for insufficiency of kidney-YANG, the sexual impotence lingering diarrhea, waist and leg ache, the scrotum is clammy, lethargy, diseases such as inappetence (establish its 30 example and be matched group, total effective rate is 46.7%)." prolonging Chang Chundan in age " is the medicine of Changchun Traditional Chinese Medical College's development treatment impotence, this medicine is made up of medicines such as Cornu Cervi Pantotrichum, Hippocampus, Gecko, Carapax et Plastrum Testudinis, Radix Ginseng, Penaeus seu panulirus, Herba Epimedii and Fructus Cnidiis, have kidney invigorating and YANG supporting, building body, the effect of the health care of prolonging life, through 165 routine clinical curative effect analysis, effective percentage reaches 88.5%, cure rate is 24.24% in the recent period, this medicine is better than traditional Chinese patent medicine Testudinis Ling Ji, Testudinis spirit collection effective percentage 67.5%, cure rate 15%." chin or cheek and spring " is the Chinese patent medicine new product that Changchun Traditional Chinese Medical College and Jilin Province prolong Aodong, limit pharmaceutical factory joint research and development, be used for the treatment of all diseases due to the insufficiency of kidney-YANG, through 6 unit clinical verification 431 examples such as Changchun Chinese medicine Affiliated Hospital, total effective rate is 96.2%, cure rate is 27.2 examples, but its treatment effective percentage statistics is not sole criterion with the sexual function.Present disclosed medea patent and patent application are maximum with medicinal liquor for strengthening yang, and other dosage forms are less, only 6 of yang-strengthening capsules.
(3) summary of the invention
The present invention is directed to the deficiencies in the prior art, a kind of Yang-strengthening drug and preparation method thereof is provided.
Yang-strengthening drug of the present invention comprises following component, is weight portion:
0～30 part of 0～30 part of Semen Cuscutae of 20～60 parts of Fructus Corni of Herba Epimedii
5～20 parts of Rhizoma Dioscoreae 0～20 part of Testis Caprae seu Ovis (band whip) 5～30 parts of Testis et Pentis Canis (doing)
20～60 parts of big 5～20 portions of Folium Allii tuberosi of Macrobrachium nipponensis(de Haan) (doing) seeds
Yang-strengthening drug of the present invention is preferably as follows component, is weight portion:
15 parts of 20 parts of Testis et Pentis Canis of 50 parts of Testis Caprae seu Ovis of Herba Epimedii (band whip)
50 parts of big 15 portions of Folium Allii tuberosi of Macrobrachium nipponensis(de Haan) seeds
Yang-strengthening drug of the present invention is preferably as follows component, is weight portion:
25 parts of 25 parts of Semen Cuscutae of 50 parts of Fructus Corni of Herba Epimedii
15 parts of Rhizoma Dioscoreae 15 parts of Testis Caprae seu Ovis (band whip) 20 parts of Testis et Pentis Canis (doing)
50 parts of big 15 portions of Folium Allii tuberosi of Macrobrachium nipponensis(de Haan) (doing) seeds
Herba Epimedii: the stem and leaf of (Epimedium Grandiflorum Norr)
Folium Allii tuberosi seed: the seed of (Allium fuberosum Rottler)
Testis Caprae seu Ovis: the external genitalia of billy (Capra hircuo L.) or sheep (Ovis aries L.)
The external genitalia and the testis of Testis et Pentis Canis male dog (Chnis familiaris L.)
Macrobrachium nipponensis(de Haan): (Macrobrachium nipponense C.de Hoan's) is all
Semen Cuscutae: the mature seed of (Cuscuta chinensis Lam)
Fructus Corni: (Cornus officinalis S et.z.) removes the removal core pulp
Rhizoma Dioscoreae: the tuber of (Dioscorea opposita Thunb.)
Folium Allii tuberosi seed acrid in the mouth, sweet, warm, return the Liver and kidney warp.It has the effect of invigorating the liver and kidney, warm waist knee joint, tonifying YANG, controlling nocturnal emission with astringent drugs, controls all kidney yang deficiency, the sexual impotence that deficiency of the liver and kindey causes, and the soreness of the waist and knees cold type of pain, Testis et Pentis Canis, Testis Caprae seu Ovis is returned kidney channel, is the in love product of flesh and blood, and with the Folium Allii tuberosi seed, big Macrobrachium nipponensis(de Haan) is we's monarch drug altogether.Semen Cuscutae acrid in the mouth, sweet flat returns liver, kidney channel to have the YANG invigorating tonifying YIN, controls man woman cold caused by deficiency, sperm adding and marrow healthing.The Fructus Corni sour in the mouth, tepor is returned liver, kidney channel, and sun that can invigorating the liver and kidney again can warming and recuperating the kidney-YANG, and promptly Jing-Yue Complete Works is said: " kind YANG invigorating person must treating YANG within YIN, then positive cloudy helping and biochemical infinite justice ".Be ministerial drug altogether.The Rhizoma Dioscoreae sweet in the mouth is flat, returns the spleen lung, kidney channel.Tonifying the spleen and stomach is arranged, and the effect of lung benefiting kidney is an adjuvant drug, and full side is sweet temperature vital energy benefiting and the kidney invigorating tonifying YANG, beneficial marrow, building body, the health care of prolonging life.
The preparation method of Yang-strengthening drug of the present invention is as follows:
A. Herba Epimedii water extract-alcohol precipitation, B. Testis Et penis Caprae seu Ovis and testis, Testis et Pentis Canis, big Macrobrachium nipponensis(de Haan) alcohol extraction, the alcohol extraction of C. fragrant-flowered garlic seed, each alcohol extract after reclaiming ethanol each extractum; D. Semen Cuscutae, Fructus Corni and Rhizoma Dioscoreae decocting, concentrate extractum; Three kinds of extractum merging of A, B and C or A, B, C and four kinds of extractum of D merge the increasing Macrobrachium nipponensis(de Haan) powder granulates, and makes capsule.
Concrete technology is as follows:
(1) extraction of Herba Epimedii: the weight portion by component is got Herba Epimedii, and decocting three times merges the water extract, concentrate concentrated solution, carry out ethanol precipitation, placed 48 hours, inclining supernatant, reclaims ethanol, water-bath volatilizes residual alcohol, must extractum.Concentration of alcohol 95 ~ 98%
(2) extraction of Testis Et penis Caprae seu Ovis and testis, Testis et Pentis Canis and big Macrobrachium nipponensis(de Haan), solvent is the ethanol of difference 93～96%, 70～78%, 50～60%:
The aquatic foods product are dried in 70～75 ℃ of drying rooms, pulverized and be coarse granule.Get the coarse granule sample by the weight portion of component, add solvent, warm macerating in pod layer pot, emit filtrate after, add solvent again, extract altogether 2～5 times with method, merge extractive liquid, reclaims solvent, gets yellow runny plaste, thin up carries out defat, and the fat that will float is removed, concentrate extractum.
(3) Folium Allii tuberosi seed: it is the coarse grain shape that the Folium Allii tuberosi seed is pulverized after 70 ℃ of oven dry, takes by weighing 50kg, adds solvent refluxing and extract in the pod layer refluxes pot, emits extracting solution, extract 2～5 times with method, merge extractive liquid, reclaims solvent, gets concentrated solution, thin up carries out defat, removes oil reservoir, concentrate extractum.Solvent is 55～65% concentration ethanol.
Semen Cuscutae, Fructus Corni and Rhizoma Dioscoreae: wash through clear water, decoct with water at last 3 times, amount of water is respectively 10,8,5 times of raw material, and decocting time is 2h, 1h, 1h, three decocting liquids is filtered merge, concentrate herbal decoction (density is 1.22～1.25).
(4) granulation and dress capsule:
Extraction extractum heating in water bath in above each step is made its dissolving, and fully stirring and evenly mixing adds the shrimp meal that extracts back 40 mesh sieves, mixes thoroughly, and 70 ℃ of oven dry in big porcelain dish are pulverized, and cross 20 mesh sieves, make granule, are sub-packed in then in the capsule of 0.2g, and press seal promptly.
By the capsule of this prepared, the average content that thin layer chromatography scanning records icariine is 6.09%, and the coefficient of variation is 1.63%, and average recovery is 99.5%.This medicine contains 22 seed amino acids and 12 kinds of trace element.The content of total amino acids is 51.45%.Comprise the necessary aminoacid of abundant human body, content has 6 kinds to be high especially with the arginine at the aminoacid more than 3.0%.K, Na, Ca, Mg, Fe and more Zn, Cu, Mn etc. that magnanimity is arranged in the trace element.Capsule disintegrate average time 5 ' 37 " (5 ' 30 "～6 ' 20 ").To storing 0,3,6,12,18 months sample carries out tlc analysis and icariine assay, the main colour developing point basically identical of each sample as a result, the content of icariine was not seen notable difference (0～18 month, the icariine content of five samples is respectively 5.76%, 5.92%, 5.79%, 5.79% and 5.78%), show that it is stable depositing under this medicine room temperature.
The function of this Yang-strengthening drug cures mainly: kidney invigorating and YANG supporting, smart marrow, vital base and primordial QI consolidating, the functions such as nourishing and fit keeping function of giving birth to of benefit.Cure mainly male's such as kidney yang deficiency syndrome sexual hypofunction and sexual impotence dysfunction disease.
Sexual impotence is controlled by the differential diagnosis in tcm opinion can be divided into the decline of the fire from the gate of life type, liver qi stagnation type, liver gallbladder damp-heat type, the terrified type of big soldier etc., this Yang-strengthening drug system is by the in love product of flesh and blood such as Testis Caprae seu Ovis, Penis et testis canitis, add tonifying YANG, nourishing the liver and kidney medicines such as Herba Epimedii, Folium Allii tuberosi seed, play kidney invigorating and YANG supporting, the smart merit of giving birth to marrow of benefit altogether, insufficiency of kidney-YANG decline of the fire from the gate of life type curative effect the best.Dysaphrodisia total effective rate to male sexual disorder is 90.9%, and the erection problem total effective rate is 83.8%, and its recent cure rate is 41.3%.With compared in the past, this Yang-strengthening drug prescription and preparation technology are different with it.
Pharmacodynamic study:
Prostate and seminal vesicle are gonophores, and its growth promoter is subjected to the adjusting of androgen.Rat goes to lose the androgen support behind the testis, the atrophy of gonophore trend, and can this medicine improve seminal vesicle and the prostate function is to judge the important evidence of its kidney invigorating and YANG supporting effect.
Go the administration after three days of testis SD rat feeding, the administration group (2ml/ day/only, suitable capsule 's content 0.043g) and raise after 30 days for commensurability distilled water matched group, take out seminal vesicle and prostate, the heavy index of the seminal vesicle of administration group as a result is than matched group big by 36% (P＜0.05), the average seminal vesicle dry weight index of administration group and matched group is respectively 0.081 and 0.049 (P＜0.01), shows that the seminal vesicle weightening finish is not that water content increases.The administration group shows that than matched group histone volume index (mg/g tissue/g body weight) big by 70% (P＜0.01) main cause of administration group prostate weightening finish is that protein increases.And administration group prostate weight in wet base, though dry weight and histone volume index, do not have statistics second justice (P＞0.05) than matched group height.Male SD rat administration group and matched group are handled with above-mentioned and are gone testis SD rat, and hungry 12h gets blood and testis after 30 days, find that the heavy index of administration group testis shows than matched group high by 17% (P＜0.05) that this medicine has animal testis and promotes the effect of growing and supporting.Administration group spermatogonium average is Duoed 27.1% (P＜0.05) than matched group, shows that this medicine can make testicular spermatogenic function be in vigorous state, and the matched group trend is old and feeble.Administration group testis LDHX (the distinctive isozyme of testis) specific activity matched group high by 33.3% (P＜0.05) shows that administration group rat spermatogenesis ability is higher than matched group.Administration group serum FSH is than matched group high by 15.4% (P＜0.05), and administration group level of serum testosterone is than matched group high by 22.6% (P＞0.05).
Pharmacodynamic experiment shows that this medicine can promote or keep the testicular function activity of male rat, and this effectiveness may be that medicine directly acts on the sexual organ or acts on a certain link of hypothalamus-hypophysis-testis axle.
The effect of this medicine defying age and enhance immunity:
Experiment and the same pharmacodynamic experiment of dosage, administration group and matched group are put to death, get full brain, (referring to Yu Jiali etc., Chinese journal of medical examination 1987 (10): 24) measure the growing amount (representing the amount of lipid peroxide) that every Borneo camphor is organized malonaldehyde, the growing amount of matched group cerebral tissue malonaldehyde is than administration group high by 68% (P＜0.05) as a result by the TBA method.The formation of lipid peroxide is a kind of biochemical indicator of animal aging, shows that this medical instrument has anti-aging effects.Macrophage phagocytic chicken red blood cell hematocrit experimental results show that, administration group and matched group macrophage phagocytic percent (engulfing the macrophage number of chicken red blood cell in 100 macrophages) and phagocytic index (several 100 macrophages, the number of average each macrophage phagocytic chicken red blood cell) notable difference (P＜0.01, P＜0.05) is all arranged.Show that this medicine has facilitation to immune status.
Treatment male's dysfunction 103 routine clinical efficacies
Case is selected:
Selected patient is the erection problem patient and the part dysaphrodisia patient of married outpatient service prescription on individual diagnosis.22～29 years old 36 age example, 30～39 years old 26 example, 40～49 years old 23 example, 50～59 years old 12 example, 60～70 years old 6 example.Patient accounts for 80% below 40 years old.Differential diagnosis in tcm belongs to insufficiency of kidney-YANG decline of the fire from the gate of life type more, and a few patients is a liver qi stagnation type, and part patient does not have card and can debate, and ascites of liver meridian damp-heat type is chosen.
Method of administration:
This medicine is a capsule preparations, every day 3 times, each 3～4 (36/box), serveing on 1 month is a course of treatment.
Diagnostic criteria
One, dysaphrodisia diagnostic criteria
(1) libido lacks fully or dislikes: refer to not have the sexual life requirement or detest sexual life.
(2) libido is very poor: the libido with the age requires to lower over half.
(3) libido is poor slightly: refer to low slightly with the libido requirement at age.
(4) libido is normal: reach the normal sexual desire requirement with the age.
Two, erection problem diagnostic criteria:
(1) start-up time: begin erection to the time (normal adult only needs 1-2 minute) of finishing the action of erecing from penis.
(2) erect the persistent period: refer to from erecing the time of back to the normal state deliquescing.
(3) erection hardness: the erection hardness of penis specifically can divide does not have erection, it is not hard to erect, it is still hard to erect, it is hard to erect.
Criterion of therapeutical effect:
One, dysaphrodisia criterion of therapeutical effect
(1) libido obviously strengthens
Meaning and taking medicine that to transfer libido to by no libido poor slightly in the back, or libido is very poor, and to transfer libido to normal.
(2) libido slightly strengthens
Meaning and taking medicine that to transfer libido to by no libido very poor in the back, or libido is very poor, and to transfer libido to poor slightly, or libido is poor slightly transfers to normally.
(3) libido does not have change: libido does not have significant change before and after referring to take medicine.
Two, erection problem criterion of therapeutical effect (with reference to " practical Chinese Internal Medicine " Science and Technology of Shanghai publishing house version in 1986, sexual impotence criterion of therapeutical effect).
(1) produce effects (treatment in the recent period): erection is hard and strong, can success during the same branch of a family.
(2) effective: hard and strong during erection, but bad during fashion, the success reluctantly or unsuccessful of having sexual intercourse.
(3) invalid: though erection makes progress, it is unsuccessful to have sexual intercourse, or the treatment no significant change in back.
It is normal but erection problem person's 19 examples are arranged to remove libido among the 103 routine patients, not keeper's 7 examples disregard count in, actual dysaphrodisia case is 77 people, wherein 70 examples effectively, 7 examples are invalid, total effective rate is 90.9%.Treatment male erectile disorder total effective rate is 83.8% among the 103 routine patients, and its, cure rate was 41.3% near-mid term, and inefficiency is 16.2%.Quickening and time lengthening and hardness enhancer more to be seen the situation of treatment male erectile disorder doing well,improving to start, and accounts for 65.04%.It is 46.7% that this medicine is done contrast (clinical verification NANBAO 30 examples) " NANBAO " treatment male erectile disorder effective percentage with commercially available " NANBAO ", is low (P＜0.01) than this medicine total effective rate 83.8%, and treatment obviously is better than " NANBAO ".This medicine has certain effect to the treatment of male sterility, takes medicine back seminal fluid chemical examination contrast as can be known according to 24 routine patients, and sperm concentration, sperm survival rate, motility of sperm all have clear improvement, and its effective percentage is about 60%.103 routine patients do not find any untoward reaction after taking this medicine, check that liver, renal function all belong to normally.
Toxicity test:
Stomaches were irritated in the anxious poison experiment of 40 of mices in continuous 7 days, 0.5ml every day (suitable capsule 's content 1.243g is equivalent to 100 times of people's dose), and none only shows unusual or dead.Show no acute toxicity.SD rat administration group and matched group dosage and handle in the sub-acute toxicity test with above-mentioned pharmacodynamic experiment, administration group as a result and matched group hemogram (Hb, RBC, WBC) routine examination no significant difference, serum GPT activity is starkly lower than matched group (P＜0.05).
Clinical and zoopery proves that all this medicine is safe and effective.
(4) specific embodiment
Embodiment 1: the Yang-strengthening drug component is as follows, is weight portion:
15 parts of 20 parts of Testis et Pentis Canis of 50 parts of Testis Caprae seu Ovis of Herba Epimedii (band whip)
50 parts of big 15 portions of Folium Allii tuberosi of Macrobrachium nipponensis(de Haan) seeds
Preparation method is as follows:
1, the extraction of Herba Epimedii: the Herba Epimedii remove impurity, get 50kg, soak and fry in shallow oil three times, each 2h; Amount of water is respectively 10,8,5 times of spice.Filter, merge three times the water extract, being concentrated into relative density is 1.09～1.14 (50 ℃).1ml is equivalent to the 1g crude drug, fully stirs slowly to add 1.5 times of amount 95% ethanol down, and 0～4 ℃ of Cryoprecipitation 48h filters, filtrate recycling ethanol, and being concentrated into relative density is 1.25～1.35, is standby extractum.
2, the extraction of Testis Et penis Caprae seu Ovis and testis, Testis et Pentis Canis and big Macrobrachium nipponensis(de Haan):
Bright sample is dried in 70～75 ℃ of drying rooms, pulverized is coarse granule, get Testis Et penis Caprae seu Ovis and testis granule 20kg, Testis et Pentis Canis and big each 15kg of Macrobrachium nipponensis(de Haan) granule, (big Macrobrachium nipponensis(de Haan) granule go into yarn bag bag), go into interlayer reflux pot, successively add grain wine 95%, 75%, 55% concentration, each concentration warm macerating 3 times, each 1h (temperature is 45～50 ℃) dosage was advisable just to flood spice, merge extractive liquid,, recovered alcohol get yellow extractum.The raw material slag adds water temperature again and soaks once, 1h, and filtrate and extractum merge, and carry out defat, remove come-up fat, concentrate to such an extent that extractum, density are 1.31～1.35 (50 ℃).
3, Folium Allii tuberosi seed: the Folium Allii tuberosi seed pulverized after 70 ℃ of oven dry to the coarse grain shape claim 50kg, in refluxing pot, interlayer adds 60% concentration ethanol reflux, extract,, emit extracting solution, so extract 3 times, each 1.5h, contain and extracting solution, reclaim ethanol, get concentrated solution, thin up, remove come-up fat, concentrate extractum (density is 1.32～1.35).
4, above three kinds of extractum heating in water bath are made its dissolving, merge, stir.Add the extraction back and cross 40 purpose shrimp meals, mix thoroughly, 70 ℃ of oven dry in big porcelain dish are pulverized, and cross 20 mesh sieves, make granule, are sub-packed in then in the capsule of 0.2g, and press seal promptly.
Embodiment 2: the Yang-strengthening drug component is as follows, is weight portion:
25 parts of 25 parts of Semen Cuscutae of 50 parts of Fructus Corni of Herba Epimedii
15 parts of Rhizoma Dioscoreae 15 parts of Testis Caprae seu Ovis (band whip) 20 parts of Testis et Pentis Canis (doing)
50 parts of big 15 portions of Folium Allii tuberosi of Macrobrachium nipponensis(de Haan) (doing) seeds
Take by weighing Semen Cuscutae, Fructus Corni and Rhizoma Dioscoreae by prescription, wash through clear water, decoct with water at last 3 times, amount of water is respectively 10,8,5 times of raw material, and decocting time is 2h, 1h, 1h, three decocting liquids is filtered merge, concentrate herbal decoction (density is 1.22～1.25).
Other component batching processing and preparation technology are with embodiment 1.
Claims (9)
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| CNB2004100237282A CN1263490C (en) | 2004-03-10 | 2004-03-10 | Yang reinforcing medicine and its preparation method |
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| CN107897926A (en) * | 2017-12-05 | 2018-04-13 | 神农架林区中医医院 | Carnis Bovis seu Bubali Herba Epimedii herbal cuisine with kidney tonifying functions and preparation method thereof |
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